Fu's Subcutaneous Needling-assisted Conservative Treatment for Distal Radius Fracture Healing: Protocol for a Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Fu's subcutaneous needling (FSN) therapy combined with rehabilitation exercises to aid healing after conservative treatment of distal radius fractures in adults aged 18 to 85. The study aims to find out whether FSN therapy speeds up bone healing seen on X-rays compared to a sham treatment and whether it improves pain, swelling, wrist movement, and anatomical stability. Participants are randomly assigned to receive either FSN therapy or a sham FSN therapy along with standard rehabilitation training. Both groups undergo 12 treatment sessions over 8 weeks, starting with three sessions in the first week, two sessions weekly during weeks 2 and 3, and one session weekly from weeks 4 to 8. FSN involves inserting needles under the skin near the affected forearm muscles and performing a sweeping motion, while the sham therapy mimics this without skin penetration. Rehabilitation exercises progress in phases from finger and shoulder movement to gentle wrist exercises and resistance training. During the study, participants will have regular assessments at weeks 2, 4, 6, 8, 10, and 12 to monitor bone healing via X-rays, pain levels, swelling, wrist range of motion, and functional ability using questionnaires. Researchers will measure outcomes such as radiographic healing scores and wrist function, with safety monitored throughout. The study lasts at least 12 weeks, combining treatment and follow-up to evaluate recovery after fracture.

Clinical Study on the Healing of Distal Radius Fractures With Conservative Treatment Assisted by Fu's Subcutaneous Needling