Objective: To evaluate whether amitriptyline is more effective than placebo in improving phantom limb pain or residual limb pain.
Design: Randomized controlled trial of amitriptyline for 6 weeks.
Setting: University hospital.
Participants: Thirty-nine persons with amputation-related pain lasting more than 6 months.
Intervention: Six-week trial of amitriptyline (titrated up to 125 mg/d) or an active placebo (benztropine mesylate).
Main outcome measures: Analyses were conducted to examine whether there was a medication group effect on the primary outcomes (average pain intensity) and secondary outcome measures (disability, satisfaction with life, handicap).
Results: No significant differences were found between the treatment groups in outcome variables when controlling for initial pain scores.
Conclusions: Our findings do not support the use of amitriptyline in the treatment of postamputation pain.