Neurofeedback for Nociplastic Pain in Rheumatoid Arthritis (NECTAR)

NCT06240299 | Recruiting

• 1 other identifier: UGN23NE390
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Rheumatoid arthritis is an autoimmune condition, causing inflammation and pain. Yet pain may persist even when inflammation has been treated. This residual pain, called nociplastic pain, has symptoms of a chronic pain condition called fibromyalgia. There are few effective therapies to address this residual pain. Published literature shows that fibromyalgia can be treated by neurofeedback, a noninvasive method that is based on the voluntary modulation of cortical activity. In this pilot study, the investigators want to test the effect of neurofeedback on the fibromyalgia component of pain in rheumatoid arthritis, and also to investigate its effects on related symptoms such as fatigue and sleep disturbance.

Conditions

Rheumatoid Arthritis; Chronic Widespread Pain

Outcome Measures

Primary Outcomes (1)

• Difference in nociplastic pain (Visual Analog Scale)

  Difference in nociplastic pain following 10 sessions of neurofeedback, compared to baseline, as measured by a on a 10 point Visual Analog Scale (VAN), from 1 to 10, where 10 is the highest possible pain. Improvement is indicated by a reduction in score.

  4 weeks

Secondary Outcomes (9)

• Difference in nociplastic pain (ACRFS)

  5 weeks

• Difference in nociplastic pain (ACRFS) 1 month post-intervention

  10 weeks

• Success of performing neurofeedback

  5 weeks

• Mental strategies during neurofeedback

  5 weeks

• Multidimensional Health Locus of Control Scale

  6 weeks

Study Arms (1)

Rheumatoid Arthritis - neurofeedback training

EXPERIMENTAL

Intervention: visual neurofeedback Research Assessments * EEG: relaxed state and motor imagery * Quantitative sensory testing Questionnaires (after each intervention session): * visual analog scale - rate pain intensity * pain description and pain intensity reporting * mental strategies, affects (emotional experience) and sensations during NF * adverse event reporting * NASA task load index Questionnaires (week before and week after intervention weeks) * Routine Assessment of Patient Index Data 3 (RAPID3) * American College of Rheumatology Fibromyalgia Scale (ACRFS) * McGill Pain Questionnaire * Patient-Reported Outcomes Measurement Information System (PROMIS) Depression * PROMIS-Anxiety * PROMIS-Fatigue * PROMIS-Sleep related impairment * Pain Number Rating Scale * Generalised Self-Efficiency Scale questionnaire * Multidimensional Health Locus of Control Scale questionnaires Remote follow-up: semi-structured interview over the telephone

Procedure: Neurofeedback

Interventions

Neurofeedback PROCEDURE

A noninvasive method based on the voluntary modulation of brain activity, with feedback provided through a graphical user interface shown on a computer screen

Rheumatoid Arthritis - neurofeedback training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfilment of the ACR/EULAR Classification Criteria for rheumatoid arthritis (RA)
• Fulfilment of the American College of Rheumatology criteria for chronic widespread pain
• Stable disease (swollen joint count ≤1 and CRP ≤10)
• Has normal or corrected to normal vision and hearing abilities
• Right-handed (to reduce baseline motor response test heterogeneity)
• Pain intensity equal or larger than 4 on the Visual Numerical Scale (0 no pain, 10, max pain imaginable)

You may not qualify if:

• Unable to understand the task.
• Unable to provide a written informed consent.
• Unable to understand English.
• Major confounding neurological diseases including Multiple Sclerosis, Stroke, Traumatic Brain Injury, Parkinson's Disease, and Alzheimer's Disease)
• Medical or psychiatric conditions that in the judgment of study personnel would preclude participation in the study (psychosis, suicidal ideation etc)
• Under active management of pain team (changing medications, other non pharmacological pain treatment)
• Involved in other interventional experimental studies

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

Clinical Research Facility (CRF), Queen Elizabeth University Hospital

Glasgow, Scotland, G51 4LS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Chronic Pain

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Neil Basu, MD, PhD

  NHS Greater Galsgow and Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandra Vuckovic, PhD

CONTACT

+44 7906441955; aleksandra.vuckovic@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: February 5, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): January 29, 2027
• Study Completion (Estimated): January 29, 2027
• Last Updated: June 15, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After study end
• Access Criteria: Data will be shared upon reasonable request

Locations

GB (1)