Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in Post-9/11 Veterans
Condition: Chronic Pain; Traumatic Brain Injury; Posttraumatic Stress Disorder; Depression; Opioid Use Disorder
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Chronic Pain; Opioid-Related Disorders; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This is a research study of an interdisciplinary pain management program for U.S. military
      veterans who served during the post-9/11 combat eras (e.g., Operations Iraqi Freedom [OIF],
      Enduring Freedom [OEF], New Dawn [OND]) presenting with chronic musculoskeletal pain related
      to military service with comorbid depression and/or posttraumatic stress disorder [PTSD]
      symptoms and/or 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 (N=130) polymorbid OEF/OIF/OND Veterans with
      chronic musculoskeletal pain (CMP) using a 1:1 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
      OEF/OIF/OND 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 1:1 block randomized clinical trial comparing the FORT-A program to treatment
      as usual for polytrauma OEF/OIF/OND 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 4/5),
      6-month follow-up (Week 30/31) and 12-month follow-up (Week 56/57).

      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
      VA's 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 (PM&R), physical therapy, speech therapy,
      prosthetists/orthotists, 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 PM&R physician for pain and other symptom management. Pain management with PM&R may
      include medications, injections, and other palliative medical interventions. The PM&R
      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.
    

Intervention name(s): FORT-A; VA Treatment as Usual
Intervention type(s): Behavioral; Other
Intervention description(s): FORT-A is based on a functional restoration paradigm of pain management in which treatment is interdisciplinary and designed to achieve a functional goal (often specified by the patient; e.g., doing more with family, returning to work). FORT-A includes intensive functional rehabilitation, group-based pain management intervention, and individual interventions tailored to the patient's specific needs (e.g., biofeedback for stress, individual psychotherapy for mood or trauma symptoms).; VA TAU includes referrals for specialty intervention, rehabilitation, and behavioral health intervention within the VA medical system. Some participants may be referred for care outside of the VA system. The South Texas Veterans Health Care System offers a wide range of pain management services.
Other intervention name(s): Functional Restoration for Pain; TAU
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic pain; pain management; trauma; ptsd; tbi; opioid medication