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

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

This trial will test whether adding Fu's subcutaneous needling to standard rehabilitation helps adults (18–85) heal distal radius fractures after closed reduction and splinting.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Guangzhou University of Chinese Medicine (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07054463 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults 18–85 with a first acute distal radius fracture (≤2 weeks) treated with closed reduction and splinting who can provide informed consent and have not previously received FSN.

Not a fit: Patients with open, pathological, or nonacute (>2 weeks) fractures, those with significant bleeding or clotting disorders, or patients who require immediate surgical fixation are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, FSN could speed radiographic healing and improve pain, mobility, and anatomical alignment after non-surgical treatment of distal radius fractures.

How similar studies have performed: There are limited small studies and case reports suggesting FSN and related needling techniques can improve musculoskeletal pain and function, but robust randomized evidence showing accelerated fracture union is currently lacking.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

• 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

Conditions Distal Radius Fractures; Fu' s subcutaneous needle therapy; distal radius fractures; conservative treatment