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Analysis of the Effect of Neuromuscular Electro-stimulation on the Performance of Isometric Rotator Cuff Strength.

Primary Purpose

Rotator Cuff Impingement Syndrome, Rotator Cuff Tendinitis, Subacromial Impingement Syndrome

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
STRENGTH EVALUATION WITH ELECTROSTIMULATOR
STRENGTH EVALUATION WITHOUT ELECTROSTIMULATOR
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rotator Cuff Impingement Syndrome focused on measuring shoulder pain, rotator cuff strength

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Complaint of shoulder pain for at least 30 days Age between 25 and 50 years Diagnosis of rotator cuff tendinopathy (Jobe, Neer, Hawkins-Kennedy and resisted external rotation test, at least 3 positive tests) Magnetic resonance imaging with findings corresponding to rotator cuff tendinopathy? Inclusion criteria in the health subjects : No history of shoulder pain at some point in life Age between 25 and 50 years Diagnostic Tests for Rotator Cuff Tendinopathy (Jobe, Neer, Hawkins-Kennedy, and resisted external rotation test) NEGATIVE Exclusion Criteria: Contraindications to the use of electrostimulation Pregnancy History of shoulder, cervical, or thoracic surgery Shoulder dislocation Fracture Labral laceration Rheumatic disease Complete or partial tear of the rotator cuff adhesive capsulitis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Isometric strength evaluation with a device of electro-stimulation

    Isometric strength evaluation

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    isometric muscle strength of rotator cuff muscles
    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.

    Secondary Outcome Measures

    Analyses of isometric strength between groups of healthy and unhealthy individuals.
    - To analyze isometric external and internal rotator strength relationships between groups of healthy and unhealthy individuals, the measures will be in kgf..
    Intra-group group analyses
    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.
    other rotator cuff muscle strength analyses
    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.
    strength relationship between symptomatic and asymptomatic
    Analyze the strength relationship between asymptomatic individuals by making comparisons between the symptomatic and asymptomatic sides., the measures will be in kgf.
    relationship between symptomatic and asymptomatic and force production
    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.
    relationship between symptomatic and asymptomatic and force production and pain
    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.
    relationship between symptomatic and asymptomatic strength and function
    Observe the relationship between shoulder function and rotator cuff muscle strength in patients with the studied condition, assessed with a scale.
    relationship between symptomatic and asymptomatic strength and pain
    Observe the relationship between shoulder function and rotator cuff muscle strength in patients with the studied condition, assessed with a scale and pain.

    Full Information

    First Posted
    August 23, 2023
    Last Updated
    August 28, 2023
    Sponsor
    University of Campinas, Brazil
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06023914
    Brief Title
    Analysis of the Effect of Neuromuscular Electro-stimulation on the Performance of Isometric Rotator Cuff Strength.
    Official Title
    Analysis of the Effect of Neuromuscular Electro-stimulation on the Performance of Isometric Rotator Cuff Strength in Patients With Tendinopathy.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2023 (Anticipated)
    Study Completion Date
    January 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Campinas, Brazil

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotator Cuff Impingement Syndrome, Rotator Cuff Tendinitis, Subacromial Impingement Syndrome
    Keywords
    shoulder pain, rotator cuff strength

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Crossover Assignment
    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.
    Masking
    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.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Isometric strength evaluation with a device of electro-stimulation
    Arm Type
    Experimental
    Arm 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 Title
    Isometric strength evaluation
    Arm Type
    Active Comparator
    Arm 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(s)
    STRENGTH EVALUATION WITH ELECTROSTIMULATOR
    Intervention Description
    Evaluation of isometric strength using an electrostimulator.
    Intervention Type
    Other
    Intervention Name(s)
    STRENGTH EVALUATION WITHOUT ELECTROSTIMULATOR
    Intervention Description
    Evaluation of isometric strength not using an electrostimulator.
    Primary Outcome Measure Information:
    Title
    isometric muscle strength of rotator cuff muscles
    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.
    Time Frame
    short term, immediately after use.
    Secondary Outcome Measure Information:
    Title
    Analyses of isometric strength between groups of healthy and unhealthy individuals.
    Description
    - To analyze isometric external and internal rotator strength relationships between groups of healthy and unhealthy individuals, the measures will be in kgf..
    Time Frame
    short term, immediately after use.
    Title
    Intra-group group analyses
    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.
    Time Frame
    short term, immediately after use.
    Title
    other rotator cuff muscle strength analyses
    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.
    Time Frame
    short term, immediately after use.
    Title
    strength relationship between symptomatic and asymptomatic
    Description
    Analyze the strength relationship between asymptomatic individuals by making comparisons between the symptomatic and asymptomatic sides., the measures will be in kgf.
    Time Frame
    short term, immediately after use.
    Title
    relationship between symptomatic and asymptomatic and force production
    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.
    Time Frame
    short term, immediately after use.
    Title
    relationship between symptomatic and asymptomatic and force production and pain
    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.
    Time Frame
    short term, immediately after use.
    Title
    relationship between symptomatic and asymptomatic strength and function
    Description
    Observe the relationship between shoulder function and rotator cuff muscle strength in patients with the studied condition, assessed with a scale.
    Time Frame
    short term, immediately after use.
    Title
    relationship between symptomatic and asymptomatic strength and pain
    Description
    Observe the relationship between shoulder function and rotator cuff muscle strength in patients with the studied condition, assessed with a scale and pain.
    Time Frame
    short term, immediately after use.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Complaint of shoulder pain for at least 30 days Age between 25 and 50 years Diagnosis of rotator cuff tendinopathy (Jobe, Neer, Hawkins-Kennedy and resisted external rotation test, at least 3 positive tests) Magnetic resonance imaging with findings corresponding to rotator cuff tendinopathy? Inclusion criteria in the health subjects : No history of shoulder pain at some point in life Age between 25 and 50 years Diagnostic Tests for Rotator Cuff Tendinopathy (Jobe, Neer, Hawkins-Kennedy, and resisted external rotation test) NEGATIVE Exclusion Criteria: Contraindications to the use of electrostimulation Pregnancy History of shoulder, cervical, or thoracic surgery Shoulder dislocation Fracture Labral laceration Rheumatic disease Complete or partial tear of the rotator cuff adhesive capsulitis
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pedro Vieira Malachias
    Phone
    +55 019 999249201
    Email
    pedrovieira.fisio@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    I will analyze each request and analyze later

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