Stanford Spine Keeper - Managing Your Low Back Pain

NCT05443503 | Suspended

• 1 other identifier: 43204
• Study Type: interventional
• Target: 500,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle

Study Arms (1)

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.

Other: Mobile health applications (mHealth apps) based intervention

Interventions

Mobile health applications (mHealth apps) based 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.

Also known as: Stanford SpineKeeper

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Redwood City, California, 94063, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Orthopaedic Surgery Director, Stanford Interventional Spine Center Director, PM&R Spine Fellowship

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: July 5, 2022
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)