updates in fibromyalgia: diagnosis and management
DESCRIPTION
I was asked to present something on Fibromyalgia during a Pain Summit. I ended up describing what we know so far about clinical features, evolution of diagnostic criteria and synthesized some recent guidelines.TRANSCRIPT
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U P D A T E S I N
SIDNEY ERWIN T. MANAHAN, MD, FPCP, FPRA
FIBROMYALGIA
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CHRONIC WIDESPREAD PAIN
• Rheumatoid Arthritis
• Spondyloarthritis
• SLE
• Vasculitic syndromes
• Infections
• Osteoarthritis
• Multiple soft tissue rheumatism
• Hypothyroidism
• Cervical myelopathy
• Spinal stenosis
• Major depression
• Drug-related
• FIBROMYALGIA
Burckhardt K, Goldenberg D. American Pain Society Clinical Practice Guideline for the Management of
Fibromyalgia Syndrome Pain in Adults and Children, 2005.
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FIBROMYALGIA
“Fibromyalgia is a chronic rheumatologic condition
characterized by widespread pain and the presence
of soft tissue tenderness.”
“Fibromyalgia is a syndrome characterized by
diffuse body pain associated with fatigue,
sleep disturbance, cognitive changes, mood
disturbance and other variable somatic
symptoms.”
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Epidemiology
Prevalence 0.5-5%
• Females 3.5%
• Males 0.5%
Age
• Common 30-55 years*
• Pediatric 1.2 – 1.4%
Fibromyalgia in Males
• Fewer pain sites
• Fewer tender points
• Less fatigue
• Less somatic symptoms
Fitzcharles MA, Yunnus M. Pain Research and Treatment 2012. doi: 10.1155/2012/184835
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FM Clinical Features
PAIN
Fatigue
Sleep disorders
Cognitive problems
Mood disorders
Anxiety disorders
100%
90%
90%
60%
50%
40%
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The Company FM Keeps Functional Somatic Syndromes
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DIAGNOSIS OF EXCLUSION?
5% 17% 22%
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1990 ACR
• Widespread Pain of at
least 3 months duration
– Left and right side
– Above and below the
waist
– Axial pain
• 11/ 18 Tender points
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Limitations of the ACR 1990
• Fails to capture other clinical features, i.e.
fatigue and sleep disturbance
• Tender points
• No. of tender points = severity; not for monitoring
• Correlates poorly with measures of disease activity
• Differences in performing the tender point
examination
• Not all meet TP criteria (e.q. those who were treated)
“25% of patients would no longer satisfy criteria
for Fibromyalgia on subsequent visits”
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Other FM Criteria (Non-TP) SYMPTOM INTENSITY SCORE
• Pain in any of the following in the last 7 days
• Fatigue Visual Analogue Score (0-10 cm)
• FMS: Pain >8 Areas AND Fatigue >6cm
R/L Jaw
Neck
R/L Shoulder
R/L Upper Arm
R/L Forearm
Upper Back
Chest
Abdomen
Lower Back
R/L Hip
R/L Thighs
R/L Calves
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Other FM Criteria (Non-TP)
Modified SYMPTOM INTENSITY SCORE
• SIS =
2
• mSIS >5.75
Fatigue VAS + Regional Pain Score
---------------------------------------------------
2
Detects Fibromyalgia
Assesses for co-morbid
depression
Over-all measure of health
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2010 ACR Diagnostic Criteria
Widespread Pain Index (WPI)
Symptom Severity Score (SS)
• Fatigue
• Waking Unrefreshed
• Cognitive symptoms
• Somatic symptoms
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2010 ACR Diagnostic Criteria
WIDESPREAD PAIN INDEX
• Pain in any of the ff areas in the last 7 days
R/L Jaw
Neck
R/L Shoulder
R/L Upper Arm
R/L Forearm
Upper Back
Chest
Abdomen
Lower Back
R/L Hip
R/L Thighs
R/L Calves
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2010 ACR Diagnostic Criteria
SYMPTOM SEVERITY Score
How severe were the following in the past 7 days
• Fatigue
• Waking unrefreshed
• Cognitive symptoms
0 – No problems
1 – Slight or mild problems; intermittent
2 – Moderate or considerable problems; often present
3 – Severe, pervasive, continuous or life-disturbing
problems
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2010 ACR Diagnostic Criteria
SYMPTOM SEVERITY Score
• Somatic Symptoms – Have you had any of the following in
the last 6 months
Blurred vision
Dry eyes
Tinnitus
Hearing difficulties
Mouth sores
Dry mouth
Dysgeusia
Headache
Dizziness
Fever
Chest pains
Dyspnea
Wheezing
Anorexia
Nausea
Heart burn
Diarrhea
Constipation
Itching
Hives/ welts
Vomiting
Easy bruising
Hair loss
Urinary symptoms
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2010 ACR Diagnostic Criteria
Widespread Pain
Index (WPI)
Symptom Severity
Score (SS)
Fatigue
Waking unrefreshed
Cognitive symptoms
Somatic Symptoms
WPI > 7 and SS Score > 5
WPI 3-6 and SS Score > 9
* Symptoms present for at least 3 months
12?
