surgical vs physical therapy interventions for lumbar spinal stenosis

Surgical vs Physical Therapy Interventions for LSS 1

Surgical vs Physical Therapy Interventions for Lumbar Spinal Stenosis: a review and best physical therapy practices

By: Daniel R. Prohaska Doctoral Candidate

University of New Mexico School of Medicine Division of Physical Therapy

Class of 2014

Advisor: Kathy Dieruf, PT, PhD

Printed Name of Advisor:______________________ Signature:________________________ Date:______________ Approved by the Division of Physical Therapy, School of Medicine, University of New Mexico in partial fulfillment of the requirements for the degree of Doctor of Physical Therapy.


Abstract

Background/Purpose

Lumbar spinal stenosis (LSS) is mostly a condition of aging, and with the world population growing

older, more cases are sure to be seen clinically. The rate of spine surgery steadily increased in recent

decades, even after adjustment for the aging of the population. However, the evidence to recommend

surgery over conservative care is sparse. This case study compared the literature on surgical and physical

therapy interventions, looking at the short and long term outcomes of the two; it also sought to find any

physical therapy interventions that were superior in producing good outcomes.

Case Description

A 72 year old male was referred to physical therapy for chronic low back pain that had been getting

progressively worse. The patient, especially after later MRI imaging of the lumbar spine, fit the LSS

category (724.02 Spinal stenosis, lumbar region, without neurogenic claudication). The patient was

experiencing several bad days per week in which he spent the entire day in 7-8/10 pain and could not find

any way to get relief. The patient was not interested in pharmaceutical or surgical interventions, and so

physical therapy seemed to best fit his current wishes.

Outcomes and Discussion

The patient was treated twice a week over a six week period with typical physical therapy

interventions including: a home exercise program, cardiorespiratory conditioning, strengthening, manual

therapy, and various modalities. The patient was able to reduce his pain to a manageable level throughout

the week, improve his sitting and driving tolerance, and was happy with his results.


Background and Purpose

Clinically, many patients present to outpatient physical therapy with low back pain. The patient in

this case study presented to the clinic with symptoms consistent with lumbar spinal stenosis. When

reviewing the literature on LSS, surgery seems to be a typical treatment, and the evidence for conservative

interventions seems scarce. According to Dr. Richard Deyo the following two facts confuse the issue: 1.

there is little consensus on how best to relieve pain from stenosis, so doctors tend to develop their own

preferences, 2. complex spinal fusion procedures have increased an astounding 1,400 percent between

2002 and 2007. i

About one fourth of U.S. adults reported low back pain in the past 3 months.ii The causes are

varied; however, one cause is degenerative change in the lumbar spine. Degenerative changes of the

spine are seen in up to 95% of people by the age of 50.iii These changes are not always correlated to low

back pain, but at times they are and the most common of these changes is called spinal stenosis.

Arthritis is the most common cause of spinal stenosis. In the spine, arthritis can result as the disk

degenerates and loses water content. This problem causes settling, or collapse, of the disk spaces and

loss of disk space height. This in turn puts more forces through the facet joints causing arthritis of the

facets. The body may respond by growing new bone in the facet joints to help support the vertebrae. Over

time these bone spurs encroach upon the intervertebral foramen putting pressure on spinal nerves.

The other structures of the spine can also change with arthritis; changes include cartilaginous

hypertrophy of the articulations surrounding the canal, intervertebral disc herniations or bulges,

spondylolisthesis, hypertrophy or calcification of the ligamentum flavum and the above mentioned

osteophyte formation.

Spinal stenosis most often occurs in adults over 60 years old. Typically, people with symptomatic

lumbar spinal stenosis have difficulty walking for extended periods. Walking can bring on a cramping kind


of pain, or numbness, or weakness in the legs. Typically, the pain rapidly subsides once the person sits.

Many people with lumbar stenosis typically experience relief when leaning forward and especially with

sitting. Pain is usually made worse by standing up straight and walking. Some individuals note that they can

ride a stationary bike or walk leaning on a shopping cart. Walking more than 1 or 2 blocks, however, may

bring on severe sciatica or weakness.iv

Most patients with LSS have tried conservative treatments for lumbar stenosis, such as lumbar

bracing, bed rest, physical therapy, and pain management (anti-inflammatories and corticosteroid

injections), but there is little evidence to guide their use and application. Nonsurgical treatment options tend

to focus on restoring function and relieving pain. Although nonsurgical methods do not improve the

narrowing of the spinal canal, many people report that these treatments do help relieve symptoms. The

disease is not always progressive and there can be a favorable outcome with conservative care in 30 to

50% of those with mild to moderate symptoms as a review from the North American Spine Society

demonstrated.v

For those patients in which symptoms are not managed well by conservative care and/or pain is

the limiting factor often surgical options are explored. There are two main surgical interventions to treat

lumbar spinal stenosis: laminectomy (also called a “decompression”) and spinal fusion (uses bone grafts

along with rods and screws). Both options can result in excellent pain relief (patients tend to see more

improvement of leg pain than back pain) according the American Academy of Orthopaedic Surgeons.vi

The PCIO question that was raised by this case study was: “Do patients with lumbar spinal

stenosis, treated with surgery versus physical therapy interventions, have better long-term outcomes?” The

secondary question was to see if there was any good evidence for specific physical therapy interventions to

treat LSS. This is especially relevant as there is an increasing incidence of surgical intervention of LSS.

Since lumbar stenosis is a slowly progressing disease early intervention is key; as with many

conditions early interventions should be conservative while providing a high reward to low risk ratio. With an


aging, active population there will be an increase in the number of lumbar stenosis cases seen. Physical

Therapists should have an important role to play in the treatment and prevention of lumbar stenosis if there

is evidence to be found to make such a case.

Case Description

Introduction The patient was a 72 year old male with a long history of slowly progressing low back pain. This

patient was referred to outpatient physical therapy for an evaluation and treatment of low back pain which

was limiting function in activities of daily living and becoming uncontrolled at times.

Patient history The patient had a history of hypertension and was on a Hydrochlorothiazide medication for this.

The patient has no other significant past medical history. The patient was retired, married, and was raising

three grandchildren. The patient worked as a produce manager for years and believes all the years on his

feet and lifting produce boxes contributed to the back pain he now experiences. The patient sometimes had

difficulty falling asleep due to pain, but more often arose with pain in the morning. Pain was relieved by

OTC acetaminophen and movement. After this the patient felt better, but on his bad days would have a

recurrence in the afternoon, or would not be able to get the initial morning pain to reduce. Pain would then

continue throughout the day causing the patient to lie on the couch all day in pain. He had not received any

other interventions except for the OTC pain medications. The patient stated he was able to do everything

he needed to do in the day and that his back pain does not cause any functional limitations in his ability to

be a caregiver for his grandchildren. The patient also stated that he wished to avoid surgical or

pharmaceutical interventions if possible.


Systems review Unremarkable except for the patient reporting dizziness or a spinning feel at times. The cause of

this could never be discovered while under the care of physical therapy. It was attributed perhaps to his

blood pressure medication, but the dizziness was intermittent and no pattern(s) could be established as

blood pressure was often normal.

Tests and Measures The patient’s primary care provider ordered a MRI of the lumbar spine that was not completed and

read until half-way through the patient’s course of physical therapy.

o Patient was concerned that MRI imaging would reveal cancer or unknown pathology. Once

the MRI was read and the only finding being degeneration of the lumbar spine, patient was

relieved and happy.

Balance – feet together, tandem stance, single leg stance (eyes open and eyes closed)

o Normal except for single leg stance with eyes open patient could not perform for more than

a few seconds.

o Berg Balance scale 46/56

Gait – observational gait analysis

o No abnormalities noted

Muscle strength – manual muscle testing of lower extremities and trunk

o Hip strength grossly 3+/5 bilaterally

o Lumbar extensors 4/5

o Abdominals 3+/5

Pain – numerical scale, taken verbally; lumbar provocational tests

o Patient stated on his bad days his pain is a 7/10

o Pain reduces to a 2-3/10 on good days; “background” pain is always present.


o Provocational tests negative

Posture – assessed visually in sitting and standing

o Thoracic kyphosis – mild

o Lumbar lordosis – lacking

Range of motion – of hips and spine taken visually and with goniometry

o Hips – with in functional limits

o Spine – lacking lumbar extension (0°), and R rotation (45°)

Neurological screen – reflexes, dermatomes, myotomes, special tests

o Normal, no abnormal neurological findings

o Straight leg raise – normal

Diagnosis Medical diagnosis: 724.02 Spinal stenosis, lumbar region, without neurogenic claudication.

Physical therapy diagnosis: Musculoskeletal pattern 4E – Impaired joint mobility, motor function, muscle

performance, and range of motion associated with localized inflammation.

Narrative Assessment The patient’s evaluation demonstrated that the patient was generally deconditioned, lacked range

of motion and strength in the trunk, and had high levels of pain several days of the week that limited his

functional mobility.

Clinical Judgments and Problem List Patient presents with balance deficits

Patient demonstrates weakness of hip, and trunk musculature

Patient has pain limiting function

Patient lacks typical spinal range of motion


Prognosis/Goals/Plan of Care Goals:

Patient will increase strength of hip, and trunk musculature by one muscle grade.

Patient will have five consecutive days in which pain level is maintained at a 2-3/10, and does not

spike higher.

Patient will demonstrate symmetry in spinal range of motion measured via goniometry.

Patient will demonstrate understanding and proficiency in home exercise program to address

deconditioning and lack of trunk stability.

Pt will increase standing balance as evidenced by a higher score (≥8 points) on the Berg Balance

scale.

Interventions Patient was instructed in a home exercise program consisting of lumbar stabilization exercises. In

the clinic the patient performed stationary recumbent cycling, Total Gym leg press for time, lumbar

stabilization exercises, manual therapy for spinal mobility, lumbar traction, and electrical stimulation with

moist heat packs. Patient was seen in clinic twice a week for a total of six weeks.

Outcomes Patient was able to improve his spinal range of motion and trunk stability to much better levels. The

most significant outcome, and which the patient was most happy about was his ability to reduce his pain

levels to a mild 3/10 at the worst for greater than five days in a row. The patient also reported improved

ability to lift and carry objects, along with increased car driving and sitting tolerance. It appeared the patient

would not be able to increase his standing balance any further due to knee OA, also patient did not seem

consistent with his HEP, but overall the major pain and functional goals were met.


Evidence Based Analysis

Methodologies of Search

Table 1, Table 2, Table 3 on the following pages show the breakdown of types of articles, levels of

evidence, purpose, outcome measures and results. Table 1 is the methods of search, Table 2 has the

included studies, and Table 3 lists the excluded studies. Included in the appendix of this paper is an

analysis of each article, as well as a one page summary of the articles.


Table 1 Methods of Search

Database Search Term(s) Filter(s) Results Inclusion/Exclusion

PubMed Lumbar AND stenosis AND conservative

None 269 papers Articles were excluded that used pharmaceutical interventions/therapies or exclusively surgical interventions.

PubMed Lumbar AND stenosis AND surgery AND physical therapy

Systematic Reviews, Randomized Controlled Trial, Meta-Analysis, Humans

30 papers Articles were excluded that used pharmaceutical interventions/therapies or exclusively surgical interventions.

PubMed Lumbar AND stenosis AND physical therapy

Systematic Reviews, Randomized Controlled Trial, Meta-Analysis, Humans

32 papers Articles were excluded that used pharmaceutical interventions/therapies or exclusively surgical interventions.

PEDro Lumbar stenosis None 47 papers Articles were excluded that used alternative medicine or did not use surgical and/or physical therapy interventions. Articles that were also retrieved in PubMed were ignored.


Table 2 Included Studies

# Study Level of Evidence

Purpose Outcome Measures Results Acceptable

1 Whitman, J.M., Flynn, T.W, Childs, J.D., Wainner, R.S., Gill, H.E., Ryder, M.G., . . . Fritz, J.M. (2006).

Oxford level 1b

The purpose of this study is to compare the outcomes of two different physical therapy programs to help inform conservative treatment choices.

Perceived recovery was assessed with a global rating of change scale. Secondary outcomes included: Oswestry, a numerical pain rating scale, a measure of satisfaction, and a treadmill test.

A greater proportion of patients in the manual physical therapy, exercise, and walking group reported recovery at 6 weeks compared with the flexion exercise and walking group (P=0.0015), with a number needed to treat for perceived recovery of 2.6 (confidence interval, 1.8 –7.8).

Yes

2 May, S., Comer, C. (2013).

Oxford level 1A

The goal of this systematic review was to examine surgical versus non-surgical treatment, and all non-surgical treatments for spinal stenosis.

Pain and disability were determined to be the key outcome measures.

Decompression surgery was more effective than conservative care in four out of five studies, but only one of these was of high quality. In six high-quality studies, there was strong evidence that steroid epidural injections were not effective; in four out of five studies (two of which were of high quality), there was moderate evidence that calcitonin was not effective. There was no evidence for the effectiveness of all other conservative interventions.

Yes

3 Amundsen, T., Weber, H., Nordal, H.J., Magnaes, B., Abdelnoor, M.,

Oxford level 1b

The goal of this study was to find guidelines applicable for the individual patient on how to choose between conservative and surgical treatment.

Pain, working ability, walking ability, level of physical activity at leisure, and any change in physical

After a period of 3 months, relief of pain had occurred in most patients. The treatment result for the patients randomized for surgical treatment was considerably better

Yes


Lilleas, F. (2000). findings. than for the patients randomized for conservative treatment.

4 Kovacs, F.M., Urruita, G., Alarcon, J.D., (2011).

Oxford level 1A

The objectives of this study were to systematically review the evidence on the effectiveness and safety of any form of surgery versus conservative treatment for symptomatic lumbar spinal stenosis. Secondarily to explore whether available data made it possible to refine indication criteria for either type of treatment, on the basis of the existence of spondylolisthesis or neurogenic claudication.

Most outcomes were patient reported. Variables that were assessed during follow-up included pain, function, claudication distance, quality of life, and patients’ overall rating and satisfaction. Disability, as measured by the Oswestry Disability Index at 2 years, was the only outcome that was assessed in 3 studies or more.

Results of surgery were similar among patients with and without spondylolisthesis, and slightly better among those with neurogenic claudication than among those without it. The advantage of surgery was noticeable at 3 to 6 months and remained for up to 2 to 4 years, although at the end of that period differences tended to be smaller.

Yes

5 Jarrett, M.S., Orlando, J.F., and Grimmer-Somers, K., (2012).

Oxford level 1A

The purpose was to review the literature to compare land based exercise interventions and surgical decompression. The secondary aim of this review was to report on the adverse effects associated with the use of these two interventions.

Studies included had to use a patient reported functional outcome measure for a land based exercise intervention or lumbar decompressive surgery.

Exercise interventions showed initial improvements, ranging from 16 to 29% above baseline. All decompressive surgical interventions demonstrated greater and sustained improvements over 2-years (range 38-67% improvement) with moderate to large effect sizes.

Yes

6 Macedo, L.G., Hum, A., Kuleba, L., Mo, J., Truong, L., Yeung, M., and

Oxford level of evidence 2a

The purpose of this study was to systematically review studies evaluating the effectiveness of physical therapy interventions in the treatment of LSS, considering the

Pain, disability, function, or quality of life.

Pooled effects results of RCTs evaluating surgery versus physical therapy demonstrated that surgery was better than physical therapy for pain and disability at long term

Yes


Battie, M.C., (2013).

specific type of physical therapy treatment and how it was applied.

(2 years) only. Other results suggested that exercise is significantly better than no exercise, that cycling and body-weight–supported treadmill walking have similar effects, and that corsets are better than no corsets.

7 Iversen, M.D., Choudhary, V.R., and Patel, S.C., (2010).

Oxford level of evidence 3a

This article examines the evidence for therapeutic exercise and manual therapy for the conservative management of LSS, and describes the effects of these interventions on select outcomes.

Percentage change in primary outcomes (pain, function and disability) were calculated.

Five studies used aerobic exercise as their primary mode or part of the primary intervention, one study demonstrated the effects of aquatic strengthening exercises only and one study reported the effects of manual therapy alone.

Yes

8 Balakatounis, K.C., Panagiotopoulou, K.A., Mitsiokapa, E.A., Mavrogenis, A.F., Angoules, A.G., Papathanasiou, J., Papagelopoulos, P.J., (2011).

Oxford level of evidence 1b

The purpose of this review was to critically appraise randomized controlled trials with a clear outline of the non-operative treatment rehabilitation approach, and to promote the formation of evidence-based strategy.

Outcomes measures were mainly subjective and reported by the patients. The Oswestry Disability Index was used extensively.

A comprehensive exercise and manual therapy protocol is more effective in reducing symptoms than a less intensive exercise program.

Yes


Table 3 Articles Excluded

# Study Database Retrieved From

Reason Excluded

1 Psychometric properties of selected tests in patients with lumbar spinal stenosis. Cleland JA, Whitman JM, Houser JL, Wainner RS, Childs JD. Spine J. 2012 Oct;12(10):921-31. doi: 10.1016/j.spinee.2012.05.004. Epub 2012 Jun 28.

PubMed

This study did not have a specific physical therapy intervention and was thus excluded.

2 Nonoperative treatment of lumbar spinal stenosis with neurogenic claudication: a systematic review. Ammendolia C, Stuber K, de Bruin LK, Furlan AD, Kennedy CA, Rampersaud YR, Steenstra IA, Pennick V. Spine (Phila Pa 1976). 2012 May 1;37(10):E609-16. doi: 10.1097/BRS.0b013e318240d57d. Review.

PubMed

This study was excluded because the patient did not have neurogenic claudication

3 Postoperative rehabilitation does not improve functional outcome in lumbar spinal stenosis: a prospective study with 2-year postoperative follow-up. Aalto TJ, Leinonen V, Herno A, Alen M, Kröger H, Turunen V, Savolainen S, Saari T, Airaksinen O. Eur Spine J. 2011 Aug;20(8):1331-40. doi: 10.1007/s00586-011-1781-y. Epub 2011 Apr 27.

PubMed

This study was excluded because the patient had not had surgery, and the intervention in question was a conservative one.

4 Efficacy of exercise and ultrasound in patients with lumbar spinal stenosis: a prospective randomized controlled trial. Goren A, Yildiz N, Topuz O, Findikoglu G, Ardic F. Clin Rehabil. 2010 Jul;24(7):623-31. doi: 10.1177/0269215510367539. Epub 2010 Jun 8.

PubMed

This study was excluded because it used a modality as one of its primary interventions. The result of ultrasound use was decreased analgesic use, not decreased disability score.

5 Early rehabilitation targeting cognition, behavior, and motor function after lumbar fusion: a randomized controlled trial. Abbott AD, Tyni-Lenné R, Hedlund R. Spine (Phila Pa 1976). 2010 Apr 15;35(8):848-57. doi: 10.1097/BRS.0b013e3181d1049f.

PubMed

This study was excluded because it was a post-surgical intervention.

6 Physical therapy treatment options for lumbar spinal stenosis. Tomkins CC, Dimoff KH, Forman HS, Gordon ES, McPhail J, Wong JR, Battié MC. J Back Musculoskelet Rehabil. 2010;23(1):31-7. doi: 10.3233/BMR-2010-0245.

PubMed

This study was excluded because it was a telephone survey of what interventions patients had received. Did not seem very reliable.

7 Effectiveness of exercise in the treatment of lumbar spinal stenosis, knee PubMed This study was excluded because the


osteoarthritis, and osteoporosis. Iwamoto J, Sato Y, Takeda T, Matsumoto H. Aging Clin Exp Res. 2010 Apr;22(2):116-22. doi: 10.3275/6593. Epub 2009 Nov 6. Review.

topic was too broad; it included knee OA and osteoporosis.

8 Enhancing function in older adults with chronic low back pain: a pilot study of endurance training. Iversen MD, Fossel AH, Katz JN. Arch Phys Med Rehabil. 2003 Sep;84(9):1324-31.

PubMed

This study was excluded because the topic is not specific to LSS, but rather generalized chronic LBP.

9 Nonoperative treatment for lumbar spinal stenosis with neurogenic claudication (Cochrane review) [with consumer summary]. Ammendolia C, Stuber KJ, Rok E, Rampersaud R, Kennedy CA, Pennick V, Steenstra IA, de Bruin LK, Furlan AD., Cochrane Database of Systematic Reviews 2013;Issue 8

PEDro This article was excluded because it was LSS with neurogenic claudication specifically.

10 Rehabilitation following surgery for lumbar spinal stenosis (Cochrane review) [with consumer summary]. McGregor AH, Probyn K, Cro S, Dore CJ, Burton AK, Balague F, Pincus T, Fairbank J., Cochrane Database of Systematic Reviews 2013;Issue 12

PEDro This article was excluded because it involved PT intervention after surgery.

11 Lumbar spinal stenosis: a brief review of the nonsurgical management. Tran DQH, Duong S, Finlayson RJ., Canadian Journal of Anaesthesia [Journal Canadien d'Anesthesie] 2010 Jul;57(7):694-703

PEDro This article was excluded because it involved too many anesthetic and pain control interventions; not focused specifically focused on physical therapy.

12 Chiropractic treatment of lumbar spinal stenosis: a review of the literature. Stuber K, Sajko S, Kristmanson K., Journal of Chiropractic Medicine 2009 Jun;8(2):77-85

PEDro This article was excluded because it was not Physical Therapy specific.

13 Early rehabilitation targeting cognition, behavior, and motor function after lumbar fusion: a randomized controlled trial [with consumer summary]., Abbott AD, Tyni-Lenne R, Hedlund R., Spine 2010 Apr 15;35(8):848-857.

PEDro This study was excluded because it was a post-surgical intervention.

14 Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS., The New England Journal of Medicine 2007 May 31;356(22):2257-2270

PEDro This study was excluded because it was too specific to spondylolisthesis.


Discussion According to the literature reviewed on surgical versus conservative care for LSS surgical

interventions seem to demonstrate better outcomesviiviiiix. In general surgery provides moderately better

outcomes than physical therapy interventions; about four fifths of severely afflicted patients had good

results. However, surgical interventions do not improve walking ability, but do improve pain, function,

disability, and quality of life.x Patients who ended up in the surgical intervention groups often had more pain

and perhaps had already failed conservative care treatments thus biasing the results for better outcomes

with surgical interventions.

The physical therapy interventions reviewed in the literature vary widely, and thus it is hard to

recommend specific interventions. Overall the literature evaluating physical therapy interventions is scarce

for patients with lumbar spinal stenosis. Some specific interventions mentioned in the literature that

produced slightly better results were: therapeutic exercise and manual therapyxixii; low-to-moderate intensity

aerobic exercise performed for at least 6 weeks in combination with flexibility, strengthening exercise and

manipulationxiii; bodyweight supported treadmill; cycling; lumbar flexion exercisesxiv. In general patients who

underwent a course of physical therapy, irrespective of the physical therapy interventions used,

experienced statistically significant improvementxv. Physical therapy was a good treatment for one half of

patients with mild symptoms; most patients had great pain relief in less than three months, while some took

up to a year to experience relief from the PT intervention.xvi

The problem in all the studies and both surgical and physical therapy interventions is that the

treatments are heterogeneous between and within studies. Also the blinding of therapists, patients, and

outcome assessors is not feasible; the outcome variables are also subjective and assessed by the patients

e.g. pain, function, severity, satisfaction. The patient with lumbar spinal stenosis should be made aware

that the benefits of surgical intervention decrease with time; after ten years there appears to be no


difference between conservative and surgical interventions.xvii Also waiting up to three years to have

surgery does not change the initial surgical outcomes (mostly pain relief).xviii

Conclusion/Bottom Line

When viewing the patient with LSS from a clinical perspective one should take into consideration

the principle that medical interventions for chronic, degenerative conditions should follow a progressive

continuum of care. The literature does support some moderate outcomes from physical therapy

interventions for patients with LSS, and as such an initial trial of conservative care seems appropriate.

Patients in which conservative treatment has failed for 3 to 6 months could be considered surgical

candidates, especially if pain is “intolerable”. The risk-benefit and costs associated with a surgical

intervention are much greater than an initial episode of physical therapy care. Therefore it seems best to

first recommend physical therapy care for a period of 2-3 months, preferably by a trained manual

therapistxix. The results experienced by the patient in this case study were comparable to the results of the

literature; a mild case of LSS who improved some with a typical course of PT. If this patient continues to

worsen over the years, surgical intervention could be considered, however waiting on surgery for a while

will not produce a worse outcome.

Appendix

Summary of Included Studies

1 Whitman, J.M., Flynn, T.W, Childs, J.D., Wainner, R.S., Gill, H.E., Ryder, M.G., . . . Fritz, J.M. (2006). A Comparison Between Two Physical Therapy Treatment Programs for Patients With Lumbar Spinal Stenosis. Spine, 31(22), 2541-2549.

Level of Evidence Oxford level 1b


Purpose No randomized clinical trial evidence could be found to inform long-term outcomes of non-surgical

treatment of lumbar spinal stenosis. The purpose of this study is to compare the outcomes of two different

physical therapy programs to help inform conservative treatment choices.

Methods Patients with pain in the lumbar spine, ≥50 years old, and with a confirmed diagnosis of LSS based

on a clinical examination and MRI findings were included in this study. Patients were scheduled for twelve

45- to 60-minute physical therapy sessions over 6 weeks (twice weekly). In addition to the physical therapy

visits, all patients were asked to take a daily walk at a pace and distance that did not irritate lower extremity

symptoms and to perform a home exercise program.

Patients were also randomized into two groups: 1) Group one (FExWG) performed lumbar flexion

exercises, a progressive treadmill walking program, and subtherapeutic ultrasound. 2) Group two

(MPTExWG) received manual physical therapy to the thoracic and lumbar spine, pelvis, and lower

extremities. Therapists instructed patients in specific exercises to address impairments in mobility, strength,

and/or coordination, including instruction in the same flexion exercises for the lumbopelvic region as group

one. Strengthening exercises were tailored to fit the individual patient’s needs. Patients also participated in

a body-weight supported (BWS) treadmill ambulation program.

Results 60 patients were enrolled in this study, and the mean follow-up for the long-term was 29 months. The

following were the percentages of those patients who meet the perceived recovery threshold:

6 weeks: 79% MPTExWG and 41% of the FExWG

1 year: 62% MPTExWG and 41% of the FExWG

Long term: 38% MPTExWG and 21% of the FExWG


As one can see from the above there was a significant association between treatment groups and

perceived recovery in the first six weeks; after that there was no longer any significance.

Critique/Bottom Line It seems that while being under the treatment and care of an Orthopaedic Manual Physical

Therapist the patients experienced a significant relief of symptoms and a high perceived recovery. This

could be attributed to the intervention itself as the other group also received one-on-one PT, but of a

different sort. The number needed to treat with this protocol was 2.6 at 6 weeks. The effects of the

MPTExWG treatment were however, most beneficial in the short-term. The good news is that patients in

both groups improved and benefitted from a PT program that included lumbar flexion exercises and a

walking program. Finally, because of the morbidity and mortality rates associated with surgical interventions

for patients in this population, it is promising that physical therapy may be a viable lower risk alternative

form of care for older adults with LSS.

2 May, S., Comer, C. (2013). Is surgery more effective than non-surgical treatment for spinal stenosis, and which non-surgical treatment is more effective? A systematic review. Physiotherapy, 99, 12-20.

Level of Evidence Oxford level 1A

Purpose Because surgical intervention for LSS is on the rise, and there is currently evidence to support both

surgery and conservative treatment, the goal of this systematic review was to examine surgical versus non-

surgical treatment, and all non-surgical treatments for spinal stenosis.

Methods The following databases were searched: Medline, Cinahl, AMED, PEDro, and Cochrane Central

Register of Controlled Trials. Search terms and combinations were as follows: spinal stenosis OR

neurogenic claudication, AND non-operative treatment OR conservative treatment OR physical therapy OR


physiotherapy OR rehabilitation, AND randomized controlled trial OR clinical trial. Inclusion criteria were as

follows: human subjects, subjects with spinal stenosis and back (leg) pain, clinical or radiological diagnosis

of spinal stenosis, RCT, and use of non-surgical treatment in one group. Studies were scored on quality

according to the PEDro scale. Data was extracted and compiled in a table; pain and disability were

determined to be the key outcome measures.

Results In this systematic review of the literature into surgical verses nonsurgical care and into different

forms of non-surgical care for patients with spinal stenosis, 31 articles and 27 separate studies were found.

Thirty-one studies met the inclusion criteria, and 18 were high-quality studies. The most common

weaknesses in the studies analyzed were lack of blinding of clinicians and patients, lack of intention-to-treat

analysis, and lack of concealed treatment allocation.

Decompression surgery was more effective than conservative care in four out of five studies, but

only one of these was of high quality. In six high-quality studies, there was strong evidence that steroid

epidural injections were not effective; in four out of five studies (two of which were of high quality), there

was moderate evidence that calcitonin was not effective. There was no evidence for the effectiveness of all

other conservative interventions.

Critique/Bottom Line Except for the surgical studies, the majority of RCTs that were included in this review had less than

1 year of follow-up. Given the chronic nature of LSS, and the likely placebo effect of any treatment

provided, there is limited validity for solely short-term outcomes. Two guidelines reviewed stated there was

insufficient evidence to firmly recommend any intervention. Surgical interventions in general produce

modestly better outcomes than conservative care. Surgery appeared to be more effective than non-

surgical care when data were analyzed in an as-treated way, but not when considered by an intention-to-

treat analysis. This large systematic review attempted to include all conservative treatment and thus all


interventions are not physical therapy related. The clinical implications of this are that no specific

conservative interventions can be recommended.

3 Amundsen, T., Weber, H., Nordal, H.J., Magnaes, B., Abdelnoor, M., Lilleas, F. (2000). Lumbar Spinal Stenosis: Conservative or Surgical Management? Spine, 25 (11), 1424-1436.

Level of Evidence Oxford level 1b

Purpose Many studies deal primarily with post-operative results of lumbar spinal stenosis. Clinical

experience indicates that many people do well without surgery, and the literature dealing with results of

non-surgical treatment are few. Controlled clinical studies comparing conservative and surgical treatment

are rare; especially long term outcomes. The goal of this study was to find guidelines applicable for the

individual patient on how to choose between conservative and surgical treatment.

Methods 100 patients with symptomatic LSS were recruited in Oslo, Norway. Inclusion criteria required that

participants have sciatic pain in the leg(s), with or without pain in the back, together with radiologic signs of

stenosis and compression of the clinically afflicted nerve root(s). Patients were excluded from the study if

they had a bulging or herniated disc, spondylolysis, coxarthosis, gonarthosis, arterial insufficiency in the

legs, polyneuropathy, concomitant serious disease, or previous surgery on the back.

Depending on the severity of symptoms patients were placed into one of four groups: 1) surgical

treatment; 2) randomized to surgical treatment; 3) randomized to conservative treatment; 4) conservative

treatment. Surgery involved various surgical procedures, but no lumbar fusions. The conservative treatment

group received a “back school” and then regular physical therapy, which consisted of general physical

training in the form of ambulation and stabilizing exercises. Patients were followed-up with at 6 months, 12

months, 4 years, and 10 years; patients reported their pain, claudication distance, effect of spinal flexion or


extension, ADLs, employment status, and whether they were better, worse or unchanged. A neurologic

examination was also performed and any change in physical findings recorded.

Results Conservative Treatment – A good result was reported by 70% of the patients after 6 months. This

dropped to 64% after 1 year, and further to 57% of patients after 4 years.

Surgery – A good result was reported by 79% of the patients at the first clinical assessment after

6 months, by 89% after 1 year, and by 84% of patients after 4 years. Only 2 patients reported being worse

after 6 months, none after 1 year, and 1 patient after 4 years. Only 1 of these patients underwent

reoperation.

Most patients had great pain relief <3 month, some took up to a year. At the follow-up assessments

up to 4 years, the surgically treated patients reported more pain from the back than the conservatively

treated patients. However, after 10 years there was no difference. There were no significant differences

between groups when it came to the outcomes of claudication, level of daily activity, neurologic deficits, or

clinical features. No association could be established between results of treatment and radiologic features.

Critique/Bottom Line The main message is that “intolerable” pain was the reason for surgery and it is a good treatment

for approximately four fifths of severely afflicted patients. It gives instant and longstanding (years of) relief

from pain without serious complications. Conservative treatment seems to be good treatment for

approximately one half of the patients with mild symptoms. Surgery seems to give the same results

whether done early on in severe LSS or delayed (up to 3 years).

4

Kovacs, F.M., Urruita, G., Alarcon, J.D., (2011). Surgery Versus Conservative Treatment for Symptomatic Lumbar Spinal Stenosis. Spine, 36(20), 1335-1351.



Purpose The objectives of this study were to systematically review the evidence on the effectiveness and

safety of any form of surgery versus conservative treatment for symptomatic lumbar spinal stenosis.

Secondarily to explore whether available data made it possible to refine indication criteria for either type of

treatment, on the basis of the existence of spondylolisthesis or neurogenic claudication.

Methods The following databases were searched: CENTRAL, MEDLINE, EMBASE, and on the Internet

through TripDatabase (only for reviews and technical reports). The terms “spinal stenosis,” “lumbar

stenosis,” “claudication,” “spinal stenos,” “surgery or surgical,” and “low back pain, lumbago, back pain or

backache” were used to identify randomized controlled trials. Studies were included in this review if they

were RCTs providing data on the comparison of the effectiveness or safety of any surgical procedure with

any form of conservative treatment in patients with neurogenic claudication or sciatica, and lumbar spinal

stenosis that had been confirmed by imaging. Methodologic quality of each study was independently

assessed and all studies included were of high quality. 11 publications (five studies) were included in this

review; neither a quantitative synthesis of data nor a sensitivity analysis was possible because of the

variability of outcome measures and the heterogeneity of the methods used across the studies.

