NCT05432453

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

June 21, 2022

Last Update Submit

February 9, 2024

Conditions

Keywords

constipationwomenrehabilitation

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • The Constipation Severity Scale

    one day

  • The Constipation Quality of Life Scale

    one day

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences Bolu Abant İzzet Baysal University

Bolu, 14300, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ömer Osman Pala

    Bolu Abant İzzet Baysal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ömer Osman Pala, Ph.D.

CONTACT

Büşra İnal, M.Sc.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 27, 2022

Study Start

May 16, 2022

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

February 12, 2024

Record last verified: 2024-02

Locations