Pilot Study for a Randomized Controlled Clinical Trial on the Effect of Global Postural Re-education in the Treatment of Idiopathic Scoliosis: a Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Cobb angle
Study Overview
Brief Summary
In North America, children and adolescents with idiopathic scoliosis (IS) are rarely referred for a rehabilitation program whereas the European guidelines stated that scientific evidences concerning scoliosis specific physiotherapy exercises were strong enough to recommend the use of these exercises at an early stage. The objectives of this pilot study is to assess feasibility of conducting a larger randomized control trial (RCT) on the effect of global postural re-education (GPR) on scoliosis progression (Cobb angle) and posture, back pain and participation and to assess the equivalence of two groups of GPR interventions. A convenience sample of 60 adolescents with IS (Cobb angle 15º-50º, Risser sign ≤3) will be recruited at CHU Sainte-Justine. Participants will be randomly allocated to GPR-A (individual sessions once a week) or GPR-B (individual sessions once per two weeks alternately with class exercises once per two weeks) for 6 months. After 6 months, groups will be interchanged for another 6 months. Feasibility outcomes will be recruitment rate, consent rate, completion rate and adherence to treatment at 12 months. The primary outcome of the effect of GPR will be the Cobb angle. Secondary outcomes will be: posture, back pain and participation at 6 and 12 months. Statistical analyses: For feasibility, percentage of eligible patients recruited, percentage of recruited patients who completed the trial and adherence to treatment will be calculated. For the preliminary effects of GPR, linear mixed-models will be used to assess differences in groups' changes from baseline, to 6 and 12-month while adjusting for covariates (age, Risser, adherence). Separate analyses will be conducted for each outcome.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •aged between 8 and 16 years old,
- •Cobb angle between 15º and 50º,
- •a Risser sign ≤3 (skeletal growth incomplete),
- •having recent x-rays (4-6 weeks),
- •ability to travel weekly to attend GPR interventions
Exclusion Criteria
- •patients who are planning surgery or have had surgery,
- •previous regular physiotherapy or other conservative treatment (chiro, osteopathy),
- •worn a brace for at least three months prior to GPR interventions,
- •scheduled for clinic follow-up later than in 6±2 months,
- •or to be discharged before 12 months.
Arms & Interventions
GPR-A
The 6-months supervised GPR-A group will receive a 1-hour-long individual session once a week plus a home program (1 or 2 exercises, 2 times a week).
Intervention: GPR-A (Other)
GPR-B
The 6-months supervised GPR-B group will receive a 1-hour long individual session once per two weeks alternately with a 1-hour-long class of exercises once per two weeks plus a home program (1 or 2 exercises, 2 times a week).
Intervention: GPR-B (Other)
Outcomes
Primary Outcomes
Change in Cobb angle
Time Frame: 6 and 12 months
Change in the frontal radiologic measure of scoliosis: a decrease in Cobb angle by more than 5 degrees indicate improvement
Secondary Outcomes
- Posture: shoulder elevation(6 and 12 months)
- Posture: right waist angle(6 and 12 months)
- Posture: left waist angle(6 and 12 months)
- Posture: thoracic scoliosis(6 and 12 months)
- Posture: lumbar scoliosis(6 and 12 months)
- Posture: frontal trunk list(6 and 12 months)
- Posture: frontal pelvic tilt(6 and 12 months)
- Posture: right sagittal pelvic tilt(6 and 12 months)
- Posture: left sagittal pelvic tilt(6 and 12 months)
- Posture: scapula asymmetry(6 and 12 months)
- Change in back pain(6 and 12 months)
- Change in score of The youth version of the Child & Adolescent Scale of Participation(12 months)
Investigators
Carole Fortin
Professor
St. Justine's Hospital