Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in Post-9/11 … (NCT02657317) | Clinical Trial Compass
CompletedNot Applicable
Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in Post-9/11 Veterans
United States103 participantsStarted 2016-04-04
Plain-language 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.
Who can participate
Age range18 Years – 72 Years
SexALL
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Inclusion criteria
✓. Demographics for inclusion in this research include both genders, all racial/ethnic groups, and ages 18-72.
✓. 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.
What they're measuring
1
Change in Oswestry Disability Index (ODI)
Timeframe: Pre-Treatment, Post-Treatment 3 weeks after Pre-Treatment, Follow-Up 6 Months After Post-Treatment, Follow-Up 12 Months After Post-Treatment
Trial details
NCT IDNCT02657317
SponsorThe University of Texas Health Science Center at San Antonio
. 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.