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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Organic gastrointestinal disorders.

Thyroid abnormalities.

Coexisting cardiovascular, respiratory, renal, or hepatic conditions.

Pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 : 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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Experimental group (vagus nerve mobilization)Experimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 weeks

Secondary outcomes

1

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.

Time frame
6 weeks
2

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.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

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