SelfBack App for Chronic Lower Back Pain

Overseen By Greg Kawchuk, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Complex back pain, Cognitive impairments, Serious mental illness, Terminal illness, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an app called SelfBack, designed to help people manage chronic lower back pain. The app offers personalized advice on exercise and education, which is not always accessible to everyone in Canada. The trial aims to determine if chiropractors can effectively distribute the app to their patients. Individuals who have experienced lower back pain affecting their daily life for over a month and are patients of certain chiropractors in Alberta may qualify. Participants need a smartphone with internet access and must speak English. As an unphased trial, this study provides a unique opportunity for patients to access innovative digital health tools to enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using an app for managing back pain, so it's best to discuss your medications with the trial coordinators or your healthcare provider.

What prior data suggests that the SelfBack app is safe for managing chronic lower back pain?

Research has shown that the SelfBack app is generally safe for users. One study found it can assist people with low back pain, even those experiencing stress or depression, indicating its effectiveness for various users.

Another study examined the app's use for long-term low back pain and suggested it might be more beneficial than traditional rehab alone. Although the evidence is not very strong, no major negative effects were reported.

In summary, current research supports the safety of the SelfBack app for managing low back pain, with no major side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for chronic lower back pain, which often include medications, physical therapy, or surgery, the SelfBack app offers a digital, self-management approach. This app is unique because it uses personalized, AI-driven recommendations to guide users through exercises and lifestyle changes tailored to their specific needs. Researchers are excited about the potential for SelfBack to empower users to take control of their own pain management, potentially reducing reliance on more invasive or medication-based treatments. Additionally, the app's accessibility and ease of use make it a promising option for those seeking a more convenient and proactive way to manage their chronic pain.

What evidence suggests that the SelfBack app is effective for chronic lower back pain?

Research has shown that the SelfBack app, provided to participants in this trial, can assist individuals with long-term lower back pain. The app uses artificial intelligence to develop personalized pain management plans. It offers tailored advice on physical activities, exercises, and educational content, and it can also support those experiencing high stress or depression. One study found that combining this app with in-person care might slightly reduce pain over time. The app also benefits users with other health issues, such as joint pain. Overall, these studies suggest that the SelfBack app could be a valuable tool for managing chronic lower back pain. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for Alberta residents aged 18 or older with persistent or recurrent lower back pain impacting daily activities for over a month. Participants must have a smartphone, internet access, and an email address. Chiropractors in Alberta using specific software can also join.

Inclusion Criteria

I am 18 or older and live in Alberta.

Clinician: Must have completed and filed a Privacy Impact Assessment with the Government of Alberta, as identified under the Health Information Act

Clinician: Practicing chiropractor in Alberta

Exclusion Criteria

I have complex back pain that needs direct doctor supervision.

Patient: Patients with serious mental illness

I have cognitive impairments or learning disabilities that limit my participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Baseline Assessment

Eligible chiropractors are trained in the SelfBack app and respond to a baseline survey. Patients download the app and complete baseline questions to tailor the app's advice.

4 weeks

1 visit (in-person) for training, app download and baseline assessment

Intervention

Participants use the SelfBack app, which provides personalized advice on education and exercise for chronic LBP. Data is collected regularly.

6 months

Regular app interactions, 1-2 visits (in-person) as needed

Follow-up

Participants are monitored for their progress and outcomes are assessed at 3 and 6 months.

2 months

2 visits (in-person) for follow-up surveys

What Are the Treatments Tested in This Trial?

Interventions

• SelfBack

Trial Overview The SelfBack app is being tested to see if it's feasible to distribute through chiropractors in Alberta. The app offers tailored self-management plans with advice on physical activity, exercises, and education for chronic lower back pain.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Those who receive the SelfBack app

SelfBack is already approved in Canada for the following indications:

Approved in Canada as SelfBack for:

• Recurrent and persistent low back pain (LBP)

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Chiropractic Association of Alberta

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

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]

In a pilot study involving 8 participants, adding a smartphone app-based self-management program to physiotherapy significantly improved pain self-efficacy and reduced disability, as measured by the Pain Self-Efficacy Questionnaire and Roland Morris Disability Questionnaire.

The self-management approach also enhanced bodily pain and mental health outcomes, suggesting that integrating technology into treatment could provide additional benefits for individuals with chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-Based Remote Self-Management of Chronic Low Back Pain: A Preliminary Study. Yang, J., Wei, Q., Ge, Y., et al.[2020]

The selfBACK app, an AI-based self-management tool for low back pain, was effective in reducing disability related to low back pain, with no significant differences in effectiveness based on age, gender, or education among participants.

However, older participants (aged ≥65 years) experienced a slightly greater benefit from the intervention, showing a 2.6-point improvement in disability scores compared to younger participants, suggesting that the app may have a more pronounced long-term positive effect for older users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do age, gender, and education modify the effectiveness of app-delivered and tailored self-management support among adults with low back pain?-Secondary analysis of the selfBACK randomised controlled trial. Bardal, EM., Sandal, LF., Nilsen, TIL., et al.[2023]

The selfBACK app, an artificial intelligence-based tool for managing nonspecific low back pain (LBP), significantly reduced LBP-related disability at 3 months compared to usual care alone, with effects lasting up to 9 months for all patients, regardless of their initial pain intensity or duration.

While the app showed a notable effect on disability for patients with high initial pain intensity at 3 months, this effect was not sustained at the 9-month follow-up, indicating that the app's benefits are consistent across varying levels of pain severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Pain Duration and Pain Intensity on the Effectiveness of App-Delivered Self-Management for Low Back Pain (selfBACK): Secondary Analysis of a Randomized Controlled Trial. Nordstoga, AL., Aasdahl, L., Sandal, LF., et al.[2023]

The quality of smartphone applications (SPApps) for managing low back pain (LBP) is generally low, with an average rating of only 2.5 out of 5 based on the Mobile App Rating Scale (MARS).

Out of 74 reviewed SPApps, only four included outcome measures that aligned with the International Classification of Functioning, Disability and Health (ICF) components for LBP, indicating a lack of comprehensive effectiveness monitoring in most apps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome measures used in the smartphone applications for the management of low back pain: a systematic scoping review. Coe-O'Brien, R., Joseph, L., Kuisma, R., et al.[2023]

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]

The SELFBACK app, an AI-based tool for managing low back pain (LBP), effectively reduces LBP-related disability regardless of the presence of multimorbidity or additional musculoskeletal pain, as shown in a study with 461 participants over a 9-month follow-up.

While individuals with multiple long-term conditions or additional pain sites had higher baseline disability and reported less improvement over time, the SELFBACK app still provided beneficial support for managing their LBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimorbidity and co-occurring musculoskeletal pain do not modify the effect of the SELFBACK app on low back pain-related disability. Øverås, CK., Nilsen, TIL., Nicholl, BI., et al.[2022]

The selfBACK app, designed to support tailored self-management of nonspecific low back pain (LBP), is being evaluated in a randomized controlled trial involving 350 participants to determine its effectiveness compared to usual care alone.

The app uses artificial intelligence to create personalized self-management plans based on individual cases, which could potentially improve pain-related disability outcomes and serve as a model for future interventions in managing other musculoskeletal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial. Sandal, LF., Stochkendahl, MJ., Svendsen, MJ., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36680381/

The selfBACK artificial intelligence-based smartphone app ... The selfBACK app can improve outcomes even in those with high levels of depressive/stress symptoms and could be recommended for patients with LBP.

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2782459

Effectiveness of App-Delivered, Tailored Self-management ... This randomized clinical trial examines a decision support tool that provides lower back pain information and self-management ...

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

Effectiveness of mobile apps in the rehabilitation of patients ... The use of an app in adjunction to in-person rehabilitation probably reduces pain intensity at long-term follow-up slightly, but probably not ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ejp.2080

The selfBACK artificial intelligence‐based smartphone app ... The selfBACK app can improve outcomes even in those with high levels of depressive/stress symptoms and could be recommended for patients with LBP.

5. bmjopen.bmj.com bmjopen.bmj.com/content/14/9/e086800

Cost-effectiveness analysis of app-delivered self ... Multimorbidity and co-occurring musculoskeletal pain do not modify the effect of the SELFBACK app on low back pain-related disability. BMC Med 2022;20:53 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8329791/

Effectiveness of App-Delivered, Tailored Self-management ... This randomized clinical trial examines a decision support tool that provides lower back pain information and self-management ...

7. mhealth.jmir.org mhealth.jmir.org/2023/1/e40422

The Role of Pain Duration and ... - JMIR mHealth and uHealth This study aims to explore if the baseline duration and intensity of LBP influence the effectiveness of the selfBACK intervention in a secondary analysis.