<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/NCT03779919</url>
  </required_header>
  <id_info>
    <org_study_id>CMMC10709-004</org_study_id>
    <nct_id>NCT03779919</nct_id>
  </id_info>
  <brief_title>The Therapeutic Effect of the Extracorporeal Shock Wave Therapy on Shoulder Calcific Tendinitis</brief_title>
  <official_title>The Therapeutic Effect of the Extracorporeal Shock Wave Therapy on Shoulder Calcific Tendinitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chimei Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chimei Medical Center</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>
      Calcific tendinopathy of the shoulder is often self-limited with a relatively benign clinical&#xD;
      course. Therefore, first-line therapy should be conservative and focused on symptom relief.&#xD;
      However, studies show patients with Large volume deposits (e.g. ≥1500 mm3) and Subacromial&#xD;
      extension of the deposits respond poorly to initial treatment such as analgesic medication,&#xD;
      glucocorticoid injection, and physical therapy. For those refractory cases, extracorporeal&#xD;
      shock wave therapy is introduced and shows resolution of symptoms and improvement in shoulder&#xD;
      function in approximately 70 percent of patients.&#xD;
&#xD;
      Extracorporeal shock wave therapy uses acoustic waves to fragment calcific deposits.&#xD;
      Variables of the settings include dose (low or high energy), duration (impulses), and the&#xD;
      interval of administration. However, an optimum value for the total cumulative dose of energy&#xD;
      that should be administered has not yet been defined. Our study thus aim to find out the&#xD;
      dosage effect of ESWT on the calcific debris sizes, pain, daily living functions, and&#xD;
      shoulder range of motions in the calcific tendinitis patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Calcific tendinopathy of the shoulder is caused by unknown etiology characterized by the&#xD;
      formation of calcific deposits in on or several tendons of the rotator cuff muscles:&#xD;
      supraspinatus, infraspinatus, teres minor, and subscapularis muscles. The calcific deposits&#xD;
      is often composed of poorly crystallized hydroxyapatite, an inorganic component of bone&#xD;
      tissue, but the pathogenesis of rotator cuff disorders is still incomplete.&#xD;
&#xD;
      The clinical presentations of calcific tendinopathy typically involve shoulder pain similar&#xD;
      to that experienced by patients with rotator cuff tendinopathy or shoulder impingement&#xD;
      syndrome. Pain is the cardinal symptom and is localized on the top or lateral aspect of the&#xD;
      shoulder or both, often with radiation towards the insertion of the deltoid. The onset of&#xD;
      pain is gradual and unassociated with trauma. Daily activities involving overhead motions,&#xD;
      such as putting on a shirt or brushing hair, can be painful, thus decreasing quality of life&#xD;
      immensely.&#xD;
&#xD;
      Calcific tendinopathy of the shoulder is often self-limited with a relatively benign clinical&#xD;
      course. Therefore, first-line therapy should be conservative and focused on symptom relief.&#xD;
      However, some remain ineffective to the initial treatment. For those refractory cases,&#xD;
      extracorporeal shock wave therapy (ESWT) is introduced and shows resolution of symptoms and&#xD;
      improvement in shoulder function in approximately 70 percent of patients.&#xD;
&#xD;
      ESWT uses acoustic waves to fragment calcific deposits. Variables of the settings include&#xD;
      dose (low or high energy), duration (impulses), and the interval of administration. However,&#xD;
      an optimum value for the total cumulative dose of energy that should be administered has not&#xD;
      yet been defined. Our study thus aim to find out the dosage effect of ESWT on the calcific&#xD;
      debris sizes, pain, daily living functions, and shoulder range of motions in the calcific&#xD;
      tendinitis patients.&#xD;
&#xD;
      The study will be a prospective assessor-blinded randomized controlled trial. Patients who&#xD;
      have calcific tendinitis diagnosed by shoulder sonography or X-ray, fail to improve despite&#xD;
      appropriate conservative treatment for three months will be recruited. The subjects will be&#xD;
      randomized distributed in 3 groups: High Energy, Low Energy, and Sham groups, and each group&#xD;
      has 30 patients.&#xD;
&#xD;
      Upon completion of the study, the result will show whether different dosage of ESWT has&#xD;
      different therapeutic effects on shoulder calcific tendinitis. In the future, the study may&#xD;
      be the foundation of the ESWT treatment guideline for rotator calcific tendinitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 18, 2018</start_date>
  <completion_date type="Anticipated">May 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2020</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes from baseline in the calcium deposits</measure>
    <time_frame>one month and 3 months after shock wave</time_frame>
    <description>Calcium deposits will be measured via X-ray or sonography.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>functional score</measure>
    <time_frame>one month and 3 months after shock wave</time_frame>
    <description>The 100-point Constant score will be used to provide an overall clinical assessment of the shoulder with respect to the degree of pain, the patient's ability to perform normal tasks of daily living (maximal score, 35), and the active range of motion and power of the shoulder, or torque (maximal score, 65)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain score</measure>
    <time_frame>one month and 3 months after shock wave</time_frame>
    <description>The severity of pain at night and during the day, both on movement and at rest, is assessed by means of a visual-analogue scale that ranges from 0 (no pain) to 10 (severe pain).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Calcific Tendinitis</condition>
  <arm_group>
    <arm_group_label>High Energy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Extracorporeal shock wave therapy with 0.3 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Energy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Extracorporeal shock wave therapy with 0.05 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Extracorporeal shock wave therapy with 0 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>extracorporeal shock wave</intervention_name>
    <description>Extracorporeal shock wave therapy uses acoustic waves to fragment calcific deposits. Variables of the settings include dose (low or high energy), duration (impulses), and the interval of administration.</description>
    <arm_group_label>High Energy</arm_group_label>
    <arm_group_label>Low Energy</arm_group_label>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ．age 20-70 with calcific tendinitis via sonography or x-ray in rotator cuff&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        ．no shoulder fracture, no abnormality, gout or autoimmune disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hsin-Han Cheng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ChiMei Medical Center, Taiwan, R.O.C.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yi-Ming Lo, MD</last_name>
    <phone>+886-6-2612611</phone>
    <phone_ext>55000</phone_ext>
    <email>loyiming@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hsin-Han Cheng, MD</last_name>
    <phone>+886926722119</phone>
    <email>a11010147@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>ChiMei Medical Center</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</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>Tendinopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03779919
org study id: CMMC10709-004
nct id: NCT03779919
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Calcific tendinopathy of the shoulder is often self-limited with a relatively benign clinical
      course. Therefore, first-line therapy should be conservative and focused on symptom relief.
      However, studies show patients with Large volume deposits (e.g. ≥1500 mm3) and Subacromial
      extension of the deposits respond poorly to initial treatment such as analgesic medication,
      glucocorticoid injection, and physical therapy. For those refractory cases, extracorporeal
      shock wave therapy is introduced and shows resolution of symptoms and improvement in shoulder
      function in approximately 70 percent of patients.

      Extracorporeal shock wave therapy uses acoustic waves to fragment calcific deposits.
      Variables of the settings include dose (low or high energy), duration (impulses), and the
      interval of administration. However, an optimum value for the total cumulative dose of energy
      that should be administered has not yet been defined. Our study thus aim to find out the
      dosage effect of ESWT on the calcific debris sizes, pain, daily living functions, and
      shoulder range of motions in the calcific tendinitis patients.
Calcific tendinopathy of the shoulder is caused by unknown etiology characterized by the
      formation of calcific deposits in on or several tendons of the rotator cuff muscles:
      supraspinatus, infraspinatus, teres minor, and subscapularis muscles. The calcific deposits
      is often composed of poorly crystallized hydroxyapatite, an inorganic component of bone
      tissue, but the pathogenesis of rotator cuff disorders is still incomplete.

      The clinical presentations of calcific tendinopathy typically involve shoulder pain similar
      to that experienced by patients with rotator cuff tendinopathy or shoulder impingement
      syndrome. Pain is the cardinal symptom and is localized on the top or lateral aspect of the
      shoulder or both, often with radiation towards the insertion of the deltoid. The onset of
      pain is gradual and unassociated with trauma. Daily activities involving overhead motions,
      such as putting on a shirt or brushing hair, can be painful, thus decreasing quality of life
      immensely.

      Calcific tendinopathy of the shoulder is often self-limited with a relatively benign clinical
      course. Therefore, first-line therapy should be conservative and focused on symptom relief.
      However, some remain ineffective to the initial treatment. For those refractory cases,
      extracorporeal shock wave therapy (ESWT) is introduced and shows resolution of symptoms and
      improvement in shoulder function in approximately 70 percent of patients.

      ESWT uses acoustic waves to fragment calcific deposits. Variables of the settings include
      dose (low or high energy), duration (impulses), and the interval of administration. However,
      an optimum value for the total cumulative dose of energy that should be administered has not
      yet been defined. Our study thus aim to find out the dosage effect of ESWT on the calcific
      debris sizes, pain, daily living functions, and shoulder range of motions in the calcific
      tendinitis patients.

      The study will be a prospective assessor-blinded randomized controlled trial. Patients who
      have calcific tendinitis diagnosed by shoulder sonography or X-ray, fail to improve despite
      appropriate conservative treatment for three months will be recruited. The subjects will be
      randomized distributed in 3 groups: High Energy, Low Energy, and Sham groups, and each group
      has 30 patients.

      Upon completion of the study, the result will show whether different dosage of ESWT has
      different therapeutic effects on shoulder calcific tendinitis. In the future, the study may
      be the foundation of the ESWT treatment guideline for rotator calcific tendinitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: changes from baseline in the calcium deposits
time frame: one month and 3 months after shock wave
description: Calcium deposits will be measured via X-ray or sonography.
measure: functional score
time frame: one month and 3 months after shock wave
description: The 100-point Constant score will be used to provide an overall clinical assessment of the shoulder with respect to the degree of pain, the patient's ability to perform normal tasks of daily living (maximal score, 35), and the active range of motion and power of the shoulder, or torque (maximal score, 65)
measure: pain score
time frame: one month and 3 months after shock wave
description: The severity of pain at night and during the day, both on movement and at rest, is assessed by means of a visual-analogue scale that ranges from 0 (no pain) to 10 (severe pain).
arm group label: High Energy
arm group type: Experimental
description: Extracorporeal shock wave therapy with 0.3 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.
arm group label: Low Energy
arm group type: Experimental
description: Extracorporeal shock wave therapy with 0.05 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.
arm group label: Sham
arm group type: Placebo Comparator
description: Extracorporeal shock wave therapy with 0 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.
intervention type: Device
intervention name: extracorporeal shock wave
description: Extracorporeal shock wave therapy uses acoustic waves to fragment calcific deposits. Variables of the settings include dose (low or high energy), duration (impulses), and the interval of administration.
arm group label: High Energy
arm group label: Low Energy
arm group label: Sham
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Hsin-Han Cheng, MD
role: Principal Investigator
affiliation: ChiMei Medical Center, Taiwan, R.O.C.
last name: Yi-Ming Lo, MD
phone: +886-6-2612611
phone ext: 55000
email: loyiming@gmail.com
last name: Hsin-Han Cheng, MD
phone: +886926722119
email: a11010147@gmail.com
facility: 
status: Recruiting
country: Taiwan
responsible party type: Sponsor
mesh term: Tendinopathy
sharing ipd: No