Distal Radius FracturesNCT07054463
Clinical Study on the Healing of Distal Radius Fractures With Conservative Treatment Assisted by Fu's Subcutaneous Needling
A study testing FSN Therapy Combined with Rehabilitation Training in people with Distal Radius Fractures, run by Guangzhou University of Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- FSN Therapy Combined with Rehabilitation Training
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- No prior history of receiving Fu's subcutaneous needling therapy.
- Signed informed consent form obtained.
Who cannot join
- 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.
- History of syncope during Fu's subcutaneous needling therapy or intolerance to the procedure.
- Participation in other interventional clinical trials within the past 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510000
Xiaoyan Li, 020-81887233-35943, llbgs@gzucm.edu.cn
Shuxu Wu, associate chief physician
About this study
Official title: Fu's Subcutaneous Needling-assisted Conservative Treatment for Distal Radius Fracture Healing: Protocol for a Randomized Controlled Trial
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?
Read more
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:
- Receive either FSN or Sham FSN therapy (12 sessions over 8 weeks) alongside standardized rehabilitation exercises.
- Undergo periodic assessments (weeks 2, 4, 6, 8, 10, and 12) for radiographic union, pain (VAS), swelling, wrist mobility, and functional status (DASH questionnaire).
- 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
- Being tested
- FSN Therapy Combined with Rehabilitation Training, Sham FSN Therapy Combined with Rehabilitation Training
- Keywords
- Fu's subcutaneous needle therapy, distal radius fractures, conservative treatment
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSN Therapy Combined with Rehabilitation TrainingOther
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 Therapy Combined with Rehabilitation TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: FSN Therapy Combined with Rehabilitation Training |
| 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. Receives: Other: Sham FSN Therapy Combined with Rehabilitation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (8)
Visual Analog Scale (VAS)
Scored from 0 to 10, with higher scores indicating more severe pain.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start15 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Chen, Guangzhou University of Chinese Medicine
- Investigators
- Jian Sun, Principal investigator, Guangzhou University of Chinese Medicine - Department of Acupuncture and Rehabilitation Clinical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054463
- Sponsor's protocol ID
- YF2025-126-01
- Status last verified
- Apr 2025
- First submitted
- 19 Jun 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fu's Subcutaneous Needling-assisted Conservative Treatment for Distal Radius Fracture Healing: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07054463
- Acronym / sponsor ID
- YF2025-126-01
- Conditions
- Distal Radius Fractures
- Keywords
- Fu's subcutaneous needle therapy, distal radius fractures, conservative treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Guangzhou University of Chinese MedicineUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Receive either FSN or Sham FSN therapy (12 sessions over 8 weeks) alongside standardized rehabilitation exercises.
- Undergo periodic assessments (weeks 2, 4, 6, 8, 10, and 12) for radiographic union, pain (VAS), swelling, wrist mobility, and functional status (DASH questionnaire).
- Follow a phased rehabilitation protocol, including finger/shoulder exercises (weeks 1-3), gentle wrist movements (weeks 4-5), and resistance training (week 6 onward).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FSN Therapy Combined with Rehabilitation Training Group | Experimental | Other: FSN Therapy Combined with Rehabilitation TrainingPatients 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. |
| Sham FSN Combined with Rehabilitation Training Group | Sham comparator | Other: Sham FSN Therapy Combined with Rehabilitation TrainingPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (6 listed)
- 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.
- History of syncope during Fu's subcutaneous needling therapy or intolerance to the procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FSN Therapy Combined with Rehabilitation TrainingPrior 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. | Other | FSN Therapy Combined with Rehabilitation Training Group |
| Sham FSN Therapy Combined with Rehabilitation TrainingPatients 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. | Other | Sham FSN Combined with Rehabilitation Training Group |
Primary outcome
the modified Radiographic Union Scale for Tibial Fractures (RUST)
Time frame: 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).
8 secondary outcomes
Visual Analog Scale (VAS)
Time frame: From enrollment to the end of treatment at 8 weeks
Swelling Severity Scale
Time frame: From enrollment to the end of treatment at 8 weeks
Wrist Joint Range of Motion (ROM)
Time frame: From enrollment to the end of treatment at 8 weeks
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: From enrollment to the end of treatment at 8 weeks
Radial height
Time frame: From enrollment to the end of treatment at 8 weeks
Ulnar Variance
Time frame: From enrollment to the end of treatment at 8 weeks
Radial Inclination (Ulnar Deviation Angle)
Time frame: From enrollment to the end of treatment at 8 weeks
Volar Tilt (Palmar Inclination Angle)
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian Sun principal investigator
Guangzhou University of Chinese Medicine - Department of Acupuncture and Rehabilitation Clinical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FSN Therapy Combined with Rehabilitation Training in people with Distal Radius Fractures, run by Guangzhou University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheng Chen (+8615007086691, 1667277586@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the modified Radiographic Union Scale for Tibial Fractures (RUST) (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.