SelfBack App for 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: 1

Duration: 8 months

100 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. It might be best to discuss this with the trial coordinators or your doctor.

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

Research shows that the SelfBack App, which uses artificial intelligence to provide personalized self-management support, can reduce disability related to lower back pain when used alongside usual care. ^{1 2 3 4 5}

Is the SelfBack App safe for humans?

The available research does not specifically address the safety of the SelfBack App, but it is developed in collaboration with clinicians and based on best evidence for self-management of low back pain, suggesting a focus on safe practices. ^{2 4 5 6 7}

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

The SelfBack App is unique because it uses artificial intelligence to provide personalized self-management support for people with lower back pain, enhancing usual care by tailoring advice based on best evidence. Unlike many other treatments, it is a digital tool that empowers users to manage their condition through a smartphone app. ^{2 3 4 5 7}

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 methodology which is a branch of artificial intelligence. This study will evaluate the feasibility of distributing the SelfBack app to persons experiencing LBP through the Rehabilitation Advice Line, a telephone service open Monday to Friday and provides rehabilitation advice and general health information for Albertans of any age. The results of this study will help us understand the barriers and facilitators of distributing and using the app in the general pollution of Alberta. 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.

Eligibility Criteria

This trial is for individuals in Alberta experiencing lower back pain (LBP), who may not have access to publicly funded education and exercise programs due to lack of extended health benefits. It aims to help those often reliant on less effective treatments like opioids or specialist referrals.

Inclusion Criteria

I have had lower back pain that affects my daily activities for more than a month.

I am over 18 and live in Alberta.

My back pain and leg symptoms are stable.

Exclusion Criteria

I do not have cognitive impairments or learning disabilities that limit my participation.

I have severe back pain that needs a doctor's close supervision.

Inability to take part in exercise/physical activity

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants use the SelfBack app to receive personalized advice on education and exercise for chronic low back pain

8 months

Regular app interactions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Data collection via app

Treatment Details

Interventions

• SelfBack

Trial Overview The SelfBack app, which offers tailored self-management plans including advice on physical activity, exercises, and educational content using artificial intelligence, is being tested. The study assesses the feasibility of distributing this app through a telephone service called the Rehabilitation Advice Line.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

The SelfBack app is a promising decision support system (DSS) App used globally to support and reinforce desired self-management behavior for LBP. Selfback's program goal is to improve the self-management of nonspecific LBP to reduce pain-related disability.

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+

Findings from Research

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]

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, 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]

Many smartphone apps for self-managing low back pain (LBP) exist, but their effectiveness in improving patient outcomes has not been rigorously evaluated, raising concerns about their reliability.

While app developers are generally choosing interventions that align with clinical guidelines, the overall quality of these apps is low, indicating a need for collaboration with healthcare professionals to enhance content accuracy and evidence-based practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone apps for the self-management of low back pain: A systematic review. Machado, GC., Pinheiro, MB., Lee, H., et al.[2022]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. 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]

3. 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]

4. 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]

5. 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]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Smartphone apps for the self-management of low back pain: A systematic review. [2022]

7. 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]