Health TrialsbyHealthPanel

Prednisone for CRPS in Distal Radius Fracture

ConditionsComplex Regional Pain SyndromesDistal Radius Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of British Columbia

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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 investigator;

Patient has allergy to prednisone or placebo ingredients;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prednisone

    Drug

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

  • Placebo

    Drug

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: PrednisoneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patient recruitment

Percentage of patients approached for recruitment who consent to study participation

Time frame
6 months
2

Proportion of patient adherence to treatment allocation and protocol - determined by patient self-reporting

Percentage of patients enrolled in the study who report to completing their 14-day course of treatment

Time frame
6 months
3

Proportion of patients with missing data from secondary and tertiary outcomes

Percentage of enrolled patients who do not have complete secondary and tertiary outcome measures

Time frame
6 months
4

Proportion of patient consent withdrawal from the study

Percentage of patients enrolled in the study who withdraw before completion of the study

Time frame
6 months

Secondary outcomes

1

Resolution of CRPS

The treating surgeon or care team will determine whether patients continue to meet criteria for CRPS diagnosis based on the Budapest CRPS Criteria

Time frame
2 weeks, 6 weeks, 3 months, 6 months
2

Total opioid consumption

Total opioids consumed post-op converted to morphine milligram equivalents by assessing remaining hydromorphone tablets

Time frame
2 weeks
3

Adverse effects

Adverse effects will be recorded. These can include but are not limited to mood changes, altered sleep, swelling of extremities, dizziness, headache, weight gain, elevated blood glucose, elevated blood pressure, upset stomach, gastrointestinal bleeding, wound complications, myopathy, infections, venous thromboembolism, hear failure, and adrenal insufficiency.

Time frame
2 weeks, 6 weeks, 3 months, 6 months

Other outcomes

1

Visual analogue scale (VAS) pain score

Score out of 10 to monitor pain level

Time frame
2 weeks, 6 weeks, 3 months, 6 months
2

Centre of Epidemiologic Studies Depression (CES-D) score

to monitor for presence of depression

Time frame
2 weeks, 6 weeks, 3 months, 6 months
3

Short Form-36 item (SF-36) questionnaire

to measure patient reported quality of life

Time frame
2 weeks, 6 weeks, 3 months, 6 months
4

Passive wrist range of motion (ROM)

dorsiflexion, palmarflexion, supination, pronation, and finger to palm distance will be measured and recorded by the physiotherapist at each follow up visit

Time frame
2 weeks, 6 weeks, 3 months, 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

Canadian Orthopaedic Foundation

Collaborator

Source ClinicalTrials.gov
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