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

NCT ID: NCT06023914

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-01-31

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.

Conditions

Rotator Cuff Tendinitis; Subacromial Impingement Syndrome; Rotator Cuff Impingement Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Isometric strength evaluation with a device of electro-stimulation

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.

Group Type: EXPERIMENTAL

STRENGTH EVALUATION WITH ELECTROSTIMULATOR

Intervention Type: OTHER

Evaluation of isometric strength using an electrostimulator.

Isometric strength evaluation

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.

Group Type: ACTIVE_COMPARATOR

STRENGTH EVALUATION WITHOUT ELECTROSTIMULATOR

Intervention Type: OTHER

Evaluation of isometric strength not using an electrostimulator.

Interventions

STRENGTH EVALUATION WITH ELECTROSTIMULATOR

Evaluation of isometric strength using an electrostimulator.

Intervention Type: OTHER

STRENGTH EVALUATION WITHOUT ELECTROSTIMULATOR

Evaluation of isometric strength not using an electrostimulator.

Intervention Type: OTHER

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?

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Campinas, Brazil

OTHER

Sponsor Role: lead

Responsible Party

Pedro Vieira Malachias

Physical Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Pedro Vieira Malachias

Role: CONTACT

pedrovieira.fisio@gmail.com

+55 019 999249201

Other Identifiers

ANEEM MRT

Identifier Type: -

Identifier Source: org_study_id