The Role of Neurofeedback Training and Pain Management in Post-operative Shoulder Rehabilitation: a Study Connecting Neural Mechanism and Clinical Results
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- Pain-related measurement 1: Changes of Visual Analogue Scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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..
Arms & Interventions
Neurofeedback group
12 training sessions within 6 weeks, starting with FAA modulation followed by the frontal midline theta upregulations.
Intervention: Neurofeedback training (Device)
Sham neurofeedback group
Same dosage as the neurofeedback group
Intervention: Sham-neurofeedback training (Device)
Pain management protocol
The PMP includes cognitive behavioral therapy techniques, and pain neuroscience education.
Intervention: Pain management protocol (Behavioral)
Care as usual
Providing medical care as they would normally receive, including a post-surgery exercise program.
Outcomes
Primary Outcomes
Pain-related measurement 1: Changes of Visual Analogue Scale (VAS)
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]
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)
Time Frame: 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
Time Frame: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Brain activity will be recorded continuously
Secondary Outcomes
- 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])
- 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])
- 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])
- 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])
- Neuropsychological assessment 2: Changes of subjective cognitive declince(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)(pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up])
- 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])
- 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])
- 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])
- Objective sleep quality(pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up])
- Neuropsychological assessment 5: Changes of the times in Color Trials Test (CTT)(pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up])
Investigators
Poyu Chen
Assistant Professor
Chang Gung Memorial Hospital