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临床试验/NCT01550497
NCT01550497已完成不适用

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

Texas Scottish Rite Hospital for Children2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2012年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Change in pain from initial visit

研究概览

简要总结

  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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Change in pain from initial visit

时间窗: Initial visit 'day 1', After 8 weeks, After 6 months

Numeric Pain Rating Scale

次要结局

  • Change in quality of life since initial visit(Initial visit 'day 1', After 8 weeks, After 6 months)
  • Change in back muscle endurance from initial visit(Initial visit 'day 1', After 8 weeks, After 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karina Zapata, PT, DPT, PhD

physical therapist

Texas Scottish Rite Hospital for Children

研究点 (2)

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