Spinal Stabilization Exercises for Low Back Pain in Adolescents With Idiopathic Scoliosis

Low Back Pain Clinical Trial

— LBPAIS  

Official title:

Effectiveness of Spinal Stabilization Exercises for Low Back Pain in Adolescents With Idiopathic Scoliosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01550497
• Other study ID #: STU 092011-073
• Status: Completed
• Phase: N/A
• Start date: March 1, 2012
• Est. completion date: October 31, 2013

Study information

• Verified date: October 2020
• Source: Texas Scottish Rite Hospital for Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 31, 2013
• Est. primary completion date: October 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Back Pain
• Low Back Pain
• Scoliosis

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Scottish Rite Hospital for Children	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Texas Scottish Rite Hospital for Children	American Physical Therapy Association, Texas Woman's University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain from initial visit	Numeric Pain Rating Scale	Initial visit 'day 1', After 8 weeks, After 6 months
Secondary	Change in back muscle endurance from initial visit	Prone double leg raise	Initial visit 'day 1', After 8 weeks, After 6 months
Secondary	Change in quality of life since initial visit	SRS-22	Initial visit 'day 1', After 8 weeks, After 6 months