Efficacy Study Image Guided, Auto-Targeted Neurostimulation for the Treatment of Non-Specific Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01132300
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : May 28, 2010
Nervomatrix Ltd. Israel
Information provided by:
Bnai Zion Medical Center

Brief Summary:

The purpose of this study is:

  • Initial evaluation of the clinical effectiveness of Image Guided Transcutaneous Electrical Stimulation (TENS) device for treatment of non-specific low back pain.
  • To assess the tolerability and acceptability of the device by the caregiver ("User Friendly").
  • To evaluate patients' tolerance by monitoring side effects and tolerability during treatment.

Condition or disease Intervention/treatment Phase
Low Back Pain Device: Image Guided TENS (Auto-Targeted Neurostimulation, NeMa-st) Not Applicable

Detailed Description:

Transcutaneous electrical nerves stimulation (TENS) devices are a drug-free alternative for managing pain. For the past thirty years, doctors have been prescribing FDA approved TENS worldwide as an effective way to relieve pain. TENS device currently utilized includes a variety of types of devices and pulse modulations. Most of these devices are applied on large surface areas, and are designed to block the pain signal (gate mechanism) to the brain. Others manual TENS devices are applied to small surface areas to stimulate peripheral nerve ends, and by that causing the release of endorphins with a significantly superior clinical outcome. Such treatments are time consuming and cumbersome and requires previous knowledge of location of nerve ends.

A novel device capable of scanning a large skin surface area, automatically locating nerve ends responsible for pain relief by utilizing skin impedance measurements and image processing with anatomical matching will be tested for stimulating these peripheral nerve ends (NeMa-st, Nervomatrix Ltd., Netanya, Israel).

For this purpose an open study to initially evaluate safety and efficacy of the intervention is designed. 20 patients will undergo 2 treatment sessions per week for a period of 4 weeks, while maintaining their pain relief medication treatment regime.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Trial Evaluating Efficacy of NeMa-st - A Computerized, Image Guided, Auto-Targeted Neurostimulation Device for the Treatment of Non Specific Low Back Pain
Study Start Date : July 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Treatment Device: Image Guided TENS (Auto-Targeted Neurostimulation, NeMa-st)
Patients will undergo 2 treatments per week during 4 weeks using the device. During the study Patients are allowed to maintain/continue taking medications/ analgesics for pain relief prescribed to them before the study. Medication use will be recorded.
Other Name: Nervomatrix Ltd. Auto-Targeted Neurostimulation, NeMa-st

Primary Outcome Measures :
  1. Visual Analogue Scale Pain Questionnaire (VAS) [ Time Frame: Baseline, before, and two hours after treatment session, 2 times a week, up to 5 weeks ]

Secondary Outcome Measures :
  1. Oswestry Disability Questionnaire [ Time Frame: once a week during the study, up to 5 weeks ]
  2. Side effect record [ Time Frame: after each treatment session, 2 times a week, up to 5 weeks ]
  3. Range of Motion - lower back and pelvic forward flexion [ Time Frame: Baseline, once a week, up to 5 weeks ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Non-specific low back pain persisted at least 1 month and no longer than 12 month before the study
  • Patients must have a baseline score>40 mm on the VAS pain scale
  • If taking analgesics, patients must agree to maintain a steady regimen for the duration of the study.
  • Able to provide written and verbal informed consent.

Exclusion Criteria:

  • Sciatica
  • Diagnosed spinal stenosis
  • Back Pain potentially attributable to specific underlying diseases or conditions (e.g. pregnancy, metastatic cancer, spondylolisthesis, fractured bones, dislocated joints, disc eruption).
  • Unstable medical or severe psychiatric conditions or dementia.
  • Previous Back surgery
  • Physically unable to undergo treatment
  • Patients receiving workers compensation or those involved in litigation
  • Minimal pain - less than 40mm score on VAS scale
  • History of pacemaker , implantable devices, history of cardiac arrhythmias
  • Allergy or intolerance to adhesive materials
  • Clinical evidence of cardiovascular, pulmonary, renal, hepatic, neurological , hematological or endocrine abnormalities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01132300

Bnai Zion Medical Center
Haifa, Israel, 31048
Sponsors and Collaborators
Bnai Zion Medical Center
Nervomatrix Ltd. Israel
Principal Investigator: Elad Schiff, MD Bnai Zion Medical Center

Responsible Party: Elad Schiff, MD, Bnai Zion Medical Center Identifier: NCT01132300     History of Changes
Other Study ID Numbers: Approval Pending
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: May 28, 2010
Last Verified: May 2010

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms