<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/NCT04440046</url>
  </required_header>
  <id_info>
    <org_study_id>2/111/729</org_study_id>
    <nct_id>NCT04440046</nct_id>
  </id_info>
  <brief_title>Real Versus Sham Manual Therapy for RCRSP</brief_title>
  <official_title>Real Versus Sham Manual Therapy in Addition to Therapeutic Exercise in the Treatment of Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alcala</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alcala</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A convenience sample of subjects with RCRSP recruited through announcements at the Benemerita&#xD;
      Universidad Autonoma de Puebla will be treated with an exercise program with sham or real&#xD;
      manual therapy for 5 weeks.&#xD;
&#xD;
      The hypothesis of the present study is that the addition of manual therapy to a therapeutic&#xD;
      exercise program produces better benefits in comparison to the same exercise program with&#xD;
      sham manual therapy procedures in the management of patients with RCRSP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to demonstrate that the combination of manual therapy and&#xD;
      therapeutic exercise achieves better results in the management of the patient with shoulder&#xD;
      pain.&#xD;
&#xD;
      For this, manual therapy techniques in the thoracic region and in the shoulder together with&#xD;
      a therapeutic exercise program will be applied.&#xD;
&#xD;
      The investigators will compare this intervention protocol with placebo manual therapy&#xD;
      techniques and the same therapeutic exercise protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 15, 2020</start_date>
  <completion_date type="Actual">April 18, 2021</completion_date>
  <primary_completion_date type="Actual">April 18, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Shoulder Pain and Disability Index (SPADI)</measure>
    <time_frame>Change from Baseline at 17- week</time_frame>
    <description>The SPADI points from 0 (no disability) to 130 (maximum degree of disability)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity measured with a visual analogue scale</measure>
    <time_frame>Change from Baseline at 17-week</time_frame>
    <description>10-cm scale where 0 is no pain and 10 is the worst pain imaginable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain-free range of movement of the shoulder</measure>
    <time_frame>Change from Baseline at 17-week</time_frame>
    <description>Flexion, extension, abduction, internal rotation and external rotation measured with a two-arm goniometer</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>Real manual therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Real manual therapy directed to the thoracic spine and glenohumeral joint added to a therapeutic exercise program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham thoracic manual therapy</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham manual therapy directed to the thoracic spine with real manual therapy directed to the glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham manual therapy</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham manual therapy directed to the thoracic spine and glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual therapy thoracic spine</intervention_name>
    <description>Manual therapy mobilization directed to the costovertebral joint.</description>
    <arm_group_label>Real manual therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual therapy glenohumeral joint</intervention_name>
    <description>Manual therapy mobilization directed to the glenohumeral joint.</description>
    <arm_group_label>Real manual therapy</arm_group_label>
    <arm_group_label>Sham thoracic manual therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham thoracic manual therapy</intervention_name>
    <description>Sham manual therapy directed to the costovertebral joint.</description>
    <arm_group_label>Sham manual therapy</arm_group_label>
    <arm_group_label>Sham thoracic manual therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham glenohumeral manual therapy</intervention_name>
    <description>Sham manual therapy directed to the glenohumeral joint.</description>
    <arm_group_label>Sham manual therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Therapeutic exercise</intervention_name>
    <description>Therapeutic exercise program consisting on isometric exercise with progressive load.</description>
    <arm_group_label>Real manual therapy</arm_group_label>
    <arm_group_label>Sham manual therapy</arm_group_label>
    <arm_group_label>Sham thoracic manual therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unilateral shoulder pain of non-traumatic origing lasting more than three months.&#xD;
&#xD;
          -  Pain evoked with active shoulder movements.&#xD;
&#xD;
          -  Pain and weakness evoked with manual muscle strength tests for abduction and/or&#xD;
             external rotation.&#xD;
&#xD;
          -  Minimal or no rest pain (less than 3 points in a numeric pain rating scale).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other shoulder pathologies than RCRSP.&#xD;
&#xD;
          -  Systemic diseases.&#xD;
&#xD;
          -  Neural symptoms.&#xD;
&#xD;
          -  Neck pain.&#xD;
&#xD;
          -  Radiculopathy.&#xD;
&#xD;
          -  To have been treated for shoulder pain in the last three months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Pecos-Martin, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Alcala</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ruben Fernandez-Matias</name>
      <address>
        <city>Alcalá De Henares</city>
        <zip>28805</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 28, 2021</last_update_submitted>
  <last_update_submitted_qc>June 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alcala</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Daniel Pecos Martín</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT04440046
org study id: 2/111/729
nct id: NCT04440046
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A convenience sample of subjects with RCRSP recruited through announcements at the Benemerita
      Universidad Autonoma de Puebla will be treated with an exercise program with sham or real
      manual therapy for 5 weeks.

      The hypothesis of the present study is that the addition of manual therapy to a therapeutic
      exercise program produces better benefits in comparison to the same exercise program with
      sham manual therapy procedures in the management of patients with RCRSP.
The objective of this study is to demonstrate that the combination of manual therapy and
      therapeutic exercise achieves better results in the management of the patient with shoulder
      pain.

      For this, manual therapy techniques in the thoracic region and in the shoulder together with
      a therapeutic exercise program will be applied.

      The investigators will compare this intervention protocol with placebo manual therapy
      techniques and the same therapeutic exercise protocol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Shoulder Pain and Disability Index (SPADI)
time frame: Change from Baseline at 17- week
description: The SPADI points from 0 (no disability) to 130 (maximum degree of disability)
measure: Pain intensity measured with a visual analogue scale
time frame: Change from Baseline at 17-week
description: 10-cm scale where 0 is no pain and 10 is the worst pain imaginable
measure: Pain-free range of movement of the shoulder
time frame: Change from Baseline at 17-week
description: Flexion, extension, abduction, internal rotation and external rotation measured with a two-arm goniometer
arm group label: Real manual therapy
arm group type: Experimental
description: Real manual therapy directed to the thoracic spine and glenohumeral joint added to a therapeutic exercise program
arm group label: Sham thoracic manual therapy
arm group type: Sham Comparator
description: Sham manual therapy directed to the thoracic spine with real manual therapy directed to the glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group
arm group label: Sham manual therapy
arm group type: Sham Comparator
description: Sham manual therapy directed to the thoracic spine and glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group
intervention type: Other
intervention name: Manual therapy thoracic spine
description: Manual therapy mobilization directed to the costovertebral joint.
arm group label: Real manual therapy
intervention type: Other
intervention name: Manual therapy glenohumeral joint
description: Manual therapy mobilization directed to the glenohumeral joint.
arm group label: Real manual therapy
arm group label: Sham thoracic manual therapy
intervention type: Other
intervention name: Sham thoracic manual therapy
description: Sham manual therapy directed to the costovertebral joint.
arm group label: Sham manual therapy
arm group label: Sham thoracic manual therapy
intervention type: Other
intervention name: Sham glenohumeral manual therapy
description: Sham manual therapy directed to the glenohumeral joint.
arm group label: Sham manual therapy
intervention type: Other
intervention name: Therapeutic exercise
description: Therapeutic exercise program consisting on isometric exercise with progressive load.
arm group label: Real manual therapy
arm group label: Sham manual therapy
arm group label: Sham thoracic manual therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Daniel Pecos-Martin, PhD
role: Study Director
affiliation: University of Alcala
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Alcala
investigator full name: Prof. Dr. Daniel Pecos Martín
investigator title: Principal Investigator
mesh term: Shoulder Pain
sharing ipd: No