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

NCT05566470 | Enrolling By Invitation DMC

• 1 other identifier: GO 22/643
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears

Keywords

Transcranial magnetic stimulation; Rotator Cuff Tear; Functionality; Psychological Resilience; Depression, anxiety, stress; Central Neuromuscular Function

Outcome Measures

Primary Outcomes (4)

• 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.

  1 day

• 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.

  1 day

• 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.

  1 day

• 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.

  1 day

Study Arms (2)

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.

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

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

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

Interventions

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

Control Group; Patient Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Atılım University

Ankara, 06450, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 32919049 BACKGROUND

• 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.

  PMID: 20067692 BACKGROUND

• 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.

  PMID: 12788015 BACKGROUND

• 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.

  PMID: 27115770 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Nur Sena Yarımkaya, BSc.

  Atılım University

  PRINCIPAL INVESTIGATOR

• Gizem İrem Kınıklı, Assoc. Prof.

  Hacettepe University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gizem İrem Kınıklı, Assoc., Prof., PT

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 4, 2022
• Study Start: August 17, 2022
• Primary Completion: December 24, 2025
• Study Completion: December 24, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

TU (1)