The E-STIM Trial: A Randomized, Double-Blind, Multicenter Trial Comparing the Efficacy of the Empi Select Transcutaneous Electrical Nerve Stimulation (TENS) to a Control for the Treatment of Chronic Lower Back Pain

Empi, A DJO Company16 个研究点分布在 1 个国家目标入组 300 人开始时间: 2008年2月1日最近更新: 2008年7月3日

适应症

试验速览

阶段: 不适用
发起方
入组人数: 300
试验地点: 16
主要终点: Relief of lower back pain as measured by a Numerical Rating Scale (NRS) of Average Daily Pain.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether transcutaneous electrical nerve stimulation (TENS) delivered via the Empi Select TENS device provides relief of chronic lower back pain.

详细描述

The E-STIM Trial is designed to collect data on the efficacy of the Empi Select Transcutaneous Electrical Nerve Stimulation (TENS) device for the treatment of chronic low back pain. This clinical trial is a non-significant risk, randomized, double-blinded, placebo-controlled 12-week trial involving the commercially available Empi Select TENS device for treating subjects with chronic (>90 days) low back pain. Multiple centers located in the United States will enroll approximately 300 subjects in this study. Eligible subjects will be randomized 1:1 to either the treatment group or the placebo group. The subjects and investigational staff are blinded to the treatment assignment. Subjects will return to the investigational center for follow-up assessments at 1, 4, 8, and 12 weeks.

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Subjects must be 18-65 years of age.
•Subjects must have reported low back pain of at least 3 months duration.
•Subjects must report a low back pain score of 4 or greater on the 0-10 point Numerical Rating Scale (NRS) for average daily pain.
•Subjects must have been on a stabilized analgesic medication regimen for 3 months or greater.
•Subjects must be willing to discontinue use of all rescue pain medications for the duration of the trial (all PRN medications for breakthrough pain), except for OTC oral acetaminophen (up to 4 grams per day).
•Subjects must be willing to refrain from starting any new lower back pain treatments for the duration of the trial.
•Subjects must be willing and able to comply with all follow-up procedures (including completion of the daily diary) and return for scheduled follow- up visits.
•Female subjects must be post-menopausal for at least 1 year, surgically sterile or willing to take a pregnancy test which must be negative prior to study enrollment.
•Subjects must be willing and able to provide written informed consent and HIPAA authorization prior to enrollment into the study.

排除标准

•Subjects that have a demand type pacemaker or defibrillator.
•Subjects that have had previous experience with electrotherapy.
•Subjects that have had any failed back surgeries.
•Subjects that have spinal stenosis which contributes to, or is the cause of lower back pain.
•Subjects that have sciatica (lower back pain with radicular symptoms).
•Subjects that have cauda equina syndrome.
•Subjects that have fibromyalgia.
•Subjects that have pain secondary to cancer.
•Subjects who have cancer in the same anatomical location as their back pain.
•Subjects that have any sensory deprivation or diagnosis of shingles or post- herpetic neuralgia (specifically in the mid-trunk region).
•Subjects that have planned surgeries during the study period.
•Subjects that have a history of alcohol or substance abuse in the last 5 years.
•Subjects on psychoactive medication(s) that:
•have had a change in dose or a change in medication type during the 3 months prior to screening, or
•are expected to require a change in dose, or a new medication during the study.
•Subjects that are seeking worker's compensation or any other legal claims.
•Subjects that are pregnant or plan to become pregnant during the study period.

结局指标

主要结局

Relief of lower back pain as measured by a Numerical Rating Scale (NRS) of Average Daily Pain.

时间窗: Baseline and at 1, 4, 8 and 12 week follow-up

次要结局

Improvement of function as measured by the Roland and Morris Back Pain Disability Scale.(Baseline and 1, 4, 8 and 12 week follow-up)
Improvement of quality of life as measured by the SF-12 Health Survey.(Baseline and 1, 4, 8 and 12 week follow-up)
Subject satisfaction as measured by the Patient Global Impression of Change scale (PGIC).(1, 4, 8 and 12 week follow-up)
Adverse Event Assessment: assess the occurrence and severity of any adverse events.(1, 4, 8 and 12 week follow-up)

研究者

发起方

Empi, A DJO Company

申办方类型

Industry

研究点 (16)

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