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FibromyalgiaWRAP Principles and Practice Strategies for Fibromyalgia. Fibromyalgia Controversies. Is it real? What is the relationship with other functional somatic syndromes? Can it be reliably diagnosed? Is it physical or psychological? Is there any effective treatment?

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fibromyalgia controversies
Fibromyalgia Controversies
  • Is it real?
  • What is the relationship with other functional somatic syndromes?
  • Can it be reliably diagnosed?
  • Is it physical or psychological?
  • Is there any effective treatment?
  • Is a diagnosis helpful or harmful?
  • What is role of rheumatology?
primary care and functional illnesses
Primary Care and Functional Illnesses
  • Account for 30-50% of office visits
  • Medical classification: FM, IBS, irritable bladder, vulvodynia, non-cardiac chest pain, TMJ, multiple chemical sensitivity, tension headaches
  • Psychiatric classification: Somatization disorder, hypochondriasis, conversion disorder, PTSD
  • Commonest primary care problem
  • Specialty referral based on most distressing syndrome
chronic pain suffering syndromes
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
  • There are many different “labels” that one can legitimately use for an individual with this type of pain (if one decides to use any label)
    • There is no agreed upon, all encompassing term to describe this entire spectrum of illness
    • No medical specialty has accepted “ownership” of these patients
american college of rheumatology acr diagnostic criteria for fm
American College of Rheumatology (ACR) Diagnostic Criteria for FM
  • 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%)
fm diagnosis is very physician dependent
FM Diagnosis is Very “Physician Dependent”

History of chronic, widespread pain for ≥3 months

History of chronic, widespread pain for ≥3 months

Rule out other conditions that may present with chronic widespread pain

Depending on physician: Mental health evaluation, sleep evaluation

Rule out other conditions that may present with chronic widespread pain (“Operator dependent”)

General physical exam, neurologic exam, selected laboratory testing (ESR, thyroid tests; avoid screening serologic tests)

General physical exam, neurologic exam, selected laboratory testing (ESR, thyroid tests; avoid screening serologic tests)

Confirm presence of tender points

(Fibromyalgia may be present, even if <11 of 18)

Confirm presence of tender points

(Fibromyalgia may be present, even if <11 of 18)

Confirm diagnosis of fibromyalgia

Confirm diagnosis of fibromyalgia

  • 6

Modified from Goldenberg JAMA 2004

problems in defining fibromyalgia
Problems in Defining Fibromyalgia
  • “Real” if no clear pathophysiologic basis?
  • Gold standard is “expert opinion”
  • Tender points, symptoms are subjective
  • Fewer than 11 tender points?
  • Symptoms are not dichotomous
  • Same diagnostic criteria and dilemma for any illness lacking objective biologic markers (depression, migraine, IBS, CFS)
earlier diagnosis of fibromyalgia
Earlier Diagnosis of Fibromyalgia
  • Long delay in diagnosis adversely affects outcome
  • Characteristic symptoms speed diagnosis:
    • “I hurt all over”
    • “It feels like I always have the flu”
    • Fatigue, Sleep and Mood disturbances
    • IBS, Irritable bladder, multiple other somatic complaints
  • Exclusion of structural or systemic disease
    • Not a “fishing” expedition
    • Avoid “screening” rheumatology tests
    • Early subspecialty referral
structured interview for fibromyalgia
Structured Interview for Fibromyalgia

A. Widespread pain (axial + upper and lower + L and R sides)

A. Generalized, chronic pain (≥ 3 months) affecting the axial, plus upper and lower segments, plus left and right sides of the body

C. At least 4 of the following symptoms

1. Generalized fatigue

2. Headaches

3. Sleep disturbance

4. Neuropsychiatric complaints

5. Numbness, tingling sensations

6. Irritable bowel symptoms

C. At least 4 of: generalized fatigue, headache, sleep disturbance, neuropsych complaints, numbness/tingling, IBS

B. 11 of 18 reproducible tender points


Explained by no other condition


Pope HG Jr, Hudson JI. Int J Psychiatry Med 1991;21(3):205-232


Why Do A Tender Point Exam?

  • Confirm Dx impression
  • Proxy for pain sensitivity
  • Compare to joint tenderness
  • Potential prognostic factor
who gets fibromyalgia
Who Gets Fibromyalgia?

No concurrent medical illness

Any age, but peak age 40-60

60-90% female in clinic, although less gender difference in population-based studies

Concurrent medical illness (e.g., SLE, RA, OA, hypothyroidism, hepatitis). Important to consider in patients with rheumatic or chronic pain disorders

Prior medical illness (e.g., Lyme disease, viral illness)

Medications (steroid taper)

medically unexplained illnesses concurrent with fibromyalgia
Medically Unexplained Illnesses Concurrent With Fibromyalgia

Chronic fatigue syndrome

Irritable bowel syndrome

Muscle, migraine headaches

Irritable bladder syndrome

Mood disturbances


Temporomandibular joint (TMJ) disorder

  • IN EACH OF THESE: Diagnosis dependent on:
  • Exclusion of disease
  • Symptoms rather than signs
  • No reproducible laboratory findings
  • Gold standard is “expert opinion”
is fm physical or psychological
Is FM Physical or Psychological?
  • Is it a psychiatric illness?
  • What is the interaction with depression?
  • Is it a maladaptive psychosocial response?
  • Is it somatization?
  • What is the role of stress?
fm and mood disorders
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), p=0.01).

Arnold LM et al. J Clin Psychiatry 2006;67:1219–1225, Arnold, et al. Arthritis Rheum 200; 50:944-952

is fibromyalgia a medical or psychiatric illness
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

fm and fragmented sleep
FM and Fragmented Sleep
  • Some patients with FM have fragmented sleep, which is associated with involuntary sleep-related periodic disturbances during the night. These disturbances include
    • Periodic limb movements (PLMs)
    • Restless leg syndrome (RLS)
    • Sleep apnea
    • An underlying periodic arousal disturbance in the sleep EEG known as sleep related periodic K-alpha or frequent cyclic alternating EEG sleep pattern (CAP)

Al-Alarvi A at al. J Clin Sleep Med. 2006;2:281-287.

Jennum P et al. J Rheumatol. 1993;201756-1759.

EEG, electroencephalogram.

CAP, cyclic alternating pattern.


Shared Features of FM and Depression:Clues to Pathophysiology

  • Both have strong genetic predisposition and similar co-morbidity
  • Similar sleep disturbances
  • Similar cognitive disturbances
  • Orthostatic features, ANS dysfunction
  • Childhood abuse, stress
  • Catastrophizing
  • Imaging studies
  • Neuroendocrine studies
fm pathophysiologic pathways
FM Pathophysiologic Pathways

Genetic factors

Fibromyalgia is strongly familial (the odds ratio is 8.5 for first-degree relatives)

No single candidate gene identified

Central pain augmentation

CSF substance P

Neuroimaging studies

Autonomic/neuroendocrine dysfunction

Immune dysfunction?

Structural changes?

genetics of fibromyalgia
Genetics of Fibromyalgia
  • Familial predisposition
    • Most recent work by Arnold, et al suggests >8 odds ratio (OR) for first-degree relatives, and much less familial aggregation (OR 2) with major mood disorders, much stronger with bipolarity, obsessive compulsive disorder1
  • Genes that may be involved
    • 5-HT2A receptor polymorphism T/T phenotype2
    • Serotonin transporter3
    • Dopamine D4 receptor exon III repeat polymorphism4
    • COMT (catecholamine o-methyl transferase)5

1. Arnold LM, et al. Arthritis Rheum. 2004;50:944-952. 2. Bondy B, et al. Neurobiol Dis. 1999;6:433-439. 3. Offenbaecher M, et al. Arthritis Rheum. 1999;42:2482-2488. 4. Buskila D, et al. Mol Psychiatry. 2004;9:730-731. 6. Gürsoy S, et al. Rheumatol Int. 2003;23:104-107.

pain matrix pain is processed in at least three domains in cns
“Pain Matrix” – 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

Melzack et al. Science. 1965;150:971-979. Casey et al. Headache. 1969;8:141-153.

specific underlying mechanisms in fibromyalgia
Specific Underlying Mechanisms in Fibromyalgia
  • Global problem with sensory processing (i.e. interoception)
    • FM patients equally sensitive to loudness of auditory tones1
    • Insular hyper-reactivity consistently seen2-4
    • H-MRS studies of glutamate levels in posterior insula5

1. Geisser et. al. J. Pain (2008); 2. Gracely et. al. Arthritis Rheum.46, 1333-1343 (2002); 3. Giesecke et. al. Arthritis Rheum. 50, 613-623 (2004); 4. Cook J Rheumatol. 31, 364-378 (2004); 5. Harris et. al. Arthritis Rheum. 58, 903-907 (2008).

neuroimaging in fibromyalgia
Neuroimaging in Fibromyalgia
  • Hypoperfusion of thalamus and head of the caudate nucleus
  • fMRI of cortical response to pain consistent with augmentated pain perception
  • In FM, levels of depression did not modulate the sensory aspects of pain but correlated with the magnitude of brain activation in the medial region of the brain.
  • Castrophizing correlated with pain response in these medial brain regions.
  • Changes in posterior insula glutamate in PET scans

Gracely et al. Arthritis Rheum. 2002;46:1333-1343.

Giesecke, et al Arthritis Rheum 2005 52:1577

Harris, et al Arthritis Rheum 2008 58, 903-907

alterations in descending analgesic activity in fm
Alterations in Descending Analgesic Activity in FM


  • Normal or high levels of CSF enkephalins1
  • Never administered in RCT, but most feel that opioids are ineffective or marginally effective
  • Harris recently used PET to show decreased mu-opioid receptor binding in fibromyalgia2


  • Elevated levels of substance P in CSF in fibromyalgia3
  • Nearly any class of drug that raises both serotonin and norepinephrine levels has demonstrated efficacy in fibromyalgia

CSF=cerebrospinal fluid; PET=positron emission tomography.

1. Baraniuk JN et al. BMC Musculoskelet Disord. 2004;5:48; 2. Harris JA et al. J Neurosci. 2007;27:7136-7140;3.Russell IJ et al. Arthritis Rheum. 1992;35:550-556.

is there any effective management of fibromyalgia
Is There Any Effective Management of 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
initial treatment of fibromyalgia

Confirm diagnosis

Identify important symptom domains, their severity,and level of patient function

Evaluate for comorbid medical and psychiatric disorders

Initial Treatment of Fibromyalgia

Assess psychosocial stressors, level of fitness, and barriers to treatment

May require referral to a specialist for full evaluation; for example:

To psychiatry, sleep clinic

Provide education about fibromyalgia

Modified from Arnold LM. Arthritis Res Ther 2006;8:212.

fm from mechanism to treatment
FM: From Mechanism to Treatment

This is primarily a neural disease and “central” factors play a critical role

This is a polygenic disorder

There is a deficiency of noradrenergic-serotonergic activity and/or excess levels of excitatory neurotransmitters

Lack of sleep or exercise increases pain and other somatic sx, even in normals

How FM patients think about their pain (cognitions) may directly influence pain levels

Treatments aimed at the periphery (ie, drugs, injections) are not very efficacious

There will be sub-groups of FM needing different treatments

Drugs that raise norepinephrine and serotonin, or lower levels of excitatory neurotransmitters, will be efficacious in some

Exercise, “sleep hygiene,” and other behavioral interventions are effective therapies for biological reasons

Cognitive therapies are effective in FM and have a biological substrate

rationale for the use of central nervous system active medications in fm
Rationale for the Use of Central Nervous System Active Medications in FM
  • No evidence for muscle pathology
  • Current research supports role of augmented central pain mechanisms
    • Genetic predisposition
      • 5-HT2A receptor polymorphism
      • ↑ Pain severity in FM patients with T/T genotype
      • ↑ Frequency of S/S genotype in FM patients compared with healthy controls
      • ↑ Incidence of COMT polymorphism in FM patients
    • Substance P increased in CSF
    • 5-HT and NE serum levels decreased in some studies
    • Imaging studies
  • Elevated lifetime rates of mood disorders in patients with FM
  • Elevated rates of mood disorders in first-degree relatives of FM patients
  • Sleep disturbances

Russell IJ et al. Arthritis Rheum. 1992;35:550-556 Bondy B et al. Neurobiol Dis. 1999;6:433-439; Offenbaecher M et al. Arthritis Rheum. 1999;42:2482-2488. Arnold LM, et al. Arthritis Rheum. 2004;50:944-52. Moldofsky H. Adv Neuroimmunol. 1995;5:39-56. Buskila D, Sarzi-Puttini P. Arthritis Res Ther. 2006;8(5):218 Harris RE, et al. Arthritis Rheum. 2008;58:903-907.


medications in fms
Medications in FMS
  • Strong evidence for efficacy
    • Amitriptyline, 25-50 mg at bedtime
    • Cyclobenzaprine, 10-30 mgs at bedtime
    • Pregabalin, 300-450 mg/day
    • Gabepentin, 1600-2400 mg/day
    • Duloxetine, 60-120 mg/day
    • Milnacipran, 100-200 mg/day
  • Modest evidence for efficacy
    • Tramadol, 200-300 mg/day
    • SSRIs (fluoxetine, sertraline)
  • Weak evidence for efficacy: pramipexole, gamma hydroxybutyrate, growth hormone, 5-hydroxytryptamine, tropisetron, s-adenosyl-methionine
  • No evidence: opioids, NSAIDS, benzodiazepene and nonbenzodiazepene hypnotics, melatonin, magnesium, DHEA, thyroid hormone, OTC including guaifenesin

Modified from Goldenberg, et al: Management of fibromyalgia syndrome. JAMA 2004; 292:2388-95.

tricylics in fibromyalgia
Tricylics in Fibromyalgia


Four placebo-controlled trials




Dose 25 – 50 mg

Duration 6-26 weeks

All showed modest efficacy


Four placebo-controlled trials

Quimby, 1989

Carette, 1994


Dose 10 – 40 mg

Duration 4 – 12 weeks

2 showed efficacy

Arnold L et al. Psychosomatics 2000;41:104-113.


Pregabalin in Fibromyalgia

Patient Global Impression of Change

p< 0.01 vs PBO

p< 0.01 vs PBO

% Patients

Treatment Group (mg/day)

Crofford L, et al. Arth Rheum 2005; 52: 1264-1273

improvement in average pain severity with duloxetine
Improvement in Average Pain Severity with Duloxetine

Phase III Study: Female Patients (N=354)












Duloxetine 60 mg QD

Duloxetine 60 mg BID



***P≤.001 vs placebo


LS Mean Change from Baseline
















Arnold LM, et al. Pain 2005; 119:5-15.



(J Rheumatol 2005;32:1975–85)

Milnacipran (3:1)

Not currently available in US. Hlife 8 h, no liver metab



Milnacipran Phase III (3 months,)

Number – 1196

Parallel, PL controlled, double blind

Randomized to M 100 or 200 mg or placebo for 3 months

Completers – 810 (68%)

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



Milnacipran Phase III (6 months)

Number – 888

Randomized to M 100 or 200 mg or placebo for 6 months

Completers – 511 (58%)

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 6 mnths

44,45% achieved Pain composite, v 28% PL (0.056, 0.032)

33,32% achieved FM composite, v 19% PL (0.028, 0.017)

nonpharmacologic strategies evidence of efficacy
Nonpharmacologic Strategies: Evidence of Efficacy

