Complex Regional Pain Syndrome Clinical Trials

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EXTRACORPOREAL SHOCKWAVE THERAPY FOR COMPLEX REGIONAL PAIN SYNDROME TYPE I FOLLOWING DISTAL RADIUS FRACTURE: A PROSPECTIVE RANDOMIZED SHAM-CONTROLLED TRIAL

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• ge 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

Locations
Other Locations
Turkey
Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey
RECRUITING
Istanbul
Contact Information
Primary
Dilek Ün Oğuzhanasiltürk, MD
dilekunoguzhan@gmail.com
+90 5056367184
Time Frame
Start Date: 2026-06-26
Estimated Completion Date: 2027-09-26
Participants
Target number of participants: 60
Treatments
Experimental: Standard Rehabilitation + Active ESWT
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.
Sham_comparator: Standard Rehabilitation + Sham ESWT
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.
Related Therapeutic Areas
Sponsors
Leads: Dilek ün oguzhanasilturk

This content was sourced from clinicaltrials.gov