Clinical trial NCT05443503: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 500000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. Self-reported "yes" to the question "Have you ever had low back pain for 6 months?"
2. Ownership of an iPhone with an updated operating system (iOS 8 or 9) compatible with Apple ResearchKit with internet connectivity.
3. Self-reported aged 18 years and older with medical-decision making capacity.
4. Literacy in the English language

Exclusion Criteria:

1. Any serious chronic medical issues (severe cardiac or pulmonary medical problems, cancer) that may limit ability to participate in physical therapy and home exercise.
2. Individuals who are pregnant, incarcerated, decisionally impaired.

Primary outcomes:
measure: Change in reported functional marker profile
timeFrame: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
measure: Change in pain score
timeFrame: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
measure: Change in daily steps
timeFrame: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
measure: Change in back range of motion
timeFrame: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
measure: Change in six-minute walk test
timeFrame: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
measure: Free-living physical activity log
timeFrame: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University
state: California
Study officials:
References: