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/NCT05983081</url>
    </required_header>
    <id_info>
      <org_study_id>TSGH</org_study_id>
      <nct_id>NCT05983081</nct_id>
    </id_info>
    <brief_title>Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis</brief_title>
    <official_title>Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tri-Service General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tri-Service General Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Objective: To evaluate the efficacy of intra-articular hyaluronic acid (HA) injections for&#xD;
        the treatment of adhesive capsulitis (AC) of the shoulder.&#xD;
  &#xD;
        Design: Prospective, case- controlled trial. Setting: Rehabilitation department of a medical&#xD;
        center hospital. Participants: Patients (30) with AC Interventions: The patients received&#xD;
        intra-articular glenohumeral joint injections of HA, 60mg, once per week for 3 consecutive&#xD;
        weeks.&#xD;
  &#xD;
        Main Outcome Measures: Active and passive range of motion (ROM) of the affected shoulder;&#xD;
        Shoulder pain and disability were measured using 2 questionnaires: the SPADI. The patients&#xD;
        were evaluated before treatment and were reevaluated 4, 6, 8, 12 weeks after the beginning of&#xD;
        the treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>group A: intra-articular glenohumeral joint injections with HA, 60mg, once per week for 3 consecutive weeks.&#xD;
  group B: physical therapy</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Shoulder Pain and Disability Index</measure>
      <time_frame>before the treatment, 4 weeks after the treatment, 6 weeks after the treatment, and 8 weeks after the treatment.</time_frame>
      <description>The SPADI consists of two subscales, pain, and disability, comprising a total of 13 items. Each item is rated on a scale from 0 (no pain/disability) to 10 (most severe pain/disability). Higher scores indicate greater functional impairment. The total score on the SPADI is used to determine the percentage of functional disability</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Range of Motion</measure>
      <time_frame>before the treatment, 4 weeks after the treatment, 6 weeks after the treatment, and 8 weeks after the treatment.</time_frame>
      <description>The ROM is assessed using a standardized goniometer in the standard position to measure the angles of shoulder joint movement on the affected side. It includes flexion, extension, abduction, external rotation, and internal rotation.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Adhesive Capsulitis</condition>
    <arm_group>
      <arm_group_label>Injection Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A- Experimental Group: Intra-articular Hyaluronic Acid Injection Treatment Regimen Patients in the experimental group received ultrasound-guided intra-articular injections of hyaluronic acid (Artibest, 60 mg/3 ml, 2%, manufactured by Kang Stem Biotech, Taiwan) into the affected shoulder joint. The injections were administered once a week for three consecutive weeks, totaling three injections per patient. The subjects were evaluated for shoulder function using the Shoulder Pain and Disability Index (SPADI) and Range of Motion (ROM) assessment at the following time points: before the treatment, 4 weeks after the treatment, 6 weeks after the treatment, and 8 weeks after the treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Physical Therapy</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>B- Control Group: Physical Therapy Patients in the control group underwent a 6-week physical therapy program, consisting of two sessions per week, with each session lasting approximately 30 minutes. The physical therapy program was conducted under the guidance and supervision of a physical therapist and included joint exercises, stretching, and muscle strengthening exercises.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Injection Treatment</intervention_name>
      <description>Physical Therapy</description>
      <arm_group_label>Injection Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          A. Patients diagnosed with frozen shoulder by a clinical physician based on the patient's&#xD;
          medical history, physical examination, X-ray, and ultrasound or magnetic resonance imaging&#xD;
          reports.&#xD;
  &#xD;
          B. Clinical course: Patients must have a pain score of less than 3, no nighttime shoulder&#xD;
          pain, and be in the post-freezing stage, primarily presenting restricted shoulder joint&#xD;
          range of motion.&#xD;
  &#xD;
          C. The affected shoulder joint must have at least two angles of shoulder joint movement&#xD;
          reduced by at least 30% compared to the healthy side: shoulder flexion, abduction, and&#xD;
          external rotation, or a single affected side abduction angle reduced by 50% relative to the&#xD;
          healthy side.&#xD;
  &#xD;
          D. Age between 40 to 70 years old.&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          A. full-thickness tear or massive tear of the rotator cuff tendons or calcific tendinitis.&#xD;
  &#xD;
          B. Presence of systemic rheumatic disease. C. History of shoulder fracture or previous&#xD;
          shoulder surgery. D. Received shoulder injections for treatment within the last 3 months.&#xD;
          E. Acute cervical nerve root compression. F. Current pregnancy or lactation. G. Patients&#xD;
          with shoulder instability or cancer. H. Patients with cognitive impairment, unable to&#xD;
          follow simple instructions, or unable to comply with the study procedures.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Tri-Service General Hospital</name>
        <address>
          <city>Taipei</city>
          <state>Alberta</state>
          <zip>114</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>CHIH-YA CHANG, MD</last_name>
        <phone>0287923311</phone>
        <phone_ext>13707</phone_ext>
        <email>gradesboy@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</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 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tri-Service General Hospital</investigator_affiliation>
      <investigator_full_name>Chih-Ya Chang</investigator_full_name>
      <investigator_title>Tri-Service General Hospital</investigator_title>
    </responsible_party>
    <keyword>frozen shoulder</keyword>
    <keyword>hyaluronic acid</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bursitis</mesh_term>
    </condition_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/NCT05983081
  org study id: TSGH
  nct id: NCT05983081
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Objective: To evaluate the efficacy of intra-articular hyaluronic acid (HA) injections for
        the treatment of adhesive capsulitis (AC) of the shoulder.
  
        Design: Prospective, case- controlled trial. Setting: Rehabilitation department of a medical
        center hospital. Participants: Patients (30) with AC Interventions: The patients received
        intra-articular glenohumeral joint injections of HA, 60mg, once per week for 3 consecutive
        weeks.
  
        Main Outcome Measures: Active and passive range of motion (ROM) of the affected shoulder;
        Shoulder pain and disability were measured using 2 questionnaires: the SPADI. The patients
        were evaluated before treatment and were reevaluated 4, 6, 8, 12 weeks after the beginning of
        the treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: group A: intra-articular glenohumeral joint injections with HA, 60mg, once per week for 3 consecutive weeks.
  group B: physical therapy
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Shoulder Pain and Disability Index
  time frame: before the treatment, 4 weeks after the treatment, 6 weeks after the treatment, and 8 weeks after the treatment.
  description: The SPADI consists of two subscales, pain, and disability, comprising a total of 13 items. Each item is rated on a scale from 0 (no pain/disability) to 10 (most severe pain/disability). Higher scores indicate greater functional impairment. The total score on the SPADI is used to determine the percentage of functional disability
  measure: Range of Motion
  time frame: before the treatment, 4 weeks after the treatment, 6 weeks after the treatment, and 8 weeks after the treatment.
  description: The ROM is assessed using a standardized goniometer in the standard position to measure the angles of shoulder joint movement on the affected side. It includes flexion, extension, abduction, external rotation, and internal rotation.
  arm group label: Injection Treatment
  arm group type: Experimental
  description: A- Experimental Group: Intra-articular Hyaluronic Acid Injection Treatment Regimen Patients in the experimental group received ultrasound-guided intra-articular injections of hyaluronic acid (Artibest, 60 mg/3 ml, 2%, manufactured by Kang Stem Biotech, Taiwan) into the affected shoulder joint. The injections were administered once a week for three consecutive weeks, totaling three injections per patient. The subjects were evaluated for shoulder function using the Shoulder Pain and Disability Index (SPADI) and Range of Motion (ROM) assessment at the following time points: before the treatment, 4 weeks after the treatment, 6 weeks after the treatment, and 8 weeks after the treatment.
  arm group label: Physical Therapy
  arm group type: No Intervention
  description: B- Control Group: Physical Therapy Patients in the control group underwent a 6-week physical therapy program, consisting of two sessions per week, with each session lasting approximately 30 minutes. The physical therapy program was conducted under the guidance and supervision of a physical therapist and included joint exercises, stretching, and muscle strengthening exercises.
  intervention type: Procedure
  intervention name: Injection Treatment
  description: Physical Therapy
  arm group label: Injection Treatment
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Principal Investigator
  investigator affiliation: Tri-Service General Hospital
  investigator full name: Chih-Ya Chang
  investigator title: Tri-Service General Hospital
  mesh term: Bursitis
  sharing ipd: No