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Completed

NCT Number: NCT01550497

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

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.

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Key information

Conditions

Adolescent Idiopathic Scoliosis Back Pain Bone Diseases Low Back Pain Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Scoliosis Signs and Symptoms Spinal Curvatures Spinal Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Scottish Rite Hospital for Children

Dallas, Texas, 75219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in pain from initial visit

    Time frame: Initial visit 'day 1', After 8 weeks, After 6 months

    Numeric Pain Rating Scale

Secondary outcomes

  1. Change in back muscle endurance from initial visit

    Time frame: Initial visit 'day 1', After 8 weeks, After 6 months

    Prone double leg raise

  2. Change in quality of life since initial visit

    Time frame: Initial visit 'day 1', After 8 weeks, After 6 months

    SRS-22

Sponsors and collaborators

Lead sponsor

Texas Scottish Rite Hospital for Children

Other

Collaborators

  • American Physical Therapy Association
  • Texas Woman's University

Registry information

Official study title

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

Acronym: LBPAIS

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 12, 2012
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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