Chronic Low-back PainNCT06347991
Alberta Chiropractic SelfBack Study
A study testing SelfBack in people with Chronic Low-back Pain, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- SelfBack
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 24 May 2024to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Clinician Inclusion Criteria:
- 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
Patient Inclusion Criteria:
- 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.
Patient exclusion criteria:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2G3
Greg Kawchuk, PhD, 780-492-6591, greg.kawchuk@ualberta.ca
About this study
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.
Read more
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.
Read the detailed description
Purpose
This study will evaluate the feasibility of distributing the SelfBack app through members of the Chiropractic Association of Alberta and the feasibility of patients using the app.
Justification
The SelfBack app is a promising decision support system (DSS) App used globally to support and reinforce desired self-management behaviour for LBP. Selfback's program goal is to improve the self-management of nonspecific low back pain (LBP) to reduce pain-related disability. Using applications (apps) has been suggested to be a promising way to increase the effectiveness of self-management interventions.
Objectives
Our primary objective is to evaluate the feasibility of distributing and using the SelfBack app. A secondary objective is to assess patient outcomes collected by the SelfBack app.
Methodology Overview
The Chiropractic Association of Alberta (CAA) will recruit members who are interested in being enrolled in the study. Those who meet the eligibility criteria and provide consent will then be trained in the SelfBack app and then respond to a baseline survey to determine their current attitudes and beliefs regarding using the SelfBack app. Trained and enrolled chiropractors will then identify chronic LBP patients in their own practice to receive the SelfBack App. Patients who are eligible and consent to participate will be provided with the SelfBack App. The SelfBack app then collects patient data and provides patients with personalized advice regarding education and exercise for chronic LBP. De-identified group-level Selfback data will then be downloaded by the investigative team at regular intervals for analysis. Finally, chiropractors will provided with a follow-up survey to evaluate their attitudes and beliefs following their involