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

Primary Purpose

Pain, Shoulder, Post Operative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neurofeedback training
Sham-neurofeedback training
Pain management protocol
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Shoulder focused on measuring Shoulder pain, Post operative pain, Pain management, Neurofeedback

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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. 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Sham Comparator

    Active Comparator

    No Intervention

    Arm Label

    Neurofeedback group

    Sham neurofeedback group

    Pain management protocol

    Care as usual

    Arm Description

    12 training sessions within 6 weeks, starting with FAA modulation followed by the frontal midline theta upregulations.

    Same dosage as the neurofeedback group

    The PMP includes cognitive behavioral therapy techniques, and pain neuroscience education.

    Providing medical care as they would normally receive, including a post-surgery exercise program.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    Neurophysiology recording 1: Changes of resting EEG oscillatory
    Brain activity will be recorded continuously

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    Objective sleep quality
    Actigraphy with an ambient light sensor
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    June 4, 2023
    Last Updated
    October 17, 2023
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05948007
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    August 15, 2026 (Anticipated)
    Study Completion Date
    August 15, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Shoulder, Post Operative Pain
    Keywords
    Shoulder pain, Post operative pain, Pain management, Neurofeedback

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Neurofeedback group
    Arm Type
    Experimental
    Arm Description
    12 training sessions within 6 weeks, starting with FAA modulation followed by the frontal midline theta upregulations.
    Arm Title
    Sham neurofeedback group
    Arm Type
    Sham Comparator
    Arm Description
    Same dosage as the neurofeedback group
    Arm Title
    Pain management protocol
    Arm Type
    Active Comparator
    Arm Description
    The PMP includes cognitive behavioral therapy techniques, and pain neuroscience education.
    Arm Title
    Care as usual
    Arm Type
    No Intervention
    Arm Description
    Providing medical care as they would normally receive, including a post-surgery exercise program.
    Intervention Type
    Device
    Intervention Name(s)
    Neurofeedback training
    Intervention Description
    12 training sessions within 6 weeks will be provided. In each training session, participants will have neurofeedback training for five 3-minute training periods.
    Intervention Type
    Device
    Intervention Name(s)
    Sham-neurofeedback training
    Intervention Description
    The Sham group has the same training dosage as the neurofeedback group.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pain management protocol
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Pain-related measurement 1: Changes of Visual Analogue Scale (VAS)
    Description
    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]
    Title
    Neuropsychological assessment 1: Changes of Montreal Cognitive Assessment (MoCA)
    Description
    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]
    Title
    Neurophysiology recording 1: Changes of resting EEG oscillatory
    Description
    Brain activity will be recorded continuously
    Time Frame
    pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
    Secondary Outcome Measure Information:
    Title
    Disease-specific outcome measurement 1: Changes of American Shoulder and Elbow Surgeons Assessment (ASES)
    Description
    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]
    Title
    Disease-specific outcome measurement 2: Changes of Constant Score (CS)
    Description
    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.
    Time Frame
    pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
    Title
    Disease-specific outcome measurement 3: Changes of the health state of EQ-5D-5L
    Description
    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]
    Title
    Mood-related measurement 1: Changes of Beck Depression Inventory II (BDI-II)
    Description
    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]
    Title
    Mood-related measurement 2: Changes of State-Trait Anxiety Inventory (STAI)
    Description
    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]
    Title
    Subjective sleep quality 1: Changes of Pittsburgh Sleep Quality Index (PSQI)
    Description
    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]
    Title
    Objective sleep quality
    Description
    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]
    Title
    Neuropsychological assessment 2: Changes of subjective cognitive declince
    Description
    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]
    Title
    Neuropsychological assessment 3: Changes of Digit Symbol Coding from Wechsler Adult Intelligence Scale III (WAIS-III)
    Description
    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]
    Title
    Neuropsychological assessment 4: Changes of Digit Span from Wechsler Adult Intelligence Scale IV (WAIS-IV)
    Description
    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]
    Title
    Neuropsychological assessment 5: Changes of the times in Color Trials Test (CTT)
    Description
    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]
    Other Pre-specified Outcome Measures:
    Title
    Pain-related measurement 3: Tampa Scale of Kinesiophobia (TSK-11)
    Description
    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.
    Time Frame
    pre-operative (T0)
    Title
    Pain-related measurement 4: Pain Catastrophizing Scale (PCS)
    Description
    The PCS is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with pain or not.
    Time Frame
    pre-operative (T0)
    Title
    Cytokine from Joint fluid (JF)
    Description
    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.
    Time Frame
    at the beginning of the surgery

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Poyu Chen, PhD
    Phone
    03-2118800
    Ext
    5449
    Email
    poyuchen@mail.cgu.edu.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Poyu Chen, PhD
    Organizational Affiliation
    Chang Gung University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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