Electro-acupuncture for post-stroke spasticity: results of a pilot pragmatic randomized controlled trial

Abstract Context. People with spasticity which occurred between 30 days and one year after stroke onset with a baseline Modified Ashworth Scale (MAS) ≥ 1. Objective To determine the practicality of a pragmatic parallel-group open-labeled randomized controlled trial, and to collect preliminary data of effectiveness and safety of electro-acupuncture for post-stroke spasticity (PSS) Methods Eligible participants were randomly allocated to the intervention group (electro-acupuncture plus usual care) or the control group (usual care alone) at a 1:1 ratio with block sizes of six. Participants received electro-acupuncture three times a week for four weeks then were followed up for another four weeks. Participants’ retention and adherence in the trial were assessed to determine the practicality of trial design. Clinical outcome measures were the change scores of MAS, Fugl-Meyer Assessment (FMA) of motor performance and Barthel Index (BI), and adverse events. Results Seventy-two people were screened for eligibility, and 30 of them were recruited and randomized. At the end, 25 participants followed the trial protocol and were included in our final data analyses using an intention-to-treat approach. No significant between-group difference was detected for the change scores of MAS, FMA or BI at the end of treatment or end of follow-up. Eighteen participants reported 37 adverse events, but none was deemed related to electro-acupuncture. Conclusion It is feasible to conduct a full-scale trial to precisely evaluate the effectiveness and safety of electro-acupuncture for treating PSS, however, longer treatment and follow-up phases should be considered in the full-scale trial.