Fu's Subcutaneous Needling-assisted Conservative Treatment for Distal Radius Fracture Healing: Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- the modified Radiographic Union Scale for Tibial Fractures (RUST)
研究概览
简要总结
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:
- Receive either FSN or Sham FSN therapy (12 sessions over 8 weeks) alongside standardized rehabilitation exercises.
- Undergo periodic assessments (weeks 2, 4, 6, 8, 10, and 12) for radiographic union, pain (VAS), swelling, wrist mobility, and functional status (DASH questionnaire).
- Follow a phased rehabilitation protocol, including finger/shoulder exercises (weeks 1-3), gentle wrist movements (weeks 4-5), and resistance training (week 6 onward).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
FSN Therapy Combined with Rehabilitation Training Group
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.
干预措施: FSN Therapy Combined with Rehabilitation Training (Other)
Sham FSN Combined with Rehabilitation Training Group
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.
干预措施: Sham FSN Therapy Combined with Rehabilitation Training (Other)
结局指标
主要结局
the modified Radiographic Union Scale for Tibial Fractures (RUST)
时间窗: From enrollment to the end of treatment at 8 weeks
The modified RUST (Radiographic Union Scale for Tibial fractures) scoring system will be utilized to evaluate each of the four cortices on both anteroposterior and lateral wrist radiographs, assigning scores of 1 (no callus), 2 (presence of callus), 3 (bridging callus), or 4 (fracture remodeled and no longer visible). The sum of the four cortical scores yields a total ranging from 4 to 16 points, with a score of 13 points indicating fracture union. Assessments will be conducted at baseline, as well as at 2, 4, 6, and 8 weeks post-treatment. Time to osseous consolidation will be expressed as the median duration with the corresponding interquartile range (IQR).
次要结局
- Ulnar Variance(From enrollment to the end of treatment at 8 weeks)
- Visual Analog Scale (VAS)(From enrollment to the end of treatment at 8 weeks)
- Swelling Severity Scale(From enrollment to the end of treatment at 8 weeks)
- Wrist Joint Range of Motion (ROM)(From enrollment to the end of treatment at 8 weeks)
- Disabilities of the Arm, Shoulder and Hand (DASH)(From enrollment to the end of treatment at 8 weeks)
- Radial height(From enrollment to the end of treatment at 8 weeks)
- Radial Inclination (Ulnar Deviation Angle)(From enrollment to the end of treatment at 8 weeks)
- Volar Tilt (Palmar Inclination Angle)(From enrollment to the end of treatment at 8 weeks)
研究者
Cheng Chen
Principal Investigator
Guangzhou University of Chinese Medicine