<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02256410</url>
  </required_header>
  <id_info>
    <org_study_id>NeMaLBP</org_study_id>
    <nct_id>NCT02256410</nct_id>
  </id_info>
  <brief_title>Pain Detecting and Analgesic Stimulating Device on Low Back Pain</brief_title>
  <official_title>The Effects of a Pain Detecting and Analgesic Stimulating Device on Low Back Pain Patients' Clinical Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vrije Universiteit Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vrije Universiteit Brussel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of study is to test in a randomized controlled trial (RCT) the effects of the&#xD;
      Nervomatrix device on various clinical outcomes of patients with low back pain, as well as&#xD;
      its mechanisms of action.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a matched randomized-controlled trial - RCT. Using random numbers from a random&#xD;
      number generator, pairs of patients will be randomized to either the Nervomatrix stimulation&#xD;
      (experimental group) or to sham stimulation (controls). Matching of pairs will be done based&#xD;
      on the baseline data of the primary outcomes - pain and disability, as well as on other&#xD;
      treatments received.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change in the amount of steps climbed during one minute</measure>
    <time_frame>measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change in central sensitization inventory</measure>
    <time_frame>measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in Pain Catastrophizing Scale</measure>
    <time_frame>measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in revised Illness perception questionnaire</measure>
    <time_frame>measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in average pain intensity</measure>
    <time_frame>measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)</time_frame>
    <description>average pain rating in the last seven days using a 100 mm Visual Analogue Scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in Quebec Back Pain Disability Scale</measure>
    <time_frame>measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in Tampa Scale of Kinesiophobia</measure>
    <time_frame>measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)</time_frame>
    <description>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 &quot;strongly disagree&quot; [1] to &quot;strongly agree&quot; [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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stimulation</intervention_name>
    <description>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</description>
    <arm_group_label>Stimulation</arm_group_label>
    <other_name>Nervomatrix</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham</intervention_name>
    <description>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.</description>
    <arm_group_label>sham stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic low back pain persisting for at least 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patho-anatomical diagnosis (such as fractures, tumors, rheumatic diseases and&#xD;
             neurological diseases)&#xD;
&#xD;
          -  initiated a new conventional therapy during the study period&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  patients having a cardiac pacemaker, implanted defibrillator, or other implanted&#xD;
             metallic or electronic device&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jo Nijs, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vrije Universiteit Brussel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vrije Universiteit Brussel</name>
      <address>
        <city>Brussel</city>
        <zip>1050</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>December 13, 2013</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>January 8, 2016</last_update_submitted>
  <last_update_submitted_qc>January 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vrije Universiteit Brussel</investigator_affiliation>
    <investigator_full_name>Jo Nijs</investigator_full_name>
    <investigator_title>Prof. dr.</investigator_title>
  </responsible_party>
  <keyword>low back pain</keyword>
  <keyword>chronic pain</keyword>
  <keyword>sensitization</keyword>
  <keyword>treatment</keyword>
  <keyword>trigger points</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02256410
org study id: NeMaLBP
nct id: NCT02256410
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: The change in the amount of steps climbed during one minute
time frame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
description: 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
measure: The change in central sensitization inventory
time frame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
description: 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.
measure: The change in Pain Catastrophizing Scale
time frame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
description: 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.
measure: The change in revised Illness perception questionnaire
time frame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
description: 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
measure: The change in average pain intensity
time frame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
description: average pain rating in the last seven days using a 100 mm Visual Analogue Scale (VAS)
measure: The change in Quebec Back Pain Disability Scale
time frame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
description: 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.
measure: The change in Tampa Scale of Kinesiophobia
time frame: measured prior to the first treatment session (baseline) and immediately following the 6th treatment session (after three weeks)
description: 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
arm group label: Stimulation
arm group type: Experimental
description: 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.
arm group label: sham stimulation
arm group type: Sham Comparator
description: 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.
intervention type: Device
intervention name: Stimulation
description: 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
arm group label: Stimulation
other name: Nervomatrix
intervention type: Other
intervention name: Sham
description: 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.
arm group label: sham stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jo Nijs, PhD
role: Principal Investigator
affiliation: Vrije Universiteit Brussel
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Vrije Universiteit Brussel
investigator full name: Jo Nijs
investigator title: Prof. dr.
mesh term: Back Pain
mesh term: Low Back Pain