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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Empi, A DJO Company.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Alquest
Information provided by:
Empi, A DJO Company
ClinicalTrials.gov Identifier:
NCT00709748
First received: July 1, 2008
Last updated: July 2, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention
Lower Back Pain
Device: Empi Select TENS Device
Device: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Empi, A DJO Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Subject satisfaction as measured by the Patient Global Impression of Change scale (PGIC). [ Time Frame: 1, 4, 8 and 12 week follow-up ] [ Designated as safety issue: No ]
  • Adverse Event Assessment: assess the occurrence and severity of any adverse events. [ Time Frame: 1, 4, 8 and 12 week follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: February 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709748

Contacts
Contact: Barbara A. Stegmeier, RAC 763-588-9836 barbs@alquest.com
Contact: Jim Pomonis, Ph.D. 651-415-7311 jpomonis@empi.com

Locations
United States, California
MedInvestigations Recruiting
Fair Oaks, California, United States, 95628
Contact: Leslie Mellor, CMA, CCRC    916-966-7452    dewey9638@aol.com   
Contact: Sharon Harp, Res. Assist.    916-966-7452    harpsharon@gmail.com   
Principal Investigator: John Champlin, M.D.         
United States, Florida
Pain Consultants of West Florida Recruiting
Pensacola, Florida, United States, 32503
Contact: Kendra Keyes, PT    850-474-4933    kendrakeyes@cox.net   
Principal Investigator: Kurt A Krueger, M.D.         
Suncoast Neuroscience Associates, Inc. Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Michele Richardson, B.A., CCRC    727-824-7135    mrichardson@suncoastmed.com   
Contact: Suzanne Lash, B.A., CCRC    727-824-7135    slash@suncoastmed.com   
Principal Investigator: Alberto Vasquez, M.D.         
United States, Georgia
Center for Prospective Outcome Studies Recruiting
Atlanta, Georgia, United States, 30327
Contact: Quin L Boynes, B.S.    404-605-0501    qboynes@synapseatlanta.com   
Contact: Shelly Shearer    404-605-0501    sshearer@synapseatlanta.com   
Principal Investigator: Larry Empting, M.D.         
Taylor Research LLC Recruiting
Marietta, Georgia, United States, 30060
Contact: Nancy Taylor, RN, MSN    770-421-8080    clinicaltrials@cpcnopain.com   
Principal Investigator: Donald R Taylor, M.D.         
United States, Illinois
Millennium Pain Center Recruiting
Bloomington, Illinois, United States, 61701
Contact: Jeffery M Kramer, Ph.D.    309-662-4321    kramer@millenniumpaincenter.com   
Contact: Sara Ditchen, BS, CCRC    309-662-4321    ditchen@millenniumpaincenter.com   
Principal Investigator: Ramsin Benyamin, M.D.         
Sub-Investigator: Ricardo Vallejo, M.D., Ph.D.         
Sub-Investigator: Atiq Rehman, M.D.         
United States, Ohio
Clinical Research Source, Inc. Recruiting
Perrysburg, Ohio, United States, 43551
Contact: Denise A Coressel, LPN, CCRC    419-873-1532    thecrsource@aol.com   
Contact: Charlotte Patterson, LPN, CCRC    419-873-1532    thecrsource@aol.com   
Principal Investigator: Robert Kalb, M.D.         
United States, Virginia
Spinal Research Foundation Recruiting
Reston, Virginia, United States, 20190
Contact: Anne Copay, Ph.D.    703-709-1114 ext 144    acopay@spinemd.com   
Contact: Marcus Martin, Ph.D.    703-709-1114 ext 140    mmartin@spinerf.org   
Principal Investigator: Thomas T Nguyen, M.D.         
Sub-Investigator: Vishal S Kancherla, D.O.         
Sponsors and Collaborators
Empi, A DJO Company
Alquest
Investigators
Study Director: Jim Pomonis, PhD Empi, A DJO Company
  More Information

Publications:

Responsible Party: Jim Pomonis, PhD / Director of Clinical Programs, Empi, A DJO company
ClinicalTrials.gov Identifier: NCT00709748     History of Changes
Other Study ID Numbers: Empi 07-1-02
Study First Received: July 1, 2008
Last Updated: July 2, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Empi, A DJO Company:
Transcutaneous electrical nerve stimulation
TENS
Empi
Electrotherapy
Back pain
Lower back pain
Chronic lower back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014