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/NCT06004609</url>
    </required_header>
    <id_info>
      <org_study_id>202209047DIPA</org_study_id>
      <nct_id>NCT06004609</nct_id>
    </id_info>
    <brief_title>Using Large-area Low-level Light Therapy for Treating Adhesive Capsulitis of the Shoulder</brief_title>
    <official_title>Using Large-area Low-level Light Therapy for Treating Adhesive Capsulitis of the Shoulder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Adhesive capsulitis, is a common problem characterized by the insidious onset of glenohumeral&#xD;
        pain and limitation of shoulder motion in all planes. Clinically, frozen shoulder could be&#xD;
        divided into freezing, frozen and thawing stage. The treatments of frozen shoulder are mainly&#xD;
        conservative, including non-steroidal anti-inflammatory medications and physiotherapy. Due to&#xD;
        debilitating pain at a certain stage and protracted clinical course, intra-articular&#xD;
        corticosteroid injection in the early stages of idiopathic adhesive capsulitis has long been&#xD;
        used to treat adhesive capsulitis with satisfactory result. However, intra-articular steroid&#xD;
        injection still raise some controversy and is still considered too invasive for some&#xD;
        patients.&#xD;
  &#xD;
        Low-level laser therapy (LLLT) is a safe and non-invasive alternative. LLLT can employ&#xD;
        photo-biomodulation effects to help normalize cellular functions and is considered to have&#xD;
        partial effect in many shoulder soft tissue disorders. Possible mechanisms include increasing&#xD;
        adenosine triphosphate production, fibroblast activity and collagen synthesis. One&#xD;
        prospective cohort study has shown that LLLT can be effective in the management of the early&#xD;
        phase (less than 6 weeks of disease onset) of adhesive capsulitis of the shoulder in elderly&#xD;
        who failed to respond to conventional physical therapy and nonsteroidal anti-inflammatory&#xD;
        medications and improvement was found maintained up to 2 years.&#xD;
  &#xD;
        To this date, no randomized controlled study has been made to establish the possible role of&#xD;
        LLLT as an adjuvant therapy on adhesive capsulitis. Also, no study has researched the effect&#xD;
        of LLLT on patient with later stage/chronic phase of adhesive capsulitis. The objective of&#xD;
        this paper is to report the clinical result of a study on the efficacy of LLLT as an add-on&#xD;
        therapy in the management of adhesive capsulitis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 21, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 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>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Shoulder range of motion</measure>
      <time_frame>24 weeks after enrollment</time_frame>
      <description>Shoulder flexion, abduction, external rotation, internal rotation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Shoulder pain score</measure>
      <time_frame>24 weeks after enrollment</time_frame>
      <description>Visual analogue scale for pain during shoulder motion (scale from 0 to 10, with higher scores mean worse outcome)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Functional evaluation</measure>
      <time_frame>Immediate upon enrollment, and 8, 12, 24 weeks after enrollment</time_frame>
      <description>Shoulder Pain Disability Index (SPADI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ultrasound examination</measure>
      <time_frame>Immediate upon enrollment, and 8, 12, 24 weeks after enrollment</time_frame>
      <description>Thickness of coracohumeral ligament and inferior glenohumeral capsule</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional evaluation</measure>
      <time_frame>Immediate upon enrollment, and 8, 12, 24 weeks after enrollment</time_frame>
      <description>Disability of the Arm, Shoulder, and Hand (DASH) questionnaire</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Adhesive Capsulitis of Shoulder</condition>
    <arm_group>
      <arm_group_label>Treatment group (low-level laser therapy with conventional physical therapy)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Low-level laser therapy three times a week, 10 minutes each time, for 8 weeks. Along with conventional physical therapy, three times a week, for 12 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional group (conventional physical therapy only)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Conventional physical therapy, three times a week, for 12 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Low-level laser therapy (LLLT)</intervention_name>
      <description>Low-level laser therapy (LLLT), three time each week, 10 minutes each time, during the first 8 weeks of the treatment trial.</description>
      <arm_group_label>Treatment group (low-level laser therapy with conventional physical therapy)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conventional physical therapy</intervention_name>
      <description>Conventional physical therapy will be applied three time each week, for 12 weeks</description>
      <arm_group_label>Conventional group (conventional physical therapy only)</arm_group_label>
      <arm_group_label>Treatment group (low-level laser therapy with conventional physical therapy)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age between 40 to 85 years old&#xD;
  &#xD;
            -  Diagnosed with adhesive capsulitis clinically. Painful restriction of both active and&#xD;
               passive flexion less than 120° and 50% restriction of the external rotation aside the&#xD;
               body&#xD;
  &#xD;
            -  Visual analog scale of shoulder motion pain greater than 3 on a scale of 10&#xD;
  &#xD;
            -  No fracture, dislocation, or arthritis in shoulder region&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of or scheduled shoulder or chest surgery&#xD;
  &#xD;
            -  Significant shoulder trauma within the previous 2 years&#xD;
  &#xD;
            -  Presence of cervical radiculopathy or other central or peripheral neurologic deficits&#xD;
               of the upper limb&#xD;
  &#xD;
            -  Known shoulder tendon tear or active tendinitis or bursitis as confirmed with US&#xD;
  &#xD;
            -  Contraindication of low-level light therapy&#xD;
  &#xD;
                 1. Pregnancy, cancer, patient with pacemaker, high bleeding tendency, or longterm&#xD;
                    corticosteroid use.&#xD;
  &#xD;
                 2. Poor consciousness state, or patients with sensory impairment&#xD;
  &#xD;
                 3. Patients hypersensitive to light&#xD;
  &#xD;
                 4. Severe circulatory system disorder&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Chueh-Hung Wu, MD, PhD</last_name>
      <phone>+886-2312-3456</phone>
      <phone_ext>66473</phone_ext>
      <email>nojred@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>En Yang, MD</last_name>
      <phone>+886-2312-3456</phone>
      <phone_ext>52370</phone_ext>
      <email>youngforever0826@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>National Taiwan University Hospital</name>
        <address>
          <city>Taipei</city>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chueh-Hung Wu, MD, PhD</last_name>
        <phone>+886-2312-3456</phone>
        <phone_ext>66473</phone_ext>
        <email>nojred@gmail.com</email>
      </contact>
      <investigator>
        <last_name>En Yang, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ying-Chun Chen, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hsing-Yu Chen</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>November 2022</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>adhesive capsulitis</keyword>
    <keyword>low-level laser therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bursitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06004609
  org study id: 202209047DIPA
  nct id: NCT06004609
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Adhesive capsulitis, is a common problem characterized by the insidious onset of glenohumeral
        pain and limitation of shoulder motion in all planes. Clinically, frozen shoulder could be
        divided into freezing, frozen and thawing stage. The treatments of frozen shoulder are mainly
        conservative, including non-steroidal anti-inflammatory medications and physiotherapy. Due to
        debilitating pain at a certain stage and protracted clinical course, intra-articular
        corticosteroid injection in the early stages of idiopathic adhesive capsulitis has long been
        used to treat adhesive capsulitis with satisfactory result. However, intra-articular steroid
        injection still raise some controversy and is still considered too invasive for some
        patients.
  
        Low-level laser therapy (LLLT) is a safe and non-invasive alternative. LLLT can employ
        photo-biomodulation effects to help normalize cellular functions and is considered to have
        partial effect in many shoulder soft tissue disorders. Possible mechanisms include increasing
        adenosine triphosphate production, fibroblast activity and collagen synthesis. One
        prospective cohort study has shown that LLLT can be effective in the management of the early
        phase (less than 6 weeks of disease onset) of adhesive capsulitis of the shoulder in elderly
        who failed to respond to conventional physical therapy and nonsteroidal anti-inflammatory
        medications and improvement was found maintained up to 2 years.
  
        To this date, no randomized controlled study has been made to establish the possible role of
        LLLT as an adjuvant therapy on adhesive capsulitis. Also, no study has researched the effect
        of LLLT on patient with later stage/chronic phase of adhesive capsulitis. The objective of
        this paper is to report the clinical result of a study on the efficacy of LLLT as an add-on
        therapy in the management of adhesive capsulitis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Shoulder range of motion
  time frame: 24 weeks after enrollment
  description: Shoulder flexion, abduction, external rotation, internal rotation
  measure: Shoulder pain score
  time frame: 24 weeks after enrollment
  description: Visual analogue scale for pain during shoulder motion (scale from 0 to 10, with higher scores mean worse outcome)
  measure: Functional evaluation
  time frame: Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
  description: Shoulder Pain Disability Index (SPADI)
  measure: Ultrasound examination
  time frame: Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
  description: Thickness of coracohumeral ligament and inferior glenohumeral capsule
  measure: Functional evaluation
  time frame: Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
  description: Disability of the Arm, Shoulder, and Hand (DASH) questionnaire
  arm group label: Treatment group (low-level laser therapy with conventional physical therapy)
  arm group type: Experimental
  description: Low-level laser therapy three times a week, 10 minutes each time, for 8 weeks. Along with conventional physical therapy, three times a week, for 12 weeks.
  arm group label: Conventional group (conventional physical therapy only)
  arm group type: Active Comparator
  description: Conventional physical therapy, three times a week, for 12 weeks.
  intervention type: Device
  intervention name: Low-level laser therapy (LLLT)
  description: Low-level laser therapy (LLLT), three time each week, 10 minutes each time, during the first 8 weeks of the treatment trial.
  arm group label: Treatment group (low-level laser therapy with conventional physical therapy)
  intervention type: Other
  intervention name: Conventional physical therapy
  description: Conventional physical therapy will be applied three time each week, for 12 weeks
  arm group label: Conventional group (conventional physical therapy only)
  arm group label: Treatment group (low-level laser therapy with conventional physical therapy)
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Chueh-Hung Wu, MD, PhD
  phone: +886-2312-3456
  phone ext: 66473
  email: nojred@gmail.com
  last name: En Yang, MD
  phone: +886-2312-3456
  phone ext: 52370
  email: youngforever0826@gmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Bursitis
  sharing ipd: No