The Relationship Between Functional Constipation and Sacroiliac Joint Dysfunction

Constipation - Functional Clinical Trial

Official title:

Investigation of the Relationship Between Functional Constipation and Sacroiliac Joint Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05432453
• Other study ID #: AIBU-FTR-BI-2
• Status: Recruiting
• Start date: May 16, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: February 2024
• Source: Abant Izzet Baysal University
• Contact: Ömer Osman Pala, Ph.D.
• Phone: +90 532 797 57 16
• Email: omerosman.pala[@]ibu.edu.tr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Constipation - Functional
• Joint Diseases
• Sacroiliac Joint Somatic Dysfunction

Locations

Country	Name	City	State
Turkey	Faculty of Health Sciences Bolu Abant Izzet Baysal University	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one day
Primary	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.	one day
Primary	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.	one day
Primary	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.	one day
Primary	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.	one day
Primary	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.	one week
Secondary	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.	one day
Secondary	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.	one day