[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597128":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":63,"collaborators":25,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":25,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Guangzhou University of Chinese Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Other: FSN Therapy Combined with Rehabilitation Training",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Other: Sham FSN Therapy Combined with Rehabilitation Training",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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.\n\nTwo needle insertion points will be selected approximately 5 cm distal to the cubital crease, corresponding to the flexor and extensor muscle groups.\n\nFollowing 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\u002Fmin for 2 minutes.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"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.\n\nFollowing 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.",[15],[31],{"name":32,"affiliation":33,"role":34},"Jian Sun","Guangzhou University of Chinese Medicine - Department of Acupuncture and Rehabilitation Clinical Medicine","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Cheng Chen","CONTACT","+8615007086691","1667277586@qq.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Guangdong Provincial Hospital of Chinese Medicine","RECRUITING","Guangzhou","Guangdong","510000","China","CN",{"type":51,"coordinates":52},"Point",[53,54],113.25,23.11667,{"lat":54,"lon":53},[57,61],{"name":58,"role":38,"phone":59,"phoneExt":25,"email":60},"Xiaoyan Li","020-81887233-35943","llbgs@gzucm.edu.cn",{"name":62,"role":34,"phone":25,"phoneExt":25,"email":25},"Shuxu Wu, associate chief physician",{"type":34,"investigatorFullName":37,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Principal Investigator","100597128","clinical-study-on-the-healing-of-distal-radius-fractures-with-conservative-treatment-assisted-by-fus-subcutaneous-needling-100597128",false,"NCT07054463","Clinical Study on the Healing of Distal Radius Fractures With Conservative Treatment Assisted by Fu's Subcutaneous Needling","Fu's Subcutaneous Needling-assisted Conservative Treatment for Distal Radius Fracture Healing: Protocol for a Randomized Controlled Trial","Inclusion Criteria:\n\nParticipants 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:\n\n1. Within 1 week post closed reduction and small splint immobilization treatment.\n2. Aged between 18 and 85 years (inclusive).\n3. Fracture caused by trauma.\n4. Acute fracture (≤2 weeks) or first-time fracture.\n5. No prior history of receiving Fu's subcutaneous needling therapy.\n6. Signed informed consent form obtained.\n\nExclusion Criteria:\n\n1. Pathological, open, or nonacute fractures (\\>2 weeks since injury).\n2. Patients with thrombocytopenia, bleeding tendency, or coagulation disorders (INR \\>1.5 or platelet count \\\u003C50×10⁹\u002FL).\n3. Cognitive impairment or psychiatric disorders affecting treatment compliance and follow-up.\n4. Local skin lesions, pregnancy, or lactation.\n5. History of syncope during Fu's subcutaneous needling therapy or intolerance to the procedure.\n6. Participation in other interventional clinical trials within the past 3 months.","ALL","18 Years","85 Years",{"count":76,"type":77},84,"ESTIMATED","INTERVENTIONAL",[80],"NA","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:\n\n* Does FSN therapy accelerate radiographic union compared to Sham FSN therapy?\n* Does FSN therapy improve functional outcomes (e.g., pain, swelling, joint mobility) and anatomical stability (e.g., volar tilt, radial height) in DRF patients?\n\nResearchers 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.\n\nParticipants will:\n\n1. Receive either FSN or Sham FSN therapy (12 sessions over 8 weeks) alongside standardized rehabilitation exercises.\n2. Undergo periodic assessments (weeks 2, 4, 6, 8, 10, and 12) for radiographic union, pain (VAS), swelling, wrist mobility, and functional status (DASH questionnaire).\n3. Follow a phased rehabilitation protocol, including finger\u002Fshoulder exercises (weeks 1-3), gentle wrist movements (weeks 4-5), and resistance training (week 6 onward).",[83],"Distal Radius Fractures",[85,86,87],"Fu's subcutaneous needle therapy","distal radius fractures","conservative treatment","2025-08-18",{"date":90,"type":91},"2025-08-19","ACTUAL",{"date":93,"type":91},"2025-04-15",{"date":95,"type":77},"2027-05",{"name":5,"class":6},1]