Treating Chronic Pain in Gulf War Illness
Condition: Chronic Pain; Gulf War Illness; Chronic Illness
MeSH terms: Chronic Pain; Chronic Disease
Study type: Interventional

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.
    

Intervention name(s): Yoga Group; Pain Management Wellness Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A 10-week yoga course designed to treat pain.; A 10-week behavioral therapy course designed to treat pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Pain; Veterans; Gulf War Illness