Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in a Combat-Injured Veterans Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- Change in Oswestry Disability Index (ODI)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 72 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Demographics for inclusion in this research include both genders, all racial/ethnic groups, and ages 18-
- •Present with chronic musculoskeletal pain (CMP) as a primary pain complaint
- •CMP is accompanied by at least moderate disability based on a score of 20% or more on the Oswestry Disability Index;
- •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.
- •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).
- •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).
- •Speak and read/understand English well enough to fully participate in the intervention and to reliably complete assessment measures.
- •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
- •Actively engaged in an intervention or program specifically targeting opioid use (including those using naloxone).
- •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.
- •CMP is not related to or exacerbated by military service during the OEF/OIF/OND combat eras.
- •Present with significantly diminished decision-making capacity (e.g., severe cognitive dysfunction related to severe TBI).
- •Pregnant women
- •Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Arms & Interventions
VA Treatment As Usual
Treatment As Usual (TAU) represents usual VA Care based on "as usual" appointments and referrals from VA providers. TAU can include active medical interventions, psychosocial intervention, and other rehabilitation strategies.
Intervention: VA Treatment as Usual (Other)
FORT-A
has been labeled "FORT-A." FORT-A is provided on an outpatient basis and includes 12 daily group pain management and physical therapy sessions spanning three weeks. Group interventions are supplemented by individual psychotherapy, biofeedback, and case staffings. CBT sessions were decreased in favor of CAM components. FORT-A participants will receive 270 minutes (4½ hours) of intervention a day for 12 days over 3 weeks.
Intervention: FORT-A (Behavioral)
Outcomes
Primary Outcomes
Change in Oswestry Disability Index (ODI)
Time Frame: Pre-Treatment, Post-Treatment 3 weeks after Pre-Treatment, Follow-Up 6 Months After Post-Treatment, Follow-Up 12 Months After Post-Treatment
self-report disability measure. The ODI is a ten-item self report which assesses an individuals perception of limitation in a number of different life domains due to pain. Each item is scored from 0-5 on a numeric rating scale. Scores for each item is summed into a total score and the total is divided by 50 an multiplied by 100 to generate a total score ranging from 0 to 100. This total score represents a % disability score which can be categorized as Minimal (0-20%), Moderate (21-40%), Severe (41-60%), Crippled (61-80%), or Bed Bound/Exaggerating (81-100%).
Secondary Outcomes
No secondary outcomes reported