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

2 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

32

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Dokki
      • Giza, Dokki, Egitto, 11432
        • Faculty of Physical Therapy
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • samar ahmed

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

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

Comparatore attivo: 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.

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Symptom severity in patients with Irritable Bowel Syndrome
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of life in patients with Irritable Bowel Syndrome
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 luglio 2026

Completamento dello studio (Stimato)

1 luglio 2026

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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