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临床试验/NCT01060553
NCT01060553已完成不适用

Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD

US Department of Veterans Affairs1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2010年7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
34
试验地点
1
主要终点
SF-36

研究概览

简要总结

The purpose of this study is to examine if acupuncture improves Post-Traumatic Stress Disorder symptoms among veterans who participated in Operations Enduring Freedom and Iraqi Freedom. This study will also examine the degree of veteran acceptance for acupuncture.

详细描述

Project Background: Acupuncture can be effective for many of the specific co-morbidities that make up war-related Trauma Spectrum Disorder in both TBI and PTSD patients, including pain, stress and anxiety, insomnia, somatic and post-operative pain. Recent studies find very large effect sizes (Cohen's D .85 to 1.4). Thus, there is good reason to believe that acupuncture will induce recovery across a number of trauma spectrum dysfunctions in patients with TBI and PTSD, at low cost and with little risk.

Project Objectives: The overall objective of this application is to determine the efficacy of adjunctive acupuncture for improving quality of life and function and alleviating co-morbidities associated with TBI and PTSD in service members injured in the current wars. The primary hypothesis of this study is: OIF/OEF veterans who screen positive for TBI or PTSD and are treated with a 12 week standard individualized acupuncture method will experience improved HRQL (as measured by the Veteran's SF-36) at 6, 12 and 24 week follow-up, compared to veterans randomly assigned to standard care alone.

Project Methods: This is a pilot study on veterans who screen positive for TBI or PTSD in the VA healthcare record, which is being submitted to obtain additional pilot data, confirmation of recruitment strategies, and information on non-participants . Frequency distribution and summary statistics for demographics and baseline variables will be presented by intervention group and for all subjects combined. Key demographic variables to be summarized are: age, gender, time to deployment, number of deployments, and diagnosis. Key baseline variables are: PTSD CAPS score, VSF-36, and ANAM score.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis or positive screen test for PTSD.
  • •Combat veterans of Operation Iraqi Freedom or Operation Enduring Freedom conflicts.

排除标准

  • •Unable to travel to East Orange VA for 12 consecutive weeks, biweekly for treatment.
  • •Does not speak English.
  • •Acupuncture or CBT treatment within the previous six months.

研究组 & 干预措施

Arm 1

Experimental

The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue (tolerance due to frequent use). The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen

干预措施: Acupuncture treatment (Other)

wait list control

No Intervention

subjects were put on a wait list control. due to small numbers completing in both groups, the data from the wait list who completed acupuncture are combined with the experimental treatment group for analysis.

结局指标

主要结局

SF-36

时间窗: baseline, 6 or 12 weeks (latest available is used)

global health functioning Mental component (MCS) and Physical component (PCS) subscales range from 0 to 100 with 100 being better; 50 is expected population average.

次要结局

  • Pittsburgh Sleep Index(baseline, 6 or 12 weeks (latest available is used))

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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