Integrative medicine rehabilitation for post-stroke limb spasticity: A multicenter randomized controlled trial

Objective: This study aimed to determine whether integrative medicine rehabilitation (IMR) that combines conventional rehabilitation (CR) with Tui Na and traditional Chinese external medicine Baimai-ruangao is more effective than CR alone for treatment of post-stroke limb spasticity. Design: We conducted a multicenter randomized controlled intervention trial that involved 16 hospitals in ten cities in China. Subject: 444 patients with post-stroke limb spasticity were randomly assigned to an IMR group (n=222) and a CR group (n=222). Methods: Tui Na was performed for patients with post-stroke limb spasticity. Traditional Chinese external medicine Baimai-ruangao as the massage medium was applied on the skin surface. The course of treatment was 1 month. Muscle tone in the spastic muscles (elbow flexors, wrist flexors, finger flexors, knee extensors, ankle plantar flexors) was evaluated using the Modified Ashworth Scale (MAS), and the primary endpoint was the change in MAS score from baseline to 4 weeks. Results: The IMR group had a significantly better reduction in the MAS scores for five muscle groups than the CR group did after 4 weeks of intervention. Improvements were sustained at the 3-month and 6-month follow-ups. Furthermore, patients who had a baseline muscle tone score of 1+ to 4 on the MAS for the affected limb were recommended to receive IMR. No adverse reaction was observed in the IMR group. Conclusion: Conventional rehabilitation combined with IMR is safe and more effective for alleviating post-stroke limb spasticity.