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NCT Number: NCT07560345

Effect of Neurodynamic Mobilization of Vagus Nerve on Irritable Bowel Syndrome in Women

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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).
  • 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.

Treatment and study plan

neurodynamic mobilization of vagus nerve

Behavioral

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 Care

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Quality of life in patients with Irritable Bowel Syndrome

    Time frame: 6 weeks

    • 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.

  2. Anxiety and depression levels in patients with Irritable Bowel Syndrome

    Time frame: 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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