Abstract

BackgroundAdolescent idiopathic scoliosis (AIS) is one of the most prevalent spinal deformities that may progress sharply during growth. The aim of this study will be to evaluate the efficacy of three-dimensionally integrated exercise on the Cobb angle, angle of trunk rotation, sagittal profile, and quality of life in patients with AIS.Methods/designThe study is designed as a randomized controlled trial. Participants include 42 patients with AIS aged 10–16 years. Randomly assigned patients will follow a 6-month treatment, either in a control group with standard care of observation following the Scoliosis Research Society criteria or in an experimental group with three-dimensionally integrated exercise for scoliosis. Blinded assessments at baseline and immediately after intervention will include the change of Cobb angle, angle of trunk rotation, sagittal index, and quality of life.DiscussionIf we find that the intervention is effective in improving Cobb angle, angle of trunk rotation, sagittal profile, and quality of life in patients with AIS, this trial will have a positive impact and warrant a change in clinical practice.Trial registrationClinicalTrials.gov, NCT03427970. Registered on February 9, 2018, and revised on July 24, 2018.

Highlights

  • Adolescent idiopathic scoliosis (AIS) is one of the most prevalent spinal deformities that may progress sharply during growth

  • If we find that the intervention is effective in improving Cobb angle, angle of trunk rotation, sagittal profile, and quality of life in patients with AIS, this trial will have a positive impact and warrant a change in clinical practice

  • Better-quality research needs to be conducted before the use of three-dimensionally integrated exercise for scoliosis can be recommended in clinical practice. The objective of this trial is to determine the effect of intervention on the Cobb angle, angle of trunk rotation (ATR), sagittal profile, and quality of life compared with standard care for patients with AIS

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Summary

Discussion

This study protocol describes an RCT that is designed to evaluate the efficacy of three-dimensionally integrated exercise on scoliosis measured as Cobb angle, the ATR in degrees, sagittal profile, and quality of life in patients with mild AIS. The patients and intervention team are not blinded, because the intervention team needs to carry out the detailed treatment plan with the patients, and the patients in each group know their treatment plan. There are separate rooms for assessment and treatment to avoid having other patients know about the treatment. The control group only needs to perform the assessment at the baseline and after the 6-month intervention, so they will have less time to communicate with the other patients. There is still no intervention to cure AIS [1, 8] The results of this RCT will provide valuable information for the family, patient, clinicians, and clinical decision makers, as well as to administrative stakeholders, and they may play an important role in providing healthcare services

Background
Methods/design
Participants Inclusion criteria
Previous surgical history involving the spine or lower extremities
Not applicable 5 4 5–10
Strengths and limitations
Findings
Limitations
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