xml: <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/NCT06023914</url>
    </required_header>
    <id_info>
      <org_study_id>ANEEM MRT</org_study_id>
      <nct_id>NCT06023914</nct_id>
    </id_info>
    <brief_title>Analysis of the Effect of Neuromuscular Electro-stimulation on the Performance of Isometric Rotator Cuff Strength.</brief_title>
    <official_title>Analysis of the Effect of Neuromuscular Electro-stimulation on the Performance of Isometric Rotator Cuff Strength in Patients With Tendinopathy.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Campinas, Brazil</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Campinas, Brazil</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>
        Introduction: Shoulder disorders are a common musculoskeletal problem causing pain and&#xD;
        functional loss in different populations. Tendinopathies are a group of pathologies commonly&#xD;
        diagnosed in patients with shoulder pain. Weakness of the rotator cuff musculature has&#xD;
        already been documented in other studies, evidence in the literature suggests that patients&#xD;
        with tendinopathies demonstrate decreased muscle activation, this is caused by pain, changes&#xD;
        in nervous system processing and apparently also by structural processes that occur in the&#xD;
        tendon .Treatment often involves resistance, isometric exercises aimed at altering pain and&#xD;
        restoring function. Some studies have been investigating the use of ENMS (neuromuscular&#xD;
        electrical stimulation) in patients undergoing surgical procedures on the shoulder, other&#xD;
        studies have also investigated its use in tendinopathies of the lower limbs, as an effective&#xD;
        way to decrease inhibition. Objective: The main objective of this study will be to analyze&#xD;
        the muscle strength of internal and external rotation of symptomatic shoulders compared to&#xD;
        asymptomatic ones when exposed to neuromuscular electrostimulation, associating muscle&#xD;
        strength with joint function. Methodology: This will be a cross-sectional study. An expected&#xD;
        total of 48 subjects will be divided into two groups, n=24 with tendinopathy of the rotator&#xD;
        cuff, confirmed by clinical diagnosis and nuclear magnetic resonance imaging, the other group&#xD;
        being healthy individuals, with no history of shoulder pain. These individuals will be&#xD;
        evaluated by a first evaluator who will perform the eligibility of the subjects and collect&#xD;
        the initial information, the second evaluator will perform the isometric strength evaluation&#xD;
        with a manual dynamometer. Two batteries of tests will be performed in both groups, a&#xD;
        conventional assessment of isometric strength and the other subject will be submitted to&#xD;
        neuromuscular electrostimulation. These strength values in Kgf were normalized for each&#xD;
        individual, being divided by the body mass index (BMI) and multiplied by 100, as already&#xD;
        performed in previous studies. Expected results: The initial hypothesis is that patients who&#xD;
        present with the studied condition when submitted to the strength test with muscular&#xD;
        electrostimulation will demonstrate greater isometric strength than when they were tested&#xD;
        without the device.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
    <phase>Phase 2/Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_model_description>The model of strength assessments will be performed randomly. After the individual has performed the first evaluation, he will be evaluated in sequence with the other technique.</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The physiotherapist responsible for carrying out the strength assessments will be blind to which patient has the pathological condition and who is the healthy individual.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>isometric muscle strength of rotator cuff muscles</measure>
      <time_frame>short term, immediately after use.</time_frame>
      <description>The primary objective will be to evaluate the isometric muscle strength of the rotator cuff muscles, comparing with the use of the electrostimulator, the measures will be in kgf.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Analyses of isometric strength between groups of healthy and unhealthy individuals.</measure>
      <time_frame>short term, immediately after use.</time_frame>
      <description>- To analyze isometric external and internal rotator strength relationships between groups of healthy and unhealthy individuals, the measures will be in kgf..</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intra-group group analyses</measure>
      <time_frame>short term, immediately after use.</time_frame>
      <description>To analyze intra-group isometric external and internal rotator strength relationships, comparing symptomatic and asymptomatic sides, dominant and non-dominant sides, the measures will be in kgf.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>other rotator cuff muscle strength analyses</measure>
      <time_frame>short term, immediately after use.</time_frame>
      <description>To analyze the effect of neuromuscular electrostimulation during the production of isometric strength of external and internal rotators of the shoulder, making comparisons between groups, intra groups, in healthy and unhealthy individuals, the measures will be in kgf.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>strength relationship between symptomatic and asymptomatic</measure>
