RecruitingNot ApplicableNCT07807852

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


Sponsor

Dilek ün oguzhanasilturk

Enrollment

60 participants

Start Date

Jun 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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. A 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. Participants 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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called 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, a medical device called Sham Extracorporeal Shock Wave Therapy (Sham ESWT), and others for people with complex regional pain syndrome type i (crps-i) and distal radius fracture. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive 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.

DEVICESham 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.

OTHERStandard 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.


Locations(1)

Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey

Istanbul, Istanbul, Turkey (Türkiye)

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NCT07807852


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