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临床试验/NCT01095783
NCT01095783撤回3 期

Treatment of Low Back Pain in Patients With End-stage Renal Disease on Hemodialysis

Federal University of São Paulo2 个研究点 分布在 1 个国家开始时间: 2009年3月1日最近更新:
适应症

试验速览

阶段
3 期
状态
撤回
发起方
试验地点
2
主要终点
Improvement in functional status of the lumbar spine as measured by the Roland Morris Disability questionnaire, consisting of 24 items wich are reported by the patient. Additionally, the lumbar pain will be assessed by a visual analogue scale.

研究概览

简要总结

The purpose of this study is to determine whether a physiotherapeutic intervention is effective in the treatment of low back pain in hemodialysis patients

详细描述

Low back pain is a significant morbidity in chronic hemodialysis patients affecting about 1/3 of them. Among the physiotherapeutic interventions, the McKenzie Method (Spine 1983;8:141-4), has shown to be an effective approach to manage patients with low back pain. More specifically, it consists on standardized repetitive flexion and extension exercises of the lumbar spine. Thus far, there has been no randomized intervention testing the effectiveness of physiotherapeutic interventions in chronic renal failure patients on hemodialysis. In this study we selected four of their main proposed exercises (flexion in standing, extension in standing, flexion in lying, and extension in lying position) to apply three times a week for eight weeks.

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
None

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

  • Diagnosis of chronic low back pain
  • Chronic renal failure
  • Hemodialysis therapy for more than 3 months

排除标准

  • Fractures of the spine
  • Psychiatric diseases
  • Alcohol of other drugs use
  • Planned living donor transplantation
  • Clinically unstable patients
  • Chronic neurologic diseases

结局指标

主要结局

Improvement in functional status of the lumbar spine as measured by the Roland Morris Disability questionnaire, consisting of 24 items wich are reported by the patient. Additionally, the lumbar pain will be assessed by a visual analogue scale.

时间窗: eight weeks

次要结局

未报告次要终点

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ricardo de Castro Cintra Sesso

Associate Professor

Federal University of São Paulo

研究点 (2)

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