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

Lower Back Pain Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00709748
• Other study ID #: Empi 07-1-02
• Status: Recruiting
• Phase: N/A
• First received: July 1, 2008
• Last updated: July 2, 2008
• Start date: February 2008
• Est. completion date: February 2009

Study information

• Verified date: July 2008
• Source: Empi, A DJO Company
• Contact: Barbara A. Stegmeier, RAC
• Phone: 763-588-9836
• Email: barbs[@]alquest.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain

Intervention

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

Locations

Country	Name	City	State
United States	Center for Prospective Outcome Studies	Atlanta	Georgia
United States	Millennium Pain Center	Bloomington	Illinois
United States	MedInvestigations	Fair Oaks	California
United States	Taylor Research LLC	Marietta	Georgia
United States	Pain Consultants of West Florida	Pensacola	Florida
United States	Clinical Research Source, Inc.	Perrysburg	Ohio
United States	Spinal Research Foundation	Reston	Virginia
United States	Suncoast Neuroscience Associates, Inc.	St. Petersburg	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Empi, A DJO Company	Alquest

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View 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. — View 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. — View 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):309-15. — View 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. — View 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. — View 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. — View 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):295-8. — View Citation

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. — View 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. Review. — View Citation

Lee KH, Chung JM, Willis WD Jr. Inhibition of primate spinothalamic tract cells by TENS. J Neurosurg. 1985 Feb;62(2):276-87. — View Citation

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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief of lower back pain as measured by a Numerical Rating Scale (NRS) of Average Daily Pain.		Baseline and at 1, 4, 8 and 12 week follow-up	No
Secondary	Improvement of function as measured by the Roland and Morris Back Pain Disability Scale.		Baseline and 1, 4, 8 and 12 week follow-up	No
Secondary	Improvement of quality of life as measured by the SF-12 Health Survey.		Baseline and 1, 4, 8 and 12 week follow-up	No
Secondary	Subject satisfaction as measured by the Patient Global Impression of Change scale (PGIC).		1, 4, 8 and 12 week follow-up	No
Secondary	Adverse Event Assessment: assess the occurrence and severity of any adverse events.		1, 4, 8 and 12 week follow-up	Yes