Stanford Spine Keeper (Who Has Your Back) - A Lifestyle Modification Program for Management of Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 500,000
- 试验地点
- 2
- 主要终点
- Free-living physical activity log
研究概览
简要总结
Mobile health applications (mHealth apps) are transforming medical research and intervention by allowing constant, instantaneous and personalized access to patients. The investigators have designed a mHealth app (Stanford SpineKeeper) utilizing the Apple ResearchKit and HealthKit platform, which is an open source software framework designed Apple Inc to be used by medical researchers to use for research purposes. The investigators will assess whether a multidisciplinary intervention delivered through the application can help improve quality of life and minimize symptoms in patients with chronic low back pain.
详细描述
The purpose of this study is to assess whether a mHealth app based intervention can improve symptoms and quality of life in human subjects. Access to human subjects is critical to the success of this project.
Recruitment:
Participants will be recruited via the Apple ResearchKit platform. Interested participants who answers "yes" to the questions "Are you having low back pain?" and "Have your back pain been an ongoing problem for 6 months or longer?" are eligible to download the mobile phone application and participate. Patients will provide electronic informed consent via the mobile application . A phone number will be provided for potential participants to call to speak to a live representative.
Materials
App Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Self-reported "yes" to the question "Have you ever had low back pain for 6 months?"
- •Ownership of an iPhone with an updated operating system (iOS 8 or 9) compatible with Apple ResearchKit with internet connectivity.
- •Self-reported aged 18 years and older with medical-decision making capacity.
- •Literacy in the English language
排除标准
- •Any serious chronic medical issues (severe cardiac or pulmonary medical problems, cancer) that may limit ability to participate in physical therapy and home exercise.
- •Individuals who are pregnant, incarcerated, decisionally impaired.
研究组 & 干预措施
Intervention
Patients can choose among or choose to be assigned to 2 tracks for management for their low back pain. The tracks include one focused on relaxation and symptom management, and another track on increasing activity. Each include educational material adapted from various sources from North America Spine Society (NASS), Center for Disease Control (CDC), National Institue of Health (NIH).
Patients will stay in track for 28 days. After this, they may choose to remain in track and continue to perform maintenance activities or to engage in a different track.
干预措施: Mobile health applications (mHealth apps) based intervention (Other)
结局指标
主要结局
Free-living physical activity log
时间窗: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
Log of free-living (outside of the laboratory) physical activity recorded using the Stanford Spine Keeper app, which utilizes the Recommended Minimum Dataset from NIH Task Force on Research Standards for Chronic Low Back.
Change in reported functional marker profile
时间窗: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
Qualitative assessment of back pain and quality of life using the Stanford Spine Keeper app, which utilizes the Recommended Minimum Dataset from NIH Task Force on Research Standards for Chronic Low Back.
Change in pain score
时间窗: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
Patient-report pain rated on a 0-10 scale (0 = no pain, 10 = worst pain) using the Stanford Spine Keeper app, which utilizes the Recommended Minimum Dataset from NIH Task Force on Research Standards for Chronic Low Back.
Change in daily steps
时间窗: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
Change in daily steps recorded using the Stanford Spine Keeper app, which utilizes the Recommended Minimum Dataset from NIH Task Force on Research Standards for Chronic Low Back.
Change in back range of motion
时间窗: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
Change in back range of motion recorded using the Stanford Spine Keeper app, which utilizes the Recommended Minimum Dataset from NIH Task Force on Research Standards for Chronic Low Back.
Change in six-minute walk test
时间窗: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
Change in six-minute walk test recorded using the Stanford Spine Keeper app, which utilizes the Recommended Minimum Dataset from NIH Task Force on Research Standards for Chronic Low Back.
次要结局
未报告次要终点
研究者
Matthew W Smuck
Assistant Professor, Orthopaedic Surgery Director, Stanford Interventional Spine Center Director, PM&R Spine Fellowship
Stanford University