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

NCT05948007 | Not Yet Recruiting

• 1 other identifier: 202102407B0
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Shoulder; Post Operative Pain

Keywords

Shoulder pain; Post operative pain; Pain management; Neurofeedback

Outcome Measures

Primary Outcomes (3)

• 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]

• 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]

• 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 Outcomes (11)

• Disease-specific outcome measurement 1: Changes of American Shoulder and Elbow Surgeons Assessment (ASES)

  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)

  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

  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)

  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)

  pre-operative (T0), post-operative 12 weeks (T1) [As after training], and post-operative 24 weeks (T2) [As follow-up]

Other Outcomes (3)

• Pain-related measurement 3: Tampa Scale of Kinesiophobia (TSK-11)

  pre-operative (T0)

• Pain-related measurement 4: Pain Catastrophizing Scale (PCS)

  pre-operative (T0)

• Cytokine from Joint fluid (JF)

  at the beginning of the surgery

Study Arms (4)

Neurofeedback group

EXPERIMENTAL

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

Device: Neurofeedback training

Sham neurofeedback group

SHAM COMPARATOR

Same dosage as the neurofeedback group

Device: Sham-neurofeedback training

Pain management protocol

ACTIVE COMPARATOR

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

Behavioral: Pain management protocol

Care as usual

NO INTERVENTION

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

Interventions

Neurofeedback training 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.

Neurofeedback group

Sham-neurofeedback training DEVICE

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

Sham neurofeedback group

Pain management protocol 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

Pain management protocol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Shoulder Pain; Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Poyu Chen, PhD

  Chang Gung University

  STUDY CHAIR

Central Study Contacts

Poyu Chen, PhD

CONTACT

03-2118800; poyuchen@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: July 17, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: October 18, 2023

Record last verified: 2023-10