Acupuncture during stroke rehabilitation: development of a manual for researching a complex intervention
BACKGROUND AND AIMS Evidence on acupuncture during stroke rehabilitation is inconsistent, with methodological problems including inappropriately standardized treatment protocols. This project developed and assessed feasibility of methods to study an individualized acupuncture intervention during acute stroke rehabilitation. DESIGN AND METHODS This three-part project aimed to 1) develop a manual for post-stroke acupuncture therapy; 2) determine feasibility of methods for future study and 3) explore stakeholder perceptions of acupuncture’s impact. First, a treatment manual was developed. Second, a cohort study used the manual to treat 48 inpatients, who had elected acupuncture treatment(n=25) or usual care only (n=23). Acupuncture was given 3-4 times weekly for 2-4 weeks. Outcomes assessed for feasibility included the Functional Independence Measure (FIM), Modified Rankin Scale of global disability (mRS) and assessments of sleep, swallowing and bowel function(at baseline and discharge, with mRS also at 6-month follow-up). Confidence intervals were compared across mild, moderate and severe subgroups. The third study assessed stakeholder perceptions of acupuncture impact. Acupuncture patients were briefly interviewed, with surveys given to family, rehabilitation therapists, nurses and physicians. Impacts of acupuncture were identified using thematic analysis, and compared quantitatively across severity groups. RESULTS Improvement in FIM scores was similar in self-selected cohorts choosing acupuncture (Mdn=37.5) and usual care (Mdn=35), 95% CI [-6, 6]. FIMiii motor domain scores trended higher in the moderate subgroup only. Feasibility criteria were met for the outcomes of 6-month mRS, bowel function, and sleep. Findings of Project 3 included a wide range of perceived benefits, with no negative impact. Benefits included improved upper and lower extremity motor function, walking, relaxation, and pain reduction. Staff reported better mood and participation in physical and occupational therapy. Reported benefits differed across severity subgroups, but proportion of stakeholders perceiving benefit was similar. CONCLUSIONS Further research on acupuncture during stroke rehabilitation is feasible, given mutually appropriate intervention, patient population and outcome measures. The widely used FIM appears inappropriate for future study, except possibly for patients in the moderate range of severity. No outcome reached statistical significance in this small non-randomized study. Trends favored the acupuncture group on most secondary outcomes including 6-month mRS, sleep and bowel function. Additional directions for further study include the relationship between cortical damage and acupuncture responsiveness, and possible benefit to the rehabilitation process itself.
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