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/NCT05977985</url>
    </required_header>
    <id_info>
      <org_study_id>2023630-12612</org_study_id>
      <nct_id>NCT05977985</nct_id>
    </id_info>
    <brief_title>The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis.</brief_title>
    <official_title>The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis. A Two-arm Double-blind Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Malaya</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Malaya</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>
        Adhesive capsulitis (AC) is a significant cause of chronic shoulder pain and disability.&#xD;
        Non-surgical option consisting of intraarticular corticosteroid (IA CS) injection with&#xD;
        structured physiotherapy (PT) is the current standard of care. More recent randomized&#xD;
        controlled trials have found that rotator interval (RI) hydro-dissection approach leads to&#xD;
        better improvement in pain as compared to IA approach. Despite being non-inferior to surgical&#xD;
        management, long-term outcome studies of patients treated with IA CS injection and PT have&#xD;
        shown that patients only achieve satisfactory outcomes in 72.3% of patients after a mean&#xD;
        symptom duration of 41.8 months. Furthermore, CS injections are associated with significant&#xD;
        systemic and local adverse effects such as Cushing syndrome, osteopenia/ osteoporosis,&#xD;
        infection, and hyperglycemia. In recent years, dextrose injection has emerged as an effective&#xD;
        alternative to CS-based injections to treat chronic painful musculoskeletal conditions such&#xD;
        as chronic low back pain, peripheral nerve entrapment and lateral epicondylitis.&#xD;
  &#xD;
        The investigators aim to study the effects of RI hydro-dissection with dextrose 5% (D5%) on&#xD;
        pain relief, shoulder ROM and shoulder function in patients with primary AC.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</primary_completion_date>
    <phase>Phase 4</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Shoulder pain</measure>
      <time_frame>1 week, 4 weeks and 12 weeks post injection</time_frame>
      <description>Shoulder pain based on Shoulder Pain and Disability Index (SPADI) pain scale. The SPADI pain scale ranges from 0 to 50, with higher score indicating greater level of pain.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Shoulder range of motion</measure>
      <time_frame>4 weeks and 12 weeks post injection</time_frame>
      <description>Shoulder range of motion in flexion, abduction, external rotation, internal rotation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Shoulder function</measure>
      <time_frame>4 weeks and 12 weeks post injection</time_frame>
      <description>Shoulder function based on Shoulder Pain and Disability Index (SPADI) disability scale. The SPADI disability scale ranges from 0 to 80, with higher score indicating greater level of disability.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Adverse events</measure>
      <time_frame>from time to injection up till 1 week post injection</time_frame>
      <description>Adverse events during or after injection</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Adhesive Capsulitis of Shoulder</condition>
    <arm_group>
      <arm_group_label>Dextrose 5%</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Rotator interval hydro-dissection with dextrose 5% solution</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Corticosteroid</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Rotator interval hydro-dissection with corticosteroid solution</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Rotator interval hydro-dissection with dextrose 5%</intervention_name>
      <description>Single injection of 20ml dextrose 5% into the rotator interval around the long head biceps tendon under ultrasound guidance using a 11-14 Hz frequency linear probe</description>
      <arm_group_label>Dextrose 5%</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Rotator interval hydro-dissection with corticosteroid solution</intervention_name>
      <description>Single injection of 20ml corticosteroid solution (1 ml triamcinolone 40 mg/ml + 19 ml saline 0.9%) into the rotator interval around the long head biceps tendon under ultrasound guidance using a 11-14 Hz frequency linear probe</description>
      <arm_group_label>Corticosteroid</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with primary adhesive capsulitis&#xD;
  &#xD;
            -  aged 35 to 65 years of age&#xD;
  &#xD;
            -  duration of symptoms in between 3 to 18 months&#xD;
  &#xD;
            -  limitation in flexion, abduction, and external rotation greater than 30 degrees&#xD;
               compared to normal&#xD;
  &#xD;
            -  limitation in internal rotation with hand to back shoulder test below L4&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  diagnosis of connective tissue disease or inflammatory arthritis&#xD;
  &#xD;
            -  history of surgery to the affected shoulder&#xD;
  &#xD;
            -  history of shoulder dislocation/ fracture&#xD;
  &#xD;
            -  neurological weakness of the affected upper limb&#xD;
  &#xD;
            -  ultrasound findings of rotator cuff or LHBT tendinopathy&#xD;
  &#xD;
            -  plain radiographs showing significant glenohumeral joint osteoarthritis&#xD;
               (Kallgren-Lawrence grade 3 or 4)&#xD;
  &#xD;
            -  other sources of chronic pain&#xD;
  &#xD;
            -  bilateral adhesive capsulitis&#xD;
  &#xD;
            -  history of pain intervention to the shoulder joint in the past 3 months&#xD;
  &#xD;
            -  allergic reaction to local anesthetic agent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Richard Teo</last_name>
      <email>richardskteo@ummc.edu.my</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bursitis</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/NCT05977985
  org study id: 2023630-12612
  nct id: NCT05977985
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Adhesive capsulitis (AC) is a significant cause of chronic shoulder pain and disability.
        Non-surgical option consisting of intraarticular corticosteroid (IA CS) injection with
        structured physiotherapy (PT) is the current standard of care. More recent randomized
        controlled trials have found that rotator interval (RI) hydro-dissection approach leads to
        better improvement in pain as compared to IA approach. Despite being non-inferior to surgical
        management, long-term outcome studies of patients treated with IA CS injection and PT have
        shown that patients only achieve satisfactory outcomes in 72.3% of patients after a mean
        symptom duration of 41.8 months. Furthermore, CS injections are associated with significant
        systemic and local adverse effects such as Cushing syndrome, osteopenia/ osteoporosis,
        infection, and hyperglycemia. In recent years, dextrose injection has emerged as an effective
        alternative to CS-based injections to treat chronic painful musculoskeletal conditions such
        as chronic low back pain, peripheral nerve entrapment and lateral epicondylitis.
  
        The investigators aim to study the effects of RI hydro-dissection with dextrose 5% (D5%) on
        pain relief, shoulder ROM and shoulder function in patients with primary AC.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Shoulder pain
  time frame: 1 week, 4 weeks and 12 weeks post injection
  description: Shoulder pain based on Shoulder Pain and Disability Index (SPADI) pain scale. The SPADI pain scale ranges from 0 to 50, with higher score indicating greater level of pain.
  measure: Shoulder range of motion
  time frame: 4 weeks and 12 weeks post injection
  description: Shoulder range of motion in flexion, abduction, external rotation, internal rotation
  measure: Shoulder function
  time frame: 4 weeks and 12 weeks post injection
  description: Shoulder function based on Shoulder Pain and Disability Index (SPADI) disability scale. The SPADI disability scale ranges from 0 to 80, with higher score indicating greater level of disability.
  measure: Adverse events
  time frame: from time to injection up till 1 week post injection
  description: Adverse events during or after injection
  arm group label: Dextrose 5%
  arm group type: Experimental
  description: Rotator interval hydro-dissection with dextrose 5% solution
  arm group label: Corticosteroid
  arm group type: Active Comparator
  description: Rotator interval hydro-dissection with corticosteroid solution
  intervention type: Drug
  intervention name: Rotator interval hydro-dissection with dextrose 5%
  description: Single injection of 20ml dextrose 5% into the rotator interval around the long head biceps tendon under ultrasound guidance using a 11-14 Hz frequency linear probe
  arm group label: Dextrose 5%
  intervention type: Drug
  intervention name: Rotator interval hydro-dissection with corticosteroid solution
  description: Single injection of 20ml corticosteroid solution (1 ml triamcinolone 40 mg/ml + 19 ml saline 0.9%) into the rotator interval around the long head biceps tendon under ultrasound guidance using a 11-14 Hz frequency linear probe
  arm group label: Corticosteroid
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Richard Teo
  email: richardskteo@ummc.edu.my
  responsible party type: Sponsor
  mesh term: Bursitis