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Orientation Booklet for Low Back Pain

2011年9月23日 更新者:Rioko Kimiko Sakata、Federal University of São Paulo

Effect of Orientation Through a Booklet of Exercise in Patients With Low Back Pain

The aim of this study was to evaluate the effect of exercises performed under monitoring of the physiotherapist and self performed at home by reading the booklet of exercise orientation for patients with nonspecific low back pain.

A prospective and randomized trial was performed in 44 patients. G1 patients received a physiotherapist orientation, and G2 patients received the booklet of exercise to self perform the exercises. Pain intensity by Visual Analogue Scale (VAS), and quality of life by SF-36 were measured before.

Results: Pain intensity was lower in G1 than in G2 after 6 and 12 weeks. Quality of life was better in G1.

The exercises under orientations of the physiotherapist promoted best effect than self performed exercises .

研究概览

地位

完全的

条件

详细说明

After approval by the Ethics Committee and signing a consent form, a prospective, randomized trial was performed in 44 patients with chronic nonspecific low back pain (lasting longer than 3 months), pain intensity greater than 3 by visual analogue scale and age > 18 years. Patients with renal and gastrointestinal disease, simultaneously submitted to another type of physical therapy, cognitive impairment, and pregnant women were excluded.

All patients received an exercise booklet which consisted of stretching and strengthening of muscles. G1 patients were orientated by the physiotherapist during the performance of exercises once a week, using the booklet, and the patients in G2 (n=22) received the booklet to self perform the exercises without orientation of the physiotherapist. Everyone should perform the exercises once a day at home.

Pain intensity by VAS, and quality of life by SF-36 were measured before the start of treatment (T0), after 6 (T6) and 12 (T12) weeks. Side effects were recorded. Acetaminophen (up to 4 g / day) could be used as necessary.

The sample size was provided by SAS 8.0, SPSS 15.0 program. To detect difference in pain intensity of 3 between the groups by VAS, with 95% of power (estimated SD= 2.0), when the alpha level is set at 0.05, the sample should be of 16. The program used for statistical analysis was SAS 8.0, SPSS 15.0. The tests used were Student's T to compare age of patients, chi-square to compare gender and analgesic complementation, and Mann Whitney test for pain intensity and quality of life.

研究类型

介入性

注册 (实际的)

44

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • chronic nonspecific low back pain (lasting longer than 3 months),
  • pain intensity greater than 3 by visual analogue scale and age > 18 years

Exclusion Criteria:

  • Patients with renal and gastrointestinal disease,
  • simultaneously submitted to another type of physical therapy,
  • cognitive impairment, and
  • pregnant women were excluded

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:physiotherapy orientated

G1 patients were orientated by the physiotherapist during the performance of physiotherapy exercises, using the booklet

G2 received the booklet to self perform the physiotherapy exercises

once a day, during 15 minutes, for 12 weeks
其他名称:
  • 运动疗法

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Pain
大体时间:12 weeks
Pain intensity was measured by VAS, and quality of life by SF-36
12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年5月1日

初级完成 (实际的)

2010年3月1日

研究完成 (实际的)

2010年9月1日

研究注册日期

首次提交

2011年9月13日

首先提交符合 QC 标准的

2011年9月23日

首次发布 (估计)

2011年9月26日

研究记录更新

最后更新发布 (估计)

2011年9月26日

上次提交的符合 QC 标准的更新

2011年9月23日

最后验证

2008年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CEP1871/07

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