adult low back pain 8

Health Care Guideline:

Adult Low Back Pain

Fourteenth Edition November 2010

I ICSI NSTITUTE FOR C LINICAL S YSTEMS I MPROVEMENT

The information contained in this ICSI Health Care Guideline is intended primarily for health profes-sionals and the following expert audiences:

• physicians, nurses, and other health care professional and provider organizations;

• health plans, health systems, health care organizations, hospitals and integrated health care delivery systems;

• health care teaching institutions;

• health care information technology departments;

• medical specialty and professional societies;

• researchers;

• federal, state and local government health care policy makers and specialists; and

• employee benefit managers.

This ICSI Health Care Guideline should not be construed as medical advice or medical opinion related to any specific facts or circumstances. If you are not one of the expert audiences listed above you are urged to consult a health care professional regarding your own situation and any specific medical questions you may have. In addition, you should seek assistance from a health care professional in interpreting this ICSI Health Care Guideline and applying it in your individual case.

This ICSI Health Care Guideline is designed to assist clinicians by providing an analytical framework for the evaluation and treatment of patients, and is not intended either to replace a clinician's judgment or to establish a protocol for all patients with a particular condition. An ICSI Health Care Guideline rarely will establish the only approach to a problem.

Copies of this ICSI Health Care Guideline may be distributed by any organization to the organization's employees but, except as provided below, may not be distributed outside of the organization without the prior written consent of the Institute for Clinical Systems Improvement, Inc. If the organization is a legally constituted medical group, the ICSI Health Care Guideline may be used by the medical group in any of the following ways:

• copies may be provided to anyone involved in the medical group's process for developing and implementing clinical guidelines;

• the ICSI Health Care Guideline may be adopted or adapted for use within the medical group only, provided that ICSI receives appropriate attribution on all written or electronic documents; and

• copies may be provided to patients and the clinicians who manage their care, if the ICSI Health Care Guideline is incorporated into the medical group's clinical guideline program.

All other copyright rights in this ICSI Health Care Guideline are reserved by the Institute for Clinical Systems Improvement. The Institute for Clinical Systems Improvement assumes no liability for any adaptations or revisions or modifications made to this ICSI Health Care Guideline.

Health Care Guideline:

Adult Low Back Pain

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I ICSI NSTITUTE FOR C LINICAL S YSTEMS I MPROVEMENT 1b

Patient education regarding primary prevention, including healthy lifestyle and general aerobic fitness.Emphasis on:• Patient responsibility for good back care• Workplace ergonomics• Home self-care treatment

A = Annotation

1aFor workers' compensation patients, see the Workers' Compensation treatment parameters at: http://www.workerscompensation.com/workers_comp_by_state.php

14aAcute Low Back PainLBP that does NOT radiate past the knee for < six weeksAcute RadiculopathyLBP with radiation past the knee for < six weeksChronic RadiculopathyAbove symptoms for > six weeks

Fourteenth EditionNovember 2010

Copyright © 2010 by Institute for Clinical Systems Improvement 1

Patient calls/presents with LBP or

sciatica/radiculopathy

1

A

Emergent or urgent?

2

Evaluation indicated?

3

A A

noHome self-care treatment program

5

A

no

Initial primary care evaluation

4

A

yes

Improving? no

Is a serious underlying condition

revealed?

8

A

Consult or refer

9

A

yes

Has the patientfailed home self-care?

10

A

no

no

6

Improving?

11

Continue self-care program

7

yes

yes

Reevaluate and consider redirection

12

A

A

Improving?

13

Is pain chronic(greater than 6

weeks)?

14

A

no

Chronic low back pain• Comprehensive physical and psychosocial reevaluation• Lumbar spine x-rays if indicated

15

A

Radiculopathy• Comprehensive physical and psychosocial reevaluation• MRI or CT lumbar imaging indications when patient is potential surgical or therapeutic injection candidate

18

A

yes

Active rehabilitation

16

A

Improving?

17

yes

Discuss options and consider possible surgical

or non-surgical spine specialist (see also ICSI

Chronic Pain guideline)

22

A

no

MRI/CT correlate with symptoms?

19

no

Consider epidural steroid injection prior to surgical

intervention

20

Improving?

21

no

yes

yes

A

yes/unsure

no

yes

yes

no

Institute for Clinical Systems Improvement

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Table of Contents

Adult Low Back PainFourteenth Edition/November 2010

Work Group LeaderDavid C. Thorson, MD Sports Medicine, Family HealthServices Minnesota

Work Group MembersChiropractic MedicineJeff Bonsell, DCHealthPartners Medical GroupFamily MedicineBrian Bonte, DOHutchinson Medical CenterTom Heinitz, MDSuperior Health CenterBecky Mueller, DOCentraCareNeurologyBret Haake, MDHealthPartners Medical GroupOccupational MedicineRobb Campbell, MD, MPH 3MMichael Goertz, MD, MPHHealthPartners Medical GroupOla Kuku, MD, MPH Allina Medical ClinicOrthopedic SurgeryGlenn Buttermann, MDMidwest Spine InstitutePaul Huddleston, MDMayo ClinicPhysical Medicine and RehabilitationAdam Locketz, MDMidwest Spine InstituteRichard Timming, MD HealthPartners Medical GroupAndrew Vo, MDMarshfield ClinicPhysical TherapyChris Kramer, PTPark Nicollet Health ServicesDenis McCarren, PTHealthPartners Medical GroupSteve Peterson, PTOrthopaedic Sports, Inc.RadiologyThomas Gilbert, MDCenter for Diagnostic ImagingSports MedicineSuzanne Hecht, MDUniversity of Minnesota PhysiciansFacilitatorsMelissa Cella, MHA, MPAICSIKari Retzer, RNICSI

Algorithms and Annotations ....................................................................................... 1-24Algorithm ........................................................................................................................... 1Disclosure of Potential Conflict of Interest ........................................................................ 3Description of Evidence Grading ....................................................................................... 4Foreword

Introduction ................................................................................................................... 5Scope and Target Population ...................................................................................... 5-6Aims .............................................................................................................................. 6Clinical Highlights ........................................................................................................ 6Related ICSI Scientific Documents .............................................................................. 6

Annotations ................................................................................................................... 7-24Quality Improvement Support ................................................................................. 25-37

Aims and Measures ..................................................................................................... 26-27Measurement Specifications .................................................................................. 28-35

Resources .......................................................................................................................... 36Resources Table ................................................................................................................ 37

Supporting Evidence.................................................................................................... 38-71Conclusion Grading Worksheet Summary ....................................................................... 39

Conclusion Grading Worksheet A – Annotation #10 (Home Self-Care) .............................................................................................. 40-47Conclusion Grading Worksheet B – Annotation #16 (Active Rehabilitation)...................................................................................... 48-54

References ................................................................................................................... 55-61Appendices .................................................................................................................. 62-71

Appendix A – Roland-Morris Disability Questionnaire ..............................................62Appendix B – Physical Functional Ability Questionnaire (FAQ5) .............................63Appendix C – Psychosocial Screening and Assessment Tools .............................. 64-67Appendix D – Upright and Positional Imaging ..................................................... 68-69Appendix E – General Guidelines for CT and MRI Order Sets for Adult Low Back Pain ........................................................................................ 70-71

Document History, Development and Acknowledgements .............................. 72-74Document History ............................................................................................................ 72ICSI Document Development and Revision Process ....................................................... 73Acknowledgements .......................................................................................................... 74


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Disclosure of Potential Conflict of InterestIn the interest of full disclosure, ICSI has adopted a policy of revealing relationships work group members have with companies that sell products or services that are relevant to this guideline topic. It is not assumed that these financial interests will have an adverse impact on content. They are simply noted here to fully inform users of the guideline.

Jeffrey Bonsell, DC is a consultant for Midwest Healthcare Consultants, EvaluMed and National Chiropractic Mutual Insurance Corporation.

Thomas Gilbert, MD has stock in Steady State Imaging and serves as a board member.

Robb Campbell, MD has stock in Medtronic and Glaxo Smith Kline.

Chris Kramer, PT received honoraria from the University of Minnesota Physical Therapy Program and St. Catherine University.

Paul Huddleston, MD is a consultant for Synthes and is a board member for Minnesota Medical Association.

Michael Goertz, MD is on the advisory council for American College of Occupational and Environmental Medicine.

Andrew Vo, MD is a consultant for North American Spine Society.

Suzanne Hecht, MD receives grant support from NFL Charities and is a board member for American Medical Society for Sports Medicine.

David Thorson, MD is a consultant for Minnesota Medical Association and MMC. He received honoraria from American Academy of Family Physicians.

Glen Buttermann, MD is a consultant for Zyga.

No other work group members have potential conflicts of interest to disclose.


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Evidence Grading A consistent and defined process is used for literature search and review for the development and revision of ICSI guidelines. Literature search terms for the current revision of this document include epidural steroid injections; modified Oswestry scale; acute low sacral dysfunction; PHQ2; conservative case for cauda equina; conservative treatment for low back pain; diagnostic imaging and low back pain; active rehabilita-tion; diagnostic imaging and radiculopathy; and surgical treatment from January 2008 through April 2010.

Individual research reports are assigned a letter indicating the class of report based on design type: A, B, C, D, M, R, X.

Evidence citations are listed in the document utilizing this format: (Author, YYYY [report class]; Author, YYYY [report class] – in chronological order, most recent date first). A full explanation of ICSI's Evidence Grading System can be found on the ICSI Web site at http://www.icsi.org.

Class Description

Primary Reports of New Data Collections

A Randomized, controlled trial

B Cohort-study

C Non-randomized trial with concurrent or historical controls

Case-control study

Study of sensitivity and specificity of a diagnostic test

Population-based descriptive study

D Cross-sectional study

Case series

Case report

Reports that Synthesize or Reflect upon Collections of Primary Reports

M Meta-analysis

Sytematic review

Decision analysis

Cost-effectiveness analysis

R Consensus statement

Consensus report

Narrative review

X Medical opinion



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ForewordIntroduction

Pain in the lower back is the fifth most common reason for all physician visits in the United States (Chou, 2007 [M]). It can be related to certain activities, poor posture, physical stress or psychological stress. Other etiologies include pregnancy; labor; menstrual period; urinary tract problems; stomach upset with nausea, vomiting and diarrhea.

Ninety percent of back pain patients improve within four to six weeks. Approximately two-thirds of the people who recover from a first episode of acute low back symptoms will have another episode within 12 months, and one out of five report substantial limitations in activity. Unless the back symptoms are very different from the first episode or the patient has a new medical condition, improvement can be expected to be similar for each episode (Chou, 2007 [M]; Hestbaek, 2003 [M]; Pengel, 2003 [M]).

When pain or weakness lasts longer than six weeks or causes significant disability that interferes with activities of daily living, more specialized treatment(s) may be needed. For this reason it is important for the patient to keep the doctor informed of his or her progress.

Treatment for low back pain has very large direct health care costs. In 1998, the costs of care in the United States were estimated at $26.3 billion. There are also substantial indirect costs related to days lost from work. Approximately two percent of the working population is compensated for back injuries each year (Chou, 2007 [M]).

Scope and Target PopulationAdult patients age 18 and over in primary care who have symptoms of low back pain or radiculopathy. The focus is on acute and chronic management, including indications for medical, non-surgical or surgical referral. For workers' compensation patients, check with state guidelines where the patient resides and where the injury took place: http://www.workerscompensation.com/workers_comp_by_state.php.

The pregnant population is excluded from this guideline; however, the following considerations are noted.

Low back pain (LBP), alone or in combination with pelvic pain, is a common problem suffered by women during pregnancy. Studies estimate 50%-80% of women will suffer from LBP during pregnancy (Sabino, 2008 [R]; Pennick, 2007 [M]), and one study found that approximately 62% of women rated the pain as moderately severe (Stapleton, 2002 [D]). Despite the significance of this problem, only one third of pregnant women reported LBP to their prenatal care providers (Pennick, 2007 [M]).

The typical course of LBP during pregnancy is that it generally begins in the mid-late 2nd trimester and resolves during the post-partum course and, unfortunately, is likely to return in subsequent pregnan-cies (Sabino, 2008 [R]). As mentioned most cases resolve in the post-partum period, although Norén reported that 20% of women with LBP during pregnancy were found to have LBP three years following delivery (Norén, 2002 [B]).

The clinical history and physical examination should include elements that focus on the mother and the fetus, and the medical care provider should consider a broad differential. The physical examination is similar to non-pregnant patients with LBP, although lumbar flexion will be limited as the pregnancy progresses and the gravid abdominal examination can be challenging (Sabino, 2008 [R]).

Lumbar radiographs are routinely avoided during pregnancy due to concern for fetal health. Magnetic resonance imaging is the test of choice for severe pregnancy-related LBP (Sabino, 2008 [R]).



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According to a Cochrane review, effective treatment of pregnancy-related LBP, as measured by pain reduction and back-pain-related sick leave, included strengthening exercises, sitting pelvic tilt exercises and water gymnastics (Pennick, 2007 [M]).

Aims 1. Improve the assessment and reassessment of patients age 18 and older with low back pain diagnosis.

(Annotations #1, 4, 15, 18)

2. Reduce unnecessary imaging for low back pain patients age 18 and older in the absence of "red flag" indicators or progressive symptoms. (Annotations #4, 18)

3. Increase the use of recommended conservative approach as first-line treatment, such as activity, self-care and analgesics for patients age 18 and older with low back pain diagnosis. (Annotation #5)

Clinical Highlights• Back pain assessment should include a subjective pain rating, functional status, patient history including

notation of presence or absence of "red flags" (Cauda Equina Syndrome or other conditions noted in Annotation #1) and psychosocial indicators, assessment of prior treatment and response, employment status, and clinician's objective assessment. (Annotations #1, 4, 15, 18; Aim #1)

• Reduce unnecessary imaging unless "red flag" indicators exist. (Annotations #4, 18; Aim #2)

• A conservative approach should be first-line treatment. Emphasize patient education and conservative home self-care, which includes early ambulation, postural advice, resumption of activities, use of ice and heat, anti-inflammatory and analgesic over-the-counter medications, and early return to work or activities. (Annotation #5; Aim #3)

• Patients with acute low back pain should be advised to stay active and continue ordinary daily activity. For chronic back pain, there is evidence that exercise therapy is effective. (Annotations #10, 16; Aim #3)

• Consult or refer to spine specialist if conservative treatment fails. (Annotation #9)

Related ICSI Scientific DocumentsGuidelines

• Major Depression in Adults in Primary Care

• Assessment and Management of Chronic Pain

Adult Low Back Pain Foreword Fourteenth Edition/November 2010


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Algorithm Annotations

1. Patient Calls/Presents with Low Back Pain or Sciatica/RadiculopathyKey Points:

• Perform medical screening for low back pain via triage evaluation.

• If low back pain is possibly a work-related injury or workers' compensation claim, it is important to follow the Workers' Compensation Treatment Guidelines.

• Educate patient on preventive care.Perform a medical screening via triage evaluation for phone contact and via provider examination for walk-ins. Each medical group may modify this proposed movement as needed.

The triage evaluation should first rule out emergent conditions such as Cauda Equina Syndrome.

Screening for low back pain:

• Recent back procedure or epidural anesthesia

• Location of pain:

- Low back pain (does not radiate past the knee)

- Radiculopathy (LBP with radiation past the knee)

• Duration of symptoms, including date of injury or onset of symptoms:

- Six weeks or less is acute

- More than six weeks is chronic

• If injury: How did injury occur?

• Severity of pain and degree of disability

• Other medical conditions

• History of previous back pain or surgery

• Psychosocial indications (See Appendix C, "Psychosocial Screening and Assessment Tools.")

For workers' compensation patients, check with state guidelines where the patient resides and where the injury took place: http://www.workerscompensation.com/workers_comp_by_state.php.

Patient Education Regarding Primary Prevention Providers in clinic systems are encouraged to provide primary education through other community educa-tion institutions/businesses to develop and make available patient education materials concerning back pain prevention and care of the healthy back. Emphasis should be on patient responsibility, workplace ergonomics, and home self-care treatment of acute low back pain. Employer groups should also make available reason-able accommodations for modified duties or activities to allow early return to work and minimize the risk of prolonged disability. Education is recommended for frontline supervisors in occupational strategies to facilitate an early return to work and to prevent prolonged disabilities.

(Snook, 1988 [R])

For other patient education resources, please see the Resources Table section of this guideline.



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2. Emergent or Urgent? Emergent – Refer to ER for Immediate Evaluation

• Sudden onset or otherwise unexplained loss or changes in bowel or bladder control (retention or incontinence)

• Back pain secondary to trauma

• Sudden onset or otherwise unexplained bilateral leg weakness

• Saddle numbness

Urgent – Appointment within 24 Hours: • Fever 38°C or 100.4°F for greater than 48 hours

• Unrelenting night pain or pain at rest

• Severe uncontrolled back or leg pain

• Progressive pain with distal (below the knee) numbness or weakness of leg(s)

• Progressive neurological deficit

If attempts to triage are unsuccessful and the patient still requests a same-day appointment, facilitate this if at all possible.

3. Evaluation Indicated?Appointment within two to seven days if the answer to any of the following is positive:

• Back pain lasting longer than six weeks

• Unexplained weight loss (greater than 10 pounds in six months)

• Over age 50

• History of cancer

• Moderate to severe new onset back pain or leg pain

4. Initial Primary Care EvaluationKey Points:

• Fear, financial problems, anger, depression, job dissatisfaction, family problems or stress can contribute to prolonged disability. The primary care evaluation includes a history and physical and consideration of psychosocial factors (Chou, 2007b [M]). See Appendices A-D for screening and assessment tools.

• Generally AP and LAT X rays are not helpful in the acute setting.If a serious underlying disease such as cancer, Cauda Equina Syndrome, significant or progressive neurologic deficit, or other systemic illness is present, consult or refer.

Adult Low Back PainAlgorithm Annotations Fourteenth Edition/November 2010


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Patient history includes:

Cancer risk factors:

• 50 years old or older

• History of cancer

• Unexplained weight loss

• Failure to improve after four to six weeks of conservative LBP therapy

If all four of the above risk factors for cancer are absent, studies suggest that cancer can be ruled out with 100% sensitivity.

Risk factors for possible spinal infection:

• IV drug use

• Immunosuppression

• Urinary infection

• History of turberculosis or active tuberculosis

Signs or symptoms of Cauda Equina Syndrome:

• New onset of urinary incontinence

• Urinary retention (if no urinary retention, the likelihood of Cauda Equina Syndrome is less than 1 in 10,000)

• Saddle anesthesia, unilateral or bilateral sciatica, sensory and motor deficits, and abnormal straight leg raising are all common

Signs or symptoms of neurologic involvement:

• Complaint of numbness or weakness in the legs

• Lumbar radiculopathy – a clinical syndrome secondary to compression or irritation of the lumbar nerve root or ganglion. Symptoms most commonly consist of thigh or leg pain, and in varying degrees, sensory changes, weakness, reflex changes, dysesthesias and paresthesias.

• Upper lumbar nerve root involvement may be suggested when pain conforms to L2, L3 or L4 dermatomal distribution and is accompanied by anatomically congruent motor weakness or reflex changes. Because more than 95% of lumbar disc herniations occur at the L4-5 or L5-S1 levels, the neurologic exam should focus on the L5 and S1 nerve roots.

Psychosocial indications:

• Belief that pain and activity are harmful

• "Sickness behaviors," such as extended rest or symptom magnification

• Depressed or negative moods, social withdrawal

• Treatment that does not fit best practice

• Problems with claim and compensation

• History of back pain, time off or other claims



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• Problems at work or low job satisfaction

• Heavy work, unsociable hours

• Overprotective family or lack of support

• Unwillingness to comply with treatment

Psychosocial indications can be barriers to recovery. Consider factors such as fear, financial problems, anger, depression, job dissatisfaction, family problems or stress, which can contribute to prolonged disability (New Zealand Guideline Group, 2004 [R]; Fritz, 2001 [B]; Chan, 1993 [C]; Deyo, 1992 [R]; Bigos, 1991 [B]; Spitzer, 1987 [R]). Provider may wish to consider using the PHQ2 at the intitial evaluation (Kroenke, 2003 [C]). Refer to the ICSI Major Depression in Adults in Primary Care guide-line for more information.

For more information on psychosocial indications, see the New Zealand Acute Low Back Pain Guide: Encorporating the Guide to Assessing Psychosocial Yellow Flags in Acute Low Back Pain, 2003.

See Appendix C, "Psychosocial Screening and Assessment Tools."

Include in the physical examination:

• Palpation for spinal tenderness

• Posture, gait and range of motion

• Neuromuscular testing

Strength testing

- Ankle dorsiflexion strength (able to heel walk)

- Great toe dorsiflexion strength

- Plantar flexion (able to toe walk)

- Hip flexors

Reflex testing

- Ankle and knee reflexes

- Knee extension

Sensory testing

- A sensory exam to evaluate the medial, dorsal and lateral aspects of the foot and the medial and lateral calf.

• Neural tension test (straight leg raise, slump, prone knee bend, femoral stretch) performed bilaterally to assess the mechanics and physiology of the respected neural system (Butler, 2000 [R]). A positive test should reproduce symptoms or associated symptoms. This information should be compared to the opposite side along with history and other objective findings. A positive test can only provide supporting evidence for a nerve root or discogenic pathology (Supik, 1994 [C]).

Surgical consultation is needed if significant or progressive neuromotor deficit is present.

Laboratory evaluation

Consider blood work if cancer or infection is suspected (Deyo, 2001 [R]).



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Lumbar spine x-ray (AP and LAT views) "red flag" indications

Generally AP and LAT x-rays are not useful in the acute setting but may be warranted with:

• unrelenting night pain or pain at rest (increased incidence of clinically significant pathology),

• history of or suspicion of cancer (rule out metastatic disease),

• fever above 38°C (100.4°F) for greater than 48 hours,

• osteoporosis,

• other systemic diseases,

• chronic oral steroids,

• increased risk of fragility fracture (such as osteoporosis or history of steroid use),

• immunosuppression,

• serious accident or injury (fall from heights, blunt trauma, motor vehicle accident) – this does not include twisting or lifting injury unless other risk factors are present (e.g., history of osteo-porosis),

• clinical suspicion of ankylosing spondylitis, and

• drug or alcohol abuse (increased incidence of osteomyelitis, trauma, fracture).

Oblique view x-rays are not recommended; they add only minimal information in a small percentage of cases, and more than double the exposure to radiation.

Referral

Consider early referral (within 16 days) to physical therapy or another trained non-surgical spine specialist when the patient presents with severe incapacitating, disabling back or leg pain, or when there is significant limitation of functional or job activities (Childs, 2004 [A]). (See Annotation #12, "Reevaluate and Consider Redirection," and Annotation #22, "Discuss Options and Consider Possible Surgical or Non-Surgical Spine Specialist," for details on specialties and treatments.)

5. Home Self-Care Treatment ProgramKey Points:

• Low back pain is common and most patients significantly improve in four to six weeks.

• The long-term course of low back pain is typically a return to previous activities.

• Reevaluate patient if there is not significant improvement in one to three weeks or if symptoms progress.

• Most patients who experience low back pain will have a recurrence within 12 months.

• Remaining active leads to a more rapid recovery with less chronic pain.

• Bed rest is not recommended.If the patient has not been previously evaluated, attempt to differentiate between untreated acute pain and ongoing chronic pain. If a patient's pain has persisted for six weeks (or longer than the anticipated healing



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time), a thorough evaluation for the cause of the chronic pain is warranted. See the ICSI Chronic Pain guideline for more information.

When patients are improving, they should continue self-care as outlined (Chou, 2007b [M]). Document the phone triage and home self-care treatment in the patient's medical record (e.g., no appointment is needed at this time, patient is improving with home self-care instructions and will call back if questions arise or condition changes).

Instruct the patient to do the following:

• Carefully introduce activities back into his or her day as he or she begins to recover from the worst of the back pain episode. Light-duty activities and regular walking are good ways to get back into action.

• Apply ice packs or heat as preferred on the sore area to keep the inflammation down, and short duration in a position of comfort may be helpful.

• Use over-the-counter anti-inflammatory medication (e.g., aspirin, ibuprofen, naproxen sodium) or acetaminophen to help ease the pain and swelling in the lower back. If stomach complaints persist, call your provider.

• Participate in activity that does not worsen symptoms.

• Identify and manage stressors.

Instruct the patient to call back if

• There is no improvement with home management in one to three weeks

• Pain or weakness worsens, progresses or persists beyond a week

• Bladder or bowel dysfunction develops

• Major weakness develops

Home Self-Care:

• Most patients who seek attention for their back pain will improve within two weeks. Most patients experience significant improvement within four weeks (Atlas, 2001 [R]).

• Approximately two-thirds of the people who recover from a first episode of acute low back symp-toms will have another episode within 12 months. Unless the back symptoms are very different from the first episode or the patient has a new medical condition, expect improvement to be similar for each episode (Hestbaek, 2003 [M]; Pengel, 2003 [M]).

• Recommend cold packs or heat as preferred by the patient (Nadler, 2002 [A]).

• Muscle relaxants are sometimes helpful for a few days but can cause drowsiness (Deyo, 2001 [R]).

• Analgesic medication for short-term (less than three months) symptom control.

• Opioid analgesics are rarely indicated in the treatment of acute low back pain. There is insufficient evidence to support opioid use (Chou, 2007a [M]). If used, it should be for only short-term inter-vention (less than two weeks) and accompanied by a comprehensive treatment plan.

• Consider the risk and benefits of any medication and prescribe the lowest effective dose possible (Nadler, 2002 [A]; Silverstein, 2000 [A]; Henry, 1996 [M]).



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• If the patient has been involved in home care and has had an adequate trial prior to the first visit, consider referral to a spine therapy professional after the initial visit (Skargren, 1997 [A]). (See Annotation #12, "Reevaluate and Consider Redirection.")

(Deyo, 1990 [R]; Spitzer, 1987 [R])

Activity recommendations:

Advise patients with acute low back pain to stay active and continue ordinary activity within the limits permitted by the pain. Remaining active leads to more rapid recovery with less chronic disability and fewer recurrent problems than either bed rest or back mobilizing exercises. [Conclusion Grade I: See Conclusion Grading Worksheet A – Annotation #10 (Home Self-Care)]

• Activity modification

- Advise continued routine activity while paying attention to correct posture.

- Patients with acute low back problems may be more comfortable if they temporarily limit or avoid specific activities known to increase mechanical stress on the spine, especially prolonged unsupported sitting, heavy lifting, and bending or twisting the back, especially while lifting (Hilde, 2002 [M]; Waddell, 1997 [M]).

- Consider the patient's age and general health, and the physical demands of the patient's job when recommending activity for the employed patient with acute low back symptoms (Malmivaara, 1995 [A]).

- Recommend discontinuation any activity or exercise that causes spread of symptoms (periph-eralization).

• Bed rest

- Bed rest is not recommended (New Zealand Guidelines Group, 2004 [R]).

- A gradual return to normal activities is more effective and leads to more rapid improvement with less chronic disability (Little, 2001 [A].

• Exercise

- Modify activity or exercise that causes spread of symptoms (peripheralization) (New Zealand Guidelines Group, 2004 [R]).

- Advise to stay active and to continue ordinary activity as normally as tolerated to give faster return to work, less chronic disability, and fewer recurrent problems (Waddell, 1997 [M]).

- Recommend consultation with a non-surgical spine specialist, who can evaluate individual characteristics and symptoms and establish a specific exercise program (Brennan, 2006 [A]; Hicks, 2005 [B]; Descarreaux, 2002 [A]).

Self-care brochure (see Quality Improvement Support, "Resources Table"):

In general, brochures and information that place a greater emphasis on reducing fear and anxiety and promoting active self-management have a greater opportunity to improve outcomes than traditional brochures that emphasize anatomy, ergonomics and specific back exercises (Little, 2001 [A]; Cherkin, 1998 [A]).

Specific content recommendations include:

• Absence of serious disease is likely when "red flags" are not present.



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• Hurt does not equal harm.

• There is a good prognosis for low back pain. The majority of patients experience significant improvements in two to four weeks (Atlas, 2001 [R]).

• Bed rest is not recommended and should be limited to no more than two days.

• Light activity will not further injure the spine, and light activity typically helps speed recovery.

• A progressive resumption of work and activity levels leads to better short-term and long-term outcomes.

• Information and advice may be helpful regarding specific painful or limited activities, such as sitting, lifting, getting up from bed.

Return to work:

• Tell patients experiencing an episode of acute back pain that their pain is likely to improve and that a large majority of patients return to work quickly. They should understand that complete pain relief usually occurs after, rather than before, resumption of normal activities, and their return to work can be before they have complete pain relief. Working despite some residual discomfort poses no threat and will not harm them (Von Korff, 1994 [R]).

• All persons recovering from back pain should understand that episodes of back pain may recur but can be handled similarly to the one from which they are recovering.

• Patients can reduce the likelihood of back pain recurrence by making exercise and lifestyle changes, as noted elsewhere.

• Consider using the following questions to guide your discussion about non-physical factors that can significantly impact risk for ongoing disability and return to work (Bigos, 1992 [R]):- Do you enjoy the tasks involved in your job?

- Do you get along with your closest or immediate supervisor?

7. Continue Self-Care ProgramWhen patients are improving, they should continue self-care as outlined in Annotation #5, "Home Self-Care Treatment Program." Reinforcement of the self-care program should occur.

8. Is a Serious Underlying Condition Revealed?Key Point:

• If a serious underlying condition is revealed, refer the patient to the appropriate specialist.Examples of serious conditions include cancer, Cauda Equina Syndrome, significant or progressive neuro-logic deficit or other systemic illness.

9. Consult or ReferComplete a diagnostic workup or refer to the appropriate specialist for serious underlying conditions (e.g., cancer, other systemic illness, or neurological deficit). Each medical group may have other indications for specialty referral.



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10. Has the Patient Failed Home Self-Care?Key Points:

• It is important to evaluate non-physical factors that may impact returning to work or ongoing disability.

• The longer-term course of low back pain is typically of a return to previous activities, though often with incomplete recovery from pain.

Because most patients with acute pain improve by two weeks, a conservative treatment approach is recom-mended (Atlas, 2001 [R]). Advise low back pain patients who are not improving or who experience significant limitation of daily activity at home or work to contact their provider within one to three weeks of the initial evaluation (Deyo, 2001 [R]). Advise patients who are improving to continue home self-care.

Review and evaluate red flag and psychosocial indicators at each contact/visit (New Zealand Guidelines Group, 2003 [R]). At each visit, do an assessment that includes a subjective pain rating, functional assess-ment, and a clinician's objective assessment.

Patients who are improving to consider a follow-up with their provider. The benefit is to reinforce education and lifestyle changes that have enabled the patient to improve. This provides for outcome measures to be assessed as identified in the aims and measures sections of the guideline.

12. Reevaluate and Consider RedirectionKey Points:

• When low back pain is the primary complaint, request a non-surgical spine care specialist who demonstrates competency and interest in low back pain and in providing therapies based on continuing education and effective techniques supported by literature.

Choice of the trained professional will be determined by availability and preference of individual medical providers and organization systems. The patient and/or physician should request a trained non-surgical spine specialist who demonstrates competency in providing therapies for patients with low back pain based on effective techniques supported by literature, as outlined in this guideline.

These therapies include education, exercise programs and appropriate use of manual/manipulative thera-pies (Nytendo, 2000 [C]; Nytendo, 2001 [B]). Participants should be in additional training and in ongoing continuing education courses in manual treatment of the spine. Individuals who may have training in these therapies include physical therapists, chiropractic providers, osteopathic or allopathic physicians.

Consider the following when selecting a non-surgical spine specialist who will effectively evaluate and treat the lumbar spine (Spitzer, 1987 [R]):

• Years of experience treating spine patients

• Volume of patients treated for spine dysfunction in the past year

• Number of referrals an individual provider receives on a regular basis

• Provides treatment interventions that include manipulation, exercise and education

• Average number of visits per episode of care for low back pain

• Percentage of patients who return to previous level of activity



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Indications for referral include:

• Failure to make improvement with home self-care after two weeks (Shekelle, 1994 [R]);

• Severe incapacitating and disabling back or leg pain

• Significant limitation of functional or job activities

Include both education and exercise in treatment plans. The treatment plan may include modalities, if neces-sary, to enable an individual to carry out an exercise program and self-care. It may also include limited passive treatments such as manual therapy (e.g., includes manipulation and mobilization), among others (Ottenbacher, 1995 [M]; Shekelle, 1992 [M]). Spinal manipulation should not be done if premanipulative testing peripheralizes symptoms.

Minimize passive treatments and use them only to progress an individual toward independence in exercise and self-care. Active treatment such as exercise must be introduced within a week of initiating passive treatments.

There are no studies the work group is aware of regarding time frames. There is work group consensus on the following:

• Within four visits, the patient must display documented improvement in order to continue therapy. If no improvement is noted, a comprehensive re-evaluation should be performed by the spine care professional for other causes of low back pain, including regional SI joint dysfunction.

• Continued improvement must be documented for continued therapy. Typically no more than four to six visits are needed.

• Somewhere between 9 and 12 visits or between 4 and 6 weeks the patient should be reassessed.

14. Is Pain Chronic (Greater Than Six Weeks)?A patient with "recurrent acute" episodes will continue a trial of conservative treatment when the current symptoms are six weeks or less from onset. "Recurrent acute" means symptoms at some point improved, separating the current episode from previous episodes. When the current symptoms are more than six weeks from onset, regard the patient as chronic and move to the corresponding sections of the algorithm (Annotation #18 and beyond).

If at initial evaluation the patient is identified as low back pain greater than six weeks see Annotation #15, "Chronic Low Back Pain," and for radiculopathy see Annotation #18, "Radiculopathy."

15. Chronic Low Back PainComprehensive reevaluation, including a general assessment (see Annotation #4, "Initial Primary Care Evalu-ation"), should be done for patients not improving after six weeks. Most patients with acute back pain will improve within six weeks. Back pain and sciatica that persists longer than six weeks are defined as chronic.

An assessment that includes a subjective pain rating, functional assessment and a clinician's objective assessment should be done.

Psychosocial factors can contribute to prolonged disability as previously noted (New Zealand Guidelines Group, 2003 [R]; Pincus, 2002 [M]; Fritz, 2001 [B]; Bigos, 1991 [B]). See Appendix C, "Psychosocial Screening and Assessment Tools." See the ICSI Major Depression in Adults in Primary Care guideline for the diagnosis and treatment of depression.

For patients not improving after six weeks, see "Lumbar Spine X-Rays (AP and LAT views) If Indicated" in this annotation and Annotation #18, "Radiculopathy," for imaging considerations.



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Of the 10% of patients with chronic symptoms, 90% fall into the chronic LBP category and only 10% fall into the chronic sciatica category.

Physical factors that may lead to delayed recovery or prolonged disability include malignancy, infection, metabolic or a bio-mechanical condition (e.g., sacroiliac joint dysfunction [SJD]) (Dreyfuss, 1994 [C]; Riddle, 2002 [C]; Schwarzer, 1995 [D]). Consider further evaluation for systematic problems.

If the patient is not better, consider other etiologies for low back pain such as:

• Fractures

• Spondylarthopathies

• Infection

• Tumor

• Abdominal/pelvic pathologies

• Other sites of origin for low back pain such as facet syndrome, piriformis syndrome, stenosis or claudication

Lumbar Spine X-Rays (AP and LAT Views) If IndicatedPatients with chronic LBP or acute low back pain who are not improving should be considered for further diagnostic testing. (See Annotation #4, "Initial Primary Care Evaluation.") Oblique view x-rays are not recommended; they add only minimal information in a small percentage of cases, and more than double the exposure to radiation (Deyo, 1986 [C]; Liang, 1982 [M]).

Several x-ray findings are of questionable clinical significance and may be unrelated to back pain. These findings include:

• Single disk space narrowing

• Spondylolysis

• Lumbarization

• Sacralization

• Schmorl nodes

• Spina bifida occulta

• Disk calcification

• Mild to moderate scoliosis

16. Active RehabilitationKey Points:

• There is strong evidence that exercise therapy is effective for chronic low back pain. However, there is inconclusive evidence in favor of one exercise over the other. [Conclusion Grade I: See Conclusion Grading Worksheet B – Annotation #16 (Active Rehabilitation)].

High-grade mobilization/manipulation has been shown to be effective early in treatment when followed by appropriate active rehabilitation.



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Include in the treatment of chronic low back pain:

• Written educational materials and advice by provider (Burton, 1999 [A])

• Active self-management

• Gradual resumption of normal light activities as tolerated

• Prevention – good body mechanics

• Exercise – many studies show the benefit of an exercise program with chronic low back pain

- Inconclusive evidence in favor of one exercise over the other (flexion, extension or fitness) (Abenhaim, 2000 [M]; Scheer, 1997 [M])

- Consider a graded active exercise program (Lindstrom, 1992b [A])

- Consider specific exercises to strengthen the core trunk stabilizing muscles (Lindstrom, 1992a [A])

- Consider intensive exercise program (Manniche, 1988 [A])

• Assess and manage psychosocial factors

• A multidisciplinary approach (Hildebrandt, 1997 [D]; Pfingsten, 1997 [D])

See also the ICSI Assessment and Management of Chronic Pain guideline.

18. RadiculopathyKey Points:

• When indicated, MRI is the preferred diagnostic test to evaluate patients. CT myelog-raphy is a useful study in patients who have a contraindication or other reason for utilizing MRI.

See Annotation #15, "Chronic Low Back Pain," for a comprehensive physical and psychosocial evaluation, including a subjective pain assessment functional assessment and a clinician's objective assessment.

MRI or Lumbar Spine CT Imaging IndicationsMRI and CT generally are not useful in the early evaluation and treatment of low back pain or radiculopathy unless the patient has major or progressive neurological symptoms, or there is a suspicion of cancer or infec-tion. Generally, cross-sectional imaging is indicated when initial non-invasive conservative regimens have failed and surgery or a therapeutic injection are considerations. If there is uncertainty, consider consulting with the appropriate professional when the patient meets surgical referral criteria. (See Annotation #20, "Consider Epidural Steroid Injection Prior to Surgical Intervention.") Each medical group may have specific arrangements for ordering CT, MRI or other special diagnostic tests prior to referral to a surgical back specialist. See Appendix E, "General Guidelines for CT and MRI Order Sets for Adult Low Back Pain," for order set general guidelines.

When indicated, MRI is the preferred diagnostic test in the evaluation of patients with low back pain with or without radiculopathy.

CT myelography is a useful study in patients who have a contraindication to MRI, for whom MRI findings are inconclusive, or for whom there is a poor correlation between symptoms and MRI findings. CT myel-ography shows comparable accuracy and is complementary to MRI. CT myelography is invasive, however, and invokes the risk of allergic reaction to contrast and post-myelographic headache.



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Plain CT is a useful study in patients who have a contraindication to MRI, for whom MRI findings are inconclusive, for whom there is a poor correlation between symptoms and MRI findings, and for whom CT myelogram is deemed inappropriate. CT can be used in the initial evaluation of patients with back pain and/or radiculopathy when high-quality MRI is not available.

(North American Spine Society, 2007 [R]; American College of Radiology, 2006 [R]; Bischoff, 1993 [C]; Modic, 1986 [D])

The Adult Low Back Pain guideline work group has listed advantages for both CT and MRI imaging and a list of conditions for each. This list is not meant to be comprehensive but to aid the clinician in making a decision.

MRI indications:

• Major or progressive neurologic deficit (e.g., foot drop or functionally limiting weakness such as hip flexion or knee extension)

• Cauda Equina Syndrome (loss of bowel or bladder control or saddle anesthesia)

• Progressively severe pain and debility despite conservative therapy

• Severe or incapacitating back or leg pain (e.g., requiring hospitalization, precluding walking or significantly limiting the activities of daily living)

• Clinical or radiological suspicion of neoplasm (e.g., lytic or sclerotic lesion on plain radiographs, history of cancer, unexplained weight loss or systemic symptoms)

• Clinical or radiological suspicion of infection (e.g., endplate destruction of plain radiographs, history of drug or alcohol abuse, or systemic symptoms)

• Trauma (fracture with neurologic deficit, compression fracture evaluation in elderly patients with question of underlying malignancy, characterization in anticipation of vertebroplasty/kyphoplasty, stress fracture or subacute spondylosis in a patient less than 18 years of age)

• Moderate to severe low back pain or radicular pain, unresponsive to conservative therapy, with indications for surgical intervention or therapeutic injection

For patients with mild to moderate claustrophobia, administering benzodiazepines an hour prior to scan may be effective. Patients who receive benzodiazepines should not drive.

MRI advantages:

• Better visualization of soft tissue pathology; better soft tissue contrast

• Direct visualization of neurological structures

• Improved sensitivity for cord pathology and for intrathecal masses

• Improved sensitivity for infection and neoplasm

• No radiation exposure

• Safer than CT for women who are pregnant, especially in the 1st trimester, due to no radiation exposure

CT/CT myelography indications:

• Major or progressive neurologic deficit (e.g., foot drop or functionally limiting weakness such as hip flexion or knee extension)



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• Cauda Equina Syndrome (loss of bowel or bladder control or saddle anesthesia)

• Progressively severe pain and debility despite conservative therapy

• Severe or incapacitating back or leg pain (e.g., requiring hospitalization, precluding walking or significantly limiting the activities of daily living)

• Clinical or radiological suspicion of neoplasm (e.g., lytic or sclerotic lesion on plain radiographs, history of cancer, unexplained weight loss or systemic symptoms)

• Clinical or radiological suspicion of infection (e.g., endplate destruction of plain radiographs, history of drug or alcohol abuse, or systemic symptoms)

• Bone tumors (to detect or characterize)

• Trauma (rule out or characterize fracture, evaluate for healing)

• Moderate or severe low back pain or radicular pain, unresponsive to conservative therapy, with indications for surgical intervention or therapeutic injection

CT advantages:

• Better visualization of calcified structures

• Direct visualization of fractures

• Direct visualization of fracture healing and fusion mass

• More accurate in the assessment of certain borderline or active benign tumors

• More available and less costly

• Better accommodation for patients over 300 pounds and patients with claustrophobia

• Safer for patients with implanted electrical devices or metallic foreign bodies

• Less patient motion – particularly useful for patients who cannot lie still or for patients who cannot cooperate for an MRI

(Deyo, 2001 [R]; Thornbury, 1993 [C]; Mazanec, 1991 [R])

Open Upright MRI

Open Upright MRI systems, as currently configured with 0.5T and 0.63T magnets, are useful modalities for routine imaging of the lumbar spine, particularly for patients with severe claustrophobia, patients who cannot fit into conventional magnets, and patients who cannot lie flat because of severe pain. There is some evidence that imaging patients in the upright position or with axial loading (i.e., functional myelography, axial loaded CT or MRI, or Open Upright MRI) yields significant additional information in older patients with radiculopathy or neurogenic intermittent claudication. There is little to no evidence to support the use of Open Upright MRI in the detection of lumbar instability or in the evaluation of positional low back pain, and these applications should remain investigational.

See Appendix D, "Upright and Positional Imaging," for more information.



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20. Consider Epidural Steroid Injection Prior to Surgical InterventionKey Points:

• Successful epidural steroid injections may allow patients to advance in a conservative treatment program.

• Perform epidural steroid injections under fluoroscopy or CT.There is limited evidence for epidural steroid injections; therefore, it is important that outcome data be gathered in order to grow the evidence.

The goal of epidural steroid injections in patients with back and leg pain and symptomatic lumbar spinal stenosis or a herniated disc on MRI or CT is pain control and functional improvement. Several studies have shown that a single epidural injection affords short-term relief from pain (Wilson-MacDonald, 2005 [M]; Cannon, 2000 [R]; Weiner, 1997 [D]) although in one randomized controlled trial, the steroid group seemed to experience a "rebound" phenomenon (Karpinnen, 2001 [A]).

There is limited evidence to support one or more epidural injections to control pain and advance appropriate conservative therapy in an attempt to avoid or decrease the incidence of surgical intervention. Buttermann reported on 169 patients who presented for surgical consult with a large disc herniation on MRI (Buttermann, 2004 [A]). Sixty-nine of these patients responded to a six-week non-invasive conservative therapy program. The remaining 100 were randomized to discectomy and epidural steroid injection therapy (ESI). The ESI group received multiple (one to three) injections performed with interlaminar approach at or above the level of the disc herniation, and 76% of these were performed with fluoroscopy and contrast. 46% of the ESI therapy group had good or excellent results and experienced the same decrease in pain as the discectomy group. 54% of the ESI group crossed over and underwent surgery at an average of one to three months. This crossover group suffered no adverse outcome as a result of this delay.

Wang, et al., studied 64 patients with symptomatic lumbar disc herniation on MRI and refractory symptoms who presented for surgery (Wang, 2002 [D]). They found that 77% of these patients avoided surgery with multiple fluoroscopically-guided contrast-enhanced transforaminal injections at the level of the herniation. Lutz, et al., Botwin, et al., and Vad, et al., in less rigorous studies, also reported a 75%-85% success rate with a multiple fluoroscopically-guided transforaminal injection regimens in patients with refractory radicular pain (Botwin, 2002 [D]; Vad, 2002 [C]; Lutz, 1998 [D]).

Riew, et al., in a prospective double-blinded and randomized study of 55 subjects, has shown that a series of injections – one to four over a period of weeks and months – can result in a decrease in the incidence of surgery (Riew, 2000 [A]).

A randomized study by Arden, et al., which enrolled 228 patients with sciatica, showed that up to three injections of lumbar epidural steroids (compared to sham treatment) showed a transient benefit at 3 weeks but not at 6 to 52 weeks, and there was no benefit of repeated epidural steroid injections over a single injection (Arden, 2005 [A]). The methods section of this paper does not indicate if the injection was done fluoroscopically or with contrast.

Based on limited data, the results appear promising. However, at this time there is insufficient evidence for the efficacy of epidural steroid injections. Only consider epidural steroid injections after initial appropriate conservative treatment program has failed. Successful epidural steroid injections may allow patients to advance in a conservative treatment program. Patients should be made aware of the general risks of short-term and long-term use of steroids.

Perform injections under fluoroscopy and with contrast in order to deliver cortisone as close to the disc herniation, area of stenosis, or nerve root impingement as determined by MRI or CT, and with as little morbidity as possible. In the case of stenosis, an adjacent segment or an alternative approach (interlaminar



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versus transforaminal) may be needed to deliver medication to the appropriate level. Failure of treatment may result from a failure to deliver medications to the treatment field or clinical unresponsiveness to cata-bolic steroid preparations.

No study has shown a clear advantage of one approach (interlaminar, caudal or transforaminal), type of corti-sone or volume of injectate (McLain, 2005 [R]; Cannon, 2000 [R]). Customize the approach to each patient.

Procedural morbidity also varies with each approach (McLain, 2005 [R]; Cannon, 2000 [R]). With interlam-inar injections there is a risk of intrathecal injection and subsequent arachnoiditis, as well as post-procedural headaches. With transforaminal injections, patients frequently report significant – although in most cases transient – leg pain and there is a risk of spinal cord infarction when injected above L2 (Somayaji, 2005 [D]; Tiso, 2004 [D]; Botwin, 2000 [D]).

Patient selection

• Patients should predominantly have, complaints of radicular pain in the lower extremity in a distribu-tion with or without corroborative examination findings for radiculopathy (reflex changes, possible motor weakness, and root tension signs). In addition, the pain should be of a severity that signifi-cantly limits function and quality of life, and that has not responded to oral analgesic medications and other conservative care measures.

• Corroborative neural axis imaging is required, either MRI or CT, of disk disease or bony stenosis that fits with the clinical syndrome.

• Patients should have no contraindications to injection therapy, including:

- No signs or symptoms of active infection either systemically or locally

- No history of bleeding disorders or current use of anticoagulants such as warfarin or clopidogral; allow the patient to "drift" to the lowest effective INR prior to procedure

- Anticoagulation guidelines:

• Cervical procedure < 1.2 INR, Lumbar procedure < 1.4 INR

• Clopidogrel, off one week; Ticlopidine, off two weeks; NSAIDS, no need to stop (Horlocker, 2010 [R]).

- Patients with non-anaphylactic reaction to iodine based contrast may be pretreated with 20 mg IV clopidogrel, 4 mg IV dexamethazone, 50 mg IV diphenhydramine. Those with documented anaphylaxis to iodine based contrast can be treated with a non-iodine based contrast such as gadolinium (Safriel, 2005 [D]).

- No allergies to local anesthetic agents, contrast agents, or corticosteroids

- No prior complications to corticosteroid injections

• Pregnancy is a contraindication for the use of fluoroscopy.

• Use caution in diabetic patients because of altered glycemic control, which is typically transient. Patients with diabetes need to be informed and aware that their blood glucose levels will rise and alterations in sliding scales will likely be needed.

• Patients with congestive heart failure need to be aware of steroid-induced fluid retention.

• Though NSAID use is not a contraindication to injections, some practitioners discontinue NSAIDs several days prior to injection.



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22. Discuss Options and Consider Possible Surgical or Non-Surgical Spine SpecialistKey Points:

• The appearance of a disc herniation does not rule out a course of conservative therapy. Unless "red flag" indications are present, all patients should undergo a trial of conser-vative therapy.

• The decision to operate is a clinical decision based on the presence of severe, uncon-trolled pain, profound or progressive neurological symptoms, or a failure to respond to conservative therapy.

Indications for specialty referral may include:

Non-surgical spine specialist

• Back pain for longer than six weeks

• Atypical chronic leg pain

• Chronic pain syndrome

• Rule out inflammatory arthopathy

• Rule out fibrositis/fibromyalgia

• Rule out metabolic bone disease (e.g., osteoporosis)

Surgical spine specialist

• Patient is a surgical candidate

• Cauda Equina Syndrome

• Progressive or moderately severe neuromotor deficit (e.g., foot drop or functional muscle weak-ness such as hip flexion weakness or quadriceps weakness)

• Persistent neuromotor deficit after four to six weeks of conservative treatment (does not include minor sensory changes or reflex changes)

• Radiculopathy with positive SLR for longer than four to six weeks

• Uncontrolled pain

(Spitzer, 1987 [R])

Special diagnostic tests can be used to help clinicians decide the appropriate referral to a specialist. To decide which test, consult with subspecialty physicians.

Patients with large, extruded, sequestered or high-signal-intensity disc herniations do not have a worse prognosis than do patients with smaller contained disc herniations or protrusions. The presence of a disc extrusion or sequestration is not an indication for immediate surgery (Deyo, 1990a [R]; Spitzer, 1987 [R]; Weber, 1983 [A]).

• The appearance of a disc herniation on MRI/CT (including extruded/sequestered disc) does not determine whether an individual patient will respond to conservative therapy. Assuming that the patient's pain can be controlled and that no "red flags" or contraindications exist, all patients should undergo a trial of conservative therapy (Henmi, 2002 [D]; Saal, 1996 [R]).



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• The decision to operate is a clinical one, not a radiologic one, and is generally based on the pres-ence of severe, uncontrolled pain, profound or progressive neurological symptoms, or a failure to respond to conservative therapy (Gundry, 1993 [D]; Bozzao, 1992 [D]).

• Even though it was not discussed above, it is important to emphasize the concept that a disc hernia-tion on MRI/CT is of relevance only with respect to specific clinical symptoms. Disc herniations can be seen in asymptomatic patients, and one can surmise from the literature quoted that if a patient's symptoms resolve and the disc herniations do not resolve, it will be present on the next examination (Buttermann, 2002 [C]; Komori, 1996 [D]; Matsubara, 1995 [D]).

See also the ICSI Assessment and Management of Chronic Pain guideline.


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This section provides resources, strategies and measurement for use in closing the gap between current clinical practice and the recommendations set forth in the guideline.

The subdivisions of this section are:

• Aims and Measures

- Measurement Specifications

• Implementation Recommendations

• Resources

• Resources Table


Quality Improvement Support:

Adult Low Back Pain

Copyright © 2010 by Institute for Clinical Systems Improvement


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Aims and Measures1. Improve the assessment and reassessment of patients age 18 and older with low back pain diagnosis.

(Annotations #1, 4, 15, 18)

Measures for accomplishing this aim:

a. Percentage of patients with a low back pain diagnosis who have all of the following at the initial visit with the physician (composite measure):

• Pain assessment

• Functional status

• Patient history, including notation of presence or absence of "red flags"

• Assessment of prior treatment and response, and

• Employment status

• Psychosocial screening that includes depression and chemical dependency screening (ICSI)

b. Percentage of patients with low back pain diagnosis who have a reassessment at each follow-up visit that includes (composite measure):

• Pain assessment

• Functional assessment

• Clinician's objective assessment, and

• Psychosocial screening that includes depression and chemical dependency screening

2. Reduce unnecessary imaging for low back pain patients age 18 years and older in the absence of "red flag" indicators or progressive symptoms. (Annotations #4, 18)


a. Percentage of patients with new low back pain who received an imaging study (plain x-ray, MRI, CT scan) conducted on the episode start date or in the 28 days following the episode start date. (NCQA)

b. Percentage of patients who received inappropriate repeat imaging studies in the absence of red flags or progressive symptoms (overuse measure, lower performance is better). (NCQA)

c. Percentage of patients with a diagnosis of back pain for whom the physician ordered imaging studies during the six weeks after pain onset, in the absence of "red flags." (NCQA overuse measure, lower performance is better.)

3. Increase the use of recommended conservative approach as first-line treatment, such as activity, self-care and analgesics for patients age 18 and older with low back pain diagnosis. (Annotation #5)


a. Percentage of patients with medical record documentation that a physician advised them to maintain or resume normal activities. (NCQA)

b. Percentage of patients with medical record documentation that a physician advised them against bed rest lasting four days or longer. (NCQA)

Adult Low Back Pain Fourteenth Edition/November 2010


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c. Percentage of patients with low back pain diagnosis who received patient education regarding low back pain self-care and the importance of maintaining an active lifestyle.

d. Percentage of patients with low back pain diagnosis returning to their primary care provider for one to three-week follow-up for reinforcement of treatment recommendations such as self-care, activity and analgesics.

e. Percentage of patients with low back pain diagnosis who received recommendation to take an anti-inflammatory or analgesic medication.

Adult Low Back PainAims and Measures Fourteenth Edition/November 2010


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Measurement SpecificationsMeasurement #1a

Percentage of patients with low back pain diagnosis who have all of the following at the initial visit with the physician (composite measure):

• Pain assessment

• Functional status

• Patient history, including notation of presence or absence of "red flags"

• Assessment of prior treatment and response

• Employment status


Population DefinitionPatients, age 18 and over, seen in primary care diagnosed with acute low back pain or radiculopathy.

Data of Interest# of patients who have the six components completed at the initial visit

# of patients with acute low back pain diagnosis

Numerator/Denominator DefinitionsNumerator: Number of patients, 18 and over and low back pain diagnosis, seen in primary care and

have following completed at the initial visit with the physician: 1) pain assessment, 2) functional status, 3) patient history (including notation of presence or absence of "red flags"), 4) assessment of prior treatment and response, 5) employment status and 6) psychosocial screening that includes depression and chemical dependency screening.

Denominator: Number of patients with diagnosis of acute low back pain

ICD-9 codes included in the denominator: 720.x, 721.x, 722.x, 724.xx, 847.2, 738.4, 738.5, 738.6, 846.x, 847.2, 847.2, 847.3, 847.4, 847.9.

Method/Source of Data CollectionIdentify a sample of at least 30 patients with with ICD-9 codes: 720.x, 721.x, 722.x, 724.xx, 847.2, 738.4, 738.5, 738.6, 846.x, 847.2, 847.2, 847.3, 847.4, 847.9. Review records to determine whether the 6 compo-nents were completed at the initial visit with the physician. In the numerator include only the records that have all six components completed.

Time Frame Pertaining to Data CollectionThe suggested time period is a calendar month; however, data collection can be done more frequently.


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NotesThis measures is based on National Committee for Quality Assurance (NCQA) and ICSI Low Back Pain guideline work group recommendations.

This measure is a process and composite measure. All six components need to be completed to include in the measurement. Improvement is associated with a higher score.



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Measurement #1bPercentage of patients with low back pain diagnosis who have an assessment at each follow-up visit that includes (composite measure):

• Pain assessment (subjective pain rating)

• Functional assessment

• Clinician's objective assessment, and


Population DefinitionPatients, age 18 and over, seen in primary care and diagnosed with acute low back pain or radiculopathy.

Data of Interest# of patients who have the four components assessed at follow-up visit


Numerator/Denominator DefinitionsNumerator: Number of patients, 18 and over and low back pain diagnosis, seen in primary care and

have following assessed at follow visit with the physician: 1) pain assessment*, 2) func-tional assessment**, 3) clinician’s objective assessment, 4) psychosocial screening that includes depression and chemical dependency screening.

* Pain assessment can be done through subjective pain rating.

** Functional assessment can be done with Oswestry Low Back Index.

Denominator: Number of patients with diagnosis of acute low back pain.


Method/Source of Data CollectionIdentify a sample of at least 30 patients with with ICD-9 codes: 720.x, 721.x, 722.x, 724.xx, 847.2, 738.4, 738.5, 738.6, 846.x, 847.2, 847.2, 847.3, 847.4, 847.9. Review records to determine whether the four components were completed at follow up visits with the physician, if any follow up visits recorded. In the numerator include only the records that have all four components completed.

Time Frame Pertaining to Data CollectionThe suggested time period is a calendar month; however, data collection can be done more frequently.


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NotesThis measures is based on National Committee for Quality Assurance (NCQA) and ICSI Low Back Pain guideline work group recommendations.

This measure is a process and composite measure. All four components need to be completed to include in the measurement. Improvement is associated with a higher score.



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Measurement #2cPercentage of patients with a diagnosis of back pain for whom the physician ordered imaging studies during the six weeks after pain onset, in the absence of "red flag." (NCQA overuse measure; see notes below.)

Population DefinitionAdult patients age 18 and over in primary care who have symptoms of acute low back pain or radiculopathy (see codes below).

Data of Interest# of patients with acute low back pain or radiculopathy receiving imaging studies (see definitions below)

# of patients with acute low back pain who present to clinic with low back pain six weeks or less from onset of pain without "red flag" indicators (see notes below)

Numerator/Denominator DefinitionsNumerator: Acute low back pain patients receiving imaging studies AP or LAT x-ray, CT scan and

MRI.

Denominator: Patients who are within six weeks of onset of low back pain, and related symptoms as identi-fied by the following ICD-9 codes: 720.x, 721.x, 722.x, 724.xx, 847.2, 738.4, 738.5, 738.6, 846.x, 847.2, 847.2, 847.3, 847.4, 847.9.

Method/Source of Data CollectionIdentify patients with acute low back pain using the above diagnosis codes. Patients should be included if the onset of symptoms was six weeks or less.

The medical record of each patient is reviewed to determine if the patient meets any of the "red flag" indi-cators. If none of the "red flag" indicators is present, the chart is further reviewed for use of AP or LAT x-ray, CT scan or MRI.

Time Frame Pertaining to Data CollectionThe suggested time period is a calendar month.

NotesMRI and CT generally are not useful in the early evaluation and treatment of low back pain or radiculopathy unless the patient has major or progressive neurological symptoms, or there is a suspicion of cancer or infection.

Generally AP and LAT x-rays are not useful in the acute setting but may be warranted with:

• unrelenting night pain or pain at rest (increased incidence of clinically significant pathology);

• history of or suspicion of cancer (rule out metastatic disease);

• fever above 38º (100.4º F) for greater than 48 hours;

• osteoporosis;

• other systemic diseases;



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• chronic oral steroids;

• immunosuppression;

• serious accident or injury (fall from heights, blunt trauma, motor vehicle accident) – this does not include twisting or lifting injury unless other risk factors are present (e.g., history of osteoporosis), and

• clinical suspicion of ankylosing spondylitis.

Other conditions that may warrant AP or LAT x-rays:

• Over 50 years old (increased risk of malignancy, compression fracture)

• Failure to respond after six weeks of conservative therapy

• Drug or alcohol abuse (increased incidence of osteomyelitis, trauma, fracture)


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Measurement #3cPercentage of patients with low back pain diagnosis who received education regarding low back pain self-care and the importance of maintaining an active lifestyle.


Data of Interest# of patients who received low back pain education


Numerator/Denominator DefinitionsNumerator: Number of patients, 18 and over and low back pain diagnosis, seen in primary care who

receive education on low back pain self-care and the importance of maintaining an active lifestyle.



Method/Source of Data CollectionIdentify a sample of at least 30 patients with with ICD-9 codes: 720.x, 721.x, 722.x, 724.xx, 847.2, 738.4, 738.5, 738.6, 846.x, 847.2, 847.2, 847.3, 847.4, 847.9. Review records to determine whether patients received education on low back pain self-care and active lifestyle.

Time Frame Pertaining to Data CollectionThe suggested time period is a calendar month; however data collection can be done more frequently.

NotesThis measure is a process measure. Improvement is associated with a higher score.


www.icsi.org

35


Measurement #3ePercentage of patients with low back pain diagnosis who received recommendation to take an anti-inflam-matory or analgesic medication.


Data of Interest# of patients who received recommendation to take anti-inflammatory or analgesic medication


Numerator/Denominator DefinitionsNumerator: Number of patients, 18 and over and low back pain diagnosis, seen in primary care who

receive recommendation to take anti-inflammatory or analgesic medication.



Method/Source of Data CollectionIdentify a sample of at least 30 patients with with ICD-9 codes: 720.x, 721.x, 722.x, 724.xx, 847.2, 738.4, 738.5, 738.6, 846.x, 847.2, 847.2, 847.3, 847.4, 847.9. Review records to determine whether patients received recommendation to take anti-inflammatory or analgesic medication.

Time Frame Pertaining to Data CollectionThe suggested time period is a calendar month; however data collection can be done more frequently.

NotesThis measure is a process measure. Improvement is associated with a higher score.


www.icsi.org

36

ResourcesCriteria for Selecting ResourcesThe following resources were selected by the guideline work group as additional resources for providers and/or patients. The following criteria were considered in selecting these resources.

• The site contains information specific to the topic of the guideline.

• The content is supported by evidence-based research.

• The content includes the source/author and contact information.

• The content clearly states revision dates or the date the information was published.

• The content is clear about potential biases, noting conflict of interest and/or disclaimers as appropriate.

Resources Available to ICSI Members OnlyICSI has a wide variety of knowledge resources that are only available to ICSI members (these are indicated with an asterisk in far left-hand column of the Resources table). In addition to the resources listed in the table, ICSI members have access to a broad range of materials including tool kits on CQI processes and Rapid Cycling that can be helpful. To obtain copies of these or other Resources, go to http://www.icsi.org/improvement_resources. To access these materials on the Web site, you must be logged in as an ICSI member.

The resources in the table on the next page that are not reserved for ICSI members are available to the public free-of-charge.



www.icsi.org

37


Resources Table* Author/Organization Title/Description Audience Web sites/Order Information

Center for the Advancement of Health

This Web site contains a series of studies on health behavior change in the clinical setting for chronic back pain.

Health Care Professionals

http://www.cfah.org/

MayoClinic.com Consumer information on back pain. Topics include definition, causes, risk factors and other topics.

Patients and Families

http://www.mayoclinic.com

National Library of Medicines MEDLINE Plus/National Institutes of Health

Federal government source of back health-related information and research, related links.

Patients and Families; Health Care Professionals

http://www.nlm.nih.gov/ hinfo.html

NIAMS: National Institute of Arthritis and Musculoskeletal and Skin Diseases

Web site provides a PDF document entitled Handout or Health: Back. The booklet is for patients and families who have back pain and want to learn more about it.


http://www.niams.nih.gov

* Park Nicollet Low Back Pain; brochure Patients and Families

http://www.icsi.org/knowledge/ Listed under Patient Education Resources

Spine-Health Web site provides patients and families with comprehensive, highly informa-tive and useful information for under-standing, preventing and seeking appro-priate treatment for back and neck pain.


http:www.spine-health.com

Spine Universe in part-nership with American Association of Neurological Surgeons, Scoliosis Research Society, AANS/CNS Joint Section on Disor-ders of the Spine and Peripheral Nerves, Inter-national Spinal Injection Society, National As-sociation of Orthopaedic Nurses, National Pain Foundation

Internet-based network dedicated to dissemination of back pain information for clinicians and patients including education, consumer information community resources.

Health Care Professionals;Patients and Families

http://www.spineuniverse.com

WebMD WebMD provides services for physicians and consumers on clinical processes and education.

Health Care ProfessionalsPatients and Families

http://www.webmd.com

* Available to ICSI members only.

38

The subdivisions of this section are:

• Conclusion Grading Worksheet Summary

- Conclusion Grading Worksheets

• References

• Appendices


Supporting Evidence:

Adult Low Back Pain

Copyright © 2010 by Institute for Clinical Systems Improvement


www.icsi.org

39

Conclusion Grading Worksheet Summary<Delete page if no Conclusion Grading Worksheets>

Individual research reports are assigned a letter indicating the class of report based on design type: A, B, C, D, M, R, X.

A full explanation of these designators is found in the Foreword of the guideline.

II. CONCLUSION GRADES

Key conclusions (as determined by the work group) are supported by a conclusion grading worksheet that summarizes the important studies pertaining to the conclusion. Individual studies are classed according to the system defined in the Foreword and are assigned a designator of +, -, or ø to reflect the study quality. Conclusion grades are determined by the work group based on the following definitions:

Grade I: The evidence consists of results from studies of strong design for answering the question addressed. The results are both clinically important and consistent with minor exceptions at most. The results are free of any significant doubts about generalizability, bias, and flaws in research design. Studies with negative results have sufficiently large samples to have adequate statistical power.

Grade II: The evidence consists of results from studies of strong design for answering the question addressed, but there is some uncertainty attached to the conclusion because of inconsistencies among the results from the studies or because of minor doubts about generalizability, bias, research design flaws, or adequacy of sample size. Alternatively, the evidence consists solely of results from weaker designs for the question addressed, but the results have been confirmed in separate studies and are consistent with minor exceptions at most.

Grade III: The evidence consists of results from studies of strong design for answering the question addressed, but there is substantial uncertainty attached to the conclusion because of inconsistencies among the results from different studies or because of serious doubts about generalizability, bias, research design flaws, or adequacy of sample size. Alternatively, the evidence consists solely of results from a limited number of studies of weak design for answering the question addressed.

Grade Not Assignable: There is no evidence available that directly supports or refutes the conclusion.

The symbols +, –, ø, and N/A found on the conclusion grading worksheets are used to designate the quality of the primary research reports and systematic reviews:

+ indicates that the report or review has clearly addressed issues of inclusion/exclusion, bias, generaliz-ability, and data collection and analysis;

– indicates that these issues have not been adequately addressed;

ø indicates that the report or review is neither exceptionally strong or exceptionally weak;

N/A indicates that the report is not a primary reference or a systematic review and therefore the quality has not been assessed.



www.icsi.org

40


Conclusion Grading Worksheet A – Annotation #10 (Home Self-Care)

Wo

rk G

rou

p's

Co

ncl

usi

on

: A

dv

ise

pat

ien

ts w

ith

acu

te l

ow

bac

k p

ain

to

sta

y a

ctiv

e an

d c

on

tin

ue

ord

inar

y a

ctiv

ity

wit

hin

th

e li

mit

s p

erm

itte

d

by

th

e p

ain

. R

emai

nin

g a

ctiv

e le

ads

to m

ore

rap

id r

eco

ver

y w

ith

les

s ch

ron

ic d

isab

ilit

y a

nd

few

er r

ecu

rren

t p

rob

lem

s th

an e

ith

er b

ed r

est

or

bac

k

mo

bil

izin

g e

xer

cise

s.

Co

ncl

usi

on

Gra

de:

I

Au

tho

r/Y

ear

Des

ign

T

yp

e C

lass

Q

ual

-it

y

+,–

,ø

Po

pu

lati

on

Stu

die

d/S

amp

le S

ize

Pri

mar

y O

utc

om

e M

easu

re(s

)/R

esu

lts

(e.g

., p

-val

ue,

co

nfi

den

ce i

nte

rval

, re

lati

ve

risk

, o

dd

s ra

tio

, li

keli

-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Lin

dst

röm

et

al.

(19

92

) R

CT

A

ø

-I

nd

ust

rial

blu

e-co

llar

wo

rker

s w

ho

w

ere

sick

-lis

ted

6 w

ks

du

e to

an

y

low

bac

k p

ain

dia

gn

osi

s an

d n

o s

ick

le

ave

du

e to

lo

w b

ack

pai

n i

n t

he

wk

s b

efo

re t

he

curr

ent

epis

od

e (s

ub

-acu

te);

ex

amin

ed b

y o

rth

op

e-d

ic s

urg

eon

-E

xcl

ud

ed:

lo

w b

ack

pai

n d

ue

to

dis

k h

ern

iati

on

, sp

on

dy

loli

sth

esis

, st

eno

sis,

in

stab

ilit

y,

pre

vio

us

bac

k

surg

ery

, v

erte

bra

l fr

actu

re,

infl

am-

mat

ory

dis

ease

s, p

reg

nan

cy,

def

ined

m

edic

al o

r p

sych

iatr

ic d

iag

no

ses,

d

rug

ab

use

-A

fter

8 w

ks

of

sick

lea

ve

ran

do

m-

ized

to

act

ivit

y (

eval

uat

ion

by

p

hy

sica

l th

erap

ist

and

mea

sure

men

t o

f fu

nct

ion

al c

apac

ity

, w

ork

pla

ce

vis

it,

bac

k s

cho

ol

edu

cati

on

, an

d

ind

ivid

ual

su

bm

axim

al g

rad

ed e

x-

erci

se p

rog

ram

wit

h g

oal

of

retu

rn-

ing

to

wo

rk)

or

con

tro

l

-Bo

th g

rou

ps

eval

uat

ed b

y o

rth

op

e-d

ic s

urg

eon

, so

cial

wo

rker

an

d

ph

ysi

cal

ther

apis

t at

on

e y

ear

-96

% f

oll

ow

-up

at

1 y

ear

(see

NO

TE

S)

-No

dif

fere

nce

s at

bas

elin

e in

ag

e, r

ang

e o

f m

oti

on

, fo

r-w

ard

ben

din

g p

ain

, p

ain

beh

avio

r, o

r d

isab

ilit

y

-Aft

er t

reat

men

t (v

s. b

asel

ine)

- a

ctiv

ity

gro

up

im

pro

ved

in

sp

inal

mo

bil

ity

(m

od

ifie

d S

cho

ber

, b

ack

war

d b

end

ing

, lu

mb

ar r

ang

e o

f m

oti

on

, ro

tati

on

, &

act

ive

leg

-lif

t);

stre

ng

th (

arm

, b

ack

mu

scle

en

du

ran

ce,

& l

ifti

ng

cap

acit

y);

an

d c

ard

iov

ascu

lar

fitn

ess

(all

p<

0.0

1)

-At

on

e y

ear

(vs.

bas

elin

e) -

act

ivit

y g

rou

p i

mp

rov

ed i

n

spin

al m

ob

ilit

y (

fin

ger

-flo

or

dis

tan

ce,

mo

dif

ied

Sch

ob

er,

& l

um

bar

ran

ge

of

mo

tio

n),

str

eng

th (

abd

om

inal

en

du

r-an

ce t

ime

& l

ifti

ng

cap

acit

y),

an

d c

ard

iov

ascu

lar

fitn

ess

(all

p<

0.0

1)

-At

on

e y

ear

acti

vit

y g

rou

p h

ad g

reat

er s

pin

al m

ob

ilit

y

(mo

dif

ied

Sch

ob

er,

bac

kw

ard

ben

din

g,

lum

bar

ran

ge

of

mo

tio

n,

late

ral

ben

d,

rota

tio

n),

gre

ater

str

eng

th (

abd

om

inal

m

usc

le e

nd

ura

nce

, b

ack

mu

scle

en

du

ran

ce,

& s

ever

al l

ift-

ing

tas

ks)

, an

d g

reat

er c

ard

iov

ascu

lar

fitn

ess

(all

p<

0.0

1)

-Nu

mb

er o

f si

ck d

ays

bef

ore

ret

urn

to

wo

rk c

orr

elat

ed

wit

h a

ctiv

ity

gro

up

pre

-tre

atm

ent

spin

al r

ota

tio

n (

r=-0

.47

),

abd

om

inal

mu

scle

en

du

ran

ce (

r=-0

.45

), a

nd

lif

tin

g c

apac

-it

y (

r=-0

.58

)

-Act

ivit

y g

rou

p r

etu

rned

to

wo

rk s

ign

ific

antl

y e

arli

er t

han

co

ntr

ol

gro

up

(1

0 w

ks

vs.

15

.1 w

ks)

(p

val

ue

no

t re

po

rted

)

-Th

e g

rad

ed a

ctiv

ity

pro

gra

m i

mp

rov

ed m

ob

ilit

y,

stre

ng

th a

nd

fit

nes

s in

th

e ac

tiv

ity

gro

up

bef

ore

re

turn

to

wo

rk.

Th

e p

rog

ram

pro

ved

to

be

a su

c-ce

ssfu

l m

eth

od

of

reg

ain

ing

occ

up

atio

nal

fu

nct

ion

an

d f

acil

itat

ing

ret

urn

to

wo

rk i

n p

atie

nts

wit

h

sub

-acu

te (

8 w

ks)

lo

w b

ack

pai

n.

NO

TE

S:

no

sp

ecif

ic n

um

ber

of

wee

ks

for

acti

v-

ity

pro

gra

m;

pat

ien

ts c

on

tin

ual

ly e

nco

ura

ged

to

re

turn

to

wo

rk;

2 p

atie

nts

in

act

ivit

y g

rou

p d

id n

ot

par

tici

pat

e in

ex

erci

se p

rog

ram

an

d d

id n

ot

atte

nd

1

-yr

foll

ow

-up

bu

t re

turn

ed t

o w

ork

aft

er 1

5 a

nd

2

9 d

ays;

3 p

atie

nts

in

co

ntr

ol

gro

up

did

no

t at

ten

d

1-y

r fo

llo

w-u

p (

2 r

etu

rned

to

wo

rk a

t 1

3 a

nd

59

d

ays;

on

e d

id n

ot

retu

rn t

o w

ork

)


www.icsi.org

41

Conclusion Grading Worksheet A – Adult Low Back Pain Annotation #10 (Home Self-Care) Fourteenth Edition/November 2010

Au

tho

r/Y

ear

D

esig

n

Ty

pe

Cla

ss

Qu

al-

ity

+

,–,ø

Po

pu

lati

on

Stu

die

d/S

am

ple

Siz

e P

rim

ary

Ou

tco

me M

eas

ure

(s)/

Res

ult

s (e

.g.,

p-v

alu

e,

con

fid

ence

inte

rval

, re

lati

ve r

isk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Faa

s, C

hav

ann

es,

v

an E

ijk

, &

Gu

b-

bel

s (1

99

3)

RC

T

A

ø

-47

3 p

atie

nts

wit

h n

ew b

ack

pai

n

epis

od

e w

ho

co

nsu

lted

gen

eral

p

ract

itio

ner

-In

clu

ded

: p

ain

bet

ween

T1

2 a

nd

g

lute

al f

old

s w

ith

or

wit

ho

ut

rad

ia-

tio

n t

o u

pp

er

leg

, p

ain

fo

r ≤

3 w

ks,

ag

e 1

6 t

o 6

5

-Ex

clu

ded

: ra

dia

tio

n o

f p

ain

belo

w

kn

ee,

sig

ns

of

ner

ve

roo

t co

mp

res-

sio

n o

r n

euro

log

ic d

efic

it,

pain

ca

use

d b

y t

rau

ma, b

ack

pai

n e

pi-

sod

e w

ith

in p

ast

2 m

os,

pre

vio

us

bac

k s

urg

ery

, su

spic

ion

of

mal

ig-

nan

cy o

r o

ther

dis

ease

, p

elv

ic

ob

liq

uit

y >

1.5

cm

, g

ibb

us

>1

cm

, p

reg

nan

cy

-All

rece

ived

sta

nd

ard

in

fo.

fro

m

ph

ysi

cian

; ra

nd

om

ized

to

usu

al

care

, p

lace

bo

ult

raso

un

d o

r ex

erc

ise

(ph

ysi

cia

n w

as

bli

nd

ed t

o t

reat

men

t g

rou

p a

ssig

nm

ent)

-P

arace

tam

ol

giv

en (

1st

mo

nth

) -

Fo

llo

w-u

p a

t 2

wk

s, 4

wk

s an

d 1

2

mo

s; m

on

thly

qu

esti

on

nair

es

-Usu

al c

are

was

in

form

atio

n a

nd

an

alg

esic

s o

n d

eman

d

-Pla

ceb

o w

as

low

est

po

ssib

le d

ose

u

ltra

son

og

rap

hy

, 2

0 m

in, 2

x p

er w

k

for

5 w

ks

-Ex

erci

se w

as i

nd

ivid

ual

inst

ruct

ion

2

0 m

in, 2

x p

er

wk

fo

r 5

wk

s; 8

ex

-er

cise

s an

d 7

pie

ces

of

adv

ice

for

dai

ly l

ivin

g;

adv

ised

to

rep

eat

dail

y

-Vis

ual

an

alo

g p

ain

scal

e fo

r p

ain

at

that

mo

men

t an

d

max

imu

m p

ain

(p

rev

iou

s m

on

th);

fu

nct

ion

al h

eal

th s

tatu

s q

ues

tio

nn

aire

fo

r p

ercei

ved

heal

th (

6 d

imen

sio

ns)

& i

nfl

u-

ence

of

perc

eiv

ed h

eal

th o

n 7

are

as

(fo

r co

nd

itio

n a

t th

at

mo

men

t an

d p

rev

iou

s m

on

th)

-Pri

mary

ou

tco

mes

- n

um

ber

an

d d

ura

tio

n o

f p

ain

ep

iso

des

and

rec

urr

ences

, ch

ang

e i

n f

un

ctio

nal

sta

tus,

mo

bil

ity

p

rob

lem

s, a

nd

in

flu

ence

on

dai

ly l

ife

-Gro

up

s w

ere

com

para

ble

at

bas

elin

e -6

0 d

rop

ped

- e

qu

al

nu

mb

ers

per

gro

up

, n

o d

iffe

ren

ces

in

re

aso

ns

for

or

tim

e o

f d

rop

pin

g o

ut

-Did

in

ten

tio

n t

o t

reat

analy

sis,

on

tre

atm

ent

anal

ysi

s, a

nd

b

est

case

s an

aly

sis

-Du

rin

g t

reatm

ent

11

8 o

f 1

56

(7

6%

) in

ex

erci

se g

rou

p

com

pli

ed a

s d

id 1

45

of

16

2 (

90

%)

in p

lace

bo

gro

up

; at

3

mo

nth

s 8

2%

of

pat

ien

ts s

aid

th

ey d

id e

xer

cise

s in

las

t 2

m

on

ths

and

at

12

mo

nth

s th

is w

as 5

4%

; 5

0%

sta

ted

th

ey

had

do

ne

exer

cise

s fo

r ≥

7 m

os;

50

% s

tate

d t

hey

had

ap

-p

lied

ad

vic

e f

or ≥

7 m

os

-32

2 h

ad ≥

1 r

ecu

rren

ce (

mean

of

1.6

per

pati

ent)

U

sual

Car

e P

laceb

o

Ex

erc

ise

Mean

du

rati

on

of

pai

n 5

7 d

ays

5

4 d

ays

5

8 d

ays

Du

rati

on

of

recu

rren

ce 5

3 d

ays

4

1 d

ays

4

5 d

ays*

*

p=

0.0

2 v

s. u

sual

car

e N

o e

ffect

mo

dif

icati

on

an

d n

o d

iffe

ren

ces

wit

h o

n t

reat

-m

ent

or

best

case

s an

aly

ses

-P

ain

, m

ob

ilit

y p

rob

lem

s an

d t

ired

nes

s im

pro

ved

fo

r all

3

gro

up

s; e

xer

cise

gro

up

was

sig

nif

ican

tly

dif

fere

nt

fro

m

usu

al c

are

on

tir

edn

ess

du

rin

g 1

st 3

mo

s an

d o

n e

mo

tio

nal

pro

ble

ms

du

rin

g t

he

1st

mo

nth

-N

o d

iffe

ren

ces

bet

ween

gro

up

s o

n m

ob

ilit

y p

rob

lem

s, i

n-

flu

ence

on

dai

ly l

ife,

or

bet

wee

n f

oll

ow

-up

co

nsu

ltat

ion

s w

ith

ph

ysi

cian

; m

ore

ph

ysi

oth

erap

y r

efer

rals

in

th

e u

sual

care

gro

up

(n

ot

sig

nif

ican

t)

-No

po

siti

ve e

ffect

s o

f ex

erci

se t

her

apy

co

uld

be

sho

wn

on

th

e n

um

ber

of

recu

rren

ces,

fu

nct

ion

al

hea

lth

sta

tus,

per

ceiv

ed p

rob

lem

s in

dai

ly l

ife,

an

d o

n m

edic

al c

are

usa

ge

-Sin

ce

exerc

ise

gro

up

did

no

t d

iffe

r fr

om

pla

ceb

o

gro

up

, p

osi

tiv

e b

enefi

ts a

re a

res

ult

of

the

ph

ysi

o-

ther

apis

t's

att

enti

on

to

pati

ent

-Pat

ien

ts r

efer

red

to

ph

ysi

oth

erap

ist

or

to b

ack

sc

ho

ol

recei

ve a

lo

t o

f n

eed

less

, ex

pen

siv

e a

tten

-ti

on

fo

r co

mp

lain

ts t

hat

in

mo

st c

ase

s w

ou

ld h

ave

dis

app

eare

d s

po

nta

neo

usl

y;

too

mu

ch a

tten

tio

n t

o

con

dit

ion

is

un

desi

rab

le

-Ex

erci

se t

her

apy

sh

ou

ld n

ot

be

reco

mm

end

ed f

or

no

nsp

ecif

ic a

cute

back

pain

W

ork

Gro

up

's C

om

men

ts:

-Did

sa

mp

le s

ize

est

ima

tio

n

-Da

ta w

as

mo

stly

sel

f-re

po

rted

-T

her

e w

as

low

er u

se o

f th

era

py a

nd

an

alg

esic

s in

exe

rcis

e g

rou

p

-Lit

tle

info

rma

tio

n o

n o

ther

acti

viti

es (

e.g

., o

ccu

-p

ati

on

al)

of

pa

tien

ts


www.icsi.org

42

Aut

hor/

Yea

rD

esig

nT

ype

Cla

ssQ

ual-

ity+

,–,ø

Popu

latio

n St

udie

d/Sa

mpl

e Si

zePr

imar

y O

utco

me

Mea

sure

(s)/

Res

ults

(e.

g., p

-val

ue,

conf

iden

ce in

terv

al, r

elat

ive

risk

, odd

s ra

tio, l

ikel

i-ho

od r

atio

, num

ber

need

ed to

trea

t)

Aut

hors

' Con

clus

ions

/W

ork

Gro

up's

Com

men

ts (

italic

ized

)

Mal

miv

aara

,H

äkki

nen,

Aro

,et

al.

(199

5)

RC

TA

ø-M

unic

ipal

em

ploy

ees

pres

enti

ngw

ith

low

bac

k pa

in a

s m

ain

sym

p-to

m (

acut

e or

exa

cerb

atio

ns o

fch

roni

c pa

in l

asti

ng <

3 w

ks)

-Inc

lude

d pa

in r

adia

ting

bel

owkn

ee-E

xclu

ded:

sci

atic

syn

drom

e,pr

egna

nt,

hist

ory

of c

ance

r, l

um-

bar

spin

e fr

actu

re,

urin

ary

trac

tdi

seas

e-B

asel

ine

and

outc

omes

res

earc

h-er

s w

ere

unaw

are

of t

reat

men

t-R

ando

miz

ed t

o be

d re

st (

2 da

ys),

exer

cise

(1

sess

ion

of i

nstr

ucti

onw

ith

exer

cise

s to

be

done

at

hom

eev

ery

othe

r ho

ur d

urin

g th

e da

yun

til

pain

sub

side

d),

or c

ontr

ol(u

sual

act

ivit

ies

wit

hin

lim

its

due

to p

ain)

-Fol

low

-up

visi

ts:

3 an

d 12

wks

-Eco

nom

ic a

naly

sis

at 1

2 w

ks -

use

and

cost

s of

hea

lth

care

ser

v-ic

es a

nd h

elp

at h

ome

-186

wer

e ra

ndom

ized

(67

to

bed

rest

, 52

to

exer

cise

, 67

to u

sual

act

ivit

y);

3 w

k fo

llow

-up

from

165

(89

%)

and

12 w

k fo

llow

-up

from

162

(87

%);

no

base

line

dif

fer-

ence

s be

twee

n th

ose

wit

h fo

llow

-up

and

thos

e lo

st t

ofo

llow

-up

-Gro

ups

wer

e si

mil

ar a

t ba

seli

ne e

xcep

t m

ore

enga

ged

in h

eavy

phy

sica

l w

ork

in c

ontr

ol g

roup

, m

ore

wit

hpa

in b

elow

the

kne

e in

bed

res

t gr

oup,

and

mor

e w

ith

prol

onge

d pa

in i

n la

st 1

2 m

onth

s in

exe

rcis

e gr

oup

-Com

plia

nce

data

:

Bed

Res

t E

xerc

ise

C

ontr

olD

aytim

e be

d re

st (

hr)

2

2

5

2

Exe

rcis

e se

ssio

ns (

#)

8

6

1

3Pr

escr

ibed

dru

gs (

%)

9

3

91

93-S

igni

fica

nt o

utco

mes

at

3 w

ks:

Con

trol

gro

up h

ad f

ewer

sic

k da

ys a

nd h

ighe

r su

bjec

-ti

ve r

atin

g of

abi

lity

to

wor

k th

an b

ed r

est

grou

p; c

on-

trol

gro

up h

ad f

ewer

sic

k da

ys,

shor

ter

dura

tion

of

pain

,an

d be

tter

bac

k-di

sabi

lity

ind

ex s

core

tha

n ex

erci

segr

oup

-Sig

nifi

cant

out

com

es a

t 12

wks

:C

ontr

ol g

roup

had

few

er s

ick

days

, lo

wer

int

ensi

ty o

fpa

in,

bett

er l

umba

r fl

exio

n, a

nd b

ette

r ba

ck-d

isab

ilit

yin

dex

scor

e th

an b

ed r

est

grou

p; c

ontr

ol g

roup

had

few

er s

ick

days

and

bet

ter

lum

bar

flex

ion

than

exe

rcis

egr

oup

-Vis

its

to d

octo

rs w

ere

mor

e fr

eque

nt i

n ex

erci

se g

roup

than

con

trol

gro

up b

ut n

o ot

her

sign

ific

ant

diff

eren

ces

in c

osts

or

use

of s

ervi

ces

-Avo

idin

g be

d re

st a

nd m

aint

aini

ng o

rdin

ary

acti

vity

as

tole

rate

d le

ad t

o th

e m

ost

rapi

d re

-co

very

NO

TE

S:

was

not

pos

sibl

e fo

r he

alth

car

e pe

r-so

nnel

to

rem

ain

com

plet

ely

unaw

are

of t

reat

-m

ent

assi

gnm

ents

; de

gree

of

sati

sfac

tion

wit

htr

eatm

ent

did

not

diff

er a

mon

g th

e th

ree

grou

ps;

com

plia

nce

was

ade

quat

e bu

t m

ay h

ave

been

ove

rest

imat

ed (

self

-rep

ort)

Wor

k G

roup

's C

omm

ents

:-D

id s

ampl

e si

ze e

stim

atio

n-O

ccup

atio

nal

heal

th s

etti

ng



www.icsi.org

43

Aut

hor/

Yea

rD

esig

nT

ype

Cla

ssQ

ual-

ity+

,–,ø

Popu

latio

n St

udie

d/Sa

mpl

e Si

zePr

imar

y O

utco

me

Mea

sure

(s)/

Res

ults

(e.

g., p

-val

ue,

conf

iden

ce in

terv

al, r

elat

ive

risk

, odd

s ra

tio, l

ikel

i-ho

od r

atio

, num

ber

need

ed to

trea

t)

Aut

hors

' Con

clus

ions

/W

ork

Gro

up's

Com

men

ts (

italic

ized

)

Lju

nggr

en,

We-

ber,

Kog

stad

,T

hom

, & K

irk-

esol

a (1

997)

RC

TA

–-P

atie

nts

wit

h "b

ack

prob

lem

s" r

e-fe

rred

to

phys

ioth

erap

y by

gen

-er

al p

ract

itio

ners

-All

wer

e oc

cupa

tion

ally

act

ive,

ages

18-

65 y

ears

, hi

stor

y of

bac

kpr

oble

ms

-Exc

lude

d pa

tien

ts f

or w

hom

any

of t

he e

xerc

ises

was

con

trai

ndi-

cate

d in

clud

ing

root

aff

ecti

ons,

spin

al s

teno

sis,

spo

ndyl

olys

is,

infl

amm

ator

y rh

eum

atic

dis

ease

s-R

ando

miz

ed t

o 2

trea

tmen

tgr

oups

: p

hysi

othe

rapi

st-

desi

gned

exe

rcis

e pr

ogra

m (

PT)

orpr

ogra

m o

n a

Ter

apiM

aste

r ap

pa-

ratu

s (T

M)

-Ins

truc

ted

by a

the

rapi

st a

nd f

ol-

low

ed f

or 6

wks

(4

tele

phon

e co

n-ta

cts

and

4 pe

rson

al v

isit

s)-A

sked

to

exer

cise

for

15-

30 m

in3X

per

wk;

9 e

xerc

ises

with

3 s

e-ri

es o

f 10

rep

etit

ions

of

each

;w

eigh

ts w

ere

adde

d if

app

ropr

iate

-Rec

orde

d ab

sent

eeis

m f

rom

wor

k, a

mou

nt o

f ex

erci

sean

d sa

tisf

acti

on w

ith

exer

cise

pro

gram

-153

wer

e en

roll

ed,

126

(82%

) co

mpl

eted

the

sup

er-

vise

d pa

rt o

f th

e st

udy

(6 w

eeks

), 1

03 (

67%

) co

mpl

eted

the

unsu

perv

ised

par

t of

the

stu

dy (

12 m

onth

s)-B

asel

ine:

di

ffer

ence

in

gend

er d

istr

ibut

ion

betw

een

the

2 gr

oups

(m

ore

mal

es i

n PT

pro

gram

, mor

e fe

mal

esin

TM

pro

gram

); h

eigh

t an

d w

eigh

t w

ere

grea

ter

in t

heP

T g

roup

; m

ore

abse

ntee

ism

in

past

12

mon

ths

in t

hePT

gro

up (

82.5

day

s vs

. 61

.6 d

ays,

NS)

; m

ore

prev

ious

back

epi

sode

s in

TM

gro

up (

84%

vs.

69%

, NS)

; m

ore

sick

lea

ve i

n la

st 1

2 m

onth

s in

PT

gro

up (

88%

vs.

68%

,N

S);

mor

e on

sic

k le

ave

at i

nclu

sion

in

TM

gro

up (

27%

vs. 1

4%, N

S)-S

igni

fica

nt r

educ

tion

in

abse

ntee

ism

was

obs

erve

dfr

om 8

2.5

days

to

5.7

days

(ov

er 1

2 m

onth

s un

supe

r-vi

sed

stud

y) f

or t

he P

T g

roup

and

fro

m 6

1.6

days

to

5.6

days

for

the

TM

gro

up;

non-

sign

ific

ant

diff

eren

ce b

e-tw

een

grou

ps-C

ompl

ianc

e an

d pa

tien

t sa

tisf

acti

on e

qual

ly g

ood

inbo

th g

roup

s; a

mou

nt o

f ex

erci

se a

nd p

atie

nt s

atis

-fa

ctio

n bo

th d

ecre

ased

dur

ing

the

unsu

perv

ised

par

t of

the

stud

y (c

ompa

red

to t

he s

uper

vise

d pa

rt)

-The

re i

s no

dif

fere

nce

betw

een

the

2 ex

erci

sepr

ogra

ms

wit

h re

gard

to

thei

r ef

fect

iven

ess

inth

e tr

eatm

ent

of b

ack

prob

lem

s

NO

TE

S:

need

mor

e at

tent

ion

to e

xerc

ise

com

-pl

ianc

e; f

requ

ent

foll

ow-u

ps b

y ph

ysio

ther

a-pi

sts

are

prob

ably

a p

rere

quis

ite

for

good

com

-pl

ianc

e; d

id n

ot s

tand

ardi

ze e

xerc

ise

regi

men

sbe

caus

e th

e ab

ilit

y to

tol

erat

e ex

erci

ses

was

not

unif

orm

am

ong

part

icip

ants

; ex

erci

ses

wer

e ta

i-lo

red

to i

ndiv

idua

l's s

tren

gth,

end

uran

ce,

fit-

ness

Wor

k G

roup

's C

omm

ents

:-6

9% o

f th

e pa

tien

ts i

n th

e co

nven

tion

al t

rain

-in

g gr

oup

and

84%

in

the

Ter

apiM

aste

r gr

oup

had

prev

ious

bac

k ep

isod

es r

esul

ting

in

ab-

sent

eeis

m-T

here

wer

e di

ffer

ence

s be

twee

n gr

oups

at

base

line

tha

t, al

thou

gh n

ot s

igni

fica

nt,

wer

esu

bsta

ntia

l



www.icsi.org

44

Aut

hor/

Yea

rD

esig

nT

ype

Cla

ssQ

ual-

ity+

,–,ø

Popu

latio

n St

udie

d/Sa

mpl

e Si

zePr

imar

y O

utco

me

Mea

sure

(s)/

Res

ults

(e.

g., p

-val

ue,

conf

iden

ce in

terv

al, r

elat

ive

risk

, odd

s ra

tio, l

ikel

i-ho

od r

atio

, num

ber

need

ed to

trea

t)

Aut

hors

' Con

clus

ions

/W

ork

Gro

up's

Com

men

ts (

italic

ized

)

Skar

gren

, Ö

berg

,C

arls

son,

&G

ade

(199

7)

RC

TA

–-P

atie

nts

wit

h lo

w b

ack

or n

eck

pain

ref

erre

d fo

r tr

eatm

ent

from

prim

ary

care

-Inc

lude

d th

ose

wit

h no

act

ive

trea

tmen

t fo

r lo

w b

ack

or n

eck

pain

wit

hin

the

past

mon

th a

nd n

oco

ntra

indi

cati

on t

o m

anip

ulat

ion

-Exc

lude

d th

ose

wit

h af

fect

edne

rve

root

, os

teop

enia

, su

spec

ted

infe

ctio

n, a

noth

er d

isea

se,

in-

volv

ed i

n ac

cide

nt i

n pa

st 1

0da

ys,

preg

nanc

y, t

reat

men

ts c

on-

side

red

irre

leva

nt-R

ando

miz

ed t

o ch

irop

ract

ic (

CP

)ca

re o

r ph

ysio

ther

apy

(PT

)

-219

ran

dom

ized

to

CP

and

192

to P

T;

179

in C

P an

d14

4 in

PT

par

tici

pate

d (3

23 t

otal

)-A

sses

sed

pain

(in

tens

ity,

fre

quen

cy,

use

of p

ain

kill

-er

s),

func

tion

(si

ck l

eave

, lo

w b

ack

pain

dis

abil

ity

ques

tion

nair

e),

and

gene

ral

heal

th;

pati

ents

exp

ecta

-ti

ons

of t

reat

men

t, fu

lfil

lmen

t of

exp

ecta

tion

s, a

ndtr

eatm

ent

effi

cacy

; di

rect

and

ind

irec

t co

sts

-Bas

elin

e: P

T g

roup

rep

orte

d gr

eate

r pa

in i

nten

sity

(p≤0

.05)

and

wor

se g

ener

al h

ealt

h (p

≤0.0

1)-C

P g

roup

rec

eive

d pr

imar

ily

man

ipul

atio

n; P

T g

roup

rece

ived

var

iety

of

trea

tmen

ts;

mea

n nu

mbe

r of

ses

-si

ons

duri

ng t

reat

men

t pe

riod

was

hig

her

for

PT

gro

up(6

.4 v

s. 4

.9,

p≤0.

001)

; al

l ha

d co

mpl

eted

tre

atm

ent

be-

fore

6 m

onth

fol

low

-up

ques

tion

nair

e-A

fter

tre

atm

ent

13%

of

CP

grou

p an

d 4%

of

PT g

roup

wen

t ba

ck f

or f

ollo

w-u

p vi

sit;

13%

of

CP

grou

p re

-ce

ived

add

itio

nal

PT t

reat

men

t an

d 6%

of

PT g

roup

re-

ceiv

ed C

P; t

he P

T g

roup

rec

eive

d m

ean

of 7

.9 t

reat

men

tse

ssio

ns (

com

bine

d PT

and

CP)

wit

h 7.

0 fo

r th

e C

Pgr

oup

-20%

of

pati

ents

in

both

gro

up u

sed

addi

tion

al h

ealt

hse

rvic

es d

urin

g tr

eatm

ent;

dur

ing

foll

ow-u

p ad

diti

onal

serv

ices

wer

e us

ed b

y 37

% o

f th

e C

P gr

oup

and

30%

of

the

PT g

roup

-No

com

plic

atio

ns d

ue t

o tr

eatm

ent

wer

e re

port

ed-H

ighl

y si

gnif

ican

t im

prov

emen

t in

pai

n, f

unct

ion,

and

gene

ral

heal

th r

elat

ed t

o th

e ba

ck o

r ne

ck p

robl

ems

imm

edia

tely

aft

er t

reat

men

t an

d at

6 m

onth

s (n

o di

ffer

-en

ce b

etw

een

grou

ps)

-Equ

al n

umbe

rs o

f pa

tien

ts r

epor

ted

recu

rren

ce-4

1% o

f C

P gr

oup

and

24%

of

PT g

roup

rep

orte

d th

attr

eatm

ent

fulf

ille

d th

eir

expe

ctat

ions

(p<

0.01

)-N

o di

ffer

ence

s in

dir

ect

or i

ndir

ect

cost

s

-No

diff

eren

ce i

n ou

tcom

e or

cos

ts b

etw

een

the

2 gr

oups

was

ide

ntif

ied,

nor

in

subg

roup

s de

-fi

ned

as d

urat

ion,

his

tory

, or

sev

erit

y of

sym

p-to

ms.

Wor

k G

roup

's C

omm

ents

:-T

here

was

no

"con

trol

" gr

oup

(i.e

., no

tre

at-

men

t or

usu

al c

are)

-No

dist

inct

ion

was

mad

e be

twee

n pa

tien

tsw

ith

low

bac

k pa

in a

nd t

hose

wit

h ne

ck p

ain

-Pat

ient

s w

ere

aske

d to

com

plet

e qu

esti

on-

nair

e an

d co

ntac

t th

erap

ist

them

selv

es -

76

neve

r co

ntac

ted

ther

apis

t or

wit

hdre

w b

efor

e1s

t tr

eatm

ent

and

12 w

ithd

rew

aft

er f

irst

trea

tmen

t



www.icsi.org

45

Aut

hor/

Yea

rD

esig

nT

ype

Cla

ssQ

ual-

ity+

,–,ø

Popu

latio

n St

udie

d/Sa

mpl

e Si

zePr

imar

y O

utco

me

Mea

sure

(s)/

Res

ults

(e.

g., p

-val

ue,

conf

iden

ce in

terv

al, r

elat

ive

risk

, odd

s ra

tio, l

ikel

i-ho

od r

atio

, num

ber

need

ed to

trea

t)

Aut

hors

' Con

clus

ions

/W

ork

Gro

up's

Com

men

ts (

italic

ized

)

Wad

dell

, Fe

der,

Lew

is (

1997

)S

yste

m-

atic

Rev

iew

Mø

-Rev

iew

ed a

ll r

ando

miz

ed c

on-

trol

led

tria

ls o

f be

d re

st a

nd o

rm

edic

al a

dvic

e to

sta

y ac

tive

for

acut

e ba

ck p

ain

-Inc

lude

d tr

ials

whe

re m

ain

sym

p-to

m w

as b

ack

pain

of

up t

o 3

mon

ths

dura

tion

, al

l tr

ials

of

bed

rest

, tr

ials

whe

re t

he i

nter

vent

ion

or c

ontr

ol w

as e

ithe

r be

d re

st o

rad

vice

on

mai

ntai

ning

nor

mal

ac-

tivi

ty l

evel

s, s

ubje

cts

≥18

yrs

-Ass

esse

d m

etho

dolo

gica

l qu

alit

y(2

ind

epen

dent

rev

iew

ers)

-10

tria

ls o

f be

d re

st a

nd 8

tri

als

of a

dvic

e to

sta

y ac

tive

(2 c

ompa

red

bed

rest

and

adv

ice

to s

tay

acti

ve a

nd w

ere

incl

uded

in

both

rev

iew

s)-5

of

10 t

rial

s of

bed

res

t ha

d m

etho

dolo

gy s

core

>50

%as

did

6 o

f 8

tria

ls o

f ad

vice

to

stay

act

ive

-8 o

f 10

tri

als

of b

ed r

est

show

ed t

hat

bed

rest

was

not

effe

ctiv

e; 1

of

the

othe

r tr

ials

use

d yo

ung

mal

e ar

my

re-

crui

ts i

n ti

ghtl

y co

ntro

lled

set

ting

and

the

oth

er c

om-

pare

d be

d re

st w

ith

cont

inuo

us t

ract

ion

vs.

bed

rest

wit

h sh

am t

ract

ion

and

didn

't ad

dres

s ef

fect

of

bed

rest

itse

lf-8

of

8 tr

ials

of

advi

ce t

o st

ay a

ctiv

e sh

owed

pos

itiv

eou

tcom

es (

wit

h di

ffer

ent

outc

ome

mea

sure

s);

no e

vi-

denc

e of

any

har

mfu

l ef

fect

or

incr

ease

d re

curr

ence

sw

ith

earl

y ac

tivi

ty-2

tri

als

com

pare

d ad

vice

to

stay

act

ive

wit

h be

d re

stan

d fo

und

fast

er r

ecov

ery

wit

h or

dina

ry a

ctiv

ity

-Mul

tipl

e tr

ials

sho

w t

hat

bed

rest

is

not

an e

f-fe

ctiv

e tr

eatm

ent

but

may

del

ay r

ecov

ery

-Adv

ice

to s

tay

acti

ve a

nd t

o co

ntin

ue o

rdin

ary

acti

vity

as

norm

ally

as

poss

ible

is

like

ly t

ogi

ve f

aste

r re

turn

to

wor

k, l

ess

chro

nic

disa

bil-

ity,

and

few

er r

ecur

rent

pro

blem

s

NO

TE

S:

diff

icul

t to

ide

ntif

y al

l re

leva

nt s

tud-

ies

due

to i

ndex

ing

in d

atab

ases

; qu

alit

y of

tri

-al

s w

as "

reas

onab

le"

- sm

all

sam

ple

size

s, i

n-su

ffic

ient

inf

o. a

bout

ran

dom

izat

ion

and

co-

inte

rven

tion

s, u

nbli

nded

ass

essm

ent

of o

ut-

com

es a

nd n

o in

tent

ion-

to-t

reat

ana

lysi

s ar

eli

mit

atio

ns

Und

erw

ood

&M

orga

n (1

998)

RC

TA

–-P

atie

nts

wit

h ba

ck p

ain

in a

gen

-er

al p

ract

ice

-Inc

lude

d: p

ain

for

<28

day

s at

tim

e tr

eatm

ent

wou

ld b

e gi

ven,

sym

ptom

-fre

e fo

r ≥2

8 da

ys b

efor

eth

is e

piso

de,

pain

fro

m 1

2th

tho-

raci

c ve

rt.

to b

utto

ck f

olds

, ag

es16

-70,

bil

ater

al p

ain,

no

peri

pher

-al

izat

ion

of p

ain

wit

h 10

rep

eate

dex

tens

ion

exer

cise

s in

sta

ndin

gpo

siti

on-E

xclu

ded:

inf

lam

mat

ory

join

tdi

seas

e, m

etas

tase

s or

inf

ecti

on,

spon

dylo

list

hesi

s,

neur

olog

ical

defi

cit,

oste

opor

osis

, pr

egna

ncy,

visc

eral

pat

holo

gy w

ith

pain

re-

ferr

ed t

o lo

wer

bac

k, p

revi

ous

tria

len

try,

int

enti

on t

o se

ek t

reat

men

tel

sew

here

-All

pat

ient

s re

ceiv

ed g

ener

al a

d-vi

ce a

bout

tre

atin

g ba

ck p

ain

-Ran

dom

ized

to

inte

rven

tion

(ap

-po

intm

ent

wit

h an

d gr

oup

teac

h-in

g se

ssio

n on

McK

enzi

e te

ch-

niqu

e) o

r co

ntro

l-Q

uest

ionn

aire

s at

1,

2, 4

, 8,

12,

and

52 w

eeks

-Out

com

es w

ere

Osw

estr

y L

ow B

ack

Dis

abili

ty S

core

,vi

sual

ana

log

scal

e fo

r pa

in,

use

of p

ain

kill

ers,

oth

erth

erap

ies,

day

s of

bac

k pa

in o

ver

prev

ious

6 m

onth

s(5

2 w

k qu

esti

onna

ire

only

)-7

8 re

ferr

ed f

or a

sses

smen

t, 3

subs

eque

ntly

exc

lude

d(d

idn'

t m

eet

elig

ibil

ity

requ

irem

ents

)-3

5 ra

ndom

ized

to

trea

tmen

t of

whi

ch 3

2 (9

1%)

at-

tend

ed;

both

gro

ups

retu

rned

84%

of

poss

ible

fol

low

-up

que

stio

nnai

res

-Bas

elin

e: c

ontr

ol g

roup

was

mor

e li

kely

to

have

tak

enpa

in k

ille

rs i

n pr

evio

us 2

4 ho

urs

(p<

0.03

); c

ontr

olgr

oup

had

high

er s

core

s fo

r di

sabi

lity

and

pai

n (N

S)

-No

sign

ific

ant

diff

eren

ces

betw

een

grou

ps i

n nu

mbe

rsof

pat

ient

s w

ith

a "g

ood"

out

com

e on

the

dis

abil

ity

scor

e or

pai

n sc

ore

at a

ny p

oint

in

stud

y-N

o di

ffer

ence

s in

pro

port

ions

rep

orti

ng t

hey

wer

e un

-ab

le t

o w

ork

at a

ny p

oint

in

stud

y-A

t on

e ye

ar m

ore

of t

reat

ed p

atie

nts

reco

rded

tha

t th

eir

back

s ha

d be

en n

o pr

oble

m t

o th

em i

n pr

eced

ing

6m

onth

s (p

<0.

007)

-Num

ber

of b

ack

pain

con

sult

atio

ns w

as s

ame

for

both

grou

ps w

ith

mor

e co

nsul

tati

ons

for

cond

itio

ns o

ther

than

bac

k pa

in i

n th

e co

ntro

l gr

oup

(p<

0.01

)

-Ear

ly i

nter

vent

ion

wit

h a

smal

l cl

ass

teac

hing

McK

enzi

e ba

ck e

xten

sion

exe

rcis

es d

id n

ot r

e-du

ce l

ong-

term

dis

abil

ity

-The

re w

as a

sug

gest

ion

that

mor

e of

the

tre

at-

men

t gr

oup

wer

e fr

ee o

f ba

ck p

robl

ems

at 1

yea

r

NO

TE

S:

goal

was

50

subj

ects

per

gro

up b

utth

is w

as n

ot a

chie

ved

beca

use

pote

ntia

lly

eli-

gibl

e pa

tien

ts w

ere

not

alw

ays

refe

rred

for

as-

sess

men

t an

d la

ter

in s

tudy

per

iod

som

e pa

-ti

ents

who

wou

ld h

ave

been

eli

gibl

e ha

d al

-re

ady

been

inc

lude

d

Wor

k G

roup

's C

omm

ents

:-8

4% o

vera

ll r

etur

n ra

te o

n qu

esti

onna

ires

(for

bot

h gr

oups

)



www.icsi.org

46

Aut

hor/

Yea

rD

esig

nT

ype

Cla

ssQ

ual-

ity+

,–,ø

Popu

latio

n St

udie

d/Sa

mpl

e Si

zePr

imar

y O

utco

me

Mea

sure

(s)/

Res

ults

(e.

g., p

-val

ue,

conf

iden

ce in

terv

al, r

elat

ive

risk

, odd

s ra

tio, l

ikel

i-ho

od r

atio

, num

ber

need

ed to

trea

t)

Aut

hors

' Con

clus

ions

/W

ork

Gro

up's

Com

men

ts (

italic

ized

)

Hid

es e

t al

.(2

001)

RC

TA

ø-3

9 pa

tien

ts;

ages

18-

45 y

rs;

mal

es &

fem

ales

; fi

rst

epis

ode

ofun

ilat

eral

mec

hani

cal

low

bac

kpa

in (

<3

wks

)-R

ando

miz

ed t

o 1)

Con

trol

(m

edi-

cal

man

agem

ent

wit

h ad

vice

on

bed

rest

, abs

ence

fro

m w

ork,

pre

-sc

ript

ion

of m

edic

atio

n, a

nd a

d-vi

ce t

o re

sum

e no

rmal

act

ivit

y or

2) S

peci

fic

Exe

rcis

e (s

ame

as C

on-

trol

plu

s sp

ecif

ic l

ocal

ized

exe

r-ci

ses

for

mul

tifi

dus

-4 w

k in

terv

enti

on;

exer

cise

2x/w

k-A

sses

smen

t:

McG

ill

Pain

Que

s-ti

onna

ire,

Vis

ual

Ana

log

Sca

le(p

ain)

, R

olan

d M

orri

s D

isab

ilit

yIn

dex,

ran

ge o

f m

otio

n, h

abit

ual

acti

vity

lev

els,

mus

cle

cros

s-se

ctio

nal

area

(w

ith

ultr

asou

nd)

-Tel

epho

ne i

nter

view

for

1-

and

3-ye

ar f

ollo

w-u

p of

rec

urre

nce

oflo

w b

ack

pain

-19

in c

ontr

ol g

roup

; 20

in

spec

ific

exe

rcis

e gr

oup

-Gro

ups

com

para

ble

at b

asel

ine

in a

ge,

gend

er d

istr

ibu-

tion

, he

ight

, w

eigh

t, du

rati

on o

f sy

mpt

oms,

sm

oker

s,w

orke

rs’

com

pens

atio

n, p

re-m

orbi

d ac

tivi

ty l

evel

s-W

eeks

1-4

: m

ulti

fidu

s si

ze w

as r

ecov

ered

mor

e co

m-

plet

ely

in t

he e

xerc

ise

grou

p at

4 w

ks a

nd a

t 10

wks

(p<

0.01

); p

ain

and

disa

bili

ty h

ad c

ompl

etel

y re

solv

edin

90%

of

pati

ents

(2

grou

ps s

imil

ar)

-39

resp

onse

s (1

00%

) at

1 y

r; 3

6 (9

2%)

at 3

yrs

-Con

trol

gro

up 1

2.4

tim

es m

ore

like

ly t

o ex

peri

ence

re-

curr

ence

s of

low

bac

k pa

in (

84%

vs.

30%

; p<

0.00

1) i

n1s

t ye

ar a

fter

ini

tial

epi

sode

and

9 t

imes

mor

e li

kely

in

year

s 2-

3 (p

<0.

01)

-19%

of

cont

rol

grou

p re

port

ed t

raum

atic

inc

iden

ce r

e-la

ted

to r

ecur

renc

e in

1st

yr

(vs.

67%

of

exer

cise

gro

up)

-Tre

atm

ent

soug

ht b

y 42

% o

f co

ntro

l gr

oup

and

15%

of

the

exer

cise

gro

up d

urin

g 1s

t yr

-Sub

ject

s w

ith

acut

e, f

irst

-epi

sode

low

bac

kpa

in w

ho r

ecei

ved

spec

ific

exe

rcis

e th

erap

y in

addi

tion

to

med

ical

man

agem

ent

and

resu

mp-

tion

of

norm

al a

ctiv

ity

expe

rien

ced

few

er r

ecur

-re

nces

of

low

bac

k pa

in i

n th

e lo

ng-t

erm

tha

nsu

bjec

ts w

ho r

ecei

ved

med

ical

man

agem

ent

only

and

res

umed

nor

mal

act

ivit

y.

NO

TE

S:

asse

ssor

s w

ere

blin

ded

to g

roup

all

o-ca

tion

and

pat

ient

pre

sent

atio

n; c

ompl

ete

shor

t-te

rm r

esul

ts p

rese

nted

in

anot

her

repo

rt



www.icsi.org

47


Au

tho

r/Y

ear

Des

ign

T

yp

e C

lass

Q

ual

-it

y

+,–

,ø

Po

pu

lati

on

Stu

die

d/S

amp

le S

ize

Pri

mar

y O

utc

om

e M

easu

re(s

)/R

esu

lts

(e.g

., p

-val

ue,

co

nfi

den

ce i

nte

rval

, re

lati

ve

risk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Lit

tle

et a

l.

(20

01

) R

CT

A

–

-C

on

secu

tiv

e p

atie

nts

see

kin

g

trea

tmen

t fo

r n

ew l

ow

bac

k p

ain

ep

iso

de

(du

rati

on

les

s th

an 3

m

on

ths

or

exac

erb

atio

n o

f ch

ron

ic

low

bac

k p

ain

) -E

xcl

ud

ed:

sta

ble

ch

ron

ic b

ack

p

ain

; ag

e <

16

or

>8

0;

dem

enti

a o

r o

ther

maj

or

psy

chia

tric

ill

nes

s; p

ro-

gre

ssiv

e o

r m

ult

ilev

el n

euro

log

ic

def

icit

; ca

ud

a eq

uin

a, p

rev

iou

s h

is-

tory

of

can

cer

or

pro

lon

ged

use

of

ora

l st

ero

ids,

pre

gn

ancy

, in

abil

ity

to

w

alk

50

yd

s -R

and

om

ized

to

co

ntr

ol,

ed

uca

-ti

on

al b

oo

kle

t, e

xer

cise

ad

vic

e,

bo

ok

let

and

ex

erci

se a

dv

ice

-All

gro

up

s to

ld t

o k

eep

as

mo

bil

e as

po

ssib

le;

exer

cise

gro

up

to

ld t

o

aim

fo

r re

gu

lar

exer

cise

(2

0 m

inu

tes

at l

east

3 t

imes

/wk

); b

oo

kle

t h

ad i

n-

form

atio

n o

n a

nat

om

y,

self

-m

anag

emen

t, e

xer

cise

ad

vic

e, p

rac-

tica

l ti

ps

for

acti

vit

ies

of

dai

ly l

iv-

ing

-P

ain

an

d f

un

ctio

n a

sses

sed

by

tel

e-p

ho

ne

at 1

wk

an

d 3

wk

s af

ter

en-

try

; q

ues

tio

nn

aire

(fo

r p

ain

, fu

nc-

tio

n,

sati

sfac

tio

n,

and

kn

ow

led

ge)

g

iven

to

pat

ien

ts t

o r

etu

rn a

fter

1

wk

-78

ran

do

miz

ed t

o c

on

tro

l g

rou

p,

81

to

bo

ok

let,

75

to

ex

-er

cise

ad

vic

e, a

nd

77

to

bo

ok

let

+ e

xer

cise

-F

oll

ow

-up

on

23

9 p

atie

nts

(5

9 c

on

tro

l, 8

1 b

oo

kle

t, 6

1 e

x-

erci

se,

56

bo

ok

let

+ e

xer

cise

) -P

ain

/Fu

nct

ion

sco

re r

edu

ced

by

8.7

% i

n b

oo

kle

t g

rou

p

(p=

0.0

5),

7.9

% i

n e

xer

cise

gro

up

(p

=0

.08

), a

nd

0.1

% i

n

bo

ok

let

+ e

xer

cise

gro

up

; at

3 w

ks

mea

n c

han

ges

wer

e 6

.3%

, 1

.4%

, an

d 4

.0%

, re

spec

tiv

ely

(n

o d

iffe

ren

ces

be-

twee

n g

rou

ps)

-A

ber

dee

n s

cale

res

ult

s w

ere

sim

ilar

- l

ow

er i

n b

oo

kle

t g

rou

p (

p=

0.0

6)

and

ex

erci

se g

rou

p (

p=

0.0

1)

bu

t n

ot

bo

ok

-le

t +

ex

erci

se g

rou

p

-No

dif

fere

nce

s in

per

cen

tag

e o

f p

atie

nts

rep

ort

ing

"b

ack

to

no

rmal

" -O

ver

all

sati

sfac

tio

n i

mp

rov

ed b

y b

oo

kle

t (p

=0

.02

) an

d

adv

ice

to e

xer

cise

(p

=0

.03

); b

oo

kle

t im

pro

ved

sat

isfa

ctio

n

wit

h a

mo

un

t o

f in

form

atio

n (

p=

0.0

03

) an

d c

on

ten

t o

f in

-fo

rmat

ion

(p

=0

.00

5)

bu

t n

ot

wit

h v

isit

or

man

agem

ent

of

bac

k p

ain

; ex

erci

se a

dv

ice

imp

rov

ed s

atis

fact

ion

wit

h

man

agem

ent

of

bac

k p

ain

(p

=0

.03

), a

mo

un

t o

f in

form

a-ti

on

(p

=0

.02

), a

nd

co

nte

nt

of

info

rmat

ion

(p

=0

.03

)

-Kn

ow

led

ge

was

hig

her

fo

r th

ose

rec

eiv

ing

bo

ok

let

or

bo

ok

let

and

ad

vic

e th

an t

ho

se i

n c

on

tro

l g

rou

p o

r ad

vic

e-al

on

e g

rou

p

-Ad

vic

e to

ex

erci

se o

r a

bo

ok

let

is l

ikel

y t

o i

n-

crea

se s

atis

fact

ion

an

d m

ake

mo

des

t ch

ang

es t

o

pai

n a

nd

fu

nct

ion

, o

ver

an

d a

bo

ve

adv

ice

to m

o-

bil

ize

and

use

sim

ple

an

alg

esia

, d

uri

ng

th

e fi

rst

wee

k a

fter

see

kin

g t

reat

men

t fo

r b

ack

pai

n.

It

may

no

t b

e h

elp

ful

to p

rov

ide

a d

etai

led

in

form

a-ti

on

bo

ok

let

and

ad

vic

e to

get

her

. N

OT

ES

: o

f 3

15

eli

gib

le,

31

1 p

arti

cip

ated

; as

-se

ssm

ent

was

bli

nd

ed;

sam

ple

siz

e es

tim

atio

n;

com

bin

ed p

ain

/fu

nct

ion

sco

re w

as v

alid

ated

fo

r th

is s

tud

y;

Ab

erd

een

pai

n a

nd

fu

nct

ion

sca

le a

lso

u

sed

Wo

rk G

rou

p's

Co

mm

ents

: i

ncl

ud

ed b

oth

acu

te

an

d c

hro

nic

ca

ses;

an

aly

sis

wa

s n

ot

by

inte

nti

on

-to

-tre

at


www.icsi.org

48

Conclusion Grading Worksheet B – Annotation #16 (Active Rehabilitation)


Wo

rk G

rou

p's

Co

ncl

usi

on

: T

her

e is

str

ong e

vid

ence

that

exer

cise

ther

apy i

s ef

fect

ive

for

chro

nic

low

bac

k p

ain. H

ow

ever

, th

ere

is i

nco

ncl

u-

sive

evid

ence

in f

avor

of

one

exer

cise

over

the

oth

er.

Co

ncl

usi

on

Gra

de:

I

Au

tho

r/Y

ear

Des

ign

T

yp

e C

lass

Q

ual

-it

y

+,–

,ø

Po

pu

lati

on

Stu

die

d/S

amp

le S

ize

Pri

mar

y O

utc

om

e M

easu

re(s

)/R

esu

lts

(e.g

., p

-val

ue,

co

nfi

den

ce i

nte

rval

, re

lati

ve

risk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Nel

son

, O

'Rei

lly

, M

ille

r, H

og

an,

Weg

ner

, &

Kel

ly

(19

95

)

Cas

e

Ser

ies

D

–

-Pat

ien

ts r

efer

red

fo

r re

hab

ilit

atio

n

-Ag

es 1

4 t

o 6

5 y

ears

-P

atie

nts

had

tri

ed a

n a

ver

age

of

6

dif

fere

nt

trea

tmen

ts;

89

% h

ad f

aile

d

a "s

up

erv

ised

ex

erci

se p

rog

ram

" -T

esti

ng

an

d r

ehab

ilit

atio

n u

sin

g a

lu

mb

ar-e

xte

nsi

on

mac

hin

e an

d a

to

rso

-ro

tati

on

mac

hin

e; a

ver

age

of

2x

per

wk

fo

r 1

hr

(als

o d

id a

ero

bic

ex

erci

se a

nd

oth

er m

usc

le s

tren

gth

-en

ing

) -W

atch

ed v

ideo

s, l

earn

ed b

od

y m

e-ch

anic

s an

d r

ead

lit

erat

ure

-G

iven

ho

me

pro

gra

m a

nd

ex

erci

se

dev

ice

at e

nd

of

pro

gra

m

-Tre

atm

ent

end

ed w

hen

pat

ien

t w

as

pai

n-f

ree

(or

nea

rly

) an

d n

ear

no

r-m

al f

un

ctio

n l

evel

, n

o l

on

ger

mak

-in

g o

bje

ctiv

e g

ain

s, o

r re

fuse

d t

o

coo

per

ate

or

giv

e g

oo

d e

ffo

rt

-Did

iso

met

ric

and

dy

nam

ic t

esti

ng

, ra

ted

bac

k a

nd

/or

leg

pai

n,

rate

d

fun

ctio

nal

ab

ilit

y

-Fo

llo

w-u

p q

ues

tio

nn

aire

at

7 t

o 1

8

mo

nth

s af

ter

dis

char

ge

-89

5 r

efer

red

: 6

27

co

mp

lete

d p

rog

ram

, 1

07

rec

om

men

ded

fo

r in

clu

sio

n b

ut

did

n't

enro

ll (

con

tro

l g

rou

p),

16

1 b

egan

b

ut

dro

pp

ed o

ut

-A

ver

age

of

18

vis

its

-Im

pro

vem

ents

in

sta

tic

stre

ng

th (

p<

0.0

01

), s

agit

tal

ran

ge

of

mo

tio

n (

17

%,

p<

0.0

01

), d

yn

amic

str

eng

th (

sag

itta

l an

d

rota

tio

nal

pla

nes

, p

<0

.00

1)

-60

2 l

iste

d l

ow

bac

k p

ain

as

a si

gn

ific

ant

com

pla

int

at

bas

elin

e; 6

4%

of

pat

ien

ts r

epo

rted

su

bst

anti

al d

ecre

ase

in

per

cep

tio

n o

f p

ain

(w

ith

12

% u

nch

ang

ed,

3%

wo

rse)

-4

29

lis

ted

leg

pai

n a

s a

sig

nif

ican

t co

mp

lain

t at

bas

elin

e;

62

% o

f p

atie

nts

rep

ort

ed s

ub

stan

tial

dec

reas

e in

pai

n (

wit

h

13

% u

nch

ang

ed,

2%

wo

rse)

-C

orr

elat

ion

bet

wee

n i

som

etri

c st

ren

gth

an

d c

han

ge

in l

ow

b

ack

pai

n w

as l

ow

(r=

0.3

2)

-Ov

eral

l re

spo

nse

to

tre

atm

ents

was

gra

ded

as

exce

llen

t b

y

46

%,

go

od

by

30

%,

fair

by

14

%,

and

po

or

by

8%

(ex

cel-

len

t o

r g

oo

d i

nd

icat

ed b

oth

su

bst

anti

al p

ain

rel

ief

and

su

b-

stan

tial

str

eng

th i

mp

rov

emen

t)

-Res

ult

s d

id n

ot

dif

fer

for

sub

gro

up

s b

ased

on

dia

gn

osi

s;

psy

cho

soci

al f

acto

rs d

id a

ffec

t re

sult

s w

ith

few

er e

xce

llen

t o

r g

oo

d r

esu

lts

in w

ork

ers'

co

mp

ensa

tio

n a

nd

/or

liti

gat

ion

ca

ses

-Dat

a fr

om

49

5 (

79

%)

of

pat

ien

ts a

t av

erag

e o

f 1

3 m

on

ths:

o

f th

ose

wit

h g

oo

d o

r ex

cell

ent

init

ial

resu

lts

94

% m

ain

-ta

ined

im

pro

vem

ent;

of

tho

se w

ith

in

itia

l fa

ir o

r p

oo

r re

-su

lts

25

% i

mp

rov

ed

-53

% r

epo

rted

usi

ng

ho

me

exer

cise

dev

ice

-G

reat

er u

tili

zati

on

of

hea

lth

car

e sy

stem

by

th

e co

ntr

ol

gro

up

(p

<0

.00

1);

co

ntr

ol

gro

up

als

o w

as l

ess

lik

ely

to

h

ave

go

tten

las

tin

g r

elie

f fr

om

tre

atm

ent

(p<

0.0

01

);

gro

up

s w

ere

sim

ilar

in

per

cen

t em

plo

yed

-Dat

a su

pp

ort

th

e u

se o

f sp

ecif

ic i

nte

nsi

ve

exer

-ci

se f

or

chro

nic

bac

k p

ain

pat

ien

ts (

reg

ard

less

of

un

der

lyin

g c

on

dit

ion

); p

rog

ram

was

su

cces

sfu

l ev

en t

ho

ug

h m

ajo

rity

had

pre

vio

usl

y t

ried

so

me

form

of

exer

cise

N

OT

ES

: c

on

tro

l g

rou

p i

s n

ot

a tr

ue

con

tro

l g

rou

p

bec

ause

sel

ecti

on

was

no

t ra

nd

om

an

d t

reat

men

t w

as n

ot

con

tro

lled

; p

oss

ible

sel

ecti

on

bia

s in

th

at

pat

ien

ts w

ere

refe

rred

to

pro

gra

m;

aver

age

cost

(i

ncl

ud

ing

all

ph

ysi

cian

fee

s an

d h

om

e eq

uip

-m

ent)

was

$2

25

0

Wo

rk G

rou

p's

Co

mm

ents

: -1

61

dro

pp

ed o

ut;

da

ta f

rom

12

2 o

f th

ose

wh

o

dro

pp

ed (

76

%)

ind

ica

ted

th

at

41

% f

elt

the

pro

-g

ram

wa

sn't h

elp

ing

(a

uth

ors

no

ted

th

at

im-

pro

vem

ents

wer

e o

ften

no

ted

on

ly a

fter

sev

era

l w

eeks

of

exer

cise

) -N

o i

nd

ica

tio

n o

f w

ha

t p

erce

nt

wer

e ju

dg

ed t

o

ha

ve c

om

ple

ted

pro

gra

m b

ase

d o

n t

he

thre

e cr

ite-

ria

-I

t is

no

t cl

ear

ho

w m

an

y p

ati

ents

ra

ted

th

e o

ver-

all

res

po

nse

to

tre

atm

ent

Sch

eer,

Wat

a-n

abe,

& R

adac

k

(19

97

)

Sy

stem

-at

ic

Rev

iew

M

ø

-Lit

erat

ure

sea

rch

fro

m 1

97

5-1

99

3

-Rev

iew

of

RC

Ts

wit

h c

on

curr

ent

con

tro

lled

su

bje

cts

that

in

clu

ded

re-

turn

-to

-wo

rk (

RT

W)

ou

tco

mes

-U

sed

26

-po

int

abst

ract

ion

sy

stem

fo

r m

eth

od

olo

gic

rig

or

-Id

enti

fied

4 d

eali

ng

wit

h e

xer

cise

an

d c

hro

nic

lo

w b

ack

pai

n

-2 o

f th

e 4

stu

die

s w

ere

of

too

lo

w q

ual

ity

to

per

mit

in

fer-

ence

s o

n v

oca

tio

nal

eff

ects

-1

of

the

stu

die

s in

clu

ded

to

o f

ew s

ub

ject

s m

issi

ng

wo

rk

-1 o

f th

e st

ud

ies

had

an

in

exp

lica

bly

pro

lon

ged

eff

ect

ov

er

1 y

ear

fro

m o

nly

4 w

eek

s o

f in

div

idu

aliz

ed e

xer

cise

-Co

uld

no

t d

raw

co

ncl

usi

on

s fo

r th

e v

alu

e o

f ex

-er

cise

fro

m s

uch

a l

imit

ed g

rou

p o

f st

ud

ies


www.icsi.org

49

Conclusion Grading Worksheet B – Adult Low Back Pain Annotation #16 (Active Rehabilitation) Fourteenth Edition/November 2010

Aut

hor/

Yea

rD

esig

nT

ype

Cla

ssQ

ual-

ity+

,–,ø

Popu

latio

n St

udie

d/Sa

mpl

e Si

zePr

imar

y O

utco

me

Mea

sure

(s)/

Res

ults

(e.

g., p

-val

ue,

conf

iden

ce in

terv

al, r

elat

ive

risk

, odd

s ra

tio, l

ikel

i-ho

od r

atio

, num

ber

need

ed to

trea

t)

Aut

hors

' Con

clus

ions

/W

ork

Gro

up's

Com

men

ts (

italic

ized

)

van

Tul

der,

Koe

s, &

Bou

ter

(199

7)

Sys

tem

-at

icR

evie

w

M+

-Lit

erat

ure

sear

ch t

hrou

gh 1

995

-Inc

lude

d tr

ials

: t

rue

RC

Ts,

trea

tmen

t in

clud

ed t

hera

peut

ic i

n-te

rven

tion

s se

lect

ed f

or s

tudy

(in

-cl

udin

g ex

erci

se),

res

ults

con

-ce

rned

acu

te o

r ch

roni

c lo

w b

ack

pain

, an

d ar

ticl

e w

as p

ubli

shed

in

Eng

lish

-Chr

onic

pai

n w

as p

ain

pers

isti

ngfo

r ≥1

2 w

ks-U

sed

100-

poin

t m

etho

dolo

gic

eval

uati

on (

2 re

view

ers)

-Pos

itiv

e st

udie

s:

Inte

rven

tion

was

mor

e ef

fect

ive

than

refe

renc

e tr

eatm

ent

wit

h re

gard

to

at l

east

one

im

port

ant

outc

ome

mea

sure

-Neg

ativ

e st

udie

s:

Inte

rven

tion

was

no

diff

eren

t fr

omor

les

s ef

fect

ive

than

the

ref

eren

ce t

reat

men

t on

at

leas

ton

e im

port

ant

outc

ome

mea

sure

-No

conc

lusi

on i

f in

terv

enti

on w

as m

ore

effe

ctiv

e on

one

outc

ome

mea

sure

but

les

s ef

fect

ive

on a

noth

er-1

6 R

CT

s pe

rtai

ning

to

exer

cise

and

chr

onic

low

bac

kpa

in;

met

hodo

logi

c sc

ores

ran

ged

from

24

to 6

1 (3

>50

)-8

had

pos

itiv

e ou

tcom

es (

incl

udin

g th

e 3

wit

h sc

ores

>50

; see

Dey

o et

al.,

Han

sen

et a

l., &

Man

nich

e et

al.,

belo

w)

and

8 ha

d ne

gati

ve o

utco

mes

-The

re i

s st

rong

evi

denc

e th

at e

xerc

ise

ther

apy

is e

ffec

tive

for

chr

onic

low

bac

k pa

in.

-The

re i

s no

evi

denc

e in

fav

or o

f on

e of

the

exer

cise

pro

gram

s du

e to

the

con

trad

icto

ryre

sult

s.


www.icsi.org

50

Au

tho

r/Y

ear

D

esig

n

Ty

pe

Cla

ss

Qu

al-

ity

+

,–,ø

Po

pu

lati

on

Stu

die

d/S

am

ple

Siz

e P

rim

ary

Ou

tco

me M

eas

ure

(s)/

Res

ult

s (e

.g.,

p-v

alu

e,

con

fid

ence

inte

rval

, re

lati

ve r

isk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Dey

o, W

alsh

, M

arti

n,

Sch

oen

-fe

ld, &

Ram

a-

mu

rth

y (

19

90

)

RC

T

A

ø

-Pat

ien

ts (

18

-70

yrs

old

) w

ith

lo

w

bac

k p

ain

≥3

mo

s d

ura

tio

n;

recru

it

via

new

spap

er a

dv

erti

sem

ent

-Ex

clu

ded

: h

isto

ry o

f can

cer

, u

se o

f co

rtic

ost

ero

ids

or

anti

coag

ula

nts

, m

ax. p

ain

ab

ov

e T

-12

, u

se o

f p

ace

-m

aker,

hea

rt d

iseas

e, s

evere

co

ex-

isti

ng

dis

eas

e, p

rev

iou

sly

un

eval

u-

ated

neu

rolo

gic

def

icit

, p

rev

iou

s T

EN

S u

se,

tho

se s

eek

ing

or

rece

iv-

ing

dis

abil

ity

co

mp

ensa

tio

n;

also

ex

clu

ded

fo

r fa

cto

rs t

hat

wo

uld

im

-p

air

foll

ow

-up

-R

and

om

ized

to

4 g

rou

ps:

T

EN

S +

ex

erc

ise,

TE

NS

on

ly,

exerc

ise

+

sham

TE

NS

, sh

am T

EN

S o

nly

; o

ther

tre

atm

ents

wer

e u

nif

orm

-M

on

ito

red

co

mp

lian

ce

-TE

NS

: c

on

ven

tio

nal

hig

h-f

req

. fo

r 2

wk

s, i

nst

ructi

on

in

acu

pu

nct

ure

-li

ke T

EN

S,

self

-sel

ect

ed m

od

e f

or

fin

al

2 w

ks

(sam

e in

stru

ctio

ns

giv

en

to s

ham

TE

NS

gro

up

) -E

xer

cise

: 1

2 s

equ

enti

al

exer

cis

es-

rela

xat

ion

an

d f

lex

ibil

ity

-I

nte

rven

tio

ns

for

4 w

ks;

vis

its

2x

p

er w

k f

or

heat

tre

atm

ent,

ad

just

-m

ent

of

TE

NS

ele

ctr

od

es

and

ad

-v

ice o

n p

ost

ure

fo

r v

ario

us

act

ivi-

ties;

ho

me h

eat

ing

pad

s w

ere

use

d

2x

per

day

fo

r 1

0 m

in

-54

3 r

esp

on

ded

to

ad

ver

tise

men

t; 1

45

wer

e en

roll

ed a

nd

ra

nd

om

ized

; 2

0 (

14

%)

dro

pp

ed o

ut b

y 4

wk

ass

essm

ent;

2

3 (

16

%)

dro

pp

ed b

y 2

mo

nth

s af

ter

trea

tmen

t -A

ssess

men

t:

Ph

ysi

cal

exam

s an

d q

uest

ion

nair

es a

t b

ase-

lin

e,

afte

r 2

an

d 4

wk

s o

f th

erap

y,

and

2 m

on

ths

afte

r en

d

of

treat

men

t; i

ncl

ud

ed f

un

cti

on

al s

tatu

s, p

ain

rat

ing

s,

ph

ysi

cal

meas

ure

s, a

nd

use

of

med

ical

serv

ices

-Base

lin

e:

Dif

fere

nces

betw

een

gro

up

s in

pro

po

rtio

n w

ith

n

euro

log

ic d

efi

cit

and

pre

vio

us

ho

spit

ali

zati

on

-Bli

nd

ing

: 1

00

% o

f th

e t

rue

TE

NS

gro

up

s g

ues

sed

th

at

thei

r T

EN

S u

nit

was

fu

ncti

on

ing

pro

perl

y;

84

% o

f sh

am

T

EN

S g

rou

ps

gu

esse

d t

he T

EN

S u

nit

was

fun

ctio

nin

g

pro

per

ly b

ut

their

deg

ree

of

cer

tain

ty w

as

less

-C

om

pli

ance:

F

ou

nd

to

be

"go

od

" fo

r tr

ue

TE

NS

, sh

am

TE

NS

, ex

erci

se,

stu

dy

vis

its

(mea

n o

f 7

.2 o

ut

of

8 v

isit

s)

and

use

of

heat

ing

pad

s -T

her

apeu

tic

Ou

tco

mes:

A

ll f

ou

r g

rou

ps

sho

wed

sig

nif

i-ca

nt

imp

rov

emen

t th

at p

rog

ress

ed f

rom

wee

k 2

to

wee

k 4

b

ut

retu

rned

to

ward

base

lin

e at

2 m

on

ths

aft

er t

reat

men

t;

no

sig

nif

ican

t d

iffe

ren

ces

in

ou

tco

mes

at 4

week

s b

etw

een

tr

ue T

EN

S a

nd

sh

am T

EN

S g

rou

ps;

sel

f-ra

ted

act

ivit

y

lev

el,

sel

f-ra

ted

im

pro

vem

ent

in p

ain

, v

isu

al-a

nal

og

scal

e im

pro

vem

ent

in p

ain

, an

d f

req

uen

cy o

f p

ain

were

all

sig

-n

ific

antl

y b

ett

er (

p<

0.0

5)

in t

he

exerc

ise g

rou

p t

han

in

th

e n

o-e

xer

cis

e g

rou

p;

at 2

mo

nth

s aft

er t

reat

men

t th

ere

wer

e n

o s

ign

ific

ant

treat

men

t eff

ects

-S

ide E

ffect

: 1

/3 o

f T

EN

S s

ub

jects

rep

ort

ed m

ino

r sk

in ir-

rita

tio

n a

t si

te o

f el

ect

rod

es;

on

e h

ad s

ever

e d

erm

atit

is t

hat

req

uir

ed d

isco

nti

nu

ati

on

of

treat

men

t

-Th

ere

was

no

ap

par

ent

ben

efi

t o

f T

EN

S.

-Th

ere

app

ear

to

be m

od

est

su

bje

cti

ve

ben

efit

s fr

om

str

etc

hin

g e

xer

cise

s b

ut

few

sh

ort

-ter

m e

f-fe

cts

on

actu

al

beh

avio

r.

-Tre

atm

ent

wit

h T

EN

S i

s n

o m

ore

eff

ect

ive

than

tr

eatm

ent

wit

h p

laceb

o a

nd

TE

NS

ad

ds

no

ap

par

-en

t b

enef

it t

o t

hat

of

exerc

ise a

lon

e N

OT

ES

: P

roto

col

pro

vid

ed f

or

all

pati

ents

to

h

ave

equ

al t

ime a

nd

att

enti

on

fro

m t

he

rese

arc

h

staf

f; m

ost

pati

ents

rep

ort

ed m

od

era

te o

r m

ild

p

ain

wit

h p

rev

iou

s m

edic

al c

are

for

low

back

pai

n

Wo

rk G

rou

p's

Co

mm

ents

: -A

na

lysi

s w

as

no

t b

y i

nte

nti

on

-to

-tre

at

-Sa

mp

le s

izes

per

gro

up

were

<3

5 e

ach



www.icsi.org

51


Au

tho

r/Y

ear

Des

ign

T

yp

e C

lass

Q

ual

-it

y

+,–

,ø

Po

pu

lati

on

Stu

die

d/S

amp

le S

ize

Pri

mar

y O

utc

om

e M

easu

re(s

)/R

esu

lts

(e.g

., p

-val

ue,

co

nfi

den

ce i

nte

rval

, re

lati

ve

risk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Han

sen

, B

end

ix,

Sk

ov

, et

al.

