<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/NCT02969135</url>
  </required_header>
  <id_info>
    <org_study_id>FYS012</org_study_id>
    <nct_id>NCT02969135</nct_id>
  </id_info>
  <brief_title>Progressive Active Exercise After Surgical Rotator Cuff Repair</brief_title>
  <official_title>Physiotherapy With Progressive Active Exercise Training After Surgical Rotator Cuff Repair -A Randomized Controlled Trial With 3 and 12 Months Follow-up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marius Henriksen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Frederiksberg University Hospital</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>
      Shoulder disorders are extremely common, with a life-time prevalence in population of 30%.&#xD;
      About 23% of the working population with shoulder problems are sick-listed. Specifically&#xD;
      rotator cuff tears are considered some of the principal causes of chronic shoulder pain and&#xD;
      disability, especially with advancing age. The National Patient Register in Denmark has&#xD;
      registered 730 rotator cuff repairs in 2006 and 990 in 2012, which represents a 35% increase.&#xD;
&#xD;
      A rotator cuff tear is defined as a rupture of the tendon (s) of the shoulder, and most&#xD;
      frequently involves the supraspinatus and/or the infraspinatus tendon, resulting in loss of&#xD;
      function due to pain and tissue weakness. Little is known about the effects of the&#xD;
      postoperative training/rehabilitation, and this provides an unclear picture of the total&#xD;
      treatment procedure of this condition.&#xD;
&#xD;
      The Danish National Clinical Guidelines from 2013 recommend that these patients are offered&#xD;
      rehabilitation and that the shoulder is immobilized post-surgery, but the evidence for&#xD;
      postoperative training is moderate- low. The past few years, there have been conducted 5&#xD;
      systematic reviews looking at different rehabilitation parameters after rotator cuff surgery.&#xD;
      They conclude that early Range-Of-Motion exercise accelerate healing, reduce stiffness, do&#xD;
      not increase risk of re-rupture and that immobilization do not increase tendon healing or&#xD;
      clinical outcome. They also conclude that there is a further need to evaluate approaches that&#xD;
      foster early initiation of rehabilitation and gradual introduction of functional load in&#xD;
      high-quality, adequately powered trials, also considering key outcomes such as return to&#xD;
      work.&#xD;
&#xD;
      Therefore, the aim of this study is to compare the effect of a progressive early passive and&#xD;
      active movement protocol with a care as usual (limited early passive movement protocol) on&#xD;
      tendon healing, physical function, pain, and quality of life, in patients operated due to&#xD;
      traumatic full thickness rotator cuff tear in a Randomized Controlled Trial.&#xD;
&#xD;
      Shortterm effects of physical function, pain, and quality of life will be studied as primary&#xD;
      patient reported outcome, while secondary outcomes will be clinical and paraclinical outcomes&#xD;
      in addition to the longterm effects of physical function, pain, and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2017</start_date>
  <completion_date type="Actual">May 10, 2020</completion_date>
  <primary_completion_date type="Actual">May 10, 2020</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>Change from baseline in Western Ontario Rotator Cuff Index (WORC)</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Western Ontario Rotator Cuff Index (WORC)</measure>
    <time_frame>6 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Disability Arm Shoulder Hand (DASH)</measure>
    <time_frame>6, 12 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Rating Scale (GRS)</measure>
    <time_frame>6, 12 and 52 weeks</time_frame>
    <description>Global perceived treatment effect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Numeric Pain Rating Scale (NPRS)</measure>
    <time_frame>6, 12 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Shoulder Range of Motion (ROM)</measure>
    <time_frame>6, 12 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Shoulder Muscle Strength (maximum isometric voluntary contraction) of external and internal rotation and scaption</measure>
    <time_frame>12 and 52 weeks</time_frame>
    <description>Maximum isometric voluntary contraction (MVC) of external and internal rotation and scaption (elevation in scapular plane) measured by IsoForce EVO2 dynamometer.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Ultrasound imaging of rotator cuff tendons</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessment of possible re-ruptures of tendons</description>
  </other_outcome>
  <other_outcome>
    <measure>Ultrasound Imaging of rotator cuff tendons</measure>
    <time_frame>52 weeks</time_frame>
    <description>Tendon healing characteristics of the repaired tendon compared to the healthy shoulder tendons</description>
  </other_outcome>
  <other_outcome>
    <measure>Return to work</measure>
    <time_frame>6 and 52 weeks</time_frame>
    <description>Patient-reported time (days) til return to full work capacity.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <arm_group>
    <arm_group_label>Progressive early passive and active movement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active exercise starts one week after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Limited early passive movement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active exercise starts six weeks after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Progressive early passive and active movement</intervention_name>
    <description>Post-surgical physical therapy including active exercise</description>
    <arm_group_label>Progressive early passive and active movement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Limited early passive movement</intervention_name>
    <description>Post-surgical physical therapy including passive mobilisation</description>
    <arm_group_label>Limited early passive movement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women and men above 18 years&#xD;
&#xD;
          -  Operated due to traumatic full thickness RC-tear&#xD;
&#xD;
          -  Involving supraspinatus (full thickness and width)&#xD;
&#xD;
          -  Present with reduced arm elevation strength and pain&#xD;
&#xD;
          -  Clinical diagnosis verified by arthroscopy&#xD;
&#xD;
          -  Fully repairable RC-tear&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with non-traumatic RC-tears of the shoulder&#xD;
&#xD;
          -  Patients with isolated teres minor or subscapularis tear&#xD;
&#xD;
          -  Patients with partial thickness/ width tear&#xD;
&#xD;
          -  Prior shoulder surgery (all shoulder joints)&#xD;
&#xD;
          -  Glenohumeral osteo arthrosis (OA), rheumatoid arthritis or periarthrosis&#xD;
&#xD;
          -  Inability to speak or read Danish&#xD;
&#xD;
          -  Inability to perform and maintain the physical training&#xD;
&#xD;
          -  Other condition negatively influencing compliance or conditions that in the opinion of&#xD;
             the investigator puts a potential participant at increased risk or otherwise makes&#xD;
             him/her unsuitable for participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bispebjerg and Frederiksberg Hospitals</name>
      <address>
        <city>Copenhagen</city>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herlev and Gentofte Hospital</name>
      <address>
        <city>Copenhagen</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 20, 2020</last_update_submitted>
  <last_update_submitted_qc>November 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Frederiksberg University Hospital</investigator_affiliation>
    <investigator_full_name>Marius Henriksen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff Injuries</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/NCT02969135
org study id: FYS012
nct id: NCT02969135
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Shoulder disorders are extremely common, with a life-time prevalence in population of 30%.
      About 23% of the working population with shoulder problems are sick-listed. Specifically
      rotator cuff tears are considered some of the principal causes of chronic shoulder pain and
      disability, especially with advancing age. The National Patient Register in Denmark has
      registered 730 rotator cuff repairs in 2006 and 990 in 2012, which represents a 35% increase.

      A rotator cuff tear is defined as a rupture of the tendon (s) of the shoulder, and most
      frequently involves the supraspinatus and/or the infraspinatus tendon, resulting in loss of
      function due to pain and tissue weakness. Little is known about the effects of the
      postoperative training/rehabilitation, and this provides an unclear picture of the total
      treatment procedure of this condition.

      The Danish National Clinical Guidelines from 2013 recommend that these patients are offered
      rehabilitation and that the shoulder is immobilized post-surgery, but the evidence for
      postoperative training is moderate- low. The past few years, there have been conducted 5
      systematic reviews looking at different rehabilitation parameters after rotator cuff surgery.
      They conclude that early Range-Of-Motion exercise accelerate healing, reduce stiffness, do
      not increase risk of re-rupture and that immobilization do not increase tendon healing or
      clinical outcome. They also conclude that there is a further need to evaluate approaches that
      foster early initiation of rehabilitation and gradual introduction of functional load in
      high-quality, adequately powered trials, also considering key outcomes such as return to
      work.

      Therefore, the aim of this study is to compare the effect of a progressive early passive and
      active movement protocol with a care as usual (limited early passive movement protocol) on
      tendon healing, physical function, pain, and quality of life, in patients operated due to
      traumatic full thickness rotator cuff tear in a Randomized Controlled Trial.

      Shortterm effects of physical function, pain, and quality of life will be studied as primary
      patient reported outcome, while secondary outcomes will be clinical and paraclinical outcomes
      in addition to the longterm effects of physical function, pain, and quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change from baseline in Western Ontario Rotator Cuff Index (WORC)
time frame: 12 weeks
measure: Change from baseline in Western Ontario Rotator Cuff Index (WORC)
time frame: 6 and 52 weeks
measure: Change from baseline in Disability Arm Shoulder Hand (DASH)
time frame: 6, 12 and 52 weeks
measure: Global Rating Scale (GRS)
time frame: 6, 12 and 52 weeks
description: Global perceived treatment effect
measure: Change from baseline in Numeric Pain Rating Scale (NPRS)
time frame: 6, 12 and 52 weeks
measure: Change from baseline in Shoulder Range of Motion (ROM)
time frame: 6, 12 and 52 weeks
measure: Change from baseline in Shoulder Muscle Strength (maximum isometric voluntary contraction) of external and internal rotation and scaption
time frame: 12 and 52 weeks
description: Maximum isometric voluntary contraction (MVC) of external and internal rotation and scaption (elevation in scapular plane) measured by IsoForce EVO2 dynamometer.
measure: Ultrasound imaging of rotator cuff tendons
time frame: 6 weeks
description: Assessment of possible re-ruptures of tendons
measure: Ultrasound Imaging of rotator cuff tendons
time frame: 52 weeks
description: Tendon healing characteristics of the repaired tendon compared to the healthy shoulder tendons
measure: Return to work
time frame: 6 and 52 weeks
description: Patient-reported time (days) til return to full work capacity.
arm group label: Progressive early passive and active movement
arm group type: Experimental
description: Active exercise starts one week after surgery.
arm group label: Limited early passive movement
arm group type: Active Comparator
description: Active exercise starts six weeks after surgery.
intervention type: Behavioral
intervention name: Progressive early passive and active movement
description: Post-surgical physical therapy including active exercise
arm group label: Progressive early passive and active movement
intervention type: Behavioral
intervention name: Limited early passive movement
description: Post-surgical physical therapy including passive mobilisation
arm group label: Limited early passive movement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Frederiksberg University Hospital
investigator full name: Marius Henriksen
investigator title: Professor
mesh term: Rotator Cuff Injuries
sharing ipd: Undecided