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

NCT ID: NCT07054463

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2027-05-31

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).

Conditions

Distal Radius Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

FSN Therapy Combined with Rehabilitation Training

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Sham FSN Therapy Combined with Rehabilitation Training

Intervention Type: 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.

Interventions

FSN 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.

Intervention Type: OTHER

Sham 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou University of Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Cheng Chen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Sun

Role: PRINCIPAL_INVESTIGATOR

Guangzhou University of Chinese Medicine - Department of Acupuncture and Rehabilitation Clinical Medicine

Locations

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Cheng Chen

Role: CONTACT

1667277586@qq.com

+8615007086691

Facility Contacts

Xiaoyan Li

Role: primary

llbgs@gzucm.edu.cn

020-81887233-35943

Other Identifiers

YF2025-126-01

Identifier Type: -

Identifier Source: org_study_id