Fu's subcutaneous needling with rehabilitation to help heal distal radius fractures after closed reduction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional trial compares Fu's subcutaneous needling (FSN) plus standardized rehabilitation to a sham FSN procedure plus the same rehabilitation in adults with acute distal radius fractures treated non-surgically. Participants receive 12 sessions of FSN or sham therapy over 8 weeks and undergo periodic clinical and radiographic assessments, including radiographic union, pain, swelling, joint mobility, volar tilt, and radial height. Enrollment is limited to patients aged 18–85 within one week after closed reduction and splint immobilization, with follow-up visits scheduled at early time points (e.g., weeks 2 and 4) and later outcome assessments. The trial aims to see if FSN accelerates fracture union and leads to better functional and anatomical recovery compared with sham.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants meeting the diagnostic criteria for distal radius fractures as outlined in both the Evidence-Based Guidelines for Diagnosis and Treatment of Adult Distal Radius Fractures (2024) (10) and the clinical practice guidelines (CPG) jointly issued by the American Academy of Orthopaedic Surgeons (AAOS) and the American Society for Surgery of the Hand (ASSH) (11), while also satisfying the following conditions, will be eligible for enrollment:

1. Within 1 week post closed reduction and small splint immobilization treatment.
2. Aged between 18 and 85 years (inclusive).
3. Fracture caused by trauma.
4. Acute fracture (≤2 weeks) or first-time fracture.
5. No prior history of receiving Fu's subcutaneous needling therapy.
6. Signed informed consent form obtained.

Exclusion Criteria:

1. Pathological, open, or nonacute fractures (\>2 weeks since injury).
2. Patients with thrombocytopenia, bleeding tendency, or coagulation disorders (INR \>1.5 or platelet count \<50×10⁹/L).
3. Cognitive impairment or psychiatric disorders affecting treatment compliance and follow-up.
4. Local skin lesions, pregnancy, or lactation.
5. History of syncope during Fu's subcutaneous needling therapy or intolerance to the procedure.
6. Participation in other interventional clinical trials within the past 3 months.

Where it's running

• Guangdong Provincial Hospital of Chinese Medicine
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Jian Sun — Guangzhou University of Chinese Medicine - Department of Acupuncture and Rehabilitation Clinical Medicine
• Study coordinator: Cheng Chen
• Email: 1667277586@qq.com
• Phone: +8615007086691

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.