跳至主要内容
临床试验/NCT03385083
NCT03385083终止不适用

Clinical Outcomes in Chronic Low Pain Back Utilizing Activity Trackers

New York Institute of Technology2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2017年5月12日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
2
主要终点
Oswestry Low Back Pain Disability Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Oswestry Low Back Pain Disability Questionnaire

时间窗: 6 weeks

Back pain assessment tool

次要结局

  • Step counts(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hallie Zwibel

Assistant Professor

New York Institute of Technology

研究点 (2)

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