ESWT for CRPS-I After Distal Radius Fracture

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.

Sixty 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.

Participants 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.

Clinical 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.

Adverse 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.

Inclusion criteria

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

Exclusion criteria

Diagnosis 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

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