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.
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Updates in Fibromyalgia: Diagnosis and Management
1. U P D A T E S I N
SIDNEY ERWIN T. MANAHAN, MD, FPCP, FPRA
FIBROMYALGIA
2. 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.
3. 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.”
4. 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
8. 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
9. 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”
10. 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
11. 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
13. 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
14. 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
15. 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
16. 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?
17. 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
18. 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?
19. What Works
Intervention LoE / SoR Pain Function
Pharmacologic
Tramadol IB / A
Antidepressants
• Amitriptyline, Fluoxetine,
Duloxetine, Milnacipran,
Moclobemide and
Pirlindole
IB / A
Pregabalin
Pramipexole
Tropisetron
IB / A
20. 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
21. What Works
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
25. 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
26. 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)
27. 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
29. 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
30. Group 1 Group 2 Group 3
ANXIETY / DEPRESSION
Moderate High Normal
CATASTROPHISM/ COPING
Moderate High Low
HYPERALGESIA/ TENDER POINTS
Low High High
31. Giesecke Group 1
• Education
• Exercise program
• For depression
– SNRI (Duloxetine, Milnacipran)
and tricyclic antidepressants
• For anxiety
– Pregabalin, SSRI, SNRI
• For hyperalgesia
– Pregabalin, gabapentin
32. 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
33. Giesecke Group 3
• Education
• Exercise program
• For hyperalgesia
– Pregabalin, gabapentin
• Do not give SNRI, SSRI, TCA
• No Cognitive Behavioral Tx
41. 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
Editor's Notes
The prevalence of chronic widespread pain (CWP) in the general population is said to be 7-11%; or 15% as the ACR had estimated in 1990. The causes vary from the inflammatory conditions (RA, SpA, SLE, vasculitis, infection) to the non-inflammatory (OA, STRs), endocrine (hypothyroidism), neurologic (cervical myelopathy, stenosis), psychiatric and drug related.Fibromyalgia is just one of our differentials for CWP and it is said to be the most common cause of CWP in rheumatology practice.
The traditional definition of fibromyalgia has been that of a chronic condition differentiated by the presence of widespread pain and the presence of tender points.However, as we’ve learned more about the spectrum of the disease, so has the definition evolved. Recent lit define fibromyalgia as a syndrome characterized by widespread pain associated with features of fatigue, sleep disturbance, cognitive changes, mood disturbance and several somatic complaints.
World wide, disease prevalence ranges from 0.5 – 5%. The typical patient is a female in her late 30s to mid 50s presenting with the syndrome. It is recognized that there children who may develop fibromyalgia and they comprise 1.2-1.4% of the total FM population. Males may also develop fibromyalgia and they are somewhat a challenge because they usually have fewer painful sites, less tender points (occasionally not meeting criteria), and complain of less fatigue and fewer somatic symptoms.
Pain is a feature seen in all FM patients – sometimes these may start as a localized type of pain soon becoming generalized. The typical pain of FM is diffuse deep and continuous and may be observed to be modulated by various factors such as psychological stress, excessive physical activity, fatigue, weather changes. Some patients describe the pain as burning or may satisfy definitions of allodynia and hyperesthesia – which often leads physicians to suspect a neuropathic cause of the pain.Fatigue is another common feature and at times it may be more bothersome and troubling than the pain.Sleep disturbances occur frequently and these may be described as non-restorative, poor in quality resulting in daytime somnolence and impaired daytime functioning. And frequently has short duration – some studies suggest FM patients sleep 2 hours less than their counterparts. Cognitive problems – referred to as FIBRO FOG – impaired cognition, spatial memory alterations, poor free recall and verbal fluency, and memory difficulties. One study suggested that cognitive deficits in patient with FM was comparable to individuals 20 years their senior.And depression and anxiety are also present in fibromyalgia patients – affecting 50% and 40% of the population.
Aside from that 20-80% of all FM patients have Functional Somatic Syndromes – group of related syndromes characterized more by their prominent symptoms and the resultant suffering and disability rather than by any structural or functional abnormality.Migraine and Tension-type headaches 10-80%Irritable Bowel Syndrome 32-80%Post-traumatic Stress Disorder 30%Interstitial Cystitis – 13-21%Chronic Pelvic Pain Syndrome – 18%Temporomandibular Joint Disorders – 75%Chronic Fatigue Syndrome 21-80%Multiple Chemical Sensitivities.
OA 5%, RA 17%, SLE 22%, Sjogren 47%
Sensitivity 88%, Specificity 81%
Wolfe 2003
Wolfe & Rasker 2006, Score 0-9.75
WPI highest score is 19SS highest score is 12Total score highest is 31
0 – no symptoms, 1 – few symptoms, 2 – moderate number of symptoms or 3 – a great deal of symptoms
146 studies – 39 pharma, 59 non-pharma
IA Systematic reviews of RCT, IB Individual RCT, 2A systematic review of cohort or low quality RCT, 2B cohort study or low quality RCT
146 studies – 39 pharma, 59 non-pharmaLook into what these interventions improve – pain or function.
Pain, Fatigue, Mood,HRQoL were small; Physical Fitness were medium
ADAPTATION – improved and maintained QOL (functional ability to perform in everyday situations) and reduction of symptoms
A stratified treatment plan should be followed in the management of FMS.Choice of treatment depends on the patient’s response to SIX MONTHS of treatment at the previous level. Effectiveness and potential AEs should be continuously monitored and that re-evaluation should take place at the end of treatment as well as SIX and TWELVE months later.
PatientsLikeMe creates online medical communities for patients to share health information, find other patients like them, and learn how to improve their outcomes. Our platform enables longitudinal study of disease progression and intervention in the real world.To date, >11,000 fibromyalgia patients have joined PatientsLikeMe.MethodologyDerived from data (up to October 2010) shared by fibromyalgia patients with experience using pregabalin and duloxetineObservational with no time line limitationsCreated internally by PatientsLikeMe and was NOT FUNDED in full or in part by industry