NCT01752010已完成不适用
A Randomized Study Comparing the Tennant BioModulator to Transcutaneous Electrical Nerve Stimulation (TENS) and Traditional Chinese Acupuncture for the Symptomatic Treatment of Chronic Pain Among Injured Service Members.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Chronic pain
研究概览
简要总结
The primary objective of this preliminary study is to compare the Tennant BioModulator with Transcutaneous Electrical Nerve Stimulation (TENS) and Traditional Chinese Acupuncture for the management of chronic pain among injured service members. The secondary objective is to investigate any associative effects or benefits on sleep, Post-Traumatic Stress Disorder (PTSD) symptoms, or depression.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be Injured service members between the ages of 18 and 60, inclusive;
- •The pain must have been present for 3 months or greater prior to entry into the study;
- •Subjects must agree to follow the medication regime as directed by the pain clinic provider for the duration of the study;
- •Subjects must be able to speak and read English and understand study procedures
排除标准
- •Pregnancy, or considering pregnancy within the study time-frame
- •Pacemaker
- •History of cardiac arrhythmias
- •Implantable devices (AICD, pump, etc.)
- •Surgical intervention during the past month for the treatment of low back pain or its underlying etiology
- •Documented history of prescription medication abuse
- •Abuse of illicit drugs within the last 6 months
- •Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
结局指标
主要结局
Chronic pain
时间窗: Baseline; post-intervention; one-month follow up.
次要结局
- Depression, PTSD symptoms, Sleep.(Baseline; post-intervention; one-month follow up.)
研究者
研究点 (2)
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