ACtive Treatment for Idiopathic AdolescenT Scoliosis: a feasibility study

Completed

• Conditions: Adolescent idiopathic scoliosis (AIS); Musculoskeletal Diseases; Juvenile idiopathic scoliosis

• Registration Number: ISRCTN90480705
• Lead Sponsor: niversity of Warwick (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-25
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Participants will be 10-16 years of age with Adolescent Idiopathic Scoliosis, defined by a Cobb angle of between 10 - 50 degrees (measured radiographically)

Exclusion Criteria

1. Individuals who have had previous surgery or are on a waiting list for spinal surgery within the next 6 months
2. Individuals with non-idiopathic scoliosis, for example congenital malformations, syringomyelia, neurofibromatosis, spina bifida, polio and cerebral palsy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Assess the feasibility to progress to a full randomised controlled trial (RCT)<br>2. Calculation of the sample size for the RCT and an understanding of recruitment rates across centres<br>3. We anticipate that the primary outcome measures for a main RCT study will be the progression/stabilisation of curvature quantified by the Cobb angle and this will be measured in the pilot RCT

Secondary Outcome Measures

Name	Time	Method
1. Progression to surgery<br>2. Changes to brace-wearing status<br>3. Respiratory function<br>4. Quality of life<br>5. Resource use associated with the provision and consequence of the different treatment options<br><br>The questionnaires to be piloted include: <br>1. Scoliosis Research Society-22 questionnaire<br>2. Paediatric Outcomes Data Collection Instrument EQ-5D-Y<br>3. Health Utilities Index and SF-6D<br><br>The commissioning brief requests measures of exercise tolerance and respiratory function and we will investigate the most appropriate method of capturing these outcomes (an incremental walk test is likely to be the best candidate).