OBJECTIVE: To compare the effects of traditional Chinese acupuncture with sham acupuncture on upper-extremity (UE) function and quality of life (QOL) in patients with chronic hemiparesis from stroke. DESIGN: A prospective, sham-controlled, randomized controlled trial (RCT). SETTING: Patients recruited through a hospital stroke rehabilitation program. PARTICIPANTS: Thirty-three subjects who incurred a stroke 0.8 to 24 years previously and had moderate to severe UE functional impairment. INTERVENTIONS: Active acupuncture tailored to traditional Chinese medicine diagnoses, including electroacupuncture, or sham acupuncture. Up to 20 treatment sessions (mean 16.9) over a mean of 10.5 weeks. MAIN OUTCOME MEASURES: UE motor function, spasticity, grip strength, range of motion (ROM), activities of daily living, QOL, and mood. All outcomes were measured at baseline and after treatment. RESULTS: Intention-to-treat (ITT) analyses found no statistically significant differences in outcomes between active and sham acupuncture groups. Analyses of protocol-compliant subjects revealed significant improvement in wrist spasticity (p < 0.01) and both wrist (p < 0.01) and shoulder (p < 0.01) ROM in the active acupuncture group, and improvement trends in UE motor function (p = 0.09) and digit ROM (p = 0.06). CONCLUSIONS: Based on ITT analyses, we conclude that acupuncture does not improve UE function or QOL in patients with chronic stroke symptoms. However, gains in UE function observed in protocol-compliant subjects suggest traditional Chinese acupuncture may help patients with chronic stroke symptoms. These results must be interpreted cautiously because of small sample sizes and multiple, unadjusted, post hoc comparisons. A larger, more definitive RCT using a similar design is feasible and warranted.

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