<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/NCT04411498</url>
  </required_header>
  <id_info>
    <org_study_id>2019-041</org_study_id>
    <nct_id>NCT04411498</nct_id>
  </id_info>
  <brief_title>Effects of Fibromyalgia Syndrome in Patients With Systemic Sclerosis</brief_title>
  <official_title>Effects of Fibromyalgia Syndrome in Patients With Diffuse Systemic Sclerosis: Evaluation With 2010 ACR Criteria Set</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Antalya Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Antalya 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>
      Systemic sclerosis [SSc]; is a multisystem disease characterized by immune activation,&#xD;
      microvascular disease and fibroblast dysfunction, which is thought to occur as a result of&#xD;
      complex and not fully understood interaction between genetic and environmental factors,&#xD;
      leading to fibrotic changes in the skin and some internal organs. It is characterized by the&#xD;
      deposition of collagen and other matrix components in the skin and some internal organs. It&#xD;
      has been shown by evaluating the health assessment questionnaire that it causes disability&#xD;
      with increasing frequency over time.&#xD;
&#xD;
      Although pain cannot be localized too well to be attributed to a particular anatomical area,&#xD;
      there are several musculoskeletal pain syndromes that can be detected in patients with&#xD;
      systemic sclerosis. These are tendonitis, polyarthritis, rheumatoid arthritis, bursitis and&#xD;
      fibromyalgia. While there are several studies on others, the relationship between&#xD;
      fibromyalgia syndrome and SSc is not known clearly. As with other connective tissue diseases,&#xD;
      fibromyalgia is not considered to be rare in SSc.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are a few studies on this subject. Except for one of these studies, the sensitive point&#xD;
      in ACR 1990 FMS diagnostic criteria set was evaluated. In 2010, ACR published new criteria,&#xD;
      which may be an alternative method in clinical practice, without sensitive points, including&#xD;
      the common pain index and symptom severity scale. It is evaluated with the common pain index&#xD;
      and symptom severity scale. This new set of criteria alone is not affected by pain, it is&#xD;
      based on patient reporting. Therefore, it seems clinically more significant in determining&#xD;
      the origin of pain in autoimmune diseases. There was only one study in the literature in&#xD;
      which SSc patients are evaluated with the 2010 FMS criteria set . Therefore, the aim of our&#xD;
      study was to evaluate the frequency of FMS according to 2010 FMS criteria and to investigate&#xD;
      its effect on quality of life in our study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">December 20, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fibromyalgia Impact Questionnaire</measure>
    <time_frame>1 week</time_frame>
    <description>The Fibromyalgia Impact Questionnaire [FIQR] was used to evaluate patients' functional status, disease progression, and outcomes. The Turkish validity study Sarmer et al. This questionnaire consists of 20 questions that question physical function, work status, depression, anxiety, sleep, pain, stiffness, fatigue and well-being. Item 1 is scored between 0-3. Other items range from 0-10 points.The total score ranges from 0-80. 80 points indicate high effectiveness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck anxiety inventory</measure>
    <time_frame>1 week</time_frame>
    <description>It was developed by Beck et al. in 1988. It is a scale that measures the severity of anxiety symptoms experienced by individuals and is filled by the patient. Questions subjective subjective anxiety and physical symptoms. It consists of 21 items and it is scored between 0 and 3 likert type. The high scores in the scale indicate the severity of the anxiety experienced by the individual. Turkish validity and reliability study was made by Ulusoy et al.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory</measure>
    <time_frame>1 week</time_frame>
    <description>It assesses risk for depression as well as level and changes in severity of depressive symptoms in the patients. This scale was developed by Beck et al. in 1961. BDI is self-reported assessment scale including 21 self-assessment statements which are rated by using 4-points Likert scale. Turkish validity and reliability was proven</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short Form-36</measure>
    <time_frame>1 week</time_frame>
    <description>It is a scale developed to measure the quality of life. Its validity and reliability in Turkish has been made. The SF-36 includes a health transition item and assesses 4 physical healthdomains as well as 4 mental health domains. The SF-36 scales can be summarized into physical component summary [PCS] and mental component summary (MCS)scores. Each SF-36 scale is scored 0-100, a higher score representing better health</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">140</enrollment>
  <condition>Systemic Sclerosis</condition>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Group of Systemic Sclerosis</arm_group_label>
    <description>Patients who were followed-up with the diagnosis of diffuse systemic sclerosis in the Hospital of Rheumatology Clinic were evaluated in terms of inclusion criteria. 44 female patients who met the inclusion criteria were included in the study. All patients were evaluated by a rheumatologist with detailed history and physical examination. Scleroderma patient group was evaluated for the presence of other rheumatic diseases that may accompany.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group of control</arm_group_label>
    <description>The healthy control group (96 female ) was evaluated for rheumatic diseases [undiagnosed connective tissue diseases and additional rheumatological diseases] that may accompany secondary FMS exclusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Fibromyalgia diagnosis in patients with SSc</intervention_name>
    <description>American College of Rheumatology (ACR) FMS diagnostic criteria set:It is evaluated by the common pain index [WPI] and symptom severity (SS) scale [19]. Diffuse pain index [WPI]; It is a scale that can be scored between 0-19 and obtained by indicating the aching regions of the patient during the last 1 week. Right shoulder, left shoulder, right hip [gluteal region], left hip [gluteal region], left chin, right chin, left upper arm, left lower arm, right upper arm, right lower arm, left upper leg, left lower leg, includes right upper leg, right lower leg, chest, neck, abdomen, upper back, lower back. Symptom Severity Scale [SSS]; evaluates weakness, tired awakening and cognitive functions. In addition, muscle pain, weakness, irritable bowel syndrome, memory problems, headache, abdominal pain, numbness, dizziness, insomnia, depression, constipation, irritability, dry mouth etc. It also evaluates somatic symptoms.</description>
    <arm_group_label>Group of Systemic Sclerosis</arm_group_label>
    <arm_group_label>Group of control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Systemic Sclerosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  SSc diagnosis is definitive and diffuse involvement&#xD;
&#xD;
          -  no additional disease known other than scleroderma (Diabetes mellitus, hypertension&#xD;
             etc.)&#xD;
&#xD;
          -  no known additional rheumatic diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To have depression and / or any psychiatric illness&#xD;
&#xD;
          -  To use steroid, antidepressant, antiepileptic, regular NSAID usage.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female patients with systemic sclerosis</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ayse Ayan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Antalya Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ethics Commitee of Antalya Training and Research Hospital</name>
      <address>
        <city>Antalya</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Perrot S, Peixoto M, Dieude P, Hachulla E, Avouac J, Ottaviani S, Allanore Y. Patient phenotypes in fibromyalgia comorbid with systemic sclerosis or rheumatoid arthritis: influence of diagnostic and screening tests. Screening with the FiRST questionnaire, diagnosis with the ACR 1990 and revised ACR 2010 criteria. Clin Exp Rheumatol. 2017 May-Jun;35 Suppl 105(3):35-42. Epub 2017 Feb 8.</citation>
    <PMID>28229811</PMID>
  </results_reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>November 19, 2020</last_update_submitted>
  <last_update_submitted_qc>November 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Antalya Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ayse Ayan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>fibromyalgia</keyword>
  <keyword>systemic sclerosis</keyword>
  <keyword>quality of life</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>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>there is a data (Statistical Package for the Social Sciences-SPSS) to make individual participant data (IPD) available to other researchers.</ipd_description>
  </patient_data>
  <!-- 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/NCT04411498
org study id: 2019-041
nct id: NCT04411498
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Systemic sclerosis [SSc]; is a multisystem disease characterized by immune activation,
      microvascular disease and fibroblast dysfunction, which is thought to occur as a result of
      complex and not fully understood interaction between genetic and environmental factors,
      leading to fibrotic changes in the skin and some internal organs. It is characterized by the
      deposition of collagen and other matrix components in the skin and some internal organs. It
      has been shown by evaluating the health assessment questionnaire that it causes disability
      with increasing frequency over time.

      Although pain cannot be localized too well to be attributed to a particular anatomical area,
      there are several musculoskeletal pain syndromes that can be detected in patients with
      systemic sclerosis. These are tendonitis, polyarthritis, rheumatoid arthritis, bursitis and
      fibromyalgia. While there are several studies on others, the relationship between
      fibromyalgia syndrome and SSc is not known clearly. As with other connective tissue diseases,
      fibromyalgia is not considered to be rare in SSc.
There are a few studies on this subject. Except for one of these studies, the sensitive point
      in ACR 1990 FMS diagnostic criteria set was evaluated. In 2010, ACR published new criteria,
      which may be an alternative method in clinical practice, without sensitive points, including
      the common pain index and symptom severity scale. It is evaluated with the common pain index
      and symptom severity scale. This new set of criteria alone is not affected by pain, it is
      based on patient reporting. Therefore, it seems clinically more significant in determining
      the origin of pain in autoimmune diseases. There was only one study in the literature in
      which SSc patients are evaluated with the 2010 FMS criteria set . Therefore, the aim of our
      study was to evaluate the frequency of FMS according to 2010 FMS criteria and to investigate
      its effect on quality of life in our study.
observational model: Case-Control
time perspective: Prospective
measure: Fibromyalgia Impact Questionnaire
time frame: 1 week
description: The Fibromyalgia Impact Questionnaire [FIQR] was used to evaluate patients' functional status, disease progression, and outcomes. The Turkish validity study Sarmer et al. This questionnaire consists of 20 questions that question physical function, work status, depression, anxiety, sleep, pain, stiffness, fatigue and well-being. Item 1 is scored between 0-3. Other items range from 0-10 points.The total score ranges from 0-80. 80 points indicate high effectiveness.
measure: Beck anxiety inventory
time frame: 1 week
description: It was developed by Beck et al. in 1988. It is a scale that measures the severity of anxiety symptoms experienced by individuals and is filled by the patient. Questions subjective subjective anxiety and physical symptoms. It consists of 21 items and it is scored between 0 and 3 likert type. The high scores in the scale indicate the severity of the anxiety experienced by the individual. Turkish validity and reliability study was made by Ulusoy et al.
measure: Beck Depression Inventory
time frame: 1 week
description: It assesses risk for depression as well as level and changes in severity of depressive symptoms in the patients. This scale was developed by Beck et al. in 1961. BDI is self-reported assessment scale including 21 self-assessment statements which are rated by using 4-points Likert scale. Turkish validity and reliability was proven
measure: Short Form-36
time frame: 1 week
description: It is a scale developed to measure the quality of life. Its validity and reliability in Turkish has been made. The SF-36 includes a health transition item and assesses 4 physical healthdomains as well as 4 mental health domains. The SF-36 scales can be summarized into physical component summary [PCS] and mental component summary (MCS)scores. Each SF-36 scale is scored 0-100, a higher score representing better health
arm group label: Group of Systemic Sclerosis
description: Patients who were followed-up with the diagnosis of diffuse systemic sclerosis in the Hospital of Rheumatology Clinic were evaluated in terms of inclusion criteria. 44 female patients who met the inclusion criteria were included in the study. All patients were evaluated by a rheumatologist with detailed history and physical examination. Scleroderma patient group was evaluated for the presence of other rheumatic diseases that may accompany.
arm group label: Group of control
description: The healthy control group (96 female ) was evaluated for rheumatic diseases [undiagnosed connective tissue diseases and additional rheumatological diseases] that may accompany secondary FMS exclusion.
intervention type: Diagnostic Test
intervention name: Fibromyalgia diagnosis in patients with SSc
description: American College of Rheumatology (ACR) FMS diagnostic criteria set:It is evaluated by the common pain index [WPI] and symptom severity (SS) scale [19]. Diffuse pain index [WPI]; It is a scale that can be scored between 0-19 and obtained by indicating the aching regions of the patient during the last 1 week. Right shoulder, left shoulder, right hip [gluteal region], left hip [gluteal region], left chin, right chin, left upper arm, left lower arm, right upper arm, right lower arm, left upper leg, left lower leg, includes right upper leg, right lower leg, chest, neck, abdomen, upper back, lower back. Symptom Severity Scale [SSS]; evaluates weakness, tired awakening and cognitive functions. In addition, muscle pain, weakness, irritable bowel syndrome, memory problems, headache, abdominal pain, numbness, dizziness, insomnia, depression, constipation, irritability, dry mouth etc. It also evaluates somatic symptoms.
arm group label: Group of Systemic Sclerosis
arm group label: Group of control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Female patients with systemic sclerosis
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ayse Ayan, MD
role: Principal Investigator
affiliation: Antalya Training and Research Hospital
facility: 
country: Turkey
citation: Perrot S, Peixoto M, Dieude P, Hachulla E, Avouac J, Ottaviani S, Allanore Y. Patient phenotypes in fibromyalgia comorbid with systemic sclerosis or rheumatoid arthritis: influence of diagnostic and screening tests. Screening with the FiRST questionnaire, diagnosis with the ACR 1990 and revised ACR 2010 criteria. Clin Exp Rheumatol. 2017 May-Jun;35 Suppl 105(3):35-42. Epub 2017 Feb 8.
PMID: 28229811
responsible party type: Principal Investigator
investigator affiliation: Antalya Training and Research Hospital
investigator full name: Ayse Ayan
investigator title: Principal Investigator
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Sclerosis
sharing ipd: No
ipd description: there is a data (Statistical Package for the Social Sciences-SPSS) to make individual participant data (IPD) available to other researchers.