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

2 mei 2026 bijgewerkt door: Samar Ahmed Ali Elsayed, Cairo University
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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

32

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Egypte
    • Dokki
      • Giza, Dokki, Egypte, 11432
        • Faculty of Physical Therapy
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • samar ahmed

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Experimental group (vagus nerve mobilization)
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.
Gedragsmatig: neurodynamic mobilization of vagus nerve

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
Actieve vergelijker: Control group
16 Females with mild to moderate IBS will receive Standard care consisted of Advice and dietary recommendations and pharmacological treatments only.for [6] weeks.
Gedragsmatig: Standard care

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Symptom severity in patients with Irritable Bowel Syndrome
Tijdsspanne: 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.
6 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Quality of life in patients with Irritable Bowel Syndrome
Tijdsspanne: 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.
6 weeks
Anxiety and depression levels in patients with Irritable Bowel Syndrome
Tijdsspanne: 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.
6 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Cairo University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 mei 2026

Primaire voltooiing (Geschat)

1 juli 2026

Studie voltooiing (Geschat)

1 juli 2026

Studieregistratiedata

Eerst ingediend

24 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 april 2026

Eerst geplaatst (Werkelijk)

1 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

2 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • P.T.REC/012/006238

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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