Chronic Low Back PainNCT05443503
Stanford Spine Keeper - Managing Your Low Back Pain
A study testing Mobile health applications (mHealth apps) based intervention in people with Chronic Low Back Pain, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Mobile health applications (mHealth apps) based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stanford Spine Keeper (Who Has Your Back) - A Lifestyle Modification Program for Management of Chronic Low Back Pain
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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Mobile health applications (mHealth apps) based intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health applications (mHealth apps) based interventionOther
Also called Stanford SpineKeeper
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 group | Role | What they receive |
|---|---|---|
| Intervention | Other | 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. Receives: Other: Mobile health applications (mHealth apps) based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
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.
Measured: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
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.
Measured: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
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.
Measured: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
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.
Measured: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
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.
Measured: Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Why it stopped: Software re-development in progress
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew W Smuck, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443503
- Sponsor's protocol ID
- 43204
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2018
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stanford Spine Keeper (Who Has Your Back) - A Lifestyle Modification Program for Management of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05443503
- Acronym / sponsor ID
- 43204
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Software re-development in progress
- Enrolment
- 500,000 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Mobile health applications (mHealth apps) based interventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile health applications (mHealth apps) based interventionAlso: Stanford SpineKeeperPatients 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 | Intervention |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health applications (mHealth apps) based intervention in people with Chronic Low Back Pain, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.