Effect of Abdominal Massage Versus Visceral Manipulation on Constipation

Constipation Chronic Idiopathic Clinical Trial

Official title:

Effect of Abdominal Massage Versus Visceral Manipulation on Constipation Status and Quality of Life in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06414525
• Other study ID #: constipation
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2024
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: Mennat Allah Ahmed
• Phone: 01228423121
• Email: mennamohamed309[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

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)

Related Conditions & MeSH terms

• Constipation
• Constipation Chronic Idiopathic

Intervention

Other:
• abdominal massage
It will include patients that will receive abdominal massage; the frequency and duration of the massage will be arranged as 3 sessions per week, with each session lasting an average of 20-25 minutes for 6 weeks.
• visceral manipulation
It will include patients that will receive visceral manipulation; the frequency and duration of the technique will be arranged as 3 sessions per week, with each session lasting an average of 20-25 minutes for 6 weeks.
• instructions on daily, dietary , toilet , and physical activity habits
It will include patients that will receive behavioral therapy: defecation mechanism and informing about negative attitudes and behaviors towards defecation), lifestyle advice (diet, water consumption, fiber food, etc.), teaching effective defecation posture, and timed toilet training.

Locations

Country	Name	City	State
Egypt	Abo Khalefa emergency hospital	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constipation Severity Instrument (CSI)	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.	6 weeks
Primary	Constipation Assessment Scale	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).	6 weeks
Primary	Patient Assessment of Constipation- Quality of Life (PAC-QOL) Questionnaire	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.	6 weeks
Primary	Bowel Function Index	(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.	6 weeks