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临床试验/NCT02837653
NCT02837653已完成不适用

Efficacy of a Physical Activity Counselling on the Severity of Chronic Low Back Pain in Patients With Cardiovascular Risk

Universidad Autonoma de Madrid2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
Severity of Chronic Pain

研究概览

简要总结

Objective: To determine the influence of a counseling of physical activity (PA) versus usual care (UC) in the magnitude of chronic pain (CP) in patients diagnosed with chronic low back pain (CLBP).

Methods: A total of 64 subjects with (CLBP) and older were randomly divided into two groups: an experimental group (UC) + counseling of (AF) and control group (UC). Each group consisted of 32 participants and were evaluated twice (pre and post-intervention), being spaced one month, both groups received telephone follow-up for their participation. The primary endpoint was the magnitude of the (CP) measured by the tool grading scale of chronic pain (EGDC), while as secondary were considered the cardiovascular risk factors, catastrophism, kinesiofobia, disabled by back pain, quality of life, anxiety and depression and the (FA).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients with low back pain more than 3 months
  • Age over 18 years old
  • Low or Medium Cardiovascular Risk

排除标准

  • Cardiovascular Risk Factors ≥ 5
  • Quirurgic procedures at spine last 10 years
  • Past of Cancer, or Fibromialgia

结局指标

主要结局

Severity of Chronic Pain

时间窗: 1 month

Graded Chronic Pain Scale

次要结局

  • Anxiety and Depression(1 month)
  • Quality of Life(1 month)
  • Amount of Physical Activity(1 month)
  • Catastrophism(1 month)
  • Kinesiophibia(1 month)
  • Cardiovascular Risk Factors(1 month)
  • Low Back Pain Percieved Disability(1 month)

研究者

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

Raúl Ferrer-Peña

Principal Investigator

Universidad Autonoma de Madrid

研究点 (2)

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