Results These results suggest that in patients with radicular pain caused by spinal stenosis, in whom

conservative treatment has failed for 3 to 6 months, decompressive surgery (with or without fusion) does

not improve walking ability, but does improve pain, function, and quality of life to a greater extent than

continuing conservative treatment. Surgery is superior to conservative treatment irrespective of the

patients’ degree of affectation whether they have spondylolisthesis or neurogenic claudication. Patients

should be aware that the benefits of surgery decrease with time but still remain significant till 4 (and

possibly 10) years later, and that delaying surgery is not associated with a poorer prognosis.


Critique/Bottom Line In all the studies included in this review, each provider decided the form of conservative or surgical

treatment applied to a given patient without following any predefined indication criteria. Therefore the

treatments within the conservative and surgical groups are heterogeneous between studies and within

studies. This prevents any conclusions being drawn on the comparative effectiveness of any particular form

of surgery or conservative treatment.

Sample sizes of the included studies may have been insufficient to detect differences for some

outcomes. Blindness (of therapists, patients, and outcome assessors) is unfeasible in studies comparing

surgical with nonsurgical procedures and the placebo effect from surgery is likely to be more powerful than

the one from conservative treatment, especially among patients in whom the latter has already failed. This

is a special concern because outcome variables are subjective and assessed by the patients (e.g ., pain

severity, function, and satisfaction). From a PT standpoint conservative care, 3 to 6 months is still the first

choice of interventions.

5

Jarrett, M.S., Orlando, J.F., and Grimmer-Somers, K., (2012). The effectiveness of land based exercise compared to decompressive surgery in the management of lumbar spinal-canal stenosis: a systematic review. BMC Musculoskeletal Disorders, 13(30), 1471-2474.


Purpose Given that lumbar spinal stenosis is a slow to progress, degenerative condition and commonly

involves surgical a surgical consult, it seems appropriate that self-management options be offered, which

may include physical therapy. Formal comparison of exercise and decompressive surgery has not been

undertaken in the literature. Although there is a limited evidence base, in clinical practice it appears that a

trial of self-management is preferred prior to surgical interventions. In light of the potential benefits of


exercise for LSS the literature was reviewed to compare land based exercise interventions and surgical

decompression. The secondary aim of this review was to report on the adverse effects associated with the

use of these two interventions.

Methods The databases MEDLINE, Embase, CINAHL, PEDro and Cochrane Library Register of Controlled

Trials were searched and the date compiled in a table. Data included study design, inclusion/exclusion

criteria, sample characteristics (sample size, mean age, gender), intervention details, outcome measures,

follow-up periods and results. Ninety-five per cent confidence intervals were calculated for mean age of

intervention arms. All prospective experimental studies, which described measurements taken pre and

post-interventions for exercise and/or surgical decompression, were considered for inclusion. Studies that

included exercise and/or surgery were reviewed; the study must have also used an outcome measure to be

considered for inclusion.

Results This review found that there is strong evidence for improvement in patient reported functional

outcomes in those who undergo decompressive surgery for LSS. Conversely, there was an overall small

initial improvement in patient reported functional outcomes in subjects with LSS who participated in an

exercise intervention. Despite the significant and sustained improvements in patient reported functional

outcomes shown with decompressive surgery in this systematic review, self-management may still be a

worthwhile option prior to consideration of surgical intervention.

Critique/Bottom Line There were four surgical studies in this review that only included subjects who had failed

conservative management. These studies may represent samples with more disabling cases of LSS. This

creates the possibility of the surgical outcomes being biased towards subjects who had failed conservative

management. The results from the included exercise studies were limited by the implementation of poor


quality interventions. For the most part individualized exercise programs were not used, the duration of

intervention too short, and the subject’s adherence to the exercise protocols varied.

The RCTs that investigated numerous exercise interventions showed that there were statistically

significant improvements (p < 0.05) within each group relative to baseline, but no significant differences

between groups when different interventions were compared. This would perhaps suggest that the

literature supports a broad approach to exercise interventions rather than supporting a particular exercise

type.

6

Macedo, L.G., Hum, A., Kuleba, L., Mo, J., Truong, L., Yeung, M., and Battie, M.C., (2013). Physical Therapy Interventions for Degenerative Lumbar Spinal Stenosis: A systematic review. Physical Therapy, 93, 1646-1660.

Level of Evidence Oxford level of evidence 2a

Purpose The purpose of this study was to systematically review studies evaluating the effectiveness of

physical therapy interventions in the treatment of LSS, considering the specific type of physical therapy

treatment and how it was applied. Previous systematic reviews have looked rather non-specifically at

conservative interventions; some of them non-physical therapy related, and others not fully delving into the

full breadth of PT.

Methods Multiple databases were searched for relevant literature. Studies were included that were clinical

trials having the following, a comparison group, interventions that were within a PT in North America’s

scope of practice, outcome measures, and a clinical diagnosis with confirming imaging of LSS. Not being

able to delineate physical therapy treatments from non–physical therapy interventions was the primary

reason for exclusions of potentially eligible studies. The PEDro scale was used to rate a total of 9 studies;


the median PEDro score of the 5 RCTs included was 7 (range 6–8). The most commonly absent item, and

thus lowering the score, was blinding of therapist or study participants.

Results The results of this review have significant implications because they contradict reports of common

clinical practice. Modalities and manual therapy are common PT interventions for LSS. If current evidence

suggests these have little or no effect above that of exercise, it may be prudent for physical therapists to

refocus their treatment to a more active approach. The results suggest that the use of lumbar support

corsets has significantly better effects in increasing walking distance than not using corsets. Cycling has

effects similar to those of a weight reduction corset or bodyweight supported treadmill walking with respect

to short-term pain and disability outcomes. Therefore, cycling would appear to be the treatment of choice

because it is less expensive, easier to apply, and requires less training and time from the treating therapist

and patient.

Critique/Bottom Line The results of this review suggest that surgery is better (moderate quality evidence) than physical

therapy for pain and disability at the long term (2 years), and the results are still somewhat controversial for

pain and disability at intermediate term and long term (6 months and 1 year). The evidence is very low

quality suggesting that the two interventions are similar in relation to walking capacity or to pain and

disability at the short term and long term.

Caution needs to be taken in generalizing the results of this review, given the small number of

studies evaluating each treatment and the quality of evidence available. The literature evaluating physical

therapy interventions for patients with LSS is scarce. Exercises appear to be a commonality among the

interventions evaluated; however, the best type of exercise (specific or general), weight reduction protocols,

corsets, and addition of manual therapy and other forms of treatment to exercise need to be further

investigated.


7

Iversen, M.D., Choudhary, V.R., and Patel, S.C., (2010). Therapeutic exercise and manual therapy for persons with lumbar spinal stenosis. International Journal of Clinical Rheumatology (5)4, 425-437.

Level of Evidence Oxford level of evidence 3a

Purpose This article examines the evidence for therapeutic exercise and manual therapy for the

conservative management of LSS, and describes the effects of these interventions on select outcomes.

This systematic review addresses the following guiding questions: what is the effect of strengthening,

balance, postural and aerobic exercise on function, disability and impairments in patients with degenerative

LSS; and which mode of exercise is most beneficial to manage the symptoms of LSS?

Methods Databases were searched for relevant literature using the search term spinal stenosis together with

combinations of the following terms: lumbar, lumbar spine, degenerative, physiotherapy, physical therapy,

therapeutic exercise, aerobic exercise, endurance exercise, strengthening exercise and flexibility exercise.

Any type of study was accepted. Information extracted from the studies included: design, setting, sample

demographics, intervention and control program features, data sources analysis and results. The quality of

the intervention and study design was evaluated and graded using the MacDermid Scale along with a 5-

point grading scale developed by Sackett. Outcome measures and study designs were too heterogeneous

to combine studies in a meta-analysis. Therefore, percentage change in primary outcomes, pain, function

and disability, were calculated to allow for a crude comparison across studies. Effect sizes were also

calculated for outcomes from randomized controlled trials using standard equations.

Results Seven studies were reviewed and included, two were randomized controlled trials, one was a

prospective cohort and four were case series/reports. Most studies evaluated the effects of mixed


interventions such as aerobic exercise in combination with flexibility exercise and manipulation/manual

techniques.

This article provides a summary of the current evidence for the effectiveness of therapeutic

exercise and manual techniques in decreasing pain and disability and increasing function for individuals

with LSS. Five studies used aerobic exercise as their primary mode or part of the primary intervention, one

study demonstrated the effects of aquatic strengthening exercises only and one study reported the effects

of manual therapy alone. Although the results of the studies were significant, variations were noted

between outcomes.

Critique/Bottom Line The majority of the studies included in this review were of moderate-to-low quality. These studies

are likely to be influenced by observational, volunteer and selection biases, and thus have inflated results.

Most samples were small, limiting generalizability and increasing the likelihood of Type II Error. Therapeutic

exercise and manual therapy appear beneficial in decreasing pain and disability and improving function in

older patients with lumbar spinal stenosis. Low-to-moderate intensity aerobic exercise performed for at

least 6 weeks and provided in combination with flexibility, strengthening exercise and manipulation is more

effective than aerobic, strengthening, flexibility exercise or manual therapy alone.

8

Balakatounis, K.C., Panagiotopoulou, K.A., Mitsiokapa, E.A., Mavrogenis, A.F., Angoules, A.G., Papathanasiou, J., Papagelopoulos, P.J., (2011). Evidence-Based Evaluation and Current Practice of Non-operative Treatment Strategies for Lumbar Stenosis. Folia Medica 2011; (53)3, 5-14.

Level of Evidence Oxford level of evidence 1b

Purpose The purpose of this review was to critically appraise randomized controlled trials with a clear

outline of the non-operative treatment rehabilitation approach, and to promote the formation of evidence-


based strategy. Current recommendations in non-operative treatment are based on expert opinion rather

than primary research. In addition, the available studies do not adequately describe the protocols used.

Methods The electronic databases MEDLINE, CINAHL, EMBASE and PEDro were searched for Medical

Subject Headings (MeSH) related to lumbar stenosis; “spinal stenosis”, “rehabilitation”, and “therapy” were

the filters. The data were abstracted using methods from the Cochrane Collaboration Back Review Group,

and study quality was assessed with the assistance of the Consolidated Standards of Reporting Trials

(CONSORT) Checklist. Search results yielded 35 RCTs; only four of these met the inclusion criteria of

RCTs outlining or describing a rehabilitation protocol. The required level of precision for the rehabilitation

protocol was a description of type of exercises and modalities or other forms of intervention such as

treadmill training and patient education.

Results A protocol has been outlined for the clinician and to clarify the effectiveness of non-operative

treatment through randomized controlled trials. The results of this study indicate that a comprehensive

exercise and manual therapy protocol is more effective in reducing symptoms than a less intensive

exercise program. A comprehensive non-operative treatment protocol including flexion exercises, manual

therapy and treadmill walking training appears to be more beneficial in reducing symptoms than a less

vigorous protocol including flexion exercises, treadmill training and home exercise.

Critique/Bottom Line Non-operative treatment consisting of non-intensive exercises has been observed to yield less

encouraging results when compared to surgery. Therefore, the non-operative treatment protocol offered by

Whitman et al in the manual therapy and exercise group of patients might be considered as the most

preferable non-operative treatment strategy, being the most comprehensive non-operative treatment group.

