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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FSN Therapy Combined with Rehabilitation Training Group | Experimental | 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. |
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| Sham FSN Combined with Rehabilitation Training Group | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FSN Therapy Combined with Rehabilitation Training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | Scored from 0 to 10, with higher scores indicating more severe pain. | From enrollment to the end of treatment at 8 weeks |
| Swelling Severity Scale | Graded as 0 (no swelling), 1 (mild swelling), 2 (moderate swelling), or 3 (severe swelling). |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng Chen | Contact | +8615007086691 | 1667277586@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Sun | Guangzhou University of Chinese Medicine - Department of Acupuncture and Rehabilitation Clinical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| Sham FSN Therapy Combined with Rehabilitation Training | Other | 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. |
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| From enrollment to the end of treatment at 8 weeks |
| Wrist Joint Range of Motion (ROM) | Measured using a goniometer for dorsiflexion, palmar flexion, radial deviation, and ulnar deviation. | From enrollment to the end of treatment at 8 weeks |
| 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. | From enrollment to the end of treatment at 8 weeks |
| Radial height | 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. | From enrollment to the end of treatment at 8 weeks |
| Ulnar Variance | 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. | From enrollment to the end of treatment at 8 weeks |
| Radial Inclination (Ulnar Deviation Angle) | 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. | From enrollment to the end of treatment at 8 weeks |
| Volar Tilt (Palmar Inclination Angle) | 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. | From enrollment to the end of treatment at 8 weeks |
| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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