Clinical trial NCT05948007: The Role of Neurofeedback Training and Pain Management in Post-operative Shoulder Rehabilitation
Official title: The Role of Neurofeedback Training and Pain Management in Post-operative Shoulder Rehabilitation: a Study Connecting Neural Mechanism and Clinical Results
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain, Shoulder
Post Operative Pain
Keywords: Shoulder pain
Post operative pain
Pain management
Neurofeedback
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will receive any medical care they would normally receive, including post-surgery exercise program. Those randomized to the usual care group are free to seek whatever treatment, if any, they would like to take.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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..
* Cancer

Primary outcomes:
measure: Pain-related measurement 1: Changes of Visual Analogue Scale (VAS)
timeFrame: 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]
measure: Neuropsychological assessment 1: Changes of Montreal Cognitive Assessment (MoCA)
timeFrame: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
measure: Neurophysiology recording 1: Changes of resting EEG oscillatory
timeFrame: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Secondary outcomes:
measure: Disease-specific outcome measurement 1: Changes of American Shoulder and Elbow Surgeons Assessment (ASES)
timeFrame: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
measure: Disease-specific outcome measurement 2: Changes of Constant Score (CS)
timeFrame: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
measure: Disease-specific outcome measurement 3: Changes of the health state of EQ-5D-5L
timeFrame: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
measure: Mood-related measurement 1: Changes of Beck Depression Inventory II (BDI-II)
timeFrame: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
measure: Mood-related measurement 2: Changes of State-Trait Anxiety Inventory (STAI)
timeFrame: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
measure: Subjective sleep quality 1: Changes of Pittsburgh Sleep Quality Index (PSQI)
timeFrame: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
measure: Objective sleep quality
timeFrame: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
measure: Neuropsychological assessment 2: Changes of subjective cognitive declince
timeFrame: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
measure: Neuropsychological assessment 3: Changes of Digit Symbol Coding from Wechsler Adult Intelligence Scale III (WAIS-III)
timeFrame: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
measure: Neuropsychological assessment 4: Changes of Digit Span from Wechsler Adult Intelligence Scale IV (WAIS-IV)
timeFrame: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
measure: Neuropsychological assessment 5: Changes of the times in Color Trials Test (CTT)
timeFrame: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Other outcomes:
measure: Pain-related measurement 3: Tampa Scale of Kinesiophobia (TSK-11)
timeFrame: pre-operative (T0)
measure: Pain-related measurement 4: Pain Catastrophizing Scale (PCS)
timeFrame: pre-operative (T0)
measure: Cytokine from Joint fluid (JF)
timeFrame: at the beginning of the surgery
Locations:
Study officials:
affiliation: Chang Gung University
name: Poyu Chen, PhD
role: STUDY_CHAIR
References: