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

Sponsor
Texas Scottish Rite Hospital for Children (Other)
Overall Status
Completed
CT.gov ID
NCT01550497
Collaborator
American Physical Therapy Association (Other), Texas Woman's University (Other)
45
1
2
20
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: supervised spinal stabilization exercises
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Spinal Stabilization Exercises for Low Back Pain in Adolescents With Idiopathic Scoliosis
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Oct 31, 2013
Actual Study Completion Date :
Oct 31, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in pain from initial visit [Initial visit 'day 1', After 8 weeks, After 6 months]

    Numeric Pain Rating Scale

Secondary Outcome Measures

  1. Change in back muscle endurance from initial visit [Initial visit 'day 1', After 8 weeks, After 6 months]

    Prone double leg raise

  2. Change in quality of life since initial visit [Initial visit 'day 1', After 8 weeks, After 6 months]

    SRS-22

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 17 Years
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 Texas Scottish Rite Hospital for Children Dallas Texas United States 75219

Sponsors and Collaborators

  • Texas Scottish Rite Hospital for Children
  • American Physical Therapy Association
  • Texas Woman's University

Investigators

  • Principal Investigator: Karina A Kunder, PT, DPT, Texas Scottish Rite Hospital for Children

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Karina Zapata, PT, DPT, PhD, physical therapist, Texas Scottish Rite Hospital for Children
ClinicalTrials.gov Identifier:
NCT01550497
Other Study ID Numbers:
  • STU 092011-073
First Posted:
Mar 12, 2012
Last Update Posted:
Oct 1, 2021
Last Verified:
Oct 1, 2020
Keywords provided by Karina Zapata, PT, DPT, PhD, physical therapist, Texas Scottish Rite Hospital for Children
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 1, 2021