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

Trial Summary

What is the purpose of this trial?

Recurrent and persistent low back pain (LBP) is a massive problem in Canada that causes a substantial pain, disability, cost, and even premature death. The good news is that treatments for recurrent and persistent LBP are available. Many guidelines now recommend education and exercise as the best intervention for chronic LBP. Unfortunately, education and exercise programs are not publicly funded in Canada-only Canadians with extended health benefits can access these programs. As a result, the 50% of Canadians who do not have extended health benefits often seek care for LBP from their publicly funded physicians. Physicians, in turn, have little choice but to reach for what they have available, including opioids, x-rays and referrals to specialists. Not only are these interventions unhelpful for chronic LBP, they are often harmful, sometimes deadly, and disproportionately affect lower socio-economic status households. A possible solution to this problem exists in a validated app (SelfBack) that provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of treatment plans to individuals is achieved by using case-based reasoning (CBR) methodology which is a branch of artificial intelligence. This study will evaluate the feasibility of distributing the SelfBack app to persons experiencing LBP through their chiropractors. The results of this study will help us understand the barriers and facilitators of distributing and using the app through Alberta Chiropractors. This information will be used to apply for funding for a larger study to understand the effectiveness of the app as an intervention for persistent and recurrent LBP.

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 data supports the effectiveness of the treatment SelfBack App for chronic lower back pain?

Research shows that the SelfBack app, which uses artificial intelligence to provide personalized self-management support, can reduce disability related to low back pain when used alongside usual care. This suggests that the app is effective in helping people manage their low back pain. ^{1 2 3 4 5}

Is the SelfBack App safe for humans?

The available research on the SelfBack App does not specifically mention any safety concerns, suggesting it is generally safe for use in managing low back pain. ^{1 2 3 6 7}

How is the SelfBack App treatment different from other treatments for chronic lower back pain?

The SelfBack App is unique because it uses artificial intelligence to provide personalized self-management support for chronic lower back pain, which is tailored to individual needs and capabilities. Unlike many other treatments, it is delivered through a smartphone app, making it easily accessible and convenient for users to integrate into their daily lives. ^{1 3 6 8 9}

Eligibility Criteria

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

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

I am 18 or older and live in Alberta.

Clinician: Practicing chiropractor in Alberta

Exclusion Criteria

I have complex back pain that needs direct doctor supervision.

Patient: Patients with serious mental illness

I don't have health issues that prevent me from doing exercises.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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, 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]

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]

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, 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]

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]

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]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Outcome measures used in the smartphone applications for the management of low back pain: a systematic scoping review. [2023]

3. England 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. [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. England pubmed.ncbi.nlm.nih.gov

Smartphone-Based Remote Self-Management of Chronic Low Back Pain: A Preliminary Study. [2020]

6. United States 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. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial. [2020]

8. 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]

9. Canada 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. [2023]