- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07560345
Effect of Neurodynamic Mobilization of Vagus Nerve on Irritable Bowel Syndrome in Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dokki
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Giza, Dokki, Egypt, 11432
- Faculty of Physical Therapy
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Contact:
- Samir Ahmed Sabahi, Professor
- Phone Number: 01128377738
- Email: ssabbahi@hotmail.com
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Contact:
- Nouran Ahmed Ibrahim, Professor
- Phone Number: 01062207203
- Email: nouran-312@cu.edu.eg
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Principal Investigator:
- samar ahmed
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 |
|
Active Comparator: 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 :
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptom severity in patients with Irritable Bowel Syndrome
Time Frame: 6 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life in patients with Irritable Bowel Syndrome
Time Frame: 6 weeks
|
|
6 weeks
|
|
Anxiety and depression levels in patients with Irritable Bowel Syndrome
Time Frame: 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).
|
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006238
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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ProgenaBiomeWithdrawnIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
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