Journal of the American Medical Directors Association
Original StudyTibetan Medicated Bathing Therapy for Patients With Post-stroke Limb Spasticity: A Randomized Controlled Clinical Trial
Section snippets
Ethics Statement and Quality Control
This prospective, blinded, randomized controlled trial was conducted in accordance with the Declaration of Helsinki, the approval of all relevant institutional review boards and ethics committees, and local regulatory requirements. All patients who participated in this trial and their families were fully informed of the study details and provided written informed consent before participation. This trial is registered on ClincalTrials.gov (http://clinicaltrials.gov/identifier), registration
Safety Evaluation
Adverse events were recorded on a case report form after evaluating relationships with the intervention.
Results
A total of 558 patients were recruited from 16 centers between December 2013 and February 2017. Four hundred forty-four patients were randomly assigned to 1 of 2 groups with 222 cases in each group. A total of 250 patients withdrew from the study for a variety of reasons (Figure 1).
Discussion
This multicenter clinical trial showed that Tibetan medicated bathing therapy in combination with conventional rehabilitation could improve limb spasticity after stroke. Furthermore, Tibetan medicated bathing therapy combined with conventional rehabilitation was beneficial for motor function, and these therapeutic benefits were sustained at the 6-month follow-up. There were no safety concerns in patients treated with Tibetan medicated bathing therapy. These findings suggest that Tibetan
Conclusions and Implications
The results of this clinical trial demonstrate that Tibetan medicated bathing therapy, in combination with conventional rehabilitation, has potential as a safe, effective treatment for the alleviation of post-stroke limb spasticity.
Acknowledgments
The authors thank all patients for their participation in this study and its follow-up. The authors would like to acknowledge the following people for providing support for this study: Zhihang Peng from the Nan Jing Medical University Teaching and Research Section of Statistics; Xiaorong Hu, Binbing Yu, Rong Cao, Yan Jiang, Yuxia Wu, Yongqiang Li, RongBian, and Shaohua Gu from the First Affiliated Hospital of Nanjing Medical University. In addition, the authors acknowledge support from the
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A randomized double-blind controlled study protocol on the efficacy and safety of Sangdantongluo granule in the treatment of post-stroke spasticity
2022, Contemporary Clinical Trials CommunicationsCitation Excerpt :According to the literature,“Meng Wang, Shouguo Liu, Zhihang Peng et al. Tibetan Medicated Bathing Therapy for Patients With Post-stroke Limb Spasticity: A Randomized Controlled Clinical Trial” [13]. After the combined treatment of Tibetan medicated bathing therapy and conventional rehabilitation for 3 months, MAS changes were 0.27 ± 0.66 in conventional rehabilitation group, and 0.65 ± 0.75 in Tibetan medicated bathing group.
M.W. and S.L. contributed equally to the study.
This study was funded by the Ministry of Science and Technology of the People’s Republic of China through the Twelfth Five-Year National Science and Technology Pillar Program (2013BAI10B04).
The authors declare no conflicts of interest.