Lower Back PainE-STIMNCT00709748
E-STIM Trial: Comparing the Efficacy of the Empi Select TENS to a Control for the Treatment of Chronic Lower Back Pain
A study testing Empi Select TENS Device in people with Lower Back Pain, run by Empi, A DJO Company at 8 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- Empi Select TENS Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 8 sitesUnited States
- Study dates
- Feb 2008to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Center for Prospective Outcome Studies
Atlanta, Georgia, 30327
Quin L Boynes, B.S., 404-605-0501, qboynes@synapseatlanta.com
Shelly Shearer, 404-605-0501, sshearer@synapseatlanta.com
- Recruiting
Millennium Pain Center
Bloomington, Illinois, 61701
Jeffery M Kramer, Ph.D., 309-662-4321, kramer@millenniumpaincenter.com
Sara Ditchen, BS, CCRC, 309-662-4321, ditchen@millenniumpaincenter.com
- Recruiting
MedInvestigations
Fair Oaks, California, 95628
Leslie Mellor, CMA, CCRC, 916-966-7452, dewey9638@aol.com
Sharon Harp, Res. Assist., 916-966-7452, harpsharon@gmail.com
- Recruiting
Taylor Research LLC
Marietta, Georgia, 30060
Nancy Taylor, RN, MSN, 770-421-8080, clinicaltrials@cpcnopain.com
Donald R Taylor, M.D.
- Recruiting
Pain Consultants of West Florida
Pensacola, Florida, 32503
Kendra Keyes, PT, 850-474-4933, kendrakeyes@cox.net
Kurt A Krueger, M.D.
- Recruiting
Clinical Research Source, Inc.
Perrysburg, Ohio, 43551
Denise A Coressel, LPN, CCRC, 419-873-1532, thecrsource@aol.com
Charlotte Patterson, LPN, CCRC, 419-873-1532, thecrsource@aol.com
- Recruiting
Spinal Research Foundation
Reston, Virginia, 20190
Anne Copay, Ph.D., 703-709-1114 ext. 144, acopay@spinemd.com
Marcus Martin, Ph.D., 703-709-1114 ext. 140, mmartin@spinerf.org
- Recruiting
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33701
Michele Richardson, B.A., CCRC, 727-824-7135, mrichardson@suncoastmed.com
Suzanne Lash, B.A., CCRC, 727-824-7135, slash@suncoastmed.com
About this 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
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.
- Conditions
- Lower Back Pain
- Being tested
- Empi Select TENS Device, Placebo
- Keywords
- Transcutaneous electrical nerve stimulation, TENS, Empi, Electrotherapy, Back pain, Lower back pain, Chronic lower back pain
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empi Select TENS DeviceDevice
Also called -Transcutaneous electrical nerve stimulation, -TENS
The Empi Select TENS device delivers therapeutic electrical currents at various frequencies (intensities) and periods of time for the treatment of pain.
PlaceboDevice
Subjects in this study arm will receive control (not fully active) Empi Select TENS devices.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Subjects in this study arm will receive treatment (fully active) Empi Select TENS devices. Receives: Device: Empi Select TENS Device |
| 2 | Placebo comparator | Subjects in this study arm will receive control (not fully active) Empi Select TENS devices. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of lower back pain as measured by a Numerical Rating Scale (NRS) of Average Daily Pain.
Measured: Baseline and at 1, 4, 8 and 12 week follow-up
Secondary outcomes (4)
Improvement of function as measured by the Roland and Morris Back Pain Disability Scale.
Measured: Baseline and 1, 4, 8 and 12 week follow-up
Improvement of quality of life as measured by the SF-12 Health Survey.
Measured: Baseline and 1, 4, 8 and 12 week follow-up
Subject satisfaction as measured by the Patient Global Impression of Change scale (PGIC).
Measured: 1, 4, 8 and 12 week follow-up
Adverse Event Assessment: assess the occurrence and severity of any adverse events.
Measured: 1, 4, 8 and 12 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2009 (estimated)
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Empi, A DJO Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alquest
- Investigators
- Jim Pomonis, PhD, Study director, Empi, A DJO Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709748
- Sponsor's protocol ID
- Empi 07-1-02
- Acronym
- E-STIM
- Status last verified
- Jul 2008
- First submitted
- 1 Jul 2008
- Last updated
- 3 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
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 17383095Deyo 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 2140432Hamza 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 10551571Graff-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 2786179Cheing 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 10084439Sluka 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 10215661Han 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 1686080Lee 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 3871474Garrison 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 8904799Garrison 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 7838579Khadilkar 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 16319752Brosseau 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 11884907Ordog 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00709748
- Acronym / sponsor ID
- E-STIM / Empi 07-1-02
- Conditions
- Lower Back Pain
- Keywords
- Transcutaneous electrical nerve stimulation, TENS, Empi, Electrotherapy, Back pain, Lower back pain, Chronic lower back pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Empi, A DJO CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Alquest
- Study start
- Feb 2008
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 3 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Empi Select TENS DeviceSubjects in this study arm will receive treatment (fully active) Empi Select TENS devices. |
| 2 | Placebo comparator | Device: PlaceboSubjects in this study arm will receive control (not fully active) Empi Select TENS devices. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empi Select TENS DeviceAlso: -Transcutaneous electrical nerve stimulation, -TENSThe Empi Select TENS device delivers therapeutic electrical currents at various frequencies (intensities) and periods of time for the treatment of pain. | Device | 1 |
| PlaceboSubjects in this study arm will receive control (not fully active) Empi Select TENS devices. | Device | 2 |
Primary outcome
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
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2008.
- Background: PubMed 17383095Johnson 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.
- Background: PubMed 2140432Deyo 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.
- Background: PubMed 10551571Hamza 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.
- Background: PubMed 2786179Graff-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.
- Background: PubMed 10084439Cheing 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.
- Background: PubMed 10215661Sluka 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.
- Background: PubMed 1686080Han 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.
- Background: PubMed 3871474Lee 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.
- Background: PubMed 8904799Garrison 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.
- Background: PubMed 7838579Garrison 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.
- Background: PubMed 16319752Khadilkar 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.
- Background: PubMed 11884907Brosseau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim Pomonis, PhD study director
Empi, A DJO Company
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empi Select TENS Device in people with Lower Back Pain, run by Empi, A DJO Company at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara A. Stegmeier, RAC (763-588-9836, barbs@alquest.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00709748, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2008.