<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/NCT03245476</url>
  </required_header>
  <id_info>
    <org_study_id>17.08/REVA17.01</org_study_id>
    <nct_id>NCT03245476</nct_id>
  </id_info>
  <brief_title>Education-based Physical Therapy Approach for Adhesive Capsulitis</brief_title>
  <official_title>Physiotherapy in Adhesive Capsulitis Pathology: Effect of an Education Based Approach on Arthroscopic Evaluation Results, Joint Range of Motion, Psychosocial Factors, Shoulder Pain and Arm Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jessa Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hasselt University</source>
  <oversight_info>
    <has_dmc>No</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>
      This study aims, by means of a randomized control trial, to investigate which treatment&#xD;
      method (corticoid injection + physiotherapy with a focus on manual therapy and home-exercises&#xD;
      versus corticosteroid injection + physiotherapy with focus on education and supported home&#xD;
      exercises) gives better results on clinically relevant outcomes (range of glenohumeral&#xD;
      motion, psychological factors, pain, shoulder function, quality of life) and on parameters&#xD;
      derived from arthroscopic glenohumeral investigation by means of MRI.&#xD;
&#xD;
      Furthermore, associations between (1) the results on the MRI investigation, (2) the range of&#xD;
      glenohumeral motion, (3) shoulder function and pain, and (4) psychological factors will be&#xD;
      assessed at different time-points (before and at 6-12-18 and 52 weeks after the first&#xD;
      injection).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 4, 2017</start_date>
  <completion_date type="Anticipated">September 4, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 4, 2019</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>
    <intervention_model_description>corticoid injection + physiotherapy with a focus on manual therapy and home-exercises versus corticosteroid injection + physiotherapy with focus on education and supported home exercises</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Scapulothoracic, glenohumeral and elbow joint range of motion</measure>
    <time_frame>baseline</time_frame>
    <description>before the first injection with corticosteroids By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scapulothoracic, glenohumeral and elbow joint range of motion</measure>
    <time_frame>week 6</time_frame>
    <description>after the first injection with corticosteroids. By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scapulothoracic, glenohumeral and elbow joint range of motion</measure>
    <time_frame>week 12</time_frame>
    <description>after the first injection with corticosteroids. By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scapulothoracic, glenohumeral and elbow joint range of motion</measure>
    <time_frame>week 18</time_frame>
    <description>after the first injection with corticosteroids. By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scapulothoracic, glenohumeral and elbow joint range of motion</measure>
    <time_frame>week 52</time_frame>
    <description>after the first injection with corticosteroids. By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>parameters on arthrographic investigation by means of MRI</measure>
    <time_frame>baseline</time_frame>
    <description>the thickness of the coracohumeral ligament, the capacity of the inferior glenohumeral joint recessus are investigated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>parameters on arthrographic investigation by means of MRI</measure>
    <time_frame>week 18</time_frame>
    <description>the thickness of the coracohumeral ligament, the capacity of the inferior glenohumeral joint recessus are investigated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability of the shoulder, elbow and hand questionnaire</measure>
    <time_frame>baseline</time_frame>
    <description>assessment of upper limb function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability of the shoulder, elbow and hand questionnaire</measure>
    <time_frame>week 6</time_frame>
    <description>assessment of upper limb function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability of the shoulder, elbow and hand questionnaire</measure>
    <time_frame>week 12</time_frame>
    <description>assessment of upper limb function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability of the shoulder, elbow and hand questionnaire</measure>
    <time_frame>week 18</time_frame>
    <description>assessment of upper limb function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability of the shoulder, elbow and hand questionnaire</measure>
    <time_frame>week 52</time_frame>
    <description>assessment of upper limb function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief pain inventory</measure>
    <time_frame>baseline</time_frame>
    <description>assessment of current, worst and night pain on a 11 point likert scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief pain inventory</measure>
    <time_frame>week 6</time_frame>
