Fibromyalgia in Family Medicine: Challenges in Pain Management

Transcription

1 Fibromyalgia in Family Medicine: Challenges in Pain Management

2 Evidence-based Recommendations The practice recommendations in this presentation are from: The European League Against Rheumatism (EULAR) Source: Carville S, et al. EULAR evidence-based recommendations for the management of fibromyalgia syndrome. Ann Rheum Dis 2008;67: Web Site: Strength of Evidence: The strength of evidence is indicated following each recommendation.

3 Evidence-based Recommendations The American Pain Society Source: American Pain Society Practice Guidelines Series No. 4: Guidelines for the management of fibromyalgia syndrome pain in adults and children Web Site: Strength of Evidence: The strength of evidence is indicated following each recommendation.

4 Evidence-based Recommendations The Ottawa Panel Source: Brosseau L, et al. Ottawa panel evidence-based clinical practice guidelines for aerobic fitness exercises in the management of fibromyalgia: Parts 1 and 2. Physical Therapy 2008;88(7): and Web Site: and Strength of Evidence: The strength of evidence is indicated following each recommendation.

5 Evidence-based Recommendations German Interdisciplinary Association of Pain Therapy Source: Hauser W, et al. Management of fibromyalgia syndrome -- An interdisciplinary evidence-based guidelines. German Medical Science 2008;16: Web Site: Strength of Evidence: The strength of evidence is indicated following each recommendation.

6 Challenges in Fibromyalgia: Diagnosis and Attitudes Module 1

7 Fibromyalgia Epidemiology Worldwide prevalence 2% North America 2% South America 2% Europe 0.05% China Rheumatologic disease is generally less frequent in China Women affected 3x more often than men Peak prevalence years old Source: Marcus DA. Gender Medicine 2009;6:

8 percentage response Polling Question Results Question: There is a lot of controversy as to whether fibromyalgia is a real diagnosis Rate on a scale of 1 to 4: 1. Strongly disagree 2. Disagree 3. Agree 4. Strongly agree 56% agreed or strongly agreed

9 percentage response Polling Question Results (contd) Question: I find it challenging to accurately diagnose fibromyalgia Rate on a scale of 1 to 4: 1. Strongly disagree 2. Disagree 3. Agree 4. Strongly agree 62.5% agreed or strongly agreed

10 American College of Rheumatology Diagnostic Criteria for Fibromyalgia Low cervical Second rib Lateral epicondyte Knee Occiput Trapezius Supraspinatus Gluteal Greater trochanter 1. Widespread pain Involving both sides of the body Above and below the waist Present for at least three months 2. Tender points Tenderness at 11 of 18 defined tender points Diagram adapted from Wolfe F, et al. Arthritis Rheum 1990;33:

11 Fibromyalgia: Additional Diagnostic Clues Associated features Fatigue Sleep disorders Memory problems Comorbid conditions Anxiety and depressive disorders Irritable bowel syndrome Migraine headaches Localized pain syndromes Noncardiac chest pain Irritable bladder Temporomandibular dysfunction Restless legs Chakrabarty S, et al. Am Fam Physician 2007;76:

12 Pain Intensity Augmented Pain Response 14 Functional MRI study Fibromyalgia Patients with fibromyalgia have 13 areas of greater cortical or subcortical brain activation with similar pain stimulus compared to controls. 2 Subjective Pain Control Stimulus Pressure Control Stimulus Intensity (kg/cm 2 ) Graph adapted from Gracely RH, et al. Arthritis Rheum 2002;46:

13 Summary Points Fibromyalgia is a real diagnosis Heightened sense of pain with neurological changes Suspect fibromyalgia in patients with Widespread pain Fatigue / sleep disturbance Confirm diagnosis with tender-point exam

14 Evidence-based Recommendation Recommendation #1: Base the clinical diagnosis of fibromyalgia on the presence of widespread pain, defined as pain in all 4 body quadrants and axial pain, for at least 3 consecutive months. The only physical examination criterion for diagnosis is the presence of excess tenderness of at least 11 of 18 muscle-tendon sites obtained on manual tender point examination. (B) American Pain Society, 2005.

15 Pharmacologic Management of Pain Associated with Fibromyalgia Module 2

16 Evidence-based Treatments: Nonpharmacologic & Pharmacologic Therapies American Pain Society European League Against Rheumatism (EULAR) German Interdisciplinary Association of Pain Therapy Aerobic exercise (A) Cognitive behavioral therapy (A) Amitriptyline* (A) Cyclobenzaprine* (A) Tramadol* (B) Heated pool (B) Aerobic exercise (C) Strength training (C) Cognitive behavioral therapy (D) Tramadol*(A) Antidepressants (A) Pregabalin (A) Aerobic exercise (A) Cognitive behavioral therapy plus relaxation (A) Antidepressants (A) Tramadol* (C) *Off-label use; not FDA approved for fibromyalgia. Strength of evidence in parentheses

17 Pathogenesis of Fibromyalgia Muscle metabolism Increased nitric oxide Low phosphorylation potential Low oxidative capacity Deficits in fast Type II muscle fibers Neural changes Increased NMDA receptors (wind-up) Upregulation delta- and κappa-opioid receptors Decreased serotonin Increased substance P Hormonal deficits Growth hormone Thyroid hormone Genetic influence HLA-DR4 antigen Serotonin transporter Catechol-O-methyltransferase D2 and D4 receptors Substance P receptor NK1 Inflammation Increased interleukins

18 Analgesics for Fibromyalgia Analgesics offer minimal benefit for fibromyalgia In controlled studies, similar to placebo 1 Tramadol, 37.5 mg, plus acetaminophen, 325 mg, moderately improves pain, function and quality of life 2,3 Opioids generally not recommended because not effective for fibromyalgia pain 1 Lautenschläger J. Scand J Rheumatol 2000;29 (suppl 113): Bennett RM, et al. Am J Med 2003;114: Bennett RM, et al. Arthritis Rheum 2005;53:

19 Medication Recommendations for Fibromyalgia 1 st tier 2 nd tier 3 rd tier SNRIs Duloxetine Milnacipran Pregabalin Sodium oxybate* Tricyclics Amitriptyline* Gabapentin* Tramadol* + APAP SSRIs Fluoxetine* Paroxetine* APAP=acetaminophen; SNRI=serotonin norepinephrine reuptake inhibitor; SSRI=selective serotonin reuptake inhibitor * Off-label use; not FDA approved for fibromyalgia. Source: Marcus DA. Fibromyalgia: A Primary Care Guide to Practical Management. Springer, 2010.

20 Comparison of First-Tier Drugs: Efficacy Effect Size Outcome Duloxetine Milnacipran Pregabalin Magnitude of Effect Pain -0.33* -0.19* -0.27* Fatigue * -0.16* Not substantial Sleep -0.31* * Mood -0.27* -0.11* 0.01 QOL -0.25* -0.17* -0.25* NNT *Statistically significant, P<0.01 NNT=Number needed to treat for a 30% pain reduction Small > Medium > Large >0.8 Pain & sleep: DUL, PGB Depression: DUL Fatigue: MLN, PGB Source: Häuser W. J Pain 2010 (in press).

21 Comparison of First-Tier Drugs: Side Effects (%) Side effect Duloxetine Milnacipran Pregabalin Headache Nausea Dry mouth Insomnia NR Dizziness Somnolence 9.6 NR 20.5 Fatigue 14.5 NR 7.7 Weight gain NR NR 11.1 NNH* *NNH=Number needed to harm; NR=not recorded Source: Häuser W. J Pain 2010 (in press).

22 Establish Realistic Target Goals and Expectations Effective medications are expected to reduce pain by about 30% Clinically meaningful pain relief is defined as reduction in pain by 30% or 2 points on a 0-10 point severity scale 1 Drugs are part of a comprehensive treatment program Before treatment initiation, establish specific functional and symptom relief goals 1 Rowbotham MC. Pain 2001;94:

23 Realistic vs. Unrealistic Goals Target Unrealistic goals Realistic goals Pain Cure pain Reduce pain by 25-30% Functional disability Mood disturbance Sleep disturbance Work full-time, manage household and attend all kids soccer games Always be happy and calm Sleep 8 hours every night with no interruptions Increase household, work, and social activities by 50% Reduce interference from mood disturbance Improve sleep initiation and duration

24 Patient Form to Identify Comorbid Treatment Target Problem Not a problem Problem occurs but does NOT limit daily routine Problem limits daily routine Fatigue Sleep disturbance Frequent constipation Frequent diarrhea Depressed or blue mood Anxiety or nervousness Headache Source: Marcus DA. Chronic Pain: A Primary Care Guide to Practical Management. Humana Press, 2009.

25 When to Seek Consultation Pain specialist or rheumatologist Psychologist or psychiatrist Occupational therapist Unable to establish diagnosis Behavioral therapy Pacing problems Disabling symptoms despite treatment Severe anxiety or Work issues depression Inadequate response Suicidal ideation Persistent Complex work or psychosocial issues Medication misuse/abuse Staff burnout Personality disorder disability for activities of daily living

26 Summary Points Medications provide modest symptom reduction SNRIs Pregabalin A comprehensive treatment plan also includes nonpharmacologic therapies Seek consultation for challenging or recalcitrant cases

27 Case Studies: Best Practices in Fibromyalgia Pain Management Case 1

28 Case 1: 42-Year-Old Woman Presents to office complaining of pain in arms and legs Ongoing for last 1-2 years, worse over past few months No paresthesias Pain associated with generalized fatigue and poor sleep Previously diagnosed with chronic pain Treated with opioids by previous physician She would like to increase opioid dose for better pain control and improved sleep

29 Case 1 (contd) PMH: Irritable bowel syndrome Medications: Oxycodone/acetaminophen (5 mg/325 mg) three times a day PE: Unremarkable except for point tenderness No joint swelling or tenderness No rash

30 Case 1: Next Steps She starts duloxetine (30 mg once a day) and stops oxycodone/acetaminophen Return in one week to review her medications. She reported that her sleep is somewhat improved but that she still has significant pain She doesn t think the treatment is working and asks to be back on her opioid medication

31 Monitoring Response to Treatment Validated self-administered questionnaires Fibromyalgia Impact Questionnaire (FIQ) J Rheumatol 1991;18: Fibromyalgia Assessment Status (FAS) Arthritis Res Ther 2009;11(4):R125.

32 Stepwise Fibromyalgia Management Step 1 Confirm the diagnosis Identify important symptom domains and their impact on functional status Pain, sleep disturbance, fatigue Evaluate and treat comorbid illness Sleep apnea, osteoarthritis, depressive or anxiety disorders Assess psychosocial stressors, level of fitness and barriers to treatment Provide education about fibromyalgia (individual or group) Adapted from Arnold LM. Arthritis Res Ther 2006;8:212.

33 Stepwise Fibromyalgia Management Step 2 Recommend treatment based on individual assessment For patients with moderate to severe pain, trial with medication: With or without lifetime depression or anxiety: Trial of SSRI or SNRI Prominent sleep disorder or anxiety: Trial of neuromodulating antiepileptic Partial response to monotherapy with either SNRI or neuromodulating antiepileptic: Trial of combination of these agents Provide any additional treatment for comorbid conditions Adapted from Arnold LM. Arthritis Res Ther 2006;8:212.

34 Stepwise Fibromyalgia Management Step 3 Select nonpharmacologic therapy Adjunctive cognitive behavior therapy for patients with prominent psychosocial stressors, or difficulty coping or functioning Exercise prescribed according to fitness level (goal of minutes of low-to-moderate intensity aerobic exercise, such as walking, pool exercises, stationary bike, at least 2-3 times a week) Encourage participation in supervised or group exercise Adapted from Arnold LM. Arthritis Res Ther 2006;8:212.

35 Case 2: 65-year-old woman PMH: Significant for fibromyalgia and depression Current medications: Cyclobenzaprine, 15 mg QHS Fluoxetine, 20 mg daily Advised to stop cyclobenzaprine by gastroenterologist due to worsening reflux and gastritis

36 Case 2 (contd) Cyclobenzaprine is stopped and pregabalin (50 mg TID) is added for pain control She returns in 2 months with improved pain. However, she s concerned about a 5-pound weight gain. Current medications: Fluoxetine (20 mg daily) Pregabalin (50 mg TID)

37 Summary Points Antidepressants and neuromodulating antiepileptics can be effective in treating pain associated with fibromyalgia and improving function Analgesics are not generally useful Stepwise approach: Start with medication that targets individualized complaints Increase dose of single agent before changing drug or considering combination therapy Nonpharmacologic therapies Work with patients to establish reasonable expectations for functional targets

38 Evidence-based Recommendations Recommendation #2: Tramadol is recommended for the treatment of pain in fibromyalgia. (A) Recommendation #3: Simple analgesics such as acetaminophen and other weak opioids can also be considered in the treatment of fibromyalgia. Corticosteroids and strong opioids are not recommended. (D) European League Against Rheumatism, 2008.

39 Evidence-based Recommendations Recommendation #4: Antidepressants such as amitriptyline, fluoxetine, duloxetine and milnacipran reduce pain and often improve function; therefore, they are recommended for the treatment of fibromyalgia. (A) Recommendation #5: Pregabalin reduces pain and is recommended for the treatment of fibromyalgia. (A) European League Against Rheumatism, 2008.

40 Multimodal Management of Pain Associated with Fibromyalgia Module 4

41 Non-drug Treatments for Fibromyalgia Effective Modestly effective Ineffective Exercise Yoga Acupuncture Education Relaxation Psychological skills Lifestyle modification Marcus DA. Fibromyalgia: A Primary Care Guide to Practical Management. Springer, 2010.

42 Ottawa Panel Exercise Recommendations Exercise Duration and frequency Significant benefits Aerobics Pool or land exercise Strengthening 60 minutes 3 times weekly 60 minutes 2 times weekly Pain Quality of life Endurance/function Pain Quality of life Muscle strength Mood More beneficial than flexibility training Bosseau L, et al. Physical Therapy 2008;88(7): and

43 Cognitive Behavioral Therapy Replace maladaptive thoughts and behaviors with adaptive behaviors and coping strategies BEFORE: This pain will never get better. I m doomed to spend the day in bed! AFTER: I need to pace my activities better and add in some extra flare management techniques when my pain increases.

44 Operant Behavioral Therapy Reduce positive reward for negative behavior Stop expressing pain, grimacing, moaning Teach significant others to avoid being overly solicitous Take medications on time-contingent basis rather than in response to pain

45 Comorbid Psychological Conditions in Fibromyalgia Mood disorders are often comorbid with fibromyalgia Mood disorders can interfere with treatment participation, compliance and efficacy Source: Arnold LM. Pain Med 2007;8:

46 Depression Screener Patients rate each statement, based on how they have felt over the last 2-3 days Adapted from the I find myself stewing over things I feel more vulnerable than usual I am critical of or hard on myself I feel guilty Nothing seems to cheer me up I feel like I have lost my core or essence I feel depressed Not true Slightly true Moderately true Very true Score = 0 Score = 1 Score = 2 Score = 3 Depression in Medically Ill screen I feel less worthwhile I feel hopeless or helpless I feel distant from other people Scoring: Sum scores from each question. A total score of 5 9 suggest mild anxiety, while a score >10 suggest moderate to severe anxiety Source: Marcus DA. Chronic Pain. A Primary Care Guide to Practical Management. Humana Press, 2009.

47 Anxiety Screener Patients rate how often they have been bothered by each item over the previous 2 weeks Adapted from the General Anxiety Disorder-7 screen Feeling nervous, anxious, or on edge Unable to stop worrying Worrying too much about different things Problems relaxing Feeling restless or unable to sit still Feeling irritable or easily annoyed Being afraid that something awful might happen Not true Several 7 or more Nearly every day Score = 0 Score = 1 Score = 2 Score = 3 Scoring: Sum scores from each question. A total score >9 suggests depression Source: Marcus DA. Chronic Pain. A Primary Care Guide to Practical Management. Humana Press, 2009.

48 Delivering Nonpharmacologic Therapy Treatment Providers Education about fibromyalgia and Physician, nurse, other extenders role of non-drug treatments Aerobic and strengthening exercise Physician, nurse, physical therapist Cognitive and operant behavioral therapies Lifestyle modification Nurse, physical therapist, behavioral psychologist Nurse, dietitian, occupational Use support staff to complement your skills and when treating patients with more severe disability. therapist, behavioral psychologist

49 Understanding the Diagnosis Fibromyalgia is a real condition Not curable but highly treatable Not a degenerative condition

50 Evidence-based Recommendations Recommendation #6: Provide all patients with basic information on fibromyalgia and treatment options, and educate them about pain management and self-management programs as an initial part of treatment. (A) Recommendation #7: Incorporate cognitive behavioral therapy into a multimodal treatment approach to reduce pain, enhance self-efficacy and improve function. (A) American Pain Society, 2005.

51 Evidence-based Recommendations Recommendation #8: Encourage and support people with fibromyalgia to perform moderately intense aerobic exercise two to three times per week. (A) Recommendation #9: Encourage people with fibromyalgia to perform muscle-strengthening exercise two times per week. (B) Recommendation #10: Offer clinician-assisted treatments, such as therapeutic massage, which may be helpful for pain relief. (B) American Pain Society, 2005.

52 Understanding the Diagnosis Fibromyalgia is a real condition Not curable but highly treatable Not a degenerative condition