Updates in Fibromyalgia: Diagnosis and Management
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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
- 5. FM Clinical Features PAIN Fatigue Sleep disorders Cognitive problems Mood disorders Anxiety disorders 100% 90% 90% 60% 50% 40%
- 6. The Company FM KeepsFunctional Somatic Syndromes
- 7. DIAGNOSIS OF EXCLUSION? 5% 17% 22%
- 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
- 12. 2010 ACR Diagnostic Criteria Widespread Pain Index (WPI) Symptom Severity Score (SS) • Fatigue • Waking Unrefreshed • Cognitive symptoms • Somatic symptoms
- 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
- 22. 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
- 23. 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
- 24. 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
- 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
- 28. PATIENT TAILORED Approach Multi-modal treatment Multi-component treatment Self-management strategies Symptom based approach
- 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
- 35. 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
- 36. 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
- 37. 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)
- 38. 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)
- 39. 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
- 40. 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
- 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
Notas del editor
- 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