Stanford Spine Keeper (Who Has Your Back) - A Lifestyle Modification Program for Management of Chronic Low Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Stanford University
- Enrollment
- 500,000
- Locations
- 2
- Primary Endpoint
- Free-living physical activity log
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Mobile health applications (mHealth apps) based intervention (Other)
Outcomes
Primary Outcomes
Free-living physical activity log
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Matthew W Smuck
Assistant Professor, Orthopaedic Surgery Director, Stanford Interventional Spine Center Director, PM&R Spine Fellowship
Stanford University