Stanford Spine Keeper - Managing Your Low Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile health applications (mHealth apps) based intervention
Sponsored by
About this trial
This is an interventional other trial for Chronic Low Back Pain
Eligibility Criteria
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.
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in reported functional marker profile
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
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
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
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
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.
Free-living physical activity log
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05443503
Brief Title
Stanford Spine Keeper - Managing Your Low Back Pain
Official Title
Stanford Spine Keeper (Who Has Your Back) - A Lifestyle Modification Program for Management of Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
Mobile health applications (mHealth apps) based intervention
Other Intervention Name(s)
Stanford SpineKeeper
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in reported functional marker profile
Description
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.
Time Frame
Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
Title
Change in pain score
Description
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.
Time Frame
Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
Title
Change in daily steps
Description
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.
Time Frame
Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
Title
Change in back range of motion
Description
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.
Time Frame
Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
Title
Change in six-minute walk test
Description
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.
Time Frame
Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
Title
Free-living physical activity log
Description
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.
Time Frame
Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Smuck, MD
Phone
650-721-7600
Email
Msmuck@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ma Agnes Ith
Phone
650-721-7600
Email
Mith@stanford.edu
Facility Information:
Facility Name
Stanford University
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ma Agnes Ith
Phone
650-721-7600
Email
Mith@stanford.edu
First Name & Middle Initial & Last Name & Degree
Justin Norden
Email
Jnorden@stanford.edu
First Name & Middle Initial & Last Name & Degree
Matthew Smuck, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Stanford Spine Keeper - Managing Your Low Back Pain
We'll reach out to this number within 24 hrs