[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655037":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":38,"studyPopulation":27,"armGroups":39,"interventions":53,"overallOfficials":27,"centralContacts":67,"locations":73,"responsibleParty":91,"collaborators":27,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":27,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":76,"whyStopped":27,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Kanuni Sultan Suleyman Training and Research Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Pain Intensity Measured by Visual Analog Scale (VAS)","Pain intensity will be assessed using a 0-10 cm Visual Analog Scale (VAS). Change in VAS score over time will be compared between the active ESWT and sham ESWT groups.","Baseline, Week 5, and Week 12",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"Change in Upper Extremity Function Measured by QuickDASH","Upper extremity function will be assessed using the QuickDASH questionnaire. Changes over time will be compared between the active ESWT and sham ESWT groups.",": Baseline, Week 5, and Week 12",{"measure":19,"description":20,"timeFrame":12},"Change in Wrist Range of Motion","Wrist flexion, extension, radial deviation, and ulnar deviation will be measured using a goniometer.",{"measure":22,"description":23,"timeFrame":12},"Change in Hand Grip Strength","Hand grip strength will be measured using a hand dynamometer and recorded in kilograms.",{"measure":25,"description":26,"timeFrame":12},"Change in Edema of the Affected Upper Extremity","Edema will be assessed using circumferential measurement of the affected extremity",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":31,"primaryPurpose":32,"observationalModel":27,"timePerspective":27,"maskingInfo":33},"RANDOMIZED","PARALLEL","Participants will be randomized in a 1:1 ratio to two parallel groups: standard rehabilitation plus active ESWT or standard rehabilitation plus sham ESWT.","TREATMENT",{"masking":34,"maskingDescription":35,"whoMasked":36},"SINGLE","The outcome assessor will remain unaware of participants' treatment allocation throughout the study.",[37],"OUTCOMES_ASSESSOR","This prospective, randomized, assessor-blinded, sham-controlled, two-arm clinical trial is designed to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) in patients with complex regional pain syndrome type I (CRPS-I) following distal radius fracture.\n\nSixty adults aged 18 to 75 years who meet the clinical diagnostic criteria for CRPS-I following distal radius fracture will be enrolled and randomized in a 1:1 ratio to an active ESWT group or a sham ESWT group. Both groups will receive a standard rehabilitation program consisting of range-of-motion exercises, stretching exercises, desensitization techniques, edema-control approaches, functional hand exercises, and a home exercise program.\n\nParticipants in the active ESWT group will receive standard rehabilitation plus active ESWT once weekly for a total of five sessions. ESWT will be applied to the affected distal forearm, wrist, and painful soft-tissue areas. Participants in the sham group will undergo the same treatment schedule and procedure using the same device, but without therapeutic energy delivery.\n\nClinical assessments will be performed by an assessor who is unaware of treatment allocation. Evaluations will be conducted at baseline, at the end of treatment at week 5, and at the follow-up visit at week 12. The primary outcome will be change in pain intensity measured using the Visual Analog Scale (VAS). Secondary outcomes will include upper extremity function assessed using the QuickDASH, wrist range of motion, hand grip strength, and edema assessed by circumferential measurement.\n\nAdverse events, treatment tolerability, and any additional treatment requirements during follow-up will be recorded. The study aims to determine whether adding ESWT to standard rehabilitation provides greater improvement in pain and functional outcomes than standard rehabilitation with sham ESWT.",[40,47],{"label":41,"type":42,"description":43,"interventionNames":44},"Standard Rehabilitation + Active ESWT","EXPERIMENTAL","Participants will receive a standard rehabilitation program consisting of range-of-motion exercises, stretching exercises, desensitization techniques, edema-control approaches, functional hand exercises, and a home exercise program. In addition, active extracorporeal shock wave therapy (ESWT) will be applied once weekly for a total of five sessions to the affected distal forearm, wrist, and painful soft-tissue areas.",[45,46],"Device: Active ESWT will be applied once weekly for a total of five sessions to the affected distal forearm, wrist, and painful soft-tissue areas.Associated Arm: Standard Rehabilitation + Active ESWT","Other: Standard Rehabilitation Program",{"label":48,"type":49,"description":50,"interventionNames":51},"Standard Rehabilitation + Sham ESWT","SHAM_COMPARATOR","Participants will receive the same standard rehabilitation program as the active ESWT group. In addition, sham extracorporeal shock wave therapy (ESWT) will be applied once weekly for a total of five sessions using the same device, treatment duration, and application procedure as the active ESWT group, but without therapeutic energy delivery.",[52,46],"Device: Sham Extracorporeal Shock Wave Therapy (Sham ESWT)",[54,59,63],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":27},"DEVICE","Active ESWT will be applied once weekly for a total of five sessions to the affected distal forearm, wrist, and painful soft-tissue areas.Associated Arm: Standard Rehabilitation + Active ESWT","Active ESWT will be applied once weekly for a total of five sessions to the affected distal forearm, wrist, and painful soft-tissue areas. Treatment will be delivered at a low-to-moderate energy level according to device safety recommendations and patient tolerance. Unlike sham ESWT, therapeutic energy will be delivered.",[41],{"type":55,"name":60,"description":61,"armGroupLabels":62,"otherNames":27},"Sham Extracorporeal Shock Wave Therapy (Sham ESWT)","Sham ESWT will be administered once weekly for a total of five sessions using the same device, treatment duration, application procedure, and session schedule as active ESWT. However, no therapeutic energy will be delivered during the sham intervention.",[48],{"type":6,"name":64,"description":65,"armGroupLabels":66,"otherNames":27},"Standard Rehabilitation Program","The standard rehabilitation program will include range-of-motion exercises, stretching exercises, desensitization techniques, edema-control approaches, functional hand exercises, and a home exercise program.",[41,48],[68],{"name":69,"role":70,"phone":71,"phoneExt":27,"email":72},"Dilek Ün Oğuzhanasiltürk, MD","CONTACT","+90 5056367184","dilekunoguzhan@gmail.com",[74],{"facility":75,"status":76,"city":77,"state":77,"zip":78,"country":79,"countryCode":27,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey","RECRUITING","Istanbul","34303","Turkey (Türkiye)",{"type":81,"coordinates":82},"Point",[83,84],28.94966,41.01384,{"lat":84,"lon":83},[87,89],{"name":69,"role":70,"phone":88,"phoneExt":27,"email":72},"+905056367184",{"name":69,"role":90,"phone":27,"phoneExt":27,"email":27},"PRINCIPAL_INVESTIGATOR",{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Dilek ün oguzhanasilturk","Physical Medicine and Rehabilitation Specialist","100655037","eswt-for-crps-i-after-distal-radius-fracture-100655037",false,"NCT07807852","ESWT for CRPS-I After Distal Radius Fracture","EXTRACORPOREAL SHOCKWAVE THERAPY FOR COMPLEX REGIONAL PAIN SYNDROME TYPE I FOLLOWING DISTAL RADIUS FRACTURE: A PROSPECTIVE RANDOMIZED SHAM-CONTROLLED TRIAL","CRPS-ESWT","Inclusion Criteria:\n\nge between 18 and 75 years Diagnosis of Complex Regional Pain Syndrome Type I (CRPS-I), stage 1-2, following distal radius fracture Meeting the Budapest clinical diagnostic criteria for CRPS-I Symptom duration between 1 and 6 months Visual Analog Scale (VAS) pain score ≥4 Ability to participate in study assessments, with or without an assistive device Adequate cognitive capacity to understand the study procedures Willingness to participate in the study and provide written informed consent\n\nExclusion Criteria:\n\nDiagnosis of Complex Regional Pain Syndrome Type II (CRPS-II) Concomitant peripheral nerve injury in the upper extremity Active infection, malignancy, or open wound Severe skin lesion or impaired skin integrity in the treatment area Bleeding diathesis or severe coagulation disorder Anticoagulant treatment that constitutes a contraindication to ESWT Pregnancy or breastfeeding ESWT applied to the relevant region within the previous 3 months Inability to comply with assessments or study procedures due to severe psychiatric disease or cognitive impairment Inability to attend the study regularly Any condition considered by the investigator to make participation inappropriate\n\n\\-","ALL","18 Years","75 Years",{"count":107,"type":108},60,"ESTIMATED","INTERVENTIONAL",[111],"NA","Complex regional pain syndrome type I (CRPS-I) can develop after a distal radius fracture and may cause persistent pain, swelling, limited wrist and hand movement, and difficulty using the affected upper limb. This study will evaluate whether extracorporeal shock wave therapy (ESWT), when added to a standard rehabilitation program, improves symptoms and function in adults with CRPS-I following distal radius fracture.\n\nA total of 60 participants will be randomly assigned to one of two groups. Both groups will receive a standard rehabilitation program. One group will also receive active ESWT, while the other group will receive sham ESWT using the same treatment procedure without therapeutic energy delivery. ESWT or sham ESWT will be administered once weekly for five weeks.\n\nParticipants will be evaluated before treatment, at the end of the 5-week treatment period, and at the 12-week follow-up. The main outcome will be change in pain intensity. Other outcomes will include upper extremity function, wrist range of motion, hand grip strength, and swelling. Adverse events and treatment tolerability will also be recorded.",[114,115],"Complex Regional Pain Syndrome Type I (CRPS-I)","Distal Radius Fracture",[117,115,118,119,120,121,122],"Complex Regional Pain Syndrome Type I","CRPS-I","ESWT","Physical Rehabilitation","Pain","Upper Extremity Function","2026-09-02",{"date":125,"type":126},"2026-09-08","ACTUAL",{"date":128,"type":126},"2026-06-26",{"date":130,"type":108},"2027-09-26",{"name":93,"class":6},1]