Health TrialsbyHealthPanel

Neurofeedback for Nociplastic Pain in Rheumatoid Arthritis (NECTAR)

ConditionsRheumatoid ArthritisChronic Widespread Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNHS Greater Glasgow and Clyde

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Neurofeedback

    Procedure/Surgery

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

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: Rheumatoid Arthritis - neurofeedback trainingExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
4 weeks

Secondary outcomes

1

Difference in nociplastic pain (ACRFS)

Difference in nociplastic pain following 10 sessions of neurofeedback, compared to baseline, as measured by the American College of Rheumatology Fibromyalgia Scale (ACRFS). The score ranges between 0-19, with improvement indicated by a reduction in score.

Time frame
5 weeks
2

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

Difference in nociplastic pain 1 month after the last session, compared to baseline, as measured by the American College of Rheumatology Fibromyalgia Scale (ACRFS). The score ranges between 0-19, with improvement indicated by a reduction in score.

Time frame
10 weeks
3

Success of performing neurofeedback

EEG power in theta (4-8 Hz), alpha (8-12 Hz) , low beta (13-20 Hz), high beta (20-30) and gamma (30-45 Hz) during NF compared to daily baseline, to assess the success of performing neurofeedback

Time frame
5 weeks
4

Mental strategies during neurofeedback

Self-reported mental strategies (a goal-directed mental action performed in order to control the graphical user interface) and affects (emotional experience e.g.happy, excited, frustrated, anxious etc.) during NF

Time frame
5 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NHS Greater Glasgow and Clyde

Lead sponsor

University of Glasgow

Collaborator

Source ClinicalTrials.gov
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