<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/NCT04474145</url>
  </required_header>
  <id_info>
    <org_study_id>20191212R</org_study_id>
    <secondary_id>NSTC 109-2314-B-341-002</secondary_id>
    <secondary_id>NSTC 110-2314-B-341-002</secondary_id>
    <nct_id>NCT04474145</nct_id>
  </id_info>
  <brief_title>The Effect of Combined Hydrodilatation, Corticosteroid Injection, and Joint Mobilization for Treament of Frozen Shoulder</brief_title>
  <official_title>The Effect of Combined Hydrodilatation, Corticosteroid Injection, and Joint Mobilization for Treament of Frozen Shoulder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shin Kong Wu Ho-Su Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Science Council, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shin Kong Wu Ho-Su Memorial 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>
      The effect of combination of hydrodilatation, corticosteroid injection, and joint&#xD;
      mobilization for treatment of frozen shoulder, compared with general physical therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Frozen shoulder (FS) is a common clinical problem which induces pain, loss of passive and&#xD;
      active range of motion (ROM) of glenohumeral joint, and leads to disability, functional&#xD;
      limitation, and decreasing quality of life. FS is usually treated with conservative&#xD;
      treatments, which include medications, physiotherapy, joint mobilization, hydrodilatation,&#xD;
      intra-articular steroid injection, etc.. The short-term effect of each treatment is variable,&#xD;
      and the long-term effect is not established. Clinically combination of each treatment is&#xD;
      common, but types of combination, and the effect of combination is still not well studied. We&#xD;
      aim to combine hydrodilatation (with corticosteroid injection), joint mobilization, and&#xD;
      general physiotherapy to treat frozen shoulder and compare the long-term effect with general&#xD;
      physical therapy alone.&#xD;
&#xD;
      This is a prospective single-blind randomized controlled trial. 70 participants will be&#xD;
      recruited from the outpatient clinic of the department of Physical Medicine and&#xD;
      Rehabilitation of Shin Kong Wu Ho-Su Memorial Hospital and randomly divided into COMB group&#xD;
      and PT group. Each subject in the COMB group will receive 2 times of ultrasound-guided&#xD;
      hydrodilatation injection (10mg triamcilonone, 2cc 1% xylocain, and 17cc normal saline)&#xD;
      through both anterior and posterior shoulder joint in a two-weekly interval. In addition,&#xD;
      joint mobilization and general physiotherapy (stretch exercise and physical modalities) will&#xD;
      also be given, 2 times a week, for 8 weeks. The PT group will receive general physical&#xD;
      therapy, 2 times a week, for 8 weeks. Outcome measures include the Shoulder Pain and&#xD;
      Disability Index (SPADI), the Shoulder Disability Questionnaire (SDQ), and active and passive&#xD;
      range of motion (ROM) of the affected shoulder, the 36-item Short Form Health Survey (SF-36),&#xD;
      and patients' self evaluation. Evaluation will be performed at baseline and at 2, 4, 6 months&#xD;
      after the beginning of the treatment. Statistics will be performed after completing the&#xD;
      patients' treatment and evaluations. We expect that the COMB group will recover sooner and&#xD;
      better than the PT group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">July 31, 2022</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Shoulder Pain and Disability Index（SPADI）</measure>
    <time_frame>change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analog scale（VAS）</measure>
    <time_frame>change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.</time_frame>
    <description>The VAS for pain is obtained using a 100-mm-long horizontal line, with 0 mm on the left, indicating no pain, and 100 mm on the right, indicating very severe pain. The pain at rest is defined as rest pain, and pain on maximal abduction of the affected shoulder is defined as activity pain. The reliability of VAS for pain is 0.94, but in the absence of a criterion standard for pain, criterion validity cannot be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion（ROM）</measure>
    <time_frame>change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.</time_frame>
    <description>All the 4 planes of ROM will be measured. It includes abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0° of abduction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder Disability Questionnaire（SDQ）</measure>
    <time_frame>change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.</time_frame>
    <description>The SDQ is a pain-related questionnaire that contains 16 items describing common situations that may induce symptoms in patients with shoulder disorders. The response options are &quot;yes,&quot; &quot;no,&quot; and &quot;not applicable.&quot; The final score is calculated by dividing the number of positively scored items by the total number of applicable items and then multiplying this number by 100, which results in a final score ranging between 0 (no disability) and 100 (the worst possible condition).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The 36-item Short Form Health Survey（SF-36）</measure>
    <time_frame>change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.</time_frame>
    <description>The SF-36 is a generic measure of quality of life and is composed of 8 subscales related to the following components: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale generates a score from 0 to 100, and higher scores indicate better health.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Frozen Shoulder</condition>
  <condition>Hydrodilatation</condition>
  <condition>Joint Mobilization</condition>
  <condition>Corticosteroid Injection</condition>
  <condition>Physical Therapy</condition>
  <condition>Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Comb group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the Comb group will receive hydrodilatation of the affected shoulder and subdeltoid bursa injection for 2 times in 2-week interval. Patients also receive mobilization exercise and conventional physical therapy (including physical modalities and stretch exercise), 3 times a week, for 8 weeks.&#xD;
The injectates for hydrodilation include 10mg triamcinolone, 2cc 1% xylocaine, and 17cc normal saline for both posterior and anterior shoulder joint injection. 10mg triamcinolone and 2cc 1% xylocaine will also be injected into the subdeltoid bursa of the affected shoulder. All injections will be performed under ultrasound guidance. For shoulder joint injection, ａ21 gauge, 3-inch needle will be used; and a 22 gauge, 1.5 inch needle will be applied for subdeltoid bursa injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PT group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 8 weeks or until total recovery of the symptoms. The stretching exercise program is similar to the stretching exercise described above. For mimicking injection in the Comb group, patients in the PT group will receive 2cc 1% xylocain injection at the posterior deltoid muscle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Comb group</intervention_name>
    <description>Patients in the Comb group will receive hydrodilatation of the affected shoulder and subdeltoid bursa injection for 2 times in 2-week interval. Patients also receive mobilization exercise and conventional physical therapy (including physical modalities and stretch exercise), 3 times a week, for 8 weeks.&#xD;
The injectates for hydrodilation include 10mg triamcinolone, 2cc 1% xylocaine, and 17cc normal saline for both posterior and anterior shoulder joint injection. 10mg triamcinolone and 2cc 1% xylocaine will also be injected into the subdeltoid bursa of the affected shoulder. All injections will be performed under ultrasound guidance. For shoulder joint injection, ａ21 gauge, 3-inch needle will be used; and a 22 gauge, 1.5 inch needle will be applied for subdeltoid bursa injection.</description>
    <arm_group_label>Comb group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PT group</intervention_name>
    <description>The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 8 weeks or until total recovery of the symptoms. The stretching exercise program is similar to the stretching exercise described above. For mimicking injection in the Comb group, patients in the PT group will receive 2cc 1% xylocain injection at the posterior deltoid muscle.</description>
    <arm_group_label>PT group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. . age between 20 to 80 years old;&#xD;
&#xD;
          2. . chronic shoulder pain for ≥ 3 months;&#xD;
&#xD;
          3. . &gt; 30% loss of passive range of motion (ROM) of the affected shoulder in either&#xD;
             external rotation or abduction, comparing with the sound side;&#xD;
&#xD;
          4. . visual analog scale for pain on maximal passive external rotation or abduction &gt; 4.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. . Severe systemic disorders including cancer, stroke, or cardiopulmonary diseases;&#xD;
&#xD;
          2. . Uncontrolled DM;&#xD;
&#xD;
          3. . Rotator cuff tear or calcification of the affected shoulder;&#xD;
&#xD;
          4. . Fracture, dislocation, or arthritis of the shoulder due to rheumatic disorders;&#xD;
&#xD;
          5. . a history of drug allergy to local anesthetics or corticosteroids;&#xD;
&#xD;
          6. . receiving corticosteroid or hyaluronic acid joint or bursa injection of the affected&#xD;
             shoulder during the preceding three months.&#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>Lin-Fen Hsieh</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shin Kong Wu Ho-Su Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shin Kong Wu Ho-Su Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>October 27, 2022</last_update_submitted>
  <last_update_submitted_qc>October 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shin Kong Wu Ho-Su Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Lin-Fen Hsieh</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>frozen shoulder</keyword>
  <keyword>hydrodilatation</keyword>
  <keyword>joint mobilization</keyword>
  <keyword>corticosteroid injection</keyword>
  <keyword>physical therapy</keyword>
  <keyword>rehabilitation</keyword>
  <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>


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/NCT04474145
org study id: 20191212R
secondary id: NSTC 109-2314-B-341-002
secondary id: NSTC 110-2314-B-341-002
nct id: NCT04474145
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The effect of combination of hydrodilatation, corticosteroid injection, and joint
      mobilization for treatment of frozen shoulder, compared with general physical therapy.
Frozen shoulder (FS) is a common clinical problem which induces pain, loss of passive and
      active range of motion (ROM) of glenohumeral joint, and leads to disability, functional
      limitation, and decreasing quality of life. FS is usually treated with conservative
      treatments, which include medications, physiotherapy, joint mobilization, hydrodilatation,
      intra-articular steroid injection, etc.. The short-term effect of each treatment is variable,
      and the long-term effect is not established. Clinically combination of each treatment is
      common, but types of combination, and the effect of combination is still not well studied. We
      aim to combine hydrodilatation (with corticosteroid injection), joint mobilization, and
      general physiotherapy to treat frozen shoulder and compare the long-term effect with general
      physical therapy alone.

