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

Bnai Zion Medical Center

Status

Completed

Conditions

Low Back Pain

Treatments

Device: Image Guided TENS (Auto-Targeted Neurostimulation, NeMa-st)

Study type

Interventional

Funder types

Other

Identifiers

NCT01132300

Approval Pending

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.