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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05948007
• Other study ID #: 202102407B0
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: August 15, 2026

Study information

• Verified date: October 2023
• Source: Chang Gung Memorial Hospital
• Contact: Poyu Chen, PhD
• Phone: 03-2118800
• Email: poyuchen[@]mail.cgu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 15, 2026
• Est. primary completion date: August 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Pain, Shoulder
• Post Operative Pain
• Shoulder Pain

Intervention

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-neurofeedback training
The Sham group has the same training dosage as the neurofeedback group.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain-related measurement 3: Tampa Scale of Kinesiophobia (TSK-11)	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.	pre-operative (T0)
Other	Pain-related measurement 4: Pain Catastrophizing Scale (PCS)	The PCS is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with pain or not.	pre-operative (T0)
Other	Cytokine from Joint fluid (JF)	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.	at the beginning of the surgery
Primary	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.	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]
Primary	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.	pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Primary	Neurophysiology recording 1: Changes of resting EEG oscillatory	Brain activity will be recorded continuously	pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Secondary	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.	pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Secondary	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.	pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Secondary	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.	pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Secondary	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.	pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Secondary	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.	pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Secondary	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.	pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Secondary	Objective sleep quality	Actigraphy with an ambient light sensor	pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]
Secondary	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.	pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Secondary	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.	pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Secondary	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.	pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]
Secondary	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.	pre-operative (T0), and post-operative 24 weeks (T2) [As follow-up]