E-STIM Trial: Comparing the Efficacy of the Empi Select TENS to a Control for the Treatment of Chronic Lower Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Lower Back Pain

Intervention / Treatment
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* Device: Empi Select TENS Device
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Subjects in this study arm will receive treatment (fully active) Empi Select TENS devices. | Device: Empi Select TENS Device<br>* The Empi Select TENS device delivers therapeutic electrical currents at various frequencies (intensities) and periods of time for the treatment of pain.<br>* Other names: -TENS;|
| Placebo Comparator: 2<br>Subjects in this study arm will receive control (not fully active) Empi Select TENS devices. | Device: Placebo<br>* Subjects in this study arm will receive control (not fully active) Empi Select TENS devices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of lower back pain as measured by a Numerical Rating Scale (NRS) of Average Daily Pain. |  | Baseline and at 1, 4, 8 and 12 week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcutaneous electrical nerve stimulation, TENS, Empi, Electrotherapy, Back pain, Lower back pain, Chronic lower back pain