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

H

Hacettepe University

Status

Completed

Conditions

Adolescent Idiopathic Scoliosis

Treatments

Other: Spinal mobilization
Other: Core stabilization exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT05765019
HacettepeUE

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

10 to 16 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Spinal mobilization group
Experimental group
Treatment:
Other: Core stabilization exercise
Other: Spinal mobilization
Core stabilization exercise group
Active Comparator group
Treatment:
Other: Core stabilization exercise

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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