FIBROMYALGIA in Primary Care

1. FIBROMYALGIAin Primary Care B. WAYNE BLOUNT, MD, MPH PROFESSOR, EMORY S.O.M.

2. OUTLINE • What is Fibromyalgia (FM)? • What causes it? • Who gets it? • How is it diagnosed? • How is it treated? • What are some of the misconceptions & controversies? • J

4. What is Fibromyalgia (FM)? • 1st recognized by AMA as a “true” illness & a cause of disability in 1987. • 1st diagnostic criteria for FM developed in 1990. • 1990 criteria established FM as an independent disorder with distinct diagnostic characteristics

5. What is Fibromyalgia? • A clinical syndrome of widespread muscle pain : • Chronic, • Non-inflammatory, with • Fatigue & • Tenderpoints

6. Chronic Pain/Suffering Syndromes • FM is the prototype for a fundamentally different type of pain syndrome where pain is • Not due to damage or inflammation of peripheral tissues • Frequently accompanied by a variety of other somatic symptoms and syndromes • Includes Chronic fatigue, IBS, some HAs

7. Fibromyalgia • Most common rheumatic cause of chronic diffuse pain. 2nd or 5th most prevalent rheumatic disorder • Generalized pain & pain amplification syndrome • Extremely common pain phenomenon occurring in a defined pattern

8. SIGNS & SYMPTOMS • Insidious in onset • Diffuse soft tissue pain • Pain increased in A.M., with weather changes, anxiety, & stress • Pain improved by mild physical activity or stress reduction • Non-restorative sleep

9. SIGNS & SYMPTOMS • Abnormal non-rapid eye movement stage IV sleep ** • Generalized fatigue or tiredness ** • Chronic headache ** • Anxiety • Irritable bowel syndrome • A.M. Stiffness

10. SIGNS & SYMPTOMS • Depression • Reduced physical endurance • Decreased social interaction • Cognitive “fog” • Subjective, non-confirmable : • Paresthesias • Swollen joints • All sx may wax & wane

11. Most Common Complaints** • # 1 : Sleep problems • # 2 : Fatigue • # 3 : Cognitive dysfunction • # 4 : Pain • Fibromyalgia is much more than a pain disorder • J

13. What causes FM? • Cause is unknown and is probably multifactorial and may be different in different patients

14. What causes FM? • Lower levels of • Serotonin: Related to sleep, pain perception, HAs, & mood disorders & • Dopamine: Related to pleasure, motivation, & motor control; lower levels in FM patients 2nd-ary to pain stimulus • Growth hormone 2nd-ary to sleep disruption: related to tissue repair

15. What causes FM? • Abnormally high levels of Substance P in spinal fluid in some patients • Substance P important in transmission and amplification of pain signals to and from brain • Areas of brain activated with mild tactile pressure: 2 in controls vs. 12 in FM • “Volume control” is turned up too high in brain’s pain centers

16. What causes FM? • Familial tendency to develop FMS suggests geneticrole • Can be triggered by physical, emotional or environmental stressors such as car accidents, repetitive injuries and certain diseases : • Rheumatoid arthritis and SLE pts. are more likely to develop FMS • J

18. Who gets FM? • Affects as many as 1 in 30 Americans • Most common in middle-aged women • Men and children also get the disorder • More likely with : • RA, SLE and Ankylosing spondylitis • Other family members with FMS • Lower income & education • Prevalence increases to age 80

19. How is FM diagnosed? • Symptoms of FM are typically very non-specific, common to many other conditions. Many sx cannot be objectively evaluated.

20. How is FM diagnosed? • Diagnosis made by evaluation of symptoms & presence of tender points • Not a diagnosis of exclusion • Widespread pain for at least 3 months and pain in 11 out of 18tenderpoint sites on digital palpation

21. ACR Diagnostic criteria • Both criteria must be satisfied • History of widespread pain for more than 3 months, on both sides of the body, above and below the waist, and axial skeleton (cervical spine, anterior chest, thoracic pain, or low back) • Pain in 11 of 18 tender point sites on digital palpation with approximate force of 4 kg. • Presence of second clinical disorder does not exclude diagnosis of fibromyalgia.

22. Differential • Hypothyroidism • Muscle overuse • Inflammatory disorders: • Myopathies • Polymyalgia rheumatica • Temporal arteritis • Chronic Fatigue • R.A. • SLE

23. Fibromyalgia Impact Questionnaire • Assesses functional abilities in daily life & • Measures patient progress & outcomes • Self-administered, 10 item questionnaire • 10 Minutes to complete • Good Validity • www.myalgia.com/FIQ/fiq.pdf

24. ACR Diagnostic Criteria • ACR diagnostic criteria • History of chronic widespread pain ≥3 months • Patients must exhibit ≥11 of 18 tender points • FM can be identified from among other rheumatologic conditions with use of ACR criteria with good sensitivity (88.4%) and specificity (81.1%)

25. Physical Exam Requirement • Systematic palpation of the 18 tender point sites • Palpation force is 4 kg or equal to the force needed to just blanch your thumbnail

26. How is FM Diagnosed? • X-rays, blood tests, specialized scans such as nuclear medicine and CT, muscle biopsies are all normal • Objective “markers of inflammation” such as ESR are normal • Distinguish from other common diffuse pain conditions; e.g. RA, SLE, Hypothyroidism and Polymyalgia Rheumatica

27. LABS to Get • ESR • CBC • TSH • If any abnormality, work it up. Probably not fibromyalgia

28. How is FM treated? • Fibromyalgia is a chronic condition managed with both medications and physical modalities • Medication therapy is largely symptomatic, as there is no definitive treatment nor cure for fibromyalgia

29. From Mechanism to Treatment Central neural factors play a critical role This is a polygenic disorder There is a deficiency of noradrenergic-serotonergic activity Lack of sleep or exercise increases pain and other somatic sx, even in normals How FM patients think about their pain may directly influence pain levels Treatments at the periphery (drugs, injections) are not efficacious There will be sub-groups of FM needing different treatments Drugs that raise norepinephrine and serotonin will be efficacious in some Exercise, “sleep hygiene,” and other behavioral interventions are effective therapies for biological reasons Cognitive therapies are effective in FM

30. Medications in FM • Strong evidence : ‘A’ Rec • Amitriptyline, 25-50 mg at bedtime • Cyclobenzaprine, 10-30 mgs at bedtime • Pregabalin, 450 mg/day • Gabepentin, 1600-2400 mg/day • Duloxetine, 60-120 mg/day • Milnacipran, 100-200 mg/day

31. Medications in FM • Modest evidence : ‘B’ Rec • Tramadol, 200-300 mg/day • SSRIs (fluoxetine, sertraline) • Weak evidence: pramipexole, gamma hydroxybutyrate, growth hormone, 5-hydroxytryptamine, tropisetron, s-adenosyl-methionine

32. No evidence: opioids, NSAIDS, benzodiazepene and nonbenzodiazepene hypnotics, melatonin, magnesium, DHEA, thyroid hormone, OTCs

33. You may have heard something about using antipsychotics • Quetiapine 25 – 100 mg/day • Ziprasidone 20 mg/day • Each has 1 study done • Both used as add-on to inadequate other therapy • Both showed some parameter improvement, but … • Both have significant side effects

34. What about a dopamine agonist? • Pramipexole, in 1 study, did show significant improvement in several parameters, but … • Again : Significant side effects

