Efficacy Study Image Guided, Auto-Targeted Neurostimulation 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.
|Low Back Pain||Device: Image Guided TENS (Auto-Targeted Neurostimulation, NeMa-st)|
|Study Design:||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|
- Visual Analogue Scale Pain Questionnaire (VAS) [ Time Frame: Baseline, before, and two hours after treatment session, 2 times a week, up to 5 weeks ]
- Oswestry Disability Questionnaire [ Time Frame: once a week during the study, up to 5 weeks ]
- Side effect record [ Time Frame: after each treatment session, 2 times a week, up to 5 weeks ]
- Range of Motion - lower back and pelvic forward flexion [ Time Frame: Baseline, once a week, up to 5 weeks ]
|Study Start Date:||July 2009|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132300
|Bnai Zion Medical Center|
|Haifa, Israel, 31048|
|Principal Investigator:||Elad Schiff, MD||Bnai Zion Medical Center|