Viewing Study NCT06023914



Ignite Creation Date: 2024-05-06 @ 7:28 PM
Last Modification Date: 2024-10-26 @ 3:07 PM
Study NCT ID: NCT06023914
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-09-05
First Post: 2023-08-23

Brief Title: Analysis of the Effect of Neuromuscular Electro-stimulation on the Performance of Isometric Rotator Cuff Strength
Sponsor: University of Campinas Brazil
Organization: University of Campinas Brazil

Study Overview

Official Title: Analysis of the Effect of Neuromuscular Electro-stimulation on the Performance of Isometric Rotator Cuff Strength in Patients With Tendinopathy
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 n24 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None