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临床试验/NCT02355275
NCT02355275终止不适用

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

Sport and Spine Rehab Clinical Research Foundation2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
22
试验地点
2
主要终点
Oswestry Disability Index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • current, chronic low back pain
  • discharging from care

排除标准

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

结局指标

主要结局

Oswestry Disability Index

时间窗: 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).

次要结局

  • Numeric Pain Rating Scale(4 weeks)

研究者

发起方
Sport and Spine Rehab Clinical Research Foundation
申办方类型
Other
责任方
Sponsor

研究点 (2)

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