Clinical trial NCT06417944: The Effect of Three-dimensional Exercise (Schroth Exercise) on Diaphragm Thickness in Adolescent Idiopathic Scoliosis Patients
Official title: The Effect of Three-dimensional Exercise (Schroth Exercise) on Diaphragm Thickness in Adolescent Idiopathic Scoliosis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spine Deformity
Scoliosis
Scoliosis Idiopathic
Scoliosis; Adolescence
Diaphragm Issues
Keywords: Adolescent Idiopathic Scoliosis
Diaphragm Thickness
Three-dimensional Exercise (Schroth Exercise)
Ultrasonographic Measurement
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2024-05-16
Enrollment: 64
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Demographic information of all individuals included in the study will be collected. According to the Barcelona Scoliosis Physical Therapy School (BSPTS) Classification by Rigo and Weiss, the diaphragm thickness in patients diagnosed with scoliosis (type 3C and 4C) with thoracic curvature and in the control group was measured in the supine position with a 7-13 Mhz linear conventional ultrasound probe (brand) on the anterior axillary line. It will be measured at the end of inspiration and expiration from the intercostal space. Three measurements will be made on the right side and the arithmetic average will be evaluated. Follow-up measurement will be made by the same person, with the same device and with the same method in the 3rd month after the treatment.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Scoliosis study form
timeFrame: Within 2 week of applying to the scoliosis outpatient clinic
measure: Pulmonary function test
timeFrame: Within 2 weeks after applying to the scoliosis clinic (pre-exercise) and 3 months after exercise
measure: Ultrasonographic Diaphragm Thickness Measurement
timeFrame: Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise
Secondary outcomes:
measure: The Pediatric Quality of Life Inventory
timeFrame: Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise
measure: Scoliosis Research Society Score
timeFrame: Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Omer Faruk Alp
state: Gaziosmanpasa
Study officials:
affiliation: Maltepe District, Askeri Firin Street, Inistanbul buildins F1 Block Flat: 82 Zeytinburnu /ISTANBUL
name: Aynur Metin Terzibasioglu, MD,Chief Assistant
role: STUDY_CHAIR
affiliation: Gaziosmanpaşa Training and Research Hospital Physical Rehabilitation Department
name: Ebru Yilmaz Yalcinkaya, MD,Professor
role: STUDY_DIRECTOR
References:
citation: 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.
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.