<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/NCT03293329</url>
  </required_header>
  <id_info>
    <org_study_id>UComplutenseMadrid Fasisifer1</org_study_id>
    <secondary_id>2017-003316-39</secondary_id>
    <nct_id>NCT03293329</nct_id>
  </id_info>
  <brief_title>Effects of Diaphragm Muscle Therapy on Pain and Shoulder Movement in Subjects With Rotator Cuff Injuries</brief_title>
  <official_title>Effects of Diaphragm Muscle Therapy on Pain and Shoulder Movement in Subjects With Rotator Cuff Injuries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Complutense de Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Complutense de Madrid</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>
      A randomised and controlled trial to people diagnosed with rotator cuff injuries who are&#xD;
      divided into 3 groups of treatment: shoulder myofascial trigger points release, manual&#xD;
      diaphragm release and diaphragm mobilization through hipopressive gymnastic exercise. The&#xD;
      pain and range of shoulder movement are assessed before and after the treatment in all the&#xD;
      participants.&#xD;
&#xD;
      Hypothesis of the clinical study: the treatment of diaphragm muscle, via manual release or&#xD;
      active mobilization, has impact on rotator cuff injury symptoms comparing with a standard&#xD;
      treatment of shoulder myofascial trigger points release.&#xD;
&#xD;
      Discussion: The relation between shoulder and diaphragm muscle, through innervation (phrenic&#xD;
      nerve and brachial plexus), embryology and myofascial connections, could lead to include in&#xD;
      clinical practice the examination and treatment of other structures besides shoulder girdle&#xD;
      such as diaphragmatic region in rotator cuff injuries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomised controlled trial evaluating clinical effects of a diaphragm&#xD;
      treatment, via manual release or active mobilization, comparing with a standard treatment of&#xD;
      shoulder myofascial trigger points release.&#xD;
&#xD;
      A description of the 3 groups of treatment:&#xD;
&#xD;
        1. - Experimental group 1: 3 diaphragm stretching techniques according to Chaitow, Ward and&#xD;
           Ricard, performed by a physical therapist are employed in this experimental group during&#xD;
           10 minutes. The participants are situated in a seated, supine and side bending position.&#xD;
&#xD;
        2. - Experimental group 2: diaphragm mobilization through active hipopressive gymnastic&#xD;
           exercise according to Caufriez in two different postures.&#xD;
&#xD;
        3. - Active comparator group: A ischemic compression technique in most painful myofascial&#xD;
           trigger points in the infraespinatus and supraespinatus muscle during one minute each&#xD;
           one.&#xD;
&#xD;
      The shoulder flexion, abduction and external rotation range of motion will be assessed pre&#xD;
      and postinterventions, as well as the pressure pain threshold with an algometer and the pain&#xD;
      experienced by the individual in shoulder mobility with a Numerical Rating Scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 9, 2020</start_date>
  <completion_date type="Actual">March 9, 2020</completion_date>
  <primary_completion_date type="Actual">March 9, 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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline to post intervention shoulder range of motion with a digital inclinometer</measure>
    <time_frame>Baseline and Immediately Post Intervention</time_frame>
    <description>Pre and post treatment assessment of flexion, abduction and external rotation at 90º abduction movements in supine, registered with a Baseline digital inclinometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline to post intervention pressure pain threshold in supraespinatus tendon and xiphoid process with a pressure algometer</measure>
    <time_frame>Baseline and Immediately Post Intervention</time_frame>
    <description>Pre and post treatment Pressure pain threshold in supraespinatus tendon and xiphoid process registered with a pressure algometer in a supine position</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline to post intervention Numerical Rating Pain Scale in shoulder mobility</measure>
    <time_frame>Baseline and Immediately Post Intervention</time_frame>
    <description>Pre and post treatment Numerical Rating Pain Scale in shoulder mobility: flexion, abduction and external rotation at 90º abduction standing</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Rotator Cuff Injury</condition>
  <condition>Diaphragm; Relaxation</condition>
  <arm_group>
    <arm_group_label>Diaphragm manual therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 diaphragm stretching techniques performed by a physical therapist are employed in this experimental group during 10 minutes. The participants are situated in a seated, supine and side bending position. 20 people are recruited in order to the inclusion criteria for the study. They have rotator cuff injuries diagnosed by ultrasounds or magnetic resonance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diaphragm hipopressive exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diaphragm mobilization through active hipopressive gymnastic exercise in two different postures. 20 people are recruited in order to the inclusion criteria for the study. They have rotator cuff injuries diagnosed by ultrasounds or magnetic resonance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Shoulder myofascial trigger points treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A ischemic compression technique in infraespinatus and supraespinatus myofascial trigger points performed by a physical therapist is employed in this group. 20 people are recruited in order to the inclusion criteria for the study. They had rotator cuff injuries diagnosed by ultrasounds or magnetic resonance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diaphragm manual therapy techniques</intervention_name>
    <description>3 diaphragm manual therapy techniques performed by a physical therapist are employed in this experimental group during 10 minutes. The participants are situated in a seated, supine and side bending position.</description>
    <arm_group_label>Diaphragm manual therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diaphragm mobilization through active hipopressive gymnastic exercise</intervention_name>
    <description>Diaphragm mobilization through active hipopressive gymnastic exercise in two different postures: standing and standing bending forward.</description>
    <arm_group_label>Diaphragm hipopressive exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ischemic compression techniques in shoulder myofascial trigger points</intervention_name>
    <description>Ischemic compression techniques in infraespinatus and supraespinatus myofascial trigger points during one minute each muscle. The pressure increases gradually until the individual feels a tolerable pain.</description>
    <arm_group_label>Shoulder myofascial trigger points treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants of both genders aged between 18 and 65 years old&#xD;
&#xD;
          -  Ultrasound and/or magnetic resonance imaging diagnosis of rotator cuff injury&#xD;
&#xD;
          -  Pain or range of movement restriction in active shoulder flexion and/or abduction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of analgesic or anti-inflammatory drugs 72 hours prior to the study&#xD;
&#xD;
          -  Individuals with glenohumeral instability due to shoulder luxation or subluxation or&#xD;
             Bankart labrum injury&#xD;
&#xD;
          -  Individuals who have received physical therapy treatment in last week&#xD;
&#xD;
          -  Individuals who underwent thoracic or shoulder surgery or people suffering from&#xD;
             rheumatisms&#xD;
&#xD;
          -  Diabetic patients&#xD;
&#xD;
          -  People with a diagnosed neurological pathology&#xD;
&#xD;
          -  Individuals with a diagnosed mental health problem&#xD;
&#xD;
          -  Not being able to understand and sign the informed consent and information sheet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidad Complutense de Madrid</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 16, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Complutense de Madrid</investigator_affiliation>
    <investigator_full_name>Isidro Fernández López</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>rotator cuff injury</keyword>
  <keyword>diaphragm</keyword>
  <keyword>physical therapy</keyword>
  <keyword>manual therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT03293329/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT03293329/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03293329
org study id: UComplutenseMadrid Fasisifer1
secondary id: 2017-003316-39
nct id: NCT03293329
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomised and controlled trial to people diagnosed with rotator cuff injuries who are
      divided into 3 groups of treatment: shoulder myofascial trigger points release, manual
      diaphragm release and diaphragm mobilization through hipopressive gymnastic exercise. The
      pain and range of shoulder movement are assessed before and after the treatment in all the
      participants.

      Hypothesis of the clinical study: the treatment of diaphragm muscle, via manual release or
      active mobilization, has impact on rotator cuff injury symptoms comparing with a standard
      treatment of shoulder myofascial trigger points release.

      Discussion: The relation between shoulder and diaphragm muscle, through innervation (phrenic
      nerve and brachial plexus), embryology and myofascial connections, could lead to include in
      clinical practice the examination and treatment of other structures besides shoulder girdle
      such as diaphragmatic region in rotator cuff injuries.
This study is a randomised controlled trial evaluating clinical effects of a diaphragm
      treatment, via manual release or active mobilization, comparing with a standard treatment of
      shoulder myofascial trigger points release.

      A description of the 3 groups of treatment:

        1. - Experimental group 1: 3 diaphragm stretching techniques according to Chaitow, Ward and
           Ricard, performed by a physical therapist are employed in this experimental group during
           10 minutes. The participants are situated in a seated, supine and side bending position.

        2. - Experimental group 2: diaphragm mobilization through active hipopressive gymnastic
           exercise according to Caufriez in two different postures.

        3. - Active comparator group: A ischemic compression technique in most painful myofascial
           trigger points in the infraespinatus and supraespinatus muscle during one minute each
           one.

      The shoulder flexion, abduction and external rotation range of motion will be assessed pre
      and postinterventions, as well as the pressure pain threshold with an algometer and the pain
      experienced by the individual in shoulder mobility with a Numerical Rating Scale.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline to post intervention shoulder range of motion with a digital inclinometer
time frame: Baseline and Immediately Post Intervention
description: Pre and post treatment assessment of flexion, abduction and external rotation at 90º abduction movements in supine, registered with a Baseline digital inclinometer
measure: Change from baseline to post intervention pressure pain threshold in supraespinatus tendon and xiphoid process with a pressure algometer
time frame: Baseline and Immediately Post Intervention
description: Pre and post treatment Pressure pain threshold in supraespinatus tendon and xiphoid process registered with a pressure algometer in a supine position
measure: Change from baseline to post intervention Numerical Rating Pain Scale in shoulder mobility
time frame: Baseline and Immediately Post Intervention
description: Pre and post treatment Numerical Rating Pain Scale in shoulder mobility: flexion, abduction and external rotation at 90º abduction standing
arm group label: Diaphragm manual therapy
arm group type: Experimental
description: 3 diaphragm stretching techniques performed by a physical therapist are employed in this experimental group during 10 minutes. The participants are situated in a seated, supine and side bending position. 20 people are recruited in order to the inclusion criteria for the study. They have rotator cuff injuries diagnosed by ultrasounds or magnetic resonance.
arm group label: Diaphragm hipopressive exercise
arm group type: Experimental
description: Diaphragm mobilization through active hipopressive gymnastic exercise in two different postures. 20 people are recruited in order to the inclusion criteria for the study. They have rotator cuff injuries diagnosed by ultrasounds or magnetic resonance.
arm group label: Shoulder myofascial trigger points treatment
arm group type: Active Comparator
description: A ischemic compression technique in infraespinatus and supraespinatus myofascial trigger points performed by a physical therapist is employed in this group. 20 people are recruited in order to the inclusion criteria for the study. They had rotator cuff injuries diagnosed by ultrasounds or magnetic resonance.
intervention type: Other
intervention name: Diaphragm manual therapy techniques
description: 3 diaphragm manual therapy techniques performed by a physical therapist are employed in this experimental group during 10 minutes. The participants are situated in a seated, supine and side bending position.
arm group label: Diaphragm manual therapy
intervention type: Other
intervention name: Diaphragm mobilization through active hipopressive gymnastic exercise
description: Diaphragm mobilization through active hipopressive gymnastic exercise in two different postures: standing and standing bending forward.
arm group label: Diaphragm hipopressive exercise
intervention type: Other
intervention name: Ischemic compression techniques in shoulder myofascial trigger points
description: Ischemic compression techniques in infraespinatus and supraespinatus myofascial trigger points during one minute each muscle. The pressure increases gradually until the individual feels a tolerable pain.
arm group label: Shoulder myofascial trigger points treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Complutense de Madrid
investigator full name: Isidro Fernández López
investigator title: Principal Investigator
mesh term: Wounds and Injuries
mesh term: Rotator Cuff Injuries
sharing ipd: Undecided
provided document: 
provided document: 