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/NCT05979974</url>
    </required_header>
    <id_info>
      <org_study_id>A202305106</org_study_id>
      <nct_id>NCT05979974</nct_id>
    </id_info>
    <brief_title>High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder</brief_title>
    <official_title>Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder: A Double-blinded, Randomized Controlled Trail</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tri-Service General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tri-Service General 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 aim of our study is to investigate the efficacy of high energy density pulse&#xD;
        electromagnetic field for patients with frozen shoulder&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Frozen shoulder causes shoulder pain and limited range of motion(ROM). It is thought to&#xD;
        afflict between 2 and 5% of the general population. Individuals of middle age are most often&#xD;
        affected, typically during the 5th to 7th decades of life. Typical symptoms include gradual&#xD;
        onset of shoulder pain, limited shoulder ROM at least in two or more directions (especially&#xD;
        in external rotation). In the case of primary adhesive capsulitis, the disease is usually&#xD;
        self-limiting, and typically lasts 18-24 months. However, persistent symptoms and movement&#xD;
        restriction beyond 3 years have been reported in up to 40% of patients, with up to 15% of&#xD;
        patients suffering permanent disability. Therefore, an effective treatment is necessary to&#xD;
        treat the shoulder pain and disability caused by frozen shoulder. High energy density pulse&#xD;
        electromagnetic field (High-PEMF), different from traditional PEMF, includes characteristics&#xD;
        as following:&#xD;
  &#xD;
          1. The short pulse duration (50μs) with a damped oscillation&#xD;
  &#xD;
          2. The broad bandwidth(200kHz~300MHz) with a basic frequency 240kHz&#xD;
  &#xD;
          3. High voltages (up to 40 kV) and peak currents (up to 10 kA) arise in the applicator&#xD;
             spool&#xD;
  &#xD;
          4. Delivery of energy per pulse of about 96Ws (Joule) with a magnetic flux density of&#xD;
             50~100mT&#xD;
  &#xD;
          5. Depth penetration for tissue and organ up to 20 cm&#xD;
  &#xD;
        It has been applied in chronic tendinopathy with positive outcomes. However, few studies&#xD;
        support its application in the setting of frozen shoulder. Hence, the aim of our study is to&#xD;
        investigate the efficacy and the underlying possible mechanism of High-PEMF for patients with&#xD;
        frozen shoulder.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</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, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in pain Visual Analogue Scale(VAS)</measure>
      <time_frame>the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months</time_frame>
      <description>The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. &quot;0&quot; means painless and &quot;10&quot; means extremely painful.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Shoulder Pain and Disability Index (SPADI)</measure>
      <time_frame>the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months</time_frame>
      <description>Shoulder function and disability were evaluated using the Chinese version of the Shoulder Pain and Disability Index (SPADI), a self-report questionnaire that yields pain and disability domain and total scores. The SPADI includes five questions on pain and eight questions on disability, referring to various problems with the shoulder encountered over the preceding week. Each item's score ranges from 0 (no pain/normal) to 10 (maximal pain/disability), with total scores of pain from 0-50 and disability from to 0-80. A higher score shows more disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood test</measure>
      <time_frame>the change from baseline, post-intervention 1 and 6 months</time_frame>
      <description>Perform blood test to analysis the change of interleukin-1α, interleukin-1β, interleukin-6, interleukin-8, interleukin-10</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood test</measure>
      <time_frame>the change from baseline, post-intervention 1 and 6 months</time_frame>
      <description>Perform blood test to analysis the change of tumor necrosis factor-α (TNF-α)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood test</measure>
      <time_frame>the change from baseline, post-intervention 1 and 6 months</time_frame>
      <description>Perform blood test to analysis the change of vascular endothelial growth factor(VEGF)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood test</measure>
      <time_frame>the change from baseline, post-intervention 1 and 6 months</time_frame>
      <description>Perform blood test to analysis the change of transforming growth factor-β(TGF-β)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Frozen Shoulder</condition>
    <arm_group>
      <arm_group_label>physiotherapy and high-PEMF</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patient undergoes physiotherapy and high-PEMF therapy twice a week, for a duration of three weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>physiotherapy and sham high-PEMF</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>The patient undergoes physiotherapy and sham high-PEMF therapy twice a week, for a duration of three weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>High energy density pulse electromagnetic field</intervention_name>
      <description>The treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. A high energy of high-PEMF with a rate of 3 pulse per second is applied to the patient.</description>
      <arm_group_label>physiotherapy and high-PEMF</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>physiotherapy</intervention_name>
      <description>Physiotherapy such as shoulder passive and active-assisted range of motion (ROM) exercises, Pendulum exercises, Codman's exercises and Cross-body reach exercises. Under the physiotherapist's guidance, the patient receives the training session about 30 minutes every time.</description>
      <arm_group_label>physiotherapy and high-PEMF</arm_group_label>
      <arm_group_label>physiotherapy and sham high-PEMF</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>sham High energy density pulse electromagnetic field</intervention_name>
      <description>The sham treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. The setting is the same as the experimental group(high energy, a rate of 3 pulse per second) with the difference that the energy output doesn't export to the patient.</description>
      <arm_group_label>physiotherapy and sham high-PEMF</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Frozen shoulder is diagnosed by physicians based on the patient's medical history,&#xD;
               physical examination, X-ray, and ultrasound reports.&#xD;
  &#xD;
            2. The symptoms persist for more than 3 months.&#xD;
  &#xD;
            3. There is a reduction of at least 30 degrees in at least two of the affected shoulder&#xD;
               joint angles compared to the angles of the healthy side: shoulder flexion, abduction,&#xD;
               and external rotation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Shoulder musculoskeletal ultrasound reveals a full-thickness tear or massive tear of&#xD;
               the shoulder rotator cuff tendons or calcific tendinitis.&#xD;
  &#xD;
            2. Systemic rheumatic disease.&#xD;
  &#xD;
            3. History of shoulder fracture or previous surgical treatment of the shoulder joint.&#xD;
  &#xD;
            4. Acute cervical nerve root compression.&#xD;
  &#xD;
            5. Patients with instability (e.g., those with symptoms of internal bleeding) or cancer&#xD;
               patients.&#xD;
  &#xD;
            6. Received shoulder injections for treatment within the past 3 months.&#xD;
  &#xD;
            7. Impaired cognitive function that prevents the patient from providing informed consent&#xD;
               or participating in rehabilitation therapy.&#xD;
  &#xD;
            8. Pregnant or breastfeeding women.&#xD;
  &#xD;
            9. Meets any of the contraindications for high-energy electromagnetic pulse therapy:&#xD;
               organ transplant recipients; individuals with implanted cardiac pacemakers,&#xD;
               defibrillators, metal implants (such as stents), cochlear implants, and insulin&#xD;
               supplementation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Liang cheng Chiang, MD, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Physical Medicine and Rehabilitation, Tri-Service General</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Liang cheng Chen, MD, MS</last_name>
      <phone>886-2-87923311</phone>
      <phone_ext>12922</phone_ext>
      <email>clctsgh@yahoo.com.tw</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Chia-Ying Lai, MD</last_name>
      <phone>886-2-87923311</phone>
      <phone_ext>13606</phone_ext>
      <email>pokerface165@gmail.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 5, 2023</last_update_submitted>
    <last_update_submitted_qc>August 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tri-Service General Hospital</investigator_affiliation>
      <investigator_full_name>Liang-Cheng Chen</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <keyword>Frozen Shoulder</keyword>
    <keyword>high energy density pulse electromagnetic field</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>
  
