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).
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.
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.
Parallel
FSN Therapy Combined with Rehabilitation Training
Other interventionPrior 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 the insertion device and sites, a disposable FSN needle will be inserted subcutaneously into the superficial fascial layer, with the needle tip directed toward the affected muscle group. The needle core will then be retracted into the soft tube, ensuring no tip exposure, and the tube base will be secured within the handle slot. A 30° fan-shaped sweeping motion will be performed bilaterally at a frequency of 100 sweeps/min for 2 minutes.
Sham FSN Therapy Combined with Rehabilitation Training
Other interventionPatients 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-dominant hand while simulating insertion motions with the dominant hand, replicating the authentic FSN technique by retracting the stylet to the locking groove. The practitioner will then perform sweeping manipulations (ensuring continuous dermal contact during the procedure). Both the operational protocol and treatment course will be identical to those of the genuine FSN intervention group.
the modified Radiographic Union Scale for Tibial Fractures (RUST)
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).
Visual Analog Scale (VAS)
Scored from 0 to 10, with higher scores indicating more severe pain.
Swelling Severity Scale
Graded as 0 (no swelling), 1 (mild swelling), 2 (moderate swelling), or 3 (severe swelling).
Wrist Joint Range of Motion (ROM)
Measured using a goniometer for dorsiflexion, palmar flexion, radial deviation, and ulnar deviation.
Disabilities of the Arm, Shoulder and Hand (DASH)
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.
Click on the lead sponsor to view all of their trials.
