Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 28, 2024
Open Peer Review Period: Jan 28, 2024 - Mar 24, 2024
Date Accepted: Jan 24, 2025
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Evaluation of the efficacy of Ru-Yi-Jin-Huang-Saan on Colles’ fracture after surgery: protocol for a randomized, double-blind, placebo-controlled trial
ABSTRACT
Background:
Colles’ fracture, a common wrist injury, often requires surgical intervention. Post-surgery, patients may experience persistent pain and reduced wrist function, potentially resulting in long-term disability. In clinical practice, Traditional Chinese Medicine practitioners frequently employ Ru-Yi-Jin-Huang-Saan (RYJHS) to treat such patients in Taiwan. RYJHS is a traditional Chinese herbal formula with a history spanning centuries, primarily utilized topically for the treatment of bone fractures and promotion of healing. However, there is currently a lack of substantial clinical evidence supporting its efficacy in the management of post-surgical Colles’ fractures. To the best of our knowledge, there are no studies evaluating the clinical effectiveness of RYJHS.
Objective:
This study aims to investigate the therapeutic potential of RYJHS in post-surgical Colles’ fracture cases. An additional objective is to provide an alternative treatment option for post-operative patients unable to take anti-inflammatory and pain relief medications.
Methods:
This is a protocol for a randomized, double-blind, placebo-controlled trial. One hundred post-operative Colles’ fracture patients, aged between 20 and 80, will be recruited for this study. They will be randomly assigned to either the experimental or control group in a 1:1 allocation ratio. Both groups will receive standard post-operative Colles’ fracture treatment. The primary outcome measure will assess wrist functional recovery using the Patient-Rated Wrist Evaluation (PRWE) score. Secondary outcomes will include C-reactive protein (CRP) levels and ultrasound measurements of wrist swelling. All of these examinations will be assessed at baseline, 3 days later, and 6 days later after surgery. Additionally, the Dyshidrotic Eczema Area and Severity Index (DASI) will be used to monitor for adverse skin reactions.
Results:
The protocol was registered at Clinical Trials.gov on December 6, 2022. It was performed in accordance with the approved guidelines and regulations of the participating institutions. Recruitment began in May 2023. Data collection is expected to conclude in May 2025. Study completion is expected in December 2025.
Conclusions:
This is the first protocol discussing the assessment of the therapeutic efficacy and safety of topical traditional Chinese medicine in post-fracture surgical patients. The protocol will establish an integrated care model that combines both traditional Chinese medicine and Western medicine for post-fracture cases. Clinical Trial: ClinicalTrials.gov NCT05638360
Citation
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