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

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Other: supervised spinal stabilization exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75219
      • Texas Scottish Rite Hospital for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home Exercise Group; Perform home exercises of unsupervised 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.
Experimental: Weeky Physical Therapy Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain from initial visit	Numeric Pain Rating Scale	Initial visit 'day 1', After 8 weeks, After 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in back muscle endurance from initial visit	Prone double leg raise	Initial visit 'day 1', After 8 weeks, After 6 months
Change in quality of life since initial visit	SRS-22	Initial visit 'day 1', After 8 weeks, After 6 months

Collaborators and Investigators

• Sponsor: Texas Scottish Rite Hospital for Children
• Collaborators: American Physical Therapy Association; Texas Woman's University
• Investigators: Principal Investigator: Karina A Kunder, PT, DPT, Texas Scottish Rite Hospital for Children

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): October 31, 2013
• Study Completion (Actual): October 31, 2013

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (Estimate): March 12, 2012

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: back pain; scoliosis; home exercise program
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Back Pain; Low Back Pain; Scoliosis
• Other Study ID Numbers: STU 092011-073