- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05443503
Stanford Spine Keeper - Managing Your Low Back Pain
Stanford Spine Keeper (Who Has Your Back) - A Lifestyle Modification Program for Management of Chronic Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
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:
The investigators designed the mobile phone application to be compatible with the Apple Inc (iPhone operating system [iOS] 8 or 9) platform - ResearchKit. Our app was based on codes from another Stanford approved ResearchKit study - MyHeart Counts. The ResearchKit platform is set up to help researchers design applications capable of performing HIPAA compliant informed consent, surveys, active tasks, account creation, and passcode pin entry. As in the original MyHeart Counts app, the smartphone consent process used here have been adapted from an opensource toolkit developed by Sage Bionetworks in collaboration with the Electronic Data Methods forum of the AHRQ (Agency for Healthcare Research & Quality). The consent process have previously been reviewed with faculty in the Stanford Center for Biomedical Ethics.
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Matthew Smuck, MD
- Phone Number: 650-721-7600
- Email: Msmuck@stanford.edu
Study Locations
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California
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Redwood City, California, United States, 94063
- Stanford University
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Contact:
- Justin Norden
- Email: Jnorden@stanford.edu
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Principal Investigator:
- Matthew Smuck, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
|
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.
|
Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
|
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.
|
Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
|
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.
|
Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
|
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.
|
Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
|
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.
|
Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 43204
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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