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 range19 Years
SexALL
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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;
✓. Patient identifies as female;
Exclusion criteria
✕. Patient has previously fractured ipsilateral wrist;
✕. Patient has neurovascular injury associated with distal radius fracture;
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 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;