    <description>assessment of current, worst and night pain on a 11 point likert scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief pain inventory</measure>
    <time_frame>week 12</time_frame>
    <description>assessment of current, worst and night pain on a 11 point likert scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief pain inventory</measure>
    <time_frame>week 18</time_frame>
    <description>assessment of current, worst and night pain on a 11 point likert scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief pain inventory</measure>
    <time_frame>week 52</time_frame>
    <description>assessment of current, worst and night pain on a 11 point likert scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L questionnaire</measure>
    <time_frame>baseline</time_frame>
    <description>Quality of life assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L questionnaire</measure>
    <time_frame>week 6</time_frame>
    <description>Quality of life assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L questionnaire</measure>
    <time_frame>week 12</time_frame>
    <description>Quality of life assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L questionnaire</measure>
    <time_frame>week 18</time_frame>
    <description>Quality of life assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L questionnaire</measure>
    <time_frame>week 52</time_frame>
    <description>Quality of life assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy questionnaire</measure>
    <time_frame>baseline</time_frame>
    <description>this questionnaire assesses the self-efficacy of a person</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy questionnaire</measure>
    <time_frame>week 6</time_frame>
    <description>this questionnaire assesses the self-efficacy of a person</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy questionnaire</measure>
    <time_frame>week 12</time_frame>
    <description>this questionnaire assesses the self-efficacy of a person</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy questionnaire</measure>
    <time_frame>week 18</time_frame>
    <description>this questionnaire assesses the self-efficacy of a person</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy questionnaire</measure>
    <time_frame>week 52</time_frame>
    <description>this questionnaire assesses the self-efficacy of a person</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tampa scale of kinesiophobia</measure>
    <time_frame>baseline</time_frame>
    <description>this scale investigates fear of movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tampa scale of kinesiophobia</measure>
    <time_frame>week 6</time_frame>
    <description>this scale investigates fear of movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tampa scale of kinesiophobia</measure>
    <time_frame>week 12</time_frame>
    <description>this scale investigates fear of movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tampa scale of kinesiophobia</measure>
    <time_frame>week 18</time_frame>
    <description>this scale investigates fear of movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tampa scale of kinesiophobia</measure>
    <time_frame>week 52</time_frame>
    <description>this scale investigates fear of movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital anxiety and depression scale</measure>
    <time_frame>baseline</time_frame>
    <description>this scale investigates anxiety and depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital anxiety and depression scale</measure>
    <time_frame>week 6</time_frame>
    <description>this scale investigates anxiety and depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital anxiety and depression scale</measure>
    <time_frame>week 12</time_frame>
    <description>this scale investigates anxiety and depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital anxiety and depression scale</measure>
    <time_frame>week 18</time_frame>
    <description>this scale investigates anxiety and depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital anxiety and depression scale</measure>
    <time_frame>week 52</time_frame>
    <description>this scale investigates anxiety and depression</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Adhesive Capsulitis</condition>
  <arm_group>
    <arm_group_label>manual therapy and home-exercises</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>corticoid injection + physiotherapy with a focus on manual therapy and home-exercises</description>
  </arm_group>
  <arm_group>
    <arm_group_label>education and supported home exercises</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>corticosteroid injection + physiotherapy with focus on education and supported home exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical therapy focus on manual therapy and home-exercises</intervention_name>
    <description>corticoid injection + physiotherapy with a focus on manual therapy and home-exercises</description>
    <arm_group_label>manual therapy and home-exercises</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical therapy focus on education and supported home exercises</intervention_name>
    <description>corticosteroid injection + physiotherapy with focus on education and supported home exercises</description>
    <arm_group_label>education and supported home exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50 % loss of passive GH external rotation motion, together with motion losses greater&#xD;
             than 25% in at least two other GH movements, as compared to the unaffected side&#xD;
&#xD;
          -  the pain accompanying the motion losses has to be present for at least one month.&#xD;
             During that month, the pain and mobility deficits have to be stable or get worse&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  bilateral frozen shoulder&#xD;
&#xD;
          -  systemic and/or neurologic disease or a self-reported pathologic condition of the&#xD;
             cervical/thoracic region, elbow or wrist/hand&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liesbet De Baets, dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Hasselt University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Annick Timmermans, prof. dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hasselt University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carl Dierickx, prof. dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Jessa ziekenhuis, Universiteit Hasselt</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liesbet De Baets, dr.</last_name>
    <phone>+32 11 29 21 29</phone>
    <email>liesbet.debaets@uhasselt.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Annick Timmermans, prof. dr.</last_name>
    <email>annick.timmermans@uhasselt.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Jessa Ziekenhuis</name>
      <address>
        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <contact>
      <last_name>Liesbet De Baets, dr.</last_name>
      <phone>+32 11 29 21 29</phone>
      <email>liesbet.debaets@uhasselt.be</email>
    </contact>
    <contact_backup>
      <last_name>Carl Dierickx</last_name>
      <email>carl.dierickx@jessazh.be</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hasselt University</investigator_affiliation>
    <investigator_full_name>Annick Timmermans</investigator_full_name>
    <investigator_title>prof. dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bursitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03245476
org study id: 17.08/REVA17.01
nct id: NCT03245476
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims, by means of a randomized control trial, to investigate which treatment
      method (corticoid injection + physiotherapy with a focus on manual therapy and home-exercises
      versus corticosteroid injection + physiotherapy with focus on education and supported home
      exercises) gives better results on clinically relevant outcomes (range of glenohumeral
      motion, psychological factors, pain, shoulder function, quality of life) and on parameters
      derived from arthroscopic glenohumeral investigation by means of MRI.

      Furthermore, associations between (1) the results on the MRI investigation, (2) the range of
      glenohumeral motion, (3) shoulder function and pain, and (4) psychological factors will be
      assessed at different time-points (before and at 6-12-18 and 52 weeks after the first
      injection).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: corticoid injection + physiotherapy with a focus on manual therapy and home-exercises versus corticosteroid injection + physiotherapy with focus on education and supported home exercises
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Scapulothoracic, glenohumeral and elbow joint range of motion
time frame: baseline
description: before the first injection with corticosteroids By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance
measure: Scapulothoracic, glenohumeral and elbow joint range of motion
time frame: week 6
description: after the first injection with corticosteroids. By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance
measure: Scapulothoracic, glenohumeral and elbow joint range of motion
time frame: week 12
description: after the first injection with corticosteroids. By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance
measure: Scapulothoracic, glenohumeral and elbow joint range of motion
time frame: week 18
description: after the first injection with corticosteroids. By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance
measure: Scapulothoracic, glenohumeral and elbow joint range of motion
time frame: week 52
description: after the first injection with corticosteroids. By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance
measure: parameters on arthrographic investigation by means of MRI
time frame: baseline
description: the thickness of the coracohumeral ligament, the capacity of the inferior glenohumeral joint recessus are investigated.
measure: parameters on arthrographic investigation by means of MRI
time frame: week 18
description: the thickness of the coracohumeral ligament, the capacity of the inferior glenohumeral joint recessus are investigated.
measure: Disability of the shoulder, elbow and hand questionnaire
time frame: baseline
description: assessment of upper limb function
measure: Disability of the shoulder, elbow and hand questionnaire
time frame: week 6
description: assessment of upper limb function
measure: Disability of the shoulder, elbow and hand questionnaire
time frame: week 12
description: assessment of upper limb function
measure: Disability of the shoulder, elbow and hand questionnaire
time frame: week 18
description: assessment of upper limb function
measure: Disability of the shoulder, elbow and hand questionnaire
time frame: week 52
description: assessment of upper limb function
measure: Brief pain inventory
time frame: baseline
description: assessment of current, worst and night pain on a 11 point likert scale
measure: Brief pain inventory
time frame: week 6
description: assessment of current, worst and night pain on a 11 point likert scale
measure: Brief pain inventory
time frame: week 12
description: assessment of current, worst and night pain on a 11 point likert scale
measure: Brief pain inventory
time frame: week 18
description: assessment of current, worst and night pain on a 11 point likert scale
measure: Brief pain inventory
time frame: week 52
description: assessment of current, worst and night pain on a 11 point likert scale
measure: EQ-5D-5L questionnaire
time frame: baseline
description: Quality of life assessment
measure: EQ-5D-5L questionnaire
time frame: week 6
description: Quality of life assessment
measure: EQ-5D-5L questionnaire
time frame: week 12
description: Quality of life assessment
measure: EQ-5D-5L questionnaire
time frame: week 18
description: Quality of life assessment
measure: EQ-5D-5L questionnaire
time frame: week 52
description: Quality of life assessment
measure: Self-efficacy questionnaire
time frame: baseline
description: this questionnaire assesses the self-efficacy of a person
measure: Self-efficacy questionnaire
time frame: week 6
description: this questionnaire assesses the self-efficacy of a person
measure: Self-efficacy questionnaire
time frame: week 12
description: this questionnaire assesses the self-efficacy of a person
measure: Self-efficacy questionnaire
time frame: week 18
description: this questionnaire assesses the self-efficacy of a person
measure: Self-efficacy questionnaire
time frame: week 52
description: this questionnaire assesses the self-efficacy of a person
measure: Tampa scale of kinesiophobia
time frame: baseline
description: this scale investigates fear of movement
measure: Tampa scale of kinesiophobia
time frame: week 6
description: this scale investigates fear of movement
measure: Tampa scale of kinesiophobia
time frame: week 12
description: this scale investigates fear of movement
measure: Tampa scale of kinesiophobia
time frame: week 18
description: this scale investigates fear of movement
measure: Tampa scale of kinesiophobia
time frame: week 52
description: this scale investigates fear of movement
measure: Hospital anxiety and depression scale
time frame: baseline
description: this scale investigates anxiety and depression
measure: Hospital anxiety and depression scale
time frame: week 6
description: this scale investigates anxiety and depression
measure: Hospital anxiety and depression scale
time frame: week 12
description: this scale investigates anxiety and depression
measure: Hospital anxiety and depression scale
time frame: week 18
description: this scale investigates anxiety and depression
measure: Hospital anxiety and depression scale
time frame: week 52
description: this scale investigates anxiety and depression
arm group label: manual therapy and home-exercises
arm group type: Active Comparator
description: corticoid injection + physiotherapy with a focus on manual therapy and home-exercises
arm group label: education and supported home exercises
arm group type: Active Comparator
description: corticosteroid injection + physiotherapy with focus on education and supported home exercises
intervention type: Other
intervention name: Physical therapy focus on manual therapy and home-exercises
description: corticoid injection + physiotherapy with a focus on manual therapy and home-exercises
arm group label: manual therapy and home-exercises
intervention type: Other
intervention name: Physical therapy focus on education and supported home exercises
description: corticosteroid injection + physiotherapy with focus on education and supported home exercises
arm group label: education and supported home exercises
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Liesbet De Baets, dr.
role: Study Chair
affiliation: Hasselt University
last name: Annick Timmermans, prof. dr.
role: Principal Investigator
affiliation: Hasselt University
last name: Carl Dierickx, prof. dr.
role: Study Chair
affiliation: Jessa ziekenhuis, Universiteit Hasselt
last name: Liesbet De Baets, dr.
phone: +32 11 29 21 29
email: liesbet.debaets@uhasselt.be
last name: Annick Timmermans, prof. dr.
email: annick.timmermans@uhasselt.be
facility: 
contact: 
contact backup: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Hasselt University
investigator full name: Annick Timmermans
investigator title: prof. dr.
mesh term: Bursitis
sharing ipd: Undecided