Original Study
Tibetan Medicated Bathing Therapy for Patients With Post-stroke Limb Spasticity: A Randomized Controlled Clinical Trial

https://doi.org/10.1016/j.jamda.2019.10.018Get rights and content

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).

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

References (20)

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Cited by (3)

  • 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 Communications
    Citation 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.

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