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

Not Applicable

Recruiting

• Conditions: Distal Radius Fractures

• Registration Number: NCT07054463
• Lead Sponsor: Guangzhou University of Chinese Medicine

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-15
• Study First Submitted: 2025-06-19
• Study First Submitted QC: 2025-06-27
• Study First Posted: 2025-07-08
• Last Update Submitted: 2025-08-18
• Last Update Posted: 2025-08-19
• Primary Completion: 2026-12
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the modified Radiographic Union Scale for Tibial Fractures (RUST)	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).

Secondary Outcome Measures

Name	Time	Method
Ulnar Variance	From enrollment to the end of treatment at 8 weeks	On posteroanterior (PA) wrist radiographs, the distance between two lines perpendicular to the longitudinal axis of the radius: one at the level of the distal radial articular surface and the other at the most distal point of the ulnar head.
Visual Analog Scale (VAS)	From enrollment to the end of treatment at 8 weeks	Scored from 0 to 10, with higher scores indicating more severe pain.
Swelling Severity Scale	From enrollment to the end of treatment at 8 weeks	Graded as 0 (no swelling), 1 (mild swelling), 2 (moderate swelling), or 3 (severe swelling).
Wrist Joint Range of Motion (ROM)	From enrollment to the end of treatment at 8 weeks	Measured using a goniometer for dorsiflexion, palmar flexion, radial deviation, and ulnar deviation.
Disabilities of the Arm, Shoulder and Hand (DASH)	From enrollment to the end of treatment at 8 weeks	The DASH questionnaire is a tool used to assess upper limb functional status, symptom severity, and disability levels. It consists of 30 items evaluating difficulties in performing physical activities due to upper limb problems during the past week, including the severity of activity-related pain, symptoms such as pain, numbness, stiffness, and weakness, as well as the impact on work, daily activities, sleep, and psychological state. The DASH score ranges from 0 to 100, with higher scores indicating more severe disability.
Radial height	From enrollment to the end of treatment at 8 weeks	On posteroanterior (PA) wrist radiographs, the distance between the tip of the radial styloid process and a line connecting the dorsal and volar edges of the lunate fossa, perpendicular to the longitudinal axis of the radial shaft.
Radial Inclination (Ulnar Deviation Angle)	From enrollment to the end of treatment at 8 weeks	On posteroanterior (PA) wrist radiographs, the angle between a line connecting the tip of the radial styloid process and the midpoint of the dorsal and volar edges of the lunate fossa, and a line perpendicular to the longitudinal axis of the radial shaft.
Volar Tilt (Palmar Inclination Angle)	From enrollment to the end of treatment at 8 weeks	On lateral wrist radiographs, the angle between a line connecting the most distal points of the volar and dorsal articular surfaces and a line perpendicular to the longitudinal axis of the distal radius.

Trial Locations

Locations (1)

Guangdong Provincial Hospital of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China