Scoliosis IdiopathicNCT06063447
Does Adolescent Idıopathic Scoliosis Cause Pelvic Floor Dysfunction?
An observational study of Scoliosis Idiopathic and Pelvic Floor Disorders, run by Cyprus International University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 11 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic, Pelvic Floor Disorders
- What is being tested?
- Examination
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2023to 15 Sep 2023
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Individuals aged between 11-18 years and followed up in physiotherapy centers that met the inclusion criteria were selected.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between the Type and Severity of Scoliosis and Pelvic Floor Dysfunctions in Individiuals With Adolescent Idiopathic Scoliosis
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.
Read the 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.
- Conditions
- Scoliosis Idiopathic, Pelvic Floor Disorders
- Being tested
- Examination
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExaminationOther
Posture Evaluation, Scoliosis Examination, Pelvic Floor Assesments
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoliosis
With X-Ray
Measured: 10 minutes
Posture Analysis
With Posture Screen Mobile Application
Measured: 5 minutes
Pelvic Floor Muscle Activity
With Real Time Transabdominal Ultrasound
Measured: 15 Minutes
Pelvic Floor Dysfunction
With Pelvic Floor Distress Inventory
Measured: 5 minutes
Dysfunctional Voiding
With Dysfunctional Voiding Scoring System
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start2 May 2023
- Primary completion4 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Cyprus International University
- Sponsor type
- University, hospital or other
- Collaborators
- Near East University, Turkey
- Responsible party
- Sponsor
- Investigators
- Salih Angın, Prof., Study chair, Cyprus International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063447
- Sponsor's protocol ID
- 020-6029
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27054800Naziri 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.
PubMed 29772989Negrini 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.
PubMed 29435499Ahmed 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 at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the Type and Severity of Scoliosis and Pelvic Floor Dysfunctions in Individiuals With Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06063447
- Acronym / sponsor ID
- 020-6029
- Conditions
- Scoliosis Idiopathic, Pelvic Floor Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cyprus International UniversityUniversity, hospital or other
- Collaborators
- Near East University, Turkey
- Study start
- 2 May 2023 (actual)
- Primary completion
- 4 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 15 Days
Who may qualify
- Ages
- 11 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Individuals aged between 11-18 years and followed up in physiotherapy centers that met the inclusion criteria were selected.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExaminationPosture Evaluation, Scoliosis Examination, Pelvic Floor Assesments | Other | – |
Primary outcome
Scoliosis
Time frame: 10 minutes
With X-Ray
Posture Analysis
Time frame: 5 minutes
With Posture Screen Mobile Application
Pelvic Floor Muscle Activity
Time frame: 15 Minutes
With Real Time Transabdominal Ultrasound
Pelvic Floor Dysfunction
Time frame: 5 minutes
With Pelvic Floor Distress Inventory
Dysfunctional Voiding
Time frame: 10 minutes
With Dysfunctional Voiding Scoring System
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- BackgroundPerkins, J., Boyer, A., Mcleish, A., & Grossnickle, K. (2012). Idiopathic scoliosis and pelvic floor dysfunction. International Journal of Therapy and Rehabilitation, 19(2), 106-110.
- Background: PubMed 27054800Meyer 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.
- Background: PubMed 29772989Naziri 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.
- Background: PubMed 29435499Negrini 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.
- BackgroundAhmed 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salih Angın, Prof. study chair
Cyprus International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Idiopathic and Pelvic Floor Disorders, run by Cyprus International University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoliosis (time frame: 10 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06063447, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.