Investigating the Correlation Between Functional Constipation and Sacroiliac Joint Disorders (SIJ disorders)
Study Overview
Status
Status
Conditions
Conditions
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Locations
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Giza Governorate
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October City, Giza Governorate, Egypt, 6892
- Bassam Ahmed Nabil
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Inclusion Criteria:
- history of Chronic Constipation (CC), as defined by either experiencing two or fewer Complete Spontaneous Bowel Movements (CSBMs) per week for a minimum of 6 consecutive months before the screening visit
- Reporting a sensation of incomplete evacuation or straining during at least a quarter of their bowel movements (according to the generally accepted definition of constipation).
- Patients must have had CC persisting for more than 6 months, failed to respond to or be intolerant of medical treatment for at least 3 months
Inclusion Criteria (for group B):
Not having functional constipation
Exclusion Criteria:
- - pregnant or lactating women
- Chronic Constipation (CC) resulting from anorectal malformations such as colorectal or anal organic lesions, pelvic floor disorders requiring surgical intervention as determined by the investigator (such as rectal prolapse, rectocele, or enterocele)
- presence of implanted electronic devices like cardiac pacemakers, defibrillators, cardiac pumps, or spinal stimulators
- CC attributable to medications or neurologic, endocrine, or metabolic conditions
- prior history of partial colectomy; conditions like megacolon, megarectum, or colonic inertia
- skin abnormalities that hinder the placement of electrodes
- women lacking adequate contraception (hormonal or intrauterine device).
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
|---|
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group A: Patients with constipation
Both the rectum and the sacroiliac joint share innervation from sacral spinal segments S2-S4.
Neural signals from the rectum can influence SI joint sensory nerves via viscerosomatic and somatovisceral reflex arcs.
This means chronic constipation may both result from and contribute to SI joint dysfunction.
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group B: Patients without constipation
Accumulated stool in the rectum and sigmoid colon can physically press on pelvic structures, stretching ligaments and tensioning muscles around the SI joint.
This may trigger or mimic SI joint dysfunction.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Distraction Test (SI Joint Gapping)
Time Frame: 6 months
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Position of patient: Supine.
force: posterior-lateral force to both ASISs at same time results: pain in SI region
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6 months
|
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Thigh Thrust Test
Time Frame: 6 months
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Position of patient: Supine, hip and knee of affected side flexed 90°.
force: Stabilize opposite ASIS, apply posterior force through femur.
result: Focal SI pain.
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6 months
|
|
Sacral Thrust Test
Time Frame: 6 months
|
Position of patient: Prone.
force: Apply an anterior shear force to sacrum (over S2).
result: Reproduction of pain in SI region.
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6 months
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2517
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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