Inflammatory Bowel DiseasesRELIEFNCT07473076
REgulating Pain Through Neurofeedback in infLammatory Bowel diseasE and Musculoskeletal Dysfunction
A study testing Experimental group in people with Inflammatory Bowel Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Experimental group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2026to 2 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Francesca Profeta contact
About this study
Official title: Regolazione Del Dolore Tramite Neurofeedback Nelle Malattie Infiammatorie Intestinali e Nelle Disfunzioni Muscoloscheletriche
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Experimental group, Placebo group
- Keywords
- microbiota, musculoskeletal pain, psychological evaluation, pain management
- Medical subject headings
- Inflammatory Bowel Diseases, Musculoskeletal Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupBehavioural
Experimental psychotherapy treatment with 8 sessions of alpha/theta neurofeedback
Placebo groupBehavioural
Classical psychological treatment according to standards of care
| Study group | Role | What they receive |
|---|---|---|
| Experimental treatment | Experimental | A group of patients will receive the experimental treatment with 8 sessions of alpha/theta neurofeedback (CE marked medical device) Receives: Behavioral: Experimental group |
| Control group | Placebo comparator | Control group that will not receive any psychological treatment with neurofeedback but only psychological support according to the standards of care Receives: Behavioral: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in pain intensity measured by the Visual Analog Scale (VAS)
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).
Measured: 8 weeks
Secondary outcomes (13)
Disease activity in patients with inflammatory bowel disease
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.
Measured: 12 weeks
Pain intensity measured by the Visual Analog Scale (VAS)
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.
Measured: 12 weeks
Health-related quality of life and psychological distress
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.
Measured: 12 weeks
Gut microbiota composition and diversity
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.
Measured: 12 weeks
Maintenance of pain reduction measured by the Visual Analog Scale (VAS)
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)
Measured: 20 weeks
Functional disability measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI)
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)
Measured: 20 weeks
Fatigue measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)
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)
Measured: 20 weeks
Neuropathic pain measured by the Neuropathic Pain Scale (NPS)
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)
Measured: 20 weeks
Pain intensity measured by the Visual Analog Scale (VAS) between intervention and control groups
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.
Measured: 12 weeks
Functional disability measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) between intervention and control groups
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.
Measured: 12 weeks
Fatigue measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) between intervention and control groups
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.
Measured: 12 weeks
Neuropathic pain measured by the Neuropathic Pain Scale (NPS) between intervention and control groups
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.
Measured: 12 weeks
Assessment of Neurofeedback Learning Measured by EEG Theta/Alpha Ratio
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.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start25 Feb 2026 (estimated)
- Primary completion2 May 2026 (estimated)
- Study completion2 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franco Scaldaferri, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473076
- Sponsor's protocol ID
- RELIEF_7654
- Acronym
- RELIEF
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regolazione Del Dolore Tramite Neurofeedback Nelle Malattie Infiammatorie Intestinali e Nelle Disfunzioni Muscoloscheletriche
- ClinicalTrials.gov ID
- NCT07473076
- Acronym / sponsor ID
- RELIEF / RELIEF_7654
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- microbiota, musculoskeletal pain, psychological evaluation, pain management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 25 Feb 2026 (estimated)
- Primary completion
- 2 May 2026 (estimated)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental treatment | Experimental | Behavioral: Experimental groupA group of patients will receive the experimental treatment with 8 sessions of alpha/theta neurofeedback (CE marked medical device) |
| Control group | Placebo comparator | Behavioral: Placebo groupControl group that will not receive any psychological treatment with neurofeedback but only psychological support according to the standards of care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupExperimental psychotherapy treatment with 8 sessions of alpha/theta neurofeedback | Behavioural | Experimental treatment |
| Placebo groupClassical psychological treatment according to standards of care | Behavioural | Control group |
Primary outcome
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).
13 secondary outcomes
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
Assessment of Neurofeedback Learning Measured by EEG Theta/Alpha Ratio
Time frame: 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesca Profeta contact
Franco Scaldaferri principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Inflammatory Bowel Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisa Foscarini (0630157103, elisa.foscarini@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in pain intensity measured by the Visual Analog Scale (VAS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.