Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in Post-9/11 Veterans

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.

Inclusion Criteria:

1. Demographics for inclusion in this research include both genders, all racial/ethnic
groups, and ages 18-72.

2. Present with chronic musculoskeletal pain (CMP) as a primary pain complaint

3. CMP is accompanied by at least moderate disability based on a score of 20% or more on
the Oswestry Disability Index;

4. Consistent with NIH Task Force recommendations, "chronic" CMP has been a problem for
the Veteran for at least half the days in the last 3 months and was acquired or
exacerbated as part of active duty U.S. military service in the Operations Iraqi
Freedom (OIF), Enduring Freedom (OEF), or New Dawn (OND) war eras.

5. CMP presents in the context of comorbid psychiatric symptoms of posttraumatic stress
disorder (PTSD; based on a score of 25 or more on the PTSD Checklist-Version 5) and/or
depression (based on a score of 10 or more on the Beck Depression Inventory-2).

6. Demonstrate prior "chronic" opioid use (defined as using opioid medication for 20 out
of every 30 days over three or more months) and discharged off of persistent opioid
medications by a VA provider since the onset of the VA Opioid Safety Initiative
(2013).

7. Speak and read/understand English well enough to fully participate in the intervention
and to reliably complete assessment measures.

8. The Veteran will be eligible to be a PRC patient (i.e., have multiple trauma related
physical and psychological injuries; VA, 2013) and be eligible for Physical Therapy
referral through the PRC (though the referral for the same service could also come
from another VHA provider). All participants will be offered Physical Therapy services
before enrollment and will be enrolled after completing or denying Physical Therapy.

Exclusion Criteria:

1. Actively engaged in an intervention or program specifically targeting opioid use
(including those using naloxone).

2. Present with active psychosis or suicidal ideation with intent. These symptoms must be
stabilized (i.e., maintained at or below moderate intensity for 6 weeks with no acute
episodes requiring higher levels of intervention) through a VHA Psychology or
Psychiatry referral and confirmed by the mental health provider before the Veteran is
eligible to participate.

3. CMP is not related to or exacerbated by military service during the OEF/OIF/OND combat
eras.

4. Present with significantly diminished decision-making capacity (e.g., severe cognitive
dysfunction related to severe TBI).

5. Pregnant women

6. Inability or unwillingness of individual or legal guardian/representative to give
written informed consent.