What is the recommended management for fibromyalgia, including non‑pharmacologic therapies and first‑ and second‑line pharmacologic options?

Fibromyalgia Management

First-Line Treatment: Non-Pharmacological Interventions

Begin immediately with aerobic and strengthening exercise as the primary intervention, which has the strongest evidence (Level Ia, Grade A) for improving pain, function, and quality of life in fibromyalgia. 1, 2

Exercise Protocol

• Start with low-impact aerobic exercise (walking, swimming, cycling) at 20–30 minutes, 2–3 times weekly, gradually increasing to 30–60 minutes, 5 days weekly over 4–8 weeks. 1, 2
• Add progressive resistance/strengthening training 2–3 times weekly once aerobic tolerance is established, targeting major muscle groups. 1, 3
• Tailor exercise intensity to each patient's baseline fitness level and progress slowly to avoid symptom flare-ups; prioritize increasing duration before intensity. 4, 1

Additional Non-Pharmacological Options

• Heated pool therapy or hydrotherapy (with or without exercise) provides benefit (Level IIa, Grade B) and may improve exercise tolerance, particularly for patients with mobility limitations; effective protocols involve 25–90 minute sessions, 2–3 times weekly for 5–24 weeks. 1, 3
• Cognitive behavioral therapy (CBT) is recommended (Level Ia, Grade A) particularly for patients with depression, anxiety, or maladaptive coping strategies, producing modest reductions in pain (effect size ≈ −0.29) and disability (effect size ≈ −0.30). 1, 2
• Acupuncture (manual technique, not electro-acupuncture) is recommended (Level Ia, Grade A) for pain reduction and quality of life improvement; initiate with twice-weekly sessions for at least 8 weeks, with needle retention for 20–30 minutes and manual stimulation. 1, 2
• Meditative movement therapies (qigong, yoga, tai chi) and mindfulness-based stress reduction improve sleep (effect size ≈ −0.61) and fatigue (effect size ≈ −0.66); recommended dose is 12–24 hours total over 8–12 weeks. 1, 2

Second-Line Treatment: Pharmacological Interventions

If pain reduction is <30% after 4–6 weeks of non-pharmacological therapy, add pharmacological treatment; duloxetine or pregabalin are preferred first-line options due to FDA approval and superior tolerability. 1

First-Line Medications

• Duloxetine 60 mg once daily (Level Ia, Grade A) for pain reduction, functional improvement, and associated depression; start at 30 mg daily for 1 week, then increase to 60 mg daily. Never exceed 60 mg/day—doses of 120 mg provide no additional benefit and increase adverse events. 1, 3, 2
• Pregabalin 300–450 mg/day in divided doses (Level Ia, Grade A) for pain reduction and sleep improvement; start at 75 mg twice daily, titrate to 150 mg twice daily over 1 week. Do not exceed 450 mg/day—higher doses do not improve efficacy and increase dose-dependent adverse reactions. Adjust dose for creatinine clearance <60 mL/min. 1, 3, 2
• Amitriptyline 25–50 mg at bedtime (Level Ia, Grade A) for pain reduction (effect size ≈ −0.40), sleep improvement (effect size 0.47), and fatigue (effect size 0.48); start at 10 mg at bedtime, increase by 10 mg weekly to target 25–50 mg nightly. Use caution in older adults (≥65 years) due to anticholinergic effects (falls, confusion, constipation, urinary retention)—start at 10 mg and titrate slowly. 1, 3, 2

Second-Line Medication (When First-Line Fails)

• Tramadol (Level Ib, Grade A) is recommended for pain management (effect size 0.657) when duloxetine, pregabalin, or amitriptyline fail after adequate trials; use with caution given opioid-related risks. 1, 2
• Weak analgesics such as paracetamol (acetaminophen) may be considered as adjuncts, though supporting evidence is limited. 1

Treatment Algorithm

1. Initiate aerobic and strengthening exercise immediately as the foundation of treatment. 1, 2
2. Add heated pool therapy, CBT, acupuncture, or meditative movement therapies based on individual patient needs and symptom profile. 1, 2
3. If pain reduction is <30% after 4–6 weeks, add duloxetine 60 mg daily or pregabalin 300–450 mg/day, tailoring selection to patient factors (comorbid depression favors duloxetine; prominent sleep disturbance may favor pregabalin). 1
4. If partial response (30–50% pain reduction) after 4–6 weeks, consider adding a second agent from a different class. 1
5. If no or inadequate pain relief at target dosage after adequate trial, switch to an alternative first-line agent from a different drug class. 1
6. When both first-line agents fail, introduce tramadol with careful monitoring for opioid-related risks. 1, 2
7. Reassess every 4–8 weeks using pain scores (0–10 scale), functional status, and patient global impression of change. 1, 2

Critical Medications to AVOID

• Corticosteroids have NO role in fibromyalgia treatment and lack efficacy (Level Ia, Grade A). 1, 3, 2
• Strong opioids (morphine, oxycodone, hydrocodone) are NOT recommended as they lack demonstrated benefit and carry significant risks (Level Ia, Grade A). 1, 3, 2
• NSAIDs (ibuprofen, naproxen) have no proven benefit over placebo when used as monotherapy since fibromyalgia is not an inflammatory condition; a weak recommendation against their use is supported by unanimous expert agreement. 1, 2

Critical Pitfalls to Avoid

• Never exceed duloxetine 60 mg/day or pregabalin 450 mg/day—higher doses do not increase efficacy and only raise the likelihood of adverse events. 1
• Do not prescribe strong opioids or corticosteroids for fibromyalgia under any circumstances. 1, 3, 2
• Avoid using NSAIDs as sole therapy because they are ineffective for fibromyalgia pain. 1, 2
• Do not rely solely on pharmacological therapy without implementing exercise and behavioral approaches. 1
• Do not discontinue medications abruptly—taper gradually over 2–4 weeks to minimize withdrawal symptoms. 1
• Avoid passive modalities (massage, chiropractic manipulation) as replacements for active exercise components; chiropractic manipulation should be avoided (93% expert agreement indicates lack of efficacy). 1

Expected Outcomes and Monitoring

• Most treatments show modest effect sizes; 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. 4, 1, 2
• Long-term management requires ongoing exercise maintenance and periodic reassessment of medication need. 2
• Patient education about fibromyalgia as a chronic condition with central sensitization is crucial for setting realistic expectations. 1, 2