Prednisone for the Early Treatment of Complex Regional Pain Syndrome After Distal Radius Fracture - a Pilot Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: t
View:

• Patient is aged 19 years or older;

• Patient has a unilateral, closed, distal radius fracture confirmed by radiographs;

• The fracture is acute, within 14 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.

Locations
Other Locations
Canada
Vancouver General Hospital
RECRUITING
Vancouver
Contact Information
Primary
David Stockton, MD, MASc, FRCSC
David.Stockton@vch.ca
604-875-5809
Backup
Alice (Wei Ting) Wang, MSc, MD
alicew22@student.ubc.ca
Time Frame
Start Date: 2024-10-10
Estimated Completion Date: 2026-07
Participants
Target number of participants: 40
Treatments
Experimental: Prednisone
40 mg PO once daily for 14 days starting day of surgery
Placebo_comparator: Placebo
placebo tablet PO once daily for 14 days starting day of surgery
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Orthopaedic Foundation
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov