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/NCT06000254</url>
    </required_header>
    <id_info>
      <org_study_id>C202305036</org_study_id>
      <nct_id>NCT06000254</nct_id>
    </id_info>
    <brief_title>High Energy Density Pulse Electromagnetic Field for Patients With Adhensive Capsulitis</brief_title>
    <official_title>Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Adhensive Capsulitis</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>
      <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 adhesive capsulitis&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Adhesive capsulitis, a condition causing shoulder pain and limited range of motion (ROM), is&#xD;
        estimated to affect 2-5% of the general population. Typically occurring in middle-aged&#xD;
        individuals during their 50s to 70s, it presents with gradually developing shoulder pain and&#xD;
        restricted ROM, particularly in external rotation.&#xD;
  &#xD;
        In cases of primary adhesive capsulitis, the condition often resolves on its own, lasting&#xD;
        around 18-24 months. However, some individuals experience persistent symptoms beyond 3 years,&#xD;
        with up to 40% of patients and 15% facing lasting disability. Therefore, effective treatment&#xD;
        is essential to alleviate the pain and disability associated with frozen shoulder.&#xD;
  &#xD;
        High energy density pulse electromagnetic field (High-PEMF) differs from traditional PEMF and&#xD;
        possesses the following characteristics:&#xD;
  &#xD;
        Brief pulse duration (50μs) with a damped oscillation. Wide bandwidth (200kHz~300MHz)&#xD;
        centered around 240kHz. High voltages (up to 40 kV) and peak currents (up to 10 kA) in the&#xD;
        applicator spool.&#xD;
  &#xD;
        Delivery of around 96Ws (Joule) of energy per pulse with a magnetic flux density of 50~100mT.&#xD;
  &#xD;
        Tissue and organ penetration up to 20 cm. Although High-PEMF has shown positive results in&#xD;
        chronic tendinopathy, there is limited evidence of its effectiveness in treating adhesive&#xD;
        capsulitis. Therefore, our study aims to explore the efficacy and potential mechanisms&#xD;
        underlying the use of High-PEMF in treating adhesive capsulitis patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 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 functionality and impairment were assessed employing the Chinese version of the Shoulder Pain and Disability Index (SPADI). This self-reported questionnaire comprises distinct pain and disability sections, yielding both domain-specific and overall scores. The SPADI encompasses five pain-related inquiries and eight disability-related questions, all pertaining to various shoulder issues encountered within the preceding week. Each item's score ranges between 0 (indicating no pain/normalcy) and 10 (reflecting maximal pain/impairment). The cumulative pain score ranges from 0 to 50, while the disability score ranges from 0 to 80. A higher score indicates a greater level of 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>Adhesive Capsulitis</condition>
    <arm_group>
      <arm_group_label>physiotherapy and high-PEMF</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patient receives physiotherapy and high-PEMF therapy twice weekly, over a period 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 receives physiotherapy and sham high-PEMF therapy twice weekly, over a period 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 positioned over the area of the shoulder that experiences the most pain, and it remains in place for a duration of 9 minutes. The patient is subjected to a high-energy high-PEMF with a frequency of 3 pulses per second during the session.</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 includes a range of activities such as passive and active-assisted shoulder range of motion (ROM) exercises, Pendulum exercises, Codman's exercises, and Cross-body reach exercises. These exercises are conducted under the supervision of a physiotherapist and each training session lasts approximately 30 minutes.</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 positioned over the area of the shoulder where maximum pain is experienced, and it remains in place for a duration of 9 minutes. The parameters are consistent with those used in the experimental group. The key distinction lies in the fact that the energy output is not delivered to the patient.</description>
      <arm_group_label>physiotherapy and sham high-PEMF</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Physicians diagnose frozen shoulder by considering the patient's medical background,&#xD;
               conducting a physical assessment, and reviewing X-ray and ultrasound findings.&#xD;
  &#xD;
            2. The symptoms endure for a duration exceeding 3 months.&#xD;
  &#xD;
            3. There exists a decrease of no less than 30 degrees in a minimum of two joint angles of&#xD;
               the affected shoulder, namely flexion, abduction, and external rotation, in comparison&#xD;
               to the corresponding angles of the unaffected side.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Musculoskeletal ultrasound of the shoulder identifies a full-thickness tear or&#xD;
               substantial tear in the rotator cuff tendons or presents calcific tendinitis.&#xD;
  &#xD;
            2. Presence of systemic rheumatic disease.&#xD;
  &#xD;
            3. Prior history of shoulder fracture or surgical intervention involving the shoulder&#xD;
               joint.&#xD;
  &#xD;
            4. Acute compression of cervical nerve root.&#xD;
  &#xD;
            5. Patients displaying instability (e.g., those with signs of internal bleeding) or&#xD;
               individuals with cancer.&#xD;
  &#xD;
            6. Recent receipt of shoulder injections for treatment within the last 3 months.&#xD;
  &#xD;
            7. Impaired cognitive function that hinders the patient's ability to provide informed&#xD;
               consent or engage in rehabilitation therapy.&#xD;
  &#xD;
            8. Expectant or breastfeeding women.&#xD;
  &#xD;
            9. Meets any of the contraindications for high-energy electromagnetic pulse therapy:&#xD;
               individuals with organ transplants, implanted cardiac pacemakers, defibrillators,&#xD;
               metal implants (such as stents), cochlear implants, and those requiring 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 Chen, 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>August 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 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>adhesive capsulitis</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/NCT06000254
  org study id: C202305036
  nct id: NCT06000254
  lead sponsor: 
  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 adhesive capsulitis
  Adhesive capsulitis, a condition causing shoulder pain and limited range of motion (ROM), is
        estimated to affect 2-5% of the general population. Typically occurring in middle-aged
        individuals during their 50s to 70s, it presents with gradually developing shoulder pain and
        restricted ROM, particularly in external rotation.
  
        In cases of primary adhesive capsulitis, the condition often resolves on its own, lasting
        around 18-24 months. However, some individuals experience persistent symptoms beyond 3 years,
        with up to 40% of patients and 15% facing lasting disability. Therefore, effective treatment
        is essential to alleviate the pain and disability associated with frozen shoulder.
  
        High energy density pulse electromagnetic field (High-PEMF) differs from traditional PEMF and
        possesses the following characteristics:
  
        Brief pulse duration (50μs) with a damped oscillation. Wide bandwidth (200kHz~300MHz)
        centered around 240kHz. High voltages (up to 40 kV) and peak currents (up to 10 kA) in the
        applicator spool.
  
        Delivery of around 96Ws (Joule) of energy per pulse with a magnetic flux density of 50~100mT.
  
        Tissue and organ penetration up to 20 cm. Although High-PEMF has shown positive results in
        chronic tendinopathy, there is limited evidence of its effectiveness in treating adhesive
        capsulitis. Therefore, our study aims to explore the efficacy and potential mechanisms
        underlying the use of High-PEMF in treating adhesive capsulitis patients.
  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 functionality and impairment were assessed employing the Chinese version of the Shoulder Pain and Disability Index (SPADI). This self-reported questionnaire comprises distinct pain and disability sections, yielding both domain-specific and overall scores. The SPADI encompasses five pain-related inquiries and eight disability-related questions, all pertaining to various shoulder issues encountered within the preceding week. Each item's score ranges between 0 (indicating no pain/normalcy) and 10 (reflecting maximal pain/impairment). The cumulative pain score ranges from 0 to 50, while the disability score ranges from 0 to 80. A higher score indicates a greater level of 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 receives physiotherapy and high-PEMF therapy twice weekly, over a period of three weeks.
  arm group label: physiotherapy and sham high-PEMF
  arm group type: Sham Comparator
  description: The patient receives physiotherapy and sham high-PEMF therapy twice weekly, over a period of three weeks.
  intervention type: Device
  intervention name: High energy density pulse electromagnetic field
  description: The treatment coil is positioned over the area of the shoulder that experiences the most pain, and it remains in place for a duration of 9 minutes. The patient is subjected to a high-energy high-PEMF with a frequency of 3 pulses per second during the session.
  arm group label: physiotherapy and high-PEMF
  intervention type: Other
  intervention name: physiotherapy
  description: Physiotherapy includes a range of activities such as passive and active-assisted shoulder range of motion (ROM) exercises, Pendulum exercises, Codman's exercises, and Cross-body reach exercises. These exercises are conducted under the supervision of a physiotherapist and each training session lasts approximately 30 minutes.
  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 positioned over the area of the shoulder where maximum pain is experienced, and it remains in place for a duration of 9 minutes. The parameters are consistent with those used in the experimental group. The key distinction lies in the fact that the energy output is not delivered 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 Chen, 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