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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06063447
Other study ID # 020-6029
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2, 2023
Est. completion date September 15, 2023

Study information

Verified date September 2023
Source Cyprus International University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study was to investigate relationship between the type and severity of scoliosis and pelvic floor dysfunctions in individuals with adolescent idiopathic scoliosis.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date September 15, 2023
Est. primary completion date September 4, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 11 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Examination
Posture Evaluation, Scoliosis Examination, Pelvic Floor Assesments

Locations

Country Name City State
Turkey Batuhan Ibrahim Mersin Lefkosa

Sponsors (2)

Lead Sponsor Collaborator
Cyprus International University Near East University, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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.

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. — View Citation

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. — View Citation

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. — View Citation

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Scoliosis With X-Ray 10 minutes
Primary Posture Analysis With Posture Screen Mobile Application 5 minutes
Primary Pelvic Floor Muscle Activity With Real Time Transabdominal Ultrasound 15 Minutes
Primary Pelvic Floor Dysfunction With Pelvic Floor Distress Inventory 5 minutes
Primary Dysfunctional Voiding With Dysfunctional Voiding Scoring System 10 minutes
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