Clinical trial NCT06288061: Effectiveness of Non-invasive Phrenic Nerve Neuromodulation in Subjects With Inflammatory Bowel Disease and Neck Pain.
Official title: Effectiveness of Non-invasive Phrenic Nerve Neuromodulation in Subjects With Inflammatory Bowel Disease and Neck Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Neck Pain
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Crohn's Disease or Ulcerative Colitis.
* Be over 18 years old.
* Disorder of the peridiaphragmatic abdominal viscera.
* Chronic mechanical neck pain.

Exclusion Criteria:

* Previous trauma or surgery to the cervical spine.
* Infection.
* Congenital vertebral anomaly.
* Neurological diseases.
* Signs of neural compression or spinal stenosis.
* Impossibility of applying neuromodulation (fever, pregnancy, pacemaker, epilepsy, neoplastic processes close to the cervical area and skin alterations).
* Severe cognitive impairment and communication deficits.
* Application of physiotherapeutic treatment three months prior to the study.
* Use of analgesics, anti-inflammatory drugs or relaxants in the 24 hours prior to the intervention.

Primary outcomes:
measure: The Visual Analogue Scale (VAS)
timeFrame: The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.
measure: Cervical mobility
timeFrame: The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.
measure: The Neck Disability Index (NDI)
timeFrame: The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.
measure: The Pressure Pain Threshold (PPT)
timeFrame: The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.
Secondary outcomes:
measure: The Inflammatory Bowel Disease Questionnaire (IBDQ-32)
timeFrame: The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.
measure: The World Health Organization Quality of Life (WHOQOL-BREF)
timeFrame: The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.
measure: The Central Sensitization Inventory (CSI)
timeFrame: The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.
Other outcomes:
Locations:
city: Puerto Real
country: Spain
facility: Hospital Universitario Puerto Real
state: Cádiz
Study officials:
References: