Effect of Global Postural Re-education in Idiopathic Scoliosis

NCT03663088 | Terminated

• 1 other identifier: StJustineH_CFortin
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Scoliosis

Keywords

Physiotherapy; Global postural re-education; Cobb angle; Posture; Back pain; Participation

Outcome Measures

Primary Outcomes (1)

• Change in Cobb angle

  Change in the frontal radiologic measure of scoliosis: a decrease in Cobb angle by more than 5 degrees indicate improvement

  6 and 12 months

Secondary Outcomes (12)

• 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

Other Outcomes (3)

• Recruitment rate

  12 months

• Completion rate

  12 months

• Adherence (compliance) with GPR treatment in terms of collaboration, presence and implication in home exercises

  12 months

Study Arms (2)

GPR-A

ACTIVE COMPARATOR

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).

Other: GPR-A

GPR-B

EXPERIMENTAL

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).

Other: GPR-B

Interventions

GPR-A OTHER

Standard Global postural re-education physiotherapy scoliosis specific exercises

GPR-A

GPR-B OTHER

Experimental Global postural re-education physiotherapy scoliosis specific exercises combining individual and class exercises

GPR-B

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carole Fortin, Ph.D.

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: September 10, 2018
• Study Start: November 15, 2018
• Primary Completion: December 15, 2020
• Study Completion: March 1, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

CA (1)