Effectiveness of Yijinjing exercise in the treatment of early-stage knee osteoarthritis: a randomized controlled trial protocol

Guangxin Guo; Yihang Wang; Xiruo Xu; Kaiqiu Lu; Xuanying Zhu; Yijia Gu; Guangpu Yang; Fei Yao; Min Fang

doi:10.1136/bmjopen-2023-074508

Effectiveness of Yijinjing exercise in the treatment of early-stage knee osteoarthritis: a randomized controlled trial protocol

BMJ Open. 2024 Mar 7;14(3):e074508. doi: 10.1136/bmjopen-2023-074508.

Authors

Guangxin Guo^{1

2}, Yihang Wang², Xiruo Xu², Kaiqiu Lu², Xuanying Zhu³, Yijia Gu⁴, Guangpu Yang⁵, Fei Yao^{1

2

6}, Min Fang^{7

6}

Affiliations

¹ Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
² School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
³ Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
⁴ School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
⁵ School of Basic Medical Sciences, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
⁶ Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
⁷ Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China fangmin19650510@163.com.

Abstract

Introduction: Knee osteoarthritis (KOA) is still a challenging degenerative joint disease with high morbidity and disease burden. Early-stage KOA, the focus of this study, could present a Window of Opportunity to arrest the disease process and reduce the disease burden. Yijinjing exercise is an important part of physical and psychological therapies in Traditional Chinese Exercise and may be an effective treatment. However, there is no clinical efficacy assessment of Yijinjing exercise for patients with early-stage KOA. Therefore, we designed a randomised controlled trial to evaluate the effectiveness of Yijinjing exercise on patients with early-stage KOA.

Methods and analysis: This is a parallel-design, two-arm, analyst assessor-blinded, randomised controlled trial. In total, 60 patients with early-stage KOA will be recruited and randomly assigned to the Yijinjing exercise group (n=30) and health education group (n=30) at a ratio of 1:1, receiving 12 weeks of Yijinjing exercise or health education accordingly. The primary outcome will be measured with the Western Ontario and McMaster Universities Osteoarthritis Index, and the secondary outcomes will include the Visual Analogue Scale, Short-Form 36 Item Health Survey Questionnaire, Beck Depression Inventory, Perceived Stress Scale, Berg Balance Scale, and Gait Analysis for a comprehensive assessment. Outcome measures are collected at baseline, at 12 week ending intervention and at the 12 week, 24 week and 48 week ending follow-up. The primay time point will be 12 weeks postintervention. Adverse events will be recorded for safety assessment.

Ethics and dissemination: This study has been approved by the ethical application of the Shanghai Municipal Hospital of Traditional Chinese Medicine Ethics Committee (2021SHL-KY-78).

Trial registration number: ChiCTR2200065178.

Keywords: COMPLEMENTARY MEDICINE; Knee; Musculoskeletal disorders; SPORTS MEDICINE.

Publication types

Clinical Trial Protocol

MeSH terms

China
Humans
Osteoarthritis, Knee* / complications
Osteoarthritis, Knee* / therapy
Outcome Assessment, Health Care
Psychological Tests*
Randomized Controlled Trials as Topic
Self Report*
Treatment Outcome

Supplementary concepts

Perceived Stress Scale