Research has also shown that treadmill training could be replaced by cycling with comparable results.


Article Analysis Worksheets

Name: Daniel Prohaska Intervention – Evidence Appraisal Worksheet

Citation (use AMA or APA format): Whitman, J.M., Flynn, T.W, Childs, J.D.,

Wainner, R.S., Gill, H.E., Ryder, M.G., . . . Fritz, J.M. (2006). A Comparison Between Two Physical Therapy Treatment Programs for Patients With Lumbar Spinal Stenosis. Spine, 31(22), 2541-2549. Level of Evidence (Oxford scale): 1b

Is the purpose and background information sufficient? Appraisal Criterion Reader’s Comments

Study Purpose Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study?

Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study

Lumbar spinal stenosis is a prevalent and disabling condition in the aging population. LSS causes physical problems and significant medical costs. With an aging population there is an increased burden on healthcare resources, thus identifying effective treatment options is a priority. Given the prevalence and cost associated with LSS, and the lack of strong evidence for nonsurgical care for these patients, the purpose of this study was to compare the clinical outcomes achieved by patients receiving two different PT programs. There is not randomized clinical trial evidence to inform nonsurgical treatment-related decision-making. Of the three studies specifically investigating nonsurgical clinical outcomes of care in patients with LSS, the study with, the largest cohort of patients was limited to short-term outcomes. Other studies did report longer-term outcomes but were retrospective, and interpretation is confounded by the use of highly variable interventions. Further, these studies failed to incorporate patient-centered outcome measures.

Does the research design have strong internal validity? Appraisal Criterion Reader’s Comments

Discuss possible threats to internal Overall the study was fairly well constructed. The down fall of any study like this is that part of the


validity in the research design. Include: Assignment Attrition History Instrumentation Maturation Testing Compensatory Equalization of

treatments Compensatory rivalry Statistical Regression

intervention was provided by different PT’s who used unspecified manual therapy treatments. Also part of the intervention was a home exercise program, and although the patients kept a journal there is a lot of room for variability here.

Are the results of this therapeutic trial valid? Appraisal Criterion Reader’s Comments

1. Did the investigators randomly assign subjects to treatment groups?

a. If no, describe what was done b. What are the potential

consequences of this assignment process for the study’s results?

Yes via a computer generated randomization scheme and sealed envelopes.

2. Did the investigators know who was being assigned to which group prior to the allocation?

a. If they were not blind, what are the potential consequences of this knowledge for the study’s results?

No they did not; all baseline information was obtained before randomization e.g. inclusion/exclusion criteria, obtained informed consent, collected self-report questionnaires, completed historical examinations, and conducted treadmill walking tolerance tests.

3. Were the groups similar at the start of the trial? Did they report the demographics of the study groups?

a. If they were not similar – what differences existed?

b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study?

No significant baseline differences were identified for demographics, baseline physical impairment, or outcomes. Demographics are reported in Table 1.

4. Did the subjects know to which treatment group they were assign?

a. If yes, what are the potential consequences of the subjects’ knowledge for this study’s results

Not clearly stated, but the subjects did not seem to know to which group they were assigned or what the other group was doing.

5. Did the investigators know to which treatment group subjects were assigned?

a. If yes, what are the potential

Yes, they did. This study involved hands on manual therapy and so at least some of the investigators knew to which group they were dealing with.


consequences of the subjects’ knowledge for this study’s results

However, research assistants, blinded to group allocation, re-administered self-report questionnaires and treadmill tests at completion of the treatment period and at 1 year.

6. Were the groups managed equally, apart from the actual experimental treatment?

a. If not, what are the potential consequences of this knowledge for the study’s results?

Yes a good job was done to keep the groups as equal as possible. For example both groups’ home exercise journals were about the same.

7. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research?

a. If not, what are the potential consequences of this knowledge for the study’s results?

Follow-up took place at 6 weeks and 1 year. This provides good data for a somewhat short term outcome. Long term effects are not known.

8. Did all the subjects originally enrolled complete the study?

a. If not how many subjects were lost?

b. What, if anything, did the authors do about this attrition?

c. What are the implications of the attrition and the way it was handled with respect to the study’s findings?

All the subjects completed the 6 week follow-up; 29 in each group. The 1 year follow-up lost 2 from intervention group one and 1 from the competing intervention group. This left 27 and 28 participants, so both groups were still relatively the same.

9. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)?

a. If not, what did the authors do with the data from these subjects?

b. If the data were excluded, what are the potential consequences for this study’s results?

All patients who met the inclusion/exclusion criteria were included in all analyses regardless of their dropout status or completion of TM testing per intention-to treat principles by carrying the last available value forward.

Are the valid results of this RCT important? Appraisal Criterion Reader’s Comments

10. What were the statistical findings of this study?

a. When appropriate use the calculation forms below to determine these values

b. Include: tests of differences With p-values and CI

c. Include effect size with p-values and CI

d. Include ARR/ABI and RRR/RBI with p-values and CI

Sample size was calculated based on the dichotomized score of the primary outcome measure, “perceived recovery.” A difference of 30% or more in success rate (“perceived recovery”) was considered to be clinically important. The number needed to treat for benefit for perceived recovery was 2.6 (confidence interval [CI], 1.8 to 7.8) at 6 weeks, 4.8 (CI, -2.3 to 21.3) at 1 year, and 4.4 (CI, -2.1 to 22.7) at the long-term follow-up. All of the secondary outcomes favored the MPTExWG at 6 weeks and 1


e. Include NNT and CI f. Other stats should be included

here

year except improvements in NPRS for lower extremity symptoms from baseline to 1 year; however, these differences were not statistically significant.

11. What is the meaning of these statistical findings for your patient/client’s case? What does this mean to your practice?

There is a small improvement in the MPTExWG group over the other, so it is the preferred treatment.

12. Do these findings exceed a minimally important difference? Was this brought up or discussed?

a. If the MCID was not met, will you still use this evidence?

Not specifically mentioned by there was a much larger, percentage wise, improvement in the MPTExWG group. The outcome measure was “perceived recovery” so this seems to be relevant.

Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? Appraisal Criterion Reader’s Comments

13. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, 3rd party coverage to provide this treatment?

It is reasonable, however the down fall is that the manual therapy varied considerably and requires highly skilled PTs to provide this intervention.

14. Are the study subjects similar to your patient/ client?

a. If not, how different? Can you use this intervention in spite of the differences?

Yes they fit into the studies parameters.

15. Do the potential benefits outweigh the potential risks using this intervention with your patient/client?

Yes the risks are low. Often the other intervention is surgical and this carries great risk and expense.

16. Does the intervention fit within your patient/client’s stated values or expectations?

a. If not, what will you do now?

Yes this intervention is very much a PT intervention and is very conservative in nature.

17. Are there any threats to external validity in this study?

There were a lot of military involvement which could be a threat to external validity as the results may not be generalizable.

What is the bottom line? Appraisal Criterion Reader’s Comments PEDRO score (see scoring at end of form)

7


Summarize your findings and relate this back to

clinical significance


Your calculations: Benefit increase or Risk Reduction (if you have raw data that has not been included in the study – please calculate the CER, EER , RBI/RRR, ABI/ ARR and NNT) + outcome - outcome

a b

c d

CER = control event rate = c/ (c+d) = EER = experimental group event rate = a/ (a+b) =

Relative risk reduction

(RRR)

Absolute risk reduction

(ARR)

Number needed to

treat (NNT)

CER EER CER – EER

CER CER-EER

1/ARR

Relative benefit

increase (RBI)

Absolute Benefit

Increase (ABI)

Number needed to

treat (NNT)

CER EER EER – CER

CER EER-CER

1/ ABI

+ intervention

- intervention


Pedro Scoring System:

Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA 2008


Name: Daniel Prohaska

Systematic Review – Evidence Appraisal Worksheet Citation (use AMA or APA format): May, S., Comer, C. (2013). Is surgery more

effective than non-surgical treatment for spinal stenosis, and which non-surgical treatment is more effective? A systematic review. Physiotherapy, 99, 12-20. Level of Evidence (Oxford scale): 1A

Does the design follow the Cochrane method? Appraisal Criterion Reader’s Comments Step 1 – formulating the question

• Do the authors identify the focus of the review

• A clearly defined question should specify the types of:

• people (participants), • interventions or exposures, • outcomes that are of interest • studies that are relevant to

answering the question

Yes, the aim of this systematic review was to examine surgical vs non-surgical treatment, and all non-surgical treatments for spinal stenosis.

Step 2 – locating studies

Should identify ALL relevant literature

Did they include multiple databases?

Was the search strategy defined and include:

o Bibliographic databases used as well as hand searching

o Terms (key words and index terms)

o Citation searching: reference lists o Contact with ‘experts’ to identify

‘grey’ literature (body of materials that cannot be found easily through conventional channels such as publishers)

o Sources for ‘grey literature’

Data bases used were Medline, Cinahl, AMED, PEDro, and Cochrane Central Register of Controlled Trials. Search terms and combinations were as follows: spinal stenosis OR neurogenic claudication, AND non-operative treatment OR conservative treatment OR physical therapy OR physiotherapy OR rehabilitation, AND randomized controlled trial OR clinical trial. The reference lists of all retrieved articles were also searched. No “grey” literature or experts were consulted.

Part 3:Critical Appraisal/Criteria for Inclusion Inclusion criteria were: human subjects; subjects


• Were criteria for selection specified? • Did more than one author assess

the relevance of each report • Were decisions concerning

relevance described; completed by non-experts, or both?

• Did the people assessing the relevance of studies know the names of the authors, institutions, journal of publication and results when they apply the inclusion criteria? Or is it blind?

with spinal stenosis and back (leg) pain; clinical or radiological diagnosis of spinal stenosis; RCT; and use of non-surgical treatment in one group. Irrelevant articles were excluded; ultimately the study’s two authors decided what was relevant and met the criteria. The authors were not blinded, but no mention was made of any biases towards study selection or conflicts of interest.

Part 3 – Critically appraise for bias:

• Selection – • Were the groups in the study

selected differently? • Random? Concealed?

• Performance- • Did the groups in the study

receive different treatment? • Was there blinding?

• Attrition – • Were the groups similar at the

end of the study? • Account for drop outs?

• Detection – • Did the study selectively report

the results? • Is there missing data?

This large systematic review attempted to include all conservative treatment options offered by a range of healthcare providers. The authors conducted independent filtering of the references, PEDro scoring and data extraction, and disagreements were settled by consensus. Non-English-language studies were included, thus avoiding the risk of language bias.

Part 4 – Collection of the data

Was a collection data form used and is it included?

Are the studies coded and is the data coding easy to follow?

Were studies identified that were excluded & did they give reasons why (i.e., which criteria they failed).

Yes a data collection form was used and is presented in table and figure. The most common weaknesses were lack of blinding of clinicians and patients, lack of intention-to-treat analysis, and lack of concealed treatment allocation.

Are the results of this SR valid? Appraisal Criterion Reader’s Comments

18. Is this a SR of randomized trials? Did they limit this to high quality studies at the top of the hierarchies

a. If not, what types of studies were

This is a systematic review of randomized trials. Many studies were rejected due to not meeting the inclusion criteria.


included? b. What are the potential

consequences of including these studies for this review’s results?

19. Did this study follow the Cochrane methods selection process and did it identify all relevant trials?

a. If not, what are the consequences for this review’s results?

The PEDro scale was used to assess the quality of the studies. The criteria used are, in fact, very similar to other contemporary methods for judging quality criteria, such as the recent Cochrane Back Review Group criteria.

20. Do the methods describe the processes and tools used to assess the quality of individual studies?


Yes, the studies were either already scored by the PEDro database or scored by the authors of this paper.

21. What was the quality of the individual

studies included? Were the results

consistent from study to study? Did the investigators provide details about the research validity or quality of the studies included in review?

Twenty-seven separate studies were included, 18 of which were considered to be of high quality using the PEDro criteria.

22. Did the investigators address publication bias

As with all reviews, the risk of publication bias could not be avoided; however, as this suggests that negative studies are less likely to be published, this would only re-enforce the conclusions.

Are the valid results of this SR important? Appraisal Criterion Reader’s Comments

23. Were the results homogenous from study to study?


After data extraction, it was determined that there was insufficient homogeneity in terms of interventions, controls, patients and outcomes to justify a meta-analysis. Hence why this study is a systematic review and not a meta-analysis.

24. If the paper is a meta-analysis did they report the statistical results? Did they include a forest plat? What other statistics do they include? Are there CIs?

25. From the findings, is it apparent what the cumulative weight of the evidence is?

The clinical implications of the findings are that decompression surgery is probably more effective than conservative care, and that it is difficult to firmly recommend any particular conservative therapy.

Can you apply this valid, important evidence from this SR in caring for your patient/client? What is the external validity? Appraisal Criterion Reader’s Comments

26. Is your patient different from those in this SR?

No it is similar, although it is hard to say how severe the LSS was in these patients. In a lot of the


studies the participants ended up getting surgery, even in the conservative care group, so this perhaps indicates that many of the patients had very severe LSS.

27. Is the treatment feasible in your setting? Do you have the facilities, skill set, time, 3rd party coverage to provide this treatment?

This large systematic review attempted to include all conservative treatment options offered by a range of healthcare providers, not just PTs, so not all treatments are feasible.


a. If not, what will you do now?

The PT interventions are feasible and do fit within the client’s expectations.

What is the bottom line? Appraisal Criterion Reader’s Comments Summarize your findings and relate this back to


The clinical implications of these findings are that it is difficult to firmly recommend any particular conservative therapy. Although there is some evidence to support bodyweight supported treadmill walking and manual therapy, this was not consistent.



Prognostic Study – Evidence Appraisal Worksheet Citation (use AMA or APA format): Amundsen, T., Weber, H., Nordal, H.J.,

Magnaes, B., Abdelnoor, M., Lilleas, F. (2000). Lumbar Spinal Stenosis: Conservative or Surgical Management? Spine, 25 (11), 1424-1436.


Level of Evidence (Oxford scale): 1b

Is the purpose and background information sufficient? Appraisal Criterion Reader’s Comments

Study Purpose Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study?

The core of the problem, addressed in this study, is to find guidelines applicable for the individual patient on how to choose between conservative and surgical treatment. The purpose is also to identify the short- and long-term results after surgical and conservative treatment, and to determine whether clinical or radiologic predictors for the treatment result can be defined.

Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study

Medical publications deal largely with results after surgery, and literature dealing with results after nonsurgical treatment are scanty. Controlled clinical studies comparing conservative and surgical treatment are rare, and few deal with long term results.

Does the research design have strong sampling techniques? Appraisal Criterion Reader’s Comments Did the investigators provide sufficient information to describe the sample in their study?

Does the study clearly define the group of patients; is there a clear inclusion and exclusion criterion? Is there a clear description of the stage and timing of the problem (illness) studied.

Inclusion criteria required that participants have sciatic pain in the leg(s), with or without pain in the back, together with radiologic signs of stenosis and compression of the clinically afflicted nerve root(s). Patients were excluded from the study if they had a bulging or herniated disc, spondylolysis, coxarthosis, gonarthosis, arterial insufficiency in the legs, olyneuropathy, concomitant serious disease, or previous surgery on the back.

Are the subjects representative of the population from which they were drawn?

Did they capture all eligible subjects?

100 patients with symptomatic lumbar spinal stenosis were recruited consecutively to the study from the Department of Neurology at Ullevål Hospital, Oslo, Norway. The long, 34 month, recruitment period resulted from the strict exclusion criteria. The study originally was meant


to include more patients in all and for randomization, but because of practical problems, it was decided to stop after inclusion of 100 patients.

Are the results of this prognostic study valid? Appraisal Criterion Reader’s Comments

1. Were the subjects assembled at a common (usually early) point in the course of their disorder?

a. If not, what are the implications of multiple starting points for this study’s results?

Patients were gathered by the above inclusion criteria and pain was the main factor for including subjects and assigning them to control groups. The problem is that patient who were already worse off were assigned to the surgical group, thus biasing the results for an improved outcome from surgery.

2. Was the study time frame long enough to capture the outcome(s) of interest? Was patient follow-up sufficiently long and complete?

a. If not, what are the potential consequences of the follow-up time for the study’s results?

Yes this study had a very long follow-up. Follow-up occurred at six months, one year, four years, and 10 years.

3. Did all subjects originally enrolled complete the study?

a. If not, how many subjects were lost

b. What if anything did the authors do about this attrition?

c. What are the implications of this attrition and the way it was handled with respect to the study’s findings?

Most patients entering the study were elderly, and some died during the observation period. During the first 4 years, 3 patients died, and an additional 11 died during the last 6 years of the study. All the deaths resulted from natural causes. The deaths were distributed rather evenly among the various treatment groups. Otherwise, no dropouts occurred because patient contact was lost.

4. Were objective outcome criteria applied to the subjects in a masked or blinded fashion??

a. If not, what are the potential consequences for this study’s results

Most of the outcome criteria a very subjective. The patients were asked to evaluate their own situation and to state whether it was better, worse, or unchanged as compared with their condition on entering the study. This, together with the opinion of the examining physician, using some objective measures, constituted the basis for the statement of overall treatment result. This makes the results subjective; especially because pain was also a large factor in the study’s design.

5. If subgroups with different prognoses are identified, was there adjustment for important prognostic or risk factors?

a. If not, what should have been included? What are the potential consequences for the lack of this

The baseline characteristics of the study participants did not have any relevance to their prognosis. Predictors for the outcome of the treatment, whether surgery or conservative treatment, are not available.


adjustment

6. Was there an independent set of patients to validate the study?

a. If not, what are the potential consequences for this study’s results?

No there was not a strict control group. Patients were placed into groups based on their severity and also randomized if they were in between the surgery and conservative group. Randomization between conservative treatment and surgery was acceptable only for patients about who serious doubt existed concerning which treatment should be recommended. The consequences are that the groups are not homogeneous and that generalizations from this study must be made with great caution.

Are the valid results of this prognostic study important? Appraisal Criterion Reader’s Comments

7. What were the statistical findings of this study?

a. When appropriate use the calculation forms below to determine these values

b. Report on correlation coefficient and/or coefficient of determination

c. Did they include a survival curve, ROC, odds ratios, relative risk ratio

d. How precise are the CIs? e. Other stats should be included

here

The association of various clinical and radiologic parameters at the start of the study with later treatment outcome was assessed by using parametric and nonparametric tests: one-way analysis of variance (ANOVA) and the Kruskall-Wallis test in the case of non-Gaussian distribution of the outcome variable and when no homogeneity of variances existed in the different groups. In comparing two independent groups, the Student’s t test and the Mann-Whitney test were used. The correlation between two continuous variables was investigated by the Pearson correlation coefficient and its 95% confidence limits. Because the situation was observational, the existence of hidden confounders and selection bias made it mandatory for the authors to be descriptive and non-inferential.

8. What is the meaning of these statistical findings for your patient/client’s case? What does this mean to your practice?

The age, gender, social status (married/not married), type of work/physical loading, satisfaction at home and at work, duration of pain, length of sick listing, level of physical activity, smoking habits, physical findings, Lasegue’s sign, and level of spinal protein were compared with the treatment results. No convincing associations were observed.

Can you apply this valid, important evidence about this prognostic study in caring for your patient/client? What is the external validity? Appraisal Criterion Reader’s Comments

9. How likely are these outcomes over time? They are likely as the outcomes really are highly variable. In general about half improved with conservative care, and those who initially were


worse off about 75% of them were better with surgery.

10. Are the study subjects similar to your patient/ client?

a. If not, how different? Can you use this test in spite of the differences?

They are similar, although these subjects were all Norwegian. The results are still applicable despite this.

11. Would sharing this information help your patient/client given their expressed values and preferences?

Yes as most patients want to know what their options are, the prognosis, and the outcome(s) of the interventions.

What is the bottom line? Appraisal Criterion Reader’s Comments

Summarize your findings and relate this back to

clinical significance and usefulness of this study

1. If pain is moderate, conservative treatment, as defined in this article, will give a satisfactory result for one-half of the patients in less than 3 months. 2. Patients with severe pain and those in whom a conservative approach does not give a satisfactory result should be offered surgical treatment. 3. Predictors for the outcome of the treatment, whether surgery or conservative treatment, are not available. In particular, clinicians should not make the mistake of attributing a poor prognosis to a patient based solely on radiologic demonstration of severe degenerative changes of the spine, nor does such a finding strengthen the indication for surgery.


Calculations if needed:

+ outcome - outcome

+ prognostic factor a b

- prognostic factor c d

Calculate the odds ratio for this data: OR=([A/B ]/[ C/D] _______________________________ Interpret this finding clinically: Calculate the relative risks: RR= [A/ A+B] / [C/ C+D]__________________________________________ Interpret this finding clinically:




Systematic Review – Evidence Appraisal Worksheet Citation (use AMA or APA format): Kovacs, F.M., Urruita, G., Alarcon, J.D., (2011).

Surgery Versus Conservative Treatment for Symptomatic Lumbar Spinal Stenosis. Spine, 36(20), 1335-1351. Level of Evidence (Oxford scale): 1A






The objectives of this study were to systematically review the evidence on the effectiveness and safety of any form of surgery versus conservative treatment for symptomatic lumbar spinal stenosis, and explore whether available data made it possible to refine indication criteria for either type of treatment, on the basis of the existence of spondylolisthesis or neurogenic claudication.










Databases searched were CENTRAL, MEDLINE, EMBASE, and on the Internet through TripDatabase (only for reviews and technical reports). The terms “spinal stenosis,” “lumbar stenosis,” “claudication,” “spinal stenos,” “surgery or surgical,” and “low back pain, lumbago, back pain or backache” were combined with the highly sensitive search strategy to identify randomized controlled trials (RCTs) developed by the Cochrane Collaboration. No experts or gray literature were included.

Part 3:Critical Appraisal/Criteria for Inclusion Studies were included in this review if they were






RCTs providing data on the comparison of the effectiveness or safety of any surgical procedure with any form of conservative treatment in patients with neurogenic claudication or sciatica, and lumbar spinal stenosis that had been confirmed by imaging. No language restriction was applied. References identified were retrieved and assessed independently by two authors to check for inclusion criteria. Disagreements were solved by consensus with the third author.










