Chronic PainNCT02657317
Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in Post-9/11 Veterans
A study testing FORT-A and VA Treatment as Usual in people with Chronic Pain and Traumatic Brain Injury, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Chronic Pain, Traumatic Brain Injury, Posttraumatic Stress Disorder
- What is being tested?
- FORT-A and VA Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2016to 18 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
South Texas Veterans Health Care System
San Antonio, Texas, 78228
About this study
Official title: Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in a Combat-Injured Veterans Population
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.
Read the 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.
- Conditions
- Chronic Pain, Traumatic Brain Injury, Posttraumatic Stress Disorder, Depression, Opioid Use Disorder
- Being tested
- FORT-A, VA Treatment as Usual
- Keywords
- chronic pain, pain management, trauma, ptsd, tbi, opioid medication
- Medical subject headings
- Chronic Pain, Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic, Depression, Opioid-Related Disorders, Agnosia, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FORT-ABehavioural
Also called Functional Restoration for Pain
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).
VA Treatment as UsualOther
Also called TAU
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: VA Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: Pre-Treatment, Post-Treatment 3 weeks after Pre-Treatment, Follow-Up 6 Months After Post-Treatment, Follow-Up 12 Months After Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study start4 Apr 2016
- Primary completion18 Feb 2020
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- South Texas Veterans Health Care System
- Responsible party
- Sponsor
- Investigators
- Donald D McGeary, PhD, Principal investigator, The University of Texas Health Science Center at San AntonioBlessen Eapen, MD, Principal investigator, South Texas Veterans Health Care SystemCindy A McGeary, PhD, Principal investigator, The University of Texas Health Science Center at San AntonioCarlos Jaramillo, MD, PhD, Principal investigator, South Texas Veterans Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657317
- Sponsor's protocol ID
- R01AT008422-01
- Other IDs
- HSC20140396
- Status last verified
- Jul 2024
- First submitted
- 17 Dec 2015
- Last updated
- 29 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 35944602
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in a Combat-Injured Veterans Population
- ClinicalTrials.gov ID
- NCT02657317
- Acronym / sponsor ID
- R01AT008422-01
- Conditions
- Chronic Pain, Traumatic Brain Injury, Posttraumatic Stress Disorder, Depression, Opioid Use Disorder
- Keywords
- chronic pain, pain management, trauma, ptsd, tbi, opioid medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- South Texas Veterans Health Care System
- Study start
- 4 Apr 2016 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Posted 29 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FORT-A | Experimental | Behavioral: FORT-Ahas 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. |
| VA Treatment As Usual | Active comparator | Other: VA Treatment as UsualTreatment 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. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FORT-AAlso: Functional Restoration for PainFORT-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). | Behavioural | FORT-A |
| VA Treatment as UsualAlso: TAUVA 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 | VA Treatment As Usual |
Primary outcome
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%).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35944602McGeary 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald D McGeary, PhD principal investigator
The University of Texas Health Science Center at San Antonio
Blessen Eapen, MD principal investigator
South Texas Veterans Health Care System
Cindy A McGeary, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FORT-A and VA Treatment as Usual in people with Chronic Pain and Traumatic Brain Injury, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02657317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.