Fibromyalgia: What Primary Care Providers Need to Know

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1 Learning Objectives Fibromyalgia: What Primary Care Providers Need to Know Susan Hutchinson, MD Director, Orange County Migraine & Headache Center Volunteer Clinical Faculty, UC Irvine Department of Family Medicine Irvine, CA Evaluate a patient with fibromyalgia complaints using the American College of Rheumatology (ACR) Diagnostic Criteria Construct a comprehensive and effective treatment plan for the patient with fibromyalgia taking into account current FDA approved medications and nonpharmacologic intervention strategies Fibromyalgia: A Controversial Diagnosis The Mystery & Burden of Fibromyalgia Delay in Diagnosis On average, takes 5 years for diagnosis 1 Only 1 out of every 4 patients with fibromyalgia (FM) are diagnosed accurately 1 FM patients visit their HCP s 2 times as much as non-fm prior to diagnosis 2 The Burden of Fibromyalgia FM patients average annual direct healthcare costs $9,573* Indirect costs include the effect on work, relationships, physical, and emotional health FM patients receive an average of 11 prescriptions in the year prior to diagnosis compared to 4.5 in the control group* 1 Arnold LM, et al. Mayo Clin Proc. 2011;86: Berger A, et al. Int J Clin Pract. 2007;61: *Berger A, et al. Int J Clin Pract. 2007;61:

2 Prevalence How Common is Fibromyalgia? Fibromyalgia - one of most common, chronic, widespread pain conditions in US Affects 2%-5% of adult population in US (5-10 million Americans) Prevalence in women 3.4% Prevalence in men.5% Wolfe F, et al. Arthritis Rheum. 1995;38: National Fibromyalgia & Chronic Pain Association. What is Fibromyalgia? Demographics Age of onset years Prevalence increases with age, reaching 7%-8% in women age % patients no precipitating event 50% attribute to physical or emotional trauma or an infection (Lyme disease or often nonspecific viral infections) Patient Video Susanne Goldenberg DL. Clinical Management of Fibromyalgia. 1 st Edition. West Ipslip, NY: Professional Communications, Inc.;2009. Fibromyalgia - General Definition Diagnosis Chronic widespread pain and fatigue Pain is predominately described in muscles Joint swelling does not occur unless other conditions such as RA or OA are present Must be present for at least 3 months History and examination are keys to diagnosis RA, rheumatoid arthritis, OA, osteoarthritis 2

3 Blood Work for Fibromyalgia ESR or CRP CBC Thyroid function In select cases: Liver function tests, CPK, ANA, RF Key Point: ESR or CRP should be normal in FM patient unless another condition co-exists History How and when symptoms began Assess level of disability Ask about mood, sleep, stress Review medications Exercise & lifestyle questions Current treatment including non-pharmacological Common Comorbid Conditions Depression Migraine/Tension headaches Sleep disorders IBS Temporomandibular joint disorder Interstitial cystitis/ chronic prostatitis Idiopathic low back pain Patient Video Susanne ACR 1990 Diagnostic Criteria Chronic widespread pain 3 months Pain is bilateral and both above and below waist At least 11 out of 18 tender points on exam Physical Examination Tender-point examination of the nine pair of tender points used for ACR Criteria of FM Use pressure of 4 kg/cm 2 or enough to whiten examiner s fingernail; apply pressure gradually using finger or thumb; endpoint is pain; compare with joint tenderness Control locations include thumb, mid forearm or forehead (palpate in same fashion; FM patients should not be as tender in these locations) Wolfe F, et al. Arthritis Rheum. 1990;33:

4 Tender-Point Examination 1. Insertion suboccipital muscle 2. Under the lower sternomastoid muscle 3. Mid upper trapezius muscle 4. Second costochrondal junction 5. Origin supraspinatus muscle 6. 2 cm distal lateral epicondyle 7. Upper outer quadrant buttock 8. Prominence of greater trochanter 9. Medial fat pad of knee What Do Tender Points Represent? Heightened pain perception as opposed to areas of tissue damage Dysfunctional sensory processing in the CNS involving both ascending and descending pain pathways has been shown to occur in studies of FM resulting in central amplification of pain signals Patient Video Susanne Alternatives to ACR Tender-Point Examination for Diagnosis CWP 3 months and a patient-completed pain diagram 1 CWP 3 months and Symptom Criteria (at least 4 out of the following 6): 2 1. Generalized fatigue 2. Headaches 3. Sleep disturbance 4. Neuropsychiatric complaints 5. Numbness or tingling sensations 6. Irritable bowel ACR 2010 Preliminary Diagnostic Criteria for Fibromyalgia* Presentation of widespread pain and symptoms for 3 months Calculation of Widespread Pain Index (WPI) by HCP Measurement of Symptom Severity (fatigue, waking unrefreshed, cognitive, and other somatic symptoms) Can be used to diagnose and track progress 1 Katz RS, et al. Arthritis Rheum. 2006;54: Hudson JI, et al. Baillieres Clin Rheumatol. 1994;8: CWP, Chronic Widespread Pain * Accessed June 2,

5 Wolfe F, et al. Arthritis Care Res. 2010;62: Wolfe F, et al. Arthritis Care Res. 2010;62: Wolfe F, et al. Arthritis Care Res. 2010;62: Wolfe F, et al. Arthritis Care Res. 2010;62: Assessment of Symptom Severity Revised Fibromyalgia Impact Questionnaire (FIQR) 1 Modified Visual Analogue Scale of the Fibromyalgia Impact Questionnaire (mvasfiq) 2 Numeric Rating Scales for Symptoms and Function in Fibromyalgia ACR Preliminary Diagnostic Criteria for Fibromyalgia 3 1 Bennett RM, et al. Arthritis Res Therap. 2009;R Boomershine C, et al. Nat Rev Rheum. 2009;5: Wolfe et al. Arthritis Care Res. 2010;62: Bennett RM, et al. Arthritis Res Therap. 2009;R120. 5

6 Boomershine C, et al. Nat Rev Rheum. 2009;5: Diagnosis Summary The American College of Rheumatology (ACR) published classification criteria for Fibromyalgia in 1990 and includes a history of chronic widespread pain for 3 months and the physical finding of at least 11 of 18 tender points. These criteria can be applied to help diagnose FM in a busy primary care setting Diagnosis Summary ACR Provisional Diagnostic Criteria were adopted in 2010 and eliminate the need for tender-point examination for the diagnosis Criteria include calculation of the patient s widespread pain index (WPI) and Symptom Severity Scale Can be used to diagnose and track progress of the FM patient in clinical practice Available on Treatment of FM - 4 Core Principles Treatment 1. Explain the condition 2. Set treatment goals in collaboration with the patient 3. Implement a comprehensive, multimodal treatment approach 4. Track progress (physical, social, emotional/cognitive, work/activity) Arnold LM, et al. Mayo Clin Proc. 2012;87:

7 Explain the Condition Chronic medical condition Cannot be cured, but can be treated Set realistic expectations Patient must be an active participant in his/her care including taking responsibility for lifestyle changes and adhering to a treatment plan Patient Education Tools National Fibromyalgia Association National Fibromyalgia Research Association Fibrocenter Informational brochures and handouts Professional Resources FibroKnowledge Information on diagnosis including both the 1990 and 2010 ACR criteria, treatment, patient resources Treatment Goals Assess impact of FM across multiple domains of a patient s life Focus treatment on areas of most concern to the patient Prioritization and goal-setting critical to avoid being too aggressive, falling short of meeting goals, and frustration for patient and provider Domains Affected by FM* Treatment Team for FM Patient Domain Physical Work/Activity Social Emotional/Cognitive Impact Pain, Fatigue, Disturbed Sleep Loss of career/reduced work hours Reduced activities of daily living Avoidance exercise/physical activity Disrupted family and friend relationships Missed social/family outings Social isolation Depression, Anxiety Cognitive impairment ( fibro pain ) Memory problems Patient Family Primary Care Provider Specialists when appropriate Mid-level professionals Allied health professionals Community resources *Adapted from: Arnold LM, et al. Patient Educ Couns. 2008;73:

8 FDA-approved Medications for Fibromyalgia Pharmacologic Treatment of Fibromyalgia Medication Drug Class Dosing for FM Duloxetine (Cymbalta) SNRI 60 mg qd; start with mg Milnacipran (Savella) SNRI 50 mg bid; start with 12.5 mg/day; increase gradually; max 100 mg bid Pregabalin (Lyrica) Alpha delta ligand mg/day; begin with mg bid; max 450 mg qd Goal of Medication for FM Alleviate symptoms Increase functionality 30%-50% improvement realistic if tolerated Note: The FDA-approved FM medications work on central pain processing pathways Pregabalin Initially approved as adjunctive therapy for partial onset seizures and neuropathic pain Reduces calcium influx at nerve terminals, inhibiting release of neurotransmitters such as glutamate and substance P Most common side effects in clinical trials: somnolence, dizziness, fluid retention, and weight gain Clinical Studies 14-week, DBPC, multicenter study compared total daily doses of 300, 450, and 600 mg pregabalin vs placebo. Significant improvement compared to placebo with 450 and 600 mg; no greater effect on pain score with 600 mg and increase in adverse side effects Randomized 6 month withdrawal study compared pregabalin with placebo; 54% able to titrate to effective and tolerable dose; 38% completed treatment with 26 weeks treatment compared to 19% placebo-controlled patients Arnold LM, et al. J Pain. 2008;9: Crofford LJ, et al. Pain. 2008;136: Duloxetine Serotonin-norepinephrine reuptake inhibitor (SNRI) Two pivotal, 12 week studies of 874 patients with FM showed efficacy over placebo in relieving pain as early as the 1 st week in the study. Duloxetine superior to placebo on the Fibromyalgia Impact Questionnaire (FIQ) total score. Efficacy independent of mood status Most common adverse events: nausea, dry mouth, constipation, decreased appetite, sleepiness, increased sweating and agitation Arnold LM, et al. Pain. 2005;119:5-15. Arnold LM, et al. J Womens Health. 2007;16:

9 SNRI Milnacipran Two pivotal, DBPC multicenter trials in >2000 patients with fibromyalgia showed efficacy of 100 and 200 mg/day of milnacipran compared to placebo. Pain improvement using the visual analogue scale (VAS) and physical improvement using the SF-36 were superior to placebo Most common adverse events: nausea, headache, constipation, hyperhidrosis, dizziness, and hot flushes Combination of Medications Duloxetine and milnacipran should not be used together Both can be used with pregabalin in patients with FM Watch for agitation, insomnia, and nausea with the SNRIs Watch for dizziness, somnolence, dry mouth, edema, and weight gain with pregabalin Mease PJ, et al. J Rheumatol. 2009;36: Clauw DJ, et al. Clin Ther. 2008;30: Non-FDA Approved Medications for FM Management - Some Evidence from Clinical Trials Tricyclics (amitriptyline) Analgesics (tramadol) SSRIs (fluoxetine, paroxetine) SNRIs (venlafaxine) Other CNS-active drugs (gabapentin) Narcotics & Opioids No randomized controlled clinical trials of opioids in FM May cause opioid-induced hyperalgesia and cause an increase in pain perception About 14% of FM patients are being treated with opioids in a survey of US academic medical centers* *Goldenberg D. Clinical Management of Fibromyalgia. 1 st edition. West Ipslip, NY: Professional Communications, Inc.;2009. Most Efficacious in Randomized Clinical Trials Non-Pharmacologic Treatment of Fibromyalgia Exercise Cognitive-behavioral therapy (CBT) Patient Education Combination therapy (physical activity, CBT, education and/or social support) 9

10 Other Non-pharmacological Approaches to FM Management Balneotherapy (medicinal bathing) Acupuncture CAM (homeopathy, mindfulness meditation, massage, transcranial electrical or magnetic stimulation) Strength training Tai-chi Chiropractic Acupuncture Two trials found no significant difference between true and sham acupuncture Sham acupuncture may have some important therapeutic effects, making it difficult to evaluate overall efficacy Assefi NP, et al. Ann Intern Med. 2005;143: Harris RE, et al. J Altern Complement Med. 2005;11: Tracking Progress Use tools for patient assessment Focus on specific goals patient has agreed to, eg, walking 10 minutes a day Look at functional outcomes in the 4 key domain areas Review medication efficacy and side effects Give homework (helps give patient ownership of their FM) Patient Video Susanne Summary Use the ACR Diagnostic Criteria to diagnose fibromyalgia in a primary care setting Ask if pain wide-spread and present for 3 months Examine the patient looking for at least 11 out of 18 tender points on exam (ACR 1990 Diagnostic Criteria) or calculate the patient s Widespread Pain Index and measure the Symptom Severity Scale (ACR Provisional Criteria 2010) Summary Direct patients to evidence-based educational sources on the Internet or in the community to save time and encourage patients to accept responsibility for their condition provide useful educational information 10

11 Summary Incorporate Validated Screening Tools such as the FM Impact Questionnaire (FIQR) to monitor patients progress on follow-up visits Utilize a combination of pharmacologic and nonpharmacologic approaches in treatment plan Refer to to stay up-to-date Thank you! 11