Methodological quality of each study was independently assessed by two of the three reviewers, following the criteria recommended by the Cochrane Back Review Group. Criteria on blindness of patients and therapists were disregarded because they were not applicable when comparing surgery with conservative treatment. Despite what was planned at the design phase, neither a quantitative synthesis of data nor a sensitivity analysis was possible because of the variability of outcome measures and the heterogeneity of the methods used across the studies. Therefore, a qualitative analysis of data was performed on the basis of the methodological quality of included trials and the consistency of their findings.





There are extensive tables of data; table 1 and table 2. This makes it easy to review all the included studies. Data from observational or nonrandomized cohorts were excluded from this review because of concerns regarding the risk of unknown biases. Nine studies were excluded because they did not focus on spinal stenosis, two studies because they were not randomized, and one publication because it mixed patients who had and had not been randomized.



There were 11 publications (five studies) included in this review. Three of these studies included data from both observational and randomized cohorts,


a. If not, what types of studies were included?

b. What are the potential consequences of including these studies for this review’s results?

but they were included because the authors provided separate data for those patients in the randomized cohorts. All the studies scored as being of high quality, although the sample size of one of them was very small. Most outcomes were self-reported by the patients and blinding of care providers and patients was not feasible. Hence, outcome assessment was not blinded.



Yes the Cochrane Back Review Group guidelines were followed. A total of 30 publications, corresponding to 17 studies were identified as eligible.



The Cochrane Back Review Group guidelines were used and only data from randomized cohorts was extracted.




No it was not included. Although the maximum possible score was nine points and a study was considered high quality if it scored five points or more. All included studies were considered to be high quality.


No they did not. No mention was made of the fact that poor outcomes from surgery may not be published.




There were overall trends and similar outcomes. The treatments however, were heterogeneous and not selected according to explicit criteria.


Oswestry Disability Index at two years was given as a forest plot both as treated and as intention to treat analysis with a 95% confidence interval.


Not really as most differences were statistically significant only in the as treated analysis and no in the intention to treat one.



Most patients fit into this category: mean age 62-70, imaging revealing spinal stenosis, and both with and without neurogenic claudication.



Treatments varied and so some of them are feasible. Conservative care is still the first recommended course of action.


b. If not, what will you do now?

Yes because conservative care is recommended initially. If a patient does not improve within 3-6 months than surgery could be considered.



In conclusion, this review shows that decompressive surgery with or without fusion are more effective than continued conservative treatment for radicular pain due to spinal stenosis in patients in whom the latter has failed for 3 to 6 months. In all the studies, surgery led to better results for pain, disability, and quality of life, although not for walking ability. Results of surgery were similar among patients with and without spondylolisthesis, and slightly better among those with neurogenic claudication than among those without it. The advantage of surgery was noticeable at 3 to 6 months and remained for up to 2 to 4 years, although at the end of that period differences tended to be smaller.



Systematic Review – Evidence Appraisal Worksheet Citation (use AMA or APA format): Jarrett, M.S., Orlando, J.F., and Grimmer-

Somers, K., (2012). The effectiveness of land based exercise compared to decompressive


surgery in the management of lumbar spinal-canal stenosis: a systematic review. BMC Musculoskeletal Disorders, 13(30), 1471-2474. Level of Evidence (Oxford scale): 1A






Comparison of exercise and decompressive surgery has not been undertaken. Although there is a limited evidence base, in clinical practice it appears that a trial of self-management is preferred prior to surgical interventions to avoid the risks associated with surgery. In light of the potential benefits of exercise for LSS, we systematically reviewed the current evidence regarding the effectiveness of land based exercise interventions compared to surgical decompression in the management of LSS. The secondary aim of this review was to report on the adverse effects associated with the use of these two interventions.










The databases searched were MEDLINE, Embase, CINAHL, PEDro and Cochrane Library Register of Controlled Trials. All prospective experimental studies, which described measurements taken pre and post-interventions for exercise and/or surgical decompression, were considered for inclusion. Table 1 lists the search terms and strategy used.

Part 3:Critical Appraisal/Criteria for Inclusion



Two authors used specific criteria of population, exposure, outcome measures, and time to filter through the literature. The methodological quality of studies was assessed using the McMaster Critical Review Form for Quantitative Studies. The




authors were not blinded and disagreements were resolved through discussion.










There appeared to be a discrepancy in mean age between exercise and surgical intervention arms; however, testing of homogeneity did not demonstrate a significant bias in sampling. This is overall a systematic review of randomized controlled trials and clinical trials. The overall bias is low, however there is somewhat of a bias towards surgery as those patients who fail conservative treatment usually end up getting surgery.





Data included study design, inclusion/exclusion criteria, sample characteristics (sample size, mean age, gender), intervention details, outcome measures, follow-up periods and results. Yes the date is presented in several tables and figures. The main reasons for exclusion were: outcomes were not patient reported functional outcome measures; non-experimental research design; populations with lumbar pathological diagnoses other than degenerative LSS; recording outcomes at variable timeframes or at greater than 2-years post intervention; insufficient details of intervention to allow comparison with other studies; and languages other than English.



A systematic review of randomized controlled trials and clinical trials ranging from level II to level lll-3 in terms of methodological quality.






The hierarchy of evidence for each study was assessed according to the National Health and Medical Research Council (NHMRC) Designation of Levels of Evidence.



The McMaster Critical Appraisal Tool was used and raw scores varied from 8 to 12 out of a possible 15, and percentages from 64.3% to 85.7%.




The included studies were generally of moderate methodological quality. Studies that did not fit the strict inclusion criteria were eliminated.


Yes as English language was one of the filters and could have presented a publication bias, but the evidence to support this is in the literature is equivocal.




The results are fairly clear, but bias is perhaps skewing the outcomes. The starting point of heterogenous interventions make the outcomes somewhat difficult to trust.


The percentage change in patient reported functional outcome scores was calculated graphically, with lines of best fit, and displayed in figure. The availability of only two randomized controlled trials limited calculation of effect sizes. The other data included was of lower quality and statistical data was not presented.


The moderate methodological quality of included studies was also likely to affect the results of this review. Common issues were small sample sizes, lack of sample size calculations, inadequate description of interventions and numerous co-interventions. Decompressive surgery was the most successful intervention in this review.




The LSS patient fits into this SR parameters.


The authors would suggest that the literature supports a broad approach to exercise interventions rather than supporting a particular exercise type. This review supports the findings of previously reported literature that a trial of conservative management with land based exercise be considered. Yes, this is feasible in most any PT setting.


c. If not, what will you do now?

Yes, because patients are in PT to hopefully avoid surgery and therefore land based exercise is appropriate.



While patients wait for surgery, and given the risks of surgery, there are potential benefits in functional improvements from land-based exercise interventions. A self-management program with a land based exercise intervention prior to consideration of surgical intervention for patients with LSS is supported.




Systematic Review – Evidence Appraisal Worksheet Citation (use AMA or APA format): Macedo, L.G., Hum, A., Kuleba, L., Mo, J.,

Truong, L., Yeung, M., and Battie, M.C., (2013). Physical Therapy Interventions for Degenerative Lumbar Spinal Stenosis: A systematic review. Physical Therapy, 93, 1646-1660. Level of Evidence (Oxford scale): 2a






The purpose of this study was to systematically review randomized controlled trials (RCTs), controlled trials, and cohort studies evaluating the effectiveness of physical therapy for LSS.










The databases examined included MEDLINE, EMBASE, CINAHL, Scopus, Cochrane Library, and PEDro. Key words related to LSS and physical therapy treatment were selected for each database (see Appendix). A manual search also was conducted on reference lists of a systematic review. Additionally, an ISI Web of Science search was conducted to identify potentially eligible studies that have cited the other studies included here.




relevance described; completed

The following were included: clinical trials with a comparison group (RCTs, CCTs, and prospective cohort studies); evaluation of interventions within the scope of physical therapist practice in North America; multimodal studies where physical therapy was offered as part of a treatment


by non-experts, or both? • Did the people assessing the

relevance of studies know the names of the authors, institutions, journal of publication and results when they apply the inclusion criteria? Or is it blind?

package were included; studies where physical therapy was offered to patients, but it was unclear whether all patients in that treatment group had received it, were excluded; outcome measures of pain, disability, function, or health-related quality of life; clinical diagnosis of LSS, with confirmatory imaging; a mean age greater than 50 years old.










This study was well done as most inconsistencies were eliminated from inclusion. Not being able to delineate physical therapy treatments from non–physical therapy interventions was the primary reason for exclusions of potentially eligible studies. Studies where physical therapy was offered to patients, but it was unclear whether all patients in that treatment group had received it, were excluded. Patients who crossed over between interventions, in one particular study, were excluded from the analysis. Several other studies had to be excluded because epidural steroids were the primary form of treatment in addition to physical therapy.





Yes there are multiple tables of data included in this study and the tables are easy to read. Inclusion and exclusion criteria are outlined and more specific details are given for certain studies.





Ten studies were included: 5 RCTs, 2 controlled trials, 2 mixed design studies, and 1 longitudinal cohort study.




Outcomes were extracted and, when possible, pooled using RevMan 5, a freely available review program from the Cochrane Library. The Cochrane Handbook for Systematic Reviews of Interventions was used to calculate information from the data.



The PEDro scale was used to assess the quality of clinical trials. A modified version of the Newcastle-Ottawa Quality Assessment scale that included modifications to better evaluate intervention-based cohort studies was used. The GRADE approach for grading the level of the evidence available was used to summarize the conclusion of this review.




One limitation of this review was the low quality and small number of studies available to include.


In one of the studies included there was a large crossover of patients between treatment groups, and the use of an intention-to-treat analysis in this case does not help in maintaining the benefits of randomization.




The weakness of the studies available that were reviewed and included was the heterogeneity in outcomes and treatments. Thus no clear recommendations could be made in regard to specific PT interventions.


Various statistical data is presented. A forest plot for physical therapy vs surgery is also presented. Confidence intervals were calculated at 95%.


Yes, that surgery is clearly superior to physical therapy.



No, the included studies are similar to my patient.


The results suggest that the use of lumbar support corsets has significantly better effects in increasing walking distance than not using corsets. Cycling has effects similar to those of a weight reduction


corset or bodyweight supported treadmill walking with respect to short-term pain and disability outcomes. Therefore, cycling would appear to be the treatment of choice because it is less expensive, easier to apply, and requires less training and time from the treating therapist and patient.


d. If not, what will you do now?

Yes, the patient is choosing PT because he does not want too many pharmaceutical or surgical interventions.



Modalities and manual therapy are common PT interventions for LSS. If current evidence suggests these have little or no effect above that of exercise, it may be prudent for physical therapists to refocus their treatment to a more active approach. Perhaps with this patient it would be worth forgoing the above interventions. Exercises appear to be a commonality among the interventions evaluated, and therefore this patient would most likely benefit from exercise interventions.



Systematic Review – Evidence Appraisal Worksheet Citation (use AMA or APA format): Iversen, M.D., Choudhary, V.R., and Patel, S.C.,

(2010). Therapeutic exercise and manual therapy for persons with lumbar spinal stenosis. International Journal of Clinical Rheumatology (5)4, 425-437. Level of Evidence (Oxford scale): 3a







This systematic review addresses the following guiding questions: * What is the effect of strengthening, balance, postural and aerobic exercise on function, disability and impairments in patients with degenerative LSS? * Which mode of exercise is most beneficial to manage the symptoms of LSS? For the purposes of this study, therapeutic exercise is defined as exercises that include aerobic, strengthening/stabilization and flexibility exercises, and endurance training, as well as manual therapy including mobilization and manipulation and postural exercises. Manual therapy includes manipulation and mobilization of the tight structures, and stabilization of the spine to restore normal function.










