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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02657317
Recruitment Status : Active, not recruiting
First Posted : January 15, 2016
Last Update Posted : September 5, 2019
Sponsor:
Collaborator:
South Texas Veterans Health Care System
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE December 17, 2015
First Posted Date  ICMJE January 15, 2016
Last Update Posted Date September 5, 2019
Actual Study Start Date  ICMJE January 2016
Actual Primary Completion Date April 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
Change in Oswestry Disability Index [ 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02657317 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
  • Change in Lifting Capacity [ 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 ]
    amount lifted in pounds from floor-to-waist level and from waist-to-eye level
  • Change in Aerobic Capacity [ 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 ]
    oxygen used during walking task (%VO2)
  • Change in Gait [ 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 ]
    distance walked (in meters) over time (in minutes/seconds)
  • Change in Range of Motion [ 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 ]
    degrees of motion a body part is able to move
  • Timeline Followback Interview for Opioid Medication Use (dose frequency) [ Time Frame: Pre-Treatment, Post-Treatment 3 weeks after Pre-Treatment, every month for 12 months after post-treatment ]
    monthly interview about opioid medication use in the past month (frequency of dose - times used per day)
  • Timeline Followback Interview for Opioid Medication Use (# pills) [ Time Frame: Pre-Treatment, Post-Treatment 3 weeks after Pre-Treatment, every month for 12 months after post-treatment ]
    monthly interview about opioid medication use in the past month (number of pills used per day)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in Post-9/11 Veterans
Official Title  ICMJE Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in a Combat-Injured Veterans Population
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Pain
  • Traumatic Brain Injury
  • Posttraumatic Stress Disorder
  • Depression
  • Opioid Use Disorder
Intervention  ICMJE
  • Behavioral: FORT-A
    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).
    Other Name: Functional Restoration for Pain
  • Other: VA Treatment as Usual
    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 Name: TAU
Study Arms  ICMJE
  • Experimental: 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: Behavioral: FORT-A
  • Active Comparator: 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: Other: VA Treatment as Usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 4, 2019)
105
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2016)
130
Estimated Study Completion Date  ICMJE August 2020
Actual Primary Completion Date April 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 72 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02657317
Other Study ID Numbers  ICMJE R01AT008422-01( U.S. NIH Grant/Contract )
HSC20140396 ( Other Identifier: UTHSCSA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE South Texas Veterans Health Care System
Investigators  ICMJE
Principal Investigator: 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
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP