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

NCT ID: NCT06288061

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-30
• Study Completion Date: 2025-02-17

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.

Conditions

Inflammatory Bowel Diseases; Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Non-invasive Phrenic Nerve Neuromodulation

Group Type: EXPERIMENTAL

Non-invasive Neuromodulation

Intervention Type: DEVICE

This intervention group will receive neuromodulation treatment two days a week for a total of six sessions.

The patient is placed in the supine position with a cushion under the knees. The physiotherapist will be positioned behind the patient's head on the side to be treated. The technique will be applied on both anterolateral sides of the neck, where the Phrenic nerve passes in front of the anterior Scalene, between the Subclavian arteries and veins. Neuromodulation will be applied with a Pointer Excel II. It will be applied with negative polarity, at a frequency of 2 Hertz (HZ) and with a current intensity varying between 0 and 45 milliamperes (mA). The intensity shall be increased progressively until the patient's diaphragmatic contraction can be observed without pain. The technique shall be applied on each side for a total of 8 minutes, divided into intervals of 10 seconds of stimulation and 20 seconds of rest.

Cervico-dorsal Massage

Group Type: PLACEBO_COMPARATOR

Cervico-dorsal Massage

Intervention Type: OTHER

This intervention group will receive manual therapy two days a week for a total of six sessions.

The patient shall be placed prone position with a cushion under his or her feet. This group will receive manual therapy on the entire posterior cervical and dorsal region, the area between the occipital bone, the shoulders and the scapulae. The massage will be carried out with a little oil or cream for about 20 minutes.

Interventions

Non-invasive Neuromodulation

This intervention group will receive neuromodulation treatment two days a week for a total of six sessions.

The patient is placed in the supine position with a cushion under the knees. The physiotherapist will be positioned behind the patient's head on the side to be treated. The technique will be applied on both anterolateral sides of the neck, where the Phrenic nerve passes in front of the anterior Scalene, between the Subclavian arteries and veins. Neuromodulation will be applied with a Pointer Excel II. It will be applied with negative polarity, at a frequency of 2 Hertz (HZ) and with a current intensity varying between 0 and 45 milliamperes (mA). The intensity shall be increased progressively until the patient's diaphragmatic contraction can be observed without pain. The technique shall be applied on each side for a total of 8 minutes, divided into intervals of 10 seconds of stimulation and 20 seconds of rest.

Intervention Type: DEVICE

Cervico-dorsal Massage

This intervention group will receive manual therapy two days a week for a total of six sessions.

The patient shall be placed prone position with a cushion under his or her feet. This group will receive manual therapy on the entire posterior cervical and dorsal region, the area between the occipital bone, the shoulders and the scapulae. The massage will be carried out with a little oil or cream for about 20 minutes.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

María Pérez Montalbán

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario Puerto Real

Puerto Real, Cádiz, Spain

Countries

Spain

Other Identifiers

Phrenic Nerve Neuromodulation

Identifier Type: -

Identifier Source: org_study_id