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Pectus Deformity of ChestNCT06009601

The Relationship Between Pectus Deformities and Spinal Pathologies

An observational study of Pectus Deformity of Chest and Spinal Deformity, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pectus deformities are common anterior chest wall pathologies. Pectus excavatum is the most common chest deformity with an incidence of 0.1-0.3%. Although the incidence of adolescent idiopathic scoliosis (AIS) is 0.2-3% in the community, some studies show that this rate rises to 17.61-25.58% when it is associated with… Read more about this study

Who is it for?
Ages 3 to 18 years
Conditions the study is for
Pectus Deformity of Chest, Spinal Deformity
What is being tested?
Pectus Study Form, Adams Test and Scoliosis Graphy
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
9 Mar 2023to 28 Apr 2023
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 3 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Pectus study forms consisting of clinical and radiological measurements of patients aged 3-18 years who applied to the outpatient clinic with chest deformity will be filled in in detail. Adams test (forward bending test) (+) was measured by Bunnell scoliometer (scoliosis assessment tool) and ATR (angle of trunk rotation angle) values were 5 degrees in those with BMI (Body Mass Index) above 85%. If it is below 85% and above 7 degrees, patients who meet the inclusion criteria will be included in the study by filling out an informed consent form and a scoliosis film will be requested. Scoliosis X-ray (orthorontgenogram) will be requested. Coronal, sagittal balance, coronal and sagittal cobb angles will be measured. Their relationship with chest deformities will be evaluated. All measurements will be made and recorded by two independent researchers.

Who may be able to join

  • Being diagnosed with pectus deformity
  • Be between 3-18 years old

Who cannot join

  • Adult type scoliosis
  • Congenital scoliosis
  • Neuromuscular scoliosis
  • Syndromic scoliosis
  • Infantile idiopathic scoliosis
  • Having surgery to the chest wall or spine
  • People with connective tissue disease will not be included in the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Deniz

    Gaziosmanpaşa, Istanbul, 34255

Other trials in Turkey (Türkiye)

About this study

Official title: Are Pectus Deformities a Projection of Spinal Pathologies?The Relationship Between Pectus Deformities and Spinal Pathologies

Pectus deformities are common anterior chest wall pathologies. Pectus excavatum is the most common chest deformity with an incidence of 0.1-0.3%. Although the incidence of adolescent idiopathic scoliosis (AIS) is 0.2-3% in the community, some studies show that this rate rises to 17.61-25.58% when it is associated with pectus deformity. While the pectus excavatum rotates the heart to the left with its ribs and cartilages, it pushes the thoracic vertebra to the right side with the internal counterforce created by the heart, which has been shown to push the spine to the right with an asymmetric horizontal force in scoliosis patients with pectus deformity.

Based on this, in study, investigators aimed to determine whether there is any relationship between pectus deformities and spinal pathologies, and if there is a relationship, with which pathology it is most common, whether the type of scoliosis seen in pectus deformities with a prominent scoliosis prevalence is a pectus-specific curve, and whether this curve seen in scoliosis is associated with pectus. To determine whether there is a footprint or not.

Read the detailed description

The study was planned as a prospective cross-sectional study. Pectus study forms consisting of clinical and radiological measurements of the patients aged 3-18 years who applied to the outpatient clinic with chest deformity will be filled in in detail, and the Adams test (forward bending test) (+) will be measured by Bunnell scoliometer (scoliosis assessment tool) and ATR (angle of trunk rotation- trunk rotation) measurements. If ATR measurement is above 7 degrees on Bunnell scoliometer, patients who meet the inclusion criteria will be included in the study by filling in the informed consent form and a scoliosis radiograph will be requested (Independent of investigators' study, it is necessary to withdraw it in line with the 2016 recommendations of the International Scientific Society for Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT).)

Coronal, sagittal balance, coronal and sagittal cobb angles will be measured from the scoliosis radiograph taken from the Posterior-Anterior (PA) (posterior-anterior) and lateral (side) films. Their relationship with chest deformities will be evaluated. All measurements will be made and recorded by two independent investigators As a result of the analysis, when the power is targeted as 95% and the error amount as 0.05, the minimum sample size required for investigators to find a significant difference between the means was determined as 36. Investigators formed a sample group of 40 people for our study, together with the fact that groups of 36 people were sufficient in terms of providing 95% power. Kappa statistical analysis will be used to determine intraobserver and interobserver variations.

Being tested
Pectus Study Form, Adams Test, Scoliosis Graphy, Pulmonary function test
Keywords
Pectus Excavatum, Pectus Carinatum, Scoliosis, Kyphosis, Lordosis
Medical subject headings
Funnel Chest, Pectus Carinatum, Scoliosis, Kyphosis, Lordosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pectus Study FormDiagnostic test

    Pectus study forms consisting of clinical and radiological measurements of patients aged 3-18 years who applied to the outpatient clinic with chest deformity will be filled in in detail.

    In addition, this study form includes 'Quality of Life Evaluation Form in Pectus Deformity', 'Social Comparison Scale', 'Sleep Disorder Scale for Children', 'Anxiety Disorders Screening Scale in Children', 'Pediatric Quality of Life Questionnaire' designed for patients and their relatives. PedsQL)', 'SRS-22 Patient Questionnaire', 'Beck Anxiety Scale' and 'Informed Consent Form' designed for patients and their relatives.

  • Adams TestDiagnostic test

    Also called Forward Bending Test

    Adams test (forward bending test) (+) was measured by Bunnell scoliometer (scoliosis assessment tool) and ATR (angle of trunk rotation angle) values were 7 degrees in patients who meet the inclusion criteria will be included in the study by filling out an informed consent form

  • Scoliosis GraphyDiagnostic test

    Also called Orthoroentgenogram

    ATR (angle of trunk rotation) values above 7 degrees on bunnell scoliometer were determined. Afterwards, patients who meet the inclusion criteria will be included in the study by filling out an informed consent form and a scoliosis graphy will be requested.

    Coronal, sagittal balance; coronal and sagittal cobb angles will be measured from posterior-anterior (PA) (posterior-anterior) and lateral (lateral) scoliosis radiographs.

  • Pulmonary function testDiagnostic test

    Also called Spirometry Function Test

    Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. This information can help your healthcare provider diagnose and decide the treatment of certain lung disorders.

    There are 2 types of disorders that cause problems with air moving in and out of the lungs:

    Obstructive. This is when air has trouble flowing out of the lungs due to airway resistance. This causes a decreased flow of air.

    Restrictive. This is when the lung tissue and/or chest muscles can't expand enough. This creates problems with air flow, mostly due to lower lung volumes.

Study groups in NCT06009601
Study groupRoleWhat they receive
Patients aged 3-18 years who were diagnosed with pectus deformityPectus study forms consisting of clinical and radiological measurements of patients aged 3-18 years who applied to the outpatient clinic with chest deformity will be filled in in detail.
Receives: Diagnostic Test: Pectus Study Form; Diagnostic Test: Adams Test; Diagnostic Test: Scoliosis Graphy; Diagnostic Test: Pulmonary function test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pectus Study Form

    In the Pectus Study Form, the clinical and radiological data of the patient will be evaluated. Coronal, sagittal balance and coronal and sagittal cobb angles of the patient will be measured in the scoliosis X-ray.

    Measured: Within 1 week of applying to the scoliosis outpatient clinic

  2. Pulmonary Function Test (PFT)

    Pulmonary function test measurements will be made for people with pectus deformity.Pulmonary function tests, or PFTs, measure how well the lungs work. For some of the test measurements, the client can breathe normally and quietly. Other tests require forced inhalation or exhalation after a deep breath. Sometimes, they will be asked to inhale a different gas or a medicine to see how it changes test results.

    Measured: Within 1 week of applying to the scoliosis outpatient clinic

  3. Body Aesthetic Clinical Evaluation (TRACE)

    Body Aesthetic Clinical Evaluation (TRACE) measurement will be performed.TRACE is a 12-point scale based on four sub-scales, shoulders (0-3), scapulae (0-2), hemi-thorax (0-2) and waist (0-4)

    Measured: Within 1 week of applying to the scoliosis outpatient clinic

Secondary outcomes (7)

  1. Quality of Life Evaluation Form in Pectus Deformity

    This questionnaire, a self-assessment one, will assist clinicians who wish to assess body image and quality of life of patients with Pectus deformity. The PEEQ is a questionnaire used to assess the disease-specific quality of life of patients with PE and their parents. The questionnaire contains 12 items and the parent form contains 13 items. Each item receives a score between 1 and 4, with higher scores indicating a better quality of life. The questionnaire has subscales that indicate psychosocial and physical quality of life for both children and parents. The questions from 1 to 9 in the child form ask about psycho-social quality of life, while the questions 10-12 ask about physical quality of life. In the parents form, the questions from 1 to 8 ask about psychosocial quality of life, while the questions from 9 to13 ask about physical quality of life.

    Measured: Within 1 week of applying to the scoliosis outpatient clinic

  2. Social Comparison Scale

    This scale was developed by Allan and Gilbert (1995) to measure self-perceptions of social rank and relative social standing. This scale uses a semantic differential methodology and consists of 11 bipolar constructs. Participants are required to make a global comparison of themselves in relation to other people and to rate themselves along a ten-point scale. For example' the scale asks:

    In relationship to others I feel: Incompetent ->1 2 3 4 5 6 7 8 9 10 <- More competent The 11-items cover judgments concerned with rank' attractiveness and how well the person thinks they 'fit in' with others in society. Low scores point to feelings of inferiority and general low rank self-perceptions.

    Measured: Within 1 week of applying to the scoliosis outpatient clinic

  3. Sleep Disorder Scale for Children

    Sleep Disorder Scale for Children (SDSC) was designed both to evaluate specific sleep disorders in children, and to provide an overall measure of sleep disturbance suitable for use in clinical screening and research. Using factor analysis, developers Bruni and colleagues divided items into six categories representing some of the most common sleep diffi culties affecting adolescents and children: disorders of initiating and maintaining sleep, sleep breathing disorders, disorders of arousal/nightmares, sleep-wake transition disorders, disorders of excessive somnolence, and sleep hyperhidrosis (nighttime sweating).

    Measured: Within 1 week of applying to the scoliosis outpatient clinic

  4. Anxiety Disorders Screening Scale in Children

    Anxiety Disorders Screening Scale in Children (SCARED) is a child self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder and social phobia. The SCARED consists of 41 items and 5 factors that parallel the DSM-IV classification of anxiety disorders.The Screen for Child Anxiety Related Emotional Disorders (SCARED) assesses a range of DSM-IV based anxiety symptomatology. More specifically, it taps symptoms of panic disorder (13 items), generalised anxiety disorder (9 items), social phobia (9 items), separation anxiety disorder (12 items), obsessive-compulsive disorder (9 items), post-traumatic stress disorder (4 items), and specific phobia (15 items). The SCARED-71 consists of 71 items rated on a three-point scale (0 = almost never, 1 = sometimes, 2 = often). The minimum score that could be obtained is 0 and the maximum score that could be obtained is 142.

    Measured: Within 1 week of applying to the scoliosis outpatient clinic

  5. The Pediatric Quality of Life Inventory

    The Pediatric Quality of Life Inventory (PedsQL) is a 23-item generic health status instrument with parent and child forms that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents ages 2 to 18. Each item of the instrument is scored on a 5-point scale from 0- 4 for ages 8-18, (0 = never a problem, 1 = almost never a problem, 2 = sometimes a problem, 3 = often a problem, 4 = almost always a problem) ad 3-point scale for young child self reporting (ages 5- 7) as following (0 = not at all a problem, 2 = sometimes a problem, 4 = a lot of a problem) the large score means worst symptoms , scores are linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) in which high score means better condition

    Measured: Within 1 week of applying to the scoliosis outpatient clinic

  6. Scoliosis Research Society Score

    The SRS-22r is a validated questionnaire intended to assess outcomes in patients with idiopathic scoliosis after spinal surgery. The first version, developed by the Scoliosis Research Society in 1999, had 24 items, and this was reduced to 22 items (accompanied by a name change) in the course of 3 major updates.The SRS-22 contains 22 questions covering 5 domains: function/activity 5 items; pain 5 items; self-perceived image 5 items; mental health 5 items; and satisfaction with treatment 2 items. Each item is scored from 1 (worst) to 5 (best). Each domain has a total sum score ranging from 5 to 25, except for satisfaction, which ranges from 2 to 10. The sum of the first 4 domains gives a maximum subtotal of 100, and when the satisfaction domain is included, the maximum total is 110

    Measured: Within 1 week of applying to the scoliosis outpatient clinic

  7. Beck Anxiety Scale

    The Beck Anxiety Inventory (BAI), created by Aaron T. Beck and other colleagues, is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in adolescents and adults ages 17 and older.The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are:0-7: Minimal, 8-15: Mild, 16-25: Moderate,and 26-63: Severe

    Measured: Within 1 week of applying to the scoliosis outpatient clinic

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2023
  2. Study start9 Mar 2023
  3. Primary completion9 Apr 2023
  4. Study completion28 Apr 2023

Resources

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
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06009601
Sponsor's protocol ID
397
Status last verified
Jun 2023
First submitted
11 Jan 2023
Last updated
24 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data that support the findings of this study will be available on request from the corresponding author (EG). The data will not be publicly available due to their containing information that could compromise the privacy of research participants.

Publications

  • Zhong W, Ye J, Feng J, Geng L, Lu G, Liu J, Zhang C. Effects of Pectus Excavatum on the Spine of Pectus Excavatum Patients with Scoliosis. J Healthc Eng. 2017;2017:5048625. doi: 10.1155/2017/5048625. Epub 2017 Jul 3.

    PubMed 29065615

  • Tomaszewski R, Wiktor L, Machala L. Evaluation of thoracic vertebrae rotation in patients with pectus excavatum. Acta Orthop Traumatol Turc. 2017 Jul;51(4):284-289. doi: 10.1016/j.aott.2017.03.005. Epub 2017 Jun 16.

    PubMed 28624480

  • Tauchi R, Kawakami N, Tsuji T, Ohara T, Suzuki Y, Saito T, Nohara A. Evaluation of thoracic factors after scoliosis surgery in patients with both scoliosis and pectus excavatum. Eur Spine J. 2018 Feb;27(2):381-387. doi: 10.1007/s00586-016-4753-4. Epub 2016 Aug 27.

    PubMed 27568387

  • Alaca N, Yuksel M. Comparison of physical functions and psychosocial conditions between adolescents with pectus excavatum, pectus carinatum and healthy controls. Pediatr Surg Int. 2021 Jun;37(6):765-775. doi: 10.1007/s00383-021-04857-7. Epub 2021 Jan 16.

    PubMed 33454849

  • Iscan M, Kilic B, Turna A, Kaynak MK. The effect of minimally invasive pectus excavatum repair on thoracic scoliosis. Eur J Cardiothorac Surg. 2020 Oct 30:ezaa328. doi: 10.1093/ejcts/ezaa328. Online ahead of print.

    PubMed 33123728

  • Tauchi R, Suzuki Y, Tsuji T, Ohara T, Saito T, Nohara A, Morishita K, Yamauchi I, Kawakami N. Clinical Characteristics and Thoracic factors in patients with Idiopathic and Syndromic Scoliosis Associated with Pectus Excavatum. Spine Surg Relat Res. 2018 Jan 27;2(1):37-41. doi: 10.22603/ssrr.2017-0027. eCollection 2018.

    PubMed 31440644

  • van Es LJM, van Royen BJ, Oomen MWN. Clinical significance of concomitant pectus deformity and adolescent idiopathic scoliosis: systematic review with best evidence synthesis. N Am Spine Soc J. 2022 Jun 25;11:100140. doi: 10.1016/j.xnsj.2022.100140. eCollection 2022 Sep.

    PubMed 35814492

  • Alaca N, Cagri Aslan D, Alaca I, Yuksel M. The psychometric properties of the Turkish version of the pectus carinatum body image quality of life questionnaire. Pediatr Surg Int. 2022 Jun;38(6):833-842. doi: 10.1007/s00383-022-05119-w. Epub 2022 Apr 7.

    PubMed 35389073

Questions about this trial

What is this clinical trial studying?

An observational study of Pectus Deformity of Chest and Spinal Deformity, run by Gaziosmanpasa Research and Education Hospital 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 2 inclusion and 7 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 24 Aug 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?

Pectus Study Form (time frame: Within 1 week of applying to the scoliosis outpatient clinic). The study lists 3 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 NCT06009601, which also lists 8 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 24 Aug 2023.

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