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Pain Detecting and Analgesic Stimulating Device on Low Back Pain

2016年1月8日 更新者:Jo Nijs、Vrije Universiteit Brussel

The Effects of a Pain Detecting and Analgesic Stimulating Device on Low Back Pain Patients' Clinical Outcomes

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.

研究概览

地位

完全的

条件

详细说明

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.

研究类型

介入性

注册 (实际的)

39

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Brussel、比利时、1050
        • Vrije Universiteit Brussel

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • chronic low back pain persisting for at least 3 months

Exclusion Criteria:

  • patho-anatomical diagnosis (such as fractures, tumors, rheumatic diseases and neurological diseases)
  • initiated a new conventional therapy during the study period
  • pregnant
  • patients having a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
The Nervomatrix device first measures skin impedance, and then creates a digital pain matrix map of the back. Regions with low resistance are then selected for brief electric stimulation, thus targeting the treatment to specific peak pain regions. Preliminary evidence supports the effectiveness of this device in reducing pain and disability over 6 sessions
其他名称:
  • Nervomatrix
假比较器: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.
The Nervomatrix device first measures skin impedance, and then creates a digital pain matrix map of the back. Regions with low resistance are then selected for brief mechanical pressure.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The change in the amount of steps climbed during one minute
大体时间: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
measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)

次要结果测量

结果测量
措施说明
大体时间
The change in central sensitization inventory
大体时间:measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
Part A of 25 statements related to current health symptoms. Each of these items is measured on a 5-point temporal Likert scale, with the following numeric rating scale: never (0), rarely (1), sometimes (2), often (3), and always (4). A cumulative score ranges from 0 to 100. Additionally information is collected in Part B on previously diagnosed central sensitivity syndromes and related conditions.
measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
The change in Pain Catastrophizing Scale
大体时间:measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
will be used to assess pain catastrophizing. It consists of 13 items describing different thoughts and feelings that individuals may experience when they are experiencing pain. Items are scored on a 5-point scale, and total scores are counted by adding up all individual items scores. Higher scores correspond to more severe catastrophic thoughts about pain.
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
大体时间:measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
will be used for assessing the patients' illness perceptions, as it is known that patients with maladaptive illness perceptions (e.g. expecting that their back problem will last for a long time, or holding weak beliefs in the controllability of their back problem) are more likely to have poor clinical outcomes 6 months after they consulted their physician
measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
The change in average pain intensity
大体时间:measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
average pain rating in the last seven days using a 100 mm Visual Analogue Scale (VAS)
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
大体时间:measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
This questionnaire consists of 20 activity related questions which the patient has to score on a six points scale (0= no; 5= not capable to perform the activity). The total score represents a percentage of functional limitations the patient experiences during daily life.
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
大体时间:measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
Tampa Scale of Kinesiophobia is a 17-item questionnaire developed to measure the fear of movement and (re)injury. Each item is scored on a four-point Likert scale ranging from "strongly disagree" [1] to "strongly agree" [4]. Ratings are added up to give a total score ranging from 17-68 points, with the higher values reflecting greater fear of (re)injury
measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年12月1日

初级完成 (实际的)

2014年12月1日

研究完成 (实际的)

2015年2月1日

研究注册日期

首次提交

2013年12月13日

首先提交符合 QC 标准的

2014年10月2日

首次发布 (估计)

2014年10月3日

研究记录更新

最后更新发布 (估计)

2016年1月12日

上次提交的符合 QC 标准的更新

2016年1月8日

最后验证

2016年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • NeMaLBP

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