<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/NCT02208752</url>
  </required_header>
  <id_info>
    <org_study_id>CARM2014</org_study_id>
    <nct_id>NCT02208752</nct_id>
  </id_info>
  <brief_title>The Effect of a Pre-operative Exercise Program for Patients With Full Thickness Rotator Cuff Tear Waiting for Surgical Repair</brief_title>
  <official_title>The Effect of a Pre-operative Exercise Program on Pain and Function in Patients With Full Thickness Rotator Cuff Tear Waiting for Surgical Repair.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Université de Montréal</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomised controlled study involving a group of 20 patients- 10 patients in a&#xD;
      control group, 10 patients in treatment group. The treatment group consists of exercises with&#xD;
      theraband for the shoulder and exercises of motor control of the scapula. The purpose of the&#xD;
      study is to measure the effects of a pre-operative physiotherapy program for patients awaitng&#xD;
      for rotator cuff surgery, The duration of the pilot project is 4 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is taken place in a genral hospital using the waiting list in the orthopedic&#xD;
      surgery department- only patients awaitng for rotator cuff surgery are included. a randomised&#xD;
      process of a block will be used. There will be 2 groups of patients an active comparator and&#xD;
      no intervention. All patients at the beginning of the project and after 4 weks will have an&#xD;
      evaluation on range of motion, strength, acromial humeral mesurement done by ultrasound and&#xD;
      questionnaire on pain(DASH) and quality of life( WORC). At 8 weeks all patients will fill in&#xD;
      the 2 questionnaires on DASH and WORC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">October 2014</completion_date>
  <primary_completion_date type="Anticipated">September 2014</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>WORC questionnaire</measure>
    <time_frame>30 days</time_frame>
    <description>To evaluate function and quality of life at 0 weeks and 4 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DASH questionnaire</measure>
    <time_frame>30 days</time_frame>
    <description>To evaluate pain at 0 weeks and 4 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultrasound measures</measure>
    <time_frame>30 days</time_frame>
    <description>Mesurement distance of acromial-humerale distance at 0 and 4 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>range of motion</measure>
    <time_frame>30 days</time_frame>
    <description>measurement of joint movement (active and passif range of motion) with goniometer at 0 and 4 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>strength</measure>
    <time_frame>30 days</time_frame>
    <description>measurement of isometric strength with the Nicolas dynamometer at 0 week and 4 week.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Rotator Cuff Tears</condition>
  <arm_group>
    <arm_group_label>Exercises</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>exericises on motor control and strengthening exercises on the Rotator Cuff</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group- No exercises</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>No exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercises</intervention_name>
    <description>exercise program on strengthening the rotator cuff muscles and motor control of the scapula</description>
    <arm_group_label>Control group- No exercises</arm_group_label>
    <arm_group_label>Exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients waitng for surgery at Cite de la Sante Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Glenohumeral Arthirtis&#xD;
&#xD;
          -  Shoulder fracture&#xD;
&#xD;
          -  Corticosteriod injections&#xD;
&#xD;
          -  Rupture of rotator cuff tear of more than 3 cm&#xD;
&#xD;
          -  CSST- Workman's compensation&#xD;
&#xD;
          -  Central and peripheral neuropathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>François Desmeules, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Université de Montréal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Cite-de-la-Santé</name>
      <address>
        <city>Laval</city>
        <state>Quebec</state>
        <zip>H7M 3L9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary Caravias, Bachelor</last_name>
      <phone>450-975-5401</phone>
      <email>mariecaravias@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>François Desmeules, Ph. D</last_name>
      <phone>514-343-6791</phone>
      <email>f.desmeules@umontreal.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 4, 2014</last_update_submitted>
  <last_update_submitted_qc>August 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université de Montréal</investigator_affiliation>
    <investigator_full_name>François Desmeules</investigator_full_name>
    <investigator_title>Principal researcher</investigator_title>
  </responsible_party>
  <keyword>rotator cuff tears</keyword>
  <keyword>ultrasound measure</keyword>
  <keyword>pain</keyword>
  <keyword>range of motion</keyword>
  <keyword>muscle force</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>May 1, 2017</submitted>
    <returned>August 11, 2017</returned>
  </pending_results>
  <!-- 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/NCT02208752
org study id: CARM2014
nct id: NCT02208752
lead sponsor: 
has dmc: No
This is a randomised controlled study involving a group of 20 patients- 10 patients in a
      control group, 10 patients in treatment group. The treatment group consists of exercises with
      theraband for the shoulder and exercises of motor control of the scapula. The purpose of the
      study is to measure the effects of a pre-operative physiotherapy program for patients awaitng
      for rotator cuff surgery, The duration of the pilot project is 4 weeks.
This study is taken place in a genral hospital using the waiting list in the orthopedic
      surgery department- only patients awaitng for rotator cuff surgery are included. a randomised
      process of a block will be used. There will be 2 groups of patients an active comparator and
      no intervention. All patients at the beginning of the project and after 4 weks will have an
      evaluation on range of motion, strength, acromial humeral mesurement done by ultrasound and
      questionnaire on pain(DASH) and quality of life( WORC). At 8 weeks all patients will fill in
      the 2 questionnaires on DASH and WORC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: WORC questionnaire
time frame: 30 days
description: To evaluate function and quality of life at 0 weeks and 4 weeks
measure: DASH questionnaire
time frame: 30 days
description: To evaluate pain at 0 weeks and 4 weeks
measure: Ultrasound measures
time frame: 30 days
description: Mesurement distance of acromial-humerale distance at 0 and 4 weeks
measure: range of motion
time frame: 30 days
description: measurement of joint movement (active and passif range of motion) with goniometer at 0 and 4 week
measure: strength
time frame: 30 days
description: measurement of isometric strength with the Nicolas dynamometer at 0 week and 4 week.
arm group label: Exercises
arm group type: Active Comparator
description: exericises on motor control and strengthening exercises on the Rotator Cuff
arm group label: Control group- No exercises
arm group type: Placebo Comparator
description: No exercises
intervention type: Other
intervention name: Exercises
description: exercise program on strengthening the rotator cuff muscles and motor control of the scapula
arm group label: Control group- No exercises
arm group label: Exercises
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: François Desmeules, Phd
role: Principal Investigator
affiliation: Université de Montréal
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Université de Montréal
investigator full name: François Desmeules
investigator title: Principal researcher
mesh term: Rotator Cuff Injuries
submitted: May 1, 2017
returned: August 11, 2017