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Thera-Band® HEP for LBP Secondary Prevention (TBKT_HEP)

Thera-Band® Based Home Exercise Program for Low Back Pain Secondary Prevention

The purpose of this study is to determine the effectiveness of a Thera-Band based home exercise program (HEP) on LBP and disability 4 weeks post treatment discharge.

研究概览

地位

终止

条件

详细说明

The effectiveness of interventions for the treatment of acute and chronic LBP has been extensively studied, but study of the strategies for preventing the progression of acute LBP episodes into chronic back pain is still lacking. Therefore, determining the most effective secondary prevention strategy for the prevention of recurrences of LBP is essential for the reduction of long term disability. The purpose of this study is to determine the effectiveness of a Thera-Band based home exercise program (HEP) on LBP and disability 4 weeks post treatment discharge. A convenience sample of 22 new patients, 18-65 years of age, with current, chronic LBP will be recruited for this study at the discharge visit from care. Exclusionary criteria will include, current pregnancy and the presence of any red flags such as tumor or cancer, vertebral fracture, or infection. Upon agreeing to the study, patients will sign an informed consent, complete a demographics questionnaire, and complete specific outcome measure assessments. The outcome measures will include Numeric Pain Rating Scale (NPRS) and Oswestry Disability Index (ODI). Additionally, subjects will be asked to complete a secondary prevention program questionnaire. Following the initial paperwork, all patients will be provided with a Thera-Band® Loop and Band and handout describing the HEP to be performed 3 times a week for 4 weeks. At the conclusion of 4 weeks, a follow-up phone call or email, based on patient preference, will be conducted. The follow-up will include pain, disability, compliance, satisfaction of program of the home program.

研究类型

介入性

注册 (实际的)

22

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Maryland
      • Rockville、Maryland、美国、20852
        • Sport & Spine Rehab

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 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • current, chronic low back pain
  • discharging from care

Exclusion Criteria:

  • current pregnancy
  • presence of any red flags such as tumor or cancer, vertebral fracture, or infection

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:预防
  • 分配:不适用
  • 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
实验性的:Home Exercise Program
All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.

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
Oswestry Disability Index
大体时间:4 weeks
Patient disability was measured using the Oswestry Disability Index (OSW), a self-report outcome measure. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. The score is calculated by totaling the values marked, divided by 50 x 100. The greater the score the greater the disability. For example, 0% to 20% would be minimal disability and 81%-100% would be bed-bound. This outcome measure was reported at baseline (T1) and 4 weeks later (T2).
4 weeks

次要结果测量

结果测量
措施说明
大体时间
Numeric Pain Rating Scale
大体时间:4 weeks
The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain. This was measured at baseline (T1) and 4 weeks (T2)
4 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

2015年1月1日

初级完成 (实际的)

2016年1月1日

研究注册日期

首次提交

2015年1月30日

首先提交符合 QC 标准的

2015年1月30日

首次发布 (估计)

2015年2月4日

研究记录更新

最后更新发布 (估计)

2016年2月9日

上次提交的符合 QC 标准的更新

2016年1月11日

最后验证

2016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

  • SSR05

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

腰背疼痛的临床试验

Home Exercise Program的临床试验

3
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