Clinical trial NCT05765019: Investigation of the Efficiency of Spinal Mobilization in Patients With Adolescent Idiopathic Scoliosis
Official title: Investigation of the Efficiency of Spinal Mobilization in Patients With Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Adolescent idiopathic scoliosis
Core stabilization exercises
Spinal mobilization
Manual therapy
Pulmonary function
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, it was aimed to evaluate the effect of spinal mobilization techniques applied in addition to core stabilization exercises in Adolescent Idiopathic Scoliosis (AIS) patients.

Consecutive adolescents with idiopathic scoliosis, aged 10 to 16 years, without a brace, and with a Cobb curvature of 10 to 25 degrees were randomly divided into two groups using the closed envelope method: Spinal mobilization and core stabilization exercise were applied to the experimental group; Only core stabilization exercises were applied to the control group.

Both groups received interventions twice a week for 10 weeks. Outcome measurements were made before treatment and after 10 weeks of treatment.

Detailed description: This study was a randomized controlled trial in which participants and assessor were blinded. This study was carried out in Amasya University Ruhi Tingiz Physical Therapy and Rehabilitation Hospital Rehabilitation Unit between August 2022 and January 2023. Ethics committee approval was obtained from Amasya University (E-76988455-050.01.04-83314) on 05.08.2022 to conduct the study. Before the study, face-to-face interviews were conducted with the all participants and parents and informed about the subject and purpose of the study. Verbal and written consent was obtained from the all participants and parents.

Sample size: The sample of the study was calculated with the G\*Power 3.1 program, and the effect size (d=1.0) was calculated according to the double-tailed hypothesis method, taking into account the study. (d=1.0; α=0.05; 1-ß=0.80). Confidence interval was determined as 80% and margin of error was 5% (α=0.05). As a result of the calculation, it was determined that there should be 17 adolescent scoliosis patients for the control group, 17 for the experimental group, and a total of 34 adolescent scoliosis patients. Considering the possible data losses of the participants, we planned to include a total of 40 participants, 20 in both groups.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with AIS
* Age 10-16 years
* Cobb angle was between 10° and 25
* Risser sing did not exceed 4
* Informed consent forms were signed by the parents and children

Exclusion Criteria:

* Used brace,
* Had previous spinal surgery, inferior limb length difference,
* Could not exercise due to another injury/diagnosis,
* Had neuromuscular, psychiatric, cardiovascular, respiratory insufficiency and mental disability

Primary outcomes:
measure: Cobb angle
timeFrame: Change from pretreatment and 10 weeks after treatment.
Secondary outcomes:
measure: Angle of Trunk Rotation
timeFrame: Change from pretreatment and 10 weeks after treatment.
measure: Pulmonary Functions Test- PEF (Peak expiratory flow)
timeFrame: Change from pretreatment and 10 weeks after treatment.
measure: Pulmonary Functions Test- FEV1 (Forced expiratory volume in the first second)
timeFrame: Change from pretreatment and 10 weeks after treatment.
measure: Pulmonary Functions Test-FVC (Forced vital capacity)
timeFrame: Change from pretreatment and 10 weeks after treatment.
measure: Pulmonary Functions Test- FEV1/FVC
timeFrame: Change from pretreatment and 10 weeks after treatment.
measure: Walter Reed Visual Assessment Scale
timeFrame: Change from pretreatment and 10 weeks after treatment.
measure: Scoliosis Research Society-22
timeFrame: Change from pretreatment and 10 weeks after treatment.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References: