NCT07054463 Clinical Study on the Healing of Distal Radius Fractures With Conservative Treatment Assisted by Fu's Subcutaneous Needling
| NCT ID | NCT07054463 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guangzhou University of Chinese Medicine |
| Condition | Distal Radius Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2025-04-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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.
Contact & Investigator
Jian Sun
PRINCIPAL INVESTIGATOR
Guangzhou University of Chinese Medicine - Department of Acupuncture and Rehabilitation Clinical Medicine
Frequently Asked Questions
Who can join the NCT07054463 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Distal Radius Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07054463 currently recruiting?
Yes, NCT07054463 is actively recruiting participants. Contact the research team at 1667277586@qq.com for enrollment information.
Where is the NCT07054463 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07054463 clinical trial?
NCT07054463 is sponsored by Guangzhou University of Chinese Medicine. The principal investigator is Jian Sun at Guangzhou University of Chinese Medicine - Department of Acupuncture and Rehabilitation Clinical Medicine. The trial plans to enroll 84 participants.