Prednisone for CRPS in Distal Radius Fracture

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Complex Regional Pain Syndromes, Distal Radius Fractures

In brief

Wrist fractures are the most prevalent adult fracture. Complex regional pain syndrome (CRPS) is a common complication that can occur, leading to permanent disability and is costly to the patient and healthcare system. In addition, amidst the opioid epidemic, the risk of increased opioid use in patients with CRPS prompts the need to find viable treatment strategies. This study aims to evaluate an anti-inflammatory medication, prednisone, in the early treatment of CRPS. Patients with wrist fractures who undergo surgical treatment will be randomized to receiving placebo vs prednisone for 2 weeks. Clinical assessments in the follow up period will be compared.

Key facts

Study ID

NCT06453447

Run by

University of British Columbia

People needed

40

Starts

2024-10-10

Expected to finish

2027-07-01

Last updated by the study team

2026-05-01

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patient is aged 19 years or older;
• Patient has a unilateral, closed, distal radius fracture confirmed by radiographs;
• The fracture is acute, within 21 days of injury;
• Patient undergoes open reduction internal fixation with volar locking plate;
• Patient is identified as at risk of developing CRPS with 2 or more of the following:
• Pain score on visual analogue scale (VAS) greater than or equal to 5/10 within 1 week of injury and beyond;
• Centre of Epidemiologic Studies Depression (CES-D) score on presentation is greater than or equal to 16;
• Patient identifies as female;
• Patient is identified as developing signs of CRPS based on the Budapest CRPS Criteria;
• Patient provides informed consent.

You may not qualify if…

• Patient has previously fractured ipsilateral wrist;
• Patient has neurovascular injury associated with distal radius fracture;
• Patient has associated extremity or polytrauma injuries that would interfere with rehabilitation and outcome measurements, in the opinion of the investigator;
• Patient has allergy to prednisone or placebo ingredients;
• Patient has contraindication to prednisone or placebo ingredients;
• Patient already takes a glucocorticoid medication;
• Patient has active bacterial, viral, or fungal infection;
• Patient is diagnosed with diabetes;
• Patient is pregnant, planning on becoming pregnant, or breastfeeding;
• Patient is anticipated to have difficulty completing study follow up, in the opinion of the investigator.

Where it is running

• Vancouver General Hospital — Vancouver, British Columbia, Canada (enrolling)

Full record on ClinicalTrials.gov

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