Prednisone for CRPS in Distal Radius Fracture (NCT06453447) | Clinical Trial Compass
RecruitingNot Applicable
Prednisone for CRPS in Distal Radius Fracture
Canada40 participantsStarted 2024-10-10
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patient recruitment
Timeframe: 6 months
2
Proportion of patient adherence to treatment allocation and protocol - determined by patient self-reporting
Timeframe: 6 months
3
Proportion of patients with missing data from secondary and tertiary outcomes
Timeframe: 6 months
4
Proportion of patient consent withdrawal from the study
Timeframe: 6 months
5
Proportion of complete patient follow up at 6 months
. 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;