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

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Device: Image Guided TENS (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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31048
    • Bnai Zion Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Nervomatrix Ltd. Auto-Targeted Neurostimulation, NeMa-st

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Analogue Scale Pain Questionnaire (VAS)	Baseline, before, and two hours after treatment session, 2 times a week, up to 5 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center
• Collaborators: Nervomatrix Ltd. Israel
• Investigators: Principal Investigator: Elad Schiff, MD, Bnai Zion Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: September 15, 2009
• First Submitted That Met QC Criteria: May 26, 2010
• First Posted (Estimate): May 28, 2010

Study Record Updates

• Last Update Posted (Estimate): May 28, 2010
• Last Update Submitted That Met QC Criteria: May 26, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Approval Pending