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

NCT ID: NCT01550497

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-01
• Study Completion Date: 2013-10-31

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.

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.

Conditions

Adolescent Idiopathic Scoliosis; Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Home Exercise Group

Perform home exercises of unsupervised spinal stabilization exercises for 8 weeks

Group Type: EXPERIMENTAL

supervised spinal stabilization exercises

Intervention Type: OTHER

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.

Weeky Physical Therapy Group

weekly physical therapy of supervised spinal stabilization exercises for 8 weeks

Group Type: EXPERIMENTAL

supervised spinal stabilization exercises

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Physical Therapy Association

OTHER

Sponsor Role: collaborator

Texas Woman's University

OTHER

Sponsor Role: collaborator

Texas Scottish Rite Hospital for Children

OTHER

Sponsor Role: lead

Responsible Party

Karina Zapata, PT, DPT, PhD

physical therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karina A Kunder, PT, DPT

Role: PRINCIPAL_INVESTIGATOR

Texas Scottish Rite Hospital for Children

Locations

Texas Scottish Rite Hospital for Children

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU 092011-073

Identifier Type: -

Identifier Source: org_study_id