<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/NCT03778476</url>
  </required_header>
  <id_info>
    <org_study_id>HR3035</org_study_id>
    <nct_id>NCT03778476</nct_id>
  </id_info>
  <brief_title>Isometric Exercise and Endogenous Pain Inhibition</brief_title>
  <official_title>Isometric Exercise and Endogenous Pain Modulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marquette University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marquette University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to identify the acute effects of isometric exercise on the&#xD;
      inhibition of pain in individuals with fibromyalgia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fibromyalgia syndrome (FMS) is a chronic pain condition that is characterized by widespread&#xD;
      pain which affects 5-8% of the general population. Past research has shown that people with&#xD;
      FMS demonstrate enhanced pain facilitation and reduced pain inhibition in the central nervous&#xD;
      system. Incorporating a biopsychosocial model of pain may help develop strategies to prevent&#xD;
      the functional decline and alleviate the suffering that occurs in this population. Exercise&#xD;
      is a mainstay of pain rehabilitation with multiple health benefits, one of which is&#xD;
      decreasing pain; a phenomenon known as exercise induced hypoalgesia (EIH). Emerging evidence&#xD;
      has shown that exercise decreases pain facilitation in healthy adults and in some individuals&#xD;
      with FMS. However, it's unclear whether exercise improves pain inhibition in individuals with&#xD;
      FMS. The purpose of this study is to investigate endogenous pain inhibition, measured by&#xD;
      conditioned pain modulation (CPM), following isometric exercise of the quadriceps muscle in&#xD;
      individuals with FMS. In addition, factors that might affect this response such as physical&#xD;
      activity, body composition, and psychosocial issues will be examined. Understanding how&#xD;
      exercise impacts pain and the contributing factors will help guide the prescription of&#xD;
      exercise to optimize pain rehabilitation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2018</start_date>
  <completion_date type="Actual">October 29, 2019</completion_date>
  <primary_completion_date type="Actual">September 29, 2019</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>Crossover Assignment</intervention_model>
    <intervention_model_description>The two groups will participate in two sessions receiving intervention or no intervention in a randomized manner.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The participant is masked to the hypotheses of the treatment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Conditioned Pain Modulation</measure>
    <time_frame>baseline, immediately after exercise or quiet rest</time_frame>
    <description>the change in pressure pain threshold (kPa) during or after the immersion of the foot in a cold water bath (approximately 6 degrees) compared with baseline (before foot submersion) constitutes the measure of conditioned pain modulation in this study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vibration Perception Threshold</measure>
    <time_frame>baseline, immediately after exercise or quiet rest</time_frame>
    <description>a biothesiometer will be used to measure sense of vibration (threshold) local and distal from the exercising muscle.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Numerical Pain Rating Scale (NPRS)</measure>
    <time_frame>baseline, during exercise, and immediately after exercise or quiet rest</time_frame>
    <description>in both sessions, pain intensity will be evaluated during ice water bath immersion (i.e. before and after exercise or quiet rest) and during exercise using an 11-point NPRS with 0 being no pain and 10 worst pain possible.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Isometric Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will perform a submaximal voluntary contraction of the quadriceps muscle to task failure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quiet Rest</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will sit quietly for a period of time that mimics the exercise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Isometric Exercise</intervention_name>
    <description>Participants will be asked to hold a submaximal voluntary contraction of the quadriceps muscle as long as they can (task failure).</description>
    <arm_group_label>Isometric Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged 18-75 diagnosed with fibromyalgia or healthy controls will be&#xD;
             included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiovascular disease, cancer, pregnancy, arthritis, diabetes, claustrophobia,&#xD;
             Reynaud's disease, osteoporosis, neuropathy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie Hoeger Bement, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Marquette University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ali Alsouhibani, PT, MS</last_name>
    <role>Study Director</role>
    <affiliation>Marquette University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marquette University</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>February 23, 2021</last_update_submitted>
  <last_update_submitted_qc>February 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>pain sensitivity</keyword>
  <keyword>fibromyalgia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</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/NCT03778476
org study id: HR3035
nct id: NCT03778476
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to identify the acute effects of isometric exercise on the
      inhibition of pain in individuals with fibromyalgia.
Fibromyalgia syndrome (FMS) is a chronic pain condition that is characterized by widespread
      pain which affects 5-8% of the general population. Past research has shown that people with
      FMS demonstrate enhanced pain facilitation and reduced pain inhibition in the central nervous
      system. Incorporating a biopsychosocial model of pain may help develop strategies to prevent
      the functional decline and alleviate the suffering that occurs in this population. Exercise
      is a mainstay of pain rehabilitation with multiple health benefits, one of which is
      decreasing pain; a phenomenon known as exercise induced hypoalgesia (EIH). Emerging evidence
      has shown that exercise decreases pain facilitation in healthy adults and in some individuals
      with FMS. However, it's unclear whether exercise improves pain inhibition in individuals with
      FMS. The purpose of this study is to investigate endogenous pain inhibition, measured by
      conditioned pain modulation (CPM), following isometric exercise of the quadriceps muscle in
      individuals with FMS. In addition, factors that might affect this response such as physical
      activity, body composition, and psychosocial issues will be examined. Understanding how
      exercise impacts pain and the contributing factors will help guide the prescription of
      exercise to optimize pain rehabilitation.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: The two groups will participate in two sessions receiving intervention or no intervention in a randomized manner.
primary purpose: Treatment
masking: Single (Participant)
masking description: The participant is masked to the hypotheses of the treatment.
measure: Conditioned Pain Modulation
time frame: baseline, immediately after exercise or quiet rest
description: the change in pressure pain threshold (kPa) during or after the immersion of the foot in a cold water bath (approximately 6 degrees) compared with baseline (before foot submersion) constitutes the measure of conditioned pain modulation in this study.
measure: Vibration Perception Threshold
time frame: baseline, immediately after exercise or quiet rest
description: a biothesiometer will be used to measure sense of vibration (threshold) local and distal from the exercising muscle.
measure: Numerical Pain Rating Scale (NPRS)
time frame: baseline, during exercise, and immediately after exercise or quiet rest
description: in both sessions, pain intensity will be evaluated during ice water bath immersion (i.e. before and after exercise or quiet rest) and during exercise using an 11-point NPRS with 0 being no pain and 10 worst pain possible.
arm group label: Isometric Exercise
arm group type: Experimental
description: Participants will perform a submaximal voluntary contraction of the quadriceps muscle to task failure.
arm group label: Quiet Rest
arm group type: No Intervention
description: Participants will sit quietly for a period of time that mimics the exercise.
intervention type: Other
intervention name: Isometric Exercise
description: Participants will be asked to hold a submaximal voluntary contraction of the quadriceps muscle as long as they can (task failure).
arm group label: Isometric Exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marie Hoeger Bement, PT, PhD
role: Principal Investigator
affiliation: Marquette University
last name: Ali Alsouhibani, PT, MS
role: Study Director
affiliation: Marquette University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes