Prednisone for CRPS in Distal Radius Fracture

Launched by UNIVERSITY OF BRITISH COLUMBIA · Jun 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of prednisone, an anti-inflammatory medication, to see if it can help prevent a painful condition called Complex Regional Pain Syndrome (CRPS) in patients who have suffered a wrist fracture. Wrist fractures are common injuries, and CRPS can be a serious complication that causes long-lasting pain and disability. The trial will involve patients who are 19 years or older and have recently had surgery for a wrist fracture. Participants will be randomly assigned to receive either prednisone or a placebo (which looks like the medication but has no active ingredients) for two weeks.

To be eligible for the trial, patients must have a specific type of wrist fracture, show signs of being at risk for CRPS, and be willing to provide informed consent. Participants can expect to have regular check-ups to assess their pain and recovery during the study. This trial is important because it aims to find effective treatments for CRPS without increasing reliance on opioid medications, which can be addictive. If you or someone you know is dealing with a wrist fracture, this trial may offer an opportunity to contribute to valuable research while exploring potential treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient is aged 19 years or older;
• • 2. Patient has a unilateral, closed, distal radius fracture confirmed by radiographs;
• • 3. The fracture is acute, within 14 days of injury;
• • 4. Patient undergoes open reduction internal fixation with volar locking plate;
• 5. Patient is identified as at risk of developing CRPS with 2 or more of the following:
• • 1. Pain score on visual analogue scale (VAS) greater than or equal to 5/10 within 1 week of injury and beyond;
• • 2. Centre of Epidemiologic Studies Depression (CES-D) score on presentation is greater than or equal to 16;
• • 3. Patient identifies as female;
• • 6. Patient is identified as developing signs of CRPS based on the Budapest CRPS Criteria;
• • 7. Patient provides informed consent.
• Exclusion Criteria:
• • 1. Patient has previously fractured ipsilateral wrist;
• • 2. Patient has neurovascular injury associated with distal radius fracture;
• • 3. Patient has associated extremity or polytrauma injuries that would interfere with rehabilitation and outcome measurements, in the opinion of the investigator;
• • 4. Patient has allergy to prednisone or placebo ingredients;
• • 5. Patient has contraindication to prednisone or placebo ingredients;
• • 6. Patient already takes a glucocorticoid medication;
• • 7. Patient has active bacterial, viral, or fungal infection;
• • 8. Patient is diagnosed with diabetes;
• • 9. Patient is pregnant, planning on becoming pregnant, or breastfeeding;
• • 10. Patient is anticipated to have difficulty completing study follow up, in the opinion of the investigator.