跳至主要内容
临床试验/NCT03169140
NCT03169140终止不适用

Effect of Biofreeze®, TheraBand® Kinesiology Tape, or the Combination of Products on Acute Low Back Pain, Disability, and Range of Motion

Sport and Spine Rehab Clinical Research Foundation2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年2月14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
120
试验地点
2
主要终点
Change in Fear Avoidance Beliefs Questionnaire (FABQ) over one week

研究概览

简要总结

The purpose of this study is to compare the effect of a combination of separate therapies of Biofreeze® and TheraBand Kinesiology Tape to advice on acute pain, disability and fear avoidance among low back patients over a 1-week period of time.

详细描述

A convenience sample of 120 acute low back pain patients will be recruited from Sport and Spine Rehab at their initial appointment. Exclusionary criteria will include pregnancy, cancer, or a corticosteroid injection within the past 2 weeks. Additionally, anyone who has a history of low back surgery will be excluded. Patients will be recruited following their initial examination if they meet the inclusion criteria of reporting low back pain for less than 2 weeks and be >18 years of age. Patients will complete the informed consent, demographics information questionnaire, Numeric Pain Rating Scale (NPRS), Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ), Fear Avoidance Beliefs Questionnaire (FABQ). Following paper documents their lumbar range of motion and posture will be analyzed using the DorsaVi ViMove device [http://us.dorsavi.com/vimove/\] (T1). After completing T1, patients will then be randomized into 1 of 4 at-home pain management groups (n=30 per group), to be followed for one week. Group 1 (Biofreeze® + Tape), Group 2 (Tape Only), Group 3 (Biofreeze Only), and Group 4 (Advice Alone). Treatment at the first office visit will be standardized to include manipulation only; no in-office therapy will be provided to either group at the first visit. Upon returning for their 2nd (T2), and 3rd (T3) office visits, all patients will rate their pain (NPRS). At one week (T4) patients will complete the paper and pencil instruments from the first visit, which assess the subjects' pain on the Numeric Pain Rating Scale (NPRS), low back disability on the Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ), and fear on the Fear Avoidance Beliefs Questionnaire (FABQ). Lumbar range of motion and posture will also be reassessed. In addition,, at home pain management compliance and pain medication will be documented on a daily basis for the entire week.

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
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

  • low back pain for less than 2 weeks and 18 years of age or older

排除标准

  • pregnancy, cancer, or a corticosteroid injection within the past 2 weeks and a history of low back surgery

结局指标

主要结局

Change in Fear Avoidance Beliefs Questionnaire (FABQ) over one week

时间窗: Baseline (T1), 1 week (T4)

Change in lumbar range of motion over one week

时间窗: Baseline (T1), 1 week (T4)

Using the DorsaVi sensor technology lumbar flexion, extension, and side bending will be measures

Change in Numeric Pain Rating Scale (NPRS) over one week

时间窗: Baseline (T1), Day 2 (T2), Day 4 (T3), 1 week (T4)

Change in Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ) over one week

时间窗: Baseline (T1), 1 week (T4)

次要结局

未报告次要终点

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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