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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorGuangzhou University of Chinese Medicine

About this trial

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).

Eligibility criteria

Qualifiers

Within 1 week post closed reduction and small splint immobilization treatment.

Aged between 18 and 85 years (inclusive).

Fracture caused by trauma.

Acute fracture (≤2 weeks) or first-time fracture.

Disqualifiers

Pathological, open, or nonacute fractures (>2 weeks since injury).

Patients with thrombocytopenia, bleeding tendency, or coagulation disorders (INR >1.5 or platelet count <50×10⁹/L).

Cognitive impairment or psychiatric disorders affecting treatment compliance and follow-up.

Local skin lesions, pregnancy, or lactation.

Trial design

Treatments tested in this trial

  • FSN Therapy Combined with Rehabilitation Training
  • Sham FSN Therapy Combined with Rehabilitation Training

Treatment groups

84 Participants
are divided into 2 treatment groups