Using prednisone to treat pain after wrist fractures

Prednisone for the Early Treatment of Complex Regional Pain Syndrome After Distal Radius Fracture - a Pilot Randomized Trial

This study is testing if prednisone can help adults with wrist fractures feel less pain and recover better from Complex Regional Pain Syndrome.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: University of British Columbia (other)
• Drugs / interventions: prednisone
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT06453447 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 and older with an acute, closed distal radius fracture who are at risk of developing CRPS.

Not a fit: Patients with previous wrist fractures, neurovascular injuries, or other significant injuries that could interfere with rehabilitation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could reduce the incidence of CRPS and improve recovery outcomes for patients with wrist fractures.

How similar studies have performed: While small studies have suggested glucocorticoids may be effective for CRPS, this approach has not been tested in a randomized controlled trial setting for distal radius fractures.

Eligibility criteria

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 this trial is running

Vancouver, British Columbia

• 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

Conditions: Complex Regional Pain Syndromes, Distal Radius Fractures, wrist fracture, pain, orthopaedic surgery