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临床试验/NCT02420457
NCT02420457已完成不适用

Tracking Outcomes in Pain Patients Using Fitness Devices

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Association of percent improvement in pain and number of steps.

研究概览

简要总结

The investigators are assessing the validity of fitness devices as surrogate measures of chronic pain survey outcomes.

详细描述

The investigators are attempting to validate the usage of personal fitness trackers against the classical survey tools used. These devices are known to be of use in measuring activity and sleep in healthy patients but their use in chronic pain patients has not been assessed. This study will follow participants with chronic back pain undergoing treatment to see if changes in clinical course can be captured with these fitness devices.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Back pain which may benefit from epidural injection
  • Assenting to epidural injection for back pain

排除标准

  • Inability to wear fitness tracking device

研究组 & 干预措施

Back pain receiving epidural injection

Patients who have chronic back pain and are scheduled for an epidural injection to treat this pain will be receive a transforaminal epidural steroid injection as determined by routine care provider

干预措施: Epidural injection (Procedure)

Back pain receiving epidural injection

Patients who have chronic back pain and are scheduled for an epidural injection to treat this pain will be receive a transforaminal epidural steroid injection as determined by routine care provider

干预措施: Epidural steroid injection as determined by routine care provider (Drug)

结局指标

主要结局

Association of percent improvement in pain and number of steps.

时间窗: Follow-up assessment approximately 2-4 weeks following epidural procedure.

Linear regression will be used to determine the association of change in percent improvement of pain (assessed at baseline and follow-up) and number of steps taken on average the week of the assessment. Increased beta-coefficient from linear regression demonstrates that increased improvement in pain is related to an increased number of steps indicating improved mobility. If the beta coefficient from the linear regression is negative, this indicates that percent improvement in pain is associated with decreased number of steps and reduced mobility.

次要结局

  • Change in survey measures of pain(Follow-up assessment approximately 2-4 weeks following the procedure.)
  • Change in pain severity following procedure(Follow-up timepoint approximately 2-4 weeks following procedure)
  • Association in minutes slept as measured by fitness device and percent improvement in pain(Follow-up assessment approximately 2-4 week following procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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