xml: <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/NCT06031207</url>
    </required_header>
    <id_info>
      <org_study_id>REC-UOL-492-08-2023</org_study_id>
      <nct_id>NCT06031207</nct_id>
    </id_info>
    <brief_title>Translation and Psychometric Properties of the Fatigue Severity Scale in Patients With Fibromyalgia</brief_title>
    <official_title>Translation and Psychometric Properties of the Fatigue Severity Scale in Patients With Fibromyalgia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Lahore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Lahore</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study will employ a Cross-Sectional Validation Study design. The study will be conducted&#xD;
        at the Department of Physical Therapy, University of Lahore Teaching Hospital, located on&#xD;
        Defence Road, Lahore.&#xD;
  &#xD;
        The anticipated duration of the study will be 09 months, commencing after the approval of the&#xD;
        synopsis.&#xD;
  &#xD;
        The sample size will be determined following the Kline Method, resulting in a total of 90&#xD;
        participants.&#xD;
  &#xD;
        A Purposive Sampling Technique will be utilized to select the study participants.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study Type: Cross-Sectional Validation Study Location: Department of Physical Therapy,&#xD;
        University of Lahore Teaching Hospital, Defence Road, Lahore Duration: 06 months&#xD;
        (post-synopsis approval) Sample Size: 90 participants Sampling Technique: Purposive Sampling&#xD;
        Consent and Ethics: Participants will provide written informed consent. Ethics approval will&#xD;
        be obtained from the University of Lahore Ethics Committee.&#xD;
  &#xD;
        Translation of FSS:&#xD;
  &#xD;
        The Fatigue Severity Scale (FSS) will be translated into Urdu for data collection.&#xD;
  &#xD;
        Two independent bilingual translators will create reports on translation difficulties and&#xD;
        rationale.&#xD;
  &#xD;
        These reports will inform a consensus meeting to develop a unified Urdu version, with&#xD;
        comments documented.&#xD;
  &#xD;
        The unified version will be backtranslated into English by native English-speaking&#xD;
        translators unaware of the questionnaire's concept.&#xD;
  &#xD;
        Expert Committee:&#xD;
  &#xD;
        An expert committee comprising physical therapists, linguists, and a methodologist will&#xD;
        review both language versions.&#xD;
  &#xD;
        The goal is to ensure semantic, idiomatic, experiential, and conceptual equivalence and reach&#xD;
        consensus on the final Urdu version of the FSS.&#xD;
  &#xD;
        Patient Involvement:&#xD;
  &#xD;
        The final Urdu FSS version will be administered to 20 fibromyalgia patients. These patients&#xD;
        will also be interviewed to assess their understanding of questionnaire items.&#xD;
  &#xD;
        Participants will receive additional information about fibromyalgia to prevent confusion.&#xD;
  &#xD;
        Data Collection:&#xD;
  &#xD;
        Data will be collected from 100 fibromyalgia patients using the final Urdu FSS version.&#xD;
  &#xD;
        A retest will be conducted after 48 hours.&#xD;
  &#xD;
        Additional Assessment:&#xD;
  &#xD;
        All 90 participants will complete the Multidimensional Fatigue Inventory (MFI).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Fatigue Severity Scale</measure>
      <time_frame>1 week</time_frame>
      <description>The Fatigue Severity Scale (FSS) is a self-reported measure of fatigue and sleep disturbance in patients with fibromyalgia. It is a 9-item scale that assesses the severity of fatigue, the impact of fatigue on daily activities, and the degree of sleep disturbance. The FSS is a widely used instrument in research and clinical practice, and has been found to be a valid and reliable measure of fatigue and sleep disturbance in patients with fibromyalgia. The FSS items are rated on a 5-point Likert scale, with responses ranging from &quot;not at all&quot; to &quot;extremely.&quot; The total score ranges from 0 to 36, with higher scores indicating greater levels of fatigue and sleep disturbance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Multidimensional Fatigue Inventory</measure>
      <time_frame>1 week</time_frame>
      <description>The Multidimensional Fatigue Inventory (MFI) is a self-report questionnaire designed to assess various dimensions of fatigue experienced by individuals. It is commonly used in research and clinical settings to measure and understand fatigue in different contexts. Respondents answer a series of questions related to each dimension on a Likert-type scale, typically ranging from 1 to 5 or 0 to 4. The scores from each dimension are summed to obtain subscale scores, and a total score is often calculated by summing all subscale scores. Higher scores indicate greater levels of fatigue.</description>
    </primary_outcome>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Fibromyalgia</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Fibromyalgia is a disease characterized by chronic pain, stiffness, and tenderness of&#xD;
          muscles, tendons, and joints, without detectable inflammation. Fibromyalgia does not cause&#xD;
          body damage or deformity. Fatigue affects 90 percent of patients and sleep disorders are&#xD;
          common. Patients diagnosed with fibromyalgia according to the American College of&#xD;
          Rheumatology (ACR) criteria will be included in this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Both genders with age of 18 years and above&#xD;
  &#xD;
            -  Diagnosed and referred patients of fibromyalgia according to the American College of&#xD;
               Rheumatology (ACR) criteria.&#xD;
  &#xD;
            -  The ability to provide informed consent and wiling to participate in the study.&#xD;
  &#xD;
            -  Fluency in the study language (i.e. Urdu in this case).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any other chronic pain condition that could affect fatigue and sleep.&#xD;
  &#xD;
            -  Diagnosed sleep disorder (such as sleep apnea or insomnia) that could affect the&#xD;
               results.&#xD;
  &#xD;
            -  History of a psychiatric disorder that could affect the results.&#xD;
  &#xD;
            -  History of substance abuse.&#xD;
  &#xD;
            -  Participation in any other study that could affect the results at the time of&#xD;
               recruitment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Memona Khan, MSPT MSK*</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Lahore</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hafiza Sana Ashraf, MSPT MSK</last_name>
      <role>Study Director</role>
      <affiliation>The University of Lahore</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ashfaq Ahmad, PhD</last_name>
      <phone>03009449192</phone>
      <email>dean@ahs.uol.edu.pk</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Lahore Teaching Hospital</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <zip>55150</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dr. Asim Arif, PhD PT*</last_name>
        <phone>+923216597727</phone>
        <email>asim.asrif@uipt.uol.edu.pk</email>
      </contact>
      <investigator>
        <last_name>Memona Khan, MSPT MSK*</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hafiza Sana Ashraf, MSPT MSK</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Fatigue Severity Scale</keyword>
    <keyword>Translation</keyword>
    <keyword>Psychometric Properties</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</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031207
  org study id: REC-UOL-492-08-2023
  nct id: NCT06031207
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study will employ a Cross-Sectional Validation Study design. The study will be conducted
        at the Department of Physical Therapy, University of Lahore Teaching Hospital, located on
        Defence Road, Lahore.
  
        The anticipated duration of the study will be 09 months, commencing after the approval of the
        synopsis.
  
        The sample size will be determined following the Kline Method, resulting in a total of 90
        participants.
  
        A Purposive Sampling Technique will be utilized to select the study participants.
  Study Type: Cross-Sectional Validation Study Location: Department of Physical Therapy,
        University of Lahore Teaching Hospital, Defence Road, Lahore Duration: 06 months
        (post-synopsis approval) Sample Size: 90 participants Sampling Technique: Purposive Sampling
        Consent and Ethics: Participants will provide written informed consent. Ethics approval will
        be obtained from the University of Lahore Ethics Committee.
  
        Translation of FSS:
  
        The Fatigue Severity Scale (FSS) will be translated into Urdu for data collection.
  
        Two independent bilingual translators will create reports on translation difficulties and
        rationale.
  
        These reports will inform a consensus meeting to develop a unified Urdu version, with
        comments documented.
  
        The unified version will be backtranslated into English by native English-speaking
        translators unaware of the questionnaire's concept.
  
        Expert Committee:
  
        An expert committee comprising physical therapists, linguists, and a methodologist will
        review both language versions.
  
        The goal is to ensure semantic, idiomatic, experiential, and conceptual equivalence and reach
        consensus on the final Urdu version of the FSS.
  
        Patient Involvement:
  
        The final Urdu FSS version will be administered to 20 fibromyalgia patients. These patients
        will also be interviewed to assess their understanding of questionnaire items.
  
        Participants will receive additional information about fibromyalgia to prevent confusion.
  
        Data Collection:
  
        Data will be collected from 100 fibromyalgia patients using the final Urdu FSS version.
  
        A retest will be conducted after 48 hours.
  
        Additional Assessment:
  
        All 90 participants will complete the Multidimensional Fatigue Inventory (MFI).
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Fatigue Severity Scale
  time frame: 1 week
  description: The Fatigue Severity Scale (FSS) is a self-reported measure of fatigue and sleep disturbance in patients with fibromyalgia. It is a 9-item scale that assesses the severity of fatigue, the impact of fatigue on daily activities, and the degree of sleep disturbance. The FSS is a widely used instrument in research and clinical practice, and has been found to be a valid and reliable measure of fatigue and sleep disturbance in patients with fibromyalgia. The FSS items are rated on a 5-point Likert scale, with responses ranging from "not at all" to "extremely." The total score ranges from 0 to 36, with higher scores indicating greater levels of fatigue and sleep disturbance.
  measure: Multidimensional Fatigue Inventory
  time frame: 1 week
  description: The Multidimensional Fatigue Inventory (MFI) is a self-report questionnaire designed to assess various dimensions of fatigue experienced by individuals. It is commonly used in research and clinical settings to measure and understand fatigue in different contexts. Respondents answer a series of questions related to each dimension on a Likert-type scale, typically ranging from 1 to 5 or 0 to 4. The scores from each dimension are summed to obtain subscale scores, and a total score is often calculated by summing all subscale scores. Higher scores indicate greater levels of fatigue.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Memona Khan, MSPT MSK*
  role: Principal Investigator
  affiliation: The University of Lahore
  last name: Hafiza Sana Ashraf, MSPT MSK
  role: Study Director
  affiliation: The University of Lahore
  last name: Ashfaq Ahmad, PhD
  phone: 03009449192
  email: dean@ahs.uol.edu.pk
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Fibromyalgia
  mesh term: Myofascial Pain Syndromes
  mesh term: Fatigue