Ignite Creation Date:
2024-05-06 @ 8:03 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02657317
Status:
COMPLETED
Last Update Posted:
2020-09-29
First Post:
2015-12-17
Brief Title:
Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in Post-911 Veterans
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in a Combat-Injured Veterans Population
Status:
COMPLETED
Status Verified Date:
2024-07
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:
This is a research study of an interdisciplinary pain management program for US military veterans who served during the post-911 combat eras eg Operations Iraqi Freedom OIF Enduring Freedom OEF New Dawn OND presenting with chronic musculoskeletal pain related to military service with comorbid depression andor posttraumatic stress disorder PTSD symptoms andor mild traumatic brain injury This study will test the efficacy of an interdisciplinary pain program compared to treatment as usual in the Veterans Health Administration on pain-related disability opioid medication use and pain coping
Detailed Description:
Study Title
Establishing Efficacy of a Functional Restoration-Based Complementary and Alternative Medicine Pain Management Program in a Combat Injured Veterans Population
Objectives
AIM 1 Assess the efficacy of the Functional Orthopedic Rehab Treatment-Amended FORT-A Program for improved pain management outcomes in N130 polymorbid OEFOIFOND Veterans with chronic musculoskeletal pain CMP using a 11 randomized clinical trial comparing FORT-A to standard Veterans Affairs VA care We will determine the improvement in pain management outcomes attributable to a fully integrated and manualized interdisciplinary pain program FORT-A compared to standard VA care
AIM 2 Assess the efficacy of FORT-A for decreasing the rate of opioid recidivism using any opioid for 3 or more days in any 30-day period compared to standard VA care in a sample of OEFOIFOND polymorbid Chronic Musculoskeletal Pain CMP Veterans discharged off of opioid medication in VA care since the start of the Opioid Safety Initiative OSI Unlike the original FORT trial this research will formally and prospectively track opioid medication use among polymorbid Veterans to sensitively detect changes in chronic opioid therapy attributable to FORT-A versus VA treatment as usual FORT-A is expected to produce a significantly lower rate of opioid recidivism by imparting numerous strategies to supplant opioid medication as a pain management strategy
EXPLORATORY AIM 3 The investigators will assess other psychosocial pain coping constructs twice a week and analyze latent changes in FORT-A and VA-treated Veterans to ascertain their role as pain management mediators
Design and Outcomes
This study is a 11 block randomized clinical trial comparing the FORT-A program to treatment as usual for polytrauma OEFOIFOND Veterans with prior persistent opioid use and chronic musculoskeletal pain who are eligible for treatment through the South Texas Veterans Health Care System STVHCS All participants will be offered Physical Therapy services before enrollment and will be enrolled in the study after completing or denying Physical Therapy up to 12 sessions as recommended by a Polytrauma Rehabilitation Center PRC Physical Medicine Rehabilitation Physician or other VA medical provider If they have already completed Physical Therapy PT before study enrollment they will not need to do so again Also if the Veteran qualifies but refuses VA Physical Therapy he or she will still be eligible to enroll in this study and will not be asked to complete PT first Veterans randomized to VA care treatment as usual will then meet with PRC and other VA medical providers per usual standards of care described below Those randomized to FORT-A will complete the standardized FORT-A Program described in detail below All participants will complete a standardized battery of assessments at pre-treatment Week 0 post-treatment Week 45 6-month follow-up Week 3031 and 12-month follow-up Week 5657
FORT-A An amended version of the military Functional Orthopedic Rehabilitation Treatment FORT program For FORT-A Cognitive and Behavioral Therapy CBT components of FORT were diminished and replaced with mindfulness and Acceptance and Commitment Therapy ACT components Individual FORT treatment sessions have been altered in FORT-A to focus on PTSD symptom management using an abbreviated manualized Prolonged Exposure treatment FORT-A includes
12 sessions 90-minutes each of manualized group pain management
12 sessions 90-minutes each of group-based functional restoration Physical Therapy
6 sessions 75 minutes each of individual psychotherapy for pain and PTSD
6 sessions 30 minutes each of biofeedback for pain management
Weekly interdisciplinary case staffings
VA and PRC Care The STVHCS PRC is the only self-contained Polytrauma Rehab Center in the VAs nationwide Polytrauma System of Care The PRC is an interdisciplinary treatment center including interdisciplinary assessment and treatment case management mental health support physical medicine and rehabilitation PMR physical therapy speech therapy prosthetistsorthotists and other integrated specialty services Though individual treatment plans may vary most PRC Veterans will complete a course of Physical Therapy and be followed by a PMR physician for pain and other symptom management Pain management with PMR may include medications injections and other palliative medical interventions The PMR physicians may also make recommendations about physical function health behaviors and mobility
Outcomes will be measured at pre-treatment post-treatment 6-month follow-up and one-year follow-up
Establishing Efficacy of a Functional Restoration-Based Complementary and Alternative Medicine Pain Management Program in a Combat Injured Veterans Population
Objectives
AIM 1 Assess the efficacy of the Functional Orthopedic Rehab Treatment-Amended FORT-A Program for improved pain management outcomes in N130 polymorbid OEFOIFOND Veterans with chronic musculoskeletal pain CMP using a 11 randomized clinical trial comparing FORT-A to standard Veterans Affairs VA care We will determine the improvement in pain management outcomes attributable to a fully integrated and manualized interdisciplinary pain program FORT-A compared to standard VA care
AIM 2 Assess the efficacy of FORT-A for decreasing the rate of opioid recidivism using any opioid for 3 or more days in any 30-day period compared to standard VA care in a sample of OEFOIFOND polymorbid Chronic Musculoskeletal Pain CMP Veterans discharged off of opioid medication in VA care since the start of the Opioid Safety Initiative OSI Unlike the original FORT trial this research will formally and prospectively track opioid medication use among polymorbid Veterans to sensitively detect changes in chronic opioid therapy attributable to FORT-A versus VA treatment as usual FORT-A is expected to produce a significantly lower rate of opioid recidivism by imparting numerous strategies to supplant opioid medication as a pain management strategy
EXPLORATORY AIM 3 The investigators will assess other psychosocial pain coping constructs twice a week and analyze latent changes in FORT-A and VA-treated Veterans to ascertain their role as pain management mediators
Design and Outcomes
This study is a 11 block randomized clinical trial comparing the FORT-A program to treatment as usual for polytrauma OEFOIFOND Veterans with prior persistent opioid use and chronic musculoskeletal pain who are eligible for treatment through the South Texas Veterans Health Care System STVHCS All participants will be offered Physical Therapy services before enrollment and will be enrolled in the study after completing or denying Physical Therapy up to 12 sessions as recommended by a Polytrauma Rehabilitation Center PRC Physical Medicine Rehabilitation Physician or other VA medical provider If they have already completed Physical Therapy PT before study enrollment they will not need to do so again Also if the Veteran qualifies but refuses VA Physical Therapy he or she will still be eligible to enroll in this study and will not be asked to complete PT first Veterans randomized to VA care treatment as usual will then meet with PRC and other VA medical providers per usual standards of care described below Those randomized to FORT-A will complete the standardized FORT-A Program described in detail below All participants will complete a standardized battery of assessments at pre-treatment Week 0 post-treatment Week 45 6-month follow-up Week 3031 and 12-month follow-up Week 5657
FORT-A An amended version of the military Functional Orthopedic Rehabilitation Treatment FORT program For FORT-A Cognitive and Behavioral Therapy CBT components of FORT were diminished and replaced with mindfulness and Acceptance and Commitment Therapy ACT components Individual FORT treatment sessions have been altered in FORT-A to focus on PTSD symptom management using an abbreviated manualized Prolonged Exposure treatment FORT-A includes
12 sessions 90-minutes each of manualized group pain management
12 sessions 90-minutes each of group-based functional restoration Physical Therapy
6 sessions 75 minutes each of individual psychotherapy for pain and PTSD
6 sessions 30 minutes each of biofeedback for pain management
Weekly interdisciplinary case staffings
VA and PRC Care The STVHCS PRC is the only self-contained Polytrauma Rehab Center in the VAs nationwide Polytrauma System of Care The PRC is an interdisciplinary treatment center including interdisciplinary assessment and treatment case management mental health support physical medicine and rehabilitation PMR physical therapy speech therapy prosthetistsorthotists and other integrated specialty services Though individual treatment plans may vary most PRC Veterans will complete a course of Physical Therapy and be followed by a PMR physician for pain and other symptom management Pain management with PMR may include medications injections and other palliative medical interventions The PMR physicians may also make recommendations about physical function health behaviors and mobility
Outcomes will be measured at pre-treatment post-treatment 6-month follow-up and one-year follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSC20140396 | OTHER | UTHSCSA | None |