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