The primary aim is to compare the efficacy of neurofeedback training (NFT) and pain management protocol (PMP) in pain reduction, restoration of shoulder function, and improved cognitive performance as the post-operative rehabilitation protocols in shoulder pain patients.
The primary aim is to compare the efficacy of neurofeedback training (NFT) and pain management protocol (PMP) in pain reduction, restoration of shoulder function, and improved cognitive performance as the post-operative rehabilitation protocols in shoulder pain patients. While the former modulates neural activity, the latter focuses on biopsychosocial aspects of pain, respectively. Also, we will measure the peripheral cytokine levels of rotator cuff injury to clarify the possible role of peripheral inflammation on central neural activities. By incorporating the behavior (both motor and cognition), peripheral inflammation, and neural activity, we believe this study would bridge the gap between mind and body as the "whole person" approach to understanding musculoskeletal pain and its appropriate therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
12 training sessions within 6 weeks will be provided. In each training session, participants will have neurofeedback training for five 3-minute training periods.
The Sham group has the same training dosage as the neurofeedback group.
The treatment components include sleep psychoeducation, sleep hygiene education, exercise consultation, and cognitive-behavioral pain management, i.e., practice in changing dysfunctional thoughts, setting and working toward behavioral goals, relaxation skills
Pain-related measurement 1: Changes of Visual Analogue Scale (VAS)
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Time frame: pre-operative (T0), before and after each training session over 6 week period, and post-operative 12 weeks (T1)[As after training], and post-operative 24 weeks (T2) [As follow-up]
Neuropsychological assessment 1: Changes of Montreal Cognitive Assessment (MoCA)
The MoCA assesses general cognitive ability. Scores range from 0 to 30. Higher scores denote better cognitive function.
Time frame: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Neurophysiology recording 1: Changes of resting EEG oscillatory
Brain activity will be recorded continuously
Time frame: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Disease-specific outcome measurement 1: Changes of American Shoulder and Elbow Surgeons Assessment (ASES)
The ASES is a reliable and validated questionnaire that evaluates functional limitations in patients with shoulder dysfunction. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Time frame: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Disease-specific outcome measurement 2: Changes of Constant Score (CS)
The CS is a reliable and valid measurement specifically designed for evaluating shoulder joint function. The maximum possible score on the CS is 100, with higher scores indicating better overall shoulder function.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Disease-specific outcome measurement 3: Changes of the health state of EQ-5D-5L
The questionnaire of EQ-5D-5L comprises 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores of each dimension range from 1 (no problem) to 5 (unable to/extreme problems); whereas, the numerical description of 5-dimension questionnaire represents the health state.
Time frame: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Mood-related measurement 1: Changes of Beck Depression Inventory II (BDI-II)
The BDI-II is a well-validated questionnaire that assesses the severity of depressive symptoms. The total score ranges from 0 to 63, with higher scores indicating more severe depressive symptoms.
Time frame: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Mood-related measurement 2: Changes of State-Trait Anxiety Inventory (STAI)
The STAI is a widely used measure of anxiety that consists of two scales: the STAI-S measures state anxiety, which assesses the individual's current emotional condition, and the STAI-T measures trait anxiety, which reflects the person's stable tendency to experience anxiety. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Time frame: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Subjective sleep quality 1: Changes of Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a widely used and reliable questionnaire that evaluates sleep quality over the past month. Scores range from 0 to 21, with lower scores indicating healthier sleep quality.
Time frame: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Objective sleep quality
Actigraphy with an ambient light sensor
Time frame: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Neuropsychological assessment 2: Changes of subjective cognitive declince
Everyday Cognition (Ecog-12) assesses general subjective cognitive decline. Scores range from 12 to 24. The score of 14 or above indicates subjective cognitive decline.
Time frame: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Neuropsychological assessment 3: Changes of Digit Symbol Coding from Wechsler Adult Intelligence Scale III (WAIS-III)
Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time (e.g. 90 or 120 sec) is measured. The more the number of correct symbols, the better the speed of processing.
Time frame: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Neuropsychological assessment 4: Changes of Digit Span from Wechsler Adult Intelligence Scale IV (WAIS-IV)
The test consists of three parts: forward span, backward span, and sequencing. In the forward span, the participant is asked to repeat the numbers read in one second intervals following the same order; whereas, in the backward span, the participant is requested to repeat the numbers read in one second intervals in reverse order from the end to the beginning. In the sequencing, the participant is asked to recall and repeat the numbers read in one second intervals in ascending order. The highest score that can be obtained for each part is 16 points, with a total score of 48 points. A higher point indicates better working memory.
Time frame: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Neuropsychological assessment 5: Changes of the times in Color Trials Test (CTT)
The CTT is a cognitive assessment tool by connecting numbered circles and color in sequence. The test consists of two parts: CTT 1 (connecting numbered circles from 1 to 25) and CTT 2 (connecting numbered circles from 1 to 25 alternating between two colors). The times in CTT 1 and CTT 2 will be measured respectively. The lesser time indicates greater cognitive flexibility and processing speed.
Time frame: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]