Clinical trial NCT02378025: Treating Chronic Pain in Gulf War Illness
Official title: A Multimodal Evaluation of the Comparative Efficacy of Yoga Versus a Patient Centered Support Group for Treating Chronic Pain in Gulf War Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Gulf War Illness
Chronic Illness
Keywords: Chronic Pain
Veterans
Gulf War Illness
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2015-03-04
Enrollment: 75
Sex: ALL
Minimum age (years): 42
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain (Brief Pain Inventory - Short Form) - Pain Severity
timeFrame: Week 10 minus Week 0
measure: Pain (Brief Pain Inventory - Short Form) - Pain Interference
timeFrame: Week 10 minus Week 0
Secondary outcomes:
measure: Fatigue (6-Minute Walk Test)
timeFrame: Week 0, Week 10
measure: Change in Number of Participants Who Used Analgesic Medication
timeFrame: Week 0, Week 10
measure: Change in Number of Participants Who Used Nonsteroidal Anti-inflammatory Drugs
timeFrame: Week 0, Week 10
measure: Change in Number of Participants Who Used Opiate Medication
timeFrame: Week 0, Week 10
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: VA Palo Alto Heath Care System
name: Peter Bayley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mathersul DC, Dixit K, Avery TJ, Schulz-Heik RJ, Zeitzer JM, Mahoney LA, Cho RH, Bayley PJ. Heart rate and heart rate variability as outcomes and longitudinal moderators of treatment for pain across follow-up in Veterans with Gulf War illness. Life Sci. 2021 Jul 15;277:119604. doi: 10.1016/j.lfs.2021.119604. Epub 2021 May 11.
citation: Bayley PJ, Schulz-Heik RJ, Cho R, Mathersul D, Collery L, Shankar K, Ashford JW, Jennings JS, Tang J, Wong MS, Avery TJ, Stanton MV, Meyer H, Friedman M, Kim S, Jo B, Younger J, Mathews B, Majmundar M, Mahoney L. Yoga is effective in treating symptoms of Gulf War illness: A randomized clinical trial. J Psychiatr Res. 2021 Nov;143:563-571. doi: 10.1016/j.jpsychires.2020.11.024. Epub 2020 Nov 11.