BridgeMD
New treatment option for Complex Regional Pain Syndromes
Official title Prednisone for CRPS in Distal Radius Fracture
ClinicalTrials.gov ID: NCT06453447
What this study is testing
What is Prednisone?
Prednisone is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for complex regional pain syndromes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Time commitment: about 8 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older. Healthy volunteers may be eligible.
You may be able to join 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:
You likely can't join 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...
- Patient has allergy to prednisone or placebo ingredients;
- Patient has contraindication to prednisone or placebo ingredients;
- Patient already takes a glucocorticoid medication;
See the full eligibility 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;
- Patient is identified as developing signs of CRPS based on the Budapest CRPS Criteria;
- Patient provides informed consent.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.