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

NCT00709748 | Unknown

• 1 other identifier: Empi 07-1-02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 8

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.

Conditions

Lower Back Pain

Keywords

Transcutaneous electrical nerve stimulation; TENS; Empi; Electrotherapy; Back pain; Lower back pain; Chronic lower back pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

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

Device: Empi Select TENS Device

2

PLACEBO COMPARATOR

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

Device: Placebo

Interventions

Empi Select TENS Device DEVICE

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

Also known as: -Transcutaneous electrical nerve stimulation, -TENS

1

Placebo DEVICE

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

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Empi, A DJO Company: lead
• Alquest: collaborator

Study Sites (8)

MedInvestigations

Fair Oaks, California, 95628, United States

RECRUITING

Pain Consultants of West Florida

Pensacola, Florida, 32503, United States

RECRUITING

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, 33701, United States

RECRUITING

Center for Prospective Outcome Studies

Atlanta, Georgia, 30327, United States

RECRUITING

Taylor Research LLC

Marietta, Georgia, 30060, United States

RECRUITING

Millennium Pain Center

Bloomington, Illinois, 61701, United States

RECRUITING

Clinical Research Source, Inc.

Perrysburg, Ohio, 43551, United States

RECRUITING

Spinal Research Foundation

Reston, Virginia, 20190, United States

RECRUITING

Related Publications (13)

• 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.

  PMID: 17383095 BACKGROUND

• 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.

  PMID: 2140432 BACKGROUND

• 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.

  PMID: 10551571 BACKGROUND

• 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.

  PMID: 2786179 BACKGROUND

• 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.

  PMID: 10084439 BACKGROUND

• 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.

  PMID: 10215661 BACKGROUND

• 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.

  PMID: 1686080 BACKGROUND

• 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.

  PMID: 3871474 BACKGROUND

• 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.

  PMID: 8904799 BACKGROUND

• 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.

  PMID: 7838579 BACKGROUND

• 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.

  PMID: 16319752 BACKGROUND

• 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.

  PMID: 11884907 BACKGROUND

• 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.

  PMID: 3545246 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Back Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Jim Pomonis, PhD

  Empi, A DJO Company

  STUDY DIRECTOR

Central Study Contacts

Barbara A. Stegmeier, RAC

CONTACT

763-588-9836; barbs@alquest.com

Jim Pomonis, Ph.D.

CONTACT

651-415-7311; jpomonis@empi.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 3, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: July 3, 2008

Record last verified: 2008-07

Locations

US (8)