<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/NCT03041727</url>
  </required_header>
  <id_info>
    <org_study_id>AOBolognini 1</org_study_id>
    <nct_id>NCT03041727</nct_id>
  </id_info>
  <brief_title>Physiotherapist Approach to Shoulder's Diseases, Differences Between Fascial Manipulation and Standard Exercises</brief_title>
  <official_title>Physiotherapist Approach to Shoulder's Diseases, Differences Between Fascial Manipulation and Standard Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera Bolognini di Seriate Bergamo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliera Bolognini di Seriate Bergamo</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>
      The study purpose is to compare the effects of Fascial Manipulation added to standard&#xD;
      exercises protocol versus the simple exercises protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The shoulder degenerative diseases are recurring in hospital employees. The early approach,&#xD;
      as we see in literature, has high probability to reduce the pain and the disfunction in the&#xD;
      long term.&#xD;
&#xD;
      In particular stretching and strengthening exercises are the standard protocol applied.&#xD;
&#xD;
      The Fascial Manipulation is a manual therapy that works on the connective tissue, by&#xD;
      increasing mobility and reducing pain.&#xD;
&#xD;
      We have added the Fascial Manipulation to prove if it make a faster recovery and a pain&#xD;
      reduction in the short and the middle term.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">August 1, 2021</completion_date>
  <primary_completion_date type="Actual">August 1, 2021</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>Participants are assigned to one of two or more groups in parallel for the duration of the study are evaluated in parallel against a control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The outcome assessor will be a statistic techinician, with any knowledge about the group composition and the rehabilitative intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Shoulder Pain</measure>
    <time_frame>Before and after the first treatment. A week after the enrollment.</time_frame>
    <description>VNS scale in the Apley 'Scratch Test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>shoulder' function</measure>
    <time_frame>Before and after the first treatment. A week after the enrollment.</time_frame>
    <description>Constant Morley Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>shoulder' function</measure>
    <time_frame>Before and after the fifth treatment, after five weeks. This will be the last treatment</time_frame>
    <description>Constant Morley Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>shoulder' function</measure>
    <time_frame>A month later the last treatment, as follow up</time_frame>
    <description>Constant Morley Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Movement of the shoulder</measure>
    <time_frame>Before and after the first treatment. A week after the enrollment.</time_frame>
    <description>Bubble Inclinometer used in the flexion, abduction and external rotation movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Movement of the shoulder</measure>
    <time_frame>Before and after the fifth treatment, after five weeks.This will be the last treatment</time_frame>
    <description>Bubble Inclinometer used in the flexion, abduction and external rotation movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Movement of the shoulder</measure>
    <time_frame>A month later the last treatment, as follow up</time_frame>
    <description>Bubble Inclinometer used in the flexion, abduction and external rotation movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The shoulder's muscular strength</measure>
    <time_frame>Before and after the first treatment. A week after the enrollment.</time_frame>
    <description>dynamometer survey in flexion and abduction movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The shoulder's muscular strength</measure>
    <time_frame>Before and after the fifth treatment, after five weeks. This will be the last treatment</time_frame>
    <description>dynamometer survey in flexion and abduction movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The shoulder's muscular strength</measure>
    <time_frame>A month later the last treatment, as follow up</time_frame>
    <description>dynamometer survey in flexion and abduction movement</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Shoulder Pain</condition>
  <condition>Manual Therapy</condition>
  <arm_group>
    <arm_group_label>Standard Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The subjects will be treated with a standard protocol of stretching and strengthening exercises , we require them to do the exercises by themselves during five weeks, one a day.&#xD;
To make sure that they will do the protocol, we'll give them a diary to sign the daily section.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects will be treated with the same protocol of the Standard Group, but in two section, they will receive a Fascial Manipulation approach.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fascial Manipulation</intervention_name>
    <description>Fascial Manipulation is a manual therapy that focused on deep muscular fascial.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard exercises protocol</intervention_name>
    <description>Stretching and strengthening exercises</description>
    <arm_group_label>Standard Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  shoulder pain and acute and relapse in six months&#xD;
&#xD;
          -  positive results in two orthopedic testes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Degenerative diseases and neurological diseases&#xD;
&#xD;
          -  Rheumatological Diseases and cancer&#xD;
&#xD;
          -  fracture of the humerus, scapula and collarbone&#xD;
&#xD;
          -  documented injury of rotator cuff.&#xD;
&#xD;
          -  cortisones therapy in action&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Massimo Busato, first level</last_name>
    <role>Study Director</role>
    <affiliation>Azienda Ospedaliera Bolognini di Seriate Bergamo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AO Bolognini</name>
      <address>
        <city>Seriate</city>
        <state>Bergamo</state>
        <zip>24068</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 14, 2022</last_update_submitted>
  <last_update_submitted_qc>February 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera Bolognini di Seriate Bergamo</investigator_affiliation>
    <investigator_full_name>silvia Bellotti</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03041727
org study id: AOBolognini 1
nct id: NCT03041727
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study purpose is to compare the effects of Fascial Manipulation added to standard
      exercises protocol versus the simple exercises protocol.
The shoulder degenerative diseases are recurring in hospital employees. The early approach,
      as we see in literature, has high probability to reduce the pain and the disfunction in the
      long term.

      In particular stretching and strengthening exercises are the standard protocol applied.

      The Fascial Manipulation is a manual therapy that works on the connective tissue, by
      increasing mobility and reducing pain.

      We have added the Fascial Manipulation to prove if it make a faster recovery and a pain
      reduction in the short and the middle term.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study are evaluated in parallel against a control group.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The outcome assessor will be a statistic techinician, with any knowledge about the group composition and the rehabilitative intervention.
measure: Shoulder Pain
time frame: Before and after the first treatment. A week after the enrollment.
description: VNS scale in the Apley 'Scratch Test
measure: shoulder' function
time frame: Before and after the first treatment. A week after the enrollment.
description: Constant Morley Scale
measure: shoulder' function
time frame: Before and after the fifth treatment, after five weeks. This will be the last treatment
description: Constant Morley Scale
measure: shoulder' function
time frame: A month later the last treatment, as follow up
description: Constant Morley Scale
measure: Range of Movement of the shoulder
time frame: Before and after the first treatment. A week after the enrollment.
description: Bubble Inclinometer used in the flexion, abduction and external rotation movement
measure: Range of Movement of the shoulder
time frame: Before and after the fifth treatment, after five weeks.This will be the last treatment
description: Bubble Inclinometer used in the flexion, abduction and external rotation movement
measure: Range of Movement of the shoulder
time frame: A month later the last treatment, as follow up
description: Bubble Inclinometer used in the flexion, abduction and external rotation movement
measure: The shoulder's muscular strength
time frame: Before and after the first treatment. A week after the enrollment.
description: dynamometer survey in flexion and abduction movement
measure: The shoulder's muscular strength
time frame: Before and after the fifth treatment, after five weeks. This will be the last treatment
description: dynamometer survey in flexion and abduction movement
measure: The shoulder's muscular strength
time frame: A month later the last treatment, as follow up
description: dynamometer survey in flexion and abduction movement
arm group label: Standard Group
arm group type: Active Comparator
description: The subjects will be treated with a standard protocol of stretching and strengthening exercises , we require them to do the exercises by themselves during five weeks, one a day.
To make sure that they will do the protocol, we'll give them a diary to sign the daily section.
arm group label: Intervention group
arm group type: Experimental
description: The subjects will be treated with the same protocol of the Standard Group, but in two section, they will receive a Fascial Manipulation approach.
intervention type: Other
intervention name: Fascial Manipulation
description: Fascial Manipulation is a manual therapy that focused on deep muscular fascial.
arm group label: Intervention group
intervention type: Other
intervention name: Standard exercises protocol
description: Stretching and strengthening exercises
arm group label: Standard Group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Massimo Busato, first level
role: Study Director
affiliation: Azienda Ospedaliera Bolognini di Seriate Bergamo
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliera Bolognini di Seriate Bergamo
investigator full name: silvia Bellotti
investigator title: Physiotherapist
mesh term: Shoulder Pain
sharing ipd: No