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

July 2, 2008 updated by: Empi, A DJO Company

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Barbara A. Stegmeier, RAC
  • Phone Number: 763-588-9836
  • Email: barbs@alquest.com

Study Contact Backup

Study Locations

  • United States
    • California
      • Fair Oaks, California, United States, 95628
        • Recruiting
        • MedInvestigations
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Champlin, M.D.
    • Florida
      • Pensacola, Florida, United States, 32503
        • Recruiting
        • Pain Consultants of West Florida
        • Contact:
        • Principal Investigator:
          • Kurt A Krueger, M.D.
      • St. Petersburg, Florida, United States, 33701
        • Recruiting
        • Suncoast Neuroscience Associates, Inc.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alberto Vasquez, M.D.
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Recruiting
        • Center for Prospective Outcome Studies
        • Contact:
        • Contact:
        • Principal Investigator:
          • Larry Empting, M.D.
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Taylor Research LLC
        • Contact:
        • Principal Investigator:
          • Donald R Taylor, M.D.
    • Illinois
      • Bloomington, Illinois, United States, 61701
        • Recruiting
        • Millennium Pain Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ramsin Benyamin, M.D.
        • Sub-Investigator:
          • Ricardo Vallejo, M.D., Ph.D.
        • Sub-Investigator:
          • Atiq Rehman, M.D.
    • Ohio
      • Perrysburg, Ohio, United States, 43551
        • Recruiting
        • Clinical Research Source, Inc.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert Kalb, M.D.
    • Virginia
      • Reston, Virginia, United States, 20190
        • Recruiting
        • Spinal Research Foundation
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas T Nguyen, M.D.
        • Sub-Investigator:
          • Vishal S Kancherla, D.O.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

    1. have had a change in dose or a change in medication type during the 3 months prior to screening, or
    2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Empi, A DJO Company

Collaborators

Alquest

Investigators

  • Study Director: Jim Pomonis, PhD, Empi, A DJO Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

February 1, 2009

Study Completion (Anticipated)

February 1, 2009

Study Registration Dates

First Submitted

July 1, 2008

First Submitted That Met QC Criteria

July 2, 2008

First Posted (Estimate)

July 3, 2008

Study Record Updates

Last Update Posted (Estimate)

July 3, 2008

Last Update Submitted That Met QC Criteria

July 2, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Empi 07-1-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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