REgulating Pain Through Neurofeedback in infLammatory Bowel diseasE and Musculoskeletal Dysfunction

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT07473076
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Mar 16, 2026
Start date
Feb 25, 2026
Status verified
Nov 2025
Primary completion
May 2, 2026
Completion
Dec 2, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Experimental treatment
    A group of patients will receive the experimental treatment with 8 sessions of alpha/theta neurofeedback (CE marked medical device)
  • Placebo Comparator: Control group
    Control group that will not receive any psychological treatment with neurofeedback but only psychological support according to the standards of care

Primary Outcome Measure

Reduction in pain intensity measured by the Visual Analog Scale (VAS) [ Time Frame: 8 weeks ]

Central Contacts

Related Studies