Inflammatory Bowel Diseases
Conditions
Keywords
microbiota, musculoskeletal pain, psychological evaluation, pain management
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.
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
BEHAVIORALExperimental group
Experimental psychotherapy treatment with 8 sessions of alpha/theta neurofeedback
BEHAVIORALPlacebo group
Classical psychological treatment according to standards of care
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in pain intensity measured by the Visual Analog Scale (VAS) | 8 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity in patients with inflammatory bowel disease | 12 weeks | Disease activity will be assessed using standard disease activity indices according to clinical practice (e.g., validated indices specific for inflammatory bowel disease). Scale ranges and interpretation depend on the specific index used; higher scores indicate greater disease activity. |
| Pain intensity measured by the Visual Analog Scale (VAS) | 12 weeks | Pain intensity will also be assessed using the Visual Analog Scale for Pain (VAS), ranging from 0 to 100 points: 0 = no pain 100 = worst imaginable pain Higher scores indicate worse pain. |
| Health-related quality of life and psychological distress | 12 weeks | Health-related quality of life and psychological distress will be assessed using validated questionnaires. Each questionnaire will be reported separately with its defined score range and interpretation according to the respective instrument. |
| Gut microbiota composition and diversity | 12 weeks | Gut microbiota composition and diversity will be assessed through stool sample analysis. Microbial diversity will be evaluated using ecological diversity metrics, including alpha-diversity and beta-diversity indices. |
| Maintenance of pain reduction measured by the Visual Analog Scale (VAS) | 20 weeks | To evaluate whether the reduction in perceived pain achieved at the end of treatment is maintained during follow-up. Pain intensity will be measured using the Visual Analog Scale for Pain (VAS). Range: 0-100 0 = no pain 100 = worst imaginable pain Higher scores indicate worse pain intensity. Pain will be assessed at: Baseline End of treatment (8 weeks) Follow-up (12 weeks after treatment completion) |
| Functional disability measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) | 20 weeks | Functional disability will be assessed using the Health Assessment Questionnaire - Disability Index (HAQ-DI). Range: 0-3 0 = no disability 3 = severe disability Higher scores indicate worse functional impairment. Assessments will be performed at: Baseline End of treatment (8 weeks) Follow-up (12 weeks after treatment completion) |
| Fatigue measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) | 20 weeks | Fatigue will be measured using the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue). Range: 0-52 Higher scores indicate less fatigue (better outcome). Assessments will be performed at: Baseline End of treatment (8 weeks) Follow-up (12 weeks after treatment completion) |
| Neuropathic pain measured by the Neuropathic Pain Scale (NPS) | 20 weeks | Neuropathic pain will be assessed using the Neuropathic Pain Scale (NPS). Total score range: 0-100 Higher scores indicate worse neuropathic pain. Assessments will be performed at: Baseline End of treatment (8 weeks) Follow-up (12 weeks after treatment completion) |
| Pain intensity measured by the Visual Analog Scale (VAS) between intervention and control groups | 12 weeks | Pain intensity will be measured using the Visual Analog Scale for Pain (VAS). Range: 0-100 0 = no pain 100 = worst imaginable pain Higher scores indicate worse pain intensity. Pain scores will be compared between the neurofeedback intervention group and the control group receiving no psychological intervention. |
| Functional disability measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) between intervention and control groups | 12 weeks | Functional disability will be measured using the HAQ-DI. Range: 0-3 Higher scores indicate worse disability. Scores will be compared between the neurofeedback intervention group and the control group. |
| Fatigue measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) between intervention and control groups | 12 weeks | Fatigue will be assessed using the FACIT-Fatigue scale. Range: 0-52 Higher scores indicate less fatigue (better outcome). Scores will be compared between the neurofeedback intervention group and the control group. |
| Neuropathic pain measured by the Neuropathic Pain Scale (NPS) between intervention and control groups | 12 weeks | Neuropathic pain will be assessed using the Neuropathic Pain Scale (NPS). Range: 0-100 Higher scores indicate worse neuropathic pain. Scores will be compared between the neurofeedback intervention group and the control group. |
| Assessment of Neurofeedback Learning Measured by EEG Theta/Alpha Ratio | 20 weeks | Neurofeedback learning will be assessed by measuring changes in the electroencephalographic (EEG) theta/alpha power ratio. The theta/alpha ratio represents the relative spectral power between theta and alpha frequency bands derived from EEG recordings. Measure: Theta/Alpha Ratio derived from EEG recordings. This is a continuous variable representing the ratio between theta-band power and alpha-band power. The measure has no fixed theoretical upper limit. Changes in the ratio reflect modifications in the relative distribution of EEG spectral power between theta and alpha frequency bands. The theta/alpha ratio will be assessed at: Baseline End of treatment (8 weeks) Follow-up (12 weeks after treatment completion) Higher or lower values will be interpreted as changes in neurophysiological activity associated with the neurofeedback training. |
Contacts
CONTACTElisa Foscarini
CONTACTFrancesca Profeta
PRINCIPAL_INVESTIGATORFranco Scaldaferri
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Outcome results
None listed