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

Guangzhou University of Chinese Medicine

Status: Enrolling

Conditions: Distal Radius Fractures

Treatments: Other: FSN Therapy Combined with Rehabilitation Training; Other: Sham FSN Therapy Combined with Rehabilitation Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07054463

YF2025-126-01

Details and patient eligibility

About

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).

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

84 participants in 2 patient groups

FSN Therapy Combined with Rehabilitation Training Group

Experimental group

Description:

Patients randomized to the FSN group will receive additional FSN therapy to the immobilized region alongside standard rehabilitation. Prior to treatment, blinding will be ensured through the use of eye masks. The treatment protocol will consist of 12 sessions over 8 weeks: three sessions in the first week (administered every other day), two weekly sessions during weeks 2-3, and one weekly session during weeks 4-8.

Treatment:

Other: FSN Therapy Combined with Rehabilitation Training

Sham FSN Combined with Rehabilitation Training Group

Sham Comparator group

Description:

Patients randomized to this group will undergo the sham intervention in the same predetermined anatomical region. Prior to the procedure, eye masks will be applied to ensure blinding. The Sham FSN device, featuring a blunt tip, will generate a pricking sensation upon spring-loaded actuator deployment without actual skin penetration, maintaining parallel alignment to the epidermal surface. The treatment protocol will consist of 12 sessions over 8 weeks: three sessions in the first week (administered every other day), two weekly sessions during weeks 2-3, and one weekly session during weeks 4-8.

Treatment:

Other: Sham FSN Therapy Combined with Rehabilitation Training