What is the recommended management for fibromyalgia?

Management of Fibromyalgia

Begin immediately with a graduated aerobic exercise program (20-30 minutes, 2-3 times weekly, progressing to 30-60 minutes, 5 days weekly over 4-8 weeks) as the sole first-line intervention with the strongest evidence (Level Ia, Grade A); reserve pharmacological therapy exclusively for patients with severe sleep disturbance or inadequate response after 4-6 weeks of optimized exercise. 1, 2

Initial Non-Pharmacological Management (First-Line, Mandatory)

Exercise Prescription (Strong Recommendation - 100% Expert Agreement)

• Start low-impact aerobic exercise (walking, swimming, cycling) at 10-15 minutes, 2-3 times weekly, gradually increasing duration before intensity to reach 20-30 minutes, 3-5 times weekly by weeks 4-6. 1, 2

• Add progressive resistance training 2-3 times weekly targeting major muscle groups once aerobic tolerance is established (typically after 4-6 weeks). 1, 2

• Tailor exercise intensity to baseline fitness level to avoid symptom flare-ups; prioritize increasing duration over intensity during initial weeks. 1

• Heated pool therapy (25-90 minutes, 2-3 times weekly for 5-24 weeks) provides additional benefit and improves exercise tolerance, particularly for patients with mobility limitations (Level IIa, Grade B). 1, 3

Cognitive Behavioral Therapy (CBT)

• Screen for major depression and anxiety using PHQ-9 and GAD-7; initiate CBT for patients with mood disorders, maladaptive coping strategies, or unhelpful illness beliefs (Level Ia, Grade A). 1, 2

• CBT produces modest reductions in pain (effect size ≈ -0.29) and disability (effect size ≈ -0.30) with durable long-term benefits. 1

Adjunctive Physical Therapies

• Manual acupuncture (20-30 minutes with needle manipulation, twice weekly for minimum 8 weeks) significantly improves quality of life immediately post-treatment and at 3-month follow-up (Level Ia, Grade A). 1, 2

• Meditative movement therapies (qigong, yoga, tai chi) improve sleep (effect size ≈ -0.61) and fatigue (effect size ≈ -0.66); recommend 12-24 total hours over 8-12 weeks (≈1-2 hours per week). 1, 2

• Mindfulness-based stress reduction programs are recommended as adjunctive therapy (Level Ia, Grade A). 1, 2

Pharmacological Management (Second-Line Only)

Indications for Initiating Medication

• Initiate pharmacotherapy ONLY after 4-6 weeks of optimized exercise, sleep hygiene, and CBT have failed to produce adequate improvement, OR for severe sleep disturbance at presentation. 1

• Pharmacotherapy is indicated for "severe pain or sleep disturbance" only after non-pharmacologic measures have been applied. 1

First-Line Medication Options

Amitriptyline (Preferred for Sleep Disturbance)

• Start 10 mg at bedtime, increase by 10 mg weekly to target 25-50 mg nightly (maximum 75 mg/day); produces moderate analgesic effect (SMD = -0.40) and modest improvements in sleep (SMD = 0.47) and fatigue (SMD = 0.48) (Level Ia, Grade A). 1, 2, 3

• Number needed to treat for 50% pain relief is 4.1. 1

• In elderly patients (≥65 years), start at 10 mg and titrate slowly due to anticholinergic burden increasing risk of falls, confusion, constipation, and urinary retention. 3

Duloxetine (Preferred for Comorbid Depression/Anxiety)

• Start 30 mg daily for 1 week, then increase to 60 mg daily (Level Ia, Grade A); approximately 50% of patients achieve at least 30% pain reduction. 1, 2, 3

• Do NOT exceed 60 mg/day; doses of 120 mg provide no additional pain relief and are associated with higher rates of adverse events and discontinuation. 1

Pregabalin (Preferred for Predominant Pain Without Mood Symptoms)

• Start 75 mg twice daily, titrate to 150 mg twice daily over 1 week, target dose 300-450 mg/day in divided doses (Level Ia, Grade A). 1, 2, 3

• Patients receiving pregabalin are 38% more likely to achieve at least 30% pain reduction compared with placebo (RR = 1.38; 95% CI 1.25-1.51). 1

• Do NOT exceed 450 mg/day; higher doses do not improve efficacy and increase dose-dependent adverse reactions. 1

• Requires dose adjustment in patients with creatinine clearance <60 mL/min and for age-related decline in renal function. 1, 3

Second-Line Medication (When First-Line Fails)

• Tramadol is recommended ONLY when duloxetine, pregabalin, and amitriptyline have proven inadequate after adequate trials; demonstrates moderate effect size of 0.657 for pain reduction (Level Ib, Grade A). 1

• Use tramadol with caution given opioid-related risks; monitor closely for dependence. 1

Alternative Second-Line Option

• Cyclobenzaprine 5-10 mg at bedtime yields small sleep benefit (effect size ≈ 0.34) but is associated with 85% side-effect rate; use ONLY if amitriptyline and pregabalin are contraindicated (weak recommendation, 75% expert agreement). 1

Treatment Algorithm

Stage 1 (Weeks 0-6)

• Provide education on fibromyalgia as chronic pain disorder with central sensitization. 1, 2

• Initiate graduated aerobic exercise program (10-15 minutes, 2-3 times weekly). 1, 2

• Implement sleep-hygiene measures and screen for primary sleep disorders. 1

• Screen for depression/anxiety using PHQ-9 and GAD-7. 1

• Advance to Stage 2 if <30% improvement in pain or sleep quality after 6 weeks. 1

Stage 2 (Weeks 6-12)

• Add CBT for insomnia/mood disorders if screening positive. 1, 2

• Consider heated-pool therapy or meditative-movement therapy. 1, 2

• If sleep remains severely impaired, start amitriptyline 10 mg nightly, titrating to 25-50 mg. 1, 3

• Advance to Stage 3 if inadequate sleep response after 4-6 weeks of amitriptyline. 1

Stage 3 (Week 12 Reassessment)

• If partial response (30-50% pain reduction), consider adding second agent from different class. 1

• If <30% pain reduction at target dosage, switch to alternative first-line medication: duloxetine 30 mg → 60 mg daily OR pregabalin 75 mg twice daily → 150 mg twice daily. 1, 2, 3

• Optimize exercise adherence and ensure progression to 30-60 minutes, 5 days weekly. 1, 2

Stage 4 (>Week 12, Severe/Refractory Cases)

• When both first-line agents fail, introduce tramadol with careful monitoring for opioid-related risks. 1

• Implement multimodal rehabilitation combining exercise, CBT, pharmacotherapy, and physical therapies (acupuncture, heated-pool therapy). 1, 2

• Reassess clinical response every 4-8 weeks using pain scores (0-10 scale), functional status, and patient global impression of change. 1, 2

Medications to AVOID (Strong Consensus Against Use)

• Strong opioids (morphine, oxycodone, hydrocodone, fentanyl) are contraindicated; they lack demonstrated efficacy and are associated with significant harm, including dependence and systemic adverse effects (Level Ia, Grade A). 1, 2, 3, 4

• Systemic corticosteroids have NO role in fibromyalgia treatment and lack efficacy (Level Ia, Grade A). 1, 2, 3, 4

• NSAIDs (ibuprofen, naproxen) have no proven benefit over placebo when used as monotherapy; fibromyalgia is not an inflammatory condition. 1, 2, 4

Critical Pitfalls to Avoid

• Do NOT initiate pharmacotherapy before establishing an aerobic exercise program; exercise is the sole "strong-for" recommendation and must be the foundation of care. 1, 2

• Never exceed duloxetine 60 mg/day or pregabalin 450 mg/day; higher doses increase adverse events without added benefit. 1

• Do NOT prescribe strong opioids or corticosteroids for fibromyalgia under any circumstances. 1, 2, 3, 4

• Avoid using NSAIDs as sole therapy because they are ineffective for fibromyalgia pain. 1, 2, 4

• Do NOT discontinue medications abruptly; taper gradually over 2-4 weeks to minimize withdrawal symptoms. 1

• Do NOT rely solely on pharmacological therapy without implementing exercise and behavioral approaches. 1

Expected Treatment Outcomes

• Effect sizes for fibromyalgia interventions are modest, typically ranging from 0.3 to 0.8 standardized mean differences; expect 30-50% pain reduction rather than complete resolution. 1, 2

• Multicomponent therapy (combining exercise, CBT, and medication) may provide greater benefit than any single intervention. 1, 2, 5, 6, 7, 8, 4

• Long-term management requires ongoing exercise maintenance and periodic reassessment of medication need. 2