The Role of Neurofeedback Training and Pain Management in Post-operative Shoulder Rehabilitation

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05948007

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Pain, Shoulder Post Operative Pain	Device: Neurofeedback training Device: Sham-neurofeedback training Behavioral: Pain management protocol	N/A

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

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

The Role of Neurofeedback Training and Pain Management in Post-operative Shoulder Rehabilitation: a Study Connecting Neural Mechanism and Clinical Results

Anticipated Study Start Date :

Aug 15, 2023

Anticipated Primary Completion Date :

Aug 15, 2026

Anticipated Study Completion Date :

Aug 15, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neurofeedback group 12 training sessions within 6 weeks, starting with FAA modulation followed by the frontal midline theta upregulations.	Device: Neurofeedback training 12 training sessions within 6 weeks will be provided. In each training session, participants will have neurofeedback training for five 3-minute training periods.
Sham Comparator: Sham neurofeedback group Same dosage as the neurofeedback group	Device: Sham-neurofeedback training The Sham group has the same training dosage as the neurofeedback group.
Active Comparator: Pain management protocol The PMP includes cognitive behavioral therapy techniques, and pain neuroscience education.	Behavioral: Pain management protocol 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
No Intervention: Care as usual Providing medical care as they would normally receive, including a post-surgery exercise program.

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.
Subjective sleep quality 2: Changes of Epworth Sleepiness Scale (ESS) [pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]]
The ESS is a widely used measure intended to subjectively measure daytime sleepiness. Scores in the 0-9 range is considered to be normal while a number in the 10-24 range indicates that expert medical advice should be sought.
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 2: Changes of Mini-Mental State Examination (MMSE) [pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]]
The MMSE assesses general cognitive ability. Scores range from 0 to 30. Higher scores denote better cognitive function.
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.
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.
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.

Other Outcome Measures

Pain-related measurement 2: Central Sensitization Inventory (CSI) [pre-operative (T0)]
The CSI is a self-report measure designed to identify patients who have symptoms that may be related to central sensitization with a good psychometric properties strong psychometric properties. The patient scores each answer on a scale of 0 (never) to 4 (always). A score of more than 40 indicates the presence of central sensitisation.
Pain-related measurement 3: Tampa Scale of Kinesiophobia (TSK-11) [pre-operative (T0)]
The TSK is one of the most frequently employed measures for assessing pain-related fear in patients with chronic musculoskeletal pain. The 11-item TSK total scores range from 11 to 44 where the lowest 11 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.
Pain-related measurement 4: Pain Catastrophizing Scale (PCS) [pre-operative (T0)]
The PCS is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with pain or not.
Cytokine from Joint fluid (JF) [at the beginning of the surgery]
The aspiration procedures will be performed immediately prior to the creation of skin incisions in the operating room by surgeons under anesthesia. The samples will be transferred to sealed vials, then frozen and stored at 80°C until analysis. The JF samples (50, 100 and 200 lL) will be subjected to measurements of IL-1b, IL-6 and IL-8 levels using ELISA kits.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.