Effectiveness of Tuina manipulation in patients with knee osteoarthritis: study protocol for a randomized controlled trial

Abstract

Background: Knee osteoarthritis (KOA) is a common musculoskeletal disorder. Previous studies reported that Tuina manipulation showed benificial effects in management of musculoskeletal disorders . However, there was no enough evidence to support the effectiveness of Tuina manipulation for KOA. The purpose of this study is to evaluate the effectiveness of Tuina manipulation on pain and dysfunction of patients with KOA compared with health care education.Methods/Design: This study is a single-centre, two-arm, open-label randomized controlled trial (RCT). A total of 170 eligible KOA patients will be randomly assigned to the Tuina manipulation group or the health care education group in a 1:1 ratio. In the Tuina manipulation group, patients will receive a 30 min treatment including pain point assessment and manual therapy. The health care education group will receive 45 min of lecture and discussion. All treatments will be conducted three times a week for four weeks. The primary outcome is the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcomes include the McGill Pain Questionnaire (MPQ) and 36-item Short-Form Health Survey (SF-36). The results will show the evidence of the effect of Tuina manipulation for KOA compared with health care education.Discussion: The design and methodology of the trial is rigorous and allows the collection of valuable data to assess the effect of a specific Tuina regimen for the treatment of KOA. Therefore, the trial will provide a solid foundation for future clinical research on KOA and Tuina therapy.Trial registration: This trial was registered with the Chinese Clinical Trial Registry on 24 February 2020 (ChiCTR2000030154), http://www.chictr.org.cn/index.aspx