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

NCT01550497 | Completed DMC

• 1 other identifier: STU 092011-073
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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)?

Conditions

Adolescent Idiopathic Scoliosis; Low Back Pain

Keywords

back pain; scoliosis; home exercise program

Outcome Measures

Primary Outcomes (1)

• Change in pain from initial visit

  Numeric Pain Rating Scale

  Initial visit 'day 1', After 8 weeks, After 6 months

Secondary Outcomes (2)

• Change in back muscle endurance from initial visit

  Initial visit 'day 1', After 8 weeks, After 6 months

• Change in quality of life since initial visit

  Initial visit 'day 1', After 8 weeks, After 6 months

Study Arms (2)

Home Exercise Group

EXPERIMENTAL

Perform home exercises of unsupervised spinal stabilization exercises for 8 weeks

Other: supervised spinal stabilization exercises

Weeky Physical Therapy Group

EXPERIMENTAL

weekly physical therapy of supervised spinal stabilization exercises for 8 weeks

Other: supervised spinal stabilization exercises

Interventions

supervised spinal stabilization exercises 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.

Home Exercise Group; Weeky Physical Therapy Group

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents (ages 10-17),
• Idiopathic Scoliosis,
• Low Back Pain (\> 2/10 on Numeric Pain Rating Scale)

You may not qualify if:

• other pathology of lumbar spine (like spondylotic lesion),
• current treatment (like bracing and chiropractic care),
• back pain located beyond the lumbar spine

Sponsors & Collaborators

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

Study Sites (1)

Texas Scottish Rite Hospital for Children

Dallas, Texas, 75219, United States

Location

MeSH Terms

Conditions

Low Back Pain; Back Pain; Scoliosis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Karina A Kunder, PT, DPT

  Texas Scottish Rite Hospital for Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physical therapist

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 12, 2012
• Study Start: March 1, 2012
• Primary Completion: October 31, 2013
• Study Completion: October 31, 2013
• Last Updated: October 1, 2021

Record last verified: 2020-10

Locations

US (1)