Clinical trial NCT05432453: The Relationship Between Functional Constipation and Sacroiliac Joint Dysfunction
Official title: Investigation of the Relationship Between Functional Constipation and Sacroiliac Joint Dysfunction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Constipation - Functional
Sacroiliac Joint Somatic Dysfunction
Keywords: constipation
women
rehabilitation
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria (for functional constipation group):

* 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

Inclusion Criteria (for control group):

* Voluntary participation in the research
* Being women
* Not having functional constipation

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Standing Forward Bend Test (One of Sacroiliac Joint Dysfunction Tests)
timeFrame: one day
measure: The Sitting Forward Bend Test (One of Sacroiliac Joint Dysfunction Tests)
timeFrame: one day
measure: The Compression Test (One of Sacroiliac Joint Dysfunction Tests)
timeFrame: one day
measure: The Posterior Friction Test (One of Sacroiliac Joint Dysfunction Tests)
timeFrame: one day
measure: The Patrick Faber Test (One of Sacroiliac Joint Dysfunction Tests)
timeFrame: one day
measure: 7-day bowel diary
timeFrame: one week
Secondary outcomes:
measure: The Constipation Severity Scale
timeFrame: one day
measure: The Constipation Quality of Life Scale
timeFrame: one day
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Faculty of Health Sciences Bolu Abant İzzet Baysal University
Study officials:
affiliation: Bolu Abant İzzet Baysal University
name: Ömer Osman Pala
role: PRINCIPAL_INVESTIGATOR
References: