NCT06453447 Prednisone for CRPS in Distal Radius Fracture
| NCT ID | NCT06453447 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Complex Regional Pain Syndromes |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-10-10 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-10-10 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 21 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.
Contact & Investigator
David Stockton, MD, MASc, FRCSC
PRINCIPAL INVESTIGATOR
University of British Columbia
Frequently Asked Questions
Who can join the NCT06453447 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Complex Regional Pain Syndromes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06453447 currently recruiting?
Yes, NCT06453447 is actively recruiting participants. Contact the research team at David.Stockton@vch.ca for enrollment information.
Where is the NCT06453447 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT06453447 clinical trial?
NCT06453447 is sponsored by University of British Columbia. The principal investigator is David Stockton, MD, MASc, FRCSC at University of British Columbia. The trial plans to enroll 40 participants.