Effectiveness of Non-invasive Phrenic Nerve Neuromodulation in Subjects With Inflammatory Bowel Disease and Neck Pain.

University of Seville

Status

Completed

Conditions

Neck Pain

Inflammatory Bowel Diseases

Treatments

Other: Cervico-dorsal Massage

Device: Non-invasive Neuromodulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06288061

Phrenic Nerve Neuromodulation

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.