- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07560345
Effect of Neurodynamic Mobilization of Vagus Nerve on Irritable Bowel Syndrome in Women
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Dokki
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Giza, Dokki, 이집트, 11432
- Faculty of Physical Therapy
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연락하다:
- Samir Ahmed Sabahi, Professor
- 전화번호: 01128377738
- 이메일: ssabbahi@hotmail.com
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연락하다:
- Nouran Ahmed Ibrahim, Professor
- 전화번호: 01062207203
- 이메일: nouran-312@cu.edu.eg
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수석 연구원:
- samar ahmed
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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 |
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활성 비교기: 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.
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Dietary advice as :
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Symptom severity in patients with Irritable Bowel Syndrome
기간: 6 weeks
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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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of life in patients with Irritable Bowel Syndrome
기간: 6 weeks
|
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6 weeks
|
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Anxiety and depression levels in patients with Irritable Bowel Syndrome
기간: 6 weeks
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Anxiety and depression levels in patients with Irritable Bowel Syndrome: Will be measured by Arbic Version Of The Hospital Anxiety and Depression Scale (HADS).
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6 weeks
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- P.T.REC/012/006238
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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