The following databases were searched, Medline, CINAHL, EBM Reviews Cochrane Database of Systematic, EBM Reviews-American College of Physician Journal Club, Database of Abstracts of Reviews of Effect (DARE), PubMed, and Physical therapy Evidence Database (PEDro). In each database, the search terms spinal stenosis together with combinations of the following terms: lumbar, lumbar spine, degenerative, physiotherapy, physical therapy, therapeutic exercise, aerobic exercise, endurance exercise, strengthening exercise and flexibility exercise were used.





• Did the people assessing the relevance of studies know the names of the authors,

Papers that met the following criteria were included: * Evaluated therapeutic exercise or manual therapy; * Male and/or female subjects aged between 40 to 80 years; * Subjects had a history of low back pain with or without radiating symptoms for 1 month or longer; * Subjects had evidence of lumbar LSS on MRI or radiograph or a diagnosis of LSS by an orthopedic specialist or physician;


institutions, journal of publication and results when they apply the inclusion criteria? Or is it blind?

* Pain, disability and function were assessed; * Available in English.










The majority of the studies included in this review were of moderate-to-low quality. These studies are likely to be influenced by observational, volunteer and selection biases, and thus have inflated results.





Information extracted from the studies included: design, setting, sample demographics, intervention and control program features, data sources analysis and results. The study selection process is summarized in Figure 1, the excluded studies are listed in Table 1, the general characteristics of the selected studies are summarized in Tables 2 & 3, and the methodological quality scores and the level of evidence of the included studies are provided in Table 4.





Seven studies were reviewed and included, two were randomized controlled trials, one was a prospective cohort and four were case series/reports. The result is that a meta-analysis could not be performed, and instead percentage changes in primary outcomes (pain, function and disability) were calculated to allow for a crude comparison across studies. Effect sizes were also calculated for outcomes of the RCTs.

63. Did this study follow the Cochrane methods selection process and did it

Strengths of this article include the strict selection criteria summarized in Figure 1.


identify all relevant trials? a. If not, what are the consequences

for this review’s results?



MacDermid's quality rating scale and the Sackett's level of evidence were used to assess quality.




The majority of the studies included in this review were of moderate-to-low quality.


No they did not.




No most were heterogeneous making comparison difficult. The result is that no recommendations or conclusions can accurately be made from reviewing these studies.


A meta-analysis was not performed.


Yes although it is a mild weight of evidence, not a strong weight.



No similar to these patients.


Yes it is therapeutic exercise and manual therapy. Although not all interventions are detailed clearly, so duplicating them is problematic.


e. If not, what will you do now?

Yes as it is typical PT and exercise interventions.

What is the bottom line?


Appraisal Criterion Reader’s Comments Summarize your findings and relate this back to


Most samples were small, limiting generalizability. Therapeutic exercise and manual therapy appear beneficial in decreasing pain and disability and improving function in older patients with lumbar spinal stenosis. Low-to-moderate intensity aerobic exercise performed for at least 6 weeks and provided in combination with flexibility, strengthening exercise and manipulation is more effective than aerobic, strengthening, flexibility exercise or manual therapy alone.



Systematic Review – Evidence Appraisal Worksheet Citation (use AMA or APA format): Balakatounis, K.C., Panagiotopoulou, K.A.,

Mitsiokapa, E.A., Mavrogenis, A.F., Angoules, A.G., Papathanasiou, J., Papagelopoulos, P.J., (2011). Evidence-Based Evaluation and Current Practice of Non-operative Treatment Strategies for Lumbar Stenosis. Folia Medica 2011; (53)3, 5-14.

Level of Evidence (Oxford scale): 1b




• people (participants),

The purpose of this review was to critically appraise randomized controlled trials with a clear outline of the non-operative treatment rehabilitation approach, and to promote the formation of evidence-based strategy.


• interventions or exposures, • outcomes that are of interest • studies that are relevant to











The electronic databases MEDLINE, CINAHL, EMBASE and PEDro were searched for Medical Subject Headings (MeSH) related to lumbar stenosis; “spinal stenosis”, “rehabilitation”, and “therapy” were the filters.






The inclusion criteria were randomized controlled trials (RCTs) outlining or describing a rehabilitation protocol. Exclusion criteria were: non randomized clinical studies, no mention or vague rehabilitation protocols, and studies employing different regimens in a single non-operative treatment group, thus prohibiting any conclusions on the efficacy of a specific rehabilitation program. The required level of precision for the rehabilitation protocol was a description of type of exercises (e.g. flexion exercises) and modalities or other forms of intervention such as treadmill training and patient education. One of the reviewers was an independent and blinded.







Subjects in all studies were randomly assigned to treatment groups. There are significant differences across studies regarding non-operative treatment protocols for spinal stenosis; noted in Table 2. One of the studies did have a high dropout rate, while the others had no observed dropout rate. Homogeneity was present in baseline characteristics between the treatment groups.









Data was presented in tables and in paragraph form. The following headings were used: inclusion criteria for symptoms and sample characteristics, treatment comparison across studies, outcome criteria, and outcomes. Exclusion criteria were: non randomized clinical studies, no mention or vague rehabilitation protocols, and studies employing different regimens in a single non-operative treatment group, thus prohibiting any conclusions on the efficacy of a specific rehabilitation program.





Yes this is an SR of RCTs. They found the highest quality studies they could; most of the studies were of moderate to low quality in the end.



The data extracted used methods developed by the Cochrane collaboration Back Review Group.



Study quality was assessed with the assistance of the Consolidated Standards of Reporting Trials (CONSORT) Checklist by the authors and an independent blinded reviewer.




The quality of the individual studies was not presented in this paper, although the authors made it seem that only good quality articles were included.

77. Did the investigators address publication No I did not see any info on this.


bias




Homogeneity in baseline characteristics between the treatment groups such as age or gender was observed, rendering the groups comparable. The study’s authors state that lumbar stenosis is a heterogeneous condition and as such should be treated heterogeneously.


(Not a meta-analysis)


A comprehensive non-operative treatment comprising of flexion exercises, manual therapy and treadmill exercises appears to be more beneficial in reducing symptoms than a less intense program.



No, similar.


Yes the treatments are fairly common and typical PT interventions.


f. If not, what will you do now?

Yes these were specifically non-operative treatments; standard PT interventions.



Non-operative treatment consisting of non-intensive exercises has been observed to yield less encouraging results when compared to surgery. Therefore, the non-operative treatment protocol offered by Whitman et al in the manual therapy and exercise group of patients might be considered as the most preferable non-operative treatment strategy, being the most comprehensive non-operative treatment group. Research has also


shown that treadmill training could be replaced by cycling with comparable results.


Endnotes i Cheney, Karen. "4 Surgeries to Avoid." AARP The Magazine. AARP, July-Aug. 2011. Web. 16 Feb. 2014. http://www.aarp.org/health/conditions-treatments/info-05-2011/4-surgeries-to-avoid.2.html ii Deyo, R.A., Mirza, S.K., Martin, B.I. (2006). Back Pain Prevalence and Visit Rates: Estimates From U.S. National

Surveys, 2002. Spine, 31(23), 2724-2727. iii Jenis, L.G., Sucato, D.J., (2013). Lumbar Spinal Stenosis. Retrieved from:

http://orthoinfo.aaos.org/topic.cfm?topic=A00329 iv Alvarez, J.A., Hardy, R.H. (1998). Lumbar Spine Stenosis: A Common Cause of Back and Leg Pain. Am Fam

Physician, 57(8), 1825-1824. Retrieved from: http://www.aafp.org/afp/1998/0415/p1825.html v Watters, W.C. 3rd, Bono, C.M., Gilbert, T.J., Kreiner, D.S., Mazanec, D.J., Shaffer, W.O., . . . Toton, J.F. (2009).

Review An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spondylolisthesis. Spine J. 9(7), 609-14. vi Jenis, L.G., Sucato, D.J., (2013). Lumbar Spinal Stenosis. Retrieved from:

http://orthoinfo.aaos.org/topic.cfm?topic=A00329 vii

May, S., Comer, C. (2013). Is surgery more effective than non-surgical treatment for spinal stenosis, and which non-surgical treatment is more effective? A systematic review. Physiotherapy, 99, 12-20. viii

Amundsen, T., Weber, H., Nordal, H.J., Magnaes, B., Abdelnoor, M., Lilleas, F. (2000). Lumbar Spinal Stenosis: Conservative or Surgical Management? Spine, 25 (11), 1424-1436. ix Kovacs, F.M., Urruita, G., Alarcon, J.D., (2011). Surgery Versus Conservative Treatment for Symptomatic Lumbar

Spinal Stenosis. Spine, 36(20), 1335-1351.

http://www.aarp.org/health/conditions-treatments/info-05-2011/4-surgeries-to-avoid.2.html

http://orthoinfo.aaos.org/topic.cfm?topic=A00329

http://www.aafp.org/afp/1998/0415/p1825.html

http://orthoinfo.aaos.org/topic.cfm?topic=A00329


x Kovacs, F.M., Urruita, G., Alarcon, J.D., (2011). Surgery Versus Conservative Treatment for Symptomatic Lumbar

Spinal Stenosis. Spine, 36(20), 1335-1351. xi Whitman, J.M., Flynn, T.W, Childs, J.D., Wainner, R.S., Gill, H.E., Ryder, M.G., . . . Fritz, J.M. (2006). A Comparison

Between Two Physical Therapy Treatment Programs for Patients With Lumbar Spinal Stenosis. Spine, 31(22), 2541-2549. xii

Iversen, M.D., Choudhary, V.R., and Patel, S.C., (2010). Therapeutic exercise and manual therapy for persons with lumbar spinal stenosis. International Journal of Clinical Rheumatology (5)4, 425-437. xiii

Iversen, M.D., Choudhary, V.R., and Patel, S.C., (2010). Therapeutic exercise and manual therapy for persons with lumbar spinal stenosis. International Journal of Clinical Rheumatology (5)4, 425-437. xiv

Balakatounis, K.C., Panagiotopoulou, K.A., Mitsiokapa, E.A., Mavrogenis, A.F., Angoules, A.G., Papathanasiou, J., Papagelopoulos, P.J., (2011). Evidence-Based Evaluation and Current Practice of Non-operative Treatment Strategies for Lumbar Stenosis. Folia Medica 2011; (53)3, 5-14. xv

Jarrett, M.S., Orlando, J.F., and Grimmer-Somers, K., (2012). The effectiveness of land based exercise compared to decompressive surgery in the management of lumbar spinal-canal stenosis: a systematic review. BMC Musculoskeletal Disorders, 13(30), 1471-2474. xvi

Amundsen, T., Weber, H., Nordal, H.J., Magnaes, B., Abdelnoor, M., Lilleas, F. (2000). Lumbar Spinal Stenosis: Conservative or Surgical Management? Spine, 25 (11), 1424-1436. xvii

Ibid. xviii

Ibid. xix

Whitman, J.M., Flynn, T.W, Childs, J.D., Wainner, R.S., Gill, H.E., Ryder, M.G., . . . Fritz, J.M. (2006). A Comparison Between Two Physical Therapy Treatment Programs for Patients With Lumbar Spinal Stenosis. Spine, 31(22), 2541-2549.

surgical vs physical therapy interventions for lumbar spinal stenosis

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