NCT06484751

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

June 26, 2024

Last Update Submit

July 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The percentage of patients who utilize the SelfBack app

    Success will be defined as 50% of patients using the app

    12 months

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Device: SelfBack

Interventions

SelfBackDEVICE

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be Albertan adults over 18 years of age
  • be persons who meet the above definition of LBP, but may also include patients with stable radiculopathy/sciatica
  • have a personal smartphone with internet access.
  • have a working e-mail address.
  • speak, read, and write English or have regular access to persons who can assist in this regard.

You may not qualify if:

  • be patients who have complex back pain that requires direct clinical oversight.
  • have cognitive impairments or learning disabilities limiting participation.
  • have a serious mental illness
  • have non-LBP illnesses or conditions that are contraindicated to participation in SelfBack (e.g. exercise).
  • have a terminal illness
  • have an inability to take part in exercise/physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta rehabilitation advice line

Edmonton, Albertta, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

July 15, 2024

Primary Completion

June 6, 2025

Study Completion

June 6, 2025

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations