Pain, ShoulderNCT05948007
The Role of Neurofeedback Training and Pain Management in Post-operative Shoulder Rehabilitation
A study testing Neurofeedback training and Pain management protocol in people with Pain, Shoulder and Post Operative Pain, run by Chang Gung Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Shoulder, Post Operative Pain
- What is being tested?
- Neurofeedback training and Pain management protocol
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 21 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: The Role of Neurofeedback Training and Pain Management in Post-operative Shoulder Rehabilitation: a Study Connecting Neural Mechanism and Clinical Results
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.
Read the 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.
- Conditions
- Pain, Shoulder, Post Operative Pain
- Being tested
- Neurofeedback training, Sham-neurofeedback training, Pain management protocol
- Keywords
- Shoulder pain, Post operative pain, Pain management, Neurofeedback
- Medical subject headings
- Shoulder Pain, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback trainingDevice
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-neurofeedback trainingDevice
The Sham group has the same training dosage as the neurofeedback group.
Pain management protocolBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback group | Experimental | 12 training sessions within 6 weeks, starting with FAA modulation followed by the frontal midline theta upregulations. Receives: Device: Neurofeedback training |
| Sham neurofeedback group | Sham comparator | Same dosage as the neurofeedback group Receives: Device: Sham-neurofeedback training |
| Pain management protocol | Active comparator | The PMP includes cognitive behavioral therapy techniques, and pain neuroscience education. Receives: Behavioral: Pain management protocol |
| Care as usual | No intervention | Providing medical care as they would normally receive, including a post-surgery exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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]
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.
Measured: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Neurophysiology recording 1: Changes of resting EEG oscillatory
Brain activity will be recorded continuously
Measured: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Secondary outcomes (11)
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.
Measured: 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)
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.
Measured: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
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.
Measured: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Objective sleep quality
Actigraphy with an ambient light sensor
Measured: 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
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.
Measured: 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)
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.
Measured: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
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.
Measured: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
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.
Measured: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Nov 2023 (estimated)
- Primary completion21 May 2026
- Study completion21 May 2026
Why it stopped: No participants were able to return for regular postoperative follow-up visits.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ShoulderStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Poyu Chen, Chang Gung Memorial Hospital
- Investigators
- Poyu Chen, PhD, Study chair, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948007
- Sponsor's protocol ID
- 202102407B0
- Status last verified
- May 2026
- First submitted
- 4 Jun 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Neurofeedback Training and Pain Management in Post-operative Shoulder Rehabilitation: a Study Connecting Neural Mechanism and Clinical Results
- ClinicalTrials.gov ID
- NCT05948007
- Acronym / sponsor ID
- 202102407B0
- Conditions
- Pain, Shoulder, Post Operative Pain
- Keywords
- Shoulder pain, Post operative pain, Pain management, Neurofeedback
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were able to return for regular postoperative follow-up visits.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback group | Experimental | Device: Neurofeedback training12 training sessions within 6 weeks, starting with FAA modulation followed by the frontal midline theta upregulations. |
| Sham neurofeedback group | Sham comparator | Device: Sham-neurofeedback trainingSame dosage as the neurofeedback group |
| Pain management protocol | Active comparator | Behavioral: Pain management protocolThe PMP includes cognitive behavioral therapy techniques, and pain neuroscience education. |
| Care as usual | No intervention | –Providing medical care as they would normally receive, including a post-surgery exercise program. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofeedback training12 training sessions within 6 weeks will be provided. In each training session, participants will have neurofeedback training for five 3-minute training periods. | Device | Neurofeedback group |
| Sham-neurofeedback trainingThe Sham group has the same training dosage as the neurofeedback group. | Device | Sham neurofeedback group |
| Pain management protocolThe 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 | Behavioural | Pain management protocol |
Primary outcome
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
11 secondary outcomes
Disease-specific outcome measurement 1: Changes of American Shoulder and Elbow Surgeons Assessment (ASES)
Time frame: 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)
Time frame: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Disease-specific outcome measurement 3: Changes of the health state of EQ-5D-5L
Time frame: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Mood-related measurement 1: Changes of Beck Depression Inventory II (BDI-II)
Time frame: 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)
Time frame: 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)
Time frame: pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Objective sleep quality
Time frame: 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
Time frame: 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)
Time frame: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Neuropsychological assessment 4: Changes of Digit Span from Wechsler Adult Intelligence Scale IV (WAIS-IV)
Time frame: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Neuropsychological assessment 5: Changes of the times in Color Trials Test (CTT)
Time frame: pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Poyu Chen, PhD study chair
Chang Gung University
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback training and Pain management protocol in people with Pain, Shoulder and Post Operative Pain, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.