Fibromyalgia : What Primary Care Providers Need to Know Learning - - PDF document

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Fibromyalgia : What Primary Care Providers Need to Know Learning - - PDF document

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Fibromyalgia : What Primary Care Providers Need to Know Learning Objectives Evaluate a patient with fibromyalgia complaints using the American College of Rheumatology (ACR) Fibrom yalgia: Diagnostic Criteria W hat Prim ary Care Providers

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Fibromyalgia: What Primary Care Providers Need to Know

1 Fibrom yalgia:

W hat Prim ary Care Providers Need to Know

Susan Hutchinson, MD

Director, Orange County Migraine & Headache Center Volunteer Clinical Faculty, UC I rvine Department of Family Medicine I rvine, CA

Learning Objectives

  • 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 non- pharmacologic intervention strategies

Fibrom yalgia: A Controversial Diagnosis

The Mystery & Burden

  • f Fibrom yalgia

Delay in Diagnosis

  • On average, takes 5 years for diagnosis1
  • Only 1 out of every 4 patients with fibromyalgia (FM)

are diagnosed accurately1

  • FM patients visit their HCP’s 2 times as much as

non-FM prior to diagnosis2

1 Arnold LM, et al. Mayo Clin Proc. 2011;86:457-464. 2 Berger A, et al. Int J Clin Pract. 2007;61:1498-1508.

The Burden of Fibrom yalgia

  • 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*

*Berger A, et al. Int J Clin Pract. 2007;61:1498-1508.

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Fibromyalgia: What Primary Care Providers Need to Know

2 How Com m on is Fibrom yalgia?

Prevalence

  • 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;38:19-28. National Fibromyalgia & Chronic Pain Association. What is Fibromyalgia? http://www.fmcpaware.org/fibromyalgia/prevalence.html

Dem ographics

  • Age of onset 35-55 years
  • Prevalence increases with age, reaching 7%-8% in

women age 60-80

  • 50% patients no precipitating event
  • 50% attribute to physical or emotional trauma or an

infection (Lyme disease or often nonspecific viral infections)

Goldenberg DL. Clinical Management of Fibromyalgia. 1st Edition. West Ipslip, NY: Professional Communications, Inc.;2009.

Patient Video Susanne

Diagnosis

Fibrom yalgia - General Definition

  • 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

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Fibromyalgia: What Primary Care Providers Need to Know

3

Blood W ork for Fibrom yalgia

  • 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

Com m on Com orbid Conditions

  • Depression
  • Migraine/Tension

headaches

  • Sleep disorders
  • IBS
  • Temporomandibular

joint disorder

  • Interstitial cystitis/

chronic prostatitis

  • Idiopathic low

back pain

Patient Video Susanne

ACR 1 9 9 0 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

Wolfe F, et al. Arthritis Rheum. 1990;33:160-172.

Physical Exam ination

  • Tender-point examination of the nine pair of tender points used

for ACR Criteria of FM

  • Use pressure of 4 kg/cm2or 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)

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Fibromyalgia: What Primary Care Providers Need to Know

4

Tender-Point Exam ination

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

W hat 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 Exam ination for Diagnosis

  • CWP ≥3 months and a patient-completed pain diagram1
  • 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

1 Katz RS, et al. Arthritis Rheum. 2006;54:169-176. 2 Hudson JI, et al. Baillieres Clin Rheumatol. 1994;8:839-856.

CWP, Chronic Widespread Pain

ACR 2 0 1 0 Prelim inary Diagnostic Criteria for Fibrom yalgia*

  • 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

*www.FibroKnowledge.com. Accessed June 2, 2015.

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Fibromyalgia: What Primary Care Providers Need to Know

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Wolfe F, et al. Arthritis Care Res. 2010;62:600-610. Wolfe F, et al. Arthritis Care Res. 2010;62:600-610. Wolfe F, et al. Arthritis Care Res. 2010;62:600-610. Wolfe F, et al. Arthritis Care Res. 2010;62:600-610.

Assessm ent of Sym ptom 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 Fibromyalgia3

1 Bennett RM, et al. Arthritis Res Therap. 2009;R120. 2 Boomershine C, et al. Nat Rev Rheum. 2009;5:191-199. 3 Wolfe et al. Arthritis Care Res. 2010;62:600-610.

Bennett RM, et al. Arthritis Res Therap. 2009;R120.

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Fibromyalgia: What Primary Care Providers Need to Know

6

Boomershine C, et al. Nat Rev Rheum. 2009;5:191-199.

Diagnosis Sum m ary

  • 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 Sum m ary

  • 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 www.FibroKnowledge.com

Treatm ent

Treatm ent of FM - 4 Core Principles

  • 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;87:488-496.

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Fibromyalgia: What Primary Care Providers Need to Know

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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
  • www.fmaware.org
  • National Fibromyalgia Research Association
  • www.nfra.net
  • Fibrocenter
  • www.fibrocenter.com
  • Informational brochures and handouts

Professional Resources

  • FibroKnowledge
  • www.FibroKnowledge.com
  • Information on diagnosis including both the 1990 and 2010

ACR criteria, treatment, patient resources

Treatm ent 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

Dom ains Affected by FM*

Domain Impact

Physical Pain, Fatigue, Disturbed Sleep Work/Activity Loss of career/reduced work hours Reduced activities of daily living Avoidance exercise/physical activity Social Disrupted family and friend relationships Missed social/family outings Social isolation Emotional/Cognitive Depression, Anxiety Cognitive impairment (“fibro pain”) Memory problems

*Adapted from: Arnold LM, et al. Patient Educ Couns. 2008;73:114-120.

Treatm ent Team for FM Patient

  • Patient
  • Family
  • Primary Care Provider
  • Specialists when appropriate
  • Mid-level professionals
  • Allied health professionals
  • Community resources
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Fibromyalgia: What Primary Care Providers Need to Know

8 Pharm acologic Treatm ent

  • f Fibrom yalgia

FDA-approved Medications for Fibrom yalgia

Medication Drug Class Dosing for FM

Duloxetine (Cymbalta) SNRI 60 mg qd; start with 20‐30 mg Milnacipran (Savella) SNRI 50 mg bid; start with 12.5 mg/day; increase gradually; max 100 mg bid Pregabalin (Lyrica) Alpha‐delta ligand 300‐450 mg/day; begin with 50‐75 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;9:792-805. Crofford LJ, et al. Pain. 2008;136:419-431.

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 1st 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;16:1145-1156.

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Fibromyalgia: What Primary Care Providers Need to Know

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Milnacipran

  • SNRI
  • 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

Mease PJ, et al. J Rheumatol. 2009;36:398-409. Clauw DJ, et al. Clin Ther. 2008;30:1988-2004.

Com bination 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 Non-FDA Approved Medications for FM Managem ent - Som e 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
  • pioids in a survey of US academic medical centers*

*Goldenberg D. Clinical Management of Fibromyalgia. 1st edition. West Ipslip, NY: Professional Communications, Inc.;2009.

Non-Pharm acologic Treatm ent of Fibrom yalgia

Most Efficacious in Random ized Clinical Trials

  • Exercise
  • Cognitive-behavioral therapy (CBT)
  • Patient Education
  • Combination therapy (physical activity, CBT, education

and/or social support)

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Fibromyalgia: What Primary Care Providers Need to Know

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Other Non-pharm acological Approaches to FM Managem ent

  • 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

  • verall efficacy

Assefi NP, et al. Ann Intern Med. 2005;143:10-19. Harris RE, et al. J Altern Complement Med. 2005;11:663-671.

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

Sum m ary

  • 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)

  • r calculate the patient’s Widespread Pain Index and

measure the Symptom Severity Scale (ACR Provisional Criteria 2010)

Sum m ary

  • Direct patients to evidence-based educational sources
  • n the Internet or in the community to save time and

encourage patients to accept responsibility for their condition

  • www.fmaware.org; www.nfra.net; www.Fibrocenter.com

provide useful educational information

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Fibromyalgia: What Primary Care Providers Need to Know

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Sum m ary

  • 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 non-

pharmacologic approaches in treatment plan

  • Refer to www.fibroknowledge.com to stay up-to-date

Thank you!