Spinal Stabilization Exercises for Low Back Pain in Adolescents With Idiopathic Scoliosis (LBPAIS)
Primary Purpose
Adolescent Idiopathic Scoliosis, Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
supervised spinal stabilization exercises
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring back pain, scoliosis, home exercise program
Eligibility 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
Sites / Locations
- Texas Scottish Rite Hospital for Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Home Exercise Group
Weeky Physical Therapy Group
Arm Description
Perform home exercises of unsupervised spinal stabilization exercises for 8 weeks
weekly physical therapy of supervised spinal stabilization exercises for 8 weeks
Outcomes
Primary Outcome Measures
Change in pain from initial visit
Numeric Pain Rating Scale
Secondary Outcome Measures
Change in back muscle endurance from initial visit
Prone double leg raise
Change in quality of life since initial visit
SRS-22
Full Information
NCT ID
NCT01550497
First Posted
March 1, 2012
Last Updated
September 30, 2021
Sponsor
Texas Scottish Rite Hospital for Children
Collaborators
American Physical Therapy Association, Texas Woman's University
1. Study Identification
Unique Protocol Identification Number
NCT01550497
Brief Title
Spinal Stabilization Exercises for Low Back Pain in Adolescents With Idiopathic Scoliosis
Acronym
LBPAIS
Official Title
Effectiveness of Spinal Stabilization Exercises for Low Back Pain in Adolescents With Idiopathic Scoliosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2012 (undefined)
Primary Completion Date
October 31, 2013 (Actual)
Study Completion Date
October 31, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Scottish Rite Hospital for Children
Collaborators
American Physical Therapy Association, Texas Woman's University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis, Low Back Pain
Keywords
back pain, scoliosis, home exercise program
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home Exercise Group
Arm Type
Experimental
Arm Description
Perform home exercises of unsupervised spinal stabilization exercises for 8 weeks
Arm Title
Weeky Physical Therapy Group
Arm Type
Experimental
Arm Description
weekly physical therapy of supervised spinal stabilization exercises for 8 weeks
Intervention Type
Other
Intervention Name(s)
supervised spinal stabilization exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain from initial visit
Description
Numeric Pain Rating Scale
Time Frame
Initial visit 'day 1', After 8 weeks, After 6 months
Secondary Outcome Measure Information:
Title
Change in back muscle endurance from initial visit
Description
Prone double leg raise
Time Frame
Initial visit 'day 1', After 8 weeks, After 6 months
Title
Change in quality of life since initial visit
Description
SRS-22
Time Frame
Initial visit 'day 1', After 8 weeks, After 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karina A Kunder, PT, DPT
Organizational Affiliation
Texas Scottish Rite Hospital for Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Scottish Rite Hospital for Children
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Spinal Stabilization Exercises for Low Back Pain in Adolescents With Idiopathic Scoliosis
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