Effect of Shi-Style Steaming and Bathing Decoction in Patients with Knee Osteoarthritis: Study Protocol for a Randomized Placebo-Controlled Trial

被引:0
|
作者
Zhang, Ran [1 ,2 ]
Lei, Ya-Jie [1 ,2 ]
Wen, Sheng-Yue [1 ,2 ]
Pang, Jian [1 ,2 ]
Cao, Yue-Long [1 ,2 ]
Zhang, Min [1 ,2 ]
Zhan, Hong-Sheng [1 ,2 ]
Lin, Xun [3 ]
Chen, Bo [1 ,2 ]
机构
[1] Shanghai Univ Tradit Chinese Med, Shis Ctr Orthoped & Traumatol, Shuguang Hosp, Shanghai, Peoples R China
[2] Shanghai Acad Tradit Chinese Med, Inst Orthoped & Traumatol, Shanghai, Peoples R China
[3] Shanghai Univ Tradit Chinese Med, Shanghai, Peoples R China
来源
JOURNAL OF PAIN RESEARCH | 2024年 / 17卷
基金
中国国家自然科学基金;
关键词
balneotherapy; traditional Chinese medicine; complementary and integrative medicine; randomized placebo-controlled trial; knee osteoarthritis; SPA THERAPY; FOLLOW-UP; EFFICACY; MANAGEMENT; SAFETY; SCALE; WOMAC; PAIN; RESPONSIVENESS; BALNEOTHERAPY;
D O I
10.2147/JPR.S466741
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Purpose: To prove more accurately that Chinese herbal bath therapy may be a safe, effective, simple alternative treatment modality for knee OA, we designed a randomized, double-blind, placebo-controlled trial to explore the effectiveness of SSBD for the relief of pain, daily activities, and quality of life in patients with knee OA. Patients and Methods: A single-center, 52-week, randomized controlled trial of SSBD versus placebo is being performed. A total of 200 patients with symptomatic knee OA will be randomly allocated to the SSBD treatment or placebo intervention group for 4 weeks. The two groups of patients are allowed to steam and bathe their knees once every other day, using one packet of SSBD each time, for 30 minutes, 3 times a week, for a total of 4 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale at 4 weeks is the primary outcome measure, and the secondary outcomes include WOMAC stiffness and function scores, the Lysholm knee scale score, quality of life, the Brief Pain Inventory score, the Patient's Global Impressions of Improvement Scale score and the Clinical Global Impressions of Severity scale score. The safety of the herbal medications will also be evaluated. Conclusion: We will discuss whether SSBD has greater advantages in terms of efficacy, safety, and patient overall perception than does placebo control in middle-aged and elderly patients with knee OA. The findings may provide new and valuable information about the efficacy and safety of Chinese herbal bath therapy in the treatment of knee osteoarthritis.
引用
收藏
页码:2851 / 2860
页数:10
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