Treatment for Fibromyalgia
Begin immediately with a graduated aerobic exercise program as the primary intervention—this is the only "strong-for" therapy with Level Ia, Grade A evidence—and reserve pharmacologic treatment for patients who have severe pain or sleep disturbance that persists after 4–6 weeks of optimized exercise and sleep hygiene. 1, 2
Initial Non-Pharmacological Management (First-Line)
Start low-impact aerobic exercise (walking, swimming, cycling) at 10–15 minutes, 2–3 times weekly, gradually increasing over 4–6 weeks to 20–30 minutes, 3–5 times weekly, then progressing to 30–60 minutes, 5 days weekly. 1, 2
Add progressive resistance/strengthening training 2–3 times weekly once aerobic tolerance is established. 1, 2
Heated pool therapy or hydrotherapy provides additional benefit (Level IIa, Grade B) and may improve exercise tolerance, particularly for patients with mobility limitations. 1, 2
Cognitive behavioral therapy (CBT) is recommended for patients with concurrent depression, anxiety, or maladaptive coping strategies (Level Ia, Grade A). 1, 2
Acupuncture (manual technique, not electro-acupuncture) is recommended for pain reduction and quality-of-life improvement, with treatment courses spanning 8–12 weeks at twice-weekly sessions initially (Level Ia, Grade A). 1, 2
Meditative movement therapies (tai chi, yoga, qigong) and mindfulness-based stress reduction are recommended, particularly for patients with prominent sleep disturbances (effect size −0.61) and fatigue (effect size −0.66). 1, 2
Pharmacological Management (Second-Line)
When to Initiate Medication
- Initiate pharmacotherapy only after 4–6 weeks of optimized sleep hygiene, aerobic exercise, and CBT have failed to produce adequate improvement in severe pain or sleep disturbance. 1
First-Line Medication Options
Amitriptyline 10 mg at bedtime, increase by 10 mg weekly to target 25–50 mg nightly (maximum 75 mg/day) for patients with prominent sleep disturbance and pain (Level Ia, Grade A); produces moderate analgesic effect (SMD −0.40) and modest improvements in sleep (SMD 0.47) and fatigue (SMD 0.48). 1, 2, 3
Duloxetine 30 mg daily for 1 week, then increase to 60 mg daily for patients with pain plus depression or anxiety (Level Ia, Grade A); do NOT exceed 60 mg/day as 120 mg provides no additional benefit but increases adverse events. 1, 2, 4, 3
Pregabalin 75 mg twice daily, titrate to 150 mg twice daily (300–450 mg/day total) over 1 week for patients with predominant pain without mood symptoms (Level Ia, Grade A); patients are 38% more likely to achieve ≥30% pain reduction (RR 1.38,95% CI 1.25–1.51); do NOT exceed 450 mg/day as higher doses increase adverse reactions without added efficacy. 1, 2, 3
Milnacipran 100–200 mg/day in divided doses (titrate starting at lower doses over approximately 1 week) for pain reduction and fatigue symptoms; 200 mg/day does not confer greater benefit than 100 mg/day. 1, 4, 3
Second-Line Medication (When First-Line Fails)
Tramadol is recommended only when duloxetine, pregabalin, and amitriptyline have proven inadequate; it demonstrates moderate pain-reduction effect size (0.657) but carries opioid-related risks requiring careful monitoring (Level Ib, Grade A). 1, 5
Cyclobenzaprine 5–10 mg at bedtime yields small sleep benefit (effect size 0.34) but has 85% side-effect rate and should be used only if amitriptyline and pregabalin are contraindicated. 1
Treatment Algorithm
| Stage | Time Frame | Actions | Advance If |
|---|---|---|---|
| Stage 1 | Weeks 0–6 | Patient education about central sensitization; graduated aerobic exercise; sleep-hygiene measures; screen for primary sleep disorders. | <30% improvement in pain or sleep quality. |
| Stage 2 | Weeks 6–12 | Add CBT for insomnia/mood disorders; consider heated-pool or meditative-movement therapy; if sleep remains severely impaired, start amitriptyline 10 mg nightly, titrating to 25–50 mg. | Inadequate sleep response after 4–6 weeks of amitriptyline. |
| Stage 3 | Week 12 reassessment | Switch to pregabalin (150 mg at bedtime, titrating to 300–450 mg/day) if amitriptyline insufficient; otherwise optimize exercise adherence. | Persistent severe sleep disturbance or functional impairment. |
| Stage 4 | >Week 12 (severe/refractory) | Implement multimodal rehabilitation combining exercise, CBT, pharmacotherapy, and physical therapies; consider tramadol if first-line agents fail. | Ongoing high disability despite prior stages. |
Medications to AVOID
Corticosteroids have NO role in fibromyalgia treatment and lack efficacy (Level Ia, Grade A). 1, 2, 3
Strong opioids (morphine, oxycodone, hydrocodone, fentanyl) are NOT recommended as they lack demonstrated benefit and are associated with significant harm including dependence (Level Ia, Grade A). 1, 2, 3, 6
NSAIDs (ibuprofen, naproxen) have no proven benefit over placebo as monotherapy since fibromyalgia is not an inflammatory condition; avoid routine use. 1, 3, 6
Monitoring and Reassessment
Evaluate treatment response every 4–8 weeks using pain scores (0–10 scale), functional status (SF-36 Physical Component Score), and patient global impression of change (PGIC). 1, 2, 4
If pain reduction is <30% after 4–6 weeks, switch to an alternative first-line agent from a different drug class. 1, 5
If partial response (30–50% pain reduction) is observed, consider adding a second agent from a different class. 1, 5
Most treatments show modest effect sizes (SMD 0.3–0.8); expect 30–50% pain reduction rather than complete resolution. 1, 7
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
Do NOT exceed amitriptyline 75 mg/day, duloxetine 60 mg/day, or pregabalin 450 mg/day; higher doses increase adverse events without added benefit. 1, 4
Do NOT rely solely on pharmacological therapy without implementing exercise and behavioral approaches. 1, 6
Do NOT prescribe strong opioids or corticosteroids under any circumstances. 1, 2, 3