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Status unknownNCT00709748E-STIMUpdated Jul 3, 2008

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

An interventional study of Empi Select TENS Device and Placebo in Lower Back Pain, sponsored by Empi, A DJO Company. Status unknown at 8 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-07-03.

Sponsored by Empi, A DJO Company · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lower Back Pain

Keywords

  • Transcutaneous electrical nerve stimulation
  • TENS
  • Empi
  • Electrotherapy
  • Back pain
  • Lower back pain
  • Chronic lower back pain
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 300 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

This is the only study on the registry with Empi, A DJO Company as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    1

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

    Device: Empi Select TENS Device

  • Placebo comparator
    2

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

    Device: Placebo

Interventions

  • DeviceEmpi 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.

    Also known as: -Transcutaneous electrical nerve stimulation, -TENS

  • DevicePlacebo

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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Subject satisfaction as measured by the Patient Global Impression of Change scale (PGIC).

    Time frame: 1, 4, 8 and 12 week follow-up

  4. Adverse Event Assessment: assess the occurrence and severity of any adverse events.

    Time frame: 1, 4, 8 and 12 week follow-up

07

Study locations

8 of 8 sites recruiting
  • MedInvestigations
    Fair Oaks, California 95628, United States
    • Leslie Mellor, CMA, CCRC · Contact · dewey9638@aol.com · 916-966-7452
    • Sharon Harp, Res. Assist. · Contact · harpsharon@gmail.com · 916-966-7452
    • John Champlin, M.D. · Principal investigator
    Recruiting
  • Pain Consultants of West Florida
    Pensacola, Florida 32503, United States
    • Kendra Keyes, PT · Contact · kendrakeyes@cox.net · 850-474-4933
    • Kurt A Krueger, M.D. · Principal investigator
    Recruiting
  • Suncoast Neuroscience Associates, Inc.
    St. Petersburg, Florida 33701, United States
    Recruiting
  • Center for Prospective Outcome Studies
    Atlanta, Georgia 30327, United States
    Recruiting
  • Taylor Research LLC
    Marietta, Georgia 30060, United States
    Recruiting
  • Millennium Pain Center
    Bloomington, Illinois 61701, United States
    Recruiting
  • Clinical Research Source, Inc.
    Perrysburg, Ohio 43551, United States
    • Denise A Coressel, LPN, CCRC · Contact · thecrsource@aol.com · 419-873-1532
    • Charlotte Patterson, LPN, CCRC · Contact · thecrsource@aol.com · 419-873-1532
    • Robert Kalb, M.D. · Principal investigator
    Recruiting
  • Spinal Research Foundation
    Reston, Virginia 20190, United States
    • Anne Copay, Ph.D. · Contact · acopay@spinemd.com · 703-709-1114
    • Marcus Martin, Ph.D. · Contact · mmartin@spinerf.org · 703-709-1114
    • Thomas T Nguyen, M.D. · Principal investigator
    • Vishal S Kancherla, D.O. · Sub investigator
    Recruiting
08

References and documents

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. doi: 10.1016/j.pain.2007.02.007. Epub 2007 Mar 23. PubMed 17383095 ↗
  • 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. doi: 10.1056/NEJM199006073222303. PubMed 2140432 ↗
  • 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. doi: 10.1097/00000542-199911000-00012. PubMed 10551571 ↗
  • 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. doi: 10.1016/0304-3959(89)90146-2. PubMed 2786179 ↗
  • 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. doi: 10.1016/s0003-9993(99)90142-9. PubMed 10084439 ↗
  • 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. PubMed 10215661 ↗
  • 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):295-298. doi: 10.1016/0304-3959(91)90218-M. PubMed 1686080 ↗
  • Lee KH, Chung JM, Willis WD Jr. Inhibition of primate spinothalamic tract cells by TENS. J Neurosurg. 1985 Feb;62(2):276-87. doi: 10.3171/jns.1985.62.2.0276. PubMed 3871474 ↗
  • 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. doi: 10.1016/0304-3940(96)13023-8. PubMed 8904799 ↗
  • 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):309-315. doi: 10.1016/0304-3959(94)90124-4. PubMed 7838579 ↗
  • 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 (Phila Pa 1976). 2005 Dec 1;30(23):2657-66. doi: 10.1097/01.brs.0000188189.21202.0f. PubMed 16319752 ↗
  • 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 (Phila Pa 1976). 2002 Mar 15;27(6):596-603. doi: 10.1097/00007632-200203150-00007. PubMed 11884907 ↗
  • 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. doi: 10.1016/0735-6757(87)90281-6. PubMed 3545246 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00709748
Lead sponsor
Empi, A DJO Company
Collaborators
Alquest
First posted
Jul 3, 2008
Start date
Feb 2008
Primary completion
Feb 2009 (estimated)
Completion
Feb 2009 (estimated)
Last update
Jul 3, 2008

Study contacts

Barbara A. Stegmeier, RAC
Contact
barbs@alquest.com
763-588-9836
Jim Pomonis, Ph.D.
Contact
jpomonis@empi.com
651-415-7311
Jim Pomonis, PhD
study director · Empi, A DJO Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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