E-STIM Trial: Comparing the Efficacy of the Empi Select TENS to a Control for the Treatment of Chronic Lower Back Pain
NCT ID: NCT00709748
Last Updated: 2008-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2008-02-29
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Subjects in this study arm will receive treatment (fully active) Empi Select TENS devices.
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
Subjects in this study arm will receive control (not fully active) Empi Select TENS devices.
Placebo
Subjects in this study arm will receive control (not fully active) Empi Select TENS devices.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Alquest
INDUSTRY
Empi, A DJO Company
INDUSTRY
Responsible Party
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Empi, A DJO company
Principal Investigators
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Jim Pomonis, PhD
Role: STUDY_DIRECTOR
Empi, A DJO Company
Locations
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MedInvestigations
Fair Oaks, California, United States
Pain Consultants of West Florida
Pensacola, Florida, United States
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, United States
Center for Prospective Outcome Studies
Atlanta, Georgia, United States
Taylor Research LLC
Marietta, Georgia, United States
Millennium Pain Center
Bloomington, Illinois, United States
Clinical Research Source, Inc.
Perrysburg, Ohio, United States
Spinal Research Foundation
Reston, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Leslie Mellor, CMA, CCRC
Role: primary
Sharon Harp, Res. Assist.
Role: backup
Kendra Keyes, PT
Role: primary
Michele Richardson, B.A., CCRC
Role: primary
Suzanne Lash, B.A., CCRC
Role: backup
Quin L Boynes, B.S.
Role: primary
Shelly Shearer
Role: backup
Nancy Taylor, RN, MSN
Role: primary
Jeffery M Kramer, Ph.D.
Role: primary
Sara Ditchen, BS, CCRC
Role: backup
Denise A Coressel, LPN, CCRC
Role: primary
Charlotte Patterson, LPN, CCRC
Role: backup
Anne Copay, Ph.D.
Role: primary
Marcus Martin, Ph.D.
Role: backup
References
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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.
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.
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.
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.
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.
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):295-298. doi: 10.1016/0304-3959(91)90218-M.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Empi 07-1-02
Identifier Type: -
Identifier Source: org_study_id