AzTrials
AzTrials

Rotator Cuff TearsNCT05566470

Central Neuromuscular Dysfunction, Functionality, Psychological Status and Rotator Cuff Surgery

An observational study of Rotator Cuff Tears, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Considering the fact that The problems experienced by the patients are not only physiological but also psychological and social. Unfortunately, there is no sufficient study focus on all these concepts. Generally, studies focus on only physiological dimensions such as functional level, muscle strength and pain. Read more about this study

Who is it for?
Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Rotator Cuff Tears
What is being tested?
Assessment of Central Neuromuscular Dysfunction, Shoulder Physical Functionality and Psychological Factors
How many people
34 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2021to 24 Jun 2023
How long will I take part?
6 Months
Phase
Observational
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 30 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: A total of 17 individuals, male and female, between the ages of 30-65 who have undergone rotator cuff tear surgery, will be included in the study. 17 healthy individuals from the close circle of the researchers reached by snowball method will be included in the control group.

Who may be able to join

  • Volunteer to participate in the study,
  • Be between the ages of 30 and 65,
  • Individuals who have been diagnosed with massive rotator cuff tear and the who have undergone rotator cuff tear surgery,
  • At least 6 months have passed after the surgery,
  • In the last 6 months, patients have not undergone shoulder surgery except for rotator cuff tear surgery,
  • Arthroscopic surgical method was performed by Prof. Dr. Gazi Huri,
Show all 9Show fewer
  • The absence of another lesion involving the shoulder joint, such as SLAP (Superior Labrum Anterior Posterior), recurrent shoulder dislocation, arthroplasty, except for massive complete tear in the patient will be included in the study.
  • Demographic characteristics (age and gender) similar to the study group,
  • Not having any diagnosis related to the shoulder joint.

Who cannot join

  • Having any additional pathology (SLAP (Superior Labrum Anterior Posterior), recurrent shoulder dislocation, arthroplasty etc.) concerning the shoulder joint,
  • Having a history of surgery involving the shoulder,
  • Having a neuromuscular and/or metabolic disease,
  • Presence of active infection
  • Other coexisting neuromuscular and musculoskeletal pathologies,
  • To have been diagnosed with bilateral RMY,
Show all 11Show fewer
  • Metal implants in the head and neck,
  • Being pregnant,
  • Those who use drugs that can change cortical excitability,
  • Being a cancer patient,
  • Individuals with cognitive and psychiatric disorders will not be included in this study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Atılım University

    Ankara, Ankara, 06450

Other trials in Turkey (Türkiye)

About this study

Official title: Assessment of Central Neuromuscular Dysfunction, Shoulder Physical Functionality and Psychological Factors in Individuals Undergoing Rotator Cuff Surgery

Considering the fact that The problems experienced by the patients are not only physiological but also psychological and social. Unfortunately, there is no sufficient study focus on all these concepts.

Generally, studies focus on only physiological dimensions such as functional level, muscle strength and pain. The aim of this study, in addition to assessment methods commonly used for functional level, muscle strength and pain, is to evaluate central neuromuscular function on individuals who have undergone rotator cuff tear surgery with transcranial magnetic stimulation. Furthermore, psychological resilience, which is considered as a positive psychological trait, will also be evaluated. Until now, only one study has evaluated the role of psychological resilience in the postoperative process of rotator cuff surgery. This study has shown that the correlation between functionality and psychological resilience. As a result of our study, the influence of resiliency on postoperative outcomes following rotator cuff surgery will be determined and central neuromuscular function, shoulder functional level, and psychological resilience changes will be revealed in physiological and psychological concepts.

Read more

Furthermore, this study may show that psychological resilience has a potential role on predicting functional level and pain.

It is planned that the results obtained will guide the postoperative rehabilitation of rotator cuff surgery for further studies on multidimensional perspectives.

Read the detailed description

The problems experienced by the patients are not only physiological but also psychological and social. Unfortunately, there is no sufficient study focus on all these concepts.

For all these reasons, it is seen that in order to offer an individualized rehabilitation program to patients, it is needed to add psychological evaluation methods that can directly affect the results of treatment as well as physical and objective evaluations during the evaluation phase.

As a physical evaluation method, the cortico-spinal excitability of the deltoid muscle will be evaluated with the Transcranial Magnetic Stimulation (TMS) to determine the effects of rotator cuff tears on the central neuromuscular function of the upper extremity muscles in patients who have undergone rotator cuff tear surgery.

Superficial electromyography (EMG) studies have shown that central neuromuscular dysfunction of deltoid muscle in chronic rotator cuff tears is associated with activation of adjacent shoulder muscles. Until now, only one study has evaluated the central neuromuscular function of deltoid muscle with Transcranial Magnetic Stimulation (TMS).

Transcranial Magnetic Stimulation (TMS) is a non-invasive evaluation method in which magnetic fields are used to stimulate neural structures such as cerebral cortex, spinal roots, cranial and spinal neurons and the responses resulting from these stimulations are recorded with EMG device One of the main symptoms of patients with Rotator Cuff Tear is pain. According to John et al. and Martinez et al., psychological resilience is an important factor during coping with pain. Higher phological resilience has been associated with less pain intensity, less pain-related limitations, more social support, and more pain self-efficacy. The American Psychological Association (2014) defines resilience as "the process of adapting well in the face of adversity, trauma, tragedy, threats or even significant sources of stress." Studies has shown that resilience has a potential role for patient recovery. Until now, only one study has evaluated the role of psychological resilience in the postoperative process of rotator cuff surgery.

Therefore, the main purpose of this study is to investigate the relationship of central neuromuscular function of deltoid muscle with functional level and psychological factors.

The psychological factors that will be evaluated are depression, anxiety, stress and psychological resilience. The effect of these psychological factors on functional level will also be examined.

Considering that psychological resilience is also associated with social participation, higher psychological resilience allows patients to receive better social support during the rehabilitation process and communicate more effectively with their environment.

As a result of our study, the influence of resiliency on postoperative outcomes following rotator cuff surgery will be determined and central neuromuscular function, shoulder functional level, and psychological resilience changes will be revealed in physiological and psychological concepts.

Furthermore, this study may show that psychological resilience has a potential role on predicting functional level and pain.

It is planned that the results obtained will guide the postoperative rehabilitation of rotator cuff surgery for further studies on multidimensional perspectives.

Being tested
Assessment of Central Neuromuscular Dysfunction, Shoulder Physical Functionality and Psychological Factors
Keywords
Transcranial magnetic stimulation, Rotator Cuff Tear, Functionality, Psychological Resilience, Depression, anxiety, stress, Central Neuromuscular Function
Medical subject headings
Rotator Cuff Injuries, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assessment of Central Neuromuscular Dysfunction, Shoulder Physical Functionality and Psychological FactorsDiagnostic test

    Each of the 2 groups will be evaluated in terms of functional level and psychological factors; American Shoulder and Elbow Surgeons evaluation form (ASES), Connor-Davidson Psychological Resilience Scale (CDPRS) and the Depression, Anxiety, Stress-21 Scale (DASS-21) will be used to evaluate these factors. Furthermore, the corticospinal excitability of the deltoid muscle will be assessed with Transcranial Magnetic Stimulation (TMS). Both deltoid muscles of the patient will be evaluated by saving motor evoked potentials signals that respond to TMS, and motor excitability will be compared between the affected arm and the unaffected arm. In addition, the control group will also be assessed in terms of functional level and psychological factors with TMS, ASES, DASS-21 and CPDRS.

Study groups in NCT05566470
Study groupRoleWhat they receive
Control Group1. Healty adults aged between 30-65 years old who do not have any pathology related to the shoulder joint and have not undergone surgery and being a volunteer to participate in the study.
Receives: Diagnostic Test: Assessment of Central Neuromuscular Dysfunction, Shoulder Physical Functionality and Psychological Factors
Patient Group1. Individuals between 30-65 years old who have been diagnosed with massive rotator cuff tear, 2. At least 6 months have passed after the surgery, 3. In the last 6 months, patients have not undergone shoulder surgery except for rotator cuff tear surgery, 4. Arthroscopic surgical method was performed by Prof. Dr. Gazi Huri, 5. The absence of another lesion involving the shoulder joint, such as SLAP (Superior Labrum Anterior Posterior), recurrent shoulder dislocation, arthroplasty, except for massive complete tear in the patient will be included in the study
Receives: Diagnostic Test: Assessment of Central Neuromuscular Dysfunction, Shoulder Physical Functionality and Psychological Factors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Transcranial Magnetic Stimulation (TMS)

    Transcranial Magnetic Stimulation (TMS) will be used to evaluate corticomotor excitability. TMS is a non-invasive evaluation method in which magnetic fields are used to stimulate neural structures such as cerebral cortex, spinal roots, cranial and spinal neurons and the responses resulting from these stimulations are recorded with electromyography (EMG) device and is used for prognostic and evaluation purposes.

