Clinical trial NCT06023914: 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
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Rotator Cuff Impingement Syndrome
Rotator Cuff Tendinitis
Subacromial Impingement Syndrome
Keywords: shoulder pain
rotator cuff strength
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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

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.


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

Primary outcomes:
measure: isometric muscle strength of rotator cuff muscles
timeFrame: short term, immediately after use.
Secondary outcomes:
measure: Analyses of isometric strength between groups of healthy and unhealthy individuals.
timeFrame: short term, immediately after use.
measure: Intra-group group analyses
timeFrame: short term, immediately after use.
measure: other rotator cuff muscle strength analyses
timeFrame: short term, immediately after use.
measure: strength relationship between symptomatic and asymptomatic
timeFrame: short term, immediately after use.
measure: relationship between symptomatic and asymptomatic and force production
timeFrame: short term, immediately after use.
measure: relationship between symptomatic and asymptomatic and force production and pain
timeFrame: short term, immediately after use.
measure: relationship between symptomatic and asymptomatic strength and function
timeFrame: short term, immediately after use.
measure: relationship between symptomatic and asymptomatic strength and pain
timeFrame: short term, immediately after use.
Other outcomes:
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