The Effects of a Pain Detecting and Analgesic Stimulating Device on Low Back Pain Patients' Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- The change in the amount of steps climbed during one minute
研究概览
简要总结
Purpose of study is to test in a randomized controlled trial (RCT) the effects of the Nervomatrix device on various clinical outcomes of patients with low back pain, as well as its mechanisms of action.
详细描述
This will be a matched randomized-controlled trial - RCT. Using random numbers from a random number generator, pairs of patients will be randomized to either the Nervomatrix stimulation (experimental group) or to sham stimulation (controls). Matching of pairs will be done based on the baseline data of the primary outcomes - pain and disability, as well as on other treatments received.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic low back pain persisting for at least 3 months
排除标准
- •patho-anatomical diagnosis (such as fractures, tumors, rheumatic diseases and neurological diseases)
- •initiated a new conventional therapy during the study period
- •patients having a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device
研究组 & 干预措施
Stimulation
Patients will undergo 6 sessions, each including 20 minutes of stimulation. These are given after the Nervomatrix device determines the peak pain regions for each patient, and selects to stimulate the top 10 regions with least skin resistance. The frequency of stimulation is 8Hz, at an intensity matched for each patient's tolerance, without inflicting any pain. The location of the stimulations will change in accordance to the changes in the peak pain regions, reflecting changes in tissue physiology possibly linked to clinical improvements.
干预措施: Stimulation (Device)
sham stimulation
Patients will undergo 6 sessions, each including 20 minutesof sham stimulation (no stimulation). These are given after the Nervomatrix device determines the peak pain regions for each patient, and selects to stimulate the top 10 regions with least skin resistance.
干预措施: Sham (Other)
结局指标
主要结局
The change in the amount of steps climbed during one minute
时间窗: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
Stair climbing: Participants were asked to climb up and down 5 stairs for 1 minute, using the rail for support if required. The total amount of steps climbed will be recorded
次要结局
- The change in average pain intensity(measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks))
- The change in Quebec Back Pain Disability Scale(measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks))
- The change in central sensitization inventory(measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks))
- The change in Pain Catastrophizing Scale(measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks))
- The change in revised Illness perception questionnaire(measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks))
- The change in Tampa Scale of Kinesiophobia(measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks))
研究者
Jo Nijs
Prof. dr.
Vrije Universiteit Brussel