The Effect of Core Stability Exercises on Pain, Muscle Strength, and Muscle Architecture in Tennis Players With Rotator Cuff Lesions

October 11, 2024 updated by: Emine Merve Ersever, Ankara University
This study aims to shed light on the supraspinatus and infraspinatus muscles, which play a significant role in rotator sheath tendinopathy and tears. It includes isometric measurements of muscle thickness, fiber length, and pennation angles, as well as muscle strength, using ultrasound to evaluate the muscle architecture of the supraspinatus and infraspinatus muscles in tennis players.

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

The shoulder joint is prone to injury due to its unique anatomy. Rotator cuff lesions (RCL) are a common cause of shoulder pain, with a prevalence of 81% (1). One effective approach for monitoring muscle function is to visualize the architectural structure of the muscle. Muscle architecture is the examination of the structural arrangement of muscle fibers, muscle thickness, pennation angle, and number of sarcomeres according to the force generation axis (2). Ultrasonographic muscle architecture measurements provide a rapid and objective evaluation to examine the pathology of the muscles associated with subacromial impingement syndrome (3).

Muscle strength measurement is a physical performance measurement used to determine the loss of strength in the muscle and to evaluate the effectiveness of the intervention by resisting the muscle (4). It is worth noting that the strength of the rotator cuff muscles, especially the external and internal force-generating muscles of the shoulder, may be somewhat reduced in athletes with RCL. Strength measurement of these muscles can provide valuable data in shoulder evaluation (5). It is also worth mentioning that shoulder injuries are quite common in tennis. In addition to physiotherapy methods, the success rate in RCL treatment may be enhanced by exercise (6). In shoulder rehabilitation, core exercises are designed to help restore functional movements through the elimination of pain and the dynamic stability of the rotator cuff and scapular muscles. The goal is to strengthen the shoulder girdle muscles and achieve sufficient joint range of motion, especially by providing neuromuscular re-education with therapeutic exercises.

References

  1. Dong W, Goost H, Lin XB, et al. Treatments for shoulder impingement syndrome: a systematic review and network meta-analysis. Medicine (Baltimore). 2015;94:e510.
  2. Lewis, J., Ginn, K.. Rotator cuff tendinopathy and subacromial pain syndrome.In: Modern Musculoskeletal Physiotherapy, fourth ed. Elsevier, pp. 2015; 563e568.
  3. Michener L, Walsworth M, Burnet E. Effectiveness of rehabilitation for patients with subacromial impingement syndrome: a systematic review. J Hand Ther, 2004, 17: 152-164.
  4. Sauers E. Effectiveness of rehabilitation for patients with subacromial impingement syndrome. J Athl Train, 2005, 40: 221-223
  5. Ersever, E. M., Güzel, N. A., Hakan, G. E. N. Ç., & Mülkoğlu, C. (2021). Subakromiyal Sikişma Sendromlu Hastalarda Egzersiz İle Elektrik Stimülasyonunun Etkileri. Ankara Eğitim ve Araştırma Hastanesi Tıp Dergisi, 54(3), 382-386.
  6. Oh, L.S., Luke, S., Brian, R, Michael P., Bruce, A., Marx, Robert G. (2007). Indications for rotator cuff repair: a systematic review. Clinical Orthopaedics and Related Research®, 455: 52-63.

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.
40

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 Locations

  • Turkey
      • Ankara, Turkey
        • Tennis Club

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Acute trauma
  • Tendinosis
  • Bursitis chronic inflammation degeneration
  • Grade 1-2 rupture
  • Having unilateral shoulder pain
  • At least two specific tests must be positive (Neer-hawkings-Lag sign-drop arm and supraspinatus isolation tests; painful shoulder internal and external rotation against resistance (IR and ER); painful arch during abduction)

Exclusion Criteria:

  • An acute trauma
  • History of surgery or a fracture in or near the shoulder and shoulder
  • A neurological deficit
  • intra-articular injections in the last six months
  • Rheumatic disease

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: muscle architecture
Other: exercise
The study will include 40 tennis players diagnosed with rotator cuff lesions who meet the inclusion criteria. The 1st group will be randomly divided into 2 groups as control (n=20) and 2nd group as core exercise (n=20). Unlike the control group, core exercises will be added to the routine exercise program of tennis players once a day, 3 days a week for 8 weeks.

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
visual pain scale
Time Frame: 8 week
The primary objective was to see if we could help to decrease the pain intensity of the patients by 4 units in a 10-unit VPS assessment.
8 week

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
ultrasonographic examination
Time Frame: 8 week
increase in supraspinatus muscle thickness = centimeters
8 week

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.
Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
May 1, 2023

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.
October 1, 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.
October 1, 2024

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).
April 29, 2024

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.
May 2, 2024

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.
May 7, 2024

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.
October 15, 2024

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.
October 11, 2024

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.
March 1, 2024

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.
  • 5678525-050.0404/1202308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Rotator Cuff Injuries

Clinical Trials on exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings