REgulating Pain Through Neurofeedback in infLammatory Bowel diseasE and Musculoskeletal Dysfunction

Regolazione Del Dolore Tramite Neurofeedback Nelle Malattie Infiammatorie Intestinali e Nelle Disfunzioni Muscoloscheletriche

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.

Clinical trial with a CE-marked medical device. Use as indicated in patients with chronic inflammatory bowel disease and musculoskeletal pain, with the primary objective of evaluating the efficacy of neurofeedback therapy in managing musculoskeletal pain in patients with chronic inflammatory bowel disease.

In addition, psychological and microbiome characteristics will be analyzed in a cohort of adult patients with IBD and joint pain. Subjects will be randomly assigned to two groups in permuted blocks of eight, with a 1:1 ratio. The sequence, generated via a computer algorithm using SAS (Statistical Analysis System) software, will be hidden from investigators to avoid selection bias.

The study will recruit 80 patients: 40 assigned to the clinical group, who will receive eight sessions of alpha/theta neurofeedback, and 40 to the control group, who will receive no psychological treatment.

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).