Clinical trial NCT01550497: Spinal Stabilization Exercises for Low Back Pain in Adolescents With Idiopathic Scoliosis
Official title: Effectiveness of Spinal Stabilization Exercises for Low Back Pain in Adolescents With Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Low Back Pain
Keywords: back pain
scoliosis
home exercise program
Lead sponsor: Texas Scottish Rite Hospital for Children
Sponsor class: OTHER
Collaborators: name: American Physical Therapy Association
name: Texas Woman's University
First posted: 2012-03-12
Enrollment: 45
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Do spinal stabilization exercises demonstrate immediate and long-term effects of weight weeks of spinal stabilization exercises as measured by pain intensity and quality of life scores?
2. Does eight weeks of spinal stabilization exercises improve back muscle endurance in adolescents with Idiopathic Scoliosis (IS) with low back pain (LBP), compared to a one-time treatment (control)?

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adolescents (ages 10-17),
* Idiopathic Scoliosis,
* Low Back Pain (\> 2/10 on Numeric Pain Rating Scale)

Exclusion Criteria:

* other pathology of lumbar spine (like spondylotic lesion),
* current treatment (like bracing and chiropractic care),
* back pain located beyond the lumbar spine

Primary outcomes:
measure: Change in pain from initial visit
timeFrame: Initial visit 'day 1', After 8 weeks, After 6 months
Secondary outcomes:
measure: Change in back muscle endurance from initial visit
timeFrame: Initial visit 'day 1', After 8 weeks, After 6 months
measure: Change in quality of life since initial visit
timeFrame: Initial visit 'day 1', After 8 weeks, After 6 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Scottish Rite Hospital for Children
state: Texas
Study officials:
affiliation: Texas Scottish Rite Hospital for Children
name: Karina A Kunder, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References: