An interventional study of supervised spinal stabilization exercises in Adolescent Idiopathic Scoliosis and Low Back Pain, sponsored by Texas Scottish Rite Hospital for Children. Completed at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-10-01.
Sponsored by Texas Scottish Rite Hospital for Children · Not applicable, Interventional, and Treatment
Hypotheses:
The research hypothesis for Question 1 is: Participants who receive eight weeks of spinal stabilization exercises will demonstrate significantly improved pain intensity and quality of life scores compared to participants who receive a one-time treatment after eight weeks of the intervention period and at six-month follow-up.
The research hypothesis for Question 2 is: Participants who receive eight weeks of the spinal stabilization exercises will demonstrate significantly improved back muscle endurance, compared to participants who receive a one-time treatment after eight weeks of intervention.
Although idiopathic scoliosis (IS) is the most common type of scoliosis, no studies have evaluated the effectiveness of physical therapy exercises for managing low back pain (LBP) in this population. Spinal stabilization exercises are of particular importance in adolescents with IS due to possible reduced spinal stability from structural deformity. Spinal stabilization exercises have been reported to prevent recurrent episodes of LBP in the adult population. However, standardized treatment options cannot be recommended for LBP in adolescents with IS, because the investigators are not certain if spinal stabilization exercises will have the same effect on this patient population. Given the high prevalence of LBP in AIS and limited evidence of conservative interventions, researching the effectiveness of spinal stabilization exercises is warranted.
Currently, there are two common practices for managing adolescents with IS who have LBP: 1) supervised physical therapy and 2) a one-time treatment with no follow-up. No studies have examined which of these two approaches is superior. This study will provide information on optimal management of LBP in AIS. If there is no difference in outcomes between these two approaches, a one-time visit will be the optimal choice of treatment since it is more cost-effective and less burdensome for the family. If the outcomes favor the eight-week supervised physical therapy, specifically the spinal stabilization exercises, this treatment approach should be recommended for managing LBP in AIS.
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's enrollment of 45 is close to the median of 44 across 344 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →Texas Scottish Rite Hospital for Children is the lead sponsor of 18 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Perform home exercises of unsupervised spinal stabilization exercises for 8 weeks
Other: supervised spinal stabilization exercises
weekly physical therapy of supervised spinal stabilization exercises for 8 weeks
Other: supervised spinal stabilization exercises
Supervised or unsupervised exercises to be done for 20 minutes at home, at least 5 times a week for the first 2 weeks and at least 3 times a week after 2 weeks. The supervised weekly physical therapy group will complete 8 weeks of weekly physical therapy. The unsupervised home exercise group will complete 8 weeks of a prescribed home exercise program.
Change in pain from initial visit
Numeric Pain Rating Scale
Time frame: Initial visit 'day 1', After 8 weeks, After 6 months
Change in back muscle endurance from initial visit
Prone double leg raise
Time frame: Initial visit 'day 1', After 8 weeks, After 6 months
Change in quality of life since initial visit
SRS-22
Time frame: Initial visit 'day 1', After 8 weeks, After 6 months
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Texas Scottish Rite Hospital for Children