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

Официальное название

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

Обзор

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).

Вмешательства

• Другое FSN Therapy Combined with Rehabilitation Training
  Prior to treatment, blinding will be ensured through the use of eye masks. Based on the "affected muscle theory," all forearm muscles within the splint-immobilized area will be considered as an affected muscle group and further subdivided into "flexor" and "extensor" subgroups according to functional anatomy. Two needle insertion points will be selected approximately 5 cm distal to the cubital crease, corresponding to the flexor and extensor muscle groups. Following standard disinfection of th
• Другое Sham FSN Therapy Combined with Rehabilitation Training
  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. Following standard aseptic preparation, the acupuncturist will stabilize the needle body with the non-domin

Первичные конечные точки

• the modified Radiographic Union Scale for Tibial Fractures (RUST) [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (8)

• Visual Analog Scale (VAS) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Swelling Severity Scale [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Wrist Joint Range of Motion (ROM) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Disabilities of the Arm, Shoulder and Hand (DASH) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Radial height [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Ulnar Variance [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Radial Inclination (Ulnar Deviation Angle) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Volar Tilt (Palmar Inclination Angle) [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

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:

• 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.
• No prior history of receiving Fu's subcutaneous needling therapy.
• Signed informed consent form obtained.

Критерии исключения

• 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.
• History of syncope during Fu's subcutaneous needling therapy or intolerance to the procedure.
• Participation in other interventional clinical trials within the past 3 months.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guangdong Provincial Hospital of Chinese Medicine — Гуанчжоу

Идентификаторы

NCT: NCT07054463 · YF2025-126-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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