The Relationship Between Functional Constipation and Sacroiliac Joint Dysfunction

February 9, 2024 updated by: Ömer Osman Pala, Abant Izzet Baysal University

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.

Study Overview

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 Type

Observational

Enrollment (Estimated)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Bolu, Turkey, 14300
        • Recruiting
        • Faculty of Health Sciences Bolu Abant Izzet Baysal University
        • Contact:
          • Ömer Osman Pala

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

one day
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.
one day
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.
one day
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.
one day
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.
one day
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.
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Constipation Severity Scale
Time Frame: one day

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
The Constipation Quality of Life Scale
Time Frame: one day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ömer Osman PALA, Bolu abant Izzet Baysal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2022

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

June 21, 2022

First Submitted That Met QC Criteria

June 21, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • AIBU-FTR-BI-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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