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

Not Applicable

Completed

• Conditions: Neck Pain; Inflammatory Bowel Diseases
• Interventions: Device: Non-invasive Neuromodulation; Other: Cervico-dorsal Massage

• Registration Number: NCT06288061
• Lead Sponsor: University of Seville

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-30
• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-02-23
• Study First Posted: 2024-03-01
• Primary Completion: 2024-11-15
• Study Completion: 2025-02-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-invasive Phrenic Nerve Neuromodulation	Non-invasive Neuromodulation	-
Cervico-dorsal Massage	Cervico-dorsal Massage	-

Primary Outcome Measures

Name	Time	Method
Cervical mobility	The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.	It shall be assessed using the iPhone level application. To measure flexion-extension, the mobile will be placed vertically centred on the external auditory canal, obtaining a range of movement between zero and 45-50 degrees. For lateroflexion, it shall be positioned horizontally at the back of the head, giving a range between zero and 45 degrees. For rotations, the mobile shall be positioned vertically on the top of the head, giving a range of movement between zero and 60-80 degrees. Measurements shall be taken with the patient in a seated position. For each movement, three measurements shall be taken to obtain an average value of the three.
The Neck Disability Index (NDI)	The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.	The Neck Disability Index (NDI) is a questionnaire for the assessment of the functional status of subjects with neck pain. It includes the measurement of 10 items, each scored from zero to five, where zero means "painless" and five means "the most pain imaginable". The points obtained are summed up to obtain a percentage.
The Visual Analogue Scale (VAS)	The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.	The Visual Analogue Scale (VAS) consists of a 100 mm line; it indicates the perceived intensity of pain, with zero mm being "no pain" and 100 mm being "the worst pain imaginable".
The Pressure Pain Threshold (PPT)	The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.	The Pressure Pain Threshold (PPT) is used to assess pressure pain and is applied with an algometer. The measurement is taken at the medial aspect of the anterior border of the upper trapezius and the spinous process of C4. The assessor shall gradually increase the pressure until the subject indicates with a "yes" when pain or discomfort appears. The patient shall be seated. For each point, three measurements shall be taken to obtain an average value of the three measurements.

Secondary Outcome Measures

Name	Time	Method
The World Health Organization Quality of Life (WHOQOL-BREF)	The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.	The World Health Organization Quality of Life (WHOQOL-BREF) is a 26-item scale consisting of four domains (physical health, psychological health, social relationships and environmental health). Each item is scored from one to five, summed to give a score from zero to 100.
The Central Sensitization Inventory (CSI)	The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.	The Central Sensitisation Inventory (CSI) is a questionnaire to identify patients who have symptoms that may be related to central sensitisation or central sensitisation syndromes. The CSI has two parts, the first includes 25 questions related to common symptoms and the second determines whether the patient has been diagnosed with central sensitisation or related disorders.
The Inflammatory Bowel Disease Questionnaire (IBDQ-32)	The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.	The Inflammatory Bowel Disease Questionnaire (IBDQ-32) is used to assess health-related quality of life in IBD. The IBDQ-32 questionnaire contains 32 items divided into four items (digestive symptoms, systemic symptoms, emotional and social involvement). Responses are scored from seven to one, with seven being the best score and one being the worst. The total number of points will be added up.

Trial Locations

Locations (1)

Hospital Universitario Puerto Real; 🇪🇸 Puerto Real, Cádiz, Spain