Clinical Outcomes in Chronic Low Pain Back Utilizing Activity Trackers
研究概览
地位
条件
详细说明
This is a randomized controlled study to assess the effects of activity monitors, with telehealth follow ups, on the treatment of chronic low back pain subjects. Subjects with low back pain will present for evaluation to the NYIT Academic Health Care Center. Once serious complications have been ruled out and a diagnosis of chronic low back pain has been made, subjects will be informed about this proposed study and asked if they would like to participate. Voluntary subjects will then be consented by designated investigators. The subjects will then be randomized into either the activity tracker and telemedicine follow up group or the control group.
Once enrolled, all subjects will complete the study as outlined in the procedures. It will involve the use of several validated assessment tools. Following the initial visit, subjects in both groups will return in 6 weeks for reassessment. Subjects in the experimental group will additionally be given an activity tracker and have 2 telemedicine visits at 2 and 4 weeks.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New York
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Old Westbury、New York、美国、11568
- NYIT
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Subject is at least 18 years age and younger than 75 years of age
- Subjects evaluated and found to have low back lasting longer than 3 months
Exclusion Criteria:
The subject suffers from any of the following:
- Foot drop
- Recent diagnosis of malignancy
- Recent infection
- Saddle anesthesia
- Urinary or bowel incontinence
Progressive neuromotor or sensory loss
- The subject is unable to complete the assessment tools
- The subject is pregnant
学习计划
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：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：ACTIVITY TRACKER
Subjects in Cohort A will receive standard of care treatments in addition to a Fitbit Flex 2 activity tracker for six weeks and recommendation for daily step counts at initial visit.
Cohort A will then meet with researchers via telehealth at 2 weeks and 4 weeks with researchers to review step counts and reaffirm targets.
Subjects in Cohorts A will be reassessed in person at the conclusion of the six week period.
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Subject counseled on step counts at initial visit and 2 and 4 weeks
Fitbit tracker given to participant
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安慰剂比较：Control
Subjects in Cohort B will receive standard of care treatments in addition to a Fitbit Flex 2 activity tracker for six weeks and recommendation for daily step counts at initial visit.
Subjects in Cohorts B will be reassessed in person at the conclusion of the six week period.
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Fitbit tracker given to participant
Subject counseled on step counts at initial visit
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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 Low Back Pain Disability Questionnaire
大体时间：6 weeks
|
Back pain assessment tool
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6 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Step counts
大体时间：6 weeks
|
Number of steps per day
|
6 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.