(1

99

3)

RC

T

A

ø

-Pat

ien

ts a

ges

21

-64

wit

h c

hro

nic

(c

urr

ent

epis

od

e o

f p

ain

las

tin

g 3

m

os)

or

sub

chro

nic

(≥

4 w

ks

wit

h a

t le

ast

2 p

ain

ep

iso

des

per

mo

nth

fo

r p

ast

yea

r) p

ain

-E

xcl

ud

ed t

ho

se w

ith

sp

ecif

ic d

is-

ease

(e.

g.,

sp

on

dy

loli

sth

esis

, ro

ot

com

pre

ssio

n),

co

llag

eno

sis,

ost

eo-

po

rosi

s, p

rev

iou

s sp

inal

fu

sio

n,

neu

-ro

mu

scu

lar

dis

ease

of

the

tru

nk

, m

alig

nan

t d

isea

se,

un

com

pen

sate

d

hy

per

ten

sio

n,

pre

gn

ancy

or

lact

a-ti

on

, an

y d

isea

se o

r m

alfu

nct

ion

th

at

wo

uld

hin

der

tre

atm

ent

-Ran

do

miz

ed (

blo

ckin

g o

n 8

var

i-ab

les)

to

: a.

in

ten

siv

e d

yn

amic

bac

k-m

usc

le

trai

nin

g (

DY

N)

- 3

ex

erci

ses,

30

0

tota

l co

ntr

acti

on

s p

er s

essi

on

b

. st

and

ard

ph

ysi

cal

ther

apy

(P

T)

- st

and

ard

pro

gra

m (

exer

cise

s, c

ou

n-

seli

ng

) p

lus

ind

ivid

ual

pro

gra

m

c. p

lace

bo

-co

ntr

ol

(CT

RL

) -

ho

t p

ack

s, t

ract

ion

-A

ll t

reat

men

ts w

ere

1 h

ou

r, 2

x p

er

wk

fo

r 4

wee

ks

-18

0 w

ere

ran

do

miz

ed,

11

nev

er s

tart

ed t

reat

men

t, 1

9

dro

pp

ed o

ut

du

rin

g t

reat

men

t an

d 1

3 d

rop

ped

ou

t d

uri

ng

fo

llo

w-u

p p

erio

d;

po

st-t

reat

men

t ev

alu

atio

n o

f 1

50

, 1

-m

on

th e

val

uat

ion

of

14

6,

6-m

on

th e

val

uat

ion

of

14

3,

12

-m

on

th e

val

uat

ion

of

13

7 (

76

% o

f th

ose

ran

do

miz

ed)

-Pai

n:

All

gro

up

s sh

ow

ed s

ign

ific

ant

(p<

0.0

1)

red

uct

ion

in

pai

n (

for

tho

se c

om

ple

tin

g a

ll f

oll

ow

-up

s);

bo

th g

rou

ps

resp

on

ded

wel

l to

PT

(p

<0

.01

fo

r m

ales

an

d p

=0

.02

fo

r fe

mal

es);

mal

es a

lso

res

po

nd

ed t

o C

TR

L (

p<

0.0

1);

fe-

mal

es a

lso

res

po

nd

ed t

o D

YN

(p

<0

.01

); t

ho

se w

ith

mo

d-

erat

e/h

eav

y w

ork

occ

up

atio

ns

resp

on

ded

to

all

tre

atm

ents

(p≤

0.0

5),

th

ose

wit

h s

eden

tary

/lig

ht

wo

rk o

ccu

pat

ion

s re

-sp

on

ded

to

DY

N &

PT

(p≤

0.0

1)

-Ov

eral

l T

reat

men

t E

ffec

t (s

elf-

asse

ssm

ent

on

vis

ual

-an

alo

g s

cale

):

No

sig

nif

ican

t d

iffe

ren

ces

bet

wee

n D

YN

an

d P

T b

ut

bo

th w

ere

sig

nif

ican

tly

mo

re e

ffec

tiv

e th

an

CT

RL

(p

<0

.01

) -F

un

ctio

nal

Sta

tus:

n

um

ber

of

day

s w

ith

pai

n d

uri

ng

th

e 1

-yr

ob

serv

atio

n p

erio

d w

as r

edu

ced

in

all

tre

atm

ent

gro

up

s co

mp

ared

to

th

e 1

yr

pri

or

to t

reat

men

t; n

o d

iffe

r-en

ces

bet

wee

n g

rou

ps

-Pat

ien

ts w

ere

succ

essf

ull

y t

reat

ed w

ith

PT

an

d

DY

N;

tho

se i

n t

he

con

tro

l g

rou

p h

ad l

ess

succ

ess-

ful

ther

apy

res

ult

s -T

her

e w

ere

dif

fere

nce

s b

etw

een

mal

es a

nd

fe-

mal

es;

DY

N h

ad a

neg

ativ

e ef

fect

fo

r m

en c

om

-p

ared

to

oth

er t

reat

men

ts;

fem

ales

had

a b

ette

r re

-sp

on

se t

o D

YN

th

an t

o p

lace

bo

-T

ho

se w

ith

lig

hte

r jo

b f

un

ctio

ns

resp

on

ded

bet

ter

to D

YN

th

an t

ho

se w

ith

mo

der

ate/

har

d j

ob

fu

nc-

tio

ns

(wh

o r

esp

on

ded

bet

ter

to P

T)

NO

TE

: A

ll p

atie

nts

wer

e em

plo

yed

in

th

e S

can

-d

inav

ian

Air

lin

e S

yst

em (

SA

S);

pai

n l

evel

in

th

ose

wh

o w

ere

ran

do

miz

ed b

ut

did

no

t co

mp

lete

tr

eatm

ent

was

sig

nif

ican

tly

hig

her

th

an f

or

tho

se

wh

o d

id c

om

ple

te t

reat

men

t (p

=0

.03

) W

ork

Gro

up

's C

om

men

ts:

-An

aly

sis

wa

s n

ot

by

inte

nti

on

-to

-tre

at

-No

rep

ort

of

com

pli

an

ce w

ith

tre

atm

ent


www.icsi.org

52

Au

tho

r/Y

ear

D

esig

n

Ty

pe

Cla

ss

Qu

al-

ity

+

,–,ø

Po

pu

lati

on

Stu

die

d/S

am

ple

Siz

e P

rim

ary

Ou

tco

me M

eas

ure

(s)/

Res

ult

s (e

.g.,

p-v

alu

e,

con

fid

ence

inte

rval

, re

lati

ve r

isk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Man

nic

he,

B

entz

en,

Hess

el-

søe,

Ch

rist

ense

n,

& L

un

db

erg

(1

98

8)

A

ND

M

ann

ich

e, L

un

d-

ber

g, C

hri

sten

-se

n,

Ben

tzen

, &

H

esse

lsø

e (1

99

1)

RC

T

A

ø

-Pat

ien

ts w

ith

ch

ron

ic l

ow

back

p

ain

wer

e re

ferr

ed

-In

clu

ded

: c

hro

nic

lo

w b

ack

pai

n a

t re

st o

r as

socia

ted

wit

h b

ack

str

ain

fo

r ≥

12

mo

s; a

cute

pai

n ≥

3x

in

p

ast

6 m

os

wit

h o

r w

ith

ou

t sc

iati

ca,

ag

es

20

-70

; ra

dio

log

ical

ex

am o

f lu

mb

ar s

pin

e in

las

t 2

yrs

-E

xcl

ud

ed:

ev

iden

ce o

f ro

ot

pre

s-su

re,

spo

nd

ylo

lysi

s, p

ain

ful

hip

ar-

thro

sis,

ost

eom

alac

ia o

f sp

ine,

ma-

lig

nan

t d

iseas

e w

ith

po

or

pro

gn

osi

s,

infl

amm

ato

ry d

iseas

e o

f jo

ints

, m

enta

l il

lness

, so

mati

c d

isease

th

at

mig

ht

inte

rfer

e w

ith

tra

inin

g,

inab

il-

ity

to

co

op

era

te

-Ran

do

miz

ed t

o:

A. h

ot

com

pre

sses,

mas

sag

e, i

so-

met

ric

exerc

ises

for

lum

bar

sp

ine;

8

sess

ion

s o

ver

1 m

on

th t

hen

no

tr

eatm

ent

for

2 m

on

ths

B. p

laceb

o w

ith

mo

dif

ied

back

st

ren

gth

enin

g (

sam

e ex

erc

ises

as C

b

ut

20

rep

s);

30

sess

ion

s o

ver

3

mo

nth

s C

. In

ten

siv

e b

ack

str

eng

then

ing

w

ith

3 e

xerc

ises

each

do

ne

10

0

tim

es;

30

sess

ion

s o

ver

3 m

on

ths

-Of

14

0 r

efe

rred

, 1

05

wer

e ra

nd

om

ized

-M

easu

red

pai

n, d

isab

ilit

y,

and

ph

ysi

cal

imp

air

men

t at

b

asel

ine,

en

d o

f tr

eat

men

t (3

mo

nth

s),

and

6 m

on

ths

afte

r st

art

of

treat

men

t (1

98

8 s

tud

y);

in

clu

ded

1-y

ear

fo

llo

w-u

p

of

sele

cted

co

mp

on

ents

(1

99

1 s

tud

y)

-Qu

alit

ativ

e A

ssess

men

t (a

fter

tre

atm

ent)

: m

ore

res

po

nd

-er

s (s

atis

fact

ory

ev

alu

atio

n)

for

gro

up

C t

han

gro

up

A

(p<

0.0

00

05

) o

r g

rou

p B

(p

<0

.05

) w

ith

no

dif

fere

nce

be-

tween

A a

nd

B (

p=

0.0

8)

-Qu

anti

tati

ve

Ass

ess

men

t (l

ow

back

pain

rat

ing

sca

le) :

g

rou

p C

was

sup

erio

r b

oth

at

end

of

treat

men

t an

d a

t 3

m

on

ths

aft

er t

reat

men

t; s

core

s im

pro

ved

fro

m b

ase

lin

e f

or

gro

up

s B

an

d C

bu

t n

ot

A;

at 1

year

, th

ose

wh

o c

on

tin

ued

w

ith

in

ten

siv

e e

xer

cise

had

a s

ign

ific

antl

y b

ette

r o

utc

om

e

than

th

ose

wh

o d

id n

ot

con

tin

ue;

gro

up

was

also

sig

nif

i-ca

ntl

y b

ett

er t

han

gro

up

A a

nd

ten

ded

to

be

bett

er t

han

g

rou

p B

-S

ub

ject

ive

ou

tco

me w

as

hig

hly

co

rrel

ated

(r=

0.7

5)

wit

h

qu

anti

tati

ve

ou

tco

mes

-15

of

10

5 r

and

om

ized

dro

pp

ed o

ut

bef

ore

en

d o

f tr

eat

-m

ent

and

wer

e n

ot

inclu

ded

in

th

e s

tati

stic

al t

ests

; if

th

e 6

w

ho

dro

pp

ed b

ecau

se o

f si

de e

ffect

s w

ere

assi

gn

ed t

he

po

ore

st q

ual

itat

ive

ou

tco

me a

nd

in

clu

ded

in

th

e a

nal

ysi

s,

the

resu

lts

wo

uld

no

t ch

ang

e

-Th

e re

sult

s co

nsi

sten

tly

fav

ore

d i

nte

nsi

ve e

xer

-ci

se.

-Th

e in

ten

siv

e ex

erci

se r

egim

en w

as

safe

wit

h a

lo

w f

req

uen

cy o

f si

de

effe

cts

req

uir

ing

wit

h-

dra

wal

(6

pati

ents

to

tal,

1 i

n g

rou

p A

, 3

in

gro

up

B

, an

d 2

in

gro

up

C)

-In

ten

siv

e b

ack

tra

inin

g o

ug

ht

to c

on

tin

ue

in a

lo

ng

er a

nd

co

nti

nu

ou

s co

urs

e i

f la

stin

g r

esu

lt i

s d

esir

ed.

No

tes:

T

he

du

rati

on

of

exerc

ise

treat

men

t m

ay

exp

lain

wh

y t

his

stu

dy

fo

un

d p

ron

ou

nce

d d

iffe

r-en

ces

bet

ween

gro

up

s; c

ann

ot

say

wh

ich

ex

er-

cise

s acc

ou

nt

for

the b

enefi

t se

en

Wo

rk G

rou

p's

Co

mm

ents

: -A

na

lysi

s w

as

no

t b

y i

nte

nti

on

-to

-tre

at

-Co

mp

lia

nce

wa

s n

ot

rep

ort

ed e

xcep

t th

at

tho

se

wh

o w

ere

ab

sen

t m

ore

th

an

30

% w

ere

to h

ave

bee

n e

xcl

ud

ed

-1-y

ear

foll

ow

-up

wa

s d

on

e b

y m

ail



www.icsi.org

53

Au

tho

r/Y

ear

D

esig

n

Ty

pe

Cla

ss

Qu

al-

ity

+

,–,ø

Po

pu

lati

on

Stu

die

d/S

am

ple

Siz

e P

rim

ary

Ou

tco

me M

eas

ure

(s)/

Res

ult

s (e

.g.,

p-v

alu

e,

con

fid

ence

inte

rval

, re

lati

ve r

isk

, o

dd

s ra

tio

, li

kel

i-h

oo

d r

atio

, n

um

ber

nee

ded

to

tre

at)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Pfi

ng

sten

, H

ild

e-b

ran

dt,

Lei

bin

g,

Fra

nz, &

Sau

r (1

99

7)

Cas

e

Ser

ies

D

ø

-90

ch

ron

ic l

ow

back

pain

pati

ents

ad

mit

ted

to

8-w

k o

utp

atie

nt

pro

-g

ram

: 3

wk

s o

f p

rep

rog

ram

(ed

uca

-ti

on

, st

retc

hin

g a

nd

cali

sth

enic

s fo

r 4

ho

urs

/day

3x

per

wk

) an

d 5

wk

s o

f in

ten

siv

e tr

eat

men

t (a

ero

bic

, fu

nct

ion

al s

tren

gth

an

d e

nd

ura

nce

exerc

ises

, b

ack

sch

oo

l, c

og

nit

ive

beh

avio

ral

ther

apy

, re

lax

ati

on

tra

in-

ing

, v

oca

tio

nal

cou

nse

lin

g f

or

7

ho

urs

/day

) -M

on

ito

red

pai

n,

treat

men

ts,

tim

e o

ff w

ork

, st

ren

gth

an

d r

ang

e o

f m

o-

tio

n, d

epre

ssio

n, d

isab

ilit

y,

cop

ing

-Ass

ess

ed a

t en

d o

f p

rog

ram

an

d 6

an

d 1

2 m

on

ths

late

r

-Sig

nif

ican

t (p

<0

.00

1)

imp

rov

emen

ts f

rom

bas

elin

e in

fl

exib

ilit

y,

stre

ng

th a

nd

en

du

ran

ce

-Sig

nif

ican

t re

du

ctio

ns

(p<

0.0

01

) in

pain

, d

isab

ilit

y a

nd

d

epre

ssio

n

-56

/90

(6

2%

) re

po

rted

sig

nif

ican

t re

du

ctio

n i

n s

ub

ject

ive

pai

n i

nte

nsi

ty a

fter

pro

gra

m (

oth

ers

had

un

chan

ged

or

gre

ater

pai

n)

-"C

ata

stro

ph

izin

g"

and

"se

arch

fo

r in

form

atio

n"

(cop

ing

ac

tiv

itie

s) w

ere

bo

th s

ign

ific

antl

y r

edu

ced

by

6 m

on

ths

af-

ter

treatm

ent

-42

% r

edu

ctio

n i

n u

se o

f an

alg

esic

s; s

ign

ific

ant

red

uct

ion

in

co

nsu

ltati

on

of

ph

ysi

cian

s an

d p

hy

sio

ther

apis

ts i

n t

he

yea

r fo

llo

win

g d

isch

arg

e fr

om

th

e p

rog

ram

(p

<0

.00

1)

-60

% r

ated

th

e p

rog

ram

's s

ucc

ess

as

go

od

or

ver

y g

oo

d,

32

% a

s m

od

erate

, an

d 6

% a

s a

com

ple

te f

ail

ure

-P

rob

abil

ity

of

a re

turn

to

wo

rk w

as m

ost

lik

ely

wh

en p

a-ti

ents

(p

rio

r to

tre

atm

ent)

had

no

t ap

pli

ed f

or

pen

sio

n, h

ad

po

siti

ve

ou

tlo

ok

co

nce

rnin

g r

etu

rn t

o w

ork

, an

d w

ere

no

t o

ut

of

wo

rk f

or

mo

re t

han

6 m

os

-Retu

rn t

o w

ork

was

mo

re l

ikely

if

trea

tmen

t re

sult

ed i

n

red

uced

dis

abil

ity

an

d r

edu

ced

dep

ress

ion

-Co

mb

ined

fu

nct

ion

al a

nd

psy

cho

log

ical

tre

at-

men

t re

sult

ed i

n s

ign

ific

ant

imp

rov

emen

ts a

mo

ng

p

atie

nts

. T

he

resu

lts

were

gen

eral

ly m

ain

tain

ed a

t th

e 6

an

d 1

2 m

on

th e

val

uat

ion

s.

Bio

gra

ph

ical

an

d m

edic

al d

ata

and

a p

ati

ent's

pre

vio

us

med

ical

his

tory

did

no

t ap

pear

to

hav

e an

im

pac

t o

n t

her

a-

peu

tic

succe

ss.

NO

TE

: n

o c

on

tro

l g

rou

p a

nd

th

eref

ore

can

no

t de-

term

ine

if o

utc

om

e r

esu

lts

wer

e a

resu

lt o

f tr

eat

-m

ent

pro

ced

ure

s, c

on

fou

nd

ing

var

iab

les,

or

the

infl

uen

ce

of

tim

e;

can

no

t d

iffe

ren

tiate

betw

een

v

ario

us

form

s o

f tr

eatm

ent

Hil

deb

ran

dt,

P

fin

gst

en, S

aur,

&

Jan

sen

(1

99

7)

Cas

e

Ser

ies

D

ø

-Sam

e as

Pfi

ng

sten

et

al.

(ab

ov

e)

-Co

nti

nu

ed i

den

tifi

cat

ion

of

fact

ors

re

late

d t

o t

reatm

ent

succ

ess

-A s

ub

ject

ive

red

uct

ion

in

pain

in

ten

sity

is

mo

re l

ikely

if

a p

atie

nt

has

no

t al

read

y a

pp

lied

fo

r a p

ensi

on

, ab

sen

ce

fro

m

wo

rk i

s <

6 m

os,

pre

vio

us

ho

spit

al

treat

men

ts f

or

back

pain

w

ere

sho

rt, p

ati

ents

un

der

wen

t fe

wer

med

ical

co

nsu

lta-

tio

ns,

an

d p

atie

nts

dem

on

stra

ted

im

pro

ved

per

form

ance

of

tru

nk

ex

ten

sio

n

-Red

ucti

on

in

pai

n i

nte

nsi

ty i

s m

ore

lik

ely

if

dis

abil

ity

can

b

e re

du

ced

an

d b

ette

r tr

un

k f

lex

ion

an

d l

eg p

ress

per

form

-an

ces

are

ach

iev

ed

-A s

ub

ject

ive

rati

ng

of

succ

ess

ful

trea

tmen

t is

mo

re l

ikely

if

med

ical

co

nsu

ltati

on

s w

ere

in

freq

uen

t, o

ver

all

tru

nk

fl

exib

ilit

y w

as

gre

ate

r, a

nd

co

pin

g w

ith

th

e d

isease

was

less

cat

ast

rop

hiz

ing

befo

re t

reatm

ent

-A f

avo

rab

le e

stim

atio

n o

f su

cce

ss w

as m

ore

lik

ely

if

dis

-ab

ilit

y w

as r

edu

ced

-Th

e m

ost

im

po

rtan

t v

aria

ble

in

det

erm

inin

g a

su

cce

ssfu

l tr

eat

men

t o

f ch

ron

ic l

ow

back

pai

n i

s th

e re

du

cti

on

of

sub

ject

ive

feel

ing

s o

f d

isab

ilit

y;

ph

ysi

cal

var

iab

les

had

on

ly l

imit

ed p

red

icti

ve

val

ue



www.icsi.org

54

Au

tho

r/Y

ear

D

esig

n

Ty

pe

Cla

ss

Qu

al-

ity

+

,–,ø

Po

pu

lati

on

Stu

die

d/S

am

ple

Siz

e P

rim

ary

Ou

tco

me M

eas

ure

(s)/

Res

ult

s (e

.g.,

p-

val

ue,

con

fid

ence

inte

rval

, re

lati

ve r

isk

, o

dd

s ra

-ti

o,

lik

eli

ho

od

rat

io, n

um

ber

need

ed t

o t

reat

)

Au

tho

rs' C

on

clu

sio

ns/

W

ork

Gro

up

's C

om

men

ts (

ita

lici

zed

)

Fro

st,

Lam

b,

Kla

ber

Mo

ffet,

F

airb

ank

, M

ose

r (1

99

8)

RC

T

A

ø

-Pat

ien

ts r

efer

red

to

a h

osp

ital

ort

ho

-p

aed

ic o

utp

atie

nt

dep

t.

-In

clu

ded

: 1

8-5

5 y

ears

old

, m

ech

anic

al

low

back

pain

fo

r ≥

6 m

os,

ab

le t

o t

rav

el

ind

epen

den

tly

, m

edic

all

y f

it

-Ex

clu

ded

: co

nst

ant

or

pers

iste

nt

sev

ere

b

ack

pai

n d

ue t

o n

erv

e r

oo

t ir

rita

tio

n,

oth

er m

usc

ulo

skele

tal

dis

abil

itie

s, s

ys-

tem

ic c

on

dit

ion

s, m

ajo

r su

rger

y w

ith

in

last

yea

r, s

po

nd

ylo

list

hesi

s, f

ract

ure

s,

ph

ysi

oth

erap

y i

n l

ast

3 m

os,

en

gag

ed i

n

mo

der

ate

ly s

tren

uo

us

spo

rtin

g a

ctiv

itie

s at

least

2x

/wk

fo

r la

st 6

mo

s, p

reg

nan

t -R

and

om

ly a

llo

cat

ed t

o t

reatm

ent

(back

sc

ho

ol,

ad

vic

e t

o c

arry

ou

t sp

eci

fied

ex

-er

cise

s at

ho

me,

in

vit

ati

on

to

att

end

fit

-n

ess

pro

gra

m)

or

con

tro

l (b

ack

sch

oo

l an

d h

om

e ex

erc

ises)

-F

itn

ess

pro

gra

m w

as

8 s

essi

on

s o

f 1

hr

(ov

er 4

wk

peri

od

); c

on

sist

ed o

f w

arm

-u

p, st

retc

hin

g, 1

5 p

rog

ress

ive

exer

cis

es,

aero

bic

ex

erci

se,

rela

xat

ion

-A

dv

ised

to

do

ho

me

exer

cise

s 2

x p

er

day

; b

ack

sch

oo

l w

as

two

90

-min

ute

se

ssio

ns

-A

ssess

ed a

t b

ase

lin

e, 6

week

s an

d 2

y

ears

aft

er i

nte

rven

tio

n

-Osw

estr

y L

ow

Back

Pain

Dis

abil

ity

In

dex

(q

ues

tio

n-

nai

re)

to a

sses

s li

mit

atio

ns

of

dail

y a

cti

vit

ies

-8

1 p

atie

nts

were

rec

ruit

ed,

10

(5

in

eac

h g

rou

p)

fail

ed

to c

om

ply

wit

h p

roto

col

-86

% a

tten

dan

ce

rate

fo

r p

ati

ents

ran

do

miz

ed t

o f

it-

nes

s g

rou

p;

at 6

wk

s 1

2 c

han

ged

fro

m c

on

tro

l to

tr

eatm

ent

gro

up

-A

t 2

yrs

, 1

9 d

id n

ot

com

ple

te f

oll

ow

-up

(7

6%

re-

spo

nse

rat

e)

-Tre

atm

ent

and

co

ntr

ol

gro

up

s d

id n

ot

dif

fer

at

bas

e-li

ne

-Dis

abil

ity

in

dex

(%

wh

ere

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(19

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8)



www.icsi.org

55

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Thornbury JR, Fryback DG, Turski PA, et al. Disk-caused nerve compression in patients with acute low-back pain: diagnosis with MR, CT myelography, and plain CT. Radiology 1993;186:731-38. (Class C)

Tiso RL, Cutler T, Catania JA, Whalen K. Adverse central nervous system sequelae after selective transforaminal block: the role of corticosteroids. Spine J 2004;4:468-74. (Class D)

Vad VB, Bhat AL, Lutz GE, Cammisa F. Transforaminal epidural steroid injections in lumbosacral radiculopathy: a prospective randomized study. Spine 2002;27:11-16. (Class C)

van Middelkoop M, Rubinstein SM, Kuijpers T, et al. A systematic review on the effectiveness of physical and rehabilitation interventions for chronic non-specific low back pain. Eur Spine J 2010. (Class M)

van Tulder MW, Koes BW, Bouter LM. Conservative treatment of acute and chronic nonspecific low back pain: a systematic review of randomized controlled trials of the most common interventions. Spine 1997;22:2128-56. (Class M)

Vitzthum HE, König A, Seifert V. Dynamic examination of the lumbar spine by using vertical, open magnetic resonance imaging. J Neurosurg 2000;93:58-64. (Class D)

Von Korff M. Studying the natural history of back pain. Spine 1994;19:2014S-46S. (Class R)

Waddell G, Feder G, Lewis M. Systematic reviews of bed rest and advice to stay active for acute low back pain. Br J Gen Pract 1997;47:647-52. (Class M)

Waddell G, McCulloch JA, Kummel E, et al. Nonorganic physical signs in low-back pain. Spine 1980;5:117-25. (Class C)

Wang JC, Lin E, Brodke DS, Youssef JA. Epidural injections for the treatment of symptomatic lumbar herniated discs. J Spinal Disord Tech 2002;15:269-72. (Class D)

Weber H. Lumbar disc herniations: a controlled, prospective study with ten years of observation. Spine 1983;8:131-40. (Class A)



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Weiner BK, Fraser RD. Foraminal injection for lateral lumbar disc herniation. J Bone Joint Surg 1997;79-B:804-07. (Class D)

Weishaupt D, Schmid MR, Zanetti M, et al. Positional MR imaging of the lumbar spine: does it demon-strate nerve root compromise not visible at conventional MR imaging? Radiology 2000;215:247-53. (Class D)

Wildermuth S, Zanetti M, Duewell S, et al. Lumbar spine: quantitative and qualitative assessment of positional (upright flexion and extension) MR imaging and myelography. Radiology 1998;207:391-98. (Class D)

Willén J, Danielson B. The diagnostic effect from axial loading of the lumbar spine during computed tomography and magnetic resonance imaging in patients with degenerative disorders. Spine 2001;26:2607-14. (Class D)

Willén J, Danielson B, Gaulitz A, et al. Dynamic effects of the lumbar spine canal: axially loaded CT-my-elography and MRI in patients with sciatica and/or neurogenic claudication. Spine 1997;22:2968-76. (Class D)

Wilmink JT, Penning L. Influence of spinal posture of abnormalities demonstrated by lumbar myelog-raphy. AJNR 1983;4:656-58. (Class D)

Wilson-MacDonald J, Burt G, Griffin D, Glynn C. Epidural steroid injection for nerve root compression: a randomised, controlled trial. J Bone Joint Surg 2005;87:352-55. (Class M)

Zamani AA, Moriarty T, Hsu L, et al. Functional MRI of the lumbar spine in erect position in a super-conducting open-configuration MR system: preliminary results. JMRI 1998;8:1329-33. (Class D)

Zander DR, Lander PH. Positionally dependent spinal stenosis: correlation of upright flexion-extension myelography and computed tomographic myelography. Can Assoc Radiol J 1998;49:256-61. (Class D)



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Appendix A – Roland-Morris Disability Questionnaire


When your back hurts, you may find it difficult to do some of the things you normally do. This list contains sentences that people have used to describe themselves when they have back pain. When you read them, you may find that some stand out because they describe you today.