      This is a prospective single-blind randomized controlled trial. 70 participants will be
      recruited from the outpatient clinic of the department of Physical Medicine and
      Rehabilitation of Shin Kong Wu Ho-Su Memorial Hospital and randomly divided into COMB group
      and PT group. Each subject in the COMB group will receive 2 times of ultrasound-guided
      hydrodilatation injection (10mg triamcilonone, 2cc 1% xylocain, and 17cc normal saline)
      through both anterior and posterior shoulder joint in a two-weekly interval. In addition,
      joint mobilization and general physiotherapy (stretch exercise and physical modalities) will
      also be given, 2 times a week, for 8 weeks. The PT group will receive general physical
      therapy, 2 times a week, for 8 weeks. Outcome measures include the Shoulder Pain and
      Disability Index (SPADI), the Shoulder Disability Questionnaire (SDQ), and active and passive
      range of motion (ROM) of the affected shoulder, the 36-item Short Form Health Survey (SF-36),
      and patients' self evaluation. Evaluation will be performed at baseline and at 2, 4, 6 months
      after the beginning of the treatment. Statistics will be performed after completing the
      patients' treatment and evaluations. We expect that the COMB group will recover sooner and
      better than the PT group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Shoulder Pain and Disability Index（SPADI）
time frame: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
measure: Visual analog scale（VAS）
time frame: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
description: The VAS for pain is obtained using a 100-mm-long horizontal line, with 0 mm on the left, indicating no pain, and 100 mm on the right, indicating very severe pain. The pain at rest is defined as rest pain, and pain on maximal abduction of the affected shoulder is defined as activity pain. The reliability of VAS for pain is 0.94, but in the absence of a criterion standard for pain, criterion validity cannot be evaluated.
measure: Range of motion（ROM）
time frame: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
description: All the 4 planes of ROM will be measured. It includes abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0° of abduction.
measure: Shoulder Disability Questionnaire（SDQ）
time frame: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
description: The SDQ is a pain-related questionnaire that contains 16 items describing common situations that may induce symptoms in patients with shoulder disorders. The response options are "yes," "no," and "not applicable." The final score is calculated by dividing the number of positively scored items by the total number of applicable items and then multiplying this number by 100, which results in a final score ranging between 0 (no disability) and 100 (the worst possible condition).
measure: The 36-item Short Form Health Survey（SF-36）
time frame: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
description: The SF-36 is a generic measure of quality of life and is composed of 8 subscales related to the following components: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale generates a score from 0 to 100, and higher scores indicate better health.
arm group label: Comb group
arm group type: Active Comparator
description: Patients in the Comb group will receive hydrodilatation of the affected shoulder and subdeltoid bursa injection for 2 times in 2-week interval. Patients also receive mobilization exercise and conventional physical therapy (including physical modalities and stretch exercise), 3 times a week, for 8 weeks.
The injectates for hydrodilation include 10mg triamcinolone, 2cc 1% xylocaine, and 17cc normal saline for both posterior and anterior shoulder joint injection. 10mg triamcinolone and 2cc 1% xylocaine will also be injected into the subdeltoid bursa of the affected shoulder. All injections will be performed under ultrasound guidance. For shoulder joint injection, ａ21 gauge, 3-inch needle will be used; and a 22 gauge, 1.5 inch needle will be applied for subdeltoid bursa injection.
arm group label: PT group
arm group type: Active Comparator
description: The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 8 weeks or until total recovery of the symptoms. The stretching exercise program is similar to the stretching exercise described above. For mimicking injection in the Comb group, patients in the PT group will receive 2cc 1% xylocain injection at the posterior deltoid muscle.
intervention type: Procedure
intervention name: Comb group
description: Patients in the Comb group will receive hydrodilatation of the affected shoulder and subdeltoid bursa injection for 2 times in 2-week interval. Patients also receive mobilization exercise and conventional physical therapy (including physical modalities and stretch exercise), 3 times a week, for 8 weeks.
The injectates for hydrodilation include 10mg triamcinolone, 2cc 1% xylocaine, and 17cc normal saline for both posterior and anterior shoulder joint injection. 10mg triamcinolone and 2cc 1% xylocaine will also be injected into the subdeltoid bursa of the affected shoulder. All injections will be performed under ultrasound guidance. For shoulder joint injection, ａ21 gauge, 3-inch needle will be used; and a 22 gauge, 1.5 inch needle will be applied for subdeltoid bursa injection.
arm group label: Comb group
intervention type: Procedure
intervention name: PT group
description: The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 8 weeks or until total recovery of the symptoms. The stretching exercise program is similar to the stretching exercise described above. For mimicking injection in the Comb group, patients in the PT group will receive 2cc 1% xylocain injection at the posterior deltoid muscle.
arm group label: PT group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lin-Fen Hsieh
role: Principal Investigator
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Shin Kong Wu Ho-Su Memorial Hospital
investigator full name: Lin-Fen Hsieh
investigator title: Principal Investigator
mesh term: Bursitis