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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a smartphone app called SelfBack can assist individuals in managing ongoing and recurring lower back pain without expensive treatments. The app uses artificial intelligence to provide personalized advice on exercise and education. It is ideal for Albertans who have experienced back pain affecting their daily life for over a month and have a smartphone with internet access. Participants should speak English and have access to email. The study will assess the app's usability and aid in planning future, larger studies. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance back pain management for many.

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

Research has shown that the SelfBack app is safe for users. The NHS (National Health Service) in the UK has approved it, indicating it meets safety standards for self-managing low back pain. Studies have found that users tolerate the app well. It provides personalized advice on physical activity and exercises, which many find helpful and easy to follow. No reports of serious side effects have emerged from using the app, suggesting it is a safe option for managing back pain without medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SelfBack app for lower back pain because it offers a fresh approach to self-managing this condition. Unlike traditional treatments that might involve medications, physical therapy, or chiropractic care, SelfBack is a decision support system app that guides users in managing their pain through personalized recommendations. The app is designed to improve self-management skills, aiming to reduce pain-related disability by reinforcing healthy behaviors, which could empower patients to take control of their condition more effectively. This tech-driven solution represents a shift away from passive treatment towards active, user-involved care, which could be groundbreaking for those struggling with nonspecific lower back pain.

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

Research shows that the SelfBack app, used by participants in this trial, helps manage lower back pain. Studies have found that the app supports self-care by providing personalized advice on physical activity, exercises, and educational information. One study found that users reported significantly less pain-related disability. The app is also considered cost-effective for managing lower back pain, offering a good alternative to more expensive treatments. Overall, the SelfBack app appears to be a promising tool for those dealing with ongoing lower back pain, especially when access to traditional care is limited. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Personal smartphone with internet access

Exclusion Criteria

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

Serious mental illness

Inability to take part in exercise/physical activity

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. 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 ...

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

Cost-effectiveness analysis of app-delivered self ... Conclusions From a healthcare perspective, the selfBACK intervention is likely to represent a cost-effective treatment for people with LBP. However, including ...

3. 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.

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

Effectiveness of mobile apps in the rehabilitation of patients ... Objective. To investigate the effectiveness of mobile apps for the treatment of patients with nonspecific low back pain (LBP). Data Sources.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34338710/

A selfBACK Randomized Clinical Trial Effectiveness of App-Delivered, Tailored Self-management Support for Adults With Lower Back Pain-Related Disability: A selfBACK Randomized Clinical Trial.

6. selfback.dk selfback.dk/en/nhs

SelfBack for the NHS: Get Started Today! Approved For Clinical Use in The NHS. NICE has conducted an assessment of nine digital technologies designed for managing non-specific low back pain (LBP).

7. rehab.jmir.org rehab.jmir.org/2020/2/e18729/

Usability and Acceptability of an App (SELFBACK) to Support ... The aim of this study was to assess the usability and acceptability of the SELFBACK smartphone app, designed to support and facilitate self-management of non- ...

8. researchprotocols.org researchprotocols.org/2019/12/e14720/

Protocol for the selfBACK Randomized Controlled Trial The selfBACK intervention is tested on a general LBP population rather than a specific subgroup to reflect that the intervention targets care- ...

9. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-020-00604-2

A digital decision support system (selfBACK) for improved self ... An app-delivered self-management program for people with low back pain: protocol for the selfBACK randomized controlled trial. JMIR Res ...