<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/NCT02239289</url>
  </required_header>
  <id_info>
    <org_study_id>FIR UQTR 2013-2014</org_study_id>
    <nct_id>NCT02239289</nct_id>
  </id_info>
  <brief_title>Use of Biofeedback Training to Correct Abnormal Neuromechanical Pattern in Chronic Low Back Pain Patients</brief_title>
  <official_title>Correction of Abnormal Flexion-relaxation Phenomenon in Chronic Low Back Pain: the Benefit Associated With Biofeedback Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université du Québec à Trois-Rivières</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Université du Québec à Trois-Rivières</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the present study is to evaluate the benefit of biofeedback training on the&#xD;
      capacity of chronic low back pain patients to decrease their lumbar paraspinal muscles&#xD;
      activity during trunk full flexion and its relationship with changes in clinical outcomes. To&#xD;
      do so, twenty patients with nonspecific mechanical low back pain will be recruited and all&#xD;
      participants will take part in four sessions of supervised biofeedback training, consisting&#xD;
      of 5 blocks with at least 12 trunk flexion-extension tasks. It is hypothesized that&#xD;
      participants will have improved neuromechanical parameters with the biofeedback training and&#xD;
      that this improvement will be positively associated to changes in clinical outcomes. This&#xD;
      study will also allow for generation of preliminary data, in order to plan for a larger&#xD;
      randomized control trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Flexion-relaxation Ratio</measure>
    <time_frame>Week 1</time_frame>
    <description>Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Flexion-relaxation Ratio</measure>
    <time_frame>Week 2</time_frame>
    <description>Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Flexion-relaxation Ratio</measure>
    <time_frame>Week 3</time_frame>
    <description>Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Flexion-relaxation Ratio</measure>
    <time_frame>Week 4</time_frame>
    <description>Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lumbo-pelvic Range of Motion During Trunk Flexion-extension</measure>
    <time_frame>Week 1</time_frame>
    <description>Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability Level</measure>
    <time_frame>Week 4</time_frame>
    <description>Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity in the Past Week</measure>
    <time_frame>Week 2</time_frame>
    <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Current Pain Intensity</measure>
    <time_frame>Week 3</time_frame>
    <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of Movement Level</measure>
    <time_frame>Week 4</time_frame>
    <description>Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Current Pain Intensity</measure>
    <time_frame>Week 2</time_frame>
    <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Current Pain Intensity</measure>
    <time_frame>Week 4</time_frame>
    <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity in the Past Week</measure>
    <time_frame>Week 3</time_frame>
    <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity in the Past Week</measure>
    <time_frame>Week 4</time_frame>
    <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lumbo-pelvic Range of Motion During Trunk Flexion-extension</measure>
    <time_frame>Week 2</time_frame>
    <description>Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lumbo-pelvic Range of Motion During Trunk Flexion-extension</measure>
    <time_frame>Week 3</time_frame>
    <description>Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lumbo-pelvic Range of Motion During Trunk Flexion-extension</measure>
    <time_frame>Week 4</time_frame>
    <description>Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <condition>Mechanical Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Biofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be provided with four sessions of supervised biofeedback training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Biofeedback</intervention_name>
    <description>Idem as described in the arm section (above)</description>
    <arm_group_label>Biofeedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being between 18 and 60 years of age.&#xD;
&#xD;
          -  Presence of non-specific chronic low back pain.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior surgery or major spine trauma.&#xD;
&#xD;
          -  Lumbar scoliosis greater than 20°.&#xD;
&#xD;
          -  Neuromuscular disease.&#xD;
&#xD;
          -  Malignant tumor.&#xD;
&#xD;
          -  Uncontrolled hypertension.&#xD;
&#xD;
          -  Infection.&#xD;
&#xD;
          -  Neurological deficit.&#xD;
&#xD;
          -  Symptomatic lumbar disc herniation.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Recent lumbar cortisone injection.&#xD;
&#xD;
          -  Active lower body injury and/or disabling pain limiting the capacity to complete the&#xD;
             experimentation.&#xD;
&#xD;
          -  Being under medications known to impair physical effort and pain perception.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Descarreaux, DC, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Université du Québec à Trois-Rivières</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Université du Québec à Trois-Rivières</name>
      <address>
        <city>Trois-Rivières</city>
        <state>Quebec</state>
        <zip>G9A 5H7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60.</citation>
    <PMID>23777436</PMID>
  </reference>
  <reference>
    <citation>Frank DL, Khorshid L, Kiffer JF, Moravec CS, McKee MG. Biofeedback in medicine: who, when, why and how? Ment Health Fam Med. 2010 Jun;7(2):85-91.</citation>
    <PMID>22477926</PMID>
  </reference>
  <reference>
    <citation>Hodges PW. Pain and motor control: From the laboratory to rehabilitation. J Electromyogr Kinesiol. 2011 Apr;21(2):220-8. doi: 10.1016/j.jelekin.2011.01.002.</citation>
    <PMID>21306915</PMID>
  </reference>
  <reference>
    <citation>Demoulin C, Crielaard JM, Vanderthommen M. Spinal muscle evaluation in healthy individuals and low-back-pain patients: a literature review. Joint Bone Spine. 2007 Jan;74(1):9-13. doi: 10.1016/j.jbspin.2006.02.013. Epub 2006 Nov 13.</citation>
    <PMID>17174584</PMID>
  </reference>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <results_first_submitted>May 26, 2015</results_first_submitted>
  <results_first_submitted_qc>July 10, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 23, 2015</results_first_posted>
  <last_update_submitted>July 10, 2015</last_update_submitted>
  <last_update_submitted_qc>July 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université du Québec à Trois-Rivières</investigator_affiliation>
    <investigator_full_name>Martin Descarreaux</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Low back pain</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Biofeedback</keyword>
  <keyword>Electromyography</keyword>
  <keyword>Kinematic</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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Biofeedback</title>
          <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Biofeedback</title>
          <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.52" spread="11.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index, mean (SD)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.55" spread="3.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of low back pain in months, mean (SD)</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88.36" spread="65.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fear of movement level</title>
          <description>Tampa scale for kinesiophobia ranges from 1 to 68. Higher score indicates a higher fear of movement level.</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.76" lower_limit="22" upper_limit="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disability level</title>
          <description>Oswestry disability index ranges from 0 to 100. Higher score indicates a higher lumbar disability level.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.95" lower_limit="0" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current pain intensity</title>
          <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.24" lower_limit="0" upper_limit="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pain intensity in the past week</title>
          <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.62" lower_limit="0" upper_limit="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Flexion-relaxation Ratio</title>
        <description>Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback</title>
            <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
          </group>
        </group_list>
        <measure>
          <title>Flexion-relaxation Ratio</title>
          <description>Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.</description>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.68" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Flexion-relaxation Ratio</title>
        <description>Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback</title>
            <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
          </group>
        </group_list>
        <measure>
          <title>Flexion-relaxation Ratio</title>
          <description>Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Flexion-relaxation Ratio</title>
        <description>Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.</description>
        <time_frame>Week 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback</title>
            <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
          </group>
        </group_list>
        <measure>
          <title>Flexion-relaxation Ratio</title>
          <description>Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Flexion-relaxation Ratio</title>
        <description>Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback</title>
            <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
          </group>
        </group_list>
        <measure>
          <title>Flexion-relaxation Ratio</title>
          <description>Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lumbo-pelvic Range of Motion During Trunk Flexion-extension</title>
        <description>Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback</title>
            <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
          </group>
        </group_list>
        <measure>
          <title>Lumbo-pelvic Range of Motion During Trunk Flexion-extension</title>
          <description>Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.</description>
          <units>Degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pelvic range</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.03" spread="9.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lumbar range</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.15" spread="9.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disability Level</title>
        <description>Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability.</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback</title>
            <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
          </group>
        </group_list>
        <measure>
          <title>Disability Level</title>
          <description>Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.70" lower_limit="0" upper_limit="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Intensity in the Past Week</title>
        <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback</title>
            <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Intensity in the Past Week</title>
          <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.90" lower_limit="10" upper_limit="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Current Pain Intensity</title>
        <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
        <time_frame>Week 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback</title>
            <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
          </group>
        </group_list>
        <measure>
          <title>Current Pain Intensity</title>
          <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.62" lower_limit="0" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fear of Movement Level</title>
        <description>Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level.</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback</title>
            <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
          </group>
        </group_list>
        <measure>
          <title>Fear of Movement Level</title>
          <description>Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.80" lower_limit="0" upper_limit="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Current Pain Intensity</title>
        <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback</title>
            <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
          </group>
        </group_list>
        <measure>
          <title>Current Pain Intensity</title>
          <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.19" lower_limit="0" upper_limit="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Current Pain Intensity</title>
        <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback</title>
            <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
          </group>
        </group_list>
        <measure>
          <title>Current Pain Intensity</title>
          <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.81" lower_limit="0" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Intensity in the Past Week</title>
        <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
        <time_frame>Week 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback</title>
            <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Intensity in the Past Week</title>
          <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.48" lower_limit="0" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Intensity in the Past Week</title>
        <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback</title>
            <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Intensity in the Past Week</title>
          <description>101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.62" lower_limit="5" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lumbo-pelvic Range of Motion During Trunk Flexion-extension</title>
        <description>Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback</title>
            <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
          </group>
        </group_list>
        <measure>
          <title>Lumbo-pelvic Range of Motion During Trunk Flexion-extension</title>
          <description>Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.</description>
          <units>Degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pelvic range</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.45" spread="8.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lumbar range</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.60" spread="11.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lumbo-pelvic Range of Motion During Trunk Flexion-extension</title>
        <description>Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.</description>
        <time_frame>Week 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback</title>
            <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
          </group>
        </group_list>
        <measure>
          <title>Lumbo-pelvic Range of Motion During Trunk Flexion-extension</title>
          <description>Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.</description>
          <units>Degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pelvic range</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.38" spread="9.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lumbar range</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.83" spread="10.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lumbo-pelvic Range of Motion During Trunk Flexion-extension</title>
        <description>Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback</title>
            <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
          </group>
        </group_list>
        <measure>
          <title>Lumbo-pelvic Range of Motion During Trunk Flexion-extension</title>
          <description>Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.</description>
          <units>Degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pelvic range</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.21" spread="9.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lumbar range</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.89" spread="9.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 weeks</time_frame>
      <desc>Only pain intensity was collected for adverse events by asking participants if their pain intensity increased at each session beginning.</desc>
      <group_list>
        <group group_id="E1">
          <title>Biofeedback</title>
          <description>Subjects will be provided with four sessions of supervised biofeedback training&#xD;
Biofeedback: Idem as described in the arm section (above)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Martin Descarreaux</name_or_title>
      <organization>Université du Québec à Trois-Rivières</organization>
      <phone>1-819-376-5011 ext 3791</phone>
      <email>martin.descarreaux@uqtr.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02239289
org study id: FIR UQTR 2013-2014
nct id: NCT02239289
lead sponsor: 
has dmc: No
The purpose of the present study is to evaluate the benefit of biofeedback training on the
      capacity of chronic low back pain patients to decrease their lumbar paraspinal muscles
      activity during trunk full flexion and its relationship with changes in clinical outcomes. To
      do so, twenty patients with nonspecific mechanical low back pain will be recruited and all
      participants will take part in four sessions of supervised biofeedback training, consisting
      of 5 blocks with at least 12 trunk flexion-extension tasks. It is hypothesized that
      participants will have improved neuromechanical parameters with the biofeedback training and
      that this improvement will be positively associated to changes in clinical outcomes. This
      study will also allow for generation of preliminary data, in order to plan for a larger
      randomized control trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Flexion-relaxation Ratio
time frame: Week 1
description: Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
measure: Flexion-relaxation Ratio
time frame: Week 2
description: Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
measure: Flexion-relaxation Ratio
time frame: Week 3
description: Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
measure: Flexion-relaxation Ratio
time frame: Week 4
description: Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
measure: Lumbo-pelvic Range of Motion During Trunk Flexion-extension
time frame: Week 1
description: Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.
measure: Disability Level
time frame: Week 4
description: Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability.
measure: Pain Intensity in the Past Week
time frame: Week 2
description: 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
measure: Current Pain Intensity
time frame: Week 3
description: 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
measure: Fear of Movement Level
time frame: Week 4
description: Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level.
measure: Current Pain Intensity
time frame: Week 2
description: 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
measure: Current Pain Intensity
time frame: Week 4
description: 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
measure: Pain Intensity in the Past Week
time frame: Week 3
description: 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
measure: Pain Intensity in the Past Week
time frame: Week 4
description: 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
measure: Lumbo-pelvic Range of Motion During Trunk Flexion-extension
time frame: Week 2
description: Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.
measure: Lumbo-pelvic Range of Motion During Trunk Flexion-extension
time frame: Week 3
description: Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.
measure: Lumbo-pelvic Range of Motion During Trunk Flexion-extension
time frame: Week 4
description: Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.
arm group label: Biofeedback
arm group type: Experimental
description: Subjects will be provided with four sessions of supervised biofeedback training
intervention type: Other
intervention name: Biofeedback
description: Idem as described in the arm section (above)
arm group label: Biofeedback
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Martin Descarreaux, DC, PhD
role: Principal Investigator
affiliation: Université du Québec à Trois-Rivières
facility: 
country: Canada
citation: Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60.
PMID: 23777436
citation: Frank DL, Khorshid L, Kiffer JF, Moravec CS, McKee MG. Biofeedback in medicine: who, when, why and how? Ment Health Fam Med. 2010 Jun;7(2):85-91.
PMID: 22477926
citation: Hodges PW. Pain and motor control: From the laboratory to rehabilitation. J Electromyogr Kinesiol. 2011 Apr;21(2):220-8. doi: 10.1016/j.jelekin.2011.01.002.
PMID: 21306915
citation: Demoulin C, Crielaard JM, Vanderthommen M. Spinal muscle evaluation in healthy individuals and low-back-pain patients: a literature review. Joint Bone Spine. 2007 Jan;74(1):9-13. doi: 10.1016/j.jbspin.2006.02.013. Epub 2006 Nov 13.
PMID: 17174584
responsible party type: Principal Investigator
investigator affiliation: Université du Québec à Trois-Rivières
investigator full name: Martin Descarreaux
investigator title: Professor
mesh term: Back Pain
mesh term: Low Back Pain
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