Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
Healthy Volunteers
ID06453447

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

Led by University of British Columbia · Updated on 2026-05-01

40

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

U

University of British Columbia

Lead Sponsor

C

Canadian Orthopaedic Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Wrist fractures, specifically distal radius fractures, are common in adults and can lead to a complication called complex regional pain syndrome (CRPS), which may cause permanent disability and increased healthcare costs. This research aims to study prednisone, an anti-inflammatory medication, to see if it can help treat early signs of CRPS after wrist fracture surgery. The study is a pilot randomized controlled trial to assess feasibility and gather initial data on prednisone's effects compared to placebo. Participants who have surgery for a distal radius fracture will be randomly assigned to receive either prednisone or a placebo tablet once daily for 14 days starting on the day of surgery. The prednisone dose is 40 mg per day. The trial will follow patients for six months, with four study visits aligned with standard post-operative check-ups. The study will monitor patients for CRPS resolution, opioid use, and any side effects during this period. During the study, participants will undergo clinical assessments including pain scoring and evaluation for CRPS symptoms using established criteria. Researchers will track adherence to the assigned treatment, withdrawal rates, and completeness of follow-up. They will also measure opioid consumption and adverse events at multiple time points up to six months. The main focus is to evaluate the study process itself, as well as gather early evidence on prednisone's potential benefits and safety in this setting.

CONDITIONS

Brief Title

Prednisone for CRPS in Distal Radius Fracture

Who Can Participate

Age: 19Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 of 5/10 or higher within 1 week of injury, CES-D score 16 or higher, or identifies as female
  • Patient is identified as developing signs of CRPS based on Budapest CRPS Criteria
  • Patient provides informed consent
Not Eligible

You will not qualify if you...

  • Patient has previously fractured the same wrist
  • Patient has neurovascular injury associated with the distal radius fracture
  • Patient has other injuries that interfere with rehabilitation or outcome measurements
  • 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 pregnancy, or breastfeeding
  • Patient is expected to have difficulty completing study follow up in investigator's opinion

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - 14 days

Participants receive a 14-day course of either oral prednisone or placebo starting on the day of surgery to treat early signs of Complex Regional Pain Syndrome after distal radius fracture.

4 visits corresponding to standard post-operative clinic visits

Follow-up

Duration - 6 months

Participants are followed for 6 months after surgery to monitor resolution of CRPS, opioid use, adverse effects, and clinical outcomes.

Approximately 4 post-operative visits over 6 months

Trial Site Locations

Total: 1 location

1

Vancouver General Hospital

Vancouver, British Columbia, Canada, V5Z 1M9

Actively Recruiting

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Research Team

D

David Stockton, MD, MASc, FRCSC

A

Alice (Wei Ting) Wang, MSc, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Intense pain soon after wrist fracture strongly predicts who will develop complex regional pain syndrome: prospective cohort study.

G Lorimer Moseley, Robert D Herbert, Timothy Parsons...

https://pubmed.ncbi.nlm.nih.gov/24268113

Incidence of and Risk Factors for Complex Regional Pain Syndrome Type 1 after Surgery for Distal Radius Fractures: A Population-based Study.

Young-Hoon Jo, KangWook Kim, Bong-Gun Lee...

https://pubmed.ncbi.nlm.nih.gov/30890732