OBJECTIVE: To determine the required sample size for, and feasibility of, a RCT examining the effectiveness of early acupuncture for acute ischaemic stroke. METHODS: Thirty-eight patients aged 40 to 85 years with a first episode of acute ischaemic stroke presenting within 72 h of stroke onset were randomly assigned to receive manual acupuncture (MA group; n = 20) plus standard care or standard care only (control group, n = 18). The acupuncture treatment was provided daily for 2 weeks. The primary outcome was the change in the National Institutes of Health Stroke Scale (NIHSS) score between baseline and 4 weeks. Secondary outcomes included changes in the Fugl-Meyer assessment (FMA) and the functional independence measure scores between baseline and 4 weeks, and changes in NIHSS, Barthel Index and modified Rankin Scale scores at 12 weeks. RESULTS: Thirty-one patients completed the study (dropout rate = 18%) and adverse effects were minimal. No significant differences were seen between groups in the improvements in NIHSS scores, although there tended to be a greater reduction in NIHSS score after 1 week in the MA group relative to the control group (p = 0.066). The post-stroke motor activity at 4 weeks was associated with a significantly increased FMA score in the acupuncture group compared with the control group (p < 0.05), but not supported by intergroup analysis. CONCLUSIONS: This pilot study indicates that acupuncture appears to be safe for patients in the acute stage of ischaemic stroke. A subsequent trial with a larger sample size (estimated at n = 122) is required to confirm whether early acupuncture intervention contributes to earlier functional improvement and to assess the longer-term clinical efficacy of acupuncture. TRIAL REGISTRATION NUMBER: NCT02210988; results.

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