The Comparison of Core Stabilization Exercise With Scientific Exercise Approach to Scoliosis in Idiopathic Scoliosis

Scoliosis Clinical Trial

Official title:

Core Stabilization Exercise Versus Scientific Exercises Approach to Scoliosis in the Treatment of Adolescent Idiopathic Scoliosis: A Randomized Single Blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02978820
• Other study ID #: GO 16/82
• Status: Completed
• Phase: N/A
• First received: November 20, 2016
• Last updated: November 28, 2016
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Scoliosis specific exercises have been shown to improve curve progression but there have been few studies that compare the different exercise approaches in adolescent idiopathic scoliosis (AIS). The objective of this study was to compare the effects of Core stabilization (CS) exercises with Scientific Exercises Approach to Scoliosis (SEAS exercises) in addition to brace wearing in patients with AIS. It is important to compare different exercise methods on different aspects of scoliotic deformity, such as curve progression, angle of trunk rotation, body symmetry, cosmetic trunk deformity, satisfaction with treatment and quality of life.

Description:

The aim of this study was to investigate whether adolescent with idiopathic scoliosis receiving scoliosis specific exercise approach, such as SEAS exercises, in accordance with the bracing approach for moderate curves would have greater improvement in curve progression, trunk deformity, body symmetry and quality of life than adolescent receiving exercise therapy based on the general core stabilization approach with similar intensity. Thirty female patients with AIS aged 12 to16 years, who have moderate curves (20 to 45 degree) randomly divided into two groups. One group received CS exercise, while other received SEAS exercise for forty-min once weekly for four months. Both groups underwent full-time bracing (23 hours per day) intervention. Outcome was based on Cobb angle, angle of trunk rotation, body symmetry (Posterior Trunk Symmetry Index), cosmetic trunk deformity (Walter Reed Visual Assessment Scale) and quality of life (Scoliosis Research Society - 22 Questionnaire) measured at baseline and after intervention period. Results were analyzed using the paired sample t-test to compare repeated measurements and independent sample t-test to compare the groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 16 Years

Eligibility

Inclusion Criteria:

• The patients included in the current study were consecutive adolescents with idiopathic scoliosis seen in our department who were referred to receive both brace and exercise treatment conservatively. Additional inclusion criteria included the following: female gender; at least age 12 years; primary curve magnitude between 20 and 45 degrees of Cobb angle; double curve (right thoracic-left lumbar) or single thoracolumbar curve having an apex in the main thoracic region; Risser 2-3 and no previous treatment.

Exclusion Criteria:

• Exclusion criteria for both groups were as follows: evidence of congenital curve; neuromuscular, rheumatologic, renal, cardiovascular, pulmonary or vestibular diseases or surgical correction history.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Other:
• SEAS exercise
Patient were referred by medical doctor with a prescription of brace and exercise training for their moderate scoliotic curves. Patients were randomly divided into two groups. The SEAS group received SEAS exercises one times in a week for four months. In addition patients in SEAS groups were wearing spinal brace for their scoliosis in this period
• CS exercise
Patient were referred by medical doctor with a prescription of brace and exercise training for their moderate scoliotic curves. Patients were randomly divided into two groups. The CS group received core stabilization exercise training one times in a week for four months. In addition patients in SEAS groups were wearing spinal brace for their scoliosis in this period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

References & Publications (7)

Fusco C, Zaina F, Atanasio S, Romano M, Negrini A, Negrini S. Physical exercises in the treatment of adolescent idiopathic scoliosis: an updated systematic review. Physiother Theory Pract. 2011 Jan;27(1):80-114. doi: 10.3109/09593985.2010.533342. Review. — View Citation

Gür G, Ayhan C, Yakut Y. The effectiveness of core stabilization exercise in adolescent idiopathic scoliosis: A randomized controlled trial. Prosthet Orthot Int. 2016 Sep 13. pii: 0309364616664151. [Epub ahead of print] — View Citation

Negrini S, Aulisa AG, Aulisa L, Circo AB, de Mauroy JC, Durmala J, Grivas TB, Knott P, Kotwicki T, Maruyama T, Minozzi S, O'Brien JP, Papadopoulos D, Rigo M, Rivard CH, Romano M, Wynne JH, Villagrasa M, Weiss HR, Zaina F. 2011 SOSORT guidelines: Orthopaedic and Rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis. 2012 Jan 20;7(1):3. doi: 10.1186/1748-7161-7-3. — View Citation

Negrini S, Grivas TB, Kotwicki T, Maruyama T, Rigo M, Weiss HR; Members of the Scientific society On Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT).. Why do we treat adolescent idiopathic scoliosis? What we want to obtain and to avoid for our patients. SOSORT 2005 Consensus paper. Scoliosis. 2006 Apr 10;1:4. — View Citation

Romano M, Negrini A, Parzini S, Tavernaro M, Zaina F, Donzelli S, Negrini S. SEAS (Scientific Exercises Approach to Scoliosis): a modern and effective evidence based approach to physiotherapic specific scoliosis exercises. Scoliosis. 2015 Feb 5;10:3. doi: 10.1186/s13013-014-0027-2. — View Citation

Smania N, Picelli A, Romano M, Negrini S. Neurophysiological basis of rehabilitation of adolescent idiopathic scoliosis. Disabil Rehabil. 2008;30(10):763-71. doi: 10.1080/17483100801921311. Review. — View Citation

Weinstein SL. Adolescent idiopathic scoliosis: prevalence and natural history. Instr Course Lect. 1989;38:115-28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cobb angle	Cobb angle is considered a gold standard to determine the magnitude of spinal curve on frontal plan radiograph	Change from baseline Cobb angle at 4 months	No
Secondary	Chance in Posterior trunk symmetry index	Posterior trunk symmetry index includes the sensitive assessment of the frontal plane asymmetry of trunk deformity as a two-dimensional surface topographic method in scoliosis. The index based on assessing trunk asymmetry with regard to C7 plumb line, shoulder and hip asymmetry based on back surface photograph of patient.	Change from baseline trunk symmetry at 4 months	No
Secondary	Change in Walter reed visual assessment scale	Walter reed visual assessment scale assesses patient's cosmetic trunk deformity with set of figures representing seven visible aspects of spinal deformity: Item 1, spinal deformity; item 2, rib prominence; item 3, lumbar prominence; item 4, thoracic deformity; item 5, trunk imbalance; item 6, shoulder asymmetry; and item 7, scapular asymmetry	Change from baseline cosmetic trunk deformity at 4 months	No
Secondary	Change in Scoliosis Research Society 22 Questionnaire	Scoliosis Research Society 22 Questionnaire is widely used to evaluate the efficacy of several treatment regimens for idiopathic scoliosis from the patient's perception of his or her condition. The questionnaire consists of 22 items exploring 5 domains related to psychophysical wellbeing: function/activity level, pain, mental health, self-image and treatment satisfaction.	Change from baseline quality of life at 4 months	No
Secondary	Change in Angle of trunk rotation	Angle of Trunk rotation is assessed with scoliometer in forward bending test	Change from baseline angle of trunk rotation at 4 months	No