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/NCT05983055</url>
    </required_header>
    <id_info>
      <org_study_id>SalemAn2018 SCD arthro injectn</org_study_id>
      <nct_id>NCT05983055</nct_id>
    </id_info>
    <brief_title>Steroid Injection for Sickle Cell Arthropathy Pain Therapy</brief_title>
    <official_title>Suitability of Periarticular Steroid Injections for Sickle Cell Arthropathy Pain Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Salem Anaesthesia Pain Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Salem Anaesthesia Pain Clinic</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>
        Sickle cell disease (SCD) is associated with arthropathy. Arthropathy may require&#xD;
        periarticular corticosteroid injection therapy. This observational study examines efficacy,&#xD;
        and safety of steroid injections in SCD patients. Data collection includes patient's gender,&#xD;
        age, race, smoking history, alcohol intake, analgesic use, pain score, sleep quality, limb&#xD;
        joint injections, post-injection analgesia, and post-injection complication. Pain is measured&#xD;
        using numeric pain scale. Sleep quality is measured using Likert scale.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sickle cell disease (SCD) is associated with arthropathy. Arthropathy causes pain which may&#xD;
        require periarticular corticosteroid injection therapy. There is inadequate data about the&#xD;
        suitability of steroid therapy in SCD patients. This prospective observational study examines&#xD;
        the efficacy, and safety of periarticular steroid injections in SCD patients.&#xD;
  &#xD;
        This is a cohort study of adult patients undergoing pain management at a pain clinic in&#xD;
        Canada. Data collection includes patient's gender, age, race, smoking history, alcohol&#xD;
        intake, analgesic usage, numeric pain score, sleep quality score, limb joint injections,&#xD;
        post-injection analgesia, and post-injection complication. Pain is measured using numeric&#xD;
        pain rating scale. Sleep quality is measured using the Likert Sleep scale. A change in the&#xD;
        pain or sleep scores by 2-points is considered significant. Data are analyzed with IBM® SPSS®&#xD;
        Statistics 25; using Student's t-test, ANOVA, Pearson Chi-square test, and regression&#xD;
        analysis. P-value &lt;0.05 is considered significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 30, 2018</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Numeric pain score, objective measurement using validated Numeric Pain Rating scale</measure>
      <time_frame>12 weeks</time_frame>
      <description>Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sleep quality score, objective measurement using validated Likert sleep scale</measure>
      <time_frame>12 weeks</time_frame>
      <description>Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep</description>
    </secondary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Sickle Cell Disease</condition>
    <condition>Sickle Cell Abnormality</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexamethasone 20mg</intervention_name>
      <description>Periarticular dexamethasone injection</description>
      <other_name>Dexamethasone injection</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          A cohort of consecutive adult patients who underwent pain management at a pain clinic&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adult chronic pain patients&#xD;
  &#xD;
            -  sickle cell disease arthropathy&#xD;
  &#xD;
            -  periarticular steroid injection therapy&#xD;
  &#xD;
            -  regular sleep diary&#xD;
  &#xD;
            -  regular pain diary&#xD;
  &#xD;
            -  informed consent for therapy and diary review&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pediatric patients&#xD;
  &#xD;
            -  patient without sickle cell disease arthropathy&#xD;
  &#xD;
            -  patient without periarticular steroid injection&#xD;
  &#xD;
            -  irregular sleep diary&#xD;
  &#xD;
            -  irregular pain diary&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Olumuyiwa Bamgbade, MD,FRCPC</last_name>
      <role>Principal Investigator</role>
      <affiliation>Salem Anaesthesia Pain Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Olumuyiwa Bamgbade, MD,FRCPC</last_name>
      <phone>17786286600</phone>
      <email>salem.painclinic@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Olu Bamgbade, MD,FRCPC</last_name>
      <phone>17786286600</phone>
      <email>salem.painclinic@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Salem Anaesthesia Pain Clinic</name>
        <address>
          <city>Surrey</city>
          <state>British Columbia</state>
          <zip>V3S 7J1</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Olumuyiwa Bamgbade, MD, FRCPC</last_name>
        <phone>+17786286600</phone>
        <email>salem.painclinic@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Sickle cell</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Joint Diseases</mesh_term>
      <mesh_term>Anemia, Sickle Cell</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexamethasone</mesh_term>
      <mesh_term>Dexamethasone acetate</mesh_term>
      <mesh_term>BB 1101</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05983055
  org study id: SalemAn2018 SCD arthro injectn
  nct id: NCT05983055
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Sickle cell disease (SCD) is associated with arthropathy. Arthropathy may require
        periarticular corticosteroid injection therapy. This observational study examines efficacy,
        and safety of steroid injections in SCD patients. Data collection includes patient's gender,
        age, race, smoking history, alcohol intake, analgesic use, pain score, sleep quality, limb
        joint injections, post-injection analgesia, and post-injection complication. Pain is measured
        using numeric pain scale. Sleep quality is measured using Likert scale.
  Sickle cell disease (SCD) is associated with arthropathy. Arthropathy causes pain which may
        require periarticular corticosteroid injection therapy. There is inadequate data about the
        suitability of steroid therapy in SCD patients. This prospective observational study examines
        the efficacy, and safety of periarticular steroid injections in SCD patients.
  
        This is a cohort study of adult patients undergoing pain management at a pain clinic in
        Canada. Data collection includes patient's gender, age, race, smoking history, alcohol
        intake, analgesic usage, numeric pain score, sleep quality score, limb joint injections,
        post-injection analgesia, and post-injection complication. Pain is measured using numeric
        pain rating scale. Sleep quality is measured using the Likert Sleep scale. A change in the
        pain or sleep scores by 2-points is considered significant. Data are analyzed with IBM® SPSS®
        Statistics 25; using Student's t-test, ANOVA, Pearson Chi-square test, and regression
        analysis. P-value <0.05 is considered significant.
  observational model: Cohort
  time perspective: Prospective
  measure: Numeric pain score, objective measurement using validated Numeric Pain Rating scale
  time frame: 12 weeks
  description: Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain
  measure: Sleep quality score, objective measurement using validated Likert sleep scale
  time frame: 12 weeks
  description: Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep
  intervention type: Drug
  intervention name: Dexamethasone 20mg
  description: Periarticular dexamethasone injection
  other name: Dexamethasone injection
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 99 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Olumuyiwa Bamgbade, MD,FRCPC
  role: Principal Investigator
  affiliation: Salem Anaesthesia Pain Clinic
  last name: Olumuyiwa Bamgbade, MD,FRCPC
  phone: 17786286600
  email: salem.painclinic@gmail.com
  last name: Olu Bamgbade, MD,FRCPC
  phone: 17786286600
  email: salem.painclinic@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Joint Diseases
  mesh term: Anemia, Sickle Cell
  mesh term: Dexamethasone
  mesh term: Dexamethasone acetate
  mesh term: BB 1101
  sharing ipd: No