Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07473076

REgulating Pain Through Neurofeedback in infLammatory Bowel diseasE and Musculoskeletal Dysfunction

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Inflammatory Bowel Diseases Agnosia Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Experimental group

Behavioral

Experimental psychotherapy treatment with 8 sessions of alpha/theta neurofeedback

Placebo group

Behavioral

Classical psychological treatment according to standards of care

Primary outcomes

  1. Reduction in pain intensity measured by the Visual Analog Scale (VAS)

    Time frame: 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 outcomes

  1. Disease activity in patients with inflammatory bowel disease

    Time frame: 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.

  2. Pain intensity measured by the Visual Analog Scale (VAS)

    Time frame: 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.

  3. Health-related quality of life and psychological distress

    Time frame: 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.

  4. Gut microbiota composition and diversity

    Time frame: 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.

  5. Maintenance of pain reduction measured by the Visual Analog Scale (VAS)

    Time frame: 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)

  6. Functional disability measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI)

    Time frame: 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)

  7. Fatigue measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)

    Time frame: 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)

  8. Neuropathic pain measured by the Neuropathic Pain Scale (NPS)

    Time frame: 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)

  9. Pain intensity measured by the Visual Analog Scale (VAS) between intervention and control groups

    Time frame: 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.

  10. Functional disability measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) between intervention and control groups

    Time frame: 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.

  11. Fatigue measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) between intervention and control groups

    Time frame: 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.

  12. Neuropathic pain measured by the Neuropathic Pain Scale (NPS) between intervention and control groups

    Time frame: 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.

  13. Assessment of Neurofeedback Learning Measured by EEG Theta/Alpha Ratio

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa Foscarini

CONTACT

[email protected]

0630157103

Francesca Profeta

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: RELIEF

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.