Constipation Chronic IdiopathicNCT06414525
Effect of Abdominal Massage Versus Visceral Manipulation on Constipation
A study testing abdominal massage, visceral manipulation and instructions on daily, dietary , toilet , and physical activity habits in people with Constipation Chronic Idiopathic, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Constipation Chronic Idiopathic
- What is being tested?
- abdominal massage, visceral manipulation and instructions on daily, dietary , toilet , and physical activity habits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2024to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
- Conditions
- Constipation Chronic Idiopathic
- Being tested
- abdominal massage, visceral manipulation, instructions on daily, dietary , toilet , and physical activity habits
- Keywords
- chronic idiopathic constipation, abdominal massage, visceral manipulation, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal massageOther
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 manipulationOther
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 habitsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal massage | Active comparator | The technique involves stroking and kneading the abdomen in a consistent pattern. Receives: Other: abdominal massage |
| visceral manipulation | Active comparator | The technique involves visceral connective tissue manipulation. Receives: Other: visceral manipulation |
| control | Active comparator | instructions on daily, dietary, toilet, and physical activity habits Receives: Other: instructions on daily, dietary , toilet , and physical activity habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start30 May 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation Chronic IdiopathicStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat Allah Mohamed Ali Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414525
- Sponsor's protocol ID
- constipation
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Abdominal Massage Versus Visceral Manipulation on Constipation Status and Quality of Life in Adults
- ClinicalTrials.gov ID
- NCT06414525
- Acronym / sponsor ID
- constipation
- Conditions
- Constipation Chronic Idiopathic
- Keywords
- chronic idiopathic constipation, abdominal massage, visceral manipulation, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 May 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Abdominal massage | Active comparator | Other: abdominal massageThe technique involves stroking and kneading the abdomen in a consistent pattern. |
| visceral manipulation | Active comparator | Other: visceral manipulationThe technique involves visceral connective tissue manipulation. |
| control | Active comparator | Other: instructions on daily, dietary , toilet , and physical activity habitsinstructions on daily, dietary, toilet, and physical activity habits |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal massageIt 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. | Other | Abdominal massage |
| visceral manipulationIt 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. | Other | visceral manipulation |
| instructions on daily, dietary , toilet , and physical activity habitsIt 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. | Other | control |
Primary outcome
Constipation Severity Instrument (CSI)
Time frame: 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
Time frame: 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).
Patient Assessment of Constipation- Quality of Life (PAC-QOL) Questionnaire
Time frame: 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.
Bowel Function Index
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal massage, visceral manipulation and instructions on daily, dietary , toilet , and physical activity habits in people with Constipation Chronic Idiopathic, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mennat Allah Ahmed (01228423121, mennamohamed309@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation Severity Instrument (CSI) (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.