mHealth App for Chronic Lower Back Pain

Overseen By Matthew Smuck, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Severe cardiac, pulmonary, cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a mobile health app (mHealth app) can help people with chronic lower back pain improve their quality of life and reduce symptoms. The app offers two tracks: one focuses on relaxation and symptom management, while the other emphasizes increasing activity. Both tracks include educational content from reputable health organizations. It suits individuals who have experienced lower back pain for at least six months and own an iPhone. Participants will use the app for 28 days and can choose to continue or switch tracks afterward. As an unphased trial, this study provides a unique opportunity to contribute to innovative research and potentially enhance personal health management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this mHealth app is safe for managing chronic lower back pain?

Research has shown that mobile health (mHealth) apps are generally safe for managing chronic lower back pain. Although specific safety data for these apps is lacking, they typically do not cause harm. Some apps include features that alert users when a doctor's visit is necessary. Users can feel confident using these apps, as they primarily offer educational information and assist in symptom management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about mHealth apps for chronic lower back pain because they offer a flexible, personalized approach to pain management. Unlike traditional treatments like physical therapy or medication, these apps provide patients with the choice to focus on relaxation and symptom management, or to increase activity through structured tracks. Each track is equipped with educational materials from reputable sources like the North America Spine Society and the CDC, giving patients access to expert information right on their smartphones. This method empowers patients to take control of their treatment and adapt it to their lifestyles, potentially leading to more consistent engagement and better outcomes.

What evidence suggests that this mHealth app is effective for chronic lower back pain?

Research has shown that mobile health apps can help manage chronic low back pain. In this trial, participants will use a mobile health app offering two tracks for managing their pain: one focused on relaxation and symptom management, and another on increasing activity. One study found these apps more effective than rehabilitation exercises alone in reducing short-term pain. Another study highlighted that an app called PainNavigator significantly improved chronic low back pain management. However, some research suggests that using mobile health apps alone might not surpass regular care in reducing pain and disability. Overall, mobile health apps show promise, but results can vary. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Literacy in the English language

I have experienced low back pain for at least 6 months.

Ownership of an iPhone with an updated operating system (iOS 8 or 9) compatible with Apple ResearchKit with internet connectivity

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Electronic consent via mobile application

Intervention

Participants choose or are assigned to a track focused on relaxation and symptom management or increasing activity, using educational materials from NASS, CDC, and NIH

4 weeks

Daily app-based interaction

Follow-up

Participants are monitored for changes in physical activity, pain score, and quality of life using the app

1 week

Daily app-based monitoring

Maintenance or Track Change

Participants may choose to continue in the same track or switch to a different track for ongoing management

4 weeks

Daily app-based interaction

What Are the Treatments Tested in This Trial?

Interventions

• Mobile health applications (mHealth apps)

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

A systematic review of six studies involving 2100 participants found that smartphone apps can lead to a significant decrease in pain intensity and disability for adults managing low back pain, but results are inconsistent and not all studies showed benefits.

Current evidence is inconclusive regarding the effectiveness of smartphone apps for low back pain self-management without professional support, highlighting the need for further research and better regulation of app content to ensure alignment with evidence-based guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of smartphone apps for the self-management of low back pain in adults: a systematic review. Didyk, C., Lewis, LK., Lange, B.[2023]

The 'Relieve my back' smartphone application significantly reduced pain intensity and disability in office workers with chronic low back pain after six weeks of use, compared to a control group that received a placebo version.

Participants using the application also experienced a notable improvement in their quality of life, as measured by the Short-Form Health Survey, indicating its potential as an effective management tool for low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an innovative smartphone application for office workers with chronic non-specific low back pain: a pilot randomized controlled trial. Almhdawi, KA., Obeidat, DS., Kanaan, SF., et al.[2022]

The selfBACK app, designed for self-management of low back pain, was tested in a pilot study with 51 participants, showing a small but significant improvement in pain-related disability after 6 weeks of use, as measured by the Roland-Morris Disability Questionnaire (RMDQ).

Recruitment and screening procedures for the study were found to be feasible, with an acceptable ratio of participants screened to those enrolled, indicating that the methods could be effectively used in a larger randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A digital decision support system (selfBACK) for improved self-management of low back pain: a pilot study with 6-week follow-up. Sandal, LF., Øverås, CK., Nordstoga, AL., et al.[2022]

A systematic review of 25 smartphone apps for low back pain management found that while the average quality of these apps was acceptable (mean MARS score of 3.9 out of 5), their potential for supporting self-management and behavior change was low (mean SMS-14 score of 3.4/14 and ABACUS score of 5.4/21).

Clinicians should be cautious when recommending these apps, as they often lack features specifically designed to enhance self-management and behavior change, despite being of average to good quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Availability, content and quality of commercially available smartphone applications for the self-management of low back pain: a systematic assessment. Didyk, C., Lewis, LK., Lange, B.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9614628/

An Evaluation of a Mobile App for Chronic Low Back Pain ... These findings show that PainNavigator has clinical significance in managing chronic low back pain and can be easily utilized to improve patient ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0003999325009074

Effectiveness of mobile apps in the rehabilitation of patients ... In a population of chronic LBP, the use of apps was significantly superior compared to rehabilitation alone on short-term pain intensity, but ...

3. mhealth.jmir.org mhealth.jmir.org/2024/1/e53262

mHealth Apps for the Self-Management of Low Back Pain Conclusions: mHealth apps are potentially promising alternatives to help people manage their LBP; however, most of the LBP self-management apps ...

4. journals.lww.com journals.lww.com/painrpts/fulltext/2025/04000/efficacy_of_mobile_health_interventions_in_the.9.aspx

Efficacy of mobile health interventions in the ... mHealth interventions show potential in reducing pain and disability among patients with CLBP in LMICs, although with inconclusive impact on QoL.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37962085/

Efficacy of mHealth Interventions for Improving the Pain ... mHealth alone was no more effective than usual care or no treatment in improving pain intensity and disability in individuals with low back pain.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10870204/

mHealth Apps for the Self-Management of Low Back Pain Even fewer, 11 (16%) apps offered safety checks for app users, including identifying red flags, signs, and symptoms of LBP that required ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772628223000559

Mobile apps to self-manage chronic low back pain The aim of this study was to explore how and why a mobile app might help a person self-manage CLBP. Since people living with CLBP are experts in ...

8. withpower.com withpower.com/trial/phase-back-pain-2023-a1559

mHealth App for Chronic Lower Back Pain The available research does not provide specific safety data for mHealth apps for chronic lower back pain, but these apps are generally considered safe as they ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jsp2.70118

Mobile Health (mHealth) for Chronic Low Back Pain ... This study introduces a mobile health (mHealth) system for cLBP assessment, aiming to collect extensive biomechanical and behavioral data from ...

10. link.springer.com link.springer.com/article/10.1007/s41666-024-00179-0

“My Back Exercise App”—mHealth for Low Back Pain This study reports on developing and usability testing My Back Exercise, an mHealth app designed to support individuals managing chronic LBP.