- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06063447
Does Adolescent Idıopathic Scoliosis Cause Pelvic Floor Dysfunction?
Relationship Between the Type and Severity of Scoliosis and Pelvic Floor Dysfunctions in Individiuals With Adolescent Idiopathic Scoliosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
While a healthy spine has a flat appearance in the axial line in the frontal plane, individuals with scoliosis have lateral flexion to one side and rotation deformity in the horizantal plane. In other words, it is a 3-dimensional problem that causes severe postural disorder in advanced stages, accompanied by lateral flexion of the spine of 10 degrees or more in the frontal plane, axial rotation in the transverse plane and kyphosis-lordosis deformity in the sagittal plane. Especially the "core" region, which is formed by 4 main muscle groups, stabilizes the pelvic organs by balancing intra-abdominal pressure increases and provides spinal stabilization. Studies showing that pelvic floor functions may be affected in normal spinal physiologic curvature changes are available in the literature. However, the relationship between the angle and severity of scoliosis and pelvic floor dysfunctions due to idiopathic scoliosis has not been clearly clarified.
In this context, the study aims to evaluate and compare scoliosis-related parameters (type of scoliosis, cobb angle, axial rotation angle), pelvic floor dynamics and dysfunctions in individuals with idiopathic scoliosis and healthy individuals with the same age group and characteristics.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Lefkosa
-
Mersin, Lefkosa, Turkey, 99258
- Batuhan Ibrahim
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Those with adolescent idiopathic scoliosis diagnosed above 10' degree,
- Under 19 years of age diagnosed with AIS,
- Individuals whose consent was obtained from their families to participate in the study
Exclusion Criteria:
- Those with congenital scoliosis,
- Those with a history of neuromuscular disease,
- Diagnosed with any systemic disease other than AIS,
- Those with a history of malignancy and/or ongoing treatment,
- Those with a history of urogenital diseases and surgical history,
- Individuals with previous spinal surgery
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scoliosis
Time Frame: 10 minutes
|
With X-Ray
|
10 minutes
|
|
Posture Analysis
Time Frame: 5 minutes
|
With Posture Screen Mobile Application
|
5 minutes
|
|
Pelvic Floor Muscle Activity
Time Frame: 15 Minutes
|
With Real Time Transabdominal Ultrasound
|
15 Minutes
|
|
Pelvic Floor Dysfunction
Time Frame: 5 minutes
|
With Pelvic Floor Distress Inventory
|
5 minutes
|
|
Dysfunctional Voiding
Time Frame: 10 minutes
|
With Dysfunctional Voiding Scoring System
|
10 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Salih Angın, Prof., Cyprus International University
Publications and helpful links
General Publications
- Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.
- Perkins, J., Boyer, A., Mcleish, A., & Grossnickle, K. (2012). Idiopathic scoliosis and pelvic floor dysfunction. International Journal of Therapy and Rehabilitation, 19(2), 106-110.
- Meyer I, McArthur TA, Tang Y, McKinney JL, Morgan SL, Richter HE. Pelvic Floor Symptoms and Spinal Curvature in Women. Female Pelvic Med Reconstr Surg. 2016 Jul-Aug;22(4):219-23. doi: 10.1097/SPV.0000000000000271.
- Naziri Q, Detolla J, Hayes W, Burekhovich S, Merola A, Akamnanu C, Paulino CB. A Systematic Review of All Smart Phone Applications Specifically Aimed for Use as a Scoliosis Screening Tool. J Long Term Eff Med Implants. 2018;28(1):25-30. doi: 10.1615/JLongTermEffMedImplants.2017020737.
- Ahmed SA., Othman NA., Sabet NA., & Salwa F. (2021). Validity and Reliability of Posture Screen Mobile Application in Adolescent Idiopathic Scoliosis. The Medical Journal of Cairo University, 89(June), 737-743.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 020-6029
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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