      <time_frame>short term, immediately after use.</time_frame>
      <description>Analyze the strength relationship between asymptomatic individuals by making comparisons between the symptomatic and asymptomatic sides., the measures will be in kgf.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>relationship between symptomatic and asymptomatic and force production</measure>
      <time_frame>short term, immediately after use.</time_frame>
      <description>To explore the relationships between isometric force production and reproduction of shoulder symptoms or discomfort in symptomatic and asymptomatic individuals., the measures will be in kgf and pain, wich will use the Visual Analog Score for pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>relationship between symptomatic and asymptomatic and force production and pain</measure>
      <time_frame>short term, immediately after use.</time_frame>
      <description>To explore the relationships between isometric force production and reproduction of shoulder symptoms or discomfort in symptomatic and asymptomatic individuals., the measures will be in kgf and correlated with pain, wich will use the Visual Analog Score for pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>relationship between symptomatic and asymptomatic strength and function</measure>
      <time_frame>short term, immediately after use.</time_frame>
      <description>Observe the relationship between shoulder function and rotator cuff muscle strength in patients with the studied condition, assessed with a scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>relationship between symptomatic and asymptomatic strength and pain</measure>
      <time_frame>short term, immediately after use.</time_frame>
      <description>Observe the relationship between shoulder function and rotator cuff muscle strength in patients with the studied condition, assessed with a scale and pain.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Rotator Cuff Impingement Syndrome</condition>
    <condition>Rotator Cuff Tendinitis</condition>
    <condition>Subacromial Impingement Syndrome</condition>
    <arm_group>
      <arm_group_label>Isometric strength evaluation with a device of electro-stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The measurement of rotator cuff strength (medial and lateral rotation) and shoulder elevation will be performed with a Medeor® manual dynamometer. To measure the strength of the medial and lateral rotators, the subject will be positioned in dorsal decubitus, with the shoulder abducted at 45º and in 30º of horizontal adduction (scapular plane), elbow flexed at 90º and neutral rotation, with the dynamometer positioned, respectively, over the distal radio-ulnar joint on the volar or dorsal surface. In all these strength assessments, individuals will be required to perform a maximum isometric contraction for 5 seconds.&#xD;
  According to the order of randomization, one of the two evaluations will be carried out initially. We will call the evaluation with electrostimulation experimental here. The device to be used will be a GLOBUS® brand equipment, the equipment presents several types of pre-programmed currents, parameters have also been used in similar studies.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Isometric strength evaluation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The measurement of rotator cuff strength (medial and lateral rotation) and shoulder elevation will be performed with a Medeor® manual dynamometer. To measure the strength of the medial and lateral rotators, the subject will be positioned in dorsal decubitus, with the shoulder abducted at 45º and in 30º of horizontal adduction (scapular plane), elbow flexed at 90º and neutral rotation, with the dynamometer positioned, respectively, over the distal radio-ulnar joint on the volar or dorsal surface. In all these strength assessments, individuals will be required to perform a maximum isometric contraction for 5 seconds.&#xD;
  We will call this intervention active comparator, as both groups of patients will undergo this evaluation, which will be performed without electrostimulation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>STRENGTH EVALUATION WITH ELECTROSTIMULATOR</intervention_name>
      <description>Evaluation of isometric strength using an electrostimulator.</description>
      <arm_group_label>Isometric strength evaluation with a device of electro-stimulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>STRENGTH EVALUATION WITHOUT ELECTROSTIMULATOR</intervention_name>
      <description>Evaluation of isometric strength not using an electrostimulator.</description>
      <arm_group_label>Isometric strength evaluation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Complaint of shoulder pain for at least 30 days&#xD;
  &#xD;
            -  Age between 25 and 50 years&#xD;
  &#xD;
            -  Diagnosis of rotator cuff tendinopathy (Jobe, Neer, Hawkins-Kennedy and resisted&#xD;
               external rotation test, at least 3 positive tests)&#xD;
  &#xD;
            -  Magnetic resonance imaging with findings corresponding to rotator cuff tendinopathy?&#xD;
  &#xD;
          Inclusion criteria in the health subjects :&#xD;
  &#xD;
            -  No history of shoulder pain at some point in life&#xD;
  &#xD;
            -  Age between 25 and 50 years&#xD;
  &#xD;
            -  Diagnostic Tests for Rotator Cuff Tendinopathy (Jobe, Neer, Hawkins-Kennedy, and&#xD;
               resisted external rotation test) NEGATIVE&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Contraindications to the use of electrostimulation&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  History of shoulder, cervical, or thoracic surgery&#xD;
  &#xD;
            -  Shoulder dislocation&#xD;
  &#xD;
            -  Fracture&#xD;
  &#xD;
            -  Labral laceration&#xD;
  &#xD;
            -  Rheumatic disease&#xD;
  &#xD;
            -  Complete or partial tear of the rotator cuff&#xD;
  &#xD;
            -  adhesive capsulitis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Pedro Vieira Malachias</last_name>
      <phone>+55 019 999249201</phone>
      <email>pedrovieira.fisio@gmail.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Campinas, Brazil</investigator_affiliation>
      <investigator_full_name>Pedro Vieira Malachias</investigator_full_name>
      <investigator_title>Physical Therapist</investigator_title>
    </responsible_party>
    <keyword>shoulder pain</keyword>
    <keyword>rotator cuff strength</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tendinopathy</mesh_term>
      <mesh_term>Shoulder Impingement Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Rotator Cuff Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>I will analyze each request and analyze later</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023914
  org study id: ANEEM MRT
  nct id: NCT06023914
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Introduction: Shoulder disorders are a common musculoskeletal problem causing pain and
        functional loss in different populations. Tendinopathies are a group of pathologies commonly
        diagnosed in patients with shoulder pain. Weakness of the rotator cuff musculature has
        already been documented in other studies, evidence in the literature suggests that patients
        with tendinopathies demonstrate decreased muscle activation, this is caused by pain, changes
        in nervous system processing and apparently also by structural processes that occur in the
        tendon .Treatment often involves resistance, isometric exercises aimed at altering pain and
        restoring function. Some studies have been investigating the use of ENMS (neuromuscular
        electrical stimulation) in patients undergoing surgical procedures on the shoulder, other
        studies have also investigated its use in tendinopathies of the lower limbs, as an effective
        way to decrease inhibition. Objective: The main objective of this study will be to analyze
        the muscle strength of internal and external rotation of symptomatic shoulders compared to
        asymptomatic ones when exposed to neuromuscular electrostimulation, associating muscle
        strength with joint function. Methodology: This will be a cross-sectional study. An expected
        total of 48 subjects will be divided into two groups, n=24 with tendinopathy of the rotator
        cuff, confirmed by clinical diagnosis and nuclear magnetic resonance imaging, the other group
        being healthy individuals, with no history of shoulder pain. These individuals will be
        evaluated by a first evaluator who will perform the eligibility of the subjects and collect
        the initial information, the second evaluator will perform the isometric strength evaluation
        with a manual dynamometer. Two batteries of tests will be performed in both groups, a
        conventional assessment of isometric strength and the other subject will be submitted to
        neuromuscular electrostimulation. These strength values in Kgf were normalized for each
        individual, being divided by the body mass index (BMI) and multiplied by 100, as already
        performed in previous studies. Expected results: The initial hypothesis is that patients who
        present with the studied condition when submitted to the strength test with muscular
        electrostimulation will demonstrate greater isometric strength than when they were tested
        without the device.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: The model of strength assessments will be performed randomly. After the individual has performed the first evaluation, he will be evaluated in sequence with the other technique.
  primary purpose: Diagnostic
  masking: Single (Outcomes Assessor)
  masking description: The physiotherapist responsible for carrying out the strength assessments will be blind to which patient has the pathological condition and who is the healthy individual.
  measure: isometric muscle strength of rotator cuff muscles
  time frame: short term, immediately after use.
  description: The primary objective will be to evaluate the isometric muscle strength of the rotator cuff muscles, comparing with the use of the electrostimulator, the measures will be in kgf.
  measure: Analyses of isometric strength between groups of healthy and unhealthy individuals.
  time frame: short term, immediately after use.
  description: - To analyze isometric external and internal rotator strength relationships between groups of healthy and unhealthy individuals, the measures will be in kgf..
  measure: Intra-group group analyses
  time frame: short term, immediately after use.
  description: To analyze intra-group isometric external and internal rotator strength relationships, comparing symptomatic and asymptomatic sides, dominant and non-dominant sides, the measures will be in kgf.
  measure: other rotator cuff muscle strength analyses
  time frame: short term, immediately after use.
  description: To analyze the effect of neuromuscular electrostimulation during the production of isometric strength of external and internal rotators of the shoulder, making comparisons between groups, intra groups, in healthy and unhealthy individuals, the measures will be in kgf.
  measure: strength relationship between symptomatic and asymptomatic
  time frame: short term, immediately after use.
  description: Analyze the strength relationship between asymptomatic individuals by making comparisons between the symptomatic and asymptomatic sides., the measures will be in kgf.
  measure: relationship between symptomatic and asymptomatic and force production
  time frame: short term, immediately after use.
  description: To explore the relationships between isometric force production and reproduction of shoulder symptoms or discomfort in symptomatic and asymptomatic individuals., the measures will be in kgf and pain, wich will use the Visual Analog Score for pain.
  measure: relationship between symptomatic and asymptomatic and force production and pain
  time frame: short term, immediately after use.
  description: To explore the relationships between isometric force production and reproduction of shoulder symptoms or discomfort in symptomatic and asymptomatic individuals., the measures will be in kgf and correlated with pain, wich will use the Visual Analog Score for pain.
  measure: relationship between symptomatic and asymptomatic strength and function
  time frame: short term, immediately after use.
  description: Observe the relationship between shoulder function and rotator cuff muscle strength in patients with the studied condition, assessed with a scale.
  measure: relationship between symptomatic and asymptomatic strength and pain
  time frame: short term, immediately after use.
  description: Observe the relationship between shoulder function and rotator cuff muscle strength in patients with the studied condition, assessed with a scale and pain.
  arm group label: Isometric strength evaluation with a device of electro-stimulation
  arm group type: Experimental
  description: The measurement of rotator cuff strength (medial and lateral rotation) and shoulder elevation will be performed with a Medeor® manual dynamometer. To measure the strength of the medial and lateral rotators, the subject will be positioned in dorsal decubitus, with the shoulder abducted at 45º and in 30º of horizontal adduction (scapular plane), elbow flexed at 90º and neutral rotation, with the dynamometer positioned, respectively, over the distal radio-ulnar joint on the volar or dorsal surface. In all these strength assessments, individuals will be required to perform a maximum isometric contraction for 5 seconds.
  According to the order of randomization, one of the two evaluations will be carried out initially. We will call the evaluation with electrostimulation experimental here. The device to be used will be a GLOBUS® brand equipment, the equipment presents several types of pre-programmed currents, parameters have also been used in similar studies.
  arm group label: Isometric strength evaluation
  arm group type: Active Comparator
  description: The measurement of rotator cuff strength (medial and lateral rotation) and shoulder elevation will be performed with a Medeor® manual dynamometer. To measure the strength of the medial and lateral rotators, the subject will be positioned in dorsal decubitus, with the shoulder abducted at 45º and in 30º of horizontal adduction (scapular plane), elbow flexed at 90º and neutral rotation, with the dynamometer positioned, respectively, over the distal radio-ulnar joint on the volar or dorsal surface. In all these strength assessments, individuals will be required to perform a maximum isometric contraction for 5 seconds.
  We will call this intervention active comparator, as both groups of patients will undergo this evaluation, which will be performed without electrostimulation.
  intervention type: Other
  intervention name: STRENGTH EVALUATION WITH ELECTROSTIMULATOR
  description: Evaluation of isometric strength using an electrostimulator.
  arm group label: Isometric strength evaluation with a device of electro-stimulation
  intervention type: Other
  intervention name: STRENGTH EVALUATION WITHOUT ELECTROSTIMULATOR
  description: Evaluation of isometric strength not using an electrostimulator.
  arm group label: Isometric strength evaluation
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Pedro Vieira Malachias
  phone: +55 019 999249201
  email: pedrovieira.fisio@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: University of Campinas, Brazil
  investigator full name: Pedro Vieira Malachias
  investigator title: Physical Therapist
  mesh term: Tendinopathy
  mesh term: Shoulder Impingement Syndrome
  mesh term: Syndrome
  mesh term: Rotator Cuff Injuries
  sharing ipd: Undecided
  ipd description: I will analyze each request and analyze later