The Role of Neurofeedback Training and Pain Management in Post-operative Shoulder Rehabilitation
- Conditions
- Pain, ShoulderPost Operative Pain
- Interventions
- Device: Sham-neurofeedback trainingDevice: Neurofeedback trainingBehavioral: Pain management protocol
- Registration Number
- NCT05948007
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Pain ≥3months and ≥3 days per week
- Pain intensity ≥ 40 (VAS scale from 0 no pain to 100 very painful)
- Participants in the neurofeedback training group and pain management group were asked not to involve other treatment when they are in the 6th-12th week intervention period.
- The surgical indication would be based on orthopedics opinions.
- shoulder surgery in the prior 3 years
- osteoporotic vertebral fractures or rheumatologic diseases
- chronic wide- spread pain syndromes (fibromyalgia or chronic fatigue syndrome)
- pain at any other location in addition to shoulder pain
- Neurological disease, i.e., stroke, parkinson's disease, etc..
- Cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham neurofeedback group Sham-neurofeedback training Same dosage as the neurofeedback group Neurofeedback group Neurofeedback training 12 training sessions within 6 weeks, starting with FAA modulation followed by the frontal midline theta upregulations. Pain management protocol Pain management protocol The PMP includes cognitive behavioral therapy techniques, and pain neuroscience education.
- Primary Outcome Measures
Name Time Method Pain-related measurement 1: Changes of Visual Analogue Scale (VAS) 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] 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.
Neuropsychological assessment 1: Changes of Montreal Cognitive Assessment (MoCA) pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up] The MoCA assesses general cognitive ability. Scores range from 0 to 30. Higher scores denote better cognitive function.
Neurophysiology recording 1: Changes of resting EEG oscillatory pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up] Brain activity will be recorded continuously
- Secondary Outcome Measures
Name Time Method Disease-specific outcome measurement 3: Changes of the health state of EQ-5D-5L pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up] 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.
Neuropsychological assessment 4: Changes of Digit Span from Wechsler Adult Intelligence Scale IV (WAIS-IV) pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up] 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.
Disease-specific outcome measurement 1: Changes of American Shoulder and Elbow Surgeons Assessment (ASES) pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up] 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.
Disease-specific outcome measurement 2: Changes of Constant Score (CS) pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up] 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.
Neuropsychological assessment 2: Changes of subjective cognitive declince pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up] 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.
Neuropsychological assessment 3: Changes of Digit Symbol Coding from Wechsler Adult Intelligence Scale III (WAIS-III) pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up] 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.
Mood-related measurement 1: Changes of Beck Depression Inventory II (BDI-II) pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up] 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.
Mood-related measurement 2: Changes of State-Trait Anxiety Inventory (STAI) pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up] 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.
Subjective sleep quality 1: Changes of Pittsburgh Sleep Quality Index (PSQI) pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up] 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.
Objective sleep quality pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up] Actigraphy with an ambient light sensor
Neuropsychological assessment 5: Changes of the times in Color Trials Test (CTT) pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up] 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.