<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/NCT01686074</url>
  </required_header>
  <id_info>
    <org_study_id>2012/679</org_study_id>
    <nct_id>NCT01686074</nct_id>
  </id_info>
  <brief_title>Motor Control in Chronic Fatigue Syndrome and Fibromyalgia</brief_title>
  <official_title>Motor Control in Chronic Fatigue Syndrome and Fibromyalgia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project is a comprehensive study, with main focus on motor control, comparing patients&#xD;
      with chronic fatigue syndrome / myalgic encephalopathy (CFS/ME) and/or fibromyalgia syndrome&#xD;
      (FMS). Focus of the present project will be on detailed movement analysis in a movement&#xD;
      laboratory and involve functional tasks such as walking and standing. Investigations will&#xD;
      also comprise muscle activity, reaction time and fine motor control.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>motor control</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Fibromyalgia</condition>
  <condition>Chronic Fatigue Syndrome</condition>
  <arm_group>
    <arm_group_label>Chronic fatigue syndrome</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>fibromyalgia</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>chronic fatigue syndrome + fibromyalgia</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy sedentary control</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic fatigue syndrome and fibromyalgia from primary care clinics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of chronic fatigue syndrome or fibromyalgia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who already had been treated.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Egil A Fors, MD prof</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Avdeling for smerte og sammensatte symptomlidelser (ASSL) St Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Rasouli O, Stensdotter AK, Van der Meer ALH. TauG-guidance of dynamic balance control during gait initiation in patients with chronic fatigue syndrome and fibromyalgia. Clin Biomech (Bristol, Avon). 2016 Aug;37:147-152. doi: 10.1016/j.clinbiomech.2016.07.008. Epub 2016 Jul 22.</citation>
    <PMID>27474799</PMID>
  </reference>
  <results_reference>
    <citation>Rasouli O, Fors EA, Borchgrevink PC, Ohberg F, Stensdotter AK. Gross and fine motor function in fibromyalgia and chronic fatigue syndrome. J Pain Res. 2017 Feb 7;10:303-309. doi: 10.2147/JPR.S127038. eCollection 2017.</citation>
    <PMID>28223840</PMID>
  </results_reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2012</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Motor control</keyword>
  <keyword>walking</keyword>
  <keyword>physical activity</keyword>
  <keyword>Muscle activity</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>
    <mesh_term>Fatigue Syndrome, Chronic</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Fatigue</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/NCT01686074
org study id: 2012/679
nct id: NCT01686074
lead sponsor: 
collaborator: 
has dmc: No
This project is a comprehensive study, with main focus on motor control, comparing patients
      with chronic fatigue syndrome / myalgic encephalopathy (CFS/ME) and/or fibromyalgia syndrome
      (FMS). Focus of the present project will be on detailed movement analysis in a movement
      laboratory and involve functional tasks such as walking and standing. Investigations will
      also comprise muscle activity, reaction time and fine motor control.
observational model: Case-Control
time perspective: Cross-Sectional
measure: motor control
time frame: 1 day
arm group label: Chronic fatigue syndrome
arm group label: fibromyalgia
arm group label: chronic fatigue syndrome + fibromyalgia
arm group label: healthy sedentary control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 49 Years
healthy volunteers: No
last name: Egil A Fors, MD prof
role: Study Director
affiliation: Norwegian University of Science and Technology
facility: 
country: Norway
citation: Rasouli O, Stensdotter AK, Van der Meer ALH. TauG-guidance of dynamic balance control during gait initiation in patients with chronic fatigue syndrome and fibromyalgia. Clin Biomech (Bristol, Avon). 2016 Aug;37:147-152. doi: 10.1016/j.clinbiomech.2016.07.008. Epub 2016 Jul 22.
PMID: 27474799
citation: Rasouli O, Fors EA, Borchgrevink PC, Ohberg F, Stensdotter AK. Gross and fine motor function in fibromyalgia and chronic fatigue syndrome. J Pain Res. 2017 Feb 7;10:303-309. doi: 10.2147/JPR.S127038. eCollection 2017.
PMID: 28223840
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
mesh term: Fatigue Syndrome, Chronic
mesh term: Syndrome
mesh term: Fatigue