Clinical trial NCT01610908: Multicenter Schroth Exercise Trial for Scoliosis
Official title: A Multicenter Randomized Controlled Trial to Compare the Effect of Schroth Exercises to Standard Care on Curve Characteristics, Posture, and Quality Of Life in Adolescents With Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis
Keywords: Adolescent
Idiopathic
Scoliosis
Schroth
Exercises
Conservative treatment
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Glenrose Foundation
name: Scoliosis Research Society
name: SickKids Foundation CIHR Institute of Human Development, Child and Youth Health
First posted: 2012-06-04
Enrollment: 158
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary aim of this multicenter randomized controlled trial is to compare the effect of a 6 month "Schroth exercise program combined with standard-of-care" to "standard-of-care alone" on scoliosis curve severity measured using the Cobb angle.

Secondary aims include:

1. To determine the effect of Schroth exercises at 6 months on secondary outcomes including quality-of-life, spinal appearance, objective posture and spinal muscle endurance measurements.
2. To determine the efficacy of 6 months of Schroth therapy offered to control participants after completing 6 months in the standard-of care group (using subjects as their own controls)
3. To determine if the effects of the 6 months supervised Schroth exercise program can be maintained after supervised therapy is terminated.

At Hopital Ste-Justine, the following secondary aims will be pursued to examine the preliminary evidence about the effect of Global Postural Re-education (to satisfy the local ethics committee request because Global Postural Re-education exercises were offered routinely to patients at that institution prior to the trial).

A. To compare the effect and to quantify the treatment effect sizes of 6 months of "Global Postural Re-education exercises with North American standard Care consisting of only observation and bracing" to "Schroth exercises combined with North American standard care" and to "North American standard care alone" on scoliosis curve severity measured using the Cobb angle.

B. To estimate the effect and quantify the treatment effect sizes of 6 months of "Global Postural Re-education exercises with North American standard Care" to "Schroth exercises combined with North American standard care" and to "North American standard care alone" on outcomes including quality-of-life, perceived spinal appearance, objective posture and spinal muscle endurance measurements.

C. To determine if the effects of "Global Postural Re-education exercises with North American standard Care" can be maintained after discontinuing supervision.

D. To estimate the feasibility of conducting a randomized trial focused on Global Postural Re-education exercises by quantifying enrollment rates, attendance at scheduled exercise sessions and compliance with the home exercises prescribed.

Detailed description: Multicenter Schroth Exercise Trial for Scoliosis (SETS study) Adolescent Idiopathic Scoliosis (AIS) is a progressive 3D deformity of the spine. It is the most common orthopedic condition in adolescents. Of those with curves larger than 10°, 90% are females. Scoliosis often results in chronic pain, poor posture, function, and self-image.

Curves greater than 30° are braced or later surgically corrected. In Europe but not the Americas, small curves (\<30°) are treated with exercises to prevent the need for bracing and moderate curves with bracing and exercises to prevent surgery. Bracing is uncomfortable and patients fear surgery. In contrast, exercises are generally well received.

Schroth exercises are the most studied scoliosis exercises and have achieved very good outcomes. Schroth was the first exercise approach to offer formal certification training. No randomized controlled trial has focused on the Schroth method. Only 1 randomized controlled trial and only 3 prospective controlled studies with important methodological flaws were included in a recent review of the effect of all types of scoliosis exercises that found that exercises slowed the worsening of scoliosis. A randomized controlled trial on Schroth exercises is needed.

Schroth exercises are asymmetric scoliosis-specific postural exercises and aim to improve the curve, posture, pain, function, and self-image. Schroth exercises target endurance and strength training of the abdominal, back, and leg muscles. Schroth exercises also aim to improve motor control of the posture by repeating corrective movements with progressively less feedback.

Objectives: (1) To compare the effect of 6 month "of Schroth exercises combined with standard-of-care" to "standard-of-care alone" on scoliosis curve severity measured using the Cobb angle.

Secondary aims include determining treatment effects on quality-of-life, spinal appearance, posture and spinal muscle endurance and monitoring if effect are maintained at long-term follow-ups.

See above for objectives corresponding to the secondary analysis planned at Hopital Ste-Justine.

Methodology:

Participants: Two hundred fifty-eight females with AIS will be recruited for this study from our scoliosis clinic. Females 10-16 years old with curves 10° to 45°, and Risser less than or equal to 3 will be included. Patients who are planning surgery, have had surgery, worn a brace or to be discharged will be excluded.

Procedures: Participants will be randomized to the standard-of-care group (observation of bracing if Boston brace criteria are met) or the Schroth exercise treatment group.

(At hospital Ste-Justine, only because of the ethics committee requested we include a third trial arm, we will randomize an equal number of subjects to each of the three trial arms (Global Postural Re-education, Schroth and Standard care) using the a variable blocked randomization specific to this site. This implies recruiting an estimated additional 52 patients to be randomized to the Global Postural Re-education group.) Outcomes will be measured by evaluators blind to randomization status at baseline and at 3 and 6 month follow-ups. The primary outcome is the spinal curvature angle on radiograph at 6 months. Secondary outcomes analyzed at 3, and 6 months include radiographs (Cobb angle, rotation), Scoliosis Research Society-22r quality-of-life domain scores (self-image, function, pain), spinal appearance questionnaire domain scores, postural measures (surface topography), and Sørensen back muscle endurance. Radiographs and Scoliosis Research Society-22 measures from routine scoliosis clinic visits will also be obtained from the clinic database until discharged from routine care. Measurement properties of all measures are adequate.

Standard-of-care subjects will be under observation or treated with bracing if they meet the Scoliosis Research Society bracing criteria for 6 months and then be offered the Schroth exercise treatment as a recruitment incentive necessary based on our pilot. Treated patients will receive supervised and standardized Schroth exercises combined with a home program in addition to standard of care for 6 months. Parents will be involved to enhance (and monitor) compliance. (At hôpital Ste-Justine only, one group will receive the 6-month supervised Global Postural Re-education intervention consisting of individual training sessions with a therapist combined with a home exercise program consisting of 1 or 2 exercises to perform twice weekly in addition the standard of care).

Analyses: Linear mixed models will be used to assess differences in group changes from baseline, to 3 months and 6-month, and adjusting for relevant covariates (including age, and risk of progression).

Expected findings: Schroth exercises will improve curve characteristics, quality of life, posture, pain, and muscular endurance in patients with adolescent idiopathic scoliosis. The study team is integrated within the Edmonton scoliosis clinic, Montréal's Centre Hospitalier Universitaire Ste-Justine clinic and Calgary's Alberta Children Hospital Clinic. Research results can directly influence practice.

Eligibility criteria: Inclusion Criteria:

* adolescent idiopathic scoliosis
* Females
* 10° to 45° according to Cobb (scoliosis curve)
* with or without a brace
* ability to travel weekly to our lab
* skeletal maturity measured by Risser (0-3)

Exclusion Criteria:

* other type of scoliosis
* patients with curves \> 50°
* surgical candidates
* patients who have had a corrective spinal surgery
* out-of town candidates, without possibility to travel to our lab

Primary outcomes:
measure: Change in Cobb angle
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Change in Vertebral rotation
timeFrame: Change from baseline to 6 months
measure: Change in Back muscle endurance
timeFrame: From baseline, to 3 months and to 6 months follow-ups
measure: Change in Scoliosis Research Society-22r questionnaire scores
timeFrame: From baseline, to 3 months and to 6 months follow-ups
measure: Change in Spinal Appearance Questionnaire scores
timeFrame: From baseline, to 3, and to 6 months
measure: Global rating of change relative to baseline
timeFrame: at 3 and at 6 months
measure: Change in Self-efficacy
timeFrame: From baseline, to 3 and to 6 months
measure: Change in numeric pain ratings and diagram
timeFrame: From baseline, to 3 and to 6 months
measure: Change in surface topography assessment of posture
timeFrame: From baseline, to 3 and to 6 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta, Faculty of Rehabilitation Medicine, Dept. Physical Therapy
state: Alberta
city: Montréal
country: Canada
facility: CHU Ste-Justine
state: Quebec
Study officials:
affiliation: University of Alberta
name: Eric C Parent, PT, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Watkins E, Bosnjak S, Parent E. Algorithms to prescribe Schroth exercises for each of four Schroth curve types. Scoliosis. 2012 Jan 27;7 Suppl 1:P22.
citation: Schreiber S, Parent E, Watkins E, Hedden D. An algorithm for determining scoliosis curve type according to Schroth. Scoliosis. 2012 Jan 27;7 Suppl 1:O53.
citation: Schreiber S, Parent EC, Hedden DM, Moreau M, Hill D, Lou E. Effect of Schroth exercises on curve characteristics and clinical outcomes in adolescent idiopathic scoliosis: protocol for a multicentre randomised controlled trial. J Physiother. 2014 Dec;60(4):234; discussion 234. doi: 10.1016/j.jphys.2014.08.005. Epub 2014 Oct 17.
citation: Schreiber S, Parent E, Khodayari Moez E, Hedden D, Hill D, Moreau M, Lou E, Watkins E, Southon S. (2016). Schroth Physiotherapeutic Scoliosis-specific exercises improve Cobb Angles in adolescents with Idiopathic Scoliosis - a randomized controlled trial.10th Annual WCHRI Research Day, Edmonton Canada, (oral 23 Page 27)
citation: Schreiber S, Parent EC, Moez EK, Hedden DM, Hill D, Moreau MJ, Lou E, Watkins EM, Southon SC. The effect of Schroth exercises added to the standard of care on the quality of life and muscle endurance in adolescents with idiopathic scoliosis-an assessor and statistician blinded randomized controlled trial: "SOSORT 2015 Award Winner". Scoliosis. 2015 Sep 18;10:24. doi: 10.1186/s13013-015-0048-5. eCollection 2015.
citation: Parent EC, Schreiber S, Hedden D, Moreau M. The effect of a 6-month Schroth exercise program: a pilot study using subjects as their own controls. Scoliosis. 2013;8(Suppl 2):045.
citation: Schreiber S, Parent EC, Hedden DM, Moreau M, Hill D, Watkins EM. The effects of a 6-month Schroth intervention for Adolescent Idiopathic Scoliosis (AIS): preliminary analysis of an ongoing randomized controlled trial. Scoliosis. 2013;8(Suppl 2):O44.
citation: Schreiber S, Parent E, Hedden D, Moreau MJ. Clinical Significance of The Effect of A Six-Months Schroth Exercise Intervention in Adolescents with Idiopathic Scoliosis. 2015 Annual Meeting Pediatric Orthopaedic Society of North America (POSNA), e-poster #18, p391, 2015
citation: Schreiber S, Parent EC, Hill DL, Hedden DM, Moreau MJ, Southon SC. Schroth physiotherapeutic scoliosis-specific exercises for adolescent idiopathic scoliosis: how many patients require treatment to prevent one deterioration? - results from a randomized controlled trial - "SOSORT 2017 Award Winner". Scoliosis Spinal Disord. 2017 Nov 14;12:26. doi: 10.1186/s13013-017-0137-8. eCollection 2017.
citation: Schreiber S, Parent EC, Khodayari Moez E, Hedden DM, Hill DL, Moreau M, Lou E, Watkins EM, Southon SC. Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial. PLoS One. 2016 Dec 29;11(12):e0168746. doi: 10.1371/journal.pone.0168746. eCollection 2016.
citation: Schreiber S**, Parent EC, Hill DL, Hedden DM, Moreau M, Southon S. (2018). How much change in the Cobb angle is needed for the patients to observe positive change in their backs following a Schroth intervention? In Abstract Book Program from XIII International Meeting of the Society for Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT), Dubrovnik, Croatia, April 19-21, 2018, P71. (Winner of the 2018 SOSORT Award)
citation: Schreiber S*, Parent E, Hill D, Hedden D, Moreau M, Southon S. (2017). Schroth Physiotherapeutic Scoliosis-Specific Exercises for Adolescent Idiopathic Scoliosis: How Many Patients Require Treatment To Prevent One Deterioration?. Book of abstracts of the 12th International Meeting of the International Society on Scoliosis Orthopaedic and Rehabilitation Treatment. Lyon, France, May 4 to 6 2017, O37.66, S7110-111
citation: Schreiber S*, Parent EC, Moez EK, Hedden DM, Hill D, Moreau M, Lou E, Watkins EM*, Southon SC. (2016). The effect of Schroth exercises added to the standard of care on the Cobb angle in adolescents with idiopathic scoliosis: An assessor and statistician blinded randomized controlled trial Scoliosis and Spinal Disorders 2017 12(Suppl 1):17 O60. Proceedings of The First Joint Meeting of the International Research Society of Spinal Deformities and the Society on Scoliosis Orthopaedic and Rehabilitation Treatment, Banff, Alberta, Canada, May 25-28, 2016. Paper O-81, pages 68-69
citation: Schreiber S*, Parent EC, Hedden DM, Hill DL Scoliosis and Spinal Disorders 2017 12(Suppl 1):17 O70. (2016). Minimal important differences in Scoliosis Research Society-22R, Spinal Appearance Questionnaire, Cobb angle and Biering-Sorensen back muscle endurance test following a six-month Schroth exercises intervention in adolescents with idiopathic scoliosis. Proceedings of The First Joint Meeting of the International Research Society of Spinal Deformities and the Society on Scoliosis Orthopaedic and Rehabilitation Treatment, Banff, Alberta, Canada, May 25-28, 2016. Paper 0-93, pages
citation: Parent EC, Schreiber S*, Moez EK, Preston S*, Hedden D, Moreau M, Hill D, Southon S, Watkins E*. (2016). Effects of Schroth exercises added to standard care in adolescents with idiopathic scoliosis (AIS) on surface topography parameters: A randomized controlled trial (RCT) Scoliosis and Spinal Disorders 2017 12(Suppl 1):17 O61. Proceedings of The First Joint Meeting of the International Research Society of Spinal Deformities and the Society on Scoliosis Orthopaedic and Rehabilitation Treatment, Banff, Alberta, Canada, May 25-28, 2016. Paper 0-82, page 69
citation: Parent EC, Ghaneei M*, Adeeb S, Schreiber S*, Moreau M, Hedden D, Hill D. (2016). Effects of Schroth exercises added to standard care in adolescents with idiopathic scoliosis (AIS) on marker-less surface topography asymmetry measurements: A randomized controlled trial (RCT) Scoliosis and Spinal Disorders 2017 12(Suppl 1):17 O62. Proceedings of The First Joint Meeting of the International Research Society of Spinal Deformities and the Society on Scoliosis Orthopaedic and Rehabilitation Treatment, Banff, Alberta, Canada, May 25-28, 2016. Paper 0-83, pages 69-70
citation: Schreiber S*, Parent E, Khodayari-Moez E, Hedden D, Hill D, Moreau M, Lou E, Watkins E*, Southon S. (2016). Schroth physiotherapeutic scoliosis-specific exercises improve Cobb angles in adolescents with idiopathic scoliosis - A randomized controlled trial. Proceedings of the 10th Annual WCHRI Research Day, Edmonton, Canada, November 16, 2016, Oral 23, page 27
citation: Schreiber S, Parent EC, Hill DL, Hedden DM, Moreau MJ, Southon SC. Patients with adolescent idiopathic scoliosis perceive positive improvements regardless of change in the Cobb angle - Results from a randomized controlled trial comparing a 6-month Schroth intervention added to standard care and standard care alone. SOSORT 2018 Award winner. BMC Musculoskelet Disord. 2019 Jul 8;20(1):319. doi: 10.1186/s12891-019-2695-9.