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Completed

NCT Number: NCT05765019

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

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.

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Key information

Conditions

Adolescent Idiopathic Scoliosis

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal mobilization

Other

Spinal mobilization and core stabilization exercise

Core stabilization exercise

Other

Stabilization exercises for the spine

Primary outcomes

  1. Cobb angle

    Time frame: Change from pretreatment and 10 weeks after treatment.

    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 outcomes

  1. Angle of Trunk Rotation

    Time frame: Change from pretreatment and 10 weeks after treatment.

    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

  2. Pulmonary Functions Test- PEF (Peak expiratory flow)

    Time frame: Change from pretreatment and 10 weeks after treatment.

    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.

  3. Pulmonary Functions Test- FEV1 (Forced expiratory volume in the first second)

    Time frame: Change from pretreatment and 10 weeks after treatment.

    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

  4. Pulmonary Functions Test-FVC (Forced vital capacity)

    Time frame: Change from pretreatment and 10 weeks after treatment.

    Forced vital capacity, the maximum amount of air you can forcibly exhale from your lungs after fully inhaling.

  5. Pulmonary Functions Test- FEV1/FVC

    Time frame: Change from pretreatment and 10 weeks after treatment.

    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.

  6. Walter Reed Visual Assessment Scale

    Time frame: Change from pretreatment and 10 weeks after treatment.

    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.

  7. Scoliosis Research Society-22

    Time frame: Change from pretreatment and 10 weeks after treatment.

    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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 13, 2023
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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