Using prednisone to treat pain after wrist fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of prednisone, an anti-inflammatory medication, in treating patients who develop Complex Regional Pain Syndrome (CRPS) following a distal radius fracture. Patients aged 19 and older with acute wrist fractures will be randomly assigned to receive either prednisone or a placebo for two weeks after surgical treatment. The study aims to assess the resolution of CRPS symptoms and gather data on patient recruitment and adherence to the treatment protocol. This pilot study will inform the design of a larger clinical trial if successful.

Why it matters

Who can join: the full rules

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.

Where it's running

• Vancouver General Hospital
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: David Stockton, MD, MASc, FRCSC — University of British Columbia
• Study coordinator: David Stockton, MD, MASc, FRCSC
• Email: David.Stockton@vch.ca
• Phone: 604-875-5809

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.