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

NCT02657317 | Completed Results DMC

• 2 other identifiers: R01AT008422-01HSC20140396
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Traumatic Brain Injury; Posttraumatic Stress Disorder; Depression; Opioid Use Disorder

Keywords

chronic pain; pain management; trauma; ptsd; tbi; opioid medication

Outcome Measures

Primary Outcomes (1)

• Change in Oswestry Disability Index (ODI)

  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%).

  Pre-Treatment, Post-Treatment 3 weeks after Pre-Treatment, Follow-Up 6 Months After Post-Treatment, Follow-Up 12 Months After Post-Treatment

Study Arms (2)

FORT-A

EXPERIMENTAL

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.

Behavioral: FORT-A

VA Treatment As Usual

ACTIVE COMPARATOR

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.

Other: VA Treatment as Usual

Interventions

FORT-A BEHAVIORAL

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).

Also known as: Functional Restoration for Pain

FORT-A

VA Treatment as Usual OTHER

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.

Also known as: TAU

VA Treatment As Usual

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• South Texas Veterans Health Care System: collaborator

Study Sites (1)

South Texas Veterans Health Care System

San Antonio, Texas, 78228, United States

Location

Related Publications (1)

• McGeary DD, Jaramillo C, Eapen B, Blount TH, Nabity PS, Moreno J, Pugh MJ, Houle TT, Potter JS, Young-McCaughan S, Peterson AL, Villarreal R, Brackins N, Sikorski Z, Johnson TR, Tapia R, Reed D, Caya CA, Bomer D, Simmonds M, McGeary CA. Mindfulness-Based Interdisciplinary Pain Management Program for Complex Polymorbid Pain in Veterans: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 Oct;103(10):1899-1907. doi: 10.1016/j.apmr.2022.06.012. Epub 2022 Aug 6.

  PMID: 35944602 DERIVED

MeSH Terms

Conditions

Chronic Pain; Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic; Depression; Opioid-Related Disorders; Agnosia; Wounds and Injuries

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Perceptual Disorders; Neurobehavioral Manifestations

Results Point of Contact

• Title: Donald McGeary, PhD
• Organization: University of Texas Health Science Center at San Antonio

mcgeary@uthscsa.edu

210-567-5454

Study Officials

• Donald D McGeary, PhD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

• Blessen Eapen, MD

  South Texas Veterans Health Care System

  PRINCIPAL INVESTIGATOR

• Cindy A McGeary, PhD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

• Carlos Jaramillo, MD, PhD

  South Texas Veterans Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: January 15, 2016
• Study Start: April 4, 2016
• Primary Completion: February 18, 2020
• Study Completion: February 18, 2020
• Last Updated: July 29, 2024
• Results First Posted: July 29, 2024

Record last verified: 2024-07

Locations

US (1)