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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01132300
• Other study ID #: Approval Pending
• Status: Completed
• Phase: N/A
• First received: September 15, 2009
• Last updated: May 26, 2010
• Start date: July 2009
• Est. completion date: February 2010

Study information

• Verified date: May 2010
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Bnai Zion Medical Center	Nervomatrix Ltd. Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale Pain Questionnaire (VAS)		Baseline, before, and two hours after treatment session, 2 times a week, up to 5 weeks	No
Secondary	Oswestry Disability Questionnaire		once a week during the study, up to 5 weeks	No
Secondary	Side effect record		after each treatment session, 2 times a week, up to 5 weeks	Yes
Secondary	Range of Motion - lower back and pelvic forward flexion		Baseline, once a week, up to 5 weeks	No