跳至主要内容
临床试验/NCT02378025
NCT02378025已完成不适用

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

Palo Alto Veterans Institute for Research1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Pain (Brief Pain Inventory - Short Form) - Pain Severity

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
42 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

Yoga Group

Experimental

Postures, meditation, breathing exercises

干预措施: Yoga Group (Behavioral)

Pain Management Wellness Group

Active Comparator

Behavioral medicine

干预措施: Pain Management Wellness Group (Behavioral)

结局指标

主要结局

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

时间窗: Week 10 minus Week 0

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

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

时间窗: Week 10 minus Week 0

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.

次要结局

  • Change in Number of Participants Who Used Analgesic Medication(Week 0, Week 10)
  • Fatigue (6-Minute Walk Test)(Week 0, Week 10)
  • Change in Number of Participants Who Used Nonsteroidal Anti-inflammatory Drugs(Week 0, Week 10)
  • Change in Number of Participants Who Used Opiate Medication(Week 0, Week 10)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Bayley

Associate Director of Cognitive Neuroscience

Palo Alto Veterans Institute for Research

研究点 (1)

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