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

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

Sponsors

Lead Sponsor: Empi, A DJO Company

Collaborator: Alquest

Source Empi, A DJO Company
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.

Overall Status Unknown status
Start Date February 2008
Completion Date February 2009
Primary Completion Date February 2009
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Secondary Outcome
Measure Time Frame
Improvement of function as measured by the Roland and Morris Back Pain Disability Scale. Baseline and 1, 4, 8 and 12 week follow-up
Improvement of quality of life as measured by the SF-12 Health Survey. Baseline and 1, 4, 8 and 12 week follow-up
Subject satisfaction as measured by the Patient Global Impression of Change scale (PGIC). 1, 4, 8 and 12 week follow-up
Adverse Event Assessment: assess the occurrence and severity of any adverse events. 1, 4, 8 and 12 week follow-up
Enrollment 300
Condition
Intervention

Intervention Type: Device

Intervention Name: Empi Select TENS Device

Description: The Empi Select TENS device delivers therapeutic electrical currents at various frequencies (intensities) and periods of time for the treatment of pain.

Arm Group Label: 1

Intervention Type: Device

Intervention Name: Placebo

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

Arm Group Label: 2

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: 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: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jim Pomonis, PhD Study Director Empi, A DJO Company
Overall Contact

Last Name: Barbara A. Stegmeier, RAC

Phone: 763-588-9836

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator:
MedInvestigations | Fair Oaks, California, 95628, United States Recruiting Leslie Mellor, CMA, CCRC 916-966-7452 [email protected] John Champlin, M.D. Principal Investigator
Pain Consultants of West Florida | Pensacola, Florida, 32503, United States Recruiting Kendra Keyes, PT 850-474-4933 [email protected] Kurt A Krueger, M.D. Principal Investigator
Suncoast Neuroscience Associates, Inc. | St. Petersburg, Florida, 33701, United States Recruiting Michele Richardson, B.A., CCRC 727-824-7135 [email protected] Alberto Vasquez, M.D. Principal Investigator
Center for Prospective Outcome Studies | Atlanta, Georgia, 30327, United States Recruiting Quin L Boynes, B.S. 404-605-0501 [email protected] Larry Empting, M.D. Principal Investigator
Taylor Research LLC | Marietta, Georgia, 30060, United States Recruiting Nancy Taylor, RN, MSN 770-421-8080 [email protected] Donald R Taylor, M.D. Principal Investigator
Millennium Pain Center | Bloomington, Illinois, 61701, United States Recruiting Jeffery M Kramer, Ph.D. 309-662-4321 [email protected] Ramsin Benyamin, M.D. Principal Investigator Ricardo Vallejo, M.D., Ph.D. Sub-Investigator Atiq Rehman, M.D. Sub-Investigator
Clinical Research Source, Inc. | Perrysburg, Ohio, 43551, United States Recruiting Denise A Coressel, LPN, CCRC 419-873-1532 [email protected] Robert Kalb, M.D. Principal Investigator
Spinal Research Foundation | Reston, Virginia, 20190, United States Recruiting Anne Copay, Ph.D. 703-709-1114 144 [email protected] Thomas T Nguyen, M.D. Principal Investigator Vishal S Kancherla, D.O. Sub-Investigator
Location Countries

United States

Verification Date

July 2008

Responsible Party

Name Title: Jim Pomonis, PhD / Director of Clinical Programs

Organization: Empi, A DJO company

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Active Comparator

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

Label: 2

Type: Placebo Comparator

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

Acronym E-STIM
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov