NCT07560345

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
May 2026Jul 2026

First Submitted

Initial submission to the registry

April 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Keywords

irritable bowel syndrome

Outcome Measures

Primary Outcomes (1)

  • Symptom severity in patients with IBS

    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 IBS

    6 weeks

Secondary Outcomes (2)

  • Quality of life in patients with IBS

    6 weeks

  • Anxiety and depression levels in patients with IBS

    6 weeks

Study Arms (2)

Experimental group (vagus nerve mobilization)

EXPERIMENTAL

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.

Behavioral: neurodynamic mobilization of vagus nerve

Control group

ACTIVE COMPARATOR

16 Females with mild to moderate IBS will receive Standard care consisted of Advice and dietary recommendations and pharmacological treatments only.for \[6\] weeks.

Behavioral: Standard care

Interventions

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

Experimental group (vagus nerve mobilization)
Standard careBEHAVIORAL

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.

Control group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female participants are eligible to participate in this study.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Giza, Dokki, 11432, Egypt

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental group : 16 subjects will receive vagal neurodynamic technique in addition to Standard care consisted of advice and dietary recommendations. Control group : 16 subjects will receive Standard care consisted of Advice and dietary recommendations only.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investegator

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations