ExerciseNCT06402162
The Effect of Core Stability Exercises on Pain, Muscle Strength, and Muscle Architecture in Tennis Players With Rotator Cuff Lesions
A study testing exercise in people with Exercise and Muscle Weakness, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Exercise, Muscle Weakness, Rotator Cuff Injuries
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Oct 2024
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- 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.
- Lewis, J., Ginn, K.. Rotator cuff tendinopathy and subacromial pain syndrome.In: Modern Musculoskeletal Physiotherapy, fourth ed. Elsevier, pp. 2015; 563e568.
- 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.
- Sauers E. Effectiveness of rehabilitation for patients with subacromial impingement syndrome. J Athl Train, 2005, 40: 221-223
- 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.
- 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.
- Conditions
- Exercise, Muscle Weakness, Rotator Cuff Injuries
- Being tested
- exercise
- Keywords
- muscle thickness, fiber length, pennation angle, pain
- Medical subject headings
- Motor Activity, Muscle Weakness, Rotator Cuff Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| muscle architecture | Experimental | Not described Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual pain scale
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.
Measured: 8 week
Secondary outcomes (1)
ultrasonographic examination
increase in supraspinatus muscle thickness = centimeters
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 May 2023
- Primary completion1 Oct 2023
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will include 40 tennis players diagnosed with rotator sheath lesions who meet the inclusion criteria. Groups will be randomly divided into 2. 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. In both groups, pain will be assessed by Visual Analog Scale (VAS), muscle strength by isokinetic dynamometer and supraspinatus muscle architecture by ultrasonography and dynamic tendon imaging.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Merve Ersever, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402162
- Sponsor's protocol ID
- 5678525-050.0404/1202308
- Status last verified
- Mar 2024
- First submitted
- 29 Apr 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Core Stability Exercises on Pain, Muscle Strength, and Muscle Architecture in Tennis Players With Rotator Cuff Lesions
- ClinicalTrials.gov ID
- NCT06402162
- Acronym / sponsor ID
- 5678525-050.0404/1202308
- Conditions
- Exercise, Muscle Weakness, Rotator Cuff Injuries
- Keywords
- muscle thickness, fiber length, pennation angle, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 7 May 2024 (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.
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.
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
- 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.
- Lewis, J., Ginn, K.. Rotator cuff tendinopathy and subacromial pain syndrome.In: Modern Musculoskeletal Physiotherapy, fourth ed. Elsevier, pp. 2015; 563e568.
- 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.
- Sauers E. Effectiveness of rehabilitation for patients with subacromial impingement syndrome. J Athl Train, 2005, 40: 221-223
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will include 40 tennis players diagnosed with rotator sheath lesions who meet the inclusion criteria. Groups will be randomly divided into 2. 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. In both groups, pain will be assessed by Visual Analog Scale (VAS), muscle strength by isokinetic dynamometer and supraspinatus muscle architecture by ultrasonography and dynamic tendon imaging.
| Arm | Type | Receives |
|---|---|---|
| muscle architecture | Experimental | Other: exercise |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Acute trauma
- Tendinosis
- Bursitis chronic inflammation degeneration
- Grade 1-2 rupture
- Having unilateral shoulder pain
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| exerciseThe 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. | Other | muscle architecture |
Primary outcome
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.
1 secondary outcome
ultrasonographic examination
Time frame: 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Application of core exercises to tennis playersLink provided by the sponsor.
- core exercises to tennis playersLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Exercise and Muscle Weakness, run by Ankara University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual pain scale (time frame: 8 week). 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 15 Oct 2024.