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

This study has been completed.
Sponsor:
Collaborators:
American Physical Therapy Association
Texas Woman's University
Information provided by (Responsible Party):
Karina Zapata, PT, DPT, PhD, Texas Scottish Rite Hospital for Children
ClinicalTrials.gov Identifier:
NCT01550497
First received: March 1, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose
  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 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

Resource links provided by NLM:


Further study details as provided by Texas Scottish Rite Hospital for Children:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 45
Study Start Date: March 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550497

Locations
United States, Texas
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
  More Information

No publications provided

Responsible Party: Karina Zapata, PT, DPT, PhD, 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: December 17, 2013
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:
Back Pain
Low Back Pain
Scoliosis
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 19, 2014