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

NCT ID: NCT05566470

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-17
• Study Completion Date: 2025-12-24

Brief 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. 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.

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.

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.

Conditions

Rotator Cuff Tears

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Control Group

1\. 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.

Assessment of Central Neuromuscular Dysfunction, Shoulder Physical Functionality and Psychological Factors

Intervention Type: DIAGNOSTIC_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.

Patient Group

1. 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

Assessment of Central Neuromuscular Dysfunction, Shoulder Physical Functionality and Psychological Factors

Intervention Type: DIAGNOSTIC_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.

Interventions

Assessment of Central Neuromuscular Dysfunction, Shoulder Physical Functionality and Psychological Factors

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Volunteer to participate in the study,

2. Be between the ages of 30 and 65,

3. Individuals who have been diagnosed with massive rotator cuff tear and the who have undergone rotator cuff tear surgery,

4. At least 6 months have passed after the surgery,

5. In the last 6 months, patients have not undergone shoulder surgery except for rotator cuff tear surgery,

6. Arthroscopic surgical method was performed by Prof. Dr. Gazi Huri,

7. 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.

1. Demographic characteristics (age and gender) similar to the study group,

2. Not having any diagnosis related to the shoulder joint.

Exclusion Criteria

1. Having any additional pathology (SLAP (Superior Labrum Anterior Posterior), recurrent shoulder dislocation, arthroplasty etc.) concerning the shoulder joint,

2. Having a history of surgery involving the shoulder,

3. Having a neuromuscular and/or metabolic disease,

4. Presence of active infection

5. Other coexisting neuromuscular and musculoskeletal pathologies,

6. To have been diagnosed with bilateral RMY,

7. Metal implants in the head and neck,

8. Being pregnant,

9. Those who use drugs that can change cortical excitability,

10. Being a cancer patient,

11. Individuals with cognitive and psychiatric disorders will not be included in this study.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Gizem Irem KINIKLI

Gizem İrem Kınıklı, Assoc., Prof., PT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nur Sena Yarımkaya, BSc.

Role: PRINCIPAL_INVESTIGATOR

Atılım University

Gizem İrem Kınıklı, Assoc. Prof.

Role: STUDY_CHAIR

Hacettepe University

Locations

Atılım University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 32919049 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20067692 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12788015 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27115770 (View on PubMed)

Other Identifiers

GO 22/643

Identifier Type: -

Identifier Source: org_study_id