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RecruitingNCT06414525Updated May 22, 2024

Effect of Abdominal Massage Versus Visceral Manipulation on Constipation

An interventional study of abdominal massage and visceral manipulation in Constipation Chronic Idiopathic, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-05-22.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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 .

02

Conditions studied

  • Constipation Chronic Idiopathic

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Keywords

  • chronic idiopathic constipation
  • abdominal massage
  • visceral manipulation
  • quality of life
03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's planned enrollment of 75 is close to the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
75 participants (estimated)

Study arms

  • Active comparator
    Abdominal massage

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

    Other: abdominal massage

  • Active comparator
    visceral manipulation

    The technique involves visceral connective tissue manipulation.

    Other: visceral manipulation

  • Active comparator
    control

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

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

Interventions

  • Otherabdominal 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.

  • Othervisceral 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.

  • Otherinstructions 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 weeks

  2. 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).

    Time frame: 6 weeks

  3. 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.

    Time frame: 6 weeks

  4. 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.

    Time frame: 6 weeks

07

Study locations

1 of 1 sites recruiting
  • Abo Khalefa emergency hospital
    Ismailia, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06414525
Lead sponsor
Cairo University
Responsible party
Mennat Allah Mohamed Ali Ahmed (head of department of physical therapy AboKhalefa hospital, Cairo University) — Principal investigator
First posted
May 16, 2024
Start date
May 30, 2024 (estimated)
Primary completion
Jul 2024 (estimated)
Completion
Aug 2024 (estimated)
Last update
May 22, 2024

Study contacts

Mennat Allah Ahmed
Contact
mennamohamed309@gmail.com
01228423121

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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