Trial Outcomes & Findings for Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in Post-9/11 Veterans (NCT NCT02657317)

Last Updated: 2024-07-29

Results Overview

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%).

Recruitment status

COMPLETED

Study phase

Target enrollment

103 participants

Primary outcome timeframe

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

Results posted on

2024-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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).	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. 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.
Overall Study STARTED	50	53
Overall Study COMPLETED	45	50
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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).	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. 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.
Overall Study Withdrawal by Subject	2	0
Overall Study Lost to Follow-up	3	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FORT-A n=50 Participants 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. 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).	VA Treatment As Usual n=53 Participants 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. 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.	Total n=103 Participants Total of all reporting groups
Age, Continuous	43.7 years STANDARD_DEVIATION 11.0 • n=99 Participants	43.7 years STANDARD_DEVIATION 9.4 • n=107 Participants	43.7 years STANDARD_DEVIATION 10.0 • n=206 Participants
Sex: Female, Male Female	9 Participants n=99 Participants	13 Participants n=107 Participants	22 Participants n=206 Participants
Sex: Female, Male Male	41 Participants n=99 Participants	40 Participants n=107 Participants	81 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=99 Participants	16 Participants n=107 Participants	42 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=99 Participants	37 Participants n=107 Participants	61 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Black or African American	5 Participants n=99 Participants	16 Participants n=107 Participants	21 Participants n=206 Participants
Race (NIH/OMB) White	36 Participants n=99 Participants	28 Participants n=107 Participants	64 Participants n=206 Participants
Race (NIH/OMB) More than one race	7 Participants n=99 Participants	5 Participants n=107 Participants	12 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants

PRIMARY outcome

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

Population: Intent to treat

Outcome measures

Outcome measures
Measure	FORT-A n=50 Participants 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. 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).	VA Treatment As Usual n=53 Participants 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. 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.
Change in Oswestry Disability Index (ODI) Pre-Treatment	48.6 score on a scale Interval 42.4 to 54.8	45.1 score on a scale Interval 39.5 to 50.7
Change in Oswestry Disability Index (ODI) Post-Treatment	38.3 score on a scale Interval 33.5 to 43.1	47.8 score on a scale Interval 42.5 to 53.0
Change in Oswestry Disability Index (ODI) 6-Month Follow-up	37.6 score on a scale Interval 32.7 to 42.5	47.1 score on a scale Interval 41.7 to 52.5
Change in Oswestry Disability Index (ODI) 12-Month Follow-up	37.9 score on a scale Interval 33.0 to 42.7	45.7 score on a scale Interval 40.1 to 51.2

Adverse Events

FORT-A

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

VA Treatment As Usual

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Donald McGeary, PhD

University of Texas Health Science Center at San Antonio

Phone: 210-567-5454

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	FORT-A n=50 participants at risk 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. 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).	VA Treatment As Usual n=53 participants at risk 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. 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.
Musculoskeletal and connective tissue disorders Knee Pain	6.0% 3/50 • Number of events 4 • 1 year definitions consistent with clinicaltrials.gov definitions	13.2% 7/53 • Number of events 10 • 1 year definitions consistent with clinicaltrials.gov definitions
Nervous system disorders Increased Anxiety	4.0% 2/50 • Number of events 4 • 1 year definitions consistent with clinicaltrials.gov definitions	15.1% 8/53 • Number of events 9 • 1 year definitions consistent with clinicaltrials.gov definitions
Psychiatric disorders Increased Nightmares	4.0% 2/50 • Number of events 2 • 1 year definitions consistent with clinicaltrials.gov definitions	0.00% 0/53 • 1 year definitions consistent with clinicaltrials.gov definitions
Psychiatric disorders Increased Anger	6.0% 3/50 • Number of events 3 • 1 year definitions consistent with clinicaltrials.gov definitions	0.00% 0/53 • 1 year definitions consistent with clinicaltrials.gov definitions
Musculoskeletal and connective tissue disorders Pain in right let	2.0% 1/50 • Number of events 1 • 1 year definitions consistent with clinicaltrials.gov definitions	1.9% 1/53 • Number of events 1 • 1 year definitions consistent with clinicaltrials.gov definitions
Musculoskeletal and connective tissue disorders Shoulder Pain	6.0% 3/50 • Number of events 3 • 1 year definitions consistent with clinicaltrials.gov definitions	22.6% 12/53 • Number of events 14 • 1 year definitions consistent with clinicaltrials.gov definitions
Nervous system disorders Numbness and tingling in feet	4.0% 2/50 • Number of events 2 • 1 year definitions consistent with clinicaltrials.gov definitions	3.8% 2/53 • Number of events 2 • 1 year definitions consistent with clinicaltrials.gov definitions
Nervous system disorders Cold and numbness in feet	2.0% 1/50 • Number of events 1 • 1 year definitions consistent with clinicaltrials.gov definitions	0.00% 0/53 • 1 year definitions consistent with clinicaltrials.gov definitions
Musculoskeletal and connective tissue disorders Neck discomfort	0.00% 0/50 • 1 year definitions consistent with clinicaltrials.gov definitions	0.00% 0/53 • 1 year definitions consistent with clinicaltrials.gov definitions
Musculoskeletal and connective tissue disorders General pain	0.00% 0/50 • 1 year definitions consistent with clinicaltrials.gov definitions	0.00% 0/53 • 1 year definitions consistent with clinicaltrials.gov definitions
Nervous system disorders Sleep difficulties due to discontinued opioid	2.0% 1/50 • Number of events 1 • 1 year definitions consistent with clinicaltrials.gov definitions	0.00% 0/53 • 1 year definitions consistent with clinicaltrials.gov definitions
General disorders Increase in pain due to discontinuation of opioid	4.0% 2/50 • Number of events 2 • 1 year definitions consistent with clinicaltrials.gov definitions	3.8% 2/53 • Number of events 2 • 1 year definitions consistent with clinicaltrials.gov definitions
Psychiatric disorders Increased irritability due to discontinuation of opioids	2.0% 1/50 • Number of events 1 • 1 year definitions consistent with clinicaltrials.gov definitions	1.9% 1/53 • Number of events 1 • 1 year definitions consistent with clinicaltrials.gov definitions
Nervous system disorders Increase in headaches due to discontinuation of opioids	2.0% 1/50 • Number of events 1 • 1 year definitions consistent with clinicaltrials.gov definitions	0.00% 0/53 • 1 year definitions consistent with clinicaltrials.gov definitions
General disorders Whole body aches	2.0% 1/50 • Number of events 1 • 1 year definitions consistent with clinicaltrials.gov definitions	0.00% 0/53 • 1 year definitions consistent with clinicaltrials.gov definitions
Musculoskeletal and connective tissue disorders Back pain	22.0% 11/50 • Number of events 12 • 1 year definitions consistent with clinicaltrials.gov definitions	18.9% 10/53 • Number of events 11 • 1 year definitions consistent with clinicaltrials.gov definitions