<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/NCT04461522</url>
  </required_header>
  <id_info>
    <org_study_id>M20191203</org_study_id>
    <nct_id>NCT04461522</nct_id>
  </id_info>
  <brief_title>Study on the Outcome of Treatment of Rotator Cuff Injury by Ultrasound-guided Injection</brief_title>
  <official_title>Prospective Cohort Study on the Outcome of Treatment of Rotator Cuff Injury by Ultrasound-guided</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</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>
      Rotator cuff injury is a common shoulder joint disease in clinic. If conservative treatment&#xD;
      fails to improve pain symptoms and range of motion, the surgical indications are. Numerous&#xD;
      studies have shown that the pain of rotator cuff injury usually comes not from the broken&#xD;
      tendon, but from periarthritis tendonitis, bursitis or adhesive shoulder capsule, etc.&#xD;
      Ultrasound-guided drug injection combined with conventional rehabilitation treatment can&#xD;
      significantly improve the pain symptoms and increase joint mobility. This study intends to&#xD;
      use prospective cohort study methods, exposed factors for ultrasound-guided injection drug&#xD;
      treatment, establish a rotator cuff injury exposure group and the control group of shoulder&#xD;
      joint dysfunction queue, whether of ultrasound guided drug injection therapy can increase the&#xD;
      shoulder joint function analysis, and explore for the rotator cuff injury method provides the&#xD;
      basis of the evidence-based conservative treatment. The establishment of a conservative&#xD;
      treatment cohort for rotator cuff injury will also lay the foundation for the accurate&#xD;
      rehabilitation treatment of rotator cuff injury.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 10, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>Beginning</time_frame>
    <description>VAS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>1 week</time_frame>
    <description>VAS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>1 month</time_frame>
    <description>VAS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>3months</time_frame>
    <description>VAS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>6 months</time_frame>
    <description>VAS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>Beginning</time_frame>
    <description>ROM</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>1 week</time_frame>
    <description>ROM</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>1 month</time_frame>
    <description>ROM</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>3months</time_frame>
    <description>ROM</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>6 months</time_frame>
    <description>ROM</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>Beginning</time_frame>
    <description>Constant Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>1 week</time_frame>
    <description>Constant Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>1 month</time_frame>
    <description>Constant Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>3months</time_frame>
    <description>Constant Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>6 months</time_frame>
    <description>Constant Test</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">134</enrollment>
  <condition>Rotator Cuff Injury</condition>
  <arm_group>
    <arm_group_label>Exposed group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound-guided drug injection</intervention_name>
    <description>The injection drugs were glucocorticoids and anesthetic drugs (1ml+2% lidocaine hydrochloride 0.5ml+0.9% sodium chloride 0.5ml), and the injection sites were subacromion deltoid bursa/coracoid bursa/biceps longhead tenosynosheath/glenohumeral joint bursa, etc.</description>
    <arm_group_label>Exposed group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        He was admitted to the third hospital of Peking University due to the dysfunction of&#xD;
        shoulder joint caused by rotator cuff injury&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chief complaint around shoulder joint discomfort or restricted movement&#xD;
&#xD;
          -  Nuclear magnetic or ultrasound in the diagnosis of rotator cuff injury and not to&#xD;
             consider surgery patients&#xD;
&#xD;
          -  Assessed by the musculoskeletal ultrasound images, diagnosed with tendonitis around&#xD;
             shoulder joint, slippery bursa phlogistic or adhesive shoulder level&#xD;
&#xD;
          -  Section capsule, such as indications of patients treated with ultrasound guided by&#xD;
             injection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of shoulder fractures, open trauma, or surgery combined with shoulder and hand&#xD;
             syndrome, gout, autoimmune arthritis, infectious arthritis, and other factors&#xD;
             resulting in shoulder pain or limited mobility&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mouwang Zhou, Doctor</last_name>
    <phone>13910092892</phone>
    <email>zhoumouwang@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mouwang Zhou, Doctor</last_name>
      <phone>13910092892</phone>
      <email>zhoumouwang@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rotator cuff injury</keyword>
  <keyword>Ultrasound-guided drug injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </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/NCT04461522
org study id: M20191203
nct id: NCT04461522
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Rotator cuff injury is a common shoulder joint disease in clinic. If conservative treatment
      fails to improve pain symptoms and range of motion, the surgical indications are. Numerous
      studies have shown that the pain of rotator cuff injury usually comes not from the broken
      tendon, but from periarthritis tendonitis, bursitis or adhesive shoulder capsule, etc.
      Ultrasound-guided drug injection combined with conventional rehabilitation treatment can
      significantly improve the pain symptoms and increase joint mobility. This study intends to
      use prospective cohort study methods, exposed factors for ultrasound-guided injection drug
      treatment, establish a rotator cuff injury exposure group and the control group of shoulder
      joint dysfunction queue, whether of ultrasound guided drug injection therapy can increase the
      shoulder joint function analysis, and explore for the rotator cuff injury method provides the
      basis of the evidence-based conservative treatment. The establishment of a conservative
      treatment cohort for rotator cuff injury will also lay the foundation for the accurate
      rehabilitation treatment of rotator cuff injury.
observational model: Cohort
time perspective: Prospective
measure: Shoulder function
time frame: Beginning
description: VAS
measure: Shoulder function
time frame: 1 week
description: VAS
measure: Shoulder function
time frame: 1 month
description: VAS
measure: Shoulder function
time frame: 3months
description: VAS
measure: Shoulder function
time frame: 6 months
description: VAS
measure: Shoulder function
time frame: Beginning
description: ROM
measure: Shoulder function
time frame: 1 week
description: ROM
measure: Shoulder function
time frame: 1 month
description: ROM
measure: Shoulder function
time frame: 3months
description: ROM
measure: Shoulder function
time frame: 6 months
description: ROM
measure: Shoulder function
time frame: Beginning
description: Constant Test
measure: Shoulder function
time frame: 1 week
description: Constant Test
measure: Shoulder function
time frame: 1 month
description: Constant Test
measure: Shoulder function
time frame: 3months
description: Constant Test
measure: Shoulder function
time frame: 6 months
description: Constant Test
arm group label: Exposed group
arm group label: Control group
intervention type: Procedure
intervention name: Ultrasound-guided drug injection
description: The injection drugs were glucocorticoids and anesthetic drugs (1ml+2% lidocaine hydrochloride 0.5ml+0.9% sodium chloride 0.5ml), and the injection sites were subacromion deltoid bursa/coracoid bursa/biceps longhead tenosynosheath/glenohumeral joint bursa, etc.
arm group label: Exposed group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mouwang Zhou, Doctor
phone: 13910092892
email: zhoumouwang@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Rotator Cuff Injuries
sharing ipd: Yes