U P DAT E S I N

FIBROMYALGIA

SIDNEY ERWIN T. MANAHAN, MD, FPCP, FPRA

 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.
 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.
 Epidemiology

Prevalence 0.5-5% Fibromyalgia in Males

Females 3.5% Fewer pain sites
Males 0.5% Fewer tender points
Less fatigue
Age Less somatic symptoms
Common 30-55 years*
Pediatric 1.2 1.4%

Fitzcharles MA, Yunnus M. Pain Research and Treatment 2012. doi: 10.1155/2012/184835
 FM Clinical Features
PAIN 100%

Fatigue 90%

Sleep disorders 90%

Cognitive problems 60%

Mood disorders 50%

Anxiety disorders 40%

Functional
The Company
Somatic
FMSyndromes
Keeps
5% 17% 22%

DIAGNOSIS OF EXCLUSION?
 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

 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
 Other FM Criteria (Non-TP)
SYMPTOM INTENSITY SCORE
Pain in any of the following in the last 7 days
R/L Jaw Chest
Neck Abdomen
R/L Shoulder Lower Back
R/L Upper Arm R/L Hip
R/L Forearm R/L Thighs
Upper Back R/L Calves

Fatigue Visual Analogue Score (0-10 cm)

FMS: Pain >8 Areas AND Fatigue >6cm
 Other FM Criteria (Non-TP)
Modified SYMPTOM INTENSITY SCORE
Regional Pain Score
Fatigue VAS + ---------------------------------------------------

2
SIS =
2

Detects Fibromyalgia
mSIS >5.75 Assesses for co-morbid
depression
Over-all measure of health
 2010 ACR Diagnostic Criteria

Widespread Pain Index (WPI)

Symptom Severity Score (SS)
Fatigue
Waking Unrefreshed
Cognitive symptoms
Somatic symptoms
 2010 ACR Diagnostic Criteria
WIDESPREAD PAIN INDEX
Pain in any of the ff areas in the last 7 days

R/L Jaw Chest

Neck Abdomen
R/L Shoulder Lower Back
R/L Upper Arm R/L Hip
R/L Forearm R/L Thighs
Upper Back R/L Calves
 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
 2010 ACR Diagnostic Criteria
SYMPTOM SEVERITY Score
Somatic Symptoms Have you had any of the following in
the last 6 months
Blurred vision Wheezing
Dry eyes Anorexia
Tinnitus Nausea
Hearing difficulties Heart burn
Mouth sores Diarrhea
Dry mouth Constipation
Dysgeusia Itching
Headache Hives/ welts
Dizziness Vomiting
Fever Easy bruising
Chest pains Hair loss
Dyspnea Urinary symptoms
2010 ACR Diagnostic Criteria
Symptom Severity
Score (SS)
Widespread Pain Fatigue
Index (WPI) Waking unrefreshed
Cognitive symptoms
Somatic Symptoms

WPI > 7 and SS Score > 5

12?
WPI 3-6 and SS Score > 9

* Symptoms present for at least 3 months

 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
 Managing Fibromyalgia
2007 (EULAR)
Carville SF, Arendt-Nielsen S, et al. Ann What?
Rheum Dis 2007; doi:10.1136
2009 (S3)
Hauser W, Eich W, et al. Dtsch Arztebl
Int 2009; 106 (23): 383-91.
2010 (Spain) How?
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. For whom?
 What Works (2007)
Intervention LoE / SoR Pain Function
Pharmacologic
Tramadol IB / A
Antidepressants
Amitriptyline, Fluoxetine,
Duloxetine, Milnacipran, IB / A
Moclobemide and
Pirlindole
Pregabalin
Pramipexole IB / A
Tropisetron
 What Works (UPDATED)
Drugs LoE Dose Comments
Amitriptyline 1A 10-50 mg Frequent side effects
FDA-approved, Long-term
PREGABALIN 1A 150-450 mg
efficacy
FDA-approved, Long-term
Duloxetine 1A 30-60 mg
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
Two RCT Tramadol 150 mg +
Tramadol 2B 50-300 mg
Paracetamol 1300 mg

IASP Pain: Clinical Updates Vol XVIII Issue 4 June 2010

 What Works (2007)
Intervention LoE / SoR
Non-Pharmacologic
Heated pool treatment IIA / B
Aerobic exercise and
IIB / C
strength training
Cognitive behavioral
IV / D
therapy
Relaxation, rehabilitation,
physiotherapy and IIB / C
psychological support
 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
* compared vs. Placebo

Hauser et al. Arth Res Ther 2010: 12: R79

 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

 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

 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
 Short term pharmacotherapy (1A)
Short term non-pharma
interventions (2A)
Multimodal booster therapy (5) 3
Complementary med (2B)

Multimodal Therapy (1A)

2
Cognitive behavioral therapy (1A)
Aerobic endurance training (1A)

Pool-based exercises (1A)

Spa therapy (1A)
Amitriptyline (1A)
1
Diagnosis and management of comorbids (5)

How to Use: S3 Guidelines

 Start Level I
Interventions

Sufficient
Improvement Yes Improvement Yes functioning in
at 6 months? 12 months? daily activities/
ADAPTATION
No No

Start Level 2
Interventions

Improvement Yes
at 6months?

No Yes

Start Level 3 Improvement

Interventions at 6months?
PATIENT TAILORED Approach

Multi-modal treatment

Multi-component treatment

Self-management strategies

Symptom based approach

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
Group 1 Group 2 Group 3
ANXIETY / DEPRESSION
Moderate High Normal
CATASTROPHISM/ COPING
Moderate High Low
HYPERALGESIA/ TENDER POINTS
Low High High
 Giesecke Group 1
Education
Exercise program
For depression
SNRI (Duloxetine, Milnacipran)
and tricyclic antidepressants
For anxiety
Pregabalin, SSRI, SNRI
For hyperalgesia
Pregabalin, gabapentin
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
 Giesecke Group 3
Education
Exercise program
For hyperalgesia
Pregabalin, gabapentin
Do not give SNRI, SSRI, TCA
No Cognitive Behavioral Tx
 Dosage of Pregabalin Used (n=1,134)
300
274

250 243

200

150

97 97 98
100 88
68 65
48 56
50

0
25 mg 50 mg 75 mg 100 mg 150 mg 200 mg 225 mg 300 mg 450 mg 600 mg
Dosages of Duloxetine Used (n=1,377)
800
714
700
600
500
400
300 239
194
200
125
100 73
23 2
0
20 mg 30 mg 40 mg 60 mg 80 mg 90 mg 120 mg
 Efficacy
40 37
35 34

30
26
25 22
20
20
15 16
15 13
10
10 7
5
0
Major Moderate Slight None Unsure
Duloxetine (n=316) Pregabalin (n=319)
 Adverse Events
35
29 30
30 28
26 25 26
25

20 19
16
15

10

0
Severe Moderate Mild None
Duloxetine (n=432) Pregabalin (n=418)
 Most Common AEs: Pregabalin

Blurry vision 76

Lack of concentration 81

Dizziness 92

AM Sleepiness 95

Brain fog 102

Weight gain 164

0 20 40 60 80 100 120 140 160 180

 Most Common AEs: Duloxetine

Insomnia 57

Brain cloud 72

Dizziness 76

Nausea 89

Increased sweating 90

Decreased libido 97

0 20 40 60 80 100 120
 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