Study Summary
This trial will compare CBT to usual care to see if it can help reduce moderate to severe persistent post-surgical pain in patients with appendicular fractures.
Eligible Conditions
- Postoperative Pain
- Chronic Pain
- Closed Fractures
- Acute Pain
- Open Fractures
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 12 months post-fracture
12 months post-fracture
Brief Pain Inventory-Short Form (BPI-SF)
Opioid Use
Return to Function Questionnaire
Short Form 36 (SF-36)
Pain, Postoperative
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Control
1 of 2
Intervention - CBT
1 of 2
Active Control
Experimental Treatment
1000 Total Participants · 2 Treatment Groups
Primary Treatment: Cognitive Behavioural Therapy · No Placebo Group · N/A
Intervention - CBT
Behavioral
Experimental Group · 1 Intervention: Cognitive Behavioural Therapy · Intervention Types: BehavioralControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioural Therapy
2016
Completed Phase 3
~3890
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months post-fracture
Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,233 Previous Clinical Trials
24,675,652 Total Patients Enrolled
McMaster UniversityLead Sponsor
801 Previous Clinical Trials
1,726,877 Total Patients Enrolled
1 Trials studying Postoperative Pain
300 Patients Enrolled for Postoperative Pain
Orthopaedic Trauma AssociationOTHER
28 Previous Clinical Trials
3,442 Total Patients Enrolled
Jason Busse, PhDPrincipal InvestigatorMcMaster University
1 Previous Clinical Trials
83 Total Patients Enrolled
Sheila Sprague, PhDPrincipal InvestigatorMcMaster University
7 Previous Clinical Trials
10,309 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have access to a smart phone or tablet that is capable of running the CBT provider's application.
Who else is applying?
What state do they live in?
| New York | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Hamilton Health Sciences - General Site | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Busse JW, Sprague S; COPE Investigators. Cognitive Behavioural Therapy to Optimize Post-Operative Fracture Recovery (COPE): protocol for a randomized controlled trial. Trials. 2022 Oct 22;23(1):894. doi: 10.1186/s13063-022-06835-3.
- 2021. "Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04274530.
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