Respiratory Function and Respiratory Muscle Strength in Adolescent Idiopathic Scoliosis

September 29, 2023 updated by: Halic University

In this study, which aims to evaluate the respiratory functions and respiratory muscle strength of individuals with Adolescent Idiopathic Scoliosis (AIS), it is planned to investigate the relationship between the respiratory parameters obtained and the severity, type, location of the curvature, rotation angle and wearing brace.

The population of the study consists of individuals with AIS, and the sample consists of individuals with AIS followed in the Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Orthopedics and Traumatology Clinic. For this purpose, it was planned to include at least 60 individuals with AIS, aged 10 years and older, with at least 20 degrees of scoliotic curvature, who applied to the clinic for the first time or came for control.

Pulmonary Function Tests (PFT) will be applied to evaluate the respiratory functions of the participants involved, and intraoral pressure measurement (MIP, MEP) will be applied to evaluate the inspiratory and expiratory muscle strengths; The severity of the scoliotic curvature will be measured with the Cobb method on the same day's radiograph, and the axial rotation angle will be measured with the Scoliometer.

IBM Statistical Package for Social Sciences Version 24 statistical program will be used in the analysis of the data. Continuous variables will be given as mean ± standard deviation, qualitative variables as numbers and percentages.

Pearson Correlation analysis will be used for the relationship between the variables, Independent Samples t-test will be used for the comparison of independent groups, and statistical significance will be taken as p≤0.05 in all measurements.

It is thought that this planned study will contribute to studies evaluating the respiratory functions and respiratory muscle strength of individuals with AIS, which have been designed in different types and reported different results in the literature.

Evidence-based data obtained by determining the clinical parameters associated with these values are expected to guide clinicians in terms of being holistic in the treatment of individuals with scoliosis, and in which situations and for what purpose pulmonary rehabilitation approaches should be included.

Study Overview

Status

Completed

Conditions

Detailed Description

Scoliosis is a complex three-dimensional deformity characterized by a lateral deviation of the spine of at least 10 degrees in the coronal plane. Scoliosis, which develops due to many reasons, is called "Adolescent Idiopathic Scoliosis (AIS)" if it occurs in the period from the onset of puberty to the closure of the growth plates.

The main treatment options for scoliosis are; Known as observation, orthosis and surgical intervention, the choice of the most appropriate treatment depends on the patient's age, menarche status, location and size of the curvature, and risk of progression.

Scoliosis can cause a significant increase in respiratory workload by directly decreasing chest wall compliance and indirectly reducing lung compliance. Abnormal ventilation patterns, especially restrictive ventilatory disorders, are seen in individuals with AIS, especially in curves greater than 45°; Sagittal diameter of the thorax, total lung area and especially vertebral rotation at T8-T9 levels can affect respiratory functions. In a study, it was shown that patients with mild or moderate idiopathic scoliosis had significantly lower Forced Vital Capacity (FVC) values compared to healthy controls. On the other hand, in a recent study in which 30 individuals with scoliosis were included, FVC values were found to be low in only two cases, which was thought to be due to the fact that the curve intensities of the participants were mild (Cobb angle< 20ᴼ). In the literature, studies examining the relationship between location, type, angle of rotation, presence of brace and duration of use, apart from the severity of the curvature, and pulmonary functions in individuals with AIS are insufficient. Low FEV1 and FVC values were found in 19% of AIS patients who had pulmonary function test preoperatively, and individuals with high grade (Cobb angle > 70ᴼ) and wide main thoracic type curves were reported to be more affected. Although no significant results were obtained in the degree of axial rotation in the same study, it was observed that the rotation angles of the cases with low PFT parameters were higher. A different study reported that the size of the thoracic curve and the number of involved vertebrae were negatively correlated with pulmonary parameters in individuals with AIS, and that spirometric examination is necessary, especially in surgical planning. Although studies have shown that respiratory muscle strength of individuals with AIS is decreased compared to healthy controls, even with mild curvatures, the cause of muscle dysfunction is not known exactly and it is thought that several factors may affect muscle function (nutritional status, physical activity, systemic inflammation, etc.). In scoliosis, especially the distortion of the thorax, the placement of the diaphragm and intercostal muscles and affecting the force production can also reduce respiratory muscle strength. In a study, a weak correlation was found between the angular value of scoliosis and respiratory muscle strength in individuals with AIS, and it was reported that respiratory muscle strength may be associated with physical deconditioning. In individuals with a high progression rate and an indication for scoliosis surgery, decreased respiratory muscle strength before surgery may cause a serious increase in respiratory workload, causing the patient to be unable to extubat, and post-operative respiratory failure due to respiratory muscle weakness. Therefore, respiratory muscle strength and function levels are important in curves with a high progression rate and surgery is planned, and it is important to use methods that prevent and reduce respiratory muscle dysfunction.

