Distal Radius Fractures
Conditions
Keywords
Fu's subcutaneous needle therapy, distal radius fractures, conservative treatment
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).
Interventions
OTHERFSN 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 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.
OTHERSham 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-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.
Sponsors
Guangzhou University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactCheng Chen
Outcome results
None listed