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 sessions per week in weeks 2–3, and one session per week in weeks 4–8, totaling 12 sessions. The primary outcome is the time to radiographic union, assessed using a modified Radiographic Union Score for Tibial fractures (RUST) adapted for distal radius fractures. Secondary outcomes include complications (e.g., pain, swelling), functional recovery (measured by the Disabilities of the Arm, Shoulder, and Hand [DASH] score), and radiographic parameters (e.g., volar tilt, radial height).
Discussion
This study is expected to validate the clinical value of FSN therapy as a safe and effective adjunctive approach for rehabilitation following DRFs, bridging the technical gap between conventional conservative treatment and functional recovery.