Fu's subcutaneous needling-assisted conservative treatment for distal radius fracture healing: protocol for a randomized controlled trial
Abstract
Background: Closed reduction is often used to treat distal radius fractures (DRFs). After that, splint immobilization is used to keep the bone in the right position. But, long-term immobilization can cause problems like joint stiffness, long-lasting swelling, and slow bone healing. Rehabilitation training is a commonly employed recovery modality following conservative management of fractures. However, its efficacy is often suboptimal, primarily attributable to two key factors: nonstandardized rehabilitation protocol design and poor patient compliance with prescribed training regimens in terms of both adherence to schedule and completion of required exercise dosage. Earlier studies show that Fu's Subcutaneous Needling (FSN) therapy can lessen wrist pain and swelling, and also improve joint movement in patients with fractures of DRFs. But we need more evidence to prove it works. This trial wants to see if combining FSN therapy with rehabilitation training can help promote fracture healing and improve post-fracture symptoms in DRFs better and safer when added to conservative treatment, compared to using sham FSN therapy with rehab exercises.
Methods and analysis: This single-center, sham-controlled clinical trial will enroll 84 eligible patients, randomly allocated to two groups (n = 42). The intervention group will receive FSN therapy, while the control group will undergo sham FSN therapy. The treatment schedule includes three sessions in the first week post-reduction, two…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 84 participants or records.
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