Clinical Trial

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

Recruiting
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Summary
The goal of this clinical trial is to evaluate the efficacy and safety of Fu's subcutaneous needling (FSN) therapy combined with rehabilitation exercises in promoting fracture healing after conservative treatment of distal radius fractures (DRFs) in adult patients (aged 18-85 years) with acute DRFs. The main questions it aims to answer are: * Does FSN therapy accelerate radiographic union compared to Sham FSN therapy? * Does FSN therapy improve functional outcomes (e.g., pain, swelling, joint mobility) and anatomical stability (e.g., volar tilt, radial height) in DRF patients? Researchers will compare the FSN therapy plus rehabilitation training group to the Sham FSN therapy plus rehabilitation training group to see if FSN provides superior clinical benefits in fracture healing and functional recovery. Participants will: 1. Receive either FSN or Sham FSN therapy (12 sessions over 8 weeks) alongside standardized rehabilitation exercises. 2. Undergo periodic assessments (weeks 2, 4, 6, 8, 10, and 12) for radiographic union, pain (VAS), swelling, wrist mobility, and functional status (DASH questionnaire). 3. Follow a phased rehabilitation protocol, including finger/shoulder exercises (weeks 1-3), gentle wrist movements (weeks 4-5), and resistance training (week 6 onward).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-27.
Trial Details
NCT Number NCT07054463
Lead Sponsor Guangzhou University of Chinese Medicine
Conditions Distal Radius Fractures
Enrollment 84 participants
Start Date 2025-04-15
Primary Completion 2026-12 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2025-08-19