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

500000 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Mobile health applications (mHealth apps) for chronic lower back pain?

Research suggests that mHealth apps can help people with chronic lower back pain by providing personalized management plans and self-management tools, which may improve their ability to manage pain and daily activities. ^{1 2 3 4 5}

Is the mHealth app for chronic lower back pain safe to use?

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 focus on self-management and rehabilitation support. ^{1 2 3 5 6}

How is the mHealth app treatment for chronic lower back pain different from other treatments?

The mHealth app for chronic lower back pain is unique because it offers personalized self-management plans through a mobile application, allowing users to access rehabilitation tutorials, track their activities, and receive remote health coach support. This approach emphasizes self-management and customization, which is different from traditional treatments that may not offer such individualized and accessible support. ^{1 2 5 7 8}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Creating a Self-management Mobile Application for People With Chronic Low Back Pain: A Focus Group Study of Unmet Needs and Strategies. [2023]

2. England 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. [2022]

3. England 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of smartphone apps for the self-management of low back pain in adults: a systematic review. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

An mHealth App for Self-Management of Chronic Lower Back Pain (Limbr): Pilot Study. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Assessment of the Quality of Mobile Applications (Apps) for Management of Low Back Pain Using the Mobile App Rating Scale (MARS). [2021]

7. England 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Exploring mHealth applications for self-management of chronic low back pain: A survey of features and benefits. [2023]