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Corticosteroid

Prednisone for Complex Regional Pain Syndrome

N/A
Recruiting
Led By David Stockton, MD, MASc, FRCSC
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is aged 19 years or older;
Patient has a unilateral, closed, distal radius fracture confirmed by radiographs;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks, 6 weeks, 3 months, 6 months

Summary

"This trial aims to evaluate the use of an anti-inflammatory medication, prednisone, in treating complex regional pain syndrome (CRPS) that can occur after wrist fractures. Patients with wrist fractures undergoing surgery

Who is the study for?
This trial is for adults aged 19 or older who have had a wrist fracture treated with surgery. Participants must be female, have pain scores of at least 5/10 post-injury, show signs of CRPS according to the Budapest Criteria, and not be depressed as indicated by a CES-D score of 16 or higher.
What is being tested?
The study tests if prednisone, an anti-inflammatory drug, can prevent complex regional pain syndrome (CRPS) after wrist fractures. Patients are randomly chosen to receive either prednisone or a placebo for two weeks following surgical repair.
What are the potential side effects?
Prednisone may cause side effects such as mood swings, increased blood pressure, blood sugar changes, increased risk of infection, and possible bone weakening with long-term use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 19 years old or older.
Select...
I have a confirmed single closed wrist fracture.
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My pain level has been 5 or more out of 10 for over a week since my injury.
Select...
I identify as female.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks, 6 weeks, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks, 6 weeks, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of complete patient follow up at 6 months
Proportion of patient adherence to treatment allocation and protocol - determined by patient self-reporting
Proportion of patient consent withdrawal from the study
+2 more
Secondary study objectives
Adverse effects
Resolution of CRPS
Total opioid consumption
Other study objectives
Centre of Epidemiologic Studies Depression (CES-D) score
Passive wrist range of motion (ROM)
Short Form-36 item (SF-36) questionnaire
+3 more

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
98%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Dysphagia-esophageal radiation
8%
Hypoglycemia
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PrednisoneExperimental Treatment1 Intervention
40 mg PO once daily for 14 days starting day of surgery
Group II: PlaceboPlacebo Group1 Intervention
placebo tablet PO once daily for 14 days starting day of surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2500

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,481 Previous Clinical Trials
2,494,876 Total Patients Enrolled
Canadian Orthopaedic FoundationOTHER
14 Previous Clinical Trials
1,596 Total Patients Enrolled
David Stockton, MD, MASc, FRCSCPrincipal InvestigatorUniversity of British Columbia
~27 spots leftby Jan 2026
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