35. Only 3 Meds are FDA Approved for FM • Duloxetine (Cymbalta) • Pregabalin (Lyrica) • Milnacipran (Savella)

36. Nonpharmacologic Strategies Strong Evidence : ‘A’ Rec Exercise Physical and psychological benefits Increases aerobic performance and tender point pain pressure threshold, and improves pain Efficacy not maintained if exercise stops Cognitive-behavioral therapy Improvements in pain, fatigue, mood, and physical function Improvement often sustained for months Patient education/self-management Improves pain, sleep, fatigue, and quality of life Combination (multidisciplinary therapy)

37. Nonpharmacologic Strategies: Modest Evidence Strength training Acupuncture Hypnotherapy EMG biofeedback Balneotherapy Weak Evidence Chiropractic Manual and massage therapy Ultrasound No Evidence Tender-point injections Flexibility exercise

38. Who Should Treat Fibromyalgia? More than 50% of visits are to primary care physicians Currently, 16% of FM visits are to rheumatologists The American College of Rheumatology suggest that rheumatologists serve as consultants (tertiary care) Other specialists should include mental health professionals, physiatrists and pain managementexperts

39. FM and Prognosis Patients treated in primary care settings and those with recent onset of symptoms generally have a better prognosis Longer-term studies needed to define prognostic factors

40. Prognosis • With resolution of sleep disturbance, may resolve totally • Aggressive physical therapy is critical in those who do not respond • Approximately 5% do not respond to any form of therapeutic intervention. Hypnosis may be attempted in that group.

41. Explaining the Typical Outcome • FM does not herald a systemic disease • No progressive, structural or organ damage • Most patients in specialty practice have chronic, persistent symptoms • Primary care patients more commonly report complete remission of symptoms • Most patients continue to work, but 10-15% are disabled • Most patients’ quality of life improves with medical management

42. Initial Treatment of Fibromyalgia As a first-line approach for patients with moderate to severe pain, trial with evidence-based medications, e.g. Trial with low-dose tricyclic antidepressants, SSRI, SNRI, antiseizure medication Provide additional treatment for comorbid conditions Stress management techniques Encourage exercise according to fitness level .

43. Further Treatment Polypharmacy; for example, trial of SSRI in AM and tricyclic in PM (‘A’ Rec) SNRI in AM and anti-seizure drug in PM Trial of additional analgesics such as tramadol Structured rehabilitation program; Formal mental health program, such as CBT for patients with prominent psychosocial stressors, and/or difficulty coping, and/or difficulty functioning Comprehensive pain management program .

44. Other Patient-Centered Management • Patient Self-Management - Schedule time to relax, including deep breathing and meditation - Establish good sleep hygiene - Self-education i.e. Arthritis Foundation, National Fibromyalgia Assn. - Support group

45. What about Diet? • No “magic” diet • No controlled studies, but … • May suggest avoidance of foods associated with fatigue : • High fat “Junk” food • Refined sugar Caffeine • White flour Salt • Fried foods Alcohol

46. A Suggested Management Strategy for Fibromyalgia? • All patients • Reassurance re diagnosis • Give explanation, including, but not solely, psychological factors • Promote return to normal activity, exercise • Most patients • Medication trial (esp antidepressants, anticonvulsants) • Cognitive behavior therapy, counseling • Physical rehabilitation or exercise

47. Patient Follow-up • Routine, regular follow-up • Monitor patient’s progress • Assess: • Pain • Sleep • Daily functioning • Global well-being • Mood disorders • Can use the FIQ

48. Conclusions • FM is a recognized disorder • Pathophysiology not completely elucidated • Choosing optimal treatment has recommendations, but may still be a trial-and-error process • Duloxetine, Pregabalin & Milnacipran are the only FDA-approved meds • Treat the whole patient, including co-morbidities • Best non-pharmacologic modalities are Exercise & CBT

49. Coming ? • Sodium Oxybate A.K.A. Xyrem • Currently approved for treatment of narcolepsy & cataplexy • Very effective in Fibromyalgia • In phase 3 trials • More evidence that sleep disturbance plays a large role in fibromyalgia • Am Assoc Pain Mgmt, Oct, 2009 • J

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