Regolazione Del Dolore Tramite Neurofeedback Nelle Malattie Infiammatorie Intestinali e Nelle Disfunzioni Muscoloscheletriche
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Reduction in pain intensity measured by the Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •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).
排除标准
- •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).
研究组 & 干预措施
Experimental treatment
A group of patients will receive the experimental treatment with 8 sessions of alpha/theta neurofeedback (CE marked medical device)
干预措施: Experimental group (Behavioral)
Control group
Control group that will not receive any psychological treatment with neurofeedback but only psychological support according to the standards of care
干预措施: Placebo group (Behavioral)
结局指标
主要结局
Reduction in pain intensity measured by the Visual Analog Scale (VAS)
时间窗: 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).
次要结局
- Disease activity in patients with inflammatory bowel disease(12 weeks)
- Pain intensity measured by the Visual Analog Scale (VAS)(12 weeks)
- Health-related quality of life and psychological distress(12 weeks)
- Gut microbiota composition and diversity(12 weeks)
- Maintenance of pain reduction measured by the Visual Analog Scale (VAS)(20 weeks)
- Functional disability measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI)(20 weeks)
- Fatigue measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)(20 weeks)
- Neuropathic pain measured by the Neuropathic Pain Scale (NPS)(20 weeks)
- Pain intensity measured by the Visual Analog Scale (VAS) between intervention and control groups(12 weeks)
- Functional disability measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) between intervention and control groups(12 weeks)
- Fatigue measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) between intervention and control groups(12 weeks)
- Neuropathic pain measured by the Neuropathic Pain Scale (NPS) between intervention and control groups(12 weeks)
- Assessment of Neurofeedback Learning Measured by EEG Theta/Alpha Ratio(20 weeks)