Effectiveness of The Neuromuscular Control-Based Exercise Training in the Treatment of Partial-Thickness Rotator Cuff Tears

August 15, 2023 updated by: Ezgi Turkmen, Istanbul University - Cerrahpasa (IUC)
The aim of this study is to determine and compare the effects of neuromuscular control exercises for the shoulder, and standard conservative exercise programs, which are different forms of exercise and have an important role in the treatment of partial thickness rotator cuff tears on treatment. Thus, it is aimed to compare these exercise types with different mechanisms on treatment, to determine the place of neuromuscular control exercises in treatment and whether they are more effective than conventional exercises.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Rotator cuff (RC) tear shows different symptoms or sometimes can progress asymptomatic. The most common symptoms associated with rotator cuff tears are loss of shoulder range of motion (ROM), shoulder pain exacerbated by overhead activities, nocturnal pain, shoulder dysfunction, and functional limitations. Conservative treatment is the first and most preferred procedure in the treatment of partial tears. Conservative treatment includes patient education, activity modifications, medication, and physiotherapy and rehabilitation programs. In the literature search, it is seen that the studies on the conservative treatment of partial RC tears often include open kinetic chain-weighted standard exercises and strengthening exercise types. It is seen that stabilization and proprioception-based neuromuscular control exercises of the shoulder, which have an important role in restoring neuromuscular control, which is reported to be impaired in shoulder pathologies, are included in some studies and these exercises are generally added to standard treatment. However, it is not known whether neuromuscular control exercises are more effective than other exercises in the standard rehabilitation programs as a result of the combined application of these exercises in this patient group. For this purpose, it is aimed to compare the treatment efficacy of a group consisting of neuromuscular control exercises for the shoulder and a group consisting of conventional exercises and to determine the place of neuromuscular control exercises in treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Büyükçekmece
      • İstanbul, Büyükçekmece, Turkey, 34500
        • İstanbul Üniversitesi-Cerrahpaşa, Sağlık Bilimleri Fakültesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Forty years of age or older patients that had been diagnosed for a partial rotator cuff tear that was unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder were included into this study.

Exclusion Criteria:

  • Patients diagnosed with full-thickness or massive rotator cuff tear, patients who had undergone previous surgery, patients diagnosed with frozen shoulder or glenohumeral instability, and athletic patients younger than 40 years of age with symptoms of acute RC tear were not included in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
Neuromuscular Control-Based Exercise Training Group
Other: Neuromuscular Control-Based Exercise Training Group
Exercises for the neuromuscular control of the shoulder will be progressed by starting with the body weight, and in the following phases, a program that progresses to exercises that will improve the dynamic stabilization, coordination and proprioception of the shoulder will be applied to train the sensorimotor system. The exercise program will be performed twice a week for 8 weeks (16 sessions).
Active Comparator: Group 2
Conventional Exercise Training Group
Other: Conventional Exercise Training Group
In this group, which will mainly benefit from conventional open kinetic chain strength exercises, a strengthening exercise program will be applied by advancing from body weight to elastic bands and weights. The exercise program will be performed twice a week for 8 weeks (16 sessions).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Constant-Murley Score
Time Frame: The Constant Murley Score assessment will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
The Constant Murley Score is a 100-point scale consisting of 15 points for pain, 20 points for daily activities, 40 points for pain-free range of motion, and 25 points for strength. High scores are positively correlated with the increased functional level. While pain and activities of daily living are evaluated by the patient, range of motion and strength are evaluated by the clinician.
The Constant Murley Score assessment will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Numerical Pain Rating Scale (NPRS)
Time Frame: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
The levels of pain felt at rest / activity / night were measured using Numerical Pain Rating Scale (NPRS). Patients were asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain.
Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Shoulder Joint Proprioception with Inclinometer
Time Frame: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Proprioception of the shoulder joint is assessed by reproduction/reposition testing using an inclinometer. The patient will be evaluated by recording the difference between the angle from which the patient comes and the target angle determined.
Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Shoulder Joint Range of Motion (ROM)
Time Frame: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
The shoulder flexion, abduction, internal and external rotation ROM were evaluated with goniometer while the patient was in supine position.
Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Shoulder Joint Muscle Strength
Time Frame: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Maximum isometric shoulder flexion, abduction, external and internal rotation strength measurements will be performed using a handheld dynamometer. During the test, while the participants were in a sitting position to measure shoulder flexion and abduction forces; for the measurement of external and internal rotational forces in the supine position, the shoulder is in 90° abduction and the elbow is in 90° flexion. For each movement, the measurements are repeated 3 times and the best measurement value is recorded.
Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Quick DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire
Time Frame: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Quick DASH is a 11-item questionnaire that questions the activities of a person in daily life, the degree of participation in recreational activities, the symptom and psychosocial state that affects their pain, and sleep quality. The total score is at least 0 and at most 100, and the high scores are positively correlated with the decreased functional level.
Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Short Form 12 (SF-12)
Time Frame: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
SF-12 was used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life.
Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Global Rating of Change (GRC) Scale
Time Frame: Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Global Rating of Change (GRC) scale was used to assess the overall satisfaction levels of the patients. Patients were asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction.
Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 3, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 26, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IstanbulUC49

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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