Effects of Integrated Traditional Chinese and Western Medicine on Knee Joint Functional Stability Reconstruction Following Anterior Cruciate Ligament Reconstruction : protocol for a assessor-blinded, randomized controlled trial

Introduction Anterior Cruciate Ligament Reconstruction (ACLR) imposes substantial socioeconomic and healthcare burdens worldwide. In China, Traditional Chinese Medicine (TCM) has emerged as a popular complementary and alternative medicine strategy to relive pain and functional stability. However, the current evidence is insufficient to support the efficacy of TCM in addressing knee pain and improving physical function. This trial aims to assess the clinical effectiveness of TCM.

and analysis A total of 132 patients, aged between 18 and 50 years, will be recruited from Shuguang hospital. Eligible participants will be randomly allocated to either the experimental group receiving integrated TCM-Western rehabilitation intervention five sessions or the control group receiving conventional rehabilitation intervention per week. Both groups will undergo a 4-week intervention phase, followed by a 4-week follow-up period. The primary outcome measure is the change from baseline in Lysholm Score, Knee Muscle Strength, the Knee Injury and Osteoarthritis Outcome Score (KOOS), effusion, Muscle Thickness, The modified Star Excursion Balance Test (SEBT), Knee Range of Motion (ROM), Knee Proprioception. All adverse events occurring during the trial will be promptly documented. Ethics and dissemination This study protocol has been approved by the Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Approval Number: 2024-1522-105-01). Prior to enrollment, written informed consent will be obtained from all eligible participants in accordance with ethical guidelines. Upon study completion, findings will be disseminated through peer-reviewed publications in academic journals and presented at relevant scientific conferences to ensure broad knowledge dissemination and contribute to evidence-based clinical practice. Trial registration The trial was registered on the Chinese Clinical Trial Platform (Registration No. ChiCTR2400085239) Funding Key Supporting Discipline Construction Projects in Shanghai’s Health System (2023ZDFC0301) Competing Interest Statement The authors have declared that no competing interests exist. Clinical Trial ChiCTR2400085239 Funding Statement Yes Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study protocol has been approved by the Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Approval Number: 2024-1522-105-01) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes Xinglai Zhang, 853296651{at}qq.com, Chen Chen, chensus2016{at}163.com, Guo Lu, 2968193249{at}qq.com, Hang Gao, 2374027175{at}qq.com, Jiayi Ren, 763388840{at}qq.com, Yuanjia Gu, 3105249962{at}qq.com, Shaohua Chen, 763717038{at}qq.com, Data Availability no data