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 40–85 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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Contributors C-HL, Y-TH and H-PT: study design, concept, data interpretation and manuscript drafting. H-CL, C-LL, T-YW, S-HL and S-HT: contributed to the data collection and evaluation of the patients' functional scores. HZ: supervised the study.
Funding Lo-Hsu Foundation.
Competing interests None declared.
Patient consent Obtained.
Ethics approval Ethics review board of the Cathay General Hospital Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
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