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/NCT06041282</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0750</org_study_id>
      <nct_id>NCT06041282</nct_id>
    </id_info>
    <brief_title>Conservative Treatment of Early Adhesive Capsulitis</brief_title>
    <official_title>A Multicentre Randomized Controlled Trial of Manipulation Under Anesthesia and Supervised Home Rehabilitation in the Treatment of Early Adhesive Capsulitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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>
        A prospective, multicentre, randomized controlled study comparing the efficacy of&#xD;
        conservative treatment for early adhesive capsulitis&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This clinical trial evaluated the most common protocols for the treatment of adhesive&#xD;
        capsulitis in secondary hospitals. To compare the efficacy of manipulation under anesthesia&#xD;
        and supervised home conservative treatment of early adhesive capsulitis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Constant-Murley Score (CMS)</measure>
      <time_frame>6months after intervention</time_frame>
      <description>The Constant-Mulery score mainly includes 8 aspects related to your shoulder in the past 4 weeks.&#xD;
  The proportion of subjective and objective components in the Constant-Mulery score is 35 points/65 points. A total of 100 points.The subjective part of the score includes the score of pain degree and the score of impact on daily life. 35 points in total.The objective part of the score includes the score of shoulder range of motion and strength. 65 points in total.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Constant-Murley Score (CMS)</measure>
      <time_frame>1 months, 3months, and 1year after intervention</time_frame>
      <description>The Constant-Mulery score mainly includes 8 aspects related to your shoulder in the past 4 weeks.&#xD;
  The proportion of subjective and objective components in the Constant-Mulery score is 35 points/65 points. A total of 100 points.The subjective part of the score includes the score of pain degree and the score of impact on daily life. 35 points in total.The objective part of the score includes the score of shoulder range of motion and strength. 65 points in total.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oxford Shoulder Score (OSS)</measure>
      <time_frame>1 months, 3months, 6 months and 1year after intervention</time_frame>
      <description>The Oxford Shoulder Score (OSS) consists of 12 questions with five options each. The light to heavy lines were assigned 1, 2, 3, 4 and 5 points respectively. So the total score is between 12 and 60. A score of 12 represents perfectly normal shoulder function and a score of 60 represents the most severe difficulty in shoulder function.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fear-avoidance belief questionnaire(FABQ)</measure>
      <time_frame>1 months, 3months, 6 months and 1year after intervention</time_frame>
      <description>The FABQ is a self-assessment scale with 16 options. Each option has 0~6 points and 7 grades (from extremely disagreeable to extremely agreed). &quot;0&quot; means completely disagreed, &quot;6&quot; means completely agreed, and &quot;1~5&quot; means not sure. The higher the score, the more inclined to fully agree</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insomnia Severity Index(ISI)</measure>
      <time_frame>1 months, 3months, 6 months and 1year after intervention</time_frame>
      <description>The scale is a simple tool for screening insomnia, including 7 items, which are used to evaluate the nature and symptoms of sleep disorders of subjects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital Anxiety and Depression Scale(HADS)</measure>
      <time_frame>1 months, 3months, 6 months and 1year after intervention</time_frame>
      <description>HADS is a self-assessment scale, including two subscales, HADS-A and HADS-D, with a total of 14 items, including 7 items for anxiety (A) and 7 items for depression (D). Each item is scored at four levels according to the frequency of symptoms in the past month. Each item is scored at 0-3 points in four levels. The higher the score, the more serious the anxiety or depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SF-36</measure>
      <time_frame>1 months, 3months, 6 months and 1year after intervention</time_frame>
      <description>SF-36 is a concise health questionnaire developed by the Boston Institute of Health, which is widely used in the measurement of the quality of life of the general population, the evaluation of clinical trials and the evaluation of health policies. SF-36 is used to assess physiological function, physiological function, physical pain, general health, energy, social function, emotional function and mental health, which are classified into &quot;physical health&quot; and &quot;mental health&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analogue scale(VAS)</measure>
      <time_frame>1 months, 3months, 6 months and 1year after intervention</time_frame>
      <description>Draw a 10cm horizontal line on the paper. One end of the line is &quot;0&quot;, indicating no pain; the other end is &quot;10&quot;, indicating severe pain; The middle represents different degrees of pain; Let the patient draw a mark on the horizontal line according to their feelings to indicate the degree of pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>range of motion</measure>
      <time_frame>1 months, 3months, 6 months and 1year after intervention</time_frame>
      <description>Measure the patient's flexion, abduction, internal rotation and external rotation angle</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Adhesive Capsulitis</condition>
    <arm_group>
      <arm_group_label>manipulation under anesthesia group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patient underwent manipulation under anesthesia</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Supervised home rehabilitation group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The patient underwent supervised home rehabilitation</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>manipulation under anesthesia</intervention_name>
