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

Subacromial Impingement Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06023914
• Other study ID #: ANEEM MRT
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: August 2023
• Source: University of Campinas, Brazil
• Contact: Pedro Vieira Malachias
• Phone: +55 019 999249201
• Email: pedrovieira.fisio[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 31, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Impingement Syndrome
• Rotator Cuff Injuries
• Rotator Cuff Tendinitis
• Shoulder Impingement Syndrome
• Subacromial Impingement Syndrome
• Syndrome
• Tendinopathy

Intervention

Other:
• STRENGTH EVALUATION WITH ELECTROSTIMULATOR
Evaluation of isometric strength using an electrostimulator.
• STRENGTH EVALUATION WITHOUT ELECTROSTIMULATOR
Evaluation of isometric strength not using an electrostimulator.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	short term, immediately after use.
Secondary	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..	short term, immediately after use.
Secondary	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.	short term, immediately after use.
Secondary	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.	short term, immediately after use.
Secondary	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.	short term, immediately after use.
Secondary	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.	short term, immediately after use.
Secondary	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.	short term, immediately after use.
Secondary	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.	short term, immediately after use.
Secondary	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.	short term, immediately after use.