Testing Prednisone against a placebo for complex regional pain syndromes
Official title: Prednisone for CRPS in Distal Radius Fracture
Prednisone for the Early Treatment of Complex Regional Pain Syndrome After Distal Radius Fracture - a Pilot Randomized Trial
- 2 groups
- One site, in Vancouver
- Recruiting
Interventions
- Medication
Prednisone
40 mg PO once daily for 14 days starting day of surgery
- Medication
Placebo
Placebo tablet (cellulose) PO once daily for 14 days starting day of surgery
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia
Eligibility Criteria
See who this study is looking for20 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
Exclusion
- −Patient has allergy to prednisone or placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → ingredients;
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →;
- −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 anticipated to have difficulty completing study follow upFollow-upContinued check-ins after the treatment part is finished.Read more →, in the opinion of the investigator.
- −Patient is pregnant, planning on becoming pregnant, or breastfeeding;
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Prednisone.
Registry label: A: Prednisone
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 19 years, with no upper limit given.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 40 people.
The study is currently expected to finish around July 2027.
The main measurement is taken over: 6 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Proportion of patient recruitment — measured over 6 months.
Proportion of patient adherence to treatment allocation and protocolProtocolThe detailed plan a study must follow.Read more → - determined by patient self-reporting — measured over 6 months.
Proportion of patients with missing data from secondary and tertiary outcomes — measured over 6 months.
Proportion of patient consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → withdrawal from the study — measured over 6 months.
The study lists 1 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06453447 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About PrednisoneDrug
40 mg PO once daily for 14 days starting day of surgery
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Placebo tablet (cellulose) PO once daily for 14 days starting day of surgery
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 19 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 19 years, with no upper limit given.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 6 months.
The study as a whole is currently expected to finish around 2027-07.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 40 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Vancouver, British Columbia, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.