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How to use criteria
AT BASELINE
• 1990/ 2010 ACR Criteria, SIS, Other Criteria
• SS Score to document baseline severity
SUBSEQUENT VISIT
• SS Score to reassess severity
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Managing Fibromyalgia 2007 (EULAR)
Carville SF, Arendt-Nielsen S, et al. Ann Rheum Dis 2007; doi:10.1136
2009 (S3) Hauser W, Eich W, et al. Dtsch Arztebl Int 2009; 106 (23): 383-91.
2010 (Spain) Alegre de Miguel C, Garcia Campayo J, et al. Actas Esp Pqiguiatr 2010; 38 (2): 108-20
2012 (Canada) Fitzcharles MA, Ste-Marie PA, et al.
What?
How?
For whom?
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What Works (2007)
Intervention LoE / SoR Pain Function
Pharmacologic
Tramadol IB / A
Antidepressants
• Amitriptyline, Fluoxetine,
Duloxetine, Milnacipran,
Moclobemide and
Pirlindole
IB / A
Pregabalin
Pramipexole
Tropisetron
IB / A
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What Works (UPDATED) Drugs LoE Dose Comments
Amitriptyline 1A 10-50 mg Frequent side effects
PREGABALIN 1A 150-450 mg FDA-approved, Long-term
efficacy
Duloxetine 1A 30-60 mg FDA-approved, Long-term
efficacy
Milnacipran 1A 25-200 mg FDA-approved
Gabapentin 1B 1200-2400 mg One large RCT
Fluoxetine 2A 20-60 mg Three small RCT
Paroxetine 2B 20 mg One large RCT
Tramadol 2B 50-300 mg Two RCT Tramadol 150 mg +
Paracetamol 1300 mg
IASP Pain: Clinical Updates Vol XVIII Issue 4 June 2010
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What Works (2007)
Intervention LoE / SoR
Non-Pharmacologic
Heated pool treatment IIA / B
Aerobic exercise and
strength training IIB / C
Cognitive behavioral
therapy IV / D
Relaxation, rehabilitation,
physiotherapy and
psychological support
IIB / C
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The Impact of Aerobic Exercise
Parameter Effect Size P-value
Pain -0.31 (-0.46, 0.17) <0.001
Fatigue -0.22 (-0.38, -0.05) 0.006
Depressed Mood -0.32 (-0.53, -0.12) 0.002
HRQoL -0.40 (-0.60, -0.20) <0.001
Physical Fitness 0.65 (0.38, 0.93) <0.001
Sleep 0.01 (-0.19, 0.21) 0.92
Hauser et al. Arth Res Ther 2010: 12: R79
* compared vs. Placebo
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Aerobic Ex Prescription
Parameter # Studies # Patients Effect Size P-value
TYPE OF EXERCISE
Land based 22 463 -0.29 (-0.46, -0.13) 0.0005
Water based 3 61 -0.67 (-1.04, -0.29) 0.0005
Mixed 4 43 -0.03 (-0.45, 0.39) 0.89
TYPE OF EXERCISE
AE only 12 273 -0.35 (-0.61, -0.09) 0.0008
Combined 17 294 -0.28 (-0.45, -0.15) 0.001
INTENSITY OF AEROBIC EXERCISE
<50% Max HR 1 37 -0.09 (-0.54, 0.36) NA
>50% Max HR 21 367 -0.26 (-0.42, -0.11) 0.02
Up to Patient 2 79 -0.42 (-0.77, -0.07) 0.0007
Hauser et al. Arth Res Ther 2010: 12: R79
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Aerobic Ex Prescription
Parameter # Studies # Patients Effect Size P-value
DURATION OF STUDY
< 7 weeks 2 32 -1.16 (-1.86, -0.48) 0.001
7 – 12 weeks 13 194 -0.24 (-0.50, -0.02) 0.03
> 12 weeks 12 338 -0.24 (-0.40, -0.08) 0.004
FREQUENCY OF TRAINING
1/ week 2 37 -0.07 (-0.52, 03.9) 0.48
2/ week 5 127 -0.69 (-0.95, -0.27) 0.0004
3/ week 16 241 -0.35 (-0.62, -0.09) 0.009
>3/ week 4 142 -0.13 (-0.38, 0.13) 0.33
Hauser et al. Arth Res Ther 2010: 12: R79
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Educating the FM Patient
• Symptoms do not lead to invalidism or shorten
life span
• Complete relief is not possible in all patients
• Goal is ADAPTATION
• Regular physical activity leads to adaptation
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1
2
3
How to Use: S3 Guidelines
• Cognitive behavioral therapy (1A)
• Aerobic endurance training (1A)
• Pool-based exercises (1A)
• Spa therapy (1A)
• Amitriptyline (1A)
• Diagnosis and management of comorbids (5)
• Multimodal Therapy (1A)
• Short term pharmacotherapy (1A)
• Short term non-pharma
interventions (2A)
• Multimodal booster therapy (5)
• Complementary med (2B)
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Start Level I
Interventions
Improvement
at 6 months?
Start Level 2
Interventions
Improvement
at 6months?
Start Level 3
Interventions
Improvement
12 months?
Improvement
at 6months?
Sufficient
functioning in
daily activities/
ADAPTATION
Yes
Yes
Yes
No
No
No
Yes
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PATIENT TAILORED Approach
Multi-modal treatment
Multi-component treatment
Self-management strategies
Symptom based approach
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Fibromyalgia Subgroups by Giesecke
• DEPRESSION
Center for Epidemiologic Studies Depression Scale
• ANXIETY
State-Trait Personality Inventory
• CATASTOPHISM
Coping Strategies Questionnaire
• HYPERALGESIA
Pain scale/ Painful Pressure
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Group 1 Group 2 Group 3
ANXIETY / DEPRESSION
Moderate High Normal
CATASTROPHISM/ COPING
Moderate High Low
HYPERALGESIA/ TENDER POINTS
Low High High
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Giesecke Group 1
• Education
• Exercise program
• For depression
– SNRI (Duloxetine, Milnacipran)
and tricyclic antidepressants
• For anxiety
– Pregabalin, SSRI, SNRI
• For hyperalgesia
– Pregabalin, gabapentin
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Giesecke Group 2
• Education
• Exercise program
• For depression
– SNRI (Duloxetine, Milnacipran)
and tricyclic antidepressants
• For anxiety
– Pregabalin, SSRI, SNRI
• For hyperalgesia
– Pregabalin, gabapentin
• Cognitive Behavior Therapy
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Giesecke Group 3
• Education
• Exercise program
• For hyperalgesia
– Pregabalin, gabapentin
• Do not give SNRI, SSRI, TCA
• No Cognitive Behavioral Tx
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Dosage of Pregabalin Used (n=1,134)
48
97 97 98
274
68 65
243
88
56
0
50
100
150
200
250
300
25 mg 50 mg 75 mg 100 mg 150 mg 200 mg 225 mg 300 mg 450 mg 600 mg
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Dosages of Duloxetine Used (n=1,377)
73
239
23
714
2
125
194
0
100
200
300
400
500
600
700
800
20 mg 30 mg 40 mg 60 mg 80 mg 90 mg 120 mg
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Efficacy
15
34
26
16
10
20
37
22
13
7
0
5
10
15
20
25
30
35
40
Major Moderate Slight None Unsure
Duloxetine (n=316) Pregabalin (n=319)
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Adverse Events
19
26 28
26
29 30
25
16
0
5
10
15
20
25
30
35
Severe Moderate Mild None
Duloxetine (n=432) Pregabalin (n=418)
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Most Common AEs: Pregabalin
164
102
95
92
81
76
0 20 40 60 80 100 120 140 160 180
Weight gain
Brain fog
AM Sleepiness
Dizziness
Lack of concentration
Blurry vision
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Most Common AEs: Duloxetine
97
90
89
76
72
57
0 20 40 60 80 100 120
Decreased libido
Increased sweating
Nausea
Dizziness
Brain cloud
Insomnia
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Summary
• Described the clinical features of fibromyalgia
• Compared the utility of the 1990 vs 2010 ACR Diagnostic Criteria
• Synthesized recommendations of different practice guidelines
• Reported patient experience on the use of two FDA-approved fibromyalgia treatments
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