Does Adolescent Idıopathic Scoliosis Cause Pelvic Floor Dysfunction?

• Sponsor: Cyprus International University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06063447
• Collaborator: Near East University, Turkey (Other)
• Enrollment: 12
• Location: 1
• Actual Duration (Months): 4.5
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Scoliosis Idiopathic; Pelvic Floor Disorders	Other: Examination

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 12 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Relationship Between the Type and Severity of Scoliosis and Pelvic Floor Dysfunctions in Individiuals With Adolescent Idiopathic Scoliosis
• Actual Study Start Date: May 2, 2023
• Actual Primary Completion Date: Sep 4, 2023
• Actual Study Completion Date: Sep 15, 2023

Outcome Measures

Primary Outcome Measures

1. Scoliosis [10 minutes]

   With X-Ray

2. Posture Analysis [5 minutes]

   With Posture Screen Mobile Application

3. Pelvic Floor Muscle Activity [15 Minutes]

   With Real Time Transabdominal Ultrasound

4. Pelvic Floor Dysfunction [5 minutes]

   With Pelvic Floor Distress Inventory

5. Dysfunctional Voiding [10 minutes]

   With Dysfunctional Voiding Scoring System

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Years to 18 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Batuhan Ibrahim	Mersin	Lefkosa	Turkey	99258

Sponsors and Collaborators

• Cyprus International University
• Near East University, Turkey

Investigators

• Study Chair: Salih Angın, Prof., Cyprus International University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Cyprus International University
• ClinicalTrials.gov Identifier: NCT06063447
• Other Study ID Numbers: 020-6029
• First Posted: Oct 2, 2023
• Last Update Posted: Oct 2, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Scoliosis; Pelvic Floor Disorders

Study Results

No Results Posted as of Oct 2, 2023