Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT05443503
Status:
SUSPENDED
Last Update Posted:
2025-11-05
First Post:
2018-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stanford Spine Keeper - Managing Your Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500000}}, 'statusModule': {'whyStopped': 'Software re-development in progress', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2018-12-04', 'studyFirstSubmitQcDate': '2022-06-29', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', '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.'}, {'measure': 'Change in pain score', 'timeFrame': 'Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle', '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.'}, {'measure': 'Change in daily steps', 'timeFrame': 'Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle', '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.'}, {'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', '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.'}, {'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', '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.'}, {'measure': 'Free-living physical activity log', 'timeFrame': 'Recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Low Back Pain']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nRecruitment:\n\nParticipants 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.\n\nMaterials\n\nApp Design:\n\nThe 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.\n\nIntervention:\n\nPatients 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).\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Self-reported "yes" to the question "Have you ever had low back pain for 6 months?"\n2. Ownership of an iPhone with an updated operating system (iOS 8 or 9) compatible with Apple ResearchKit with internet connectivity.\n3. Self-reported aged 18 years and older with medical-decision making capacity.\n4. Literacy in the English language\n\nExclusion Criteria:\n\n1. Any serious chronic medical issues (severe cardiac or pulmonary medical problems, cancer) that may limit ability to participate in physical therapy and home exercise.\n2. Individuals who are pregnant, incarcerated, decisionally impaired.'}, 'identificationModule': {'nctId': 'NCT05443503', 'briefTitle': 'Stanford Spine Keeper - Managing Your Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Stanford Spine Keeper (Who Has Your Back) - A Lifestyle Modification Program for Management of Chronic Low Back Pain', 'orgStudyIdInfo': {'id': '43204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '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).\n\nPatients 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.', 'interventionNames': ['Other: Mobile health applications (mHealth apps) based intervention']}], 'interventions': [{'name': 'Mobile health applications (mHealth apps) based intervention', 'type': 'OTHER', 'otherNames': ['Stanford SpineKeeper'], '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.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Orthopaedic Surgery Director, Stanford Interventional Spine Center Director, PM&R Spine Fellowship', 'investigatorFullName': 'Matthew W Smuck', 'investigatorAffiliation': 'Stanford University'}}}}