REgulating Pain Through Neurofeedback in infLammatory Bowel diseasE and Musculoskeletal Dysfunction

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Experimental group
  Experimental psychotherapy treatment with 8 sessions of alpha/theta neurofeedback
• Поведенческое Placebo group
  Classical psychological treatment according to standards of care

Первичные конечные точки

• Reduction in pain intensity measured by the Visual Analog Scale (VAS) [Срок оценки: 8 weeks]

Вторичные конечные точки (12)

• Disease activity in patients with inflammatory bowel disease [Срок оценки: 12 weeks]
• Pain intensity measured by the Visual Analog Scale (VAS) [Срок оценки: 12 weeks]
• Health-related quality of life and psychological distress [Срок оценки: 12 weeks]
• Gut microbiota composition and diversity [Срок оценки: 12 weeks]
• Maintenance of pain reduction measured by the Visual Analog Scale (VAS) [Срок оценки: 20 weeks]
• Functional disability measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) [Срок оценки: 20 weeks]
• Fatigue measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) [Срок оценки: 20 weeks]
• Neuropathic pain measured by the Neuropathic Pain Scale (NPS) [Срок оценки: 20 weeks]
• Pain intensity measured by the Visual Analog Scale (VAS) between intervention and control groups [Срок оценки: 12 weeks]
• Functional disability measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) between intervention and control groups [Срок оценки: 12 weeks]
• Fatigue measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) between intervention and control groups [Срок оценки: 12 weeks]
• Neuropathic pain measured by the Neuropathic Pain Scale (NPS) between intervention and control groups [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07473076 · RELIEF_7654

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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