<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/NCT01691157</url>
  </required_header>
  <id_info>
    <org_study_id>11/NI/0026 version 3.1</org_study_id>
    <nct_id>NCT01691157</nct_id>
  </id_info>
  <brief_title>Exercise in the Physiotherapy Management of Shoulder Impingement</brief_title>
  <acronym>EaSI</acronym>
  <official_title>The Effectiveness of Exercise in the Physiotherapy Management of Subacromial Impingement Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Ulster</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Belfast Health and Social Care Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northern Health and Social Care Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Keele University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Ulster</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial is to investigate the effectiveness of an evidence based exercise&#xD;
      program for shoulder impingement. Approximately 1% of adults consult their General&#xD;
      Practitioner (GP) with shoulder pain each year, making it the third most common reason for&#xD;
      musculoskeletal GP consultations in the UK. A further 50% of these patients are diagnosed&#xD;
      with subacromial impingement syndrome (SAIS) (shoulder impingement syndrome) and commonly&#xD;
      referred for physiotherapy treatment. This trial aims to compare the effectiveness of an&#xD;
      evidence based exercise protocol with usual physiotherapy care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physiotherapy management of shoulder impingement frequently involves exercise, however there&#xD;
      is little evidence underpinning exercise prescription and outcomes are poor. Few trials have&#xD;
      investigated which muscles should be targeted and how they should be strengthened with&#xD;
      respect to the mode, frequency, duration, intensity and progression. This is a randomized&#xD;
      controlled trial(RCT) investigating the effectiveness of an evidence based exercise program&#xD;
      for shoulder impingement. This research may have an impact on how physiotherapists provide&#xD;
      exercise programs to patients with shoulder impingement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">May 2013</completion_date>
  <primary_completion_date type="Anticipated">May 2013</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>change from baseline in average pain scores at rest and at night using 100mm visual analogue scale (VAS).</measure>
    <time_frame>Outcomes measured at 0, 6 and 12 weeks</time_frame>
    <description>Primary outcome measure: Average pain scores at rest and at night for the week prior to measurement will be recorded using a 100mm visual analogue scale (VAS). The change in pain scores at 6 and 12 weeks from baseline will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Western Ontario Rotator Cuff Index (WORC</measure>
    <time_frame>0, 6 and 12 weeks</time_frame>
    <description>Secondary outcome measures will focus on function, disability and quality of life, consisting of a combination of generic, region specific and disease-specific health questionnaires. The change in scores from baseline will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The American Shoulder and Elbow Surgeons function score.</measure>
    <time_frame>0. 6 and 12 weeks</time_frame>
    <description>Limb specific outcome measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 Health Survey • SF-36 Health Survey</measure>
    <time_frame>0, 6 and 12 weeks</time_frame>
    <description>Generic measure of health status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Isometric strength and range of movement of shoulder flexion, abduction, external rotation and internal rotation using a hand held dynamometer.</measure>
    <time_frame>0, 6 and 12 weeks</time_frame>
    <description>objective measures of strength and ROM</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">94</enrollment>
  <condition>Subacromial Impingement Syndrome</condition>
  <arm_group>
    <arm_group_label>Usual physiotherapy without exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Will receive 6 sessions of modified usual physiotherapy care that can consist of any physiotherapeutic modalities normally provided except exercise. this may consist of postural advice, taping, electrotherapy, acupuncture, manual joint mobilizations of the shoulder, cervical or thoracic spine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive an evidence based exercise protocol but no other physiotherapeutic modalities</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evidence based exercise protocol</intervention_name>
    <description>An evidence based graduated exercise rehabilitation protocol will be provided and supervised by a physiotherapist. patients will receive 6 sessions of supervised physiotherapy</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual physiotherapy without exercise</intervention_name>
    <description>Will receive modified usual physiotherapy care that can consist of any physiotherapeutic modalities normally provided except exercise. this may consist of postural advice, taping, electrotherapy, acupuncture, manual joint mobilizations of the shoulder, cervical or thoracic spine.</description>
    <arm_group_label>Usual physiotherapy without exercise</arm_group_label>
    <other_name>Usual care</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be aged 18 years and older.&#xD;
&#xD;
          -  Shoulder pain of at least 3/10 in severity that has been diagnosed by a consultant&#xD;
             rheumatologist, orthopaedic surgeon or general practitioner within the past 12 months.&#xD;
&#xD;
          -  Positive Hawkins-Kennedy test.&#xD;
&#xD;
          -  Positive on testing either supraspinatus (empty can test) or infraspinatus (resisted&#xD;
             external rotation in neutral).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute traumatic conditions.&#xD;
&#xD;
          -  Evidence of rotator cuff tear (positive drop arm test) or any other shoulder joint&#xD;
             pathology (e.g. adhesive capsulitis, labral tears).&#xD;
&#xD;
          -  A history of fractures of the upper arm, shoulder or clavicle within the past two&#xD;
             years.&#xD;
&#xD;
          -  A history of dislocation of the shoulder within the previous two years.&#xD;
&#xD;
          -  Postoperative conditions involving the upper arm, shoulder or clavicle.&#xD;
&#xD;
          -  Inflammatory or systemic diseases.&#xD;
&#xD;
          -  Current signs and symptoms of acute nerve root pain arising from the cervical or upper&#xD;
             thoracic spine.&#xD;
&#xD;
          -  Previous physiotherapy for the same condition involving an exercise regime.&#xD;
&#xD;
          -  Previous corticosteroid injection of the affected shoulder within the past 6 months.&#xD;
&#xD;
          -  Unwilling participant.&#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>Joseph G McVeigh, BSc Hons</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ulster</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Catherine E Hanratty, BSc Hons</last_name>
    <phone>0044 2890 368732</phone>
    <email>hanratty-c@email.ulster.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Joseph G McVeigh, BSc Hons</last_name>
    <phone>0044 2890 368148</phone>
    <email>j.mcveigh@ulster.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Musgrave Park Hospital</name>
      <address>
        <city>Belfast</city>
        <state>N.Ireland</state>
        <zip>BT9 7JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ingrid Traynor, Physio</last_name>
      <phone>0044289090</phone>
      <phone_ext>2078</phone_ext>
      <email>ingrid.traynor@belfasttrust.hscni.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Waveney Hospital</name>
      <address>
        <city>Ballymena</city>
        <state>N.I</state>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Colin Brennan, physio</last_name>
      <phone>00442870347853</phone>
      <email>colin.brennan@hscni.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Robinson Memorial Hospital</name>
      <address>
        <city>Ballymoney</city>
        <state>N.I</state>
        <zip>BT53 6HB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Colin Brennan, Physio</last_name>
      <phone>00442870347853</phone>
      <email>colin.brennan@northerntrust.hscni.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Fort Centre, Physiotherapy Department</name>
      <address>
        <city>Coleraine</city>
        <state>N.I</state>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Colin Brennan, Physio</last_name>
      <phone>00442870347853</phone>
      <email>colin.brennan@hscni.net</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>October 11, 2012</last_update_submitted>
  <last_update_submitted_qc>October 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Ulster</investigator_affiliation>
    <investigator_full_name>Dr Joseph G McVeigh</investigator_full_name>
    <investigator_title>Lecturer in Physiotherapy and PhD supervisor</investigator_title>
  </responsible_party>
  <keyword>Subacromial impingement syndrome</keyword>
  <keyword>Rotator cuff</keyword>
  <keyword>Exercise</keyword>
  <keyword>Physiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Impingement Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT01691157
org study id: 11/NI/0026 version 3.1
nct id: NCT01691157
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this trial is to investigate the effectiveness of an evidence based exercise
      program for shoulder impingement. Approximately 1% of adults consult their General
      Practitioner (GP) with shoulder pain each year, making it the third most common reason for
      musculoskeletal GP consultations in the UK. A further 50% of these patients are diagnosed
      with subacromial impingement syndrome (SAIS) (shoulder impingement syndrome) and commonly
      referred for physiotherapy treatment. This trial aims to compare the effectiveness of an
      evidence based exercise protocol with usual physiotherapy care.
Physiotherapy management of shoulder impingement frequently involves exercise, however there
      is little evidence underpinning exercise prescription and outcomes are poor. Few trials have
      investigated which muscles should be targeted and how they should be strengthened with
      respect to the mode, frequency, duration, intensity and progression. This is a randomized
      controlled trial(RCT) investigating the effectiveness of an evidence based exercise program
      for shoulder impingement. This research may have an impact on how physiotherapists provide
      exercise programs to patients with shoulder impingement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: change from baseline in average pain scores at rest and at night using 100mm visual analogue scale (VAS).
time frame: Outcomes measured at 0, 6 and 12 weeks
description: Primary outcome measure: Average pain scores at rest and at night for the week prior to measurement will be recorded using a 100mm visual analogue scale (VAS). The change in pain scores at 6 and 12 weeks from baseline will be measured.
measure: Western Ontario Rotator Cuff Index (WORC
time frame: 0, 6 and 12 weeks
description: Secondary outcome measures will focus on function, disability and quality of life, consisting of a combination of generic, region specific and disease-specific health questionnaires. The change in scores from baseline will be measured.
measure: The American Shoulder and Elbow Surgeons function score.
time frame: 0. 6 and 12 weeks
description: Limb specific outcome measure
measure: SF-36 Health Survey • SF-36 Health Survey
time frame: 0, 6 and 12 weeks
description: Generic measure of health status
measure: Isometric strength and range of movement of shoulder flexion, abduction, external rotation and internal rotation using a hand held dynamometer.
time frame: 0, 6 and 12 weeks
description: objective measures of strength and ROM
arm group label: Usual physiotherapy without exercise
arm group type: Active Comparator
description: Will receive 6 sessions of modified usual physiotherapy care that can consist of any physiotherapeutic modalities normally provided except exercise. this may consist of postural advice, taping, electrotherapy, acupuncture, manual joint mobilizations of the shoulder, cervical or thoracic spine.
arm group label: Exercise
arm group type: Experimental
description: Will receive an evidence based exercise protocol but no other physiotherapeutic modalities
intervention type: Other
intervention name: Evidence based exercise protocol
description: An evidence based graduated exercise rehabilitation protocol will be provided and supervised by a physiotherapist. patients will receive 6 sessions of supervised physiotherapy
arm group label: Exercise
intervention type: Other
intervention name: Usual physiotherapy without exercise
description: Will receive modified usual physiotherapy care that can consist of any physiotherapeutic modalities normally provided except exercise. this may consist of postural advice, taping, electrotherapy, acupuncture, manual joint mobilizations of the shoulder, cervical or thoracic spine.
arm group label: Usual physiotherapy without exercise
other name: Usual care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joseph G McVeigh, BSc Hons
role: Principal Investigator
affiliation: University of Ulster
last name: Catherine E Hanratty, BSc Hons
phone: 0044 2890 368732
email: hanratty-c@email.ulster.ac.uk
last name: Joseph G McVeigh, BSc Hons
phone: 0044 2890 368148
email: j.mcveigh@ulster.ac.uk
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Ulster
investigator full name: Dr Joseph G McVeigh
investigator title: Lecturer in Physiotherapy and PhD supervisor
mesh term: Shoulder Impingement Syndrome
mesh term: Syndrome
mesh term: Rotator Cuff Injuries