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Investigation of the Efficiency of Spinal Mobilization in Patients With Adolescent Idiopathic Scoliosis

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Spinal mobilization
Core stabilization exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Adolescent idiopathic scoliosis, Core stabilization exercises, Spinal mobilization, Manual therapy, Pulmonary function

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spinal mobilization group

Core stabilization exercise group

Arm Description

Outcomes

Primary Outcome Measures

Cobb angle
The most accepted way of scoliosis evaluation is Cobb angle measurement performed on frontal plane x-ray. The Cobb angle is the curvature of the spine, and measuring it is essential for determining the severity of scoliosis, selecting the best course of action, and monitoring the progression or regression of cases following treatment. The Cobb angle measure as the vertically intersecting angle after determining the vertebrae above the apex and below the apex, which are the most tilted from the concave side of the curvature of the spine.

Secondary Outcome Measures

Angle of Trunk Rotation
It assessed with a Bunnell scoliometer is a type of inclinometer that measures the asymmetry of the degree of axial rotation on both sides of the body. Assessment is in a standing, forward-bending position bent-over position (arms dangling, palms pressed together) with the pelvis horizontal, and subject standing on a foot template
Pulmonary Functions Test- PEF (Peak expiratory flow)
Peak expiratory flow (PEF) is the volume of air forcefully expelled from the lungs in one quick exhalation, and is a reliable indicator of ventilation adequacy as well as airflow obstruction.
Pulmonary Functions Test- FEV1 (Forced expiratory volume in the first second)
The forced expiratory volume in 1 second (FEV1) is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration
Pulmonary Functions Test-FVC (Forced vital capacity)
Forced vital capacity, the maximum amount of air you can forcibly exhale from your lungs after fully inhaling.
Pulmonary Functions Test- FEV1/FVC
The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs.
Walter Reed Visual Assessment Scale
It was designed to measure physical deformity as perceived by patients with idiopathic scoliosis. The scale assesses seven aspects of the deformity: spinal curvature, rib prominence, flank prominence, deformity/alignment of the thorax with respect to the pelvis, trunk imbalance, shoulder asymmetry and scapular asymmetry. Scores for each catagory range from 1 (no deformity) to 5 (the worst deformity), and the total score is generated from the sum of the scores from the seven domains.
Scoliosis Research Society-22
Scale is a simple and practical quality of life questionnaire specially created for individuals with scoliosis. SRS includes parameters such as pain, self-image/appearance, function/activity, mental health, and satisfaction with treatment. It is also stated that it is effective in evaluating the changes that occur with treatment. The questionnaire has a total of 22 items that are scored from 1 (worst) to 5 (best) for each item.

Full Information

First Posted
February 19, 2023
Last Updated
March 10, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05765019
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 5, 2022 (Actual)
Primary Completion Date
February 5, 2023 (Actual)
Study Completion Date
February 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
Adolescent idiopathic scoliosis, Core stabilization exercises, Spinal mobilization, Manual therapy, Pulmonary function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal mobilization group
Arm Type
Experimental
Arm Title
Core stabilization exercise group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Spinal mobilization
Intervention Description
Spinal mobilization and core stabilization exercise
Intervention Type
Other
Intervention Name(s)
Core stabilization exercise
Intervention Description
Stabilization exercises for the spine
Primary Outcome Measure Information:
Title
Cobb angle
Description
The most accepted way of scoliosis evaluation is Cobb angle measurement performed on frontal plane x-ray. The Cobb angle is the curvature of the spine, and measuring it is essential for determining the severity of scoliosis, selecting the best course of action, and monitoring the progression or regression of cases following treatment. The Cobb angle measure as the vertically intersecting angle after determining the vertebrae above the apex and below the apex, which are the most tilted from the concave side of the curvature of the spine.
Time Frame
Change from pretreatment and 10 weeks after treatment.
Secondary Outcome Measure Information:
Title
Angle of Trunk Rotation
Description
It assessed with a Bunnell scoliometer is a type of inclinometer that measures the asymmetry of the degree of axial rotation on both sides of the body. Assessment is in a standing, forward-bending position bent-over position (arms dangling, palms pressed together) with the pelvis horizontal, and subject standing on a foot template
Time Frame
Change from pretreatment and 10 weeks after treatment.
Title
Pulmonary Functions Test- PEF (Peak expiratory flow)
Description
Peak expiratory flow (PEF) is the volume of air forcefully expelled from the lungs in one quick exhalation, and is a reliable indicator of ventilation adequacy as well as airflow obstruction.
Time Frame
Change from pretreatment and 10 weeks after treatment.
Title
Pulmonary Functions Test- FEV1 (Forced expiratory volume in the first second)
Description
The forced expiratory volume in 1 second (FEV1) is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration
Time Frame
Change from pretreatment and 10 weeks after treatment.
Title
Pulmonary Functions Test-FVC (Forced vital capacity)
Description
Forced vital capacity, the maximum amount of air you can forcibly exhale from your lungs after fully inhaling.
Time Frame
Change from pretreatment and 10 weeks after treatment.
Title
Pulmonary Functions Test- FEV1/FVC
Description
The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs.
Time Frame
Change from pretreatment and 10 weeks after treatment.
Title
Walter Reed Visual Assessment Scale
Description
It was designed to measure physical deformity as perceived by patients with idiopathic scoliosis. The scale assesses seven aspects of the deformity: spinal curvature, rib prominence, flank prominence, deformity/alignment of the thorax with respect to the pelvis, trunk imbalance, shoulder asymmetry and scapular asymmetry. Scores for each catagory range from 1 (no deformity) to 5 (the worst deformity), and the total score is generated from the sum of the scores from the seven domains.
Time Frame
Change from pretreatment and 10 weeks after treatment.
Title
Scoliosis Research Society-22
Description
Scale is a simple and practical quality of life questionnaire specially created for individuals with scoliosis. SRS includes parameters such as pain, self-image/appearance, function/activity, mental health, and satisfaction with treatment. It is also stated that it is effective in evaluating the changes that occur with treatment. The questionnaire has a total of 22 items that are scored from 1 (worst) to 5 (best) for each item.
Time Frame
Change from pretreatment and 10 weeks after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06000
Country
Turkey

12. IPD Sharing Statement

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Investigation of the Efficiency of Spinal Mobilization in Patients With Adolescent Idiopathic Scoliosis

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