FIBROMYALGIA in Primary Care

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FIBROMYALGIAin Primary Care

• B. WAYNE BLOUNT, MD, MPH
• PROFESSOR,
• EMORY S.O.M.

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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

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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

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What is Fibromyalgia?

• A clinical syndrome of widespread muscle pain
• Chronic,
• Non-inflammatory, with
• Fatigue
• Tender points

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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

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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

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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

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SIGNS SYMPTOMS

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

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SIGNS SYMPTOMS

• Depression
• Reduced physical endurance
• Decreased social interaction
• Cognitive fog
• Subjective, non-confirmable
• Paresthesias
• Swollen joints
• All sx may wax wane

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Most Common Complaints

• 1 Sleep problems
• 2 Fatigue
• 3 Cognitive dysfunction
• 4 Pain
• Fibromyalgia is much more than a pain disorder
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What causes FM?

• Cause is unknown and is probably multifactorial
  and may be different in different patients

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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

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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 brains
  pain centers

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What causes FM?

• Familial tendency to develop FMS suggests genetic
  role
• 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
• 
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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

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How is FM diagnosed?

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

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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 18 tender point sites on
  digital palpation

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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.

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Differential

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

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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

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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)

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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

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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

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LABS to Get

• ESR
• CBC
• TSH
• If any abnormality,
• work it up. Probably not fibromyalgia

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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

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From Mechanism to Treatment

• 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

• Central neural factors play a critical role
• This is a polygenic disorder
• There is a deficiency of noradrenergic-serotonerg
  ic 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

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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

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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

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• No evidence
• opioids, NSAIDS, benzodiazepene
• and nonbenzodiazepene
• hypnotics, melatonin, magnesium,
• DHEA, thyroid hormone, OTCs

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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

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What about a dopamine agonist?

• Pramipexole, in 1 study, did show significant
  improvement in several parameters, but
• Again Significant side effects

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Only 3 Meds are FDA Approved for FM

• Duloxetine (Cymbalta)
• Pregabalin (Lyrica)
• Milnacipran (Savella)

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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)
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Nonpharmacologic Strategies

Modest Evidence Strength training Acupuncture Hypn
otherapy EMG biofeedback Balneotherapy
Weak Evidence Chiropractic Manual and massage
therapy Ultrasound

• No Evidence
• Tender-point injections
• Flexibility exercise

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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 management
  experts

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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

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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.

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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

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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
.
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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
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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

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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

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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

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Patient Follow-up

• Routine, regular follow-up
• Monitor patients progress
• Assess
• Pain
• Sleep
• Daily functioning
• Global well-being
• Mood disorders
• Can use the FIQ

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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
• 
  

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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
• 
  
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Bibliography

• Wolfe F et al. The American College of
  Rheumatology 1990 criteria for the classification
  of fibromyalgia. Report of the Multicenter
  Criteria Committee. Arthritis Rheum
  199033160-72
• Okifuji A et al. A standardized manula tender
  point survey. 1. Development determination of a
  threshold point for the identification of
  positive tender points in fibromyalgia syndrome.
  J Rheum 199724377-83.
• www.fmnetnews.com
• Chakrabarty S Zoorob R. Fibromyalgia. Am Fam
  Physician 200776247-54

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Bibliography

• Cochrane Database www.cochrane.org/reviews/en/
• www.medscape.com/viewarticle/707578
• Rooks DS. Fibromyalgia Treatment Update. Curr
  opin Rheumatol. 200719111-7.
• Carville SF et al. EULAR evidence based
  recommendations for the management of
  fibromyalgia syndrome. Ann Rheum Dis.
  200867536-41.

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Tricylics in Fibromyalgia

• AMITRIPTYLINE
• Four placebo-controlled trials
• Goldenberg,1985
• Carette,1986
• Carette,1994
• Dose 25 50 mg
• Duration 6-26 weeks
• All showed modest efficacy

• CYCLOBENZAPRINE
• Four placebo-controlled trials
• Quimby, 1989
• Carette, 1994
• Reynolds,1991
• Dose 10 40 mg
• Duration 4 12 weeks
• 2 showed efficacy

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Pregabalin in Fibromyalgia
Patient Global Impression of Change
p lt 0.01 vs PBO
p lt 0.01 vs PBO
Patients
Treatment Group (mg/day)
Crofford L, et al. Arth Rheum 2005 52 1264-1273
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Milnacipran
Number 1196 PL controlled, double blind,
Randomized Pain composite VAS - 30 very
much or much impr on PGIC FM composite pain
composite 6 pt impr on PCS of SF36 Secondary
PGIC, SF36 (PCS and MCS) and FIQ total Baseline
observation carried forward (BOCF) at 3 mnths
39,46 achieved Pain composite, v 25 PL
(0.011, 0.015) 25,26 achieved FM composite, v
13 PL (0.025, 0.004) Generally well tolerated
(discontinuations 34,35 v 28 PL) Common AEs
nausea M 37, PL -20 (both studies)
headache M 18, PL -14
constipation M 16, PL -4
hyperhidrosis M 9, PL - 2 NB no sig
hypertension or wt gain
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Past Fibromyalgia Controversies

• Is it real?
• Can it be reliably diagnosed?
• Is it physical or psychological?
• Is a diagnosis helpful or harmful?

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Controversies ?

• Its not a real illness, its in the
• patients head
• FALSE
• A real condition with severe physical effects in
  some, although psychologic factors including
  depression may be the major determinant of pain
  in others

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Controversies ?

• The prognosis is hopeless
• FALSE
• Early, aggressive treatment can prevent physical
  deconditioning and loss of function

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Fibromyalgia Controversies

• Does the diagnostic label promote helplessness
  and disability?
• Only one controlled study it didnt
• Diagnosis should be reassuring and end doctor
  shopping
• Only if diagnosis is coupled with education

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Fibromyalgia Controversies

• Does the diagnosis promote litigation?
• Not because of the diagnosis but rather
  medico-legal misconceptions
• This can lead to symptom amplification and
  rehabilitation difficulties
• Problems with causation
• Use headache or fatigue models

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Total Rate of Diagnostic Tests Performed on FM
Cases and on Matched Controls (N2,260)
Positive Impact of Fibromyalgia Diagnosis in
Clinical Practice
200
95 CI
Case
Control
150
100
Rate per 100 person-years
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The vertical line at 0 indicates the date of
fibromyalgia diagnosis
0
-5
0
5
-10
Years relative to index date
Decrease in diagnostic testing and visit rates
following diagnosis
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Is Fibromyalgia a Medical or Psychiatric Illness?

• Harmful and unproductive argument
• Fruitless quandary to work out what came first
• For all patients, symptoms are real and can be
  disabling
• Need a dual treatment approach targeting both
  physical and psychological symptoms

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FM and Mood Disorders

• At the time of FM diagnosis, mood disorders are
  present in 30-50, primarily depression.
• Increased prevalence of mood disorders is
  primarily in tertiary-referral patients.
• Increased lifetime and family history of mood
  disorders in FM vs RA (Odds 2.0).
• Fibromyalgia co-aggregates with major mood
  disorder in families (OR 1.8 95 CI 1.1, 2.9),
  p0.01).

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Pain is Processed in at Least Three Domains in
CNS

• Sensory - Where it is and how much it hurts
• Primary and secondary somatosensory cortices
• Thalamus
• Posterior insula
• Affective Emotional valence of pain
• Anterior cingulate cortex
• Anterior insula
• Amygdala
• Cognitive Similar to affective plus pre-frontal
  regions