The Effect of Three-dimensional Exercise (Schroth Exercise) on Diaphragm Thickness in Adolescent Idiopathic Scoliosis Patients

Scoliosis Clinical Trial

Official title:

The Effect of Three-dimensional Exercise (Schroth Exercise) on Diaphragm Thickness in Adolescent Idiopathic Scoliosis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06417944
• Other study ID #: 326
• Status: Recruiting
• Start date: May 14, 2024
• Est. completion date: October 30, 2024

Study information

• Verified date: April 2024
• Source: Gaziosmanpasa Research and Education Hospital
• Contact: Omer Faruk Alp, MD
• Phone: +90 541 785 10 26
• Email: ofalp3456[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Spinal deformity is common in childhood and adolescence, and can often present as scoliosis or increased thoracic kyphosis deformity with various etiologies.The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions.Any spinal deformity, especially one that affects the thoracic spine, can affect lung function.In the planned thesis study, investigators will measure the diaphragm thickness in adolescent idiopathic scoliosis patients with scoliosis deformities affecting the thoracic region, whether there is any relationship between the impact in the thoracic region and the diaphragm thickness, and the three-dimensional exercise (Schroth exercise-Barcelona Schroth therapy) applied in investigators' clinic for scoliosis, before and after the treatment of the diaphragm. Investigators aimed to show whether there is any change in thickness.

Description:

Spinal deformity is common in childhood and adolescence, and can often present as scoliosis or increased thoracic kyphosis deformity with various etiologies. Any spinal deformity, especially one that affects the thoracic spine, can affect lung function. If left untreated, the curves may distort over time as skeletal growth accelerates. In some patients, this can lead to restrictive or obstructive lung disease and, rarely, death as a result of cor pulmonale. The alignment of the skeletal system in the chest and its harmony with the compliance of the chest wall are related to respiratory function; Thoracic kyphosis and the resulting changes in the rib cage lead to a decrease in lung capacity. The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions. In recent years, ultrasonography (USG) has gained increasing utility for visualizing the diaphragm and assessing its function, with several advantages. In the planned thesis study, investigators will measure the diaphragm thickness in adolescent idiopathic scoliosis patients with scoliosis deformities affecting the thoracic region, whether there is any relationship between the impact in the thoracic region and the diaphragm thickness, and the three-dimensional exercise (Schroth exercise-Barcelona Schroth therapy) applied in investigators' clinic for scoliosis, before and after the treatment of the diaphragm. Investigators aimed to show whether there is any change in thickness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 30, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• Having scoliosis affecting the thoracic region according to BSPTS (type 3C, type 4C and its subtypes)
• Being between the ages of 10-18
• Being able to perform a respiratory function test
• Having the mental capacity to answer surveys

Exclusion Criteria:

• Congenital spinal, costal and diaphragmatic anomalies
• Neuromuscular disease
• Respiratory system diseases that affect lung functions
• Patients who cannot cooperate with spirometry.
• Having surgery to the chest wall or spine

Related Conditions & MeSH terms

• Diaphragm Issues
• Scoliosis
• Scoliosis Idiopathic
• Scoliosis; Adolescence
• Spine Deformity

Intervention

Diagnostic Test:
• Scoliosis study form
Scoliosis study form consisting of clinical and radiological measurements of patients aged 10-18 years who applied to the outpatient clinic with spine deformity will be filled in detail.
• Scoliosis X-ray (orthorontgenogram)
Patients whose Adam's forward bending test and clinical evaluation results are compatible with scoliosis, scoliosis graphy are requested. (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.).Coronal, sagittal balance; coronal and sagittal Cobb angles will be measured from posterior-anterior (PA) and lateral scoliosis radiographs.
• Pulmonary 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. We will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second)(L), FEV1 (%predicted), FVC (Forced Vital Capacity) (L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken.
• Ultrasonographic Measurement
Diaphragm thickness will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. End-expiratory (Forced residual capacity-FRC) (centimeter- cm), end-inspiratory (Total Lung Capacity) (centimeter-cm) and thickening rate (%) (thickness TLC / thickness FRC) will be evaluated three times and the arithmetic average of these three measurements will be taken.

Procedure:
• Three-dimensional Exercise (BSPTS Schroth Exercise)
It only provides outpatient treatment, but it has different practices, intensive or regular, depending on local and external patients. For local patients, it is applied once a week, accompanied by a therapist, and the treatment duration is determined according to the patient's condition. In patients coming from outside; It can be continued as 2 hours a day for 10 days, then as additional treatment for 1-2 weeks for 3-6 months depending on the patient's condition. I In regular treatment; 30 sessions of 90 minutes group treatment, the first 8 sessions are carried out under the supervision of a therapist for a shorter period of time. We will give 10 sessions of BSPTS Schroth exercises, either outpatient or inpatient. After 10 sessions of the Schroth exercise program, the home program will continue two months after outpatient/inpatient schroth exercise(Home program: 5 days/week, 45-60 minutes for all patients).
• Home Exercise
In the home exercise program; daily living activities, neutral pelvis exercises, coronal balance exercises, rotational angular breathing exercises and axial elongation exercises were taught by the physiotherapist in one session. A total of 10-week home exercise program was planned, with exercises to be performed twice a week for the first two weeks, once every 15 days for 1 month (twice in one month), and then once a month.

Locations

Country	Name	City	State
Turkey	Omer Faruk Alp	Istanbul	Gaziosmanpasa

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Jagger F, Tsirikos AI, Blacklock S, Urquhart DS. Adaptation to reduced lung function in children and young people with spinal deformity. J Clin Orthop Trauma. 2020 Mar-Apr;11(2):191-195. doi: 10.1016/j.jcot.2019.12.013. Epub 2020 Jan 3. — View Citation

Karaali E, Ciloglu O, Gorgulu FF, Ekiz T. Ultrasonographic measurement of diaphragm thickness in patients with severe thoracic scoliosis. J Ultrasound. 2021 Mar;24(1):75-79. doi: 10.1007/s40477-020-00536-w. Epub 2021 Feb 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scoliosis study form	Scoliosis study form consisting of clinical and radiological measurements of patients aged 10-18 years who applied to the outpatient clinic with spine deformity will be filled in detail.	Within 2 week of applying to the scoliosis outpatient clinic
Primary	Pulmonary function test	We will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second) (Liter-L), FEV1 (%predicted), FVC (Forced Vital Capacity) (Liter-L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken.	Within 2 weeks after applying to the scoliosis clinic (pre-exercise) and 3 months after exercise
Primary	Ultrasonographic Diaphragm Thickness Measurement	Diaphragm thickness (millimeter-mm) will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. Diaphragm thickness of End-expiratory (Forced residual capacity-FRC) (millimeter-mm), diaphragm thickness of end-inspiratory (Total Lung Capacity) (millimeter-mm) and thickening rate (%) (thickness TLC / thickness FRC) will be evaluated three times and the arithmetic average of these three measurements will be taken.	Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise
Secondary	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	Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise
Secondary	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	Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise