<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/NCT03778801</url>
  </required_header>
  <id_info>
    <org_study_id>2018/155</org_study_id>
    <nct_id>NCT03778801</nct_id>
  </id_info>
  <brief_title>Kinesiophobia in Patients With Fibromyalgia Syndrome and Chronic Neck Pain</brief_title>
  <official_title>Evaluation of Kinesiophobia and Physical Activity Levels in Patients With Fibromyalgia Syndrome and Chronic Neck Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aksaray University Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aksaray University Training and Research Hospital</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>
      Kinesiophobia which is described as fear of movement reduces physical activity levels and&#xD;
      increases the risk of chronic pain. We consider that kinesiophobia levels were higher in&#xD;
      patients with fibromyalgia syndrome and chronic neck pain so that physical activity levels&#xD;
      were lower in this patients groups. Because there are not enough studies, we aimed to&#xD;
      evaluate kinesiophobia and physical activity levels in this patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To evaluate pain, kinesiophobia, physical activity, depression, disease severity,&#xD;
      and fatigue in patients with fibromyalgia syndrome or chronic neck pain and healthy controls.&#xD;
&#xD;
      Design: Cross-sectional study. Setting: Tertiary Health Care Center, Aksaray, Turkey&#xD;
      Participants: 30 patients with fibromyalgia syndrome (Group 1), 30 patients with chronic neck&#xD;
      pain (Group 2), and 30 healthy individuals (Group 3) were included.&#xD;
&#xD;
      Main Outcome Measures: Outcome measures were Visual Analogue Scale (VAS)-pain and fatigue,&#xD;
      Tampa Scale of Kinesiophobia (TSK), Beck Depression Inventory (BDI), International Physical&#xD;
      Activity Questionnaire (IPAQ) Short Form, Fibromyalgia Impact Questionnaire (FIQ), Neck Pain&#xD;
      Disability Index (NPDI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">December 7, 2018</completion_date>
  <primary_completion_date type="Actual">December 3, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tampa Scale of Kinesiophobia</measure>
    <time_frame>4-8 minutes</time_frame>
    <description>Based on a four-point Likert type, this scale contains 17 items that evaluate fear and anxiety related to physical activity. A total score of greater than 37 is accepted as statistically significant and interpreted as a high level of kinesiophobia. minimal and maximal scores could be between 17-68 points. higher scores indicate higher levels of kinesiophobia.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>International Physical Activity Questionnaire Short Form</measure>
    <time_frame>5-10 minutes</time_frame>
    <description>It consists of seven items that measure the duration of the participants' physical activity, walking and sitting within the last seven days in the metabolic equivalent (MET)-min/week unit. 3 or more days of vigorous activity of at least 20 minutes per day or 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day or 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 metabolic equivalent (MET)-minutes/week are proposed to be moderate level. Vigorous-intensity activity on at least 3 days and accumulating at least 1500 metabolic equivalent (MET)-minutes/week or 7 or more days of any combination of walking, moderate- or vigorous-intensity activities accumulating at least 3000 metabolic equivalent (MET)-minutes/week are proposed to be high level. Some activity is reported but not enough to meet categories of moderate or high levels.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory</measure>
    <time_frame>10 minutes</time_frame>
    <description>This is a 21-item questionnaire that investigates the characteristic attitudes and symptoms of depression. A score of 10 or higher indicates depression. Minimal and maximal scores can be 0-63 points. Higher scores indicate higher levels of depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fibromyalgia Impact Questionnaire</measure>
    <time_frame>5 minutes</time_frame>
    <description>It aims to evaluate the arthritis symptoms and functional status of patients with fibromyalgia syndrome through 21 questions that inquire about physical functions, work-related situations, depression, anxiety, waking up tired, pain, stiffness, and fatigue. Higher scores indicate greater impact of fibromyalgia on functioning. Final score should range from 0 to 80.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck Pain Disability Index</measure>
    <time_frame>5-8 minutes</time_frame>
    <description>This index consists of 20 questions that assess severity of neck pain and the extent to which the pain affects the social, professional and daily activities of patients.Final score should range from 0 to 100. Higher scores indicate greater levels of disability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analog Scale for the Evaluation of Pain and Fatigue</measure>
    <time_frame>0.5 minutes</time_frame>
    <description>For this evaluation, the patient is asked to mark his/her severity of pain and fatigue on a horizontal 10-cm line with number 0 on one end representing &quot;no pain or no fatigue&quot; and number 10 on the other end indicating &quot;very severe pain or very severe fatigue&quot;. Higher scores indicate higher levels of pain intensity or fatigue.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Fibromyalgia</condition>
  <condition>Neck Pain</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>fibromyalgia syndrome</arm_group_label>
    <description>Thirty patients with a diagnosis of fibromyalgia syndrome according to the 2016 revised American College of Rheumatology Fibromyalgia Syndrome diagnostic criteria and a disease duration of longer than three months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>chronic neck pain</arm_group_label>
    <description>30 patients with chronic neck pain lasting for more than three months and didn't meet 2016 revised American College of Rheumatology Fibromyalgia Syndrome diagnostic criteria.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy controls</arm_group_label>
    <description>30 healthy controls without pain or additional disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>fibromyalgia syndrome and chronic neck pain</intervention_name>
    <description>We assessed pain intensity, kinesiophobia, fatigue, depression, physical activity level and disability in patients with fibromyalgia syndrome and chronic neck pain, and healthy individuals in this cross-sectional study.</description>
    <arm_group_label>chronic neck pain</arm_group_label>
    <arm_group_label>fibromyalgia syndrome</arm_group_label>
    <arm_group_label>healthy controls</arm_group_label>
    <other_name>physical activity level</other_name>
    <other_name>pain intensity</other_name>
    <other_name>disability</other_name>
    <other_name>fatigue</other_name>
    <other_name>depression</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients were recruited from a physical medicine and rehabilitation outpatients clinic&#xD;
        of Aksaray University Training and Research Hospital, Aksaray, Turkey. The healthy control&#xD;
        group was consisting of doctors, nurses, medical secretaries who work in Aksaray University&#xD;
        Training and Research Hospital, and patient care providers that have no pain and additional&#xD;
        diseases&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        disease duration more than three years for patient groups no pain and additional disease&#xD;
        for healthy controls&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        malignancy systemic infectious and rheumatic diseases history of operation having received&#xD;
        physical therapy or intra-articular or intra-ligamentary injection within the last three&#xD;
        months previous diagnosis of a psychological or cognitive disorder history of pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melek A Selçuk</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aksaray University Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aksaray University Training and Research Hospital</name>
      <address>
        <city>Aksaray</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 16, 2018</last_update_submitted>
  <last_update_submitted_qc>December 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aksaray University Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Melek Aykut Selçuk</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>kinesiophobia</keyword>
  <keyword>physical activity</keyword>
  <keyword>disability</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>Neck Pain</mesh_term>
    <mesh_term>Kinesiophobia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 16, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT03778801/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>December 18, 2018</submitted>
    <returned>March 28, 2019</returned>
  </pending_results>
  <!-- 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/NCT03778801
org study id: 2018/155
nct id: NCT03778801
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Kinesiophobia which is described as fear of movement reduces physical activity levels and
      increases the risk of chronic pain. We consider that kinesiophobia levels were higher in
      patients with fibromyalgia syndrome and chronic neck pain so that physical activity levels
      were lower in this patients groups. Because there are not enough studies, we aimed to
      evaluate kinesiophobia and physical activity levels in this patients.
Objective: To evaluate pain, kinesiophobia, physical activity, depression, disease severity,
      and fatigue in patients with fibromyalgia syndrome or chronic neck pain and healthy controls.

      Design: Cross-sectional study. Setting: Tertiary Health Care Center, Aksaray, Turkey
      Participants: 30 patients with fibromyalgia syndrome (Group 1), 30 patients with chronic neck
      pain (Group 2), and 30 healthy individuals (Group 3) were included.

      Main Outcome Measures: Outcome measures were Visual Analogue Scale (VAS)-pain and fatigue,
      Tampa Scale of Kinesiophobia (TSK), Beck Depression Inventory (BDI), International Physical
      Activity Questionnaire (IPAQ) Short Form, Fibromyalgia Impact Questionnaire (FIQ), Neck Pain
      Disability Index (NPDI).
observational model: Cohort
time perspective: Cross-Sectional
measure: Tampa Scale of Kinesiophobia
time frame: 4-8 minutes
description: Based on a four-point Likert type, this scale contains 17 items that evaluate fear and anxiety related to physical activity. A total score of greater than 37 is accepted as statistically significant and interpreted as a high level of kinesiophobia. minimal and maximal scores could be between 17-68 points. higher scores indicate higher levels of kinesiophobia.
measure: International Physical Activity Questionnaire Short Form
time frame: 5-10 minutes
description: It consists of seven items that measure the duration of the participants' physical activity, walking and sitting within the last seven days in the metabolic equivalent (MET)-min/week unit. 3 or more days of vigorous activity of at least 20 minutes per day or 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day or 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 metabolic equivalent (MET)-minutes/week are proposed to be moderate level. Vigorous-intensity activity on at least 3 days and accumulating at least 1500 metabolic equivalent (MET)-minutes/week or 7 or more days of any combination of walking, moderate- or vigorous-intensity activities accumulating at least 3000 metabolic equivalent (MET)-minutes/week are proposed to be high level. Some activity is reported but not enough to meet categories of moderate or high levels.
measure: Beck Depression Inventory
time frame: 10 minutes
description: This is a 21-item questionnaire that investigates the characteristic attitudes and symptoms of depression. A score of 10 or higher indicates depression. Minimal and maximal scores can be 0-63 points. Higher scores indicate higher levels of depression.
measure: Fibromyalgia Impact Questionnaire
time frame: 5 minutes
description: It aims to evaluate the arthritis symptoms and functional status of patients with fibromyalgia syndrome through 21 questions that inquire about physical functions, work-related situations, depression, anxiety, waking up tired, pain, stiffness, and fatigue. Higher scores indicate greater impact of fibromyalgia on functioning. Final score should range from 0 to 80.
measure: Neck Pain Disability Index
time frame: 5-8 minutes
description: This index consists of 20 questions that assess severity of neck pain and the extent to which the pain affects the social, professional and daily activities of patients.Final score should range from 0 to 100. Higher scores indicate greater levels of disability.
measure: Visual Analog Scale for the Evaluation of Pain and Fatigue
time frame: 0.5 minutes
description: For this evaluation, the patient is asked to mark his/her severity of pain and fatigue on a horizontal 10-cm line with number 0 on one end representing "no pain or no fatigue" and number 10 on the other end indicating "very severe pain or very severe fatigue". Higher scores indicate higher levels of pain intensity or fatigue.
arm group label: fibromyalgia syndrome
description: Thirty patients with a diagnosis of fibromyalgia syndrome according to the 2016 revised American College of Rheumatology Fibromyalgia Syndrome diagnostic criteria and a disease duration of longer than three months
arm group label: chronic neck pain
description: 30 patients with chronic neck pain lasting for more than three months and didn't meet 2016 revised American College of Rheumatology Fibromyalgia Syndrome diagnostic criteria.
arm group label: healthy controls
description: 30 healthy controls without pain or additional disease
intervention type: Diagnostic Test
intervention name: fibromyalgia syndrome and chronic neck pain
description: We assessed pain intensity, kinesiophobia, fatigue, depression, physical activity level and disability in patients with fibromyalgia syndrome and chronic neck pain, and healthy individuals in this cross-sectional study.
arm group label: chronic neck pain
arm group label: fibromyalgia syndrome
arm group label: healthy controls
other name: physical activity level
other name: pain intensity
other name: disability
other name: fatigue
other name: depression
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Melek A Selçuk
role: Principal Investigator
affiliation: Aksaray University Training and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Aksaray University Training and Research Hospital
investigator full name: Dr. Melek Aykut Selçuk
investigator title: Principal Investigator
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
mesh term: Neck Pain
mesh term: Kinesiophobia
sharing ipd: Undecided
provided document: 
submitted: December 18, 2018
returned: March 28, 2019