Trials / Enrolling By Invitation
Enrolling By InvitationNCT05566470
Central Neuromuscular Dysfunction, Functionality, Psychological Status and Rotator Cuff Surgery
Assessment of Central Neuromuscular Dysfunction, Shoulder Physical Functionality and Psychological Factors in Individuals Undergoing Rotator Cuff Surgery
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 34 (estimated)
- Sponsor
- Hacettepe University · Academic / Other
- Sex
- All
- Age
- 30 Years – 65 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | 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. |
Timeline
- Start date
- 2022-08-17
- Primary completion
- 2025-12-24
- Completion
- 2025-12-24
- First posted
- 2022-10-04
- Last updated
- 2025-03-11
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT05566470. Inclusion in this directory is not an endorsement.