Meng Wang1, Shouguo Liu2, Zhihang Peng3, Yi Zhu4, Xiaodong Feng5, Yihuang Gu6, Jianhua Sun7, Qiang Tang8, Hongxia Chen9, Xiaolin Huang10, Jun Hu11, Wei Chen12, Jie Xiang13, ChunXiao Wan14, Gangqi Fan15, Jianhu Lu15, Wenguang Xia16, Xiao Lu17, Jianan Li18. 1. Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Jiangsu, China; The Second Clinical Medical School, Nanjing University of Chinese Medicine, Jiangsu, China. 2. Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Jiangsu, China. 3. The Teaching and Research Department of Statistics, Nanjing Medical University, Jiangsu, China. 4. Rehabilitation Center, The Second Affiliated Hospital of HaiNan Medical University, Hainan, China. 5. The Rehabilitation Department, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Henan, China. 6. The Second Clinical Medical School, Nanjing University of Chinese Medicine, Jiangsu, China. 7. The Acupuncture Rehabilitation Department, Jiangsu Province Hospital of Traditional Chinese Medicine, Jiangsu, China. 8. Rehabilitation Center, The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Heilongjiang, China. 9. The Rehabilitation Department, Guangdong Provincial Traditional Chinese Medicine Hospital, Guangdong, China. 10. The Rehabilitation Department, Tongji Medical College Huazhong University of Science & Technology, Hubei, China. 11. The Neurological Rehabilitation Department, Shanghai University of Traditional Chinese Medicine, Shanghai, China. 12. Rehabilitation Center, Xuzhou Central Hospital, Jiangsu, China. 13. The Rehabilitation Department, The Affiliated Hospital of Xuzhou Medical University, Jiangsu, China. 14. The Rehabilitation Department, Tianjin Medical University General Hospital, Tianjin, China. 15. The Neurology Department, Nanjing Hospital of Traditional Chinese Medicine, Jiangsu, China. 16. The Rehabilitation Department, Hubei Provincial Hospital of Integrated Chinese & Western Medicine, Hubei, China. 17. Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Jiangsu, China. Electronic address: luxiao1972@163.com. 18. Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Jiangsu, China. Electronic address: jiananli77@126.com.
Abstract
OBJECTIVE: To determine the short- (4 weeks) and long-term (6 month) effectiveness of Tibetan medicated bathing therapy in patients with post-stroke limb spasticity. DESIGN: Prospective, blinded, randomized controlled trial. SUBJECTS:Post-stroke patients with limb spasticity were recruited between December 2013 and February 2017 and randomly assigned 1:1 to a control group that received conventional rehabilitation (n = 222) or an experimental group that received Tibetan medicated bathing therapy in combination with conventional rehabilitation (n = 222). METHODS: All patients received conventional rehabilitation. In addition, the experimental group received Tibetan medicated bathing therapy. The interventions were conducted 5 times per week for 4 weeks. The primary endpoint was changes from baseline after 4 weeks of therapy in muscle tone in the spastic muscles (elbow flexors, wrist flexors, finger flexors, knee extensors, ankle plantar flexors), as measured by the Modified Ashworth Scale (MAS). RESULTS: The mean change from baseline after 4 weeks of therapy in the MAS score for the elbow flexors (P = .017), wrist flexors (P < .001), and ankle plantar flexors (P < .001) was significantly greater in patients in the experimental group compared to the control group. The benefit was maintained for 3 muscle groups (elbow flexors P < .001, wrist flexors P = .001, and ankle plantar flexors P < .001) and 6 months (elbow flexors P < .001, wrist flexors P = .002, and ankle plantar flexors P < .001) after therapy. All adverse events were mild, and no serious adverse reactions to Tibetan medicated bathing therapy were recorded. CONCLUSIONS AND IMPLICATIONS: Tibetan medicated bathing therapy, in combination with conventional rehabilitation, has potential as a safe, effective treatment for the alleviation of post-stroke upper limb spasticity. Tibetan medicated bathing therapy was most advantageous for patients who had a baseline muscle tone score of 1+ to 2 on the MAS in the affected limb and recent onset of stroke (duration of the disease of 1-3 months).
RCT Entities:
OBJECTIVE: To determine the short- (4 weeks) and long-term (6 month) effectiveness of Tibetan medicated bathing therapy in patients with post-stroke limb spasticity. DESIGN: Prospective, blinded, randomized controlled trial. SUBJECTS: Post-strokepatients with limb spasticity were recruited between December 2013 and February 2017 and randomly assigned 1:1 to a control group that received conventional rehabilitation (n = 222) or an experimental group that received Tibetan medicated bathing therapy in combination with conventional rehabilitation (n = 222). METHODS: All patients received conventional rehabilitation. In addition, the experimental group received Tibetan medicated bathing therapy. The interventions were conducted 5 times per week for 4 weeks. The primary endpoint was changes from baseline after 4 weeks of therapy in muscle tone in the spastic muscles (elbow flexors, wrist flexors, finger flexors, knee extensors, ankle plantar flexors), as measured by the Modified Ashworth Scale (MAS). RESULTS: The mean change from baseline after 4 weeks of therapy in the MAS score for the elbow flexors (P = .017), wrist flexors (P < .001), and ankle plantar flexors (P < .001) was significantly greater in patients in the experimental group compared to the control group. The benefit was maintained for 3 muscle groups (elbow flexors P < .001, wrist flexors P = .001, and ankle plantar flexors P < .001) and 6 months (elbow flexors P < .001, wrist flexors P = .002, and ankle plantar flexors P < .001) after therapy. All adverse events were mild, and no serious adverse reactions to Tibetan medicated bathing therapy were recorded. CONCLUSIONS AND IMPLICATIONS: Tibetan medicated bathing therapy, in combination with conventional rehabilitation, has potential as a safe, effective treatment for the alleviation of post-stroke upper limb spasticity. Tibetan medicated bathing therapy was most advantageous for patients who had a baseline muscle tone score of 1+ to 2 on the MAS in the affected limb and recent onset of stroke (duration of the disease of 1-3 months).