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

Chang Gung Medical Foundation

Status: Not yet enrolling

Conditions: Pain, Shoulder; Post Operative Pain

Treatments: Device: Sham-neurofeedback training; Behavioral: Pain management protocol; Device: Neurofeedback training

Study type: Interventional

Funder types: Other

Identifiers

NCT05948007

202102407B0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

Neurofeedback group

Experimental group

Description:

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

Treatment:

Device: Neurofeedback training

Sham neurofeedback group

Sham Comparator group

Description:

Same dosage as the neurofeedback group

Treatment:

Device: Sham-neurofeedback training

Pain management protocol

Active Comparator group

Description:

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

Treatment:

Behavioral: Pain management protocol

Care as usual

No Intervention group

Description:

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