Treating Chronic Pain in Gulf War Illness

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.

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.