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Efficacy of three-dimensionally integrated exercise for scoliosis in patients with adolescent idiopathic scoliosis: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Adolescent 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/DESIGN:The 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. DISCUSSION: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. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03427970 . Registered on February 9, 2018, and revised on July 24, 2018.

SUBMITTER: Liang J

PROVIDER: S-EPMC6131734 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Efficacy of three-dimensionally integrated exercise for scoliosis in patients with adolescent idiopathic scoliosis: study protocol for a randomized controlled trial.

Liang Juping J Zhou Xuan X Chen Nan N Li Xin X Yu Hong H Yang Yuqi Y Song Yuanyuan Y Du Qing Q

Trials 20180910 1

<h4>Background</h4>Adolescent 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.<h4>Methods/design</h4>The study is designed as a randomized controlled trial. Participants include 42 patients with AIS aged 10-16 years. Randomly assig ...[more]

PMID: 30201050

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Project description:ImportanceModerate-grade adolescent idiopathic scoliosis (AIS) may be treated with full-time bracing. For patients who reject full-time bracing, the effects of alternative, conservative interventions are unknown.ObjectiveTo determine whether self-mediated physical activity combined with either nighttime bracing (NB) or scoliosis-specific exercise (SSE) is superior to a control of physical activity alone (PA) in preventing Cobb angle progression in moderate-grade AIS.Design, setting, and participantsThe Conservative Treatment for Adolescent Idiopathic Scoliosis (CONTRAIS) randomized clinical trial was conducted from January 10, 2013, through October 23, 2018, in 6 public hospitals across Sweden. Male and female children and adolescents aged 9 to 17 years with an AIS primary curve Cobb angle of 25° to 40°, apex T7 or caudal, and skeletal immaturity based on estimated remaining growth of at least 1 year were included in the study. Dates of analysis were from October 25, 2021, to January 28, 2023.InterventionsInterventions included self-mediated physical activity in combination with either NB or SSE or PA (control). Patients with treatment failure were given the option to transition to a full-time brace until skeletal maturity.Main outcomes and measuresThe primary outcome was curve progression of 6° or less (treatment success) or curve progression of more than 6° (treatment failure) seen on 2 consecutive posteroanterior standing radiographs compared with the inclusion radiograph before skeletal maturity. A secondary outcome of curve progression was the number of patients undergoing surgery up until 2 years after the primary outcome.ResultsThe CONTRAIS study included 135 patients (45 in each of the 3 groups) with a mean (SD) age of 12.7 (1.4) years; 111 (82%) were female. Treatment success was seen in 34 of 45 patients (76%) in the NB group and in 24 of 45 patients (53%) in the PA group (odds ratio [OR], 2.7; 95% CI, 1.1-6.6). The number needed to treat to prevent curve progression with NB was 4.5 (95% CI, 2.4-33.5). Treatment success occurred in 26 of 45 patients (58%) in the SSE group (OR for SE vs PA, 1.2; 95% CI, 0.5-2.8). Up to 2 years after the primary outcome time point, 9 patients in each of the 3 groups underwent surgery.Conclusions and relevanceIn this randomized clinical trial, treatment with NB prevented curve progression of more than 6° to a significantly higher extent than did PA, while SSE did not; in addition, allowing transition to full-time bracing after treatment failure resulted in similar surgical frequencies independent of initial treatment. These results suggest that NB may be an effective alternative intervention in patients rejecting full-time bracing.Trial registrationClinicalTrials.gov Identifier: NCT01761305.

Project description:INTRODUCTION:Adolescent idiopathic scoliosis (AIS) affects up to 3% of children around the world. There is limited knowledge of AIS aetiopathogenesis, and this evidence is needed to develop new management strategies. Paraspinal muscle in AIS demonstrates evidence of differential fibrosis based on curve sidedness. Fibrosis is the hallmark of macrophage-driven inflammation and tissue remodelling, yet the mechanisms of fibrosis in paraspinal muscle in AIS are poorly understood. OBJECTIVES:The primary objective of this study is to determine the influence of curve sidedness on paraspinal muscle inflammation. Secondary objectives include defining the mechanisms of macrophage homing to muscle, and determining muscle-macrophage crosstalk in muscle fibrosis in AIS. METHODS AND ANALYSIS:This is a cross-sectional study conducted in a tertiary paediatric centre in Hamilton, Ontario, Canada. We will recruit boys and girls, 10-17?years of age, who are having surgery to correct AIS. We will exclude children who have an active infection or are on immunosuppressive therapies within 2?weeks of surgery, smokers and pregnant girls. Paraspinal muscle biopsies will be obtained at the start of surgery. Also, blood and urine samples will be collected from participants, who will fill questionnaires about their lifestyle. Anthropometric measures will also be collected including height, weight, waist and hip circumferences. ETHICS AND DISSEMINATION:This study has received ethics authorisation by the institutional review board. This work will be published in peer-reviewed journals and will be presented in oral and poster formats at scientific meetings. DISCUSSION:This study will explore the mechanisms of paraspinal muscle inflammation, remodelling and fibrosis in AIS. This will help identify pathways and molecules as potential therapeutic targets to treat and prevent AIS. It may also yield markers that predict scoliosis progression and response to treatment in these children.

Dataset Information

Efficacy of three-dimensionally integrated exercise for scoliosis in patients with adolescent idiopathic scoliosis: study protocol for a randomized controlled trial.

Publications

Efficacy of three-dimensionally integrated exercise for scoliosis in patients with adolescent idiopathic scoliosis: study protocol for a randomized controlled trial.

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