Spinal Stabilization Exercises for Low Back Pain in Adolescents With Idiopathic Scoliosis (LBPAIS)
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Purpose
- 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?
- 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.
| Condition | Intervention |
|---|---|
|
Adolescent Idiopathic Scoliosis Low Back Pain |
Other: supervised spinal stabilization exercises |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effectiveness of Spinal Stabilization Exercises for Low Back Pain in Adolescents With Idiopathic Scoliosis |
- Change in pain from initial visit [ Time Frame: Initial visit 'day 1', After 8 weeks, After 6 months ] [ Designated as safety issue: No ]Numeric Pain Rating Scale
- Change in back muscle endurance from initial visit [ Time Frame: Initial visit 'day 1', After 8 weeks, After 6 months ] [ Designated as safety issue: No ]Prone double leg raise
- Change in quality of life since initial visit [ Time Frame: Initial visit 'day 1', After 8 weeks, After 6 months ] [ Designated as safety issue: No ]SRS-22
| Estimated Enrollment: | 32 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Home Exercise Group
Perform home 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.
|
|
Experimental: Weeky Physical Therapy Group
weekly physical therapy 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.
|
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| Ages Eligible for Study: | 10 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Karina A Kunder, PT, DPT | 214-559-7790 | karina.kunder@tsrh.org |
| United States, Texas | |
| Texas Scottish Rite Hospital for Children | Recruiting |
| Dallas, Texas, United States, 75219 | |
| Contact: Karina Kunder, PT, DPT 214-559-7790 | |
| Principal Investigator: | Karina A Kunder, PT, DPT | Texas Scottish Rite Hospital for Children |
More Information
No publications provided
| Responsible Party: | Karina Kunder, PT, DPT, physical therapist, Texas Scottish Rite Hospital for Children |
| ClinicalTrials.gov Identifier: | NCT01550497 History of Changes |
| Other Study ID Numbers: | STU 092011-073 |
| Study First Received: | March 1, 2012 |
| Last Updated: | May 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Texas Scottish Rite Hospital for Children:
|
back pain scoliosis home exercise program |
Additional relevant MeSH terms:
|
Scoliosis Back Pain Low Back Pain Pain Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013