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mHealth App for Chronic Lower Back Pain
N/A
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether a new app can help improve quality of life and minimize symptoms in patients with chronic low back pain.
Who is the study for?
This trial is for adults over 18 with chronic low back pain lasting at least 6 months, who can make medical decisions and read English. They must own an iPhone compatible with Apple ResearchKit (iOS 8 or 9) and have internet access. Pregnant individuals, prisoners, those decisionally impaired, or with severe health issues limiting physical therapy participation are excluded.
What is being tested?
The trial is testing a mobile app called Stanford SpineKeeper designed to manage chronic lower back pain through personalized interventions. It uses the Apple ResearchKit platform to deliver a multidisciplinary approach aimed at improving quality of life for patients.
What are the potential side effects?
Since this intervention involves using a mobile health application rather than medication, traditional side effects are not expected. However, users may experience discomfort from increased activity if recommended by the app.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recorded daily for 7 days starting at enrollment and after the completion of each 28-day cycle
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in back range of motion
Change in daily steps
Change in pain score
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 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.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,475 Previous Clinical Trials
17,001,483 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant, in jail, or unable to make decisions for yourself.I don't have severe health issues that would stop me from doing physical therapy.I have experienced low back pain for at least 6 months.I am 18 or older and can make my own medical decisions.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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