Constipation - FunctionalNCT05432453
The Relationship Between Functional Constipation and Sacroiliac Joint Dysfunction
An observational study of Constipation - Functional and Sacroiliac Joint Somatic Dysfunction, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study; to compare individuals with and without chronic constipation in terms of sacroiliac joint dysfunction and to examine the relationship between chronic constipation and sacroiliac joint. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Constipation - Functional, Sacroiliac Joint Somatic Dysfunction
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2022to 1 May 2024
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Functional constipation criteria (Rome IV) will be use for functional constipation group. 1. Must include 2 or more of the following: 1. Straining during more than one-fourth (25%) of defecations 2. Lumpy or hard stools (BSFS 1-2) more than one-fourth (25%) of defecations 3. Sensation of incomplete evacuation more than one-fourth (25%) of defecations 4. Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations 5. Manual maneuvers to facilitate more than one fourth (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) 6. Fewer than three spontaneous bowel movements per week 2. Loose stools are rarely present without the use of laxatives 3. Insufficient criteria for irritable bowel syndrome
Who may be able to join
- Voluntary participation in the research
- Fulfill the diagnostic criteria for functional constipation (Rome IV)
- Being women
- Not using laxatives for at least the last 4 weeks
- Voluntary participation in the research
- Being women
- Not having functional constipation
Who cannot join
- Having cooperation problems
- Being pregnant
- Being breast-feeding
- Taking medication for depression, hypertension, sleep disorders, and pain
- Having parkinson, stroke, spinal cord injury, multiple sclerosis, hypothyroidism, Diabetes Mellitus, cerebral Palsy, thyroid problems, cancer, presence of tumor, presence of hernia, endometriosis, neuropathy, myopathy, scleroderma, inflammatory bowel diseases (Crohn, gastrointestinal tuberculosis, celiac, colon diverticulum, colonoscopy), cognitive impairment
- Having neurological or metabolic or malignant disorders
- Having a history of open abdominal surgery
- Having a history of pelvic and abdominal radiotherapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Faculty of Health Sciences Bolu Abant İzzet Baysal University
Bolu, 14300
Ömer Osman Pala
About this study
Official title: Investigation of the Relationship Between Functional Constipation and Sacroiliac Joint Dysfunction
The purpose of this study; to compare individuals with and without chronic constipation in terms of sacroiliac joint dysfunction and to examine the relationship between chronic constipation and sacroiliac joint.
Read the detailed description
Constipation is a heterogeneous, polysymptomatic and multifactorial disease. Many symptoms are used to define the term constipation, such as hard stool, excessive straining, few bowel movements, use of digital maneuvers during defecation, abdominal bloating, and a feeling of inadequate evacuation.
Chronic constipation is seen in approximately 14% of the world. It is seen on average 2 times more in women.
Visceral and somatic neural control of defecation is provided by the Sacral 2-4 segments of the spinal cord. It is in neural relationship with the sacroiliac joint and pelvic floor muscles, which also provide innervation from the same segments. These visceral and somatic structures can affect each other through viscerosomatic and somatovisceral reflexes. This means that an afferent input from the rectum can reflect on and around the sacroiliac joint.
Based on this connection, we think that primary chronic constipation without an organic cause may be associated with sacroiliac joint dysfunction. In the literature review, no study examining this relationship was found.
This study is planned to evaluate individuals with and without chronic constipation in terms of sacroiliac joint dysfunction and to examine the relationship between chronic constipation and sacroiliac joint.
- Keywords
- constipation, women, rehabilitation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with constipation | Bowel functional markers (defecation frequency, defecation time, and stool density) and constipation-related quality of life of women with constipation will be evaluated with the Constipation Severity Scale, Constipation Quality of Life Scale, 7-day bowel diary, and Bristol Stool Scale. Sacroiliac joint dysfunctions of women with constipation will be evaluated by standing forward bending test, sitting forward bending test, compression test, posterior friction test and Patrick-Faber test. | |
| Women without constipation (Control) | Bowel functional markers (defecation frequency, defecation time, and stool density) and constipation-related quality of life of women without constipation will be evaluated with the Constipation Severity Scale, Constipation Quality of Life Scale, 7-day bowel diary, and Bristol Stool Scale. Sacroiliac joint dysfunctions of women without constipation will be evaluated by standing forward bending test, sitting forward bending test, compression test, posterior friction test and Patrick-Faber test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Standing Forward Bend Test (One of Sacroiliac Joint Dysfunction Tests)
The participant stands with their feet shoulder-width apart. The physiotherapist places the thumbs on the participant's posterior superior iliac spine. The physiotherapist stands or kneels behind the participant with their eyes aligned with the posterior superior iliac spine. The participant is instructed to lean forward, trying to touch their fingers. The forward bending movement should be done without bending the knees and in a way that does not cause pain.
The standing forward bending test gives information about whether there is a blockage in one of the sacroiliac joints and if there is a blockage, on which side it is. At the end of the movement, the test is positive on the anterior side of the spina iliaca posterior superior. In the positivity of this test, the forward bending test in sitting is performed to distinguish between iliac and sacrum dysfunction.
Measured: one day
The Sitting Forward Bend Test (One of Sacroiliac Joint Dysfunction Tests)
The participant sits with their legs slightly apart. The physiotherapist stands or kneels behind the participant with their eyes aligned with the posterior superior iliac spine and palps the posterior superior of the spina iliaca. The participant is asked to lean forward as far as possible without pain. If at the end of the movement the asymmetry in the posterior superior spina iliaca becomes more pronounced than in the foot, it is defined as a dysfunction of the sacrum, less pronounced than that of the foot, or a dysfunction of the ilium if absent.
Measured: one day
The Compression Test (One of Sacroiliac Joint Dysfunction Tests)
The participant lies on their side with their hips flexed to 45° and knees flexed to 90°. The physiotherapist stands behind the participant and applies pressure over the iliac crest to the contralateral iliac crest. The test is applied to the other side as well. Pain caused by compression makes the test positive.
Measured: one day
The Posterior Friction Test (One of Sacroiliac Joint Dysfunction Tests)
Axial pressure is applied across the femur, bringing the hip of the participant in the supine position to 90° flexion and adduction of the femur. The occurrence of pain suggests a pathology in the sacroiliac joint.
Measured: one day
The Patrick Faber Test (One of Sacroiliac Joint Dysfunction Tests)
The ipsilateral hip and knee joint of the participant in the supine position is flexed, and the heel is placed on the opposite knee. The physiotherapist provides stabilization over the contralateral spina iliaca anterior superior to maintain the neutral position. The test stresses the anterior sacroiliac ligaments and hip joint. The test is considered positive with pain occurring in the sacroiliac joint area.
Measured: one day
7-day bowel diary
Individuals will be asked to complete a bowel diary for 7 days for evaluation. Individuals will be asked to mark each day they defecate, how long they stay in the toilet at each defecation, mark if there is a feeling of incomplete emptying, note the changes in nutrition and fluid consumption and drug use, and record their stool consistency by looking at the Bristol stool scale.
Measured: one week
Secondary outcomes (2)
The Constipation Severity Scale
Constipation severity of individuals will be evaluated with the Constipation Severity Scale.
star_border The Constipation Severity Scale is a scale to determine the frequency, density and difficulty/difficulty of individuals during defecation. There are 16 questions in the scale.The lowest total score that can be obtained from the constipation severity scale is 0, and the highest is 73. A high score from the scale indicates that the symptoms are serious.
Measured: one day
The Constipation Quality of Life Scale
This scale consists of 28 items and consists of "physical discomfort" (questions 1-4), "psychosocial discomfort" (questions 5-12), "worry/anxiety" (questions 13-23) and "satisfaction" (questions 24-28). It has 4 subdomains. The answer options for the scale questions are in the five-point Likert scale type and the item scores range from 1 to 5. The lowest score that can be obtained from the scale is 28, and the highest score is 140. Higher scores on the scale mean that quality of life is more negatively affected.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start16 May 2022
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Osman Pala, Abant Izzet Baysal University
- Investigators
- Ömer Osman Pala, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432453
- Sponsor's protocol ID
- AIBU-FTR-BI-2
- Status last verified
- Feb 2024
- First submitted
- 21 Jun 2022
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Functional Constipation and Sacroiliac Joint Dysfunction
- ClinicalTrials.gov ID
- NCT05432453
- Acronym / sponsor ID
- AIBU-FTR-BI-2
- Keywords
- constipation, women, rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 27 Jun 2022 (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 purpose of this study; to compare individuals with and without chronic constipation in terms of sacroiliac joint dysfunction and to examine the relationship between chronic constipation and sacroiliac joint.
Detailed description
Constipation is a heterogeneous, polysymptomatic and multifactorial disease. Many symptoms are used to define the term constipation, such as hard stool, excessive straining, few bowel movements, use of digital maneuvers during defecation, abdominal bloating, and a feeling of inadequate evacuation.
Chronic constipation is seen in approximately 14% of the world. It is seen on average 2 times more in women.
Visceral and somatic neural control of defecation is provided by the Sacral 2-4 segments of the spinal cord. It is in neural relationship with the sacroiliac joint and pelvic floor muscles, which also provide innervation from the same segments. These visceral and somatic structures can affect each other through viscerosomatic and somatovisceral reflexes. This means that an afferent input from the rectum can reflect on and around the sacroiliac joint.
Based on this connection, we think that primary chronic constipation without an organic cause may be associated with sacroiliac joint dysfunction. In the literature review, no study examining this relationship was found.
This study is planned to evaluate individuals with and without chronic constipation in terms of sacroiliac joint dysfunction and to examine the relationship between chronic constipation and sacroiliac joint.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with constipation | – | –Bowel functional markers (defecation frequency, defecation time, and stool density) and constipation-related quality of life of women with constipation will be evaluated with the Constipation Severity Scale, Constipation Quality of Life Scale, 7-day bowel diary, and Bristol Stool Scale. Sacroiliac joint dysfunctions of women with constipation will be evaluated by standing forward bending test, sitting forward bending test, compression test, posterior friction test and Patrick-Faber test. |
| Women without constipation (Control) | – | –Bowel functional markers (defecation frequency, defecation time, and stool density) and constipation-related quality of life of women without constipation will be evaluated with the Constipation Severity Scale, Constipation Quality of Life Scale, 7-day bowel diary, and Bristol Stool Scale. Sacroiliac joint dysfunctions of women without constipation will be evaluated by standing forward bending test, sitting forward bending test, compression test, posterior friction test and Patrick-Faber test. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Functional constipation criteria (Rome IV) will be use for functional constipation group. 1. Must include 2 or more of the following: 1. Straining during more than one-fourth (25%) of defecations 2. Lumpy or hard stools (BSFS 1-2) more than one-fourth (25%) of defecations 3. Sensation of incomplete evacuation more than one-fourth (25%) of defecations 4. Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations 5. Manual maneuvers to facilitate more than one fourth (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) 6. Fewer than three spontaneous bowel movements per week 2. Loose stools are rarely present without the use of laxatives 3. Insufficient criteria for irritable bowel syndrome
Key inclusion criteria (7 listed)
- Voluntary participation in the research
- Fulfill the diagnostic criteria for functional constipation (Rome IV)
- Being women
- Not using laxatives for at least the last 4 weeks
- Voluntary participation in the research
Key exclusion criteria (8 listed)
- Having cooperation problems
- Being pregnant
- Being breast-feeding
- Taking medication for depression, hypertension, sleep disorders, and pain
- Having parkinson, stroke, spinal cord injury, multiple sclerosis, hypothyroidism, Diabetes Mellitus, cerebral Palsy, thyroid problems, cancer, presence of tumor, presence of hernia, endometriosis, neuropathy, myopathy, scleroderma, inflammatory bowel diseases (Crohn, gastrointestinal tuberculosis, celiac, colon diverticulum, colonoscopy), cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Standing Forward Bend Test (One of Sacroiliac Joint Dysfunction Tests)
Time frame: one day
The participant stands with their feet shoulder-width apart. The physiotherapist places the thumbs on the participant's posterior superior iliac spine. The physiotherapist stands or kneels behind the participant with their eyes aligned with the posterior superior iliac spine. The participant is instructed to lean forward, trying to touch their fingers. The forward bending movement should be done without bending the knees and in a way that does not cause pain. The standing forward bending test gives information about whether there is a blockage in one of the sacroiliac joints and if there is a blockage, on which side it is. At the end of the movement, the test is positive on the anterior side of the spina iliaca posterior superior. In the positivity of this test, the forward bending test in sitting is performed to distinguish between iliac and sacrum dysfunction.
The Sitting Forward Bend Test (One of Sacroiliac Joint Dysfunction Tests)
Time frame: one day
The participant sits with their legs slightly apart. The physiotherapist stands or kneels behind the participant with their eyes aligned with the posterior superior iliac spine and palps the posterior superior of the spina iliaca. The participant is asked to lean forward as far as possible without pain. If at the end of the movement the asymmetry in the posterior superior spina iliaca becomes more pronounced than in the foot, it is defined as a dysfunction of the sacrum, less pronounced than that of the foot, or a dysfunction of the ilium if absent.
The Compression Test (One of Sacroiliac Joint Dysfunction Tests)
Time frame: one day
The participant lies on their side with their hips flexed to 45° and knees flexed to 90°. The physiotherapist stands behind the participant and applies pressure over the iliac crest to the contralateral iliac crest. The test is applied to the other side as well. Pain caused by compression makes the test positive.
The Posterior Friction Test (One of Sacroiliac Joint Dysfunction Tests)
Time frame: one day
Axial pressure is applied across the femur, bringing the hip of the participant in the supine position to 90° flexion and adduction of the femur. The occurrence of pain suggests a pathology in the sacroiliac joint.
The Patrick Faber Test (One of Sacroiliac Joint Dysfunction Tests)
Time frame: one day
The ipsilateral hip and knee joint of the participant in the supine position is flexed, and the heel is placed on the opposite knee. The physiotherapist provides stabilization over the contralateral spina iliaca anterior superior to maintain the neutral position. The test stresses the anterior sacroiliac ligaments and hip joint. The test is considered positive with pain occurring in the sacroiliac joint area.
7-day bowel diary
Time frame: one week
Individuals will be asked to complete a bowel diary for 7 days for evaluation. Individuals will be asked to mark each day they defecate, how long they stay in the toilet at each defecation, mark if there is a feeling of incomplete emptying, note the changes in nutrition and fluid consumption and drug use, and record their stool consistency by looking at the Bristol stool scale.
2 secondary outcomes
The Constipation Severity Scale
Time frame: one day
The Constipation Quality of Life Scale
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 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.
Ömer Osman Pala principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation - Functional and Sacroiliac Joint Somatic Dysfunction, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 7 inclusion and 8 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 12 Feb 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 Turkey (Türkiye). 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 Ömer Osman Pala, Ph.D. (+90 532 797 57 16, omerosman.pala@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Standing Forward Bend Test (One of Sacroiliac Joint Dysfunction Tests) (time frame: one day). The study lists 6 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 12 Feb 2024.