Neurofeedback for Nociplastic Pain in Rheumatoid Arthritis (NECTAR) (NCT06240299) | Clinical Trial Compass
RecruitingNot Applicable
Neurofeedback for Nociplastic Pain in Rheumatoid Arthritis (NECTAR)
United Kingdom16 participantsStarted 2024-06-24
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in nociplastic pain (Visual Analog Scale)