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

Analysis of the Effect of Neuromuscular Electro-stimulation on the Performance of Isometric Rotator Cuff Strength in Patients With Tendinopathy.

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06023914
Enrollment
60
Registered
2023-09-05
Start date
2023-09-01
Completion date
2024-01-31
Last updated
2023-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

shoulder pain, rotator cuff strength

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.

Interventions

OTHERSTRENGTH EVALUATION WITH ELECTROSTIMULATOR

Evaluation of isometric strength using an electrostimulator.

OTHERSTRENGTH EVALUATION WITHOUT ELECTROSTIMULATOR

Evaluation of isometric strength not using an electrostimulator.

Sponsors

University of Campinas, Brazil
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
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.

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.

Eligibility

Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
isometric muscle strength of rotator cuff musclesshort term, immediately after use.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

MeasureTime frameDescription
relationship between symptomatic and asymptomatic strength and painshort term, immediately after use.Observe the relationship between shoulder function and rotator cuff muscle strength in patients with the studied condition, assessed with a scale and pain.
Analyses of isometric strength between groups of healthy and unhealthy individuals.short term, immediately after use.\- 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 analysesshort term, immediately after use.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.
relationship between symptomatic and asymptomatic strength and functionshort term, immediately after use.Observe the relationship between shoulder function and rotator cuff muscle strength in patients with the studied condition, assessed with a scale.
strength relationship between symptomatic and asymptomaticshort term, immediately after use.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 productionshort term, immediately after use.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 painshort term, immediately after use.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.
other rotator cuff muscle strength analysesshort term, immediately after use.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.

Contacts

Primary ContactPedro Vieira Malachias
pedrovieira.fisio@gmail.com+55 019 999249201

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026