REgulating Pain Through Neurofeedback in infLammatory Bowel diseasE and Musculoskeletal Dysfunction

NCT07473076 | Not Yet Recruiting DMC

• 1 other identifier: RELIEF_7654
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical trial with a CE-marked medical device. Use as indicated in patients with chronic inflammatory bowel disease and musculoskeletal pain. The aim of this study is to evaluate the efficacy of neurofeedback therapy in managing musculoskeletal pain in patients with chronic inflammatory bowel disease.

Conditions

Inflammatory Bowel Diseases

Keywords

microbiota; musculoskeletal pain; psychological evaluation; pain management

Outcome Measures

Primary Outcomes (1)

• Reduction in pain intensity measured by the Visual Analog Scale (VAS)

  The Visual Analog Scale for Pain ranges from 0 to 100 points, where: 0 = no pain 100 = worst imaginable pain Higher scores indicate greater pain intensity (worse outcome).

  8 weeks

Secondary Outcomes (13)

• Disease activity in patients with inflammatory bowel disease

  12 weeks

• Pain intensity measured by the Visual Analog Scale (VAS)

  12 weeks

• Health-related quality of life and psychological distress

  12 weeks

• Gut microbiota composition and diversity

  12 weeks

• Maintenance of pain reduction measured by the Visual Analog Scale (VAS)

  20 weeks

Study Arms (2)

Experimental treatment

EXPERIMENTAL

A group of patients will receive the experimental treatment with 8 sessions of alpha/theta neurofeedback (CE marked medical device)

Behavioral: Experimental group

Control group

PLACEBO COMPARATOR

Control group that will not receive any psychological treatment with neurofeedback but only psychological support according to the standards of care

Behavioral: Placebo group

Interventions

Experimental group BEHAVIORAL

Experimental psychotherapy treatment with 8 sessions of alpha/theta neurofeedback

Experimental treatment

Placebo group BEHAVIORAL

Classical psychological treatment according to standards of care

Control group

Eligibility Criteria

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

You may qualify if:

• 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)
• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Musculoskeletal Pain; Agnosia

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Franco Scaldaferri

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Foscarini

CONTACT

0630157103; elisa.foscarini@policlinicogemelli.it

Francesca Profeta

CONTACT

francesca.profeta@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: March 16, 2026
• Study Start: February 25, 2026
• Primary Completion: May 2, 2026
• Study Completion (Estimated): December 2, 2026
• Last Updated: March 16, 2026

Record last verified: 2025-11