Acupuncture is widely used to enhance stroke recovery in Eastern countries. However, a recent randomized controlled trial demonstrated that acupuncture has no specific efficacy in stroke rehabilitation . A meta-analysis of sham-controlled randomized clinical trials concluded that there is insufficient evidence to support the use of acupuncture for functional recovery after stroke . These data have led to ongoing controversy regarding the use of acupuncture therapy after stroke, despite the thousands years of evidence from traditional Chinese medicine practice.
The occupational therapists’ technique in the manipulation and selection of acupoints is the most important factor that determines the efficacy of acupuncture therapy . In the present study, all occupational therapists are experts with more than ten years of acupuncture practice and plenty of experience with stroke treatments. The acupoints selected in this trial correspond to a complex prescription for stroke therapy originating in over 60 years of clinical application. Moreover, all the occupational therapists will receive special training to achieve a sound understanding of the acupoint selection and to normalize the practices across different therapists. The trial complies with the STRICTA (STandards for Reporting Interventions in Controlled Trials of Acupuncture).
The efficacy of acupuncture is different at different levels of stroke severity. It may have limit efficacy in very severe strokes, particularly in cases of extensive brain damage [20, 21]. However, for mild or moderately severe strokes, acupuncture might be a superior treatment. In this trial, we will recruit patients with moderately severe acute strokes without severe deformity, and with NIHSS grades from 4 to 21, Glasgow Coma Scores of greater than or equal to 7, and mRS grades of less than or equal to 1.
Recovery of function after stroke is a long steady process that continues for several weeks or even months before reaching a stable phase. The effects of acupuncture occur within the same time frame. Several previous studies did not show any beneficial effect of acupuncture, and this may in part be explained by an assessment of efficacy too soon after acupuncture treatment (in most cases 2–3 weeks after stroke) [22, 23]. An assessment or reassessment at a minimum of 4 weeks, and ideally at least 3 to 6 months after the completion of treatment is essential. We followed the time course of the normal process of stroke recovery in designing our study protocol. Thus, we will assess efficacy at baseline and at 4, 12 and 24 weeks after acupuncture intervention.
The primary endpoint for this study is the change in the quality of life in the intervention and control groups, from baseline to 4, 12 and 24 weeks post-therapy. Neurological deficits, disability, and dependence in activities of daily living will be evaluated by NIHSS and mRS as the secondary endpoints.
Many acupuncturists consider the main effect of acupuncture on the human body after stroke to be the rehabilitation of motor function, whereas few have considered the patients’ life quality, which includes factors such as dependence in activities of daily living, feeding, dressing, and continence of bowels and bladder. To address this, we will use the BI and SS-QOL questionnaires to measure the quality of life as the primary outcomes.