protocolSection identificationModule nctId: NCT06288061, orgStudyIdInfo id: Phrenic Nerve Neuromodulation, briefTitle: Effectiveness of Non-invasive Phrenic Nerve Neuromodulation in Subjects With Inflammatory Bowel Disease and Neck Pain., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-06-06, completionDateStruct date: 2025-07-04, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Seville, class: OTHER, descriptionModule briefSummary: Inflammatory bowel diseases (IBD) are chronic relapsing diseases that generate an autoimmune response against the bowel and its microbiota. Its prevalence is increasing worldwide. These include Ulcerative Colitis (UC) and Crohn's Disease(CD).The Phrenic nerve originates at the roots C3-C4-C5 carrying motor and sensory information. Directly or through connections it innervates the diaphragm, pleura, right atrium, pericardium, oesophagus, peritoneum, stomach, falciform and coronary ligaments of the liver, Glisson's capsule, hepatic and inferior vena cava, liver (parenchyma), gallbladder and the rest of the biliary tract, pancreas, small intestine and adrenal glands. It also has fibres of the autonomic nervous system.Studies show that there is a link between people suffering from IBD and hepatopancreato-biliary diseases. It can therefore generate referred pain to the C3-C4-C5 dermatomes.Based on the above, the main objective would be to analyse whether non-invasive neuromodulation of the Phrenic nerve reduces neck pain in people with IBD. Secondary objectives were to assess the impact of treatment on quality of life and to study the relationship between IBD and cervical pain.Hypothesis:Non-invasive Phrenic nerve neuromodulation in subjects suffering from inflammatory bowel disease and neck pain will improve their quality of live, disability and sensitisation, as well as neck pain and mobility., conditionsModule conditions: Inflammatory Bowel Diseases, conditions: Neck Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Non-invasive Neuromodulation, interventions name: Cervico-dorsal Massage, outcomesModule primaryOutcomes measure: The Visual Analogue Scale (VAS), primaryOutcomes measure: Cervical mobility, primaryOutcomes measure: The Neck Disability Index (NDI), primaryOutcomes measure: The Pressure Pain Threshold (PPT), secondaryOutcomes measure: The Inflammatory Bowel Disease Questionnaire (IBDQ-32), secondaryOutcomes measure: The World Health Organization Quality of Life (WHOQOL-BREF), secondaryOutcomes measure: The Central Sensitization Inventory (CSI), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario Puerto Real, city: Puerto Real, state: Cádiz, zip: 11510, country: Spain, geoPoint lat: 36.52819, lon: -6.19011, hasResults: False