  
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/NCT05979974
  org study id: A202305106
  nct id: NCT05979974
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of our study is to investigate the efficacy of high energy density pulse
        electromagnetic field for patients with frozen shoulder
  Frozen shoulder causes shoulder pain and limited range of motion(ROM). It is thought to
        afflict between 2 and 5% of the general population. Individuals of middle age are most often
        affected, typically during the 5th to 7th decades of life. Typical symptoms include gradual
        onset of shoulder pain, limited shoulder ROM at least in two or more directions (especially
        in external rotation). In the case of primary adhesive capsulitis, the disease is usually
        self-limiting, and typically lasts 18-24 months. However, persistent symptoms and movement
        restriction beyond 3 years have been reported in up to 40% of patients, with up to 15% of
        patients suffering permanent disability. Therefore, an effective treatment is necessary to
        treat the shoulder pain and disability caused by frozen shoulder. High energy density pulse
        electromagnetic field (High-PEMF), different from traditional PEMF, includes characteristics
        as following:
  
          1. The short pulse duration (50μs) with a damped oscillation
  
          2. The broad bandwidth(200kHz~300MHz) with a basic frequency 240kHz
  
          3. High voltages (up to 40 kV) and peak currents (up to 10 kA) arise in the applicator
             spool
  
          4. Delivery of energy per pulse of about 96Ws (Joule) with a magnetic flux density of
             50~100mT
  
          5. Depth penetration for tissue and organ up to 20 cm
  
        It has been applied in chronic tendinopathy with positive outcomes. However, few studies
        support its application in the setting of frozen shoulder. Hence, the aim of our study is to
        investigate the efficacy and the underlying possible mechanism of High-PEMF for patients with
        frozen shoulder.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Change in pain Visual Analogue Scale(VAS)
  time frame: the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months
  description: The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. "0" means painless and "10" means extremely painful.
  measure: Change in Shoulder Pain and Disability Index (SPADI)
  time frame: the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months
  description: Shoulder function and disability were evaluated using the Chinese version of the Shoulder Pain and Disability Index (SPADI), a self-report questionnaire that yields pain and disability domain and total scores. The SPADI includes five questions on pain and eight questions on disability, referring to various problems with the shoulder encountered over the preceding week. Each item's score ranges from 0 (no pain/normal) to 10 (maximal pain/disability), with total scores of pain from 0-50 and disability from to 0-80. A higher score shows more disability.
  measure: Blood test
  time frame: the change from baseline, post-intervention 1 and 6 months
  description: Perform blood test to analysis the change of interleukin-1α, interleukin-1β, interleukin-6, interleukin-8, interleukin-10
  measure: Blood test
  time frame: the change from baseline, post-intervention 1 and 6 months
  description: Perform blood test to analysis the change of tumor necrosis factor-α (TNF-α)
  measure: Blood test
  time frame: the change from baseline, post-intervention 1 and 6 months
  description: Perform blood test to analysis the change of vascular endothelial growth factor(VEGF)
  measure: Blood test
  time frame: the change from baseline, post-intervention 1 and 6 months
  description: Perform blood test to analysis the change of transforming growth factor-β(TGF-β)
  arm group label: physiotherapy and high-PEMF
  arm group type: Experimental
  description: The patient undergoes physiotherapy and high-PEMF therapy twice a week, for a duration of three weeks.
  arm group label: physiotherapy and sham high-PEMF
  arm group type: Sham Comparator
  description: The patient undergoes physiotherapy and sham high-PEMF therapy twice a week, for a duration of three weeks.
  intervention type: Device
  intervention name: High energy density pulse electromagnetic field
  description: The treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. A high energy of high-PEMF with a rate of 3 pulse per second is applied to the patient.
  arm group label: physiotherapy and high-PEMF
  intervention type: Other
  intervention name: physiotherapy
  description: Physiotherapy such as shoulder passive and active-assisted range of motion (ROM) exercises, Pendulum exercises, Codman's exercises and Cross-body reach exercises. Under the physiotherapist's guidance, the patient receives the training session about 30 minutes every time.
  arm group label: physiotherapy and high-PEMF
  arm group label: physiotherapy and sham high-PEMF
  intervention type: Device
  intervention name: sham High energy density pulse electromagnetic field
  description: The sham treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. The setting is the same as the experimental group(high energy, a rate of 3 pulse per second) with the difference that the energy output doesn't export to the patient.
  arm group label: physiotherapy and sham high-PEMF
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Liang cheng Chiang, MD, MS
  role: Principal Investigator
  affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General
  last name: Liang cheng Chen, MD, MS
  phone: 886-2-87923311
  phone ext: 12922
  email: clctsgh@yahoo.com.tw
  last name: Chia-Ying Lai, MD
  phone: 886-2-87923311
  phone ext: 13606
  email: pokerface165@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Tri-Service General Hospital
  investigator full name: Liang-Cheng Chen
  investigator title: Director
  mesh term: Bursitis