      <description>After the anesthesia took effect, the patient was placed in the supine position, and the experienced surgeon stood at the head of the bed to release the affected limb by four angles of forward flexion, abduction, external rotation and internal rotation. After the operation is completed, 1ml de Bosson (MSD) +2.5ml sodium hyaluronate (Biochemical Industries Co., LTD.) is injected once.</description>
      <arm_group_label>manipulation under anesthesia group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>supervised home rehabilitation</intervention_name>
      <description>The doctor instructs the patient in exercise training at the outpatient clinic. At each clinic visit, the doctor will guide the different stages of the movement. At the first visit, the doctor guides the patient through the first phase of the rehabilitation program to improve the patient's basic mobility. At the first month of follow-up, the second phase of rehabilitation program was guided, and the recovery of mobility was accompanied by muscle training, including wall climbing and muscle resistance exercises. 1ml Debossone (MSD) +2.5ml sodium hyaluronate (Biochemical Industries Co., LTD.) was injected once at the clinic. All the training required patients to do their best at home to complete 3 sets of 5 each. At the end of each day, the patient will upload a video to the platform, and the doctor will evaluate whether the patient's recovery is in place.</description>
      <arm_group_label>Supervised home rehabilitation group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients in our hospital who need manual release of periarthritis of shoulder or home&#xD;
               rehabilitation treatment;&#xD;
  &#xD;
            -  Unilateral and primary periarthritis of shoulder&#xD;
  &#xD;
            -  Age ≥40 years old and ≤80 years old, regardless of gender.&#xD;
  &#xD;
            -  Forward flexion movement is more than 50% limited compared with the contralateral.&#xD;
  &#xD;
            -  Duration of disease ≤3 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a previous history of shoulder joint surgery&#xD;
  &#xD;
            -  Patients who did not complete the follow-up within the specified time&#xD;
  &#xD;
            -  Patients with other shoulder diseases.&#xD;
  &#xD;
            -  Patient with systemic immune disease.&#xD;
  &#xD;
            -  Patients who have participated in clinical trials or are conducting other clinical&#xD;
               trials within 3 months before screening&#xD;
  &#xD;
            -  Patients with serious primary cardiovascular diseases, lung diseases, endocrine and&#xD;
               metabolic diseases, or serious diseases affecting their survival, such as tumor or&#xD;
               AIDS, are considered not suitable for admission.&#xD;
  &#xD;
            -  Patients with serious liver diseases, kidney diseases, hematological diseases, such as&#xD;
               kidney function (BUN, Cr) more than the upper limit of normal, liver function (ALT,&#xD;
               AST, TBIL) more than 2 times the upper limit of normal.&#xD;
  &#xD;
            -  Patients with viral hepatitis, infectious diseases, abnormal blood coagulation&#xD;
               mechanism and other diseases that researchers consider inappropriate for surgery.&#xD;
  &#xD;
            -  Pregnant or lactating women, or those planning to get pregnant during the test, with&#xD;
               positive urine HCG test results before the test; Menstruating women should wait until&#xD;
               their period is over before undergoing surgery.&#xD;
  &#xD;
            -  Patients with severe neurological and mental diseases.&#xD;
  &#xD;
            -  Suspected or true history of alcohol and drug abuse.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>weiliang shen, doctor</last_name>
      <phone>+86 0571 87783759</phone>
      <email>wlshen@zju.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>2nd Affiliated Hospital, School of Medicine, Zhejiang University</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310058</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>weiliang shen, Doctor</last_name>
        <phone>86-0571-86995513</phone>
        <email>wlshen@zju.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>manipulation under anesthesia</keyword>
    <keyword>supervised home rehabilitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bursitis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anesthetics</mesh_term>
    </intervention_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/NCT06041282
  org study id: 2023-0750
  nct id: NCT06041282
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  A prospective, multicentre, randomized controlled study comparing the efficacy of
        conservative treatment for early adhesive capsulitis
  This clinical trial evaluated the most common protocols for the treatment of adhesive
        capsulitis in secondary hospitals. To compare the efficacy of manipulation under anesthesia
        and supervised home conservative treatment of early adhesive capsulitis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Constant-Murley Score (CMS)
  time frame: 6months after intervention
  description: The Constant-Mulery score mainly includes 8 aspects related to your shoulder in the past 4 weeks.
  The proportion of subjective and objective components in the Constant-Mulery score is 35 points/65 points. A total of 100 points.The subjective part of the score includes the score of pain degree and the score of impact on daily life. 35 points in total.The objective part of the score includes the score of shoulder range of motion and strength. 65 points in total.
  measure: Constant-Murley Score (CMS)
  time frame: 1 months, 3months, and 1year after intervention
  description: The Constant-Mulery score mainly includes 8 aspects related to your shoulder in the past 4 weeks.
  The proportion of subjective and objective components in the Constant-Mulery score is 35 points/65 points. A total of 100 points.The subjective part of the score includes the score of pain degree and the score of impact on daily life. 35 points in total.The objective part of the score includes the score of shoulder range of motion and strength. 65 points in total.
  measure: Oxford Shoulder Score (OSS)
  time frame: 1 months, 3months, 6 months and 1year after intervention
  description: The Oxford Shoulder Score (OSS) consists of 12 questions with five options each. The light to heavy lines were assigned 1, 2, 3, 4 and 5 points respectively. So the total score is between 12 and 60. A score of 12 represents perfectly normal shoulder function and a score of 60 represents the most severe difficulty in shoulder function.
  measure: Fear-avoidance belief questionnaire(FABQ)
  time frame: 1 months, 3months, 6 months and 1year after intervention
  description: The FABQ is a self-assessment scale with 16 options. Each option has 0~6 points and 7 grades (from extremely disagreeable to extremely agreed). "0" means completely disagreed, "6" means completely agreed, and "1~5" means not sure. The higher the score, the more inclined to fully agree
  measure: Insomnia Severity Index(ISI)
  time frame: 1 months, 3months, 6 months and 1year after intervention
  description: The scale is a simple tool for screening insomnia, including 7 items, which are used to evaluate the nature and symptoms of sleep disorders of subjects.
  measure: Hospital Anxiety and Depression Scale(HADS)
  time frame: 1 months, 3months, 6 months and 1year after intervention
  description: HADS is a self-assessment scale, including two subscales, HADS-A and HADS-D, with a total of 14 items, including 7 items for anxiety (A) and 7 items for depression (D). Each item is scored at four levels according to the frequency of symptoms in the past month. Each item is scored at 0-3 points in four levels. The higher the score, the more serious the anxiety or depression
  measure: SF-36
  time frame: 1 months, 3months, 6 months and 1year after intervention
  description: SF-36 is a concise health questionnaire developed by the Boston Institute of Health, which is widely used in the measurement of the quality of life of the general population, the evaluation of clinical trials and the evaluation of health policies. SF-36 is used to assess physiological function, physiological function, physical pain, general health, energy, social function, emotional function and mental health, which are classified into "physical health" and "mental health"
  measure: Visual analogue scale(VAS)
  time frame: 1 months, 3months, 6 months and 1year after intervention
  description: Draw a 10cm horizontal line on the paper. One end of the line is "0", indicating no pain; the other end is "10", indicating severe pain; The middle represents different degrees of pain; Let the patient draw a mark on the horizontal line according to their feelings to indicate the degree of pain.
  measure: range of motion
  time frame: 1 months, 3months, 6 months and 1year after intervention
  description: Measure the patient's flexion, abduction, internal rotation and external rotation angle
  arm group label: manipulation under anesthesia group
  arm group type: Experimental
  description: The patient underwent manipulation under anesthesia
  arm group label: Supervised home rehabilitation group
  arm group type: Active Comparator
  description: The patient underwent supervised home rehabilitation
  intervention type: Procedure
  intervention name: manipulation under anesthesia
  description: After the anesthesia took effect, the patient was placed in the supine position, and the experienced surgeon stood at the head of the bed to release the affected limb by four angles of forward flexion, abduction, external rotation and internal rotation. After the operation is completed, 1ml de Bosson (MSD) +2.5ml sodium hyaluronate (Biochemical Industries Co., LTD.) is injected once.
  arm group label: manipulation under anesthesia group
  intervention type: Procedure
  intervention name: supervised home rehabilitation
  description: The doctor instructs the patient in exercise training at the outpatient clinic. At each clinic visit, the doctor will guide the different stages of the movement. At the first visit, the doctor guides the patient through the first phase of the rehabilitation program to improve the patient's basic mobility. At the first month of follow-up, the second phase of rehabilitation program was guided, and the recovery of mobility was accompanied by muscle training, including wall climbing and muscle resistance exercises. 1ml Debossone (MSD) +2.5ml sodium hyaluronate (Biochemical Industries Co., LTD.) was injected once at the clinic. All the training required patients to do their best at home to complete 3 sets of 5 each. At the end of each day, the patient will upload a video to the platform, and the doctor will evaluate whether the patient's recovery is in place.
  arm group label: Supervised home rehabilitation group
  criteria: 
  gender: All
  gender based: Yes
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: weiliang shen, doctor
  phone: +86 0571 87783759
  email: wlshen@zju.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Bursitis
  mesh term: Anesthetics