Ignite Creation Date:
2024-05-06 @ 10:12 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03196258
Status:
TERMINATED
Last Update Posted:
2020-02-24
First Post:
2017-06-13
Brief Title:
Cognitive Behavioural Therapy to Reduce Persistent Post-Surgical Pain After Fracture
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Cognitive Behavioural Therapy to Improve Outcomes of High Risk Patients Following Internal Fixation of Extremity Fractures A Randomized Controlled Trial SPOC-CBT
Status:
TERMINATED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Feasibility issues with the study treatment in-person CBT resulted in the study ending earlier than anticipated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPOC_CBT
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 In order to study this relationship researchers at McMaster University have developed the Somatic Pre-Occupation and Coping SPOC questionnaire which identifies illness beliefs that may help to predict which patients are at risk for ongoing pain reduced quality of life and delays in returning to work and leisure activities after a fracture requiring surgical treatment Previous research using the SPOC questionnaire suggests the possibility that fracture patients with illness beliefs that put them at risk for developing ongoing pain could be identified early in the treatment process These patients may benefit from 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 is effective in reducing ongoing pain and improving quality of life in fracture patients who show illness beliefs that may place them at risk for developing ongoing pain
Detailed Description:
In North America chronic non-cancer pain affects approximately 30 of the population with similar rates in Europe and Australia Surgery and trauma are frequently cited as triggering events responsible for the development of chronic pain A survey of 5130 patients attending 10 outpatient clinics located throughout North Britain found that 41 attributed their chronic pain to a traumatic event or surgery The presence of persistent pain can have a major impact on patients quality of life including their ability to return to work and their daily activities
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
Clinical outcomes following operatively managed fractures of the extremities are variable and many patients continue to experience persistent pain and disability one-year after surgery and beyond In a recent trial involving patients with open extremity fractures 65 of patients reported moderate to very severe pain and 35 reported moderate to extreme pain interference at one-year A systematic review of 20 observational studies of traumatic tibial fracture repairs found the mean incidence of persistent post-surgical pain PPSP was 474 range 10 to 86 at an average of 239 months after surgery Although several risk factors for PPSP have been identified many such as younger age and female gender are non-modifiable and thus not amendable to direct intervention
The effect of patients beliefs and expectations on their recovery following traumatic injuries is an under-investigated area In response to this gap Busse et al developed and evaluated the Somatic Pre-Occupation and Coping SPOC questionnaire to identify unhelpful illness beliefs that are predictive of poorer functional outcomes post-fracture This self-administered questionnaire identified unhelpful illness beliefs among approximately one third of patients with operatively managed extremity fractures Furthermore high somatic pre-occupation and poor coping at 6-weeks post-fracture as measured by the SPOC questionnaire were found to be strongly associated with PPSP functional limitations unemployment and reduced quality of life 1 year after fracture fixation This suggests the possibility that fracture patients who exhibit unhelpful illness beliefs can be identified and targeted for concurrent therapy designed to modify such cognitions and improve prognosis At present however there are no approaches that have been shown effective for improving recovery among high-risk patients
The findings from the FLOW trial highlight the importance of patient beliefs in recovery from orthopaedic trauma A number of systematic reviews have shown patients perceptions regarding their illness experience can be modified and that such efforts can improve outcomes Moss-Morris and colleagues explored the effect of CBT among patients attending a multidisciplinary chronic pain clinic and found that changes in cognitive processes accounted for 26 of the variation in improved health-related quality of life scores Collectively these findings suggest that targeting and modifying unhelpful beliefs through CBT may provide an effective strategy to improve outcomes among high-risk trauma patients
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
Clinical outcomes following operatively managed fractures of the extremities are variable and many patients continue to experience persistent pain and disability one-year after surgery and beyond In a recent trial involving patients with open extremity fractures 65 of patients reported moderate to very severe pain and 35 reported moderate to extreme pain interference at one-year A systematic review of 20 observational studies of traumatic tibial fracture repairs found the mean incidence of persistent post-surgical pain PPSP was 474 range 10 to 86 at an average of 239 months after surgery Although several risk factors for PPSP have been identified many such as younger age and female gender are non-modifiable and thus not amendable to direct intervention
The effect of patients beliefs and expectations on their recovery following traumatic injuries is an under-investigated area In response to this gap Busse et al developed and evaluated the Somatic Pre-Occupation and Coping SPOC questionnaire to identify unhelpful illness beliefs that are predictive of poorer functional outcomes post-fracture This self-administered questionnaire identified unhelpful illness beliefs among approximately one third of patients with operatively managed extremity fractures Furthermore high somatic pre-occupation and poor coping at 6-weeks post-fracture as measured by the SPOC questionnaire were found to be strongly associated with PPSP functional limitations unemployment and reduced quality of life 1 year after fracture fixation This suggests the possibility that fracture patients who exhibit unhelpful illness beliefs can be identified and targeted for concurrent therapy designed to modify such cognitions and improve prognosis At present however there are no approaches that have been shown effective for improving recovery among high-risk patients
The findings from the FLOW trial highlight the importance of patient beliefs in recovery from orthopaedic trauma A number of systematic reviews have shown patients perceptions regarding their illness experience can be modified and that such efforts can improve outcomes Moss-Morris and colleagues explored the effect of CBT among patients attending a multidisciplinary chronic pain clinic and found that changes in cognitive processes accounted for 26 of the variation in improved health-related quality of life scores Collectively these findings suggest that targeting and modifying unhelpful beliefs through CBT may provide an effective strategy to improve outcomes among high-risk trauma patients
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