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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2009

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.

Interventions

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary 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

Secondary 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
  • 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
  • Subject satisfaction as measured by the Patient Global Impression of Change scale (PGIC).
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Empi, A DJO Company
  • Collaborator
    • Alquest
  • Provider of Information About this Clinical Study
    • Jim Pomonis, PhD / Director of Clinical Programs, Empi, A DJO company
  • Overall Official(s)
    • Jim Pomonis, PhD, Study Director, Empi, A DJO Company
  • Overall Contact(s)
    • Barbara A. Stegmeier, RAC, 763-588-9836, barbs@alquest.com

References

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 (Phila Pa 1976). 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 (Phila Pa 1976). 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.

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