NCT06347991

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 (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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 17, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 24, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

1.8 years

First QC Date

March 17, 2024

Last Update Submit

April 14, 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

    8 months

Secondary Outcomes (1)

  • The percentage of clinicians who utilize the SelfBack app

    8 months

Study Arms (1)

Intervention

EXPERIMENTAL

Those who receive the SelfBack app

Behavioral: SelfBack

Interventions

SelfBackBEHAVIORAL

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:

  • Practicing chiropractor in Alberta.
  • Will have access to ATLAS, ChiroSUITE, or Jane software packages
  • Must have completed and filed a Privacy Impact Assessment with the Government of Alberta, as identified under the Health Information Act.
  • Connected to Alberta's electronic health record, Netcare
  • Patients of enrolled chiropractors having persistent and/or recurrent LBP defined as those currently having LBP that has impacted daily activities for \> 1 month. I
  • Alberta resident 18 years of age or older
  • Must have a personal smartphone with internet access.
  • Must have a working e-mail address.
  • Must speak, read, and write English or have regular access to persons who can assist in this regard.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

RECRUITING

Central Study Contacts

Greg Kawchuk, PhD

CONTACT

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

March 17, 2024

First Posted

April 4, 2024

Study Start

May 24, 2024

Primary Completion

March 15, 2026

Study Completion

March 15, 2026

Last Updated

April 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations