Effect of Abdominal Massage Versus Visceral Manipulation on Constipation

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

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 .

Study Overview

• Status: Recruiting
• Conditions: Constipation Chronic Idiopathic
• Intervention / Treatment: Other: abdominal massage; Other: visceral manipulation; Other: instructions on daily, dietary , toilet , and physical activity habits

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mennat Allah Ahmed; Phone Number: 01228423121; Email: mennamohamed309@gmail.com

Study Locations

• Egypt
  • Ismailia, Egypt
    • Recruiting
    • Abo Khalefa emergency hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Abdominal massage; The technique involves stroking and kneading the abdomen in a consistent pattern.	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.
Active Comparator: visceral manipulation; The technique involves visceral connective tissue manipulation.	Other: 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.
Active Comparator: control; instructions on daily, dietary, toilet, and physical activity habits	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; abdominal massage; chronic idiopathic constipation; visceral manipulation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: constipation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No