Modest Evidence

Strength training



EMG biofeedback

Balneotherapy (medicinal bathing)

Transcranial electrical stimulation

Strong Evidence


Physical and psychological benefits

May increase aerobic performance and tender point pain pressure threshold,and improve 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, andquality of life

Combination (multidisciplinary therapy)

Weak Evidence


Manual and massage therapy


No Evidence

Tender-point injections

Flexibility exercise

Goldenberg DL, et al. JAMA. 2004;292:2388-2395; Williams DA, et al. J Rheumatol. 2002;29:1280-1286; Busch AJ, et al. Cochrane Database Syst Rev. 2002

fm and prognosis
FM and Prognosis

Children and individuals treated in primary care settings and those with recent onset of symptoms generally have a better prognosis

Longer-term studies with larger study populations are needed to define risk factors for prognosis and to determine outcome relative to those risk factors

Modified from Horizon A and Weisman MH.

In Fibromyalgia and Other Pain Related Syndromes. 2006, p. 401.

patient family education
Patient, Family Education
  • Primary care or specialist setting.
  • Core set of information should always be provided.
  • Pathophysiology best based on biopsychological illness model.
  • Anticipate common patient questions and concerns.
  • Recognize the wealth of patient misinformation.
  • Encourage patient participation.
who should treat fibromyalgia
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


Multidisciplinary FM Treatment

  • Physical medicine/rehabilitation
    • Avoiding inactivity
    • Analgesic advice and non-pharmacologic treatment (trigger point injections)
    • Cardiovascular fitness
    • Stretching, strengthening
    • OT, work rehab, ergonomics
  • Mental health professional
    • Psychopharmacology
    • Counseling
    • CBT
fibromyalgia controversies1
Fibromyalgia Controversies
  • Does the diagnostic label promote helplessness and disability?
    • Only one controlled study; it didn’t
    • Diagnosis should be reassuring and end doctor shopping
    • Only if diagnosis is coupled with education
fibromyalgia controversies2
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
total rate of diagnostic tests performed on fm cases and on matched controls n 2 260

Positive Impact of Fibromyalgia Diagnosis in Clinical Practice

Total Rate of Diagnostic Tests Performed on FM Cases and on Matched Controls (N=2,260)


95% CI





Rate per 100 person-years


The vertical line at 0 indicates the date of fibromyalgia diagnosis






Years relative to index date

Decrease in diagnostic testing and visit rates following diagnosis

Hughes G, et al. Arthritis Rheum. 2006;54:177-183.

initial medication and non pharmacologic treatment of fibromyalgia
Initial Medication and Non-pharmacologic Treatment of Fibromyalgia

As a first-line approach for patients with moderate to severe pain, trial with evidence-based medications for example: 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

Modified From Arnold LM. Arthritis Res Ther 2006;8:212.

further medication and non pharmacologic treatment of fibromyalgia often with specialists input
Further Medication and Non-pharmacologic Treatment of Fibromyalgia: Often with Specialists’ Input

Polypharmacy; for example, trial of SSRI in AM and tricyclic in PM, 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

Modified from Arnold LM. Arthritis Res Ther 2006;8:212.

explaining the typical outcome in fibromyalgia
Explaining the Typical Outcome in Fibromyalgia
  • FM does not herald the onset of a systemic disease
  • There is 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
  • There is often adverse impact on work and leisure activities
  • Most patients quality of life improves with medical management

Granges G, Zilko P, Littlejohn GO.Fibromyalgia syndrome: assessment of the severity of the

condition 2 years after diagnosis. J Rheumatol 21:523-529, 1994

Felson DT, Goldenberg DL. The natural history of fibromyalgia. Arthritis Rheum. 1986;29:1522-1526.

interdisciplinary pain management


Pain Specialist








Social Worker



Physician Assistant

Occupational Therapist

Physical Therapist

Interdisciplinary Pain Management

Integrated Coordinated