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Treating Chronic Pain in Gulf War Illness

A Multimodal Evaluation of the Comparative Efficacy of Yoga Versus a Patient Centered Support Group for Treating Chronic Pain in Gulf War Illness

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02378025
Enrollment
75
Registered
2015-03-04
Start date
2015-06-01
Completion date
2018-03-31
Last updated
2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Gulf War Illness, Chronic Illness

Keywords

Chronic Pain, Veterans, Gulf War Illness

Brief summary

The purpose of this study is to determine whether yoga is effective for the treatment of chronic pain in Gulf War Illness.

Detailed description

Background: Many military personnel who participated in the Gulf War in 1990-1991 reported negative health consequences subsequent to their deployment. The most prevalent of these health consequences involves a triad of symptoms that include fatigue, pain and cognitive disturbances, commonly referred to as Gulf War Illness (GWI). No clear, unifying patho-physiological disease process or effective treatment has yet been identified for GWI. Results from a diverse spectrum of research studies support the view that veterans with GWI are medically ill, but the physiological abnormalities that contribute to their illness are not currently well understood nor sufficiently treated by conventional medicine. While the cause of GWI remains unknown, a potential link between GWI and autonomic nervous system (ANS) dysregulation has been suggested. Yoga has been suggested to exert its therapeutic effects through adjusting imbalances in the ANS. In addition, yoga has been shown to be clinically effective in treating many of the physical symptoms typically found in GWI, including chronic pain and fatigue. As chronic pain is perhaps the most prevalent and debilitating symptom of GWI, we propose to target pain. Significantly for this application, no improvements in pain have yet been reported in any clinical trial involving GWI. Furthermore, no published studies have investigated yoga as an intervention in GWI. Objectives: The primary objective is to investigate yoga for the treatment of chronic pain in veterans with GWI. A secondary objective is to provide veterans with skills in yoga breathing, postures, and meditation that can be used to promote health and well-being. Hypothesis 1 (primary): 1. The subjective experience of pain, as measured by the Brief Pain Inventory-Short Form, will be reduced at end of treatment in the group given a 10-week yoga treatment program, compared to a pain support group (control). 2. This effect will be sustained across time and will be found at the end of the 24-week post-treatment follow-up. Hypothesis 2 (secondary): Yoga will have a beneficial effect on general well-being; thus, compared to the control group, the yoga treatment group will show benefits across a broad range of measures, including quality of life, fatigue, and medication use. Specific Aims: 1. To assess the efficacy of yoga in reducing chronic pain and determine if the health-related benefits of yoga persist after termination of the treatment program. 2. To obtain symptom-based outcome measures for veterans with GWI (before and after randomization) to assess pain, fatigue, physical functional status and quality of life. Study Design: The intervention to be tested is a 10-week yoga treatment program that has been specially designed for the treatment of chronic pain, as experienced by veterans with GWI. One hundred patients will be randomly assigned to one of two treatment groups: group yoga or a pain management wellness group (control). The control group has been carefully designed to control for many features of a yoga intervention. Patients in both groups will attend weekly classes for 10 weeks, followed by 6 months of follow up. Monitoring will include periodic measures of pain, fatigue, quality of life, and ANS function. Impact: Despite increasing demand from veterans for yoga and other forms of complementary and alternative treatments, the provision of yoga in veteran healthcare remains sparse. This is due, in large part, to a lack of randomized clinical trials capable of demonstrating the efficacy and safety of yoga for the treatment of conditions such as GWI. Such a demonstration would strengthen the case to offer yoga as a widely-available treatment for pain in GWI and would help promote yoga as part of integrative healthcare. This treatment trial is designed to begin to determine potential mechanisms of pain maintenance in GWI. If yoga leads to improvement in pain outcome, this would support performing a larger clinical trial of yoga for treating pain and other symptoms of GWI.

Interventions

BEHAVIORALYoga Group

A 10-week yoga course designed to treat pain.

BEHAVIORALPain Management Wellness Group

A 10-week behavioral therapy course designed to treat pain.

Sponsors

United States Department of Defense
CollaboratorFED
Palo Alto Veterans Institute for Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
42 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Served in the military in 1990-1991, regardless of deployment. * History of chronic pain. * Able to attend weekly visits at the study center for 10 weeks. * If on a psychotropic medication, the regimen will be stable for at least 4 weeks, prior to entry in the study.

Exclusion criteria

* Participation in another clinical trial. * Unable to visit the study center. * Unable to stand or walk.

Design outcomes

Primary

MeasureTime frameDescription
Pain (Brief Pain Inventory - Short Form) - Pain SeverityWeek 10 minus Week 0Model - estimated change in the Pain Severity subscale of the Brief Pain Inventory - Short Form from baseline to end of treatment. The subscale's minimum score is 0; maximum is 10; more negative change scores indicate greater improvement from baseline to end of treatment
Pain (Brief Pain Inventory - Short Form) - Pain InterferenceWeek 10 minus Week 0Model - estimated change in the Pain Interference subscale of the Brief Pain Inventory - Short Form from baseline to end of treatment. The subscale's minimum score is 0; maximum is 10; more negative change scores indicate greater improvement from baseline to end of treatment.

Secondary

MeasureTime frameDescription
Fatigue (6-Minute Walk Test)Week 0, Week 10Increase from baseline to end of treatment in distance walked during 6-Minute Walk Test. Greater values indicate more increase and therefore a more positive outcome.
Change in Number of Participants Who Used Analgesic MedicationWeek 0, Week 10Change in number of participants who self-reported use of analgesic medication(s) from Week 0 to Week 10.
Change in Number of Participants Who Used Nonsteroidal Anti-inflammatory DrugsWeek 0, Week 10Change in number of participants who self-reported use of Nonsteroidal Anti-inflammatory Drug(s) from Week 0 to Week 10.
Change in Number of Participants Who Used Opiate MedicationWeek 0, Week 10Change in number of participants who self-reported use of Opiate Medication(s) from Week 0 to Week 10.

Countries

United States

Participant flow

Participants by arm

ArmCount
Yoga Group
Postures, meditation, breathing exercises Yoga Group: A 10-week yoga course designed to treat pain.
39
Pain Management Wellness Group
Behavioral medicine Pain Management Wellness Group: A 10-week behavioral therapy course designed to treat pain.
36
Total75

Baseline characteristics

CharacteristicYoga GroupTotalPain Management Wellness Group
Age, Continuous53.8 years
STANDARD_DEVIATION 7.2
53.0 years
STANDARD_DEVIATION 7.1
52.0 years
STANDARD_DEVIATION 6.8
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants15 Participants7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
31 Participants60 Participants29 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants6 Participants3 Participants
Race (NIH/OMB)
Asian
6 Participants9 Participants3 Participants
Race (NIH/OMB)
Black or African American
7 Participants11 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants13 Participants6 Participants
Race (NIH/OMB)
White
16 Participants36 Participants20 Participants
Region of Enrollment
United States
39 participants75 participants36 participants
Sex: Female, Male
Female
8 Participants18 Participants10 Participants
Sex: Female, Male
Male
31 Participants57 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 390 / 36
other
Total, other adverse events
0 / 390 / 36
serious
Total, serious adverse events
0 / 390 / 36

Outcome results

Primary

Pain (Brief Pain Inventory - Short Form) - Pain Interference

Model - estimated change in the Pain Interference subscale of the Brief Pain Inventory - Short Form from baseline to end of treatment. The subscale's minimum score is 0; maximum is 10; more negative change scores indicate greater improvement from baseline to end of treatment.

Time frame: Week 10 minus Week 0

Population: Note: One participant was not included in this analysis because he discontinued participation in the study before completing this portion of the baseline assessment.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Yoga GroupPain (Brief Pain Inventory - Short Form) - Pain Interference-1.60 units on a scaleStandard Deviation 2.32
Pain Management Wellness GroupPain (Brief Pain Inventory - Short Form) - Pain Interference-.59 units on a scaleStandard Deviation 2.36
p-value: 0.08Mixed Models Analysis
Primary

Pain (Brief Pain Inventory - Short Form) - Pain Severity

Model - estimated change in the Pain Severity subscale of the Brief Pain Inventory - Short Form from baseline to end of treatment. The subscale's minimum score is 0; maximum is 10; more negative change scores indicate greater improvement from baseline to end of treatment

Time frame: Week 10 minus Week 0

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Yoga GroupPain (Brief Pain Inventory - Short Form) - Pain Severity-.87 units on a scaleStandard Deviation 2.49
Pain Management Wellness GroupPain (Brief Pain Inventory - Short Form) - Pain Severity-.24 units on a scaleStandard Deviation 2.4
p-value: 0.25Mixed Models Analysis
Secondary

Change in Number of Participants Who Used Analgesic Medication

Change in number of participants who self-reported use of analgesic medication(s) from Week 0 to Week 10.

Time frame: Week 0, Week 10

Population: Week 0 data reflects all participants who responded to the item; some participants left the item blank. Some participants stated that they could not recall all the medications they were taking. Week 10 reflects all participants who completed the Week 10 assessment and answered the item.

ArmMeasureGroupValue (NUMBER)
Yoga GroupChange in Number of Participants Who Used Analgesic MedicationUsed at Week 02 participants
Yoga GroupChange in Number of Participants Who Used Analgesic MedicationUsed at Week 104 participants
Pain Management Wellness GroupChange in Number of Participants Who Used Analgesic MedicationUsed at Week 07 participants
Pain Management Wellness GroupChange in Number of Participants Who Used Analgesic MedicationUsed at Week 105 participants
p-value: 0.25Regression, Logistic
Secondary

Change in Number of Participants Who Used Nonsteroidal Anti-inflammatory Drugs

Change in number of participants who self-reported use of Nonsteroidal Anti-inflammatory Drug(s) from Week 0 to Week 10.

Time frame: Week 0, Week 10

Population: Week 0 data reflects all participants who responded to the item; some participants left the item blank. Some participants stated that they could not recall all the medications they were taking. Week 10 reflects all participants who completed the Week 10 assessment and answered the item.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Yoga GroupChange in Number of Participants Who Used Nonsteroidal Anti-inflammatory DrugsUsed at Week 014 Participants
Yoga GroupChange in Number of Participants Who Used Nonsteroidal Anti-inflammatory DrugsUsed at Week 1012 Participants
Pain Management Wellness GroupChange in Number of Participants Who Used Nonsteroidal Anti-inflammatory DrugsUsed at Week 015 Participants
Pain Management Wellness GroupChange in Number of Participants Who Used Nonsteroidal Anti-inflammatory DrugsUsed at Week 1011 Participants
p-value: 0.22Regression, Logistic
Secondary

Change in Number of Participants Who Used Opiate Medication

Change in number of participants who self-reported use of Opiate Medication(s) from Week 0 to Week 10.

Time frame: Week 0, Week 10

Population: Week 0 data reflects all participants who responded to the item; some participants left the item blank. Some participants stated that they could not recall all the medications they were taking. Week 10 reflects all participants who completed the Week 10 assessment and answered the item.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Yoga GroupChange in Number of Participants Who Used Opiate MedicationParticipants who used opiates at Week 04 Participants
Yoga GroupChange in Number of Participants Who Used Opiate MedicationParticipants who used opiates at Week 105 Participants
Pain Management Wellness GroupChange in Number of Participants Who Used Opiate MedicationParticipants who used opiates at Week 04 Participants
Pain Management Wellness GroupChange in Number of Participants Who Used Opiate MedicationParticipants who used opiates at Week 105 Participants
p-value: 0.41Regression, Logistic
Secondary

Fatigue (6-Minute Walk Test)

Increase from baseline to end of treatment in distance walked during 6-Minute Walk Test. Greater values indicate more increase and therefore a more positive outcome.

Time frame: Week 0, Week 10

Population: Three participants did not complete this assessment at baseline, therefore 72 participants are included in this analysis.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Yoga GroupFatigue (6-Minute Walk Test)46.4 metersStandard Deviation 119
Pain Management Wellness GroupFatigue (6-Minute Walk Test)14.5 metersStandard Deviation 96.7
p-value: 0.04Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026