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

NCT ID: NCT05948007

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-08-15

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.

Conditions

Pain, Shoulder; Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Neurofeedback group

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

Group Type: EXPERIMENTAL

Neurofeedback training

Intervention Type: DEVICE

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 group

Same dosage as the neurofeedback group

Group Type: SHAM_COMPARATOR

Sham-neurofeedback training

Intervention Type: DEVICE

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

Pain management protocol

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

Group Type: ACTIVE_COMPARATOR

Pain management protocol

Intervention Type: BEHAVIORAL

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

Care as usual

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Sham-neurofeedback training

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

Intervention Type: DEVICE

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

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Poyu Chen

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Poyu Chen, PhD

Role: STUDY_CHAIR

Chang Gung University

Central Contacts

Poyu Chen, PhD

Role: CONTACT

poyuchen@mail.cgu.edu.tw

03-2118800 ext. 5449

Other Identifiers

202102407B0

Identifier Type: -

Identifier Source: org_study_id