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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale Pain Questionnaire (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Visual Analogue Scale Pain Questionnaire (VAS)
时间窗: Baseline, before, and two hours after treatment session, 2 times a week, up to 5 weeks
次要结局
- 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)