Irritable Bowel SyndromeNCT07560345
Effect of Neurodynamic Mobilization of Vagus Nerve on Irritable Bowel Syndrome in Women
A study testing neurodynamic mobilization of vagus nerve in people with Irritable Bowel Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
goal of this interventional study to investigate the effect of neurodynamic mobilization of vagus nerve on irritable bowel syndrome in women. The main question it aims to answer is: is there an effect of neurodynamic mobilization of the vagus nerve on irritable bowel syndrome? The intervention will include… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- neurodynamic mobilization of vagus nerve
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 32 Females with mild to moderate IBS ,were recruited for this study by referral from a physician.
- aged 20-45 (i.e., the most common age for developing IBS)
- Patients must experience abdominal pain recurring at least once weekly over the past three months.
- This pain must be linked to two or more of the following features: occurring in relation to defecation, accompanied by a change in stool frequency, or accompanied by a change in stool form or appearance.
- Symptoms should have been present during the last three months, with onset at least six months before diagnosis.
Who cannot join
- Subjects will be excluded if they have:
- Organic gastrointestinal disorders.
- Thyroid abnormalities.
- Coexisting cardiovascular, respiratory, renal, or hepatic conditions.
- Pregnancy.
- Blood disorders. (e.g., hemophilia, coagulation disorders, leukemia, thalassemia, sickle cell disease).
Show all 12Show fewer
- Neurological or musculoskeletal conditions affecting muscle tone.
- Psychiatric illnesses ( patients with depression in the absence of IBS).
- Fibromyalgia.
- A history of gastrointestinal surgery or resection, , or other chronic diseases associated with gastrointestinal issues such as inflammatory bowel disease, ulcers, or cancer.
- A history of alcohol or drug abuse, abdominal surgery within the past six months.
- Recent cervical or cardiac surgery, or recent major trauma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of physical therapy
Giza, Dokki, 11432
Samir Ahmed Sabahi, Professor, 01128377738, ssabbahi@hotmail.com
Nouran Ahmed Ibrahim, Professor, 01062207203, nouran-312@cu.edu.eg
About this study
goal of this interventional study to investigate the effect of neurodynamic mobilization of vagus nerve on irritable bowel syndrome in women. The main question it aims to answer is: is there an effect of neurodynamic mobilization of the vagus nerve on irritable bowel syndrome? The intervention will include neurodynamic mobilization of vagus nerve sessions ,Participants will receive the treatment for 6 week. Assessment will be done before and after treatment.
Read the detailed description
IBS is a chronic functional gastrointestinal disorder that profoundly affects patients' quality of life (QOL). Among the various symptoms, abdominal pain was the most commonly reported and often perceived as the most debilitating. Some patients, particularly mothers, even described it as more intense than labor pain. This pain led to a range of negative consequences, including impaired concentration, sleep disturbances, episodes of fainting, vomiting, physical immobility, inability to work, and feelings of depression .Neural mobilization promotes improved mobility and interaction between nerves and adjacent tissues (interfaces) through the application of manual techniques or specific exercises .Neurodynamic techniques targeting the vagus nerve have shown potential as an effective approach to promote parasympathetic nervous system activation. The application of vagus nerve neurodynamic techniques was associated with a significant reduction in mean heart rate (HR), suggesting a positive modulatory effect on parasympathetic nervous system activity .The potential therapeutic role of vagus nerve neurodynamic mobilization in managing IBS has not been extensively explored in the literature.
Therefore, this study aims to investigate the effectiveness of neurodynamic techniques targeting the vagus nerve in alleviating symptoms and improving quality of life in patients with IBS.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- neurodynamic mobilization of vagus nerve, Standard care
- Keywords
- irritable bowel syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurodynamic mobilization of vagus nerveBehavioural
To target the intracranial portion of the vagus nerve, upper cervical flexion combined with contralateral lateral flexion was utilized, while ipsilateral cervical rotation was employed to load the cervical portion of the nerve. The neurodynamic intervention involved passive movements applied to the cervical spine, including rotation toward the side of the vagus nerve being treated, lateral flexion to the opposite side, and flexion. different medications seem to help with various IBS complaints. Antispasmodics along with tricyclic antidepressants tend to decrease abdominal pain.
Dietary advice as control group
Standard careBehavioural
Dietary advice as :
- Eating meals at the same time each day with regular intervals.
- Avoid eating too little or too much.
- Staying well-hydrated.
- Cutting down on processed, fatty, and spicy foods.
- It is advisable to limit caffeine, carbonated drinks, and alcohol.
- Start with small amounts of soluble fiber and gradually increase it to improve tolerance.
