ESWT added to rehabilitation for CRPS-I after a distal radius fracture

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, randomized, assessor-blinded trial compares active ESWT plus standard rehabilitation to sham ESWT plus standard rehabilitation in 60 adults with CRPS-I following distal radius fracture. Participants receive five weekly ESWT sessions targeting the forearm and wrist, with outcomes assessed at baseline, after week 5, and at week 12. The primary outcome is change in pain on the Visual Analog Scale, with secondary measures of upper-extremity function and other functional or clinical assessments. The study aims to determine if ESWT provides additional pain relief and functional benefits beyond conventional rehabilitation. Participants are adults aged 18 to 75 meeting Budapest criteria for CRPS-I and are randomized 1:1 to active or sham ESWT.

Why it matters

Who can join: the full rules

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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Where it's running

• Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey
  Istanbul, Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Dilek Ün Oğuzhanasiltürk, MD
• Email: dilekunoguzhan@gmail.com
• Phone: +90 5056367184

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.