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

This study has been completed.
Sponsor:
Collaborator:
Nervomatrix Ltd. Israel
Information provided by:
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT01132300
First received: September 15, 2009
Last updated: May 26, 2010
Last verified: May 2010
History of Changes
  Purpose

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 Intervention
Low Back Pain
 Device: Image Guided TENS (Auto-Targeted Neurostimulation, NeMa-st)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • Visual Analogue Scale Pain Questionnaire (VAS) [ Time Frame: Baseline, before, and two hours after treatment session, 2 times a week, up to 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oswestry Disability Questionnaire [ Time Frame: once a week during the study, up to 5 weeks ] [ Designated as safety issue: No ]
  • Side effect record [ Time Frame: after each treatment session, 2 times a week, up to 5 weeks ] [ Designated as safety issue: Yes ]
  • Range of Motion - lower back and pelvic forward flexion [ Time Frame: Baseline, once a week, up to 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132300

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

No publications provided

Responsible Party: Elad Schiff, MD, Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT01132300     History of Changes
Other Study ID Numbers: Approval Pending
Study First Received: September 15, 2009
Last Updated: May 26, 2010
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013