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

2. mai 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

32

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Dokki
      • Giza, Dokki, Egypt, 11432
        • Faculty of Physical Therapy
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • samar ahmed

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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

Aktiv komparator: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Symptom severity in patients with Irritable Bowel Syndrome
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quality of life in patients with Irritable Bowel Syndrome
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mai 2026

Primær fullføring (Antatt)

1. juli 2026

Studiet fullført (Antatt)

1. juli 2026

Datoer for studieregistrering

Først innsendt

24. april 2026

Først innsendt som oppfylte QC-kriteriene

24. april 2026

Først lagt ut (Faktiske)

1. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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