Clinical trial NCT03663088: Effect of Global Postural Re-education in Idiopathic Scoliosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Idiopathic Scoliosis
Keywords: Physiotherapy
Global postural re-education
Cobb angle
Posture
Back pain
Participation
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Cobb angle
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Posture: shoulder elevation
timeFrame: 6 and 12 months
measure: Posture: right waist angle
timeFrame: 6 and 12 months
measure: Posture: left waist angle
timeFrame: 6 and 12 months
measure: Posture: thoracic scoliosis
timeFrame: 6 and 12 months
measure: Posture: lumbar scoliosis
timeFrame: 6 and 12 months
measure: Posture: frontal trunk list
timeFrame: 6 and 12 months
measure: Posture: frontal pelvic tilt
timeFrame: 6 and 12 months
measure: Posture: right sagittal pelvic tilt
timeFrame: 6 and 12 months
measure: Posture: left sagittal pelvic tilt
timeFrame: 6 and 12 months
measure: Posture: scapula asymmetry
timeFrame: 6 and 12 months
measure: Change in back pain
timeFrame: 6 and 12 months
measure: Change in score of The youth version of the Child & Adolescent Scale of Participation
timeFrame: 12 months
Other outcomes:
measure: Recruitment rate
timeFrame: 12 months
measure: Completion rate
timeFrame: 12 months
measure: Adherence (compliance) with GPR treatment in terms of collaboration, presence and implication in home exercises
timeFrame: 12 months
Locations:
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Carole Fortin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: