Additional effects of acupuncture on early comprehensive rehabilitation in patients with mild to moderate acute ischemic stroke: a multicenter randomized controlled trial.

ABSTRACT

BACKGROUND: Acupuncture is not considered a conventional therapy for post-stroke sequelae but it might have some additional positive effects on early rehabilitation. We conducted this trial to determine whether acupuncture has additional effects in early comprehensive rehabilitation for acute ischemic stroke and dysfunctions secondary to stroke. METHODS: Two hundred fifty patients were randomized into two groups acupuncture (AG) or no acupuncture (NAG). Eighteen acupuncture treatment sessions were performed over a 3-week period. The primary outcome was blindly measured with National Institutes of Health Stroke Scale (NIHSS) at week 1, week 3, and week 7. Secondary outcomes included Fugl-Meyer Assessment (FMA) for motor function, bedside swallowing assessment (BSA) and videofluoroscopic swallowing study (VFSS) for swallowing function, the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) for cognitive function, and the adverse reaction of acupuncture for safety assessment. RESULTS: Significant improvements from acupuncture treatment were observed in NIHSS (p < 0.001), VFSS (p < 0.001), MMSE (p < 0.001), MoCA (p = 0.001), but not obtained from FMA (p = 0.228). Changes from baseline of all above variables (except FMA) also had the same favorable results. A significant improvement in FMA lower extremity subscale appeared in AG (p = 0.020), but no significant difference was found for the upper extremity subscale (p = 0.707). More patients with swallowing disorder recovered in AG (p = 0.037). Low incidence of mild reaction of acupuncture indicated its safety. CONCLUSIONS: This trial showed acupuncture is safe and has additional multi-effect in improving neurologic deficits, swallowing disorder, cognitive impairment, and lower extremity function, but has no significant improvement for upper extremity function during this short-term study period. TRIAL REGISTRATION Chictr.org ChiCTR-TRC -12001971 (March 2012).