As you read the list, think of yourself today. When you read a sentence that describes you today, put a tick against it. If the sentence does not describe you, then leave the space blank and go on to the next one. Remember, only tick the sentence if you are sure it describes you today.

1. I stay at home most of the time because of my back.2. I change position frequently to try and get my back comfortable.3. I walk more slowly than usual because of my back.4. Because of my back I am not doing any of the jobs that I usually do around the house.5. Because of my back, I use a handrail to get upstairs.6. Because of my back, I lie down to rest more often.7. Because of my back, I have to hold on to something to get out of an easy chair.8. Because of my back, I try to get other people to do things for me.9. I get dressed more slowly then usual because of my back.10. I only stand for short periods of time because of my back.11. Because of my back, I try not to bend or kneel down.12. I find it difficult to get out of a chair because of my back.13. My back is painful almost all the time.14. I find it difficult to turn over in bed because of my back.15. My appetite is not very good because of my back pain.16. I have trouble putting on my socks (or stockings) because of the pain in my back.17. I only walk short distances because of my back.18. I sleep less well because of my back.19. Because of my back pain, I get dressed with help from someone else.20. I sit down for most of the day because of my back.21. I avoid heavy jobs around the house because of my back.22. Because of my back pain, I am more irritable and bad tempered with people than usual.23. Because of my back, I go upstairs more slowly than usual.24. I stay in bed most of the time because of my back.

Note to users:

The score of the RDQ is the total number of items checked – i.e., from a minimum of 0 to a maximum of 24. The questionnaire may be adapted for use online or by telephone. Thirty-six translations and adapta-tions are available.This questionnaire is from Roland MO, Morris RW. A study of the natural history of back pain. Part 1: Development of a reliable and sensi-tive measure of disability in low back pain. Spine 1983;8:141-44. The original questionnaire and all translations are in the public domain. No permission is required for their use or reproduction. More information can be found at: at www.rmdq.org.


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Appendix B – Physical Functional Ability Questionnaire (FAQ5)

Instructions: Circle the number (1-4) in each of the groups which best summarizes your ability. Add the numbers and multiply by 5 for total score out of 100.

Self-care ability assessment1. Require total care – for bathing, toilet, dressing, moving and eating2. Require frequent assistance3. Require occasional assistance4. Independent with self-careFamily and social ability assessment1. Unable to perform any – chores, hobbies, driving, sex and social activities2. Able to perform some3. Able to perform many4. Able to perform all Get up and go ability assessment1. Able to get up and walk with assistance, unable to climb stairs2. Able to get up and walk independently, able to climb one flight of stairs3. Able to walk short distances and climb more than one flight of stairs4. Able to walk long distances and climb stairs without difficultyLifting ability assessment 1. Able to lift up to 10# occasionally2. Able to lift up to 20# occasionally3. Able to lift up to 50# occasionally 4. Able to lift over 50# occasionallyWork ability assessment 1. Unable to do any work2. Able to work part-time and with physical limitations3. Able to work part-time or with physical limitations4. Able to perform normal workPhysical Functional Ability Score (FAQ5)

© 2010 Peter S. Marshall, MD

Name:

Date:

Date of Birth:

MR #:


A validation study is currently underway for this tool. At this time, work group consensus was to include it as an example due to lack of other validated and easy to use functional assessment tools available for low back pain.


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Appendix C – Psychosocial Screening and Assessment Tools


The screening and assessment tools noted below may help identify psychosocial factors for prolonged disability and chronic pain. Treat OR refer to the appropriate mental health professional if indicated.

Waddell's SignsWaddell's Signs assess the possibility of psychological distress or malingering or both by testing the consis-tency and reproducibility of patient responses to non-organic physical signs. Waddell demonstrates that when three of five tests are positive, there is a high probability of non-organic pathology. Three positive tests identify the individual who needs further psychological assessment.1. Tenderness: Positive is generalized tenderness overlying the entire lumbar area when skin is lightly

pinched or rolled.2. Simulation: The object of these tests is to give the patient the impression that a specific test is being

performed when in fact it is not.• Axial loading: Positive when LBP is reported on vertical loading over the standing patient's skull

by the examiner's hands. Neck pain is common and should be discounted.• Rotation: Positive if LBP is reported when shoulders and pelvis are passively rotated in the same

plane as the patient stands relaxed with feet together.3. Distraction: The object of this test is to distract the patient in such a way that a positive result under

normal testing circumstances becomes negative in the distracted patient. The most useful test involves Straight Leg Raising (see Annotation #4, "Primary Care Evaluation"). When the patient complains of pain doing SLR while supine but does not complain of pain doing SLR while sitting, the test is positive. This test is commonly referred to as the "flip test."

4. Regionalization: Pain distributions are a function of known anatomic pathways and structures. Inter-pretation of the exam depends on patient giving non-anatomic or non-physiologic responses to testing.

- Weakness: Positive test is a voluntary muscle contraction accompanied by recurrent giving way, producing motions similar to a cogwheel. Patient may show weakness on testing but have adequate strength spontaneously.

- Sensory: Alterations in sensibility to touch and pinprick occur in a non-anatomic pattern (stocking-glove distribution or diminished sensation over entire half or quadrant of body).

5. Overreaction: Disproportionate verbalization, facial expression, muscle tension, tremor, collapsing or sweating. Consider cultural variations.

(Waddell, 1980 [C])

Sitting

Supine

Straight leg raising


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DSM-IV TR Diagnosis Criteria for DepressionConsider psychosocial factors. For a diagnosis of a major depressive episode, at least five of the symptoms listed below must be present nearly every day for at least two weeks and represent a change from previous functioning. At least one of the symptoms must be either be depressed mood or loss of interest or pleasure.

1. Depressed mood

2. Markedly diminished interest or pleasure in all or almost all activities

3. Significant (greater than 5% body weight) weight loss or gain or decrease or increase in appetite

4. Insomnia or hypersomnia

5. Psychomotor agitation or retardation

6. Fatigue or loss of energy

7. Feeling of worthlessness or inappropriate guilt

8. Diminished concentration or indecisiveness

9. Recurrent thoughts of death or suicide

Appendix C – Adult Low Back PainPsychosocial Screening and Assessment Tools Fourteenth Edition/November 2010


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Modified Work APGAR (Adaptation, Partnership, Growth, Affection and Resolve) Almost

always

Some of the

time

Hardly

ever

1. I am satisfied that I can turn to a fellow worker for

help when something is troubling me.

2. I am satisfied with the way my fellow workers talk

things over with me and share problems with me.

3. I am satisfied that my fellow workers accept and

support my new ideas or thoughts.

4. I am satisfied with the way my fellow workers

respond to my emotions, such as anger, sorrow or

laughter.

5. I am satisfied with the way my fellow workers and

I share time together.

*6. I enjoy the tasks involved in my job.

*7. Please check the column that indicates

how well you get along with your

closest or immediate supervisor.

* Modified Work APGAR score assesses job task enjoyment. A low score means that patient rarely enjoys job tasks.

Negative responses often indicate a higher risk of chronic back pain/disability. Items 1-5 may be omitted. Items 6 and 7

usually are the most predictive for prolonged disability in low back pain patients.

Used with permission from Spine 1991,16:1-6, "A prosective study of work perceptions and psychosocial factors affecting the report of back injury" by Bigos SJ, Battie MC, Spengler DM, et al.

Psychological Risk FactorsThere is work group consensus that the following factors are important to note and consistently predict poor outcomes:

• Belief that pain and activity are harmful

• "Sickness behaviors," such as extended rest

• Depressed or negative moods, social withdrawal

• Treatment that does not fit best practice

• Problems with claim and compensation

• History of back pain, time off or other claims

• Problems at work or low job satisfaction

• Heavy work, unsociable hours

• Overprotective family or lack of support



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Groups of Risk FactorsClinical assessment of risk factors may identify the risk of long-term disability, distress and work loss due to:

• Attitudes and beliefs about back pain

• Emotions

• Behaviors

• Family

• Compensation issues

• Work

• Diagnostic and treatment issues

How to Judge If a Person Is at RiskA person may be at risk if:

• there is a cluster of a few very salient factors, or

• there is a group of several less important factors that combine cumulatively.

Six Specific Screening QuestionsSuggested questions (to be phrased in treatment provider's own words):

• Have you had time off work in the past with back pain?

• What do you understand is the cause of your back pain?

• What are you expecting will help you?

• How is your employer responding to your back pain? Your co-workers? Your family?

• What are you doing to cope with back pain?

• Do you think you will return to work? When?



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Appendix D – Upright and Positional Imaging


Open Upright MRI is an evolving modality using a 0.63T solid magnet and an architecture that allows imaging with the patient lying flat, sitting or standing in the neutral, extended and/or flexed positions. This system can be and is often used for routine MRI imaging of the spine. Merl, et al., in a prospective study, compared the accuracy of MRI on a low field strength 0.2T system to that on conventional high field strength systems and found no significant difference in accuracy (Merl, 1999 [C]). Open Upright MRI is also very useful for imaging patients with severe claustrophobia, patients who are too large to fit into conventional closed MRI systems, or in patients who have difficulty lying flat because of severe pain. Open Upright MRI may also be useful in patients with dynamic spondylolisthesis and dynamic stenosis.

Evaluation of Dynamic StenosisFunctional myelography. Initial reports of dynamic narrowing of the central canal were made with standing flexion and extension radiographs following myelography, which has been referred to as functional myelog-raphy. Sortland, et al. reported the results of static and dynamic myelography in patients with a clinical diagnosis of spinal stenosis, and compared these findings to those in a control group of patients with back pain without a diagnosis of spinal stenosis. In this study, patients with a clinical diagnosis of spinal stenosis frequently demonstrated narrowing of the canal that worsened significantly in extension. In 8/36 stenosis patients, a complete myelographic block was seen on the images obtained in extension but not on images with the patient in the neutral position. Only small differences in canal dimensions with flexion and exten-sion were noted in the control group (Sortland, 1997 [D]).

Zander, et al. noted significant dynamic changes in 33 of 210 patients with back pain, radiculopathy or neurogenic claudication who underwent functional myelography and CT myelography. At five levels, stenosis of 70% or more seen on flexion-extension myelography measured less than 50% on supine CT scans (Zander, 1998 [D]). Similar findings were reported in other studies (Sortland, 1997 [D]; Ping, 1994 [D]; Wilmink, 1983 [D]).

Axial loaded MRI. Several studies have reported on the presence of additional findings on patients who have undergone MRI, CTM or CT with axial loading applied to simulate weight bearing (Manenti, 2003 [D]; Danielson, 1998 [D]; Willen, 1997 [D]). Willen et al., in a study of 172 patients, reported significant changes on axial CT in 69% of patients with neurogenic intermittent claudication and 0% of patients with isolated back pain (Willen, 2001 [D]).

Hiwatashi, et al., in a study of 20 patients, showed that the additional information obtained with axial loading on MRI can influence treatment decisions by neurosurgeons. In five of these patients, all three neurosur-geons changed their treatment plans from conservative therapy to surgical decompression after reviewing the findings on the axial loaded exams. One or two of the neurosurgeons changed their treatment plan in another five patients (Hiwatashi, 2004 [D]). The significance of these findings relative to the patients' outcome has not been addressed.

Open Upright MRI. Open Upright MRI can image patients in anatomic positions of axial loading such as sitting and standing, in flexion and extension, and in positions that might reproduce pain.

Zamani, et al., examined 30 patients with Open Upright MRI using sitting neutral and sitting flexion and extension images. Fifteen of these patients also underwent conventional high field strength imaging. The authors noted a decrease in the size of the central canal in 50% of patients and the foraminal canal in 27% of patients with extension. These changes were most notable at levels with disc dessication. The authors also noted some decrease in image quality compared with the conventional images. They did not quanti-tate or determine the significance of the changes on Open Upright MRI relative to the patients' symptoms. Patients were not consecutive, and interpretation of the images were not blinded to the results of the high field strength exams (Zamani, 1998 [D]).


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Wildermuth, et al. examined 30 consecutive patients with functional myelography and Open Upright flexion and extension MRI. They found a high correlation of the measured AP dural sac diameter on the two techniques. The authors also reported positional changes in foraminal size in a small number of patients. Patients were recruited in a consecutive manner after completion of the myelographic examina-tion (Wildermuth, 1998 [D]).

Weishaupt, et al. examined 30 patients with chronic low back or leg pain unresponsive to conservative therapy and disc protrusions and/or extrusions without neural compression on routine supine MRI. The authors found that positional dependent changes in nerve root impingement and foraminal size were frequent, and correlated with the severity of patient symptoms. Patients were not consecutive and were recruited after completion of the supine recumbent exam. Blinding of results of the conventional imaging is not noted (Weishaupt, 2000 [D]).

Ferriro Perez, et al. evaluated the differences in findings between supine recumbent and upright sitting neutral images in 89 patients, 45 of whom underwent studies of the lumbar spine. Twenty-four disc hernia-tions were seen in the lumbar spine, 2 (8%) of which were only seen on the upright exam, and 14 (58%) of which increased in size on the upright exam. Anterior spondylolisthesis was seen in 13 lumbar spine cases, was only seen on the upright exam in 4 (31%), and increased in severity on the upright exam in 7 (54%). Patients were not consecutive, and findings were not correlated with symptoms. Motion artifact prohibited accurate measurements in 20% of images. Blinding of results of the conventional imaging is not noted (Ferriro Perez, 2007 [D]).

Vitzthum, et al. studied 50 healthy volunteers and 50 patients who suffered from symptoms correlating to monosegmental disease awaiting surgical decompression (41 disc herniations, 5 lateral recess stenosis, 4 degenerative spondylolisthesis). The authors felt that the dynamic open upright flexion-extension MRI added important additional information in 32 patients. Rotational examinations contributed important additional information in 5 patients. The authors did not note whether the patients were consecutive, and did not detail the nature of the important additional information. They did note an increase in the rotation at degenerated segments with a decrease segmental flexion-extension (Vitzthum, 2000 [D]).

Adult Low Back PainAppendix D – Upright and Positional Imaging Fourteenth Edition/November 2010


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Appendix E – General Guidelines for CT and MRI Order Sets for Adult Low Back Pain


The primary purpose of the initial order sheet is to provide patient identification and the exam requested. Secondary purposes are to provide clinical information to support the appropriateness of the request and to assist the radiologist in the interpretation of the exam. Information on the initial order should assist the radiology department to determine whether the patient has contraindications to the exam or special needs, and to prompt the radiology department to address these needs prior to the patient's appointment.

The initial order sheet should include:

I. Patient Info

a. Name

b. Gender

c. Birth date

d. Weight and height

e. Contact information

II. Physician information

a. Requesting provider

b. Primary caregiver

c. Clinic or hospital

d. Contact information including telephone number and fax.

III. Exam requested from list of offered studies

IV. Insurance information, workers' comp, auto, etc.

V. Clinical symptoms such as

a. Pain, severity and location (pain diagram is very useful but is easier to obtain on the clinical infor-mation form filled out by the patient on check-in; VAS would also be very useful on intake)

b. Neurogenic intermittent claudication

c. Neurologic loss

d. Weakness or difficulty walking

e. Urinary or fecal incontinence

f. Functional limitations: e.g., work status, difficulty caring for oneself (Oswestry score would also be very useful to obtain at patient check-in and may be required for future appropriateness reviews)

VI. Suspected diagnosis such as

a. discogenic pain

b. disc herniation

c. stenosis


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VII. Response to and duration of prior conservative care

a. Chiropractic care

b. Physical therapy

c. Oral medications

VIII. Relevant history

a. History and date of previous injury

b. Prior imaging of the area in question

c. History of prior surgery in the examined area

d. Red flags including

i. history of trauma

ii. IV drug abuse

iii. immunosuppression

iv. long-term steroid use

v. cancer

e. Claustrophobia

f. Contraindications to contrast including

i. history of renal failure

ii. diabetes

iii. allergy to iodine or contrast

IX. Special requests

a. Sedation for claustrophobia, pain control or pediatric imaging

b. Transportation assistance

c. Image delivery

i. films

ii. copy with patient

iii. CD-Rom

iv. electronic only

Appendix E – General Guidelines Adult Low Back Painfor CT and MRI Order Sets for Adult Low Back Pain Fourteenth Edition/November 2010

72Copyright © 2010 by Institute for Clinical Systems Improvement

Contact ICSI at:8009 34th Avenue South, Suite 1200; Bloomington, MN 55425; (952) 814-7060; (952) 858-9675 (fax)

Online at http://www.ICSI.org


Document History, Development and Acknowledgements:

Adult Low Back Pain

Released in November 2010 for Fourteenth Edition. The next scheduled revision will occur within 24 months.

Document Drafted Apr – Jul 1993

First Edition Jun 1994

Second Edition Aug 1995

Third Edition Dec 1996

Fourth Edition Nov 1997

Fifth Edition Dec 1998

Sixth Edition Dec 1999

Seventh Edition Jun 2001

Eighth Edition Oct 2002

Ninth Edition Oct 2003

Tenth Edition Oct 2004

Eleventh Edition Oct 2005

Twelfth Edition Oct 2006

Thirteenth Edition Dec 2008

Fourteenth Edition Begins Dec 2010

Original Work Group MembersMichael Koopmeiners, MDFamily PracticeGroup Health, Inc.Dominic Korbuly, MDRadiologyPark Nicollet Medical CenterGeorge Kramer, MDPhysical Medicine and RehabPark Nicollet Medical CenterKathy Kurdelmeier, PTPhysical TherapyPark Nicollet Medical CenterSteven Lewis, DCChiropracticsGroup Health, Inc.

Mark DePaolis, MDFamily PracticePark Nicollet Medical CenterSherwin Goldman, MDOrthopedic SurgeryMayo ClinicBrenda Gorder, RNFacilitatorGroup Health, Inc.Robert Gorman, MD, MPHOccupational Medicine, Work Group LeaderPark Nicollet Medical CenterFred HamacherBusiness Health Care Action GroupDayton Hudson Corporation

Peter Marshall, MDFamily PracticeGroup Health, Inc.Jane NorstromHealth EducationPark Nicollet Medical FoundationDavid C. Thorson, MDSports MedicineMinnHealth, P.A.Catherine Wisner, PhDMeasurement AdvisorGroup Health Foundation


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ICSI Document Development and Revision ProcessOverviewSince 1993, the Institute for Clinical Systems Improvement (ICSI) has developed more than 60 evidence-based health care documents that support best practices for the prevention, diagnosis, treatment or manage-ment of a given symptom, disease or condition for patients.

Document Development and Revision ProcessThe development process is based on a number of long-proven approaches. ICSI staff first conducts a literature search to identify pertinent clinical trials, meta-analysis, systematic reviews, regulatory statements and other professional guidelines. The literature is reviewed and graded based on the ICSI Evidence Grading System.

ICSI facilitators identify gaps between current and optimal practices. The work group uses this informa-tion to develop or revise the clinical flow and algorithm, drafting of annotations and identification of the literature citations. ICSI staff reviews existing regulatory and standard measures and drafts outcome and process measures for work group consideration. The work group gives consideration to the importance of changing systems and physician behavior so that outcomes such as health status, patient and provider satisfaction, and cost/utilization are maximized.

Medical groups, who are members of ICSI, review each guideline as part of the revision process. The medical groups provide feedback on new literature, identify areas needing clarification, offer recommended changes, outline successful implementation strategies and list barriers to implementation. A summary of the feedback from all medical groups is provided to the guideline work group for use in the revision of the guideline.

Implementation Recommendations and MeasuresEach guideline includes implementation strategies related to key clinical recommendations. In addition, ICSI offers guideline-derived measures. Assisted by measurement consultants on the guideline develop-ment work group, ICSI's measures flow from each guideline's clinical recommendations and implementation strategies. Most regulatory and publicly reported measures are included but, more importantly, measures are recommended to assist medical groups with implementation; thus, both process and outcomes measures are offered.

Document Revision CycleScientific documents are revised every 12-24 months as indicated by changes in clinical practice and literature. Each ICSI staff monitors major peer-reviewed journals every month for the guidelines for which they are responsible. Work group members are also asked to provide any pertinent literature through check-ins with the work group mid-cycle and annually to determine if there have been changes in the evidence significant enough to warrant document revision earlier than scheduled. This process complements the exhaustive literature search that is done on the subject prior to development of the first version of a guideline.


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AcknowledgementsICSI Patient Advisory CouncilThe work group would like to acknowledge the work done by the ICSI Patient Advisory Council in reviewing the Adult Low Back Pain guideline and thank them for their suggestion(s) to improve the motivation and compliance in patients from the providers with their home-based rehabilitation programs. This included keeping a journal to share with the provider, frequent follow-up from the provider such as a call, having a DVD that demonstrates exercises, and considering the patient's daily routine and living situations.

The ICSI Patient Advisory Council meets regularly to respond to any scientific document review requests put forth by ICSI facilitators and work groups. Patient advisors who serve on the council consistently share their experiences and perspectives in either a comprehensive or partial review of a document, and engaging in discussion and answering questions. In alignment with the Institute of Medicine's triple aims, ICSI and its member groups are committed to improving the patient experience when developing health care recom-mendations.