Effect of Abdominal Massage Versus Visceral Manipulation on Constipation

Not Applicable

Recruiting

• Conditions: Constipation Chronic Idiopathic
• Interventions: Other: abdominal massage; Other: visceral manipulation; Other: instructions on daily, dietary , toilet , and physical activity habits

• Registration Number: NCT06414525
• Lead Sponsor: Cairo University

Brief Summary

The study compares the effect of abdominal massage vs. visceral manipulation on constipation status and quality of life in adults.

Chronic idiopathic constipation (CIC) is considered a common functional bowel disorder characterized by difficult, infrequent, and/or incomplete defecation. It has a great impact on the quality of life and on the healthcare system and represents an important financial strain .

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-10
• Study First Posted: 2024-05-16
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Study Start: 2024-05-30
• Primary Completion: 2024-07
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Patients of both sex with age ranges (20-40) years old.
• having a diagnosis of functional constipation according to Rome IV criteria onset of constipation symptoms from 6-12 months .
• having body mass index 18.5-29.9 kg/m2 , waist height ratio </=0.5
• Subjects bothered by their constipation

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Exclusion Criteria

• Pregnancy.
• Having comorbidities (chronic pelvic pain, neurological (Parkinson's, multiple sclerosis, spinal cord lesion, etc.), metabolic / endocrine (diabetes mellitus, hypercalcemia, hypothyroid, etc.), cardiorespiratory diseases
• Health problems which may prevent standing from sitting, walking (orthopedic, neurological, cardiorespiratory, etc.)
• Malignancy, acute inflammation, intestinal tumor
• History of gastrointestinal and pelvic surgery or spinal surgery other than cholecystectomy, appendectomy, or hysterectomy
• Visual, auditory or cognitive problems which may prevent participation to the study.
• Tumor, presence of skin problems in the application area
• Presence of laxative use for functional constipation in the last four weeks or patients on laxative therapy.
• Alarm symptoms (unexplained, more than 10% weight loss in 3 months, hemorrhoids and anal fissures, rectal bleeding, family history of colon cancer)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abdominal massage	abdominal massage	The technique involves stroking and kneading the abdomen in a consistent pattern.
visceral manipulation	visceral manipulation	The technique involves visceral connective tissue manipulation.
control	instructions on daily, dietary , toilet , and physical activity habits	instructions on daily, dietary, toilet, and physical activity habits

Primary Outcome Measures

Name	Time	Method
Bowel Function Index	6 weeks	(Scale 0 - 100), will be calculated as the mean of three variables (ease of defecation, feeling of incomplete bowel evacuation, and personal judgement of constipation) was developed to evaluate bowel function.
Patient Assessment of Constipation- Quality of Life (PAC-QOL) Questionnaire	6 weeks	Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) will be used to evaluate quality of life. PAC-QOL consists a total of 28 items in four subscales: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). Higher scores of PAC-QOL indicate more negative effects of constipation on the quality of life.
Constipation Severity Instrument (CSI)	6 weeks	Constipation Severity Instrument (CSI) will be used to evaluate the severity of the constipation. The Constipation Severity Instrument is a 16-item patient-reported outcome measure that investigates symptoms of constipation based on frequency, severity, and bother of symptoms. CSI consists of three subscales: obstructive defecation, colonic inertia, and pain.; Higher scores of CSI indicate more severe constipation.
Constipation Assessment Scale	6 weeks	Constipation assessment scale will be used to evaluate the severity of the constipation. The constipation assessment scale is a eight-item scale that assess the presence and severity of constipation.; The patient rates each constipation item on a three-point scale (no problem to severe problem). Total scores range from 0 (no constipation) to 16 (worst possible constipation).

Trial Locations

Locations (1)

Abo Khalefa emergency hospital; 🇪🇬 Ismailia, Egypt