Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05703737
Status:
COMPLETED
Last Update Posted:
2023-10-02
First Post:
2023-01-13
Brief Title:
Respiratory Function and Respiratory Muscle Strength in Adolescent Idiopathic Scoliosis
Sponsor:
Halic University
Organization:
Halic University
Study Overview
Official Title:
Respiratory Function and Respiratory Muscle Strength in Adolescent Idiopathic Scoliosis
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 days 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 p005 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
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 days 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 p005 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
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 patients 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
The main treatment options for scoliosis are Known as observation orthosis and surgical intervention the choice of the most appropriate treatment depends on the patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None