Ignite Creation Date:
2024-05-06 @ 1:13 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03965897
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2019-05-24
Brief Title:
Preventing Persistent Post-Surgical Pain and Dysfunction
Sponsor:
Barbara A Rakel
Organization:
University of Iowa
Study Overview
Official Title:
Preventing Persistent Post-Surgical Pain and Dysfunction in At-Risk Veterans Effect of a Brief Behavioral Intervention
Status:
RECRUITING
Status Verified Date:
2023-11
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:
None
Brief Summary:
Primary Aim To examine the superior efficacy of ACT versus Attention Control AC on postoperative pain intensity and functioning in at-risk Veterans undergoing TKA Changes in pain intensity and functioning from baseline to 6 weeks 3 months and 6 months post-TKA will be compared Level of pain intensity will be measured using the BPI Pain Severity Subscale and level of functioning will be measured using the KOOS Activities of Daily Living and Quality Of Life Subscales
Secondary Aims A To examine the superior efficacy of ACT versus AC on the severity of anxiety and depressive symptoms and improvements in coping skills Changes from baseline to 6 weeks 3 months and 6 months post-TKA will be compared Anxiety and depressive symptoms will be measured with the Hamilton Rating Scales Ham-A and Ham-D respectively Coping skills ie Pain Acceptance and Engagement in Values-Based Behavior will be measured with the Chronic Pain Acceptance Questionnaire and the Chronic Pain Values Inventory B To evaluate whether decreases in distress-based symptoms and increases in coping skills mediate changes in pain and functioning at 6 months in Veterans receiving ACT Changes in anxiety symptoms depressive symptoms pain acceptance and engagement in values-based behavior from baseline to 6 weeks and 3 months will be used as potential mediators for changes in pain and functioning at 6 months
Exploratory Aim Describe the pharmacological and non-pharmacological strategies Veterans are using to manage pain and their perceived helpfulness This will provide insights into the effects of the current opioid restrictions on pain management strategies These strategies their perceived helpfulness will be assessed using the Pain Management Strategies Survey at baseline 6 weeks 3 and 6 months
Secondary Aims A To examine the superior efficacy of ACT versus AC on the severity of anxiety and depressive symptoms and improvements in coping skills Changes from baseline to 6 weeks 3 months and 6 months post-TKA will be compared Anxiety and depressive symptoms will be measured with the Hamilton Rating Scales Ham-A and Ham-D respectively Coping skills ie Pain Acceptance and Engagement in Values-Based Behavior will be measured with the Chronic Pain Acceptance Questionnaire and the Chronic Pain Values Inventory B To evaluate whether decreases in distress-based symptoms and increases in coping skills mediate changes in pain and functioning at 6 months in Veterans receiving ACT Changes in anxiety symptoms depressive symptoms pain acceptance and engagement in values-based behavior from baseline to 6 weeks and 3 months will be used as potential mediators for changes in pain and functioning at 6 months
Exploratory Aim Describe the pharmacological and non-pharmacological strategies Veterans are using to manage pain and their perceived helpfulness This will provide insights into the effects of the current opioid restrictions on pain management strategies These strategies their perceived helpfulness will be assessed using the Pain Management Strategies Survey at baseline 6 weeks 3 and 6 months
Detailed Description:
Persistent post-surgical pain PPSP is a common and debilitating problem following surgery1 Orthopedic surgeries such as Total Knee Arthoplasty TKA are consistently associated with high postoperative pain putting patients at risk for PPSP2 3 In fact TKA has the highest rate of PPSP at 6 months 49 when compared to a variety of surgeries4 Pain that persists beyond the expected period of healing serves little or no useful purpose and can be devastating to ones sense of well-being Notably pain severity is highly correlated with adverse effects on physical functioning recovery and quality of life including negative impacts on sleep mood daily activities cognitive functions and social life2 5-13 PPSP is also highly correlated with prolonged opioid use following surgery When pain and addiction are present the patients level of desperation rises medical and psychiatric illness severity increases and there is greater utilization of health care services
Strong and consistent evidence indicates that patients with high levels of pain anxiety andor depressive symptoms distress prior to surgery are at risk for PPSP5 14-23 Notably Veterans are at a particularly high risk for post-surgical problems because 80 experience some level of psychological distress prior to surgery and 50 report experiencing pain on a regular basis9 24 Furthermore surgery presents a unique set of circumstances in which the precise timing of the physical insult and ensuing pain are known in advance 25 It is therefore possible and critical that these risk factors be attended to in order to improve postoperative pain management and disrupt processes responsible for the transition from acute to chronic pain
As proof of concept co-PIs Rakel and Dindo completed an R34-funded study evaluating the feasibility and potential efficacy of an intensive 1-day Acceptance and Commitment Therapy ACT workshop for preventing PPSP and prolonged opioid use following orthopedic surgery in at-risk Veterans ACT is trans-diagnostic with effectiveness across a range of conditions including chronic pain depression and anxiety16-18 The brief 1-day format was used to optimize treatment adherence and chances for dissemination into clinical settings Results were promising 100 of the Veterans attending completed the 1-day intervention Compared to controls Veterans randomly assigned to ACT reported a larger decrease in pain intensity 3 months post-TKA and reached pain and opioid cessation criteria sooner Importantly Veterans reporting larger changes in behavioral engagement targeted mediator of ACT exhibited significantly larger decreases in pain and opioid use This application builds on these promising preliminary findings using a rigorous design to establish the unique effects of ACT beyond attention and explore mediators of treatment response
In the context of the current opioid epidemic it is also important for us to better understand how changes in opioid prescribing patterns are influencing postoperative pain management strategies It is likely that complaints of pain will increase putting patients at higher risk for PPSP and impaired functioning Early reports suggests that patients are looking for substitute sources of pain relief such as rogue Fentanyl powder and Gabapentin26 27 Using a multi-site double-blind two-arm parallel randomized controlled trial with Veterans at-risk for PPSP post-TKA the following aims will be addressed
Primary Aim To examine the superior efficacy of ACT versus Attention Control AC on postoperative pain intensity and functioning in at-risk Veterans undergoing TKA Changes in pain intensity and functioning from baseline to 6 weeks 3 months and 6 months post-TKA will be compared Level of pain intensity will be measured using the BPI Pain Severity Subscale and level of functioning will be measured using the KOOS Activities of Daily Living and Quality Of Life Subscales
Secondary Aims A To examine the superior efficacy of ACT versus AC on the severity of anxiety and depressive symptoms and improvements in coping skills Changes from baseline to 6 weeks 3 months and 6 months post-TKA will be compared Anxiety and depressive symptoms will be measured with the Hamilton Rating Scales Ham-A and Ham-D respectively Coping skills ie Pain Acceptance and Engagement in Values-Based Behavior will be measured with the Chronic Pain Acceptance Questionnaire and the Chronic Pain Values Inventory B To evaluate whether decreases in distress-based symptoms and increases in coping skills mediate changes in pain and functioning at 6 months in Veterans receiving ACT Changes in anxiety symptoms depressive symptoms pain acceptance and engagement in values-based behavior from baseline to 6 weeks and 3 months will be used as potential mediators for changes in pain and functioning at 6 months
Exploratory Aim Describe the pharmacological and non-pharmacological strategies Veterans are using to manage pain and their perceived helpfulness This will provide insights into the effects of the current opioid restrictions on pain management strategies These strategies their perceived helpfulness will be assessed using the Pain Management Strategies Survey at baseline 6 weeks 3 and 6 months
This project builds on promising preliminary data and has the potential to translate what is known about effective treatments of chronic pain to prevent poor surgical outcomes It incorporates an interdisciplinary approach to the care of Veterans that attends to major risk factors of postoperative sequelae that significantly impact Veterans quality of life and healthcare utilization Using an effective highly accepted and deployable intervention increases the clinical usefulness of these results which may be extended in the future to the many other conditions leading to chronic pain in both Veterans and Civilians
Strong and consistent evidence indicates that patients with high levels of pain anxiety andor depressive symptoms distress prior to surgery are at risk for PPSP5 14-23 Notably Veterans are at a particularly high risk for post-surgical problems because 80 experience some level of psychological distress prior to surgery and 50 report experiencing pain on a regular basis9 24 Furthermore surgery presents a unique set of circumstances in which the precise timing of the physical insult and ensuing pain are known in advance 25 It is therefore possible and critical that these risk factors be attended to in order to improve postoperative pain management and disrupt processes responsible for the transition from acute to chronic pain
As proof of concept co-PIs Rakel and Dindo completed an R34-funded study evaluating the feasibility and potential efficacy of an intensive 1-day Acceptance and Commitment Therapy ACT workshop for preventing PPSP and prolonged opioid use following orthopedic surgery in at-risk Veterans ACT is trans-diagnostic with effectiveness across a range of conditions including chronic pain depression and anxiety16-18 The brief 1-day format was used to optimize treatment adherence and chances for dissemination into clinical settings Results were promising 100 of the Veterans attending completed the 1-day intervention Compared to controls Veterans randomly assigned to ACT reported a larger decrease in pain intensity 3 months post-TKA and reached pain and opioid cessation criteria sooner Importantly Veterans reporting larger changes in behavioral engagement targeted mediator of ACT exhibited significantly larger decreases in pain and opioid use This application builds on these promising preliminary findings using a rigorous design to establish the unique effects of ACT beyond attention and explore mediators of treatment response
In the context of the current opioid epidemic it is also important for us to better understand how changes in opioid prescribing patterns are influencing postoperative pain management strategies It is likely that complaints of pain will increase putting patients at higher risk for PPSP and impaired functioning Early reports suggests that patients are looking for substitute sources of pain relief such as rogue Fentanyl powder and Gabapentin26 27 Using a multi-site double-blind two-arm parallel randomized controlled trial with Veterans at-risk for PPSP post-TKA the following aims will be addressed
Primary Aim To examine the superior efficacy of ACT versus Attention Control AC on postoperative pain intensity and functioning in at-risk Veterans undergoing TKA Changes in pain intensity and functioning from baseline to 6 weeks 3 months and 6 months post-TKA will be compared Level of pain intensity will be measured using the BPI Pain Severity Subscale and level of functioning will be measured using the KOOS Activities of Daily Living and Quality Of Life Subscales
Secondary Aims A To examine the superior efficacy of ACT versus AC on the severity of anxiety and depressive symptoms and improvements in coping skills Changes from baseline to 6 weeks 3 months and 6 months post-TKA will be compared Anxiety and depressive symptoms will be measured with the Hamilton Rating Scales Ham-A and Ham-D respectively Coping skills ie Pain Acceptance and Engagement in Values-Based Behavior will be measured with the Chronic Pain Acceptance Questionnaire and the Chronic Pain Values Inventory B To evaluate whether decreases in distress-based symptoms and increases in coping skills mediate changes in pain and functioning at 6 months in Veterans receiving ACT Changes in anxiety symptoms depressive symptoms pain acceptance and engagement in values-based behavior from baseline to 6 weeks and 3 months will be used as potential mediators for changes in pain and functioning at 6 months
Exploratory Aim Describe the pharmacological and non-pharmacological strategies Veterans are using to manage pain and their perceived helpfulness This will provide insights into the effects of the current opioid restrictions on pain management strategies These strategies their perceived helpfulness will be assessed using the Pain Management Strategies Survey at baseline 6 weeks 3 and 6 months
This project builds on promising preliminary data and has the potential to translate what is known about effective treatments of chronic pain to prevent poor surgical outcomes It incorporates an interdisciplinary approach to the care of Veterans that attends to major risk factors of postoperative sequelae that significantly impact Veterans quality of life and healthcare utilization Using an effective highly accepted and deployable intervention increases the clinical usefulness of these results which may be extended in the future to the many other conditions leading to chronic pain in both Veterans and Civilians
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