Effect of Abdominal Massage Versus Visceral Manipulation on Constipation

NCT06414525 | Recruiting

• 1 other identifier: constipation
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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 .

Conditions

Constipation Chronic Idiopathic

Keywords

chronic idiopathic constipation; abdominal massage; visceral manipulation; quality of life

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Abdominal massage

ACTIVE COMPARATOR

The technique involves stroking and kneading the abdomen in a consistent pattern.

Other: abdominal massage

visceral manipulation

ACTIVE COMPARATOR

The technique involves visceral connective tissue manipulation.

Other: visceral manipulation

control

ACTIVE COMPARATOR

instructions on daily, dietary, toilet, and physical activity habits

Other: instructions on daily, dietary , toilet , and physical activity habits

Interventions

abdominal massage OTHER

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.

Abdominal massage

visceral manipulation OTHER

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.

visceral manipulation

instructions on daily, dietary , toilet , and physical activity habits OTHER

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.

control

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Abo Khalefa emergency hospital

Ismailia, Egypt

RECRUITING

MeSH Terms

Interventions

Diet; Bathroom Equipment

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Equipment and Supplies

Central Study Contacts

Mennat Allah Ahmed

CONTACT

01228423121; mennamohamed309@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of department of physical therapy AboKhalefa hospital

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 16, 2024
• Study Start: May 30, 2024
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

EG (1)