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

Sponsor:	Empi, A DJO Company
Collaborator:	Alquest
Information provided by:	Empi, A DJO Company
ClinicalTrials.gov Identifier:	NCT00709748

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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

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
1: Active Comparator 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.
2: Placebo Comparator 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

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:

Johnson M, Martinson M. Efficacy of electrical nerve stimulation for chronic musculoskeletal pain: a meta-analysis of randomized controlled trials. Pain. 2007 Jul;130(1-2):157-65. Epub 2007 Mar 23.

Deyo RA, Walsh NE, Martin DC, Schoenfeld LS, Ramamurthy S. A controlled trial of transcutaneous electrical nerve stimulation (TENS) and exercise for chronic low back pain. N Engl J Med. 1990 Jun 7;322(23):1627-34.

Hamza MA, White PF, Ahmed HE, Ghoname EA. Effect of the frequency of transcutaneous electrical nerve stimulation on the postoperative opioid analgesic requirement and recovery profile. Anesthesiology. 1999 Nov;91(5):1232-8.

Graff-Radford SB, Reeves JL, Baker RL, Chiu D. Effects of transcutaneous electrical nerve stimulation on myofascial pain and trigger point sensitivity. Pain. 1989 Apr;37(1):1-5.

Cheing GL, Hui-Chan CW. Transcutaneous electrical nerve stimulation: nonparallel antinociceptive effects on chronic clinical pain and acute experimental pain. Arch Phys Med Rehabil. 1999 Mar;80(3):305-12.

Sluka KA, Deacon M, Stibal A, Strissel S, Terpstra A. Spinal blockade of opioid receptors prevents the analgesia produced by TENS in arthritic rats. J Pharmacol Exp Ther. 1999 May;289(2):840-6.

Han JS, Chen XH, Sun SL, Xu XJ, Yuan Y, Yan SC, Hao JX, Terenius L. Effect of low- and high-frequency TENS on Met-enkephalin-Arg-Phe and dynorphin A immunoreactivity in human lumbar CSF. Pain. 1991 Dec;47(3):295-8.

Lee KH, Chung JM, Willis WD Jr. Inhibition of primate spinothalamic tract cells by TENS. J Neurosurg. 1985 Feb;62(2):276-87.

Garrison DW, Foreman RD. Effects of transcutaneous electrical nerve stimulation (TENS) on spontaneous and noxiously evoked dorsal horn cell activity in cats with transected spinal cords. Neurosci Lett. 1996 Sep 27;216(2):125-8.

Garrison DW, Foreman RD. Decreased activity of spontaneous and noxiously evoked dorsal horn cells during transcutaneous electrical nerve stimulation (TENS). Pain. 1994 Sep;58(3):309-15.

Khadilkar A, Milne S, Brosseau L, Wells G, Tugwell P, Robinson V, Shea B, Saginur M. Transcutaneous electrical nerve stimulation for the treatment of chronic low back pain: a systematic review. Spine. 2005 Dec 1;30(23):2657-66. Review.

Brosseau L, Milne S, Robinson V, Marchand S, Shea B, Wells G, Tugwell P. Efficacy of the transcutaneous electrical nerve stimulation for the treatment of chronic low back pain: a meta-analysis. Spine. 2002 Mar 15;27(6):596-603.

Ordog GJ. Transcutaneous electrical nerve stimulation versus oral analgesic: a randomized double-blind controlled study in acute traumatic pain. Am J Emerg Med. 1987 Jan;5(1):6-10.

Responsible Party:	Empi, A DJO company ( Jim Pomonis, PhD / Director of Clinical Programs )
Study ID Numbers:	Empi 07-1-02
Study First Received:	July 1, 2008
Last Updated:	July 2, 2008
ClinicalTrials.gov Identifier:	NCT00709748 History of Changes
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:

Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations

Low Back Pain
Pain
Back Pain

ClinicalTrials.gov processed this record on February 08, 2010