    Measured: 1 day

  2. The American Shoulder and Elbow Surgeons Score (ASES)

    ASES Standardized Shoulder Assessment form was used to evaluate patient-rated shoulder pain and function. ASES consists of two parts in which therapists evaluate patients and patients evaluate themselves. The questionnaire includes questions about patients' pain and activities of daily living. Evaluation is made over 100 points. 0 is the minimum score, 100 is the maximum points. Higher scores indicate a better functional level.

    Measured: 1 day

  3. Connor-Davidson Psychological Resilience Scale (CDPRS)

    It was developed to measure psychological resilience. The answers to the scale are sorted as 0: not correct at all, 1: rarely correct, 2: sometimes correct, 3: often correct, 4: almost always correct. Each question is scored between 0 and 4 points. There are 3 sub-dimensions of the scale. Perseverance and personal competence, tolerance to negative phenomena and spiritual inclination are the main headings of the 3 sub-dimensions. The highest score to be obtained from the first sub-dimension, perseverance and personal competence, is 60, the highest score that can be obtained from tolerance to negative phenomena, which is the second sub-dimension, is 24, and the highest score to be obtained from the third sub-dimension, spiritual tendency, is 16. In conclusion, evaluation is made over 100 points. 0 is the minimum score, 100 is the maximum points. Higher scores indicate a better resilience status.

    Measured: 1 day

  4. Depression, Anxiety, Stress-21 Scale (DASS-21)

    The scale is used to measure the symptoms of depression, anxiety and stress both in the clinical sample and in the normal sample.

    In this measurement tool, the 0-7 score range is normal depression, the 0-7 point range is normal anxiety, and the 0-14 point range is normal stress indicator. There are 7 questions to measure each of the dimensions of depression, stress and anxiety. On the scale, 0 is scored as "never", 1 as "sometimes", 2 as "quite often", and 3 as "always".

    The fact that the individual receives 5 points and above from the depression sub-dimension, 4 points and above from anxiety, and 8 points and above from stress shows that the symptoms are not normal.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2022
  2. Study start1 Dec 2021
  3. Primary completion24 Jun 2023
  4. Study completion24 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
34 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05566470
Sponsor's protocol ID
GO 22/643
Status last verified
Sep 2026
First submitted
30 Sep 2022
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Porter A, Hill MA, Harm R, Greiwe RM. Resiliency influences postoperative outcomes following rotator cuff repair. J Shoulder Elbow Surg. 2021 May;30(5):1181-1185. doi: 10.1016/j.jse.2020.08.024. Epub 2020 Sep 9.

    PubMed 32919049
  • Berth A, Pap G, Awiszus F, Neumann W. Central motor deficits of the deltoid muscle in patients with chronic rotator cuff tears. Acta Chir Orthop Traumatol Cech. 2009 Dec;76(6):456-61.

    PubMed 20067692
  • Nollet H, Van Ham L, Deprez P, Vanderstraeten G. Transcranial magnetic stimulation: review of the technique, basic principles and applications. Vet J. 2003 Jul;166(1):28-42. doi: 10.1016/s1090-0233(03)00025-x.

    PubMed 12788015
  • Hassett AL, Finan PH. The Role of Resilience in the Clinical Management of Chronic Pain. Curr Pain Headache Rep. 2016 Jun;20(6):39. doi: 10.1007/s11916-016-0567-7.

    PubMed 27115770

Questions about this trial

What is this clinical trial studying?

An observational study of Rotator Cuff Tears, run by Hacettepe 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 9 inclusion and 11 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 17 Sep 2026. 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?

Transcranial Magnetic Stimulation (TMS) (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05566470, which also lists 4 linked publications.

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 17 Sep 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in