Central Neuromuscular Dysfunction, Functionality, Psychological Status and Rotator Cuff Surgery
- Sponsor
- Hacettepe University
- Study ID
- NCT05566470
- Status
- Enrolling By Invitation
Conditions
- Rotator Cuff Tears
Eligibility Criteria
- Sex
- ALL
- Age
- 30 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- Assessment of Central Neuromuscular Dysfunction, Shoulder Physical Functionality and Psychological Factors — DIAGNOSTIC_TESTEach 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 Details
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.
Key Dates
- First listed
- Oct 4, 2022
- Start date
- Aug 17, 2022
- Status verified
- Mar 2025
- Primary completion
- Dec 24, 2025
- Completion
- Dec 24, 2025
Study Design
- Enrollment
- 34 participants (estimated)
Arms
- Arm: 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.
- Arm: 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
Primary Outcome Measure
Transcranial Magnetic Stimulation (TMS) [ Time Frame: 1 day ]
Related Studies
- E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in AdultsPHASE1 · Enrolling By Invitation · Hospital for Special Surgery, New York · New York, New York
- Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus BlockRecruiting · Duke University · Durham, North Carolina
- Genetic Epidemiology of Rotator Cuff Tears: The cuffGEN StudyRecruiting · University of Michigan · Iowa City, Iowa
- Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized TrialPHASE2 · Recruiting · University of Utah · Salt Lake City, Utah