Rotator Cuff Impingement SyndromePhase 2/3NCT06023914
Analysis of the Effect of Neuromuscular Electro-stimulation on the Performance of Isometric Rotator Cuff Strength.
A Phase 2/3 study testing STRENGTH EVALUATION WITH ELECTROSTIMULATOR and STRENGTH EVALUATION WITHOUT ELECTROSTIMULATOR in people with Rotator Cuff Impingement Syndrome and Rotator Cuff Tendinitis, run by University of Campinas, Brazil.
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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Impingement Syndrome, Rotator Cuff Tendinitis, Subacromial Impingement Syndrome
- What is being tested?
- STRENGTH EVALUATION WITH ELECTROSTIMULATOR and STRENGTH EVALUATION WITHOUT ELECTROSTIMULATOR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 31 Jan 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Contraindications to the use of electrostimulation
- Pregnancy
- History of shoulder, cervical, or thoracic surgery
- Shoulder dislocation
- Fracture
- Labral laceration
Show all 9Show fewer
- Rheumatic disease
- Complete or partial tear of the rotator cuff
- adhesive capsulitis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Analysis of the Effect of Neuromuscular Electro-stimulation on the Performance of Isometric Rotator Cuff Strength in Patients With Tendinopathy.
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 Impingement Syndrome, Rotator Cuff Tendinitis, Subacromial Impingement Syndrome
- Being tested
- STRENGTH EVALUATION WITH ELECTROSTIMULATOR, STRENGTH EVALUATION WITHOUT ELECTROSTIMULATOR
- Keywords
- shoulder pain, rotator cuff strength
- Medical subject headings
- Shoulder Impingement Syndrome, Rotator Cuff Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRENGTH EVALUATION WITH ELECTROSTIMULATOROther
Evaluation of isometric strength using an electrostimulator.
STRENGTH EVALUATION WITHOUT ELECTROSTIMULATOROther
Evaluation of isometric strength not using an electrostimulator.
| Study group | Role | What they receive |
|---|---|---|
| Isometric strength evaluation with a device of electro-stimulation | Experimental | 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. Receives: Other: STRENGTH EVALUATION WITH ELECTROSTIMULATOR |
| Isometric strength evaluation | Active comparator | 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. Receives: Other: STRENGTH EVALUATION WITHOUT ELECTROSTIMULATOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: short term, immediately after use.
Secondary outcomes (8)
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..
Measured: short term, immediately after use.
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.
Measured: short term, immediately after use.
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.
Measured: short term, immediately after use.
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.
Measured: short term, immediately after use.
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.
Measured: short term, immediately after use.
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.
Measured: short term, immediately after use.
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.
Measured: short term, immediately after use.
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.
Measured: short term, immediately after use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Vieira Malachias, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023914
- Sponsor's protocol ID
- ANEEM MRT
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I will analyze each request and analyze later
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effect of Neuromuscular Electro-stimulation on the Performance of Isometric Rotator Cuff Strength in Patients With Tendinopathy.
- ClinicalTrials.gov ID
- NCT06023914
- Acronym / sponsor ID
- ANEEM MRT
- Conditions
- Rotator Cuff Impingement Syndrome, Rotator Cuff Tendinitis, Subacromial Impingement Syndrome
- Keywords
- shoulder pain, rotator cuff strength
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Isometric strength evaluation with a device of electro-stimulation | Experimental | Other: STRENGTH EVALUATION WITH ELECTROSTIMULATORThe 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. |
| Isometric strength evaluation | Active comparator | Other: STRENGTH EVALUATION WITHOUT ELECTROSTIMULATORThe 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. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- Contraindications to the use of electrostimulation
- Pregnancy
- History of shoulder, cervical, or thoracic surgery
- Shoulder dislocation
- Fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STRENGTH EVALUATION WITH ELECTROSTIMULATOREvaluation of isometric strength using an electrostimulator. | Other | Isometric strength evaluation with a device of electro-stimulation |
| STRENGTH EVALUATION WITHOUT ELECTROSTIMULATOREvaluation of isometric strength not using an electrostimulator. | Other | Isometric strength evaluation |
Primary outcome
isometric muscle strength of rotator cuff muscles
Time frame: short 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.
8 secondary outcomes
Analyses of isometric strength between groups of healthy and unhealthy individuals.
Time frame: short term, immediately after use.
Intra-group group analyses
Time frame: short term, immediately after use.
other rotator cuff muscle strength analyses
Time frame: short term, immediately after use.
strength relationship between symptomatic and asymptomatic
Time frame: short term, immediately after use.
relationship between symptomatic and asymptomatic and force production
Time frame: short term, immediately after use.
relationship between symptomatic and asymptomatic and force production and pain
Time frame: short term, immediately after use.
relationship between symptomatic and asymptomatic strength and function
Time frame: short term, immediately after use.
relationship between symptomatic and asymptomatic strength and pain
Time frame: short term, immediately after use.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: Undecided. I will analyze each request and analyze later
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing STRENGTH EVALUATION WITH ELECTROSTIMULATOR and STRENGTH EVALUATION WITHOUT ELECTROSTIMULATOR in people with Rotator Cuff Impingement Syndrome and Rotator Cuff Tendinitis, run by University of Campinas, Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro Vieira Malachias (+55 019 999249201, pedrovieira.fisio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
isometric muscle strength of rotator cuff muscles (time frame: short term, immediately after use.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.