REgulating Pain Through Neurofeedback in infLammatory Bowel diseasE and Musculoskeletal Dysfunction
Not applicable · Testing Experimental group · Sites not listed yet · Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Experimental group (a behavioral program) as supportive care (to help with symptoms or quality of life). Condition(s) listed: Inflammatory Bowel Diseases.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is single-blind: participants do not know which group they are in.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- Patients aged between 18 and 65 years.
- Patients diagnosed with IBD for at least six months.
- Ability to understand and provide signed informed consent.
Plus 2 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 80 participants are expected to take part.
- Start date: 2026-02-25 (planned).
- Main results expected around 2026-05-02 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Reduction in pain intensity measured by the Visual Analog Scale (VAS) (8 weeks)
In the researchers’ words
Clinical trial with a CE-marked medical device. Use as indicated in patients with chronic inflammatory bowel disease and musculoskeletal pain.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases |
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Enrollment | 80 (estimated) |
| Start date | 2026-02-25 |
| Primary completion (est.) | 2026-05-02 |
| First posted | 2026-03-16 |
| Last updated | 2026-03-16 |
| Official title | Regolazione Del Dolore Tramite Neurofeedback Nelle Malattie Infiammatorie Intestinali e Nelle Disfunzioni Muscoloscheletriche |
| ClinicalTrials.gov ID | NCT07473076 |
Interventions
- Experimental group (Behavioral)
Experimental psychotherapy treatment with 8 sessions of alpha/theta neurofeedback - Placebo group (Behavioral)
Classical psychological treatment according to standards of care
Full eligibility criteria (from the record)
Inclusion Criteria: * Patients aged between 18 and 65 years. * Patients diagnosed with IBD for at least six months. * Ability to understand and provide signed informed consent. * Patients with IBD and a prior diagnosis of axial/peripheral spondyloarthritis without objective evidence of joint inflammation (clinical and/or instrumental, as per rheumatological assessment), but with persistent musculoskeletal pain (VAS scale score >50/100 in the last week; HAQ-DI score >0.5; FACIT Fatigue Scale score ≥40; NPS score >1) Or • Patients with IBD and musculoskeletal pain who do not meet the criteria for the diagnosis of spondyloarthritis or other inflammatory arthritis (as per rheumatological assessment), but with persistent musculoskeletal pain (VAS scale score >5/10 in the last week; HAQ-DI score >0.5; FACIT Fatigue Scale score ≥40; NPS score >1). Exclusion Criteria: * Patients under 18 or over 65 years of age. * Patients affected by Inflammatory Bowel Disease-Unclassified (IBD-U). * Inability to provide informed consent. * Refusal to provide informed consent. * Presence of severe language deficits. * Patients diagnosed with axial/peripheral spondyloarthritis with objective evidence of joint inflammation (clinical and/or instrumental, as per rheumatological assessment). * Patients with other comorbidities that may invalidate rheumatological evaluation (Substance Use Disorder, Schizophrenia Spectrum and other Psychotic Disorders, Diabetes Mellitus, other rheumatological diseases).
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.