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临床试验/NCT01919268
NCT01919268已完成不适用

Effectiveness of the Addition of the Interferential Current to the Pilates Method in the Treatment of Patients With Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial

Universidade Cidade de Sao Paulo2 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2013年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
148
试验地点
2
主要终点
Pressure pain threshold

研究概览

简要总结

This study aims to evaluate the effectiveness of the addition of the interferential current to Pilates method exercises in the treatment of 148 patients with chronic nonspecific low back pain.

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

入选标准

  • Sedentary patients with chronic nonspecific low back pain longer than 12 weeks
  • Pain greater than three points in Pain Numerical Rating Scale

排除标准

  • Contra indications to physical exercise
  • Serious spinal pathologies (e.g. tumors, fractures and inflammatory diseases)
  • Nerve root compromise
  • Pregnancy
  • Infection and/or skin lesions at the site of the application of the interferential current
  • Cardiac pacemaker
  • Changes in sensitivity or allergy in the region of electrode placement
  • Previous surgery on spine or physical therapy for chronic nonspecific low back pain in the last six months
  • Previous experience with the Pilates method

结局指标

主要结局

Pressure pain threshold

时间窗: Six weeks after randomization

Pressure pain threshold will be evaluated using a pressure algometer

Pain intensity

时间窗: Six weeks after randomization

Pain intensity will be measured by an 11-point Pain Numerical Rating Scale

Disability

时间窗: Six weeks after randomization

Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire

次要结局

  • Specific disability(Six weeks and six months after randomization)
  • Pain intensity(Six months after randomization)
  • Global impression of recovery(Six weeks and six months after randomization)
  • Kinesiophobia(Six weeks and six months after randomization)
  • Disability(Six months after randomization)

研究者

发起方
Universidade Cidade de Sao Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristina Maria Nunes Cabral

Associate Professor

Universidade Cidade de Sao Paulo

研究点 (2)

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