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临床试验/NCT02729181
NCT02729181已完成不适用

Assessment of Activities of Daily Living in Adults With Chronic Low Back Pain Using a Nonoperative Treatment Modality: A Retrospective Study

Integrity Life Sciences0 个研究点目标入组 116 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
116
主要终点
Lower back pain measured on an 11-point numeric rating scale (VAS) with 0 reflecting no pain at all and 10 the worst imaginable pain.

研究概览

简要总结

The investigators hypothesize that treatment with non-invasive spinal decompression reduces discogenic low back pain (LBP), decreases visual analog pain scale scores, increases activities of daily living and decreases medication use.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 18 years of age;
  • consented to the physician prescribed protocol;
  • presented with discogenic low back pain defined as low back pain for minimum of 12 weeks;
  • current CT scan

排除标准

  • metastatic cancer;
  • previous spinal fusion or placement of stabilization hardware within 6 months;
  • instrumentation or artificial discs;
  • neurologic motor deficits, bladder, or sexual dysfunction;
  • alcohol or drug abuse
  • patient's with extremes of height (< 147 cm or > 203 cm) and body weight (> 136 kg).

结局指标

主要结局

Lower back pain measured on an 11-point numeric rating scale (VAS) with 0 reflecting no pain at all and 10 the worst imaginable pain.

时间窗: 12-16 weeks

0= no pain; 10=worst pain

次要结局

  • Functional capacity, measured by activities of daily living(12-16 weeks)
  • Proportion of patients using adjuvant analgesic medication(12-16 weeks)

研究者

发起方
Integrity Life Sciences
申办方类型
Other
责任方
Sponsor

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