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临床试验/NCT01611792
NCT01611792已完成不适用

Effects and Mechanisms of Specific Trunk Exercises in Low Back Pain

University of Vermont2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2003年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
2
主要终点
Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%)

研究概览

简要总结

Low back pain affects 80% of Americans at some time during their lives. Although recovery usually occurs within 6 months, there is a 50% recurrence within one year's time. It has long been thought that poor control of trunk muscle may lead to abnormal forces across the spine, which then damage local spinal structures, thus, leading to low back pain. However, the investigators know little about the function of specific trunk muscles in healthy subjects during various activities of daily life. Furthermore, the precise muscle dysfunction associated with low back pain has not been well characterized at all. In addition, the investigators know little about which exercise protocol is most beneficial for particular subgroups of people with low back pain. Thus, the purposes of this study are to learn more about: 1) how trunk muscles are affected by low back pain; 2) which exercises might be most beneficial for people with certain kinds of low back pain; and 3) how these exercises influence trunk muscle function. By having a better understanding of which trunk muscles are affected by low back pain, rehabilitation specialists can design exercise programs and therapeutic interventions that are more specific and more effective.

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
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • a history of chronic LBP with or without recurrences for a minimum of 12 months
  • between 21 - 55 years of age
  • able to stand and walk without assistance
  • have an Oswestry Disability Score of 19% or higher

排除标准

  • any major structural spinal deformity including scoliosis, kyphosis, or stenosis
  • spinal fracture or dislocation
  • osteoporosis
  • ankylosing spondylitis
  • rheumatoid arthritis
  • disc herniation with corroborating clinical signs and symptoms
  • serious spinal complications such as tumor or infection
  • previous spinal surgery
  • frank neurological loss, i.e., weakness and sensory loss
  • pain or paresthesia below the knee
  • etiology of LBP other than the lumbar spine, e.g., hip joint
  • history of neurological disease which required hospitalization
  • active treatment for cancer
  • history of unresolved cancer
  • pregnancy or less than 6 months post-partum or less than 6 months post weaning
  • magnified symptom-behavior
  • worker's compensation or disability case
  • in litigation for the LBP problem
  • have a BMI ≥ 30

研究组 & 干预措施

Stabilization

Experimental

干预措施: Stabilization exercise protocol (Other)

Strengthening and Conditioning

Active Comparator

干预措施: Strength and conditioning exercise protocol (Other)

结局指标

主要结局

Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%)

时间窗: Baseline and 11 weeks

Disability; Scale 0-100% Lower score is considered better/improved Negative value indicates improvement

Change From Baseline to 6 Months in Oswestry Disability Scale (0-100%)

时间窗: Baseline and 6 Months

Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement

Change From Baseline to 6 Months in Numeric Pain Rating Scale (0-10 Points)

时间窗: Baseline and 6 months

Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement

Change From 11 Weeks to 6 Months in Oswestry Disability Scale (0-100%)

时间窗: 11 Weeks and 6 Months

Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement

Change From Baseline to 11 Weeks in Numeric Pain Rating Scale (0-10 Points)

时间窗: Baseline and 11 weeks

Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement

Change From 11 Weeks to 6 Months in Numeric Pain Rating Scale (0-10 Points)

时间窗: 11 weeks and 6 months

Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement

次要结局

未报告次要终点

研究者

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

Sharon M. Henry

Professor

University of Vermont

研究点 (2)

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