Ignite Creation Date:
2024-05-06 @ 2:17 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04274530
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2020-02-14
Brief Title:
Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Cognitive Behavioral Therapy to Optimize Post-Operative Recovery COPE A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPE
Brief Summary:
Psychological factors such as stress distress anxiety depression and poor coping strategies may be associated with ongoing pain following injuries such as fractures To study this relationship patients will undergo cognitive behavioural therapy CBT which is designed to modify such thoughts with the goal of reducing ongoing pain and improving quality of life The goal of this study is to determine if CBT versus usual care reduces the prevalence of moderate to severe persistent post-surgical pain PPSP over 12-months post-fracture in patients with an open or closed fracture of the appendicular skeleton treated with internal fixation
Detailed Description:
The relationship between psychological factors behaviors and cognitive processes and the sensation of pain is well documented Stress distress anxiety depression catastrophizing fear-avoidance behaviors and poor coping strategies appear to have a significant positive relationship with both acute and chronic pain Evidence suggests that these psychological factors can cause alterations along the spinal and supraspinal pain pathways which influence the perception of pain Previous studies suggest that patients beliefs and expectations may be associated with clinical outcomes including self-reported pain Previous studies in trauma patients have demonstrated patients beliefs and expectations regarding their recovery following surgery are associated with functional limitations lower rates of return to work and reduced quality of life one year after injury Furthermore up to two thirds of patients with operative managed extremity fractures demonstrate unhelpful illness beliefs that increase risks of negative outcomes including persistent pain Psychological interventions such as cognitive behavioural therapy CBT that are designed to modify unhelpful beliefs and behaviours have the potential to reduce persistent post-surgical pain and its associated effects among trauma patients
Our primary objective is to determine if CBT versus usual care reduces the prevalence of moderate to severe PPSP over 12 months post-fracture in participants with an open or closed fracture of the appendicular skeleton Our secondary objectives are to determine if CBT versus usual care 1 increases physical functioning 2 improves mental functioning 3 accelerates return to function 4 reduces pain severity and 5 reduces pain interference over 12 months post-fracture and 6 reduces the proportion of participants prescribed opioid class medications and average dose at 6 and 12 months post-fracture This trial is a multi-centre randomized controlled trial RCT of 1000 participants with an open fracture of the appendicular skeleton or closed fracture of the lower extremity or pelvis treated with internal fixation
Our primary objective is to determine if CBT versus usual care reduces the prevalence of moderate to severe PPSP over 12 months post-fracture in participants with an open or closed fracture of the appendicular skeleton Our secondary objectives are to determine if CBT versus usual care 1 increases physical functioning 2 improves mental functioning 3 accelerates return to function 4 reduces pain severity and 5 reduces pain interference over 12 months post-fracture and 6 reduces the proportion of participants prescribed opioid class medications and average dose at 6 and 12 months post-fracture This trial is a multi-centre randomized controlled trial RCT of 1000 participants with an open fracture of the appendicular skeleton or closed fracture of the lower extremity or pelvis treated with internal fixation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None