In the literature, studies evaluating respiratory muscle strength and related parameters of individuals with AIS are very limited. In our study, it was aimed to measure the respiratory functions and respiratory muscle strength of individuals with AIS objectively and to investigate the relationship of these values with the severity of curvature, type, location, rotation angle and corset use. It is expected that the evidence-based data obtained will guide the treatment of individuals with scoliosis to be holistic and in which situations and for what purpose pulmonary rehabilitation approaches should be included.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Prof. Dr. Süleyman Yalçın City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Cases with Adolescent Idiopathic Scoliosis followed in a Prof. Dr. Suleyman Yalcin City Hospital (Secondary health institution)

Description

Inclusion Criteria:

  • Volunteer to participate in the study
  • 10 years and older
  • Having been diagnosed with Adolescent Idiopathic Scoliosis,
  • At least 20 degrees of scoliotic curvature in the coronal plane

Exclusion Criteria:

  • Individuals aged 9 and under, 20 years and over
  • Individuals with neuromuscular and congenital scoliosis
  • Individuals with pulmonary dysfunction due to a different pathology
  • Individuals with a history of surgery
  • Cases with mental retardation
  • Individuals who do not understand, cannot apply, and cannot cooperate with respiratory tests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1 (liter)
Time Frame: During the 3-month data collection process, pulmonary function measurements are made on the same day as the day the participants came to the hospital for examination or control.
This is the amount of air with pulmonary function test that the patient can force out of their lungs in one second.
During the 3-month data collection process, pulmonary function measurements are made on the same day as the day the participants came to the hospital for examination or control.
FEV1 (%-percentage)
Time Frame: During the 3-month data collection process, pulmonary function measurements are made on the same day as the day the participants came to the hospital for examination or control.
This is the percentage of air with pulmonary function test that the patient can force out of their lungs in one second.
During the 3-month data collection process, pulmonary function measurements are made on the same day as the day the participants came to the hospital for examination or control.
FVC (liter)
Time Frame: During the 3-month data collection process, pulmonary function measurements are made on the same day as the day the participants came to the hospital for examination or control.
This is the greatest total amount of air patient can forcefully breathe out after breathing in as deeply as possible.
During the 3-month data collection process, pulmonary function measurements are made on the same day as the day the participants came to the hospital for examination or control.
FVC (%-percentage)
Time Frame: During the 3-month data collection process, pulmonary function measurements are made on the same day as the day the participants came to the hospital for examination or control.
This is the percentage of total amount of air patient can forcefully breathe out after breathing in as deeply as possible.
During the 3-month data collection process, pulmonary function measurements are made on the same day as the day the participants came to the hospital for examination or control.
FEV1/FVC (percentage)
Time Frame: During the 3-month data collection process, pulmonary function measurements are made on the same day as the day the participants came to the hospital for examination or control.
The FEV1/FVC ratio is a number that represents the percentage of patient lung capacity patient is able to exhale in one second.
During the 3-month data collection process, pulmonary function measurements are made on the same day as the day the participants came to the hospital for examination or control.
Inspiratory muscle test
Time Frame: During the 3-month data collection process, intraoral pressure measurements are made on the same day as the day the participants came to the hospital for examination or control.
Maximal inspiratory pressure (MIP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).
During the 3-month data collection process, intraoral pressure measurements are made on the same day as the day the participants came to the hospital for examination or control.
Expiratory muscle test
Time Frame: During the 3-month data collection process, intraoral pressure measurements are made on the same day as the day the participants came to the hospital for examination or control.
Maximal expiratory pressure (MEP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).
During the 3-month data collection process, intraoral pressure measurements are made on the same day as the day the participants came to the hospital for examination or control.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cobb method
Time Frame: During the 3-month data collection process, Cobb measurements are made on the same day as the day the participants came to the hospital for examination or control.
It is the standard measurement method used in coronal grading of the angle of scoliotic curvature on anteroposterior radiography. On the graph, the angle between the lines drawn parallel to the upper vertebral edge of the curvature at the upper end and the lower edge of the vertebrae at the lower end gives the cobb angle (Morrissy et al, 1990; Pruijs JE et al, 1994). In order to prevent differences between measurements, measurements are made by the same researcher with the same equipment.
During the 3-month data collection process, Cobb measurements are made on the same day as the day the participants came to the hospital for examination or control.
Scoliometer
Time Frame: During the 3-month data collection process, axial trunk rotation measurements are made on the same day as the day the participants came to the hospital for examination or control.
It is a practical, noninvasive, valid and reliable measurement method used in the objective evaluation of axial trunk rotation. During scoliometer measurement, patients lean forward until their torso is parallel to the ground and hold their torso upright with their arms hanging down (Amendt et al, 1990; Coelho et al, 2013). In our study, the maximum trunk axial rotation value in the thoracic and lumbar regions is evaluated by the same investigator with the same Scoliometer (Orthopedic Systems Inc, Hayward, CA, USA).
During the 3-month data collection process, axial trunk rotation measurements are made on the same day as the day the participants came to the hospital for examination or control.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Halic University

Collaborators

Goztepe Prof Dr Suleyman Yalcın City Hospital

Investigators

  • Principal Investigator: İrem Çetinkaya, MSc, Halic University
  • Study Director: Tuğba Kuru Çolak, Phd, Marmara University
  • Study Chair: Mehmet Fatih Korkmaz, Phd, Istanbul Medeniyet University
  • Principal Investigator: Seda Saka, Phd, Halic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

January 15, 2023

Study Completion (Actual)

February 10, 2023

Study Registration Dates

First Submitted

January 13, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • karanki2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Adolescent Idiopathic Scoliosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe