Recruiting

Empi Select TENS

Sponsor:

Empi, A DJO Company

Code:

NCT00709748

Conditions

Lower Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Empi Select TENS Device

Placebo

Study Details

Brief summary:

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.

Conditions

Lower Back Pain

Study ID

NCT00709748

Start date

Feb, 2008

Status verified date

Jul, 2008

Completion date

Feb, 2009

Anticipated

Primary completion date

Feb, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1

Subjects in this study arm will receive treatment (fully active) Empi Select TENS devices.

placebo comparator: 2

Subjects in this study arm will receive control (not fully active) Empi Select TENS devices.

Interventions

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.

Placebo

Subjects in this study arm will receive control (not fully active) Empi Select TENS devices.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Barbara A. Stegmeier, RAC

763-588-9836barbs@alquest.com

Jim Pomonis, Ph.D.

651-415-7311jpomonis@empi.com

Locations

MedInvestigations

Recruiting

Fair Oaks, California, United States, 95628

Contacts

Leslie Mellor, CMA, CCRC

916-966-7452dewey9638@aol.com

Sharon Harp, Res. Assist.

916-966-7452harpsharon@gmail.com

Principal Investigator:

John Champlin, M.D.

Pain Consultants of West Florida

Recruiting

Pensacola, Florida, United States, 32503

Contacts

Kendra Keyes, PT

850-474-4933kendrakeyes@cox.net

Principal Investigator:

Kurt A Krueger, M.D.

Suncoast Neuroscience Associates, Inc.

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Michele Richardson, B.A., CCRC

727-824-7135mrichardson@suncoastmed.com

Suzanne Lash, B.A., CCRC

727-824-7135slash@suncoastmed.com

Principal Investigator:

Alberto Vasquez, M.D.

Center for Prospective Outcome Studies

Recruiting

Atlanta, Georgia, United States, 30327

Contacts

Quin L Boynes, B.S.

404-605-0501qboynes@synapseatlanta.com

Shelly Shearer

404-605-0501sshearer@synapseatlanta.com

Principal Investigator:

Larry Empting, M.D.

Taylor Research LLC

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Nancy Taylor, RN, MSN

770-421-8080clinicaltrials@cpcnopain.com

Principal Investigator:

Donald R Taylor, M.D.

Millennium Pain Center

Recruiting

Bloomington, Illinois, United States, 61701

Contacts

Jeffery M Kramer, Ph.D.

309-662-4321kramer@millenniumpaincenter.com

Sara Ditchen, BS, CCRC

309-662-4321ditchen@millenniumpaincenter.com

Principal Investigator:

Ramsin Benyamin, M.D.

Clinical Research Source, Inc.

Recruiting

Perrysburg, Ohio, United States, 43551

Contacts

Denise A Coressel, LPN, CCRC

419-873-1532thecrsource@aol.com

Charlotte Patterson, LPN, CCRC

419-873-1532thecrsource@aol.com

Principal Investigator:

Robert Kalb, M.D.

Spinal Research Foundation

Recruiting

Reston, Virginia, United States, 20190

Contacts

Anne Copay, Ph.D.

703-709-1114acopay@spinemd.com

Marcus Martin, Ph.D.

703-709-1114mmartin@spinerf.org

Principal Investigator:

Thomas T Nguyen, M.D.

More Information

Sponsor

Empi, A DJO Company

Last update posted

Jul 3, 2008

Last verified

Jul, 2008

Keywords

  • Transcutaneous electrical nerve stimulation
  • TENS
  • Empi
  • Electrotherapy
  • Back pain
  • Lower back pain
  • Chronic lower back pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Empi, A DJO Company on 2008-07-03.