NCT05948007

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Shoulder
• Post Operative Pain

Interventions

Type	Name	Description
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.
DEVICE	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

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-08-15
• Completion: 2026-08-15
• First posted: 2023-07-17
• Last updated: 2023-10-18