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

Primary Purpose

Lower Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Empi Select TENS Device
Placebo
Sponsored by
Empi, A DJO Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Back Pain focused on measuring Transcutaneous electrical nerve stimulation, TENS, Empi, Electrotherapy, Back pain, Lower back pain, Chronic lower back pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MedInvestigationsRecruiting
  • Pain Consultants of West FloridaRecruiting
  • Suncoast Neuroscience Associates, Inc.Recruiting
  • Center for Prospective Outcome StudiesRecruiting
  • Taylor Research LLCRecruiting
  • Millennium Pain CenterRecruiting
  • Clinical Research Source, Inc.Recruiting
  • Spinal Research FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Relief of lower back pain as measured by a Numerical Rating Scale (NRS) of Average Daily Pain.

Secondary Outcome Measures

Improvement of function as measured by the Roland and Morris Back Pain Disability Scale.
Improvement of quality of life as measured by the SF-12 Health Survey.
Subject satisfaction as measured by the Patient Global Impression of Change scale (PGIC).
Adverse Event Assessment: assess the occurrence and severity of any adverse events.

Full Information

First Posted
July 1, 2008
Last Updated
July 2, 2008
Sponsor
Empi, A DJO Company
Collaborators
Alquest
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1. Study Identification

Unique Protocol Identification Number
NCT00709748
Brief Title
E-STIM Trial: Comparing the Efficacy of the Empi Select TENS to a Control for the Treatment of Chronic Lower Back Pain
Acronym
E-STIM
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
February 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Empi, A DJO Company
Collaborators
Alquest

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain
Keywords
Transcutaneous electrical nerve stimulation, TENS, Empi, Electrotherapy, Back pain, Lower back pain, Chronic lower back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Subjects in this study arm will receive treatment (fully active) Empi Select TENS devices.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Subjects in this study arm will receive control (not fully active) Empi Select TENS devices.
Intervention Type
Device
Intervention Name(s)
Empi Select TENS Device
Other Intervention Name(s)
-Transcutaneous electrical nerve stimulation, -TENS
Intervention Description
The Empi Select TENS device delivers therapeutic electrical currents at various frequencies (intensities) and periods of time for the treatment of pain.
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Subjects in this study arm will receive control (not fully active) Empi Select TENS devices.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
Subject satisfaction as measured by the Patient Global Impression of Change scale (PGIC).
Time Frame
1, 4, 8 and 12 week follow-up
Title
Adverse Event Assessment: assess the occurrence and severity of any adverse events.
Time Frame
1, 4, 8 and 12 week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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: have had a change in dose or a change in medication type during the 3 months prior to screening, or 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara A. Stegmeier, RAC
Phone
763-588-9836
Email
barbs@alquest.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jim Pomonis, Ph.D.
Phone
651-415-7311
Email
jpomonis@empi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Pomonis, PhD
Organizational Affiliation
Empi, A DJO Company
Official's Role
Study Director
Facility Information:
Facility Name
MedInvestigations
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Mellor, CMA, CCRC
Phone
916-966-7452
Email
dewey9638@aol.com
First Name & Middle Initial & Last Name & Degree
Sharon Harp, Res. Assist.
Phone
916-966-7452
Email
harpsharon@gmail.com
First Name & Middle Initial & Last Name & Degree
John Champlin, M.D.
Facility Name
Pain Consultants of West Florida
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendra Keyes, PT
Phone
850-474-4933
Email
kendrakeyes@cox.net
First Name & Middle Initial & Last Name & Degree
Kurt A Krueger, M.D.
Facility Name
Suncoast Neuroscience Associates, Inc.
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Richardson, B.A., CCRC
Phone
727-824-7135
Email
mrichardson@suncoastmed.com
First Name & Middle Initial & Last Name & Degree
Suzanne Lash, B.A., CCRC
Phone
727-824-7135
Email
slash@suncoastmed.com
First Name & Middle Initial & Last Name & Degree
Alberto Vasquez, M.D.
Facility Name
Center for Prospective Outcome Studies
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quin L Boynes, B.S.
Phone
404-605-0501
Email
qboynes@synapseatlanta.com
First Name & Middle Initial & Last Name & Degree
Shelly Shearer
Phone
404-605-0501
Email
sshearer@synapseatlanta.com
First Name & Middle Initial & Last Name & Degree
Larry Empting, M.D.
Facility Name
Taylor Research LLC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Taylor, RN, MSN
Phone
770-421-8080
Email
clinicaltrials@cpcnopain.com
First Name & Middle Initial & Last Name & Degree
Donald R Taylor, M.D.
Facility Name
Millennium Pain Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffery M Kramer, Ph.D.
Phone
309-662-4321
Email
kramer@millenniumpaincenter.com
First Name & Middle Initial & Last Name & Degree
Sara Ditchen, BS, CCRC
Phone
309-662-4321
Email
ditchen@millenniumpaincenter.com
First Name & Middle Initial & Last Name & Degree
Ramsin Benyamin, M.D.
First Name & Middle Initial & Last Name & Degree
Ricardo Vallejo, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Atiq Rehman, M.D.
Facility Name
Clinical Research Source, Inc.
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise A Coressel, LPN, CCRC
Phone
419-873-1532
Email
thecrsource@aol.com
First Name & Middle Initial & Last Name & Degree
Charlotte Patterson, LPN, CCRC
Phone
419-873-1532
Email
thecrsource@aol.com
First Name & Middle Initial & Last Name & Degree
Robert Kalb, M.D.
Facility Name
Spinal Research Foundation
City
Reston
State/Province
Virginia
ZIP/Postal Code
20190
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Copay, Ph.D.
Phone
703-709-1114
Ext
144
Email
acopay@spinemd.com
First Name & Middle Initial & Last Name & Degree
Marcus Martin, Ph.D.
Phone
703-709-1114
Ext
140
Email
mmartin@spinerf.org
First Name & Middle Initial & Last Name & Degree
Thomas T Nguyen, M.D.
First Name & Middle Initial & Last Name & Degree
Vishal S Kancherla, D.O.

12. IPD Sharing Statement

Citations:
PubMed Identifier
17383095
Citation
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Results Reference
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PubMed Identifier
2140432
Citation
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.
Results Reference
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PubMed Identifier
10551571
Citation
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.
Results Reference
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PubMed Identifier
2786179
Citation
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.
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PubMed Identifier
10084439
Citation
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.
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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Citation
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.
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Citation
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.
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Citation
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.
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PubMed Identifier
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Citation
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.
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E-STIM Trial: Comparing the Efficacy of the Empi Select TENS to a Control for the Treatment of Chronic Lower Back Pain

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