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临床试验/NCT02356783
NCT02356783已完成不适用

Implementation of Wireless Pedometer for Monitoring Step Count Before and After Lumbar Epidural Steroid Injection for Radicular Pain.

Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2015年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
1
主要终点
Percentage of Patients With Available Step Count Data at Baseline.

研究概览

简要总结

Our aim is to assess usability and compliance of a wireless pedometer for monitoring step count after a lumbar epidural steroid injection for the treatment of radicular pain in low back pain patients. Our main hypothesis is to demonstrate pedometer measured step count can be used to measure efficacy of pain interventions.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • 18 years of age and older
  • Patients receiving lumbar epidural steroid injections as pain management to be scheduled at least one week away (-2 days/1 month).
  • Patients who are able to understand how the Fitbit instrument works and are willing to consent to the study.
  • Patient who used web-based communication frequently, e.g. Email.
  • Patients who can speak, understand, and write in English.
  • Prior MRI or an appointment to obtain an MRI prior to the procedure.

排除标准

  • Workers' compensation cases.
  • Patient does not have a computer at home.
  • Non-ambulatory patients.
  • Patients who have received a lumbar epidural steroid injection in the past 6 months.
  • Nursing or pregnant women.

研究组 & 干预措施

Interlaminar

Other

Approach for lumbar epidural steroid injection for this arm will be interlaminar.

We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.

干预措施: Pedometer (Device)

Transforaminal

Other

Approach for lumbar epidural steroid injection for this arm will be transforaminal.

We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.

干预措施: Pedometer (Device)

结局指标

主要结局

Percentage of Patients With Available Step Count Data at Baseline.

时间窗: A week pre-procedure.

Percentage of patients with available step count data 7 days pre-procedure. Step count will be obtained daily for 7 days using a wireless pedometer.

Percentage of Patients With Available Step Count Data Post-procedure.

时间窗: Duration of 60 days after procedure.

Percentage of patients with available step count data 60 days post-procedure. Step count will be obtained using a wireless pedometer daily for a period of 60 days post-procedure.

次要结局

未报告次要终点

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

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