<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/NCT03013205</url>
  </required_header>
  <id_info>
    <org_study_id>201609026RINB</org_study_id>
    <nct_id>NCT03013205</nct_id>
  </id_info>
  <brief_title>Efficacy of Corticosteroid Injection Into Coracohumeral Ligament in Patients With Adhesive Capsulitis of the Shoulder</brief_title>
  <official_title>Efficacy of Corticosteroid Injection Into Coracohumeral Ligament in Patients With Adhesive Capsulitis of the Shoulder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Steroid injections are widely utilized to reduce inflammation and fibrosis in patients with&#xD;
      the frozen shoulder. In this study, investigators will compare intra-articular steroid&#xD;
      injections with direct coracohumeral ligament steroid injection to conventional&#xD;
      intra-articular steroid injection. Investigators will measure the primary outcome as shoulder&#xD;
      function improvement and secondary outcomes as ROM, pain scale and stiffness of coracohumeral&#xD;
      ligament under elastogram.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adhesive capsulitis of the shoulder, also known as the frozen shoulder, often leads to severe&#xD;
      pain and shoulder range of motion limitation. Steroid injections are widely utilized to&#xD;
      reduce inflammation and fibrosis. The thickening of the coracohumeral ligament was thought to&#xD;
      play an important role in the pathogenesis of frozen shoulder, resulting in limited external&#xD;
      rotation of the shoulder. While the elastogram of coracohumeral ligament will significantly&#xD;
      increase stiffness under the shear-wave ultrasound (shear-wave elastography).&#xD;
&#xD;
      Therefore, in this study, investigators will compare intra-articular steroid injections with&#xD;
      direct coracohumeral ligament steroid injection to conventional intra-articular steroid&#xD;
      injection. Investigators will measure the primary outcome as shoulder function improvement&#xD;
      and secondary outcomes as ROM, pain scale and stiffness of coracohumeral ligament under&#xD;
      elastogram.&#xD;
&#xD;
      (the patient will not have additional risk of injection under ultrasound guidance)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Shoulder function (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash) improvement</measure>
    <time_frame>2 years</time_frame>
    <description>shoulder function improvement (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash), score 0-100</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Visual analogue scale</measure>
    <time_frame>2 years</time_frame>
    <description>Visual analogue scale: scale 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder range of motion improvement</measure>
    <time_frame>2 years</time_frame>
    <description>Range of motion improvement: flexion, abduction, external rotation (degree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stiffness of coracohumeral ligament under elastogram (KPa)</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Direct Coracohumeral Ligament Steroid Injection</condition>
  <arm_group>
    <arm_group_label>PT+IA+CHL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intraarticular triamcinolone injection&#xD;
Intraarticular Xylocaine injection&#xD;
Coracohumeral ligament triamcinolone injection&#xD;
Physiotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PT+IA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intraarticular triamcinolone injection&#xD;
Intraarticular Xylocaine injection&#xD;
Physiotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intraarticular triamcinolone injection</intervention_name>
    <description>triamcinolone 10mg/mL</description>
    <arm_group_label>PT+IA</arm_group_label>
    <arm_group_label>PT+IA+CHL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intraarticular Xylocaine injection</intervention_name>
    <description>Xylocaine 1% 4ml</description>
    <arm_group_label>PT+IA</arm_group_label>
    <arm_group_label>PT+IA+CHL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Coracohumeral ligament triamcinolone injection</intervention_name>
    <description>triamcinolone 10mg/mL</description>
    <arm_group_label>PT+IA+CHL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Physiotherapy</intervention_name>
    <arm_group_label>PT+IA</arm_group_label>
    <arm_group_label>PT+IA+CHL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        A.Inclusion criteria：&#xD;
&#xD;
          1. Age 20-80 years old&#xD;
&#xD;
          2. Unilateral shoulder pain more than 3 months&#xD;
&#xD;
          3. At least one shoulder ROM limitation in three dimensions which decreased over 50%&#xD;
             (Abduction, Flexion, External rotation)&#xD;
&#xD;
          4. Visual analog scale more than 30 (total 100)&#xD;
&#xD;
          5. No fracture or subluxation or arthritis in shoulder Xray.&#xD;
&#xD;
        B.Exclusion criteria：&#xD;
&#xD;
          1. History of shoulder or chest surgery&#xD;
&#xD;
          2. History of shoulder trauma in 2 recent years&#xD;
&#xD;
          3. Ever receiving shoulder joint injection in recent 3 months&#xD;
&#xD;
          4. With cervical radiculopathy or any central CNS disorders&#xD;
&#xD;
          5. With osteoarthritis or rheumatic arthritis of shoulder&#xD;
&#xD;
          6. Diagnosed as rotator cuff tear, tendon calcification or bursitis&#xD;
&#xD;
          7. Systemic diseases including diabetes or thyroid disorder&#xD;
&#xD;
          8. Allergy history of steroid&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chueh-Hung Wu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NTUH PMR</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chueh-Hung Wu</last_name>
    <phone>0972651208</phone>
    <email>nojred@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Test1</city>
        <state>Test2</state>
        <zip>test3</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <contact>
      <last_name>Chueh-Hung Wu, MD</last_name>
      <phone>0972651208</phone>
      <email>nojred@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adhesive capsulitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bursitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Triamcinolone Acetonide</mesh_term>
    <mesh_term>Triamcinolone hexacetonide</mesh_term>
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Triamcinolone diacetate</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03013205
org study id: 201609026RINB
nct id: NCT03013205
lead sponsor: 
has dmc: No
Steroid injections are widely utilized to reduce inflammation and fibrosis in patients with
      the frozen shoulder. In this study, investigators will compare intra-articular steroid
      injections with direct coracohumeral ligament steroid injection to conventional
      intra-articular steroid injection. Investigators will measure the primary outcome as shoulder
      function improvement and secondary outcomes as ROM, pain scale and stiffness of coracohumeral
      ligament under elastogram.
Adhesive capsulitis of the shoulder, also known as the frozen shoulder, often leads to severe
      pain and shoulder range of motion limitation. Steroid injections are widely utilized to
      reduce inflammation and fibrosis. The thickening of the coracohumeral ligament was thought to
      play an important role in the pathogenesis of frozen shoulder, resulting in limited external
      rotation of the shoulder. While the elastogram of coracohumeral ligament will significantly
      increase stiffness under the shear-wave ultrasound (shear-wave elastography).

      Therefore, in this study, investigators will compare intra-articular steroid injections with
      direct coracohumeral ligament steroid injection to conventional intra-articular steroid
      injection. Investigators will measure the primary outcome as shoulder function improvement
      and secondary outcomes as ROM, pain scale and stiffness of coracohumeral ligament under
      elastogram.

      (the patient will not have additional risk of injection under ultrasound guidance)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Shoulder function (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash) improvement
time frame: 2 years
description: shoulder function improvement (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash), score 0-100
measure: Change of Visual analogue scale
time frame: 2 years
description: Visual analogue scale: scale 0-10
measure: Shoulder range of motion improvement
time frame: 2 years
description: Range of motion improvement: flexion, abduction, external rotation (degree)
measure: Stiffness of coracohumeral ligament under elastogram (KPa)
time frame: 2 years
arm group label: PT+IA+CHL
arm group type: Experimental
description: Intraarticular triamcinolone injection
Intraarticular Xylocaine injection
Coracohumeral ligament triamcinolone injection
Physiotherapy
arm group label: PT+IA
arm group type: Active Comparator
description: Intraarticular triamcinolone injection
Intraarticular Xylocaine injection
Physiotherapy
intervention type: Procedure
intervention name: Intraarticular triamcinolone injection
description: triamcinolone 10mg/mL
arm group label: PT+IA
arm group label: PT+IA+CHL
intervention type: Procedure
intervention name: Intraarticular Xylocaine injection
description: Xylocaine 1% 4ml
arm group label: PT+IA
arm group label: PT+IA+CHL
intervention type: Procedure
intervention name: Coracohumeral ligament triamcinolone injection
description: triamcinolone 10mg/mL
arm group label: PT+IA+CHL
intervention type: Procedure
intervention name: Physiotherapy
arm group label: PT+IA
arm group label: PT+IA+CHL
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Chueh-Hung Wu, MD
role: Principal Investigator
affiliation: NTUH PMR
last name: Chueh-Hung Wu
phone: 0972651208
email: nojred@gmail.com
facility: 
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Bursitis
mesh term: Triamcinolone
mesh term: Triamcinolone Acetonide
mesh term: Triamcinolone hexacetonide
mesh term: Lidocaine
mesh term: Triamcinolone diacetate