Inflammatory Bowel DiseasesNCT06288061
Effectiveness of Non-invasive Phrenic Nerve Neuromodulation in Subjects With Inflammatory Bowel Disease and Neck Pain.
A study testing Non-invasive Neuromodulation and Cervico-dorsal Massage in people with Inflammatory Bowel Diseases and Neck Pain, run by University of Seville at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Neck Pain
- What is being tested?
- Non-invasive Neuromodulation and Cervico-dorsal Massage
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jan 2024to 17 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Crohn's Disease or Ulcerative Colitis.
- Be over 18 years old.
- Disorder of the peridiaphragmatic abdominal viscera.
- Chronic mechanical neck pain.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Non-invasive Neuromodulation, Cervico-dorsal Massage
- Medical subject headings
- Inflammatory Bowel Diseases, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive NeuromodulationDevice
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 MassageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive Phrenic Nerve Neuromodulation | Experimental | Not described Receives: Device: Non-invasive Neuromodulation |
| Cervico-dorsal Massage | Placebo comparator | Not described Receives: Other: Cervico-dorsal Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Visual Analogue Scale (VAS)
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".
Measured: The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.
Cervical mobility
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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 (3)
The Inflammatory Bowel Disease Questionnaire (IBDQ-32)
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.
Measured: 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)
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.
Measured: 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 Sensitization Inventory (CSI)
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.
Measured: The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start30 Jan 2024
- Primary completion15 Nov 2024
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Pérez Montalbán, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288061
- Sponsor's protocol ID
- Phrenic Nerve Neuromodulation
- Status last verified
- Mar 2025
- First submitted
- 23 Feb 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perez-Montalban M, Sanchez-Alcala D, Garcia-Dominguez E, Mata-Perdigon FJ, Oliva-Pascual-Vaca A. Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Subjects With Inflammatory Bowel Disease and Neck Pain: A Randomized Clinical Trial. Neuromodulation. 2026 Jun;29(4):667-677. doi: 10.1016/j.neurom.2025.09.311. Epub 2025 Oct 31.
PubMed 41171220
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Non-invasive Phrenic Nerve Neuromodulation in Subjects With Inflammatory Bowel Disease and Neck Pain.
- ClinicalTrials.gov ID
- NCT06288061
- Acronym / sponsor ID
- Phrenic Nerve Neuromodulation
- Conditions
- Inflammatory Bowel Diseases, Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-invasive Phrenic Nerve Neuromodulation | Experimental | Device: Non-invasive Neuromodulation |
| Cervico-dorsal Massage | Placebo comparator | Other: Cervico-dorsal Massage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Crohn's Disease or Ulcerative Colitis.
- Be over 18 years old.
- Disorder of the peridiaphragmatic abdominal viscera.
- Chronic mechanical neck pain.
Key exclusion criteria (9 listed)
- Previous trauma or surgery to the cervical spine.
- Infection.
- Congenital vertebral anomaly.
- Neurological diseases.
- Signs of neural compression or spinal stenosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive NeuromodulationThis 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. | Device | Non-invasive Phrenic Nerve Neuromodulation |
| Cervico-dorsal MassageThis 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. | Other | Cervico-dorsal Massage |
Primary outcome
The Visual Analogue Scale (VAS)
Time frame: 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".
Cervical mobility
Time frame: 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)
Time frame: 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 Pressure Pain Threshold (PPT)
Time frame: 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.
3 secondary outcomes
The Inflammatory Bowel Disease Questionnaire (IBDQ-32)
Time frame: 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)
Time frame: 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 Sensitization Inventory (CSI)
Time frame: The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 41171220Perez-Montalban M, Sanchez-Alcala D, Garcia-Dominguez E, Mata-Perdigon FJ, Oliva-Pascual-Vaca A. Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Subjects With Inflammatory Bowel Disease and Neck Pain: A Randomized Clinical Trial. Neuromodulation. 2026 Jun;29(4):667-677. doi: 10.1016/j.neurom.2025.09.311. Epub 2025 Oct 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive Neuromodulation and Cervico-dorsal Massage in people with Inflammatory Bowel Diseases and Neck Pain, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Visual Analogue Scale (VAS) (time frame: The scale shall be measured before starting treatment, before the third session, before the fifth session and two weeks after the last session.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06288061, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.