Cognitive Behavioural Therapy for Postoperative Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Postoperative Pain+4 MoreCognitive Behavioural Therapy - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

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

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: Behavioral
ControlNoIntervention 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 York100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Hamilton Health Sciences - General Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%