REgulating Pain Through Neurofeedback in infLammatory Bowel diseasE and Musculoskeletal Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental group, Placebo group.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Diseases. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Regolazione Del Dolore Tramite Neurofeedback Nelle Malattie Infiammatorie Intestinali e Nelle Disfunzioni Muscoloscheletriche
Overview
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.
Detailed description
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.
Interventions
- Behavioral Experimental group
Experimental psychotherapy treatment with 8 sessions of alpha/theta neurofeedback - Behavioral Placebo group
Classical psychological treatment according to standards of care
Primary outcome measures
- Reduction in pain intensity measured by the Visual Analog Scale (VAS) [Time frame: 8 weeks]
Secondary outcome measures (12)
- Disease activity in patients with inflammatory bowel disease [Time frame: 12 weeks]
- Pain intensity measured by the Visual Analog Scale (VAS) [Time frame: 12 weeks]
- Health-related quality of life and psychological distress [Time frame: 12 weeks]
- Gut microbiota composition and diversity [Time frame: 12 weeks]
- Maintenance of pain reduction measured by the Visual Analog Scale (VAS) [Time frame: 20 weeks]
- Functional disability measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) [Time frame: 20 weeks]
- Fatigue measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) [Time frame: 20 weeks]
- Neuropathic pain measured by the Neuropathic Pain Scale (NPS) [Time frame: 20 weeks]
- Pain intensity measured by the Visual Analog Scale (VAS) between intervention and control groups [Time frame: 12 weeks]
- Functional disability measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) between intervention and control groups [Time frame: 12 weeks]
- Fatigue measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) between intervention and control groups [Time frame: 12 weeks]
- Neuropathic pain measured by the Neuropathic Pain Scale (NPS) between intervention and control groups [Time frame: 12 weeks]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07473076 · RELIEF_7654