Recruiting

Prednisone

Sponsor:

University of British Columbia

Code:

NCT06453447

Conditions

Complex Regional Pain Syndromes

Distal Radius Fractures

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Interventions

Prednisone

Placebo

Study Details

Brief 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.

Conditions

Complex Regional Pain Syndromes

Distal Radius Fractures

Study ID

NCT06453447

Start date

Oct 10, 2024

Status verified date

Apr, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prednisone

40 mg PO once daily for 14 days starting day of surgery

placebo comparator: Placebo

placebo tablet PO once daily for 14 days starting day of surgery

Interventions

Prednisone

40 mg PO once daily for 14 days starting day of surgery

Placebo

Placebo tablet (cellulose) PO once daily for 14 days starting day of surgery

Primary outcome measure

  • Proportion of patient recruitment [ Time Frame: 6 months ]
  • Proportion of patient adherence to treatment allocation and protocol - determined by patient self-reporting [ Time Frame: 6 months ]
  • Proportion of patients with missing data from secondary and tertiary outcomes [ Time Frame: 6 months ]
  • Proportion of patient consent withdrawal from the study [ Time Frame: 6 months ]
  • Proportion of complete patient follow up at 6 months [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

David Stockton, MD, MASc, FRCSC

604-875-5809David.Stockton@vch.ca

Alice (Wei Ting) Wang, MSc, MD

alicew22@student.ubc.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

David Stockton, MD, MASc, FRCSC

604-875-5809david.stockton@vch.ca

More Information

Sponsor

University of British Columbia

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • wrist fracture
  • pain
  • orthopaedic surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-05-01.