- Avoid insoluble fibers, gas-producing foods like beans, and artificial sweeteners.
- Being aware of and avoiding foods that cause intolerance. different medications seem to help with various IBS complaints. Antispasmodics along with tricyclic antidepressants tend to decrease abdominal pain
- Increasing physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (vagus nerve mobilization) | Experimental | 16 Females with mild to moderate IBS will receive vagal neurodynamic technique in addition to Standard care consisted of advice, dietary recommendations and pharmacological treatments .The sessions will be performed [3] times per week for [6] weeks. Receives: Behavioral: neurodynamic mobilization of vagus nerve |
| Control group | Active comparator | 16 Females with mild to moderate IBS will receive Standard care consisted of Advice and dietary recommendations and pharmacological treatments only.for [6] weeks. Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom severity in patients with Irritable Bowel Syndrome
- Symptom severity will be measured by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS).
- measured pre- and post-intervention to determine the effectiveness of the treatment in improving Symptom in patients with Irritable Bowel Syndrome.
- It comprises five items assessing abdominal pain severity, pain frequency, bloating, bowel habit dissatisfaction, and life interference due to IBS symptoms.
- Each item is scored on a 100-point visual scale, resulting in a total score ranging from 0 to 500. Higher scores indicate more severe symptomatology.
- Scores will be interpreted as follows: mild IBS:75-175. moderate IBS:175-300. severe IBS: above 300.
- The total score will be calculated for each participant and documented for statistical analysis. This tool has demonstrated strong validity and reliability in both clinical and research settings.
Measured: 6 weeks
Secondary outcomes (2)
Quality of life in patients with Irritable Bowel Syndrome
- Quality of life in patients with Irritable Bowel Syndrome: will be measured by Arbic Version Of World Health Organization Quality of Life Measure (WHOQOL- BREF).
- measured pre- and post-intervention .
- The World Health Organization Quality of Life Measure-BREF is a self-report questionnaire consisting of 26 items designed to evaluate four key domains of quality of life as defined by the World Health Organization: physical health, psychological well-being, social relationships, and environmental factors. The first two items specifically assess an individual's general perception of their quality of life and overall health. Responses are scored using a 5-point Likert scale, ranging from 1 (indicating very poor, very dissatisfied, or never) to 5 (indicating very good, very satisfied, or always). Scores from the four domains are summed and positively scaled, with higher totals reflecting better quality of life.
Measured: 6 weeks
Anxiety and depression levels in patients with Irritable Bowel Syndrome
Anxiety and depression levels in patients with Irritable Bowel Syndrome: Will be measured by Arbic Version Of The Hospital Anxiety and Depression Scale (HADS).
- measured pre- and post-intervention.
- This tool comprises two subscales one for anxiety and another for depression each consisting of seven items. Responses are rated using a 4 point Likert scale ranging from 0 to 3. For both subscales, scores between 0 and 7 are considered normal, 8 to 10 indicate borderline cases, and scores from 11 to 21 suggest the presence of clinical anxiety or depression.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 May 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- Experimental group : 16 subjects will receive vagal neurodynamic technique in addition to Standard care consisted of advice and dietary recommendations. Control group : 16 subjects will receive Standard care consisted of Advice and dietary recommendations only.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Ahmed Ali Elsayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560345
- Sponsor's protocol ID
- P.T.REC/012/006238
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neurodynamic Mobilization of Vagus Nerve on Irritable Bowel Syndrome in Women
- ClinicalTrials.gov ID
- NCT07560345
- Acronym / sponsor ID
- P.T.REC/012/006238
- Conditions
- Irritable Bowel Syndrome
- Keywords
- irritable bowel syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 1 May 2026 (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.
goal of this interventional study to investigate the effect of neurodynamic mobilization of vagus nerve on irritable bowel syndrome in women. The main question it aims to answer is: is there an effect of neurodynamic mobilization of the vagus nerve on irritable bowel syndrome? The intervention will include neurodynamic mobilization of vagus nerve sessions ,Participants will receive the treatment for 6 week. Assessment will be done before and after treatment.
Detailed description
IBS is a chronic functional gastrointestinal disorder that profoundly affects patients' quality of life (QOL). Among the various symptoms, abdominal pain was the most commonly reported and often perceived as the most debilitating. Some patients, particularly mothers, even described it as more intense than labor pain. This pain led to a range of negative consequences, including impaired concentration, sleep disturbances, episodes of fainting, vomiting, physical immobility, inability to work, and feelings of depression .Neural mobilization promotes improved mobility and interaction between nerves and adjacent tissues (interfaces) through the application of manual techniques or specific exercises .Neurodynamic techniques targeting the vagus nerve have shown potential as an effective approach to promote parasympathetic nervous system activation. The application of vagus nerve neurodynamic techniques was associated with a significant reduction in mean heart rate (HR), suggesting a positive modulatory effect on parasympathetic nervous system activity .The potential therapeutic role of vagus nerve neurodynamic mobilization in managing IBS has not been extensively explored in the literature.
Therefore, this study aims to investigate the effectiveness of neurodynamic techniques targeting the vagus nerve in alleviating symptoms and improving quality of life in patients with IBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental group : 16 subjects will receive vagal neurodynamic technique in addition to Standard care consisted of advice and dietary recommendations. Control group : 16 subjects will receive Standard care consisted of Advice and dietary recommendations only.
| Arm | Type | Receives |
|---|---|---|
| Experimental group (vagus nerve mobilization) | Experimental | Behavioral: neurodynamic mobilization of vagus nerve16 Females with mild to moderate IBS will receive vagal neurodynamic technique in addition to Standard care consisted of advice, dietary recommendations and pharmacological treatments .The sessions will be performed [3] times per week for [6] weeks. |
| Control group | Active comparator | Behavioral: Standard care16 Females with mild to moderate IBS will receive Standard care consisted of Advice and dietary recommendations and pharmacological treatments only.for [6] weeks. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 32 Females with mild to moderate IBS ,were recruited for this study by referral from a physician.
- aged 20-45 (i.e., the most common age for developing IBS)
- Patients must experience abdominal pain recurring at least once weekly over the past three months.
- This pain must be linked to two or more of the following features: occurring in relation to defecation, accompanied by a change in stool frequency, or accompanied by a change in stool form or appearance.
- Symptoms should have been present during the last three months, with onset at least six months before diagnosis.
Key exclusion criteria (12 listed)
- Organic gastrointestinal disorders.
- Thyroid abnormalities.
- Coexisting cardiovascular, respiratory, renal, or hepatic conditions.
- Pregnancy.
- Blood disorders. (e.g., hemophilia, coagulation disorders, leukemia, thalassemia, sickle cell disease).
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 |
|---|---|---|
| neurodynamic mobilization of vagus nerveTo target the intracranial portion of the vagus nerve, upper cervical flexion combined with contralateral lateral flexion was utilized, while ipsilateral cervical rotation was employed to load the cervical portion of the nerve. The neurodynamic intervention involved passive movements applied to the cervical spine, including rotation toward the side of the vagus nerve being treated, lateral flexion to the opposite side, and flexion. different medications seem to help with various IBS complaints. Antispasmodics along with tricyclic antidepressants tend to decrease abdominal pain. Dietary advice as control group | Behavioural | Experimental group (vagus nerve mobilization) |
| Standard careDietary advice as : 1. Eating meals at the same time each day with regular intervals. 2. Avoid eating too little or too much. 3. Staying well-hydrated. 4. Cutting down on processed, fatty, and spicy foods. 5. It is advisable to limit caffeine, carbonated drinks, and alcohol. 6. Start with small amounts of soluble fiber and gradually increase it to improve tolerance. 7. Avoid insoluble fibers, gas-producing foods like beans, and artificial sweeteners. 8. Being aware of and avoiding foods that cause intolerance. different medications seem to help with various IBS complaints. Antispasmodics along with tricyclic antidepressants tend to decrease abdominal pain 9. Increasing physical activity. | Behavioural | Control group |
Primary outcome
Symptom severity in patients with Irritable Bowel Syndrome
Time frame: 6 weeks
* Symptom severity will be measured by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS). * measured pre- and post-intervention to determine the effectiveness of the treatment in improving Symptom in patients with Irritable Bowel Syndrome. * It comprises five items assessing abdominal pain severity, pain frequency, bloating, bowel habit dissatisfaction, and life interference due to IBS symptoms. * Each item is scored on a 100-point visual scale, resulting in a total score ranging from 0 to 500. Higher scores indicate more severe symptomatology. * Scores will be interpreted as follows: mild IBS:75-175. moderate IBS:175-300. severe IBS: above 300. - The total score will be calculated for each participant and documented for statistical analysis. This tool has demonstrated strong validity and reliability in both clinical and research settings.
2 secondary outcomes
Quality of life in patients with Irritable Bowel Syndrome
Time frame: 6 weeks
Anxiety and depression levels in patients with Irritable Bowel Syndrome
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurodynamic mobilization of vagus nerve in people with Irritable Bowel Syndrome, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 7 May 2026. 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 Egypt. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom severity in patients with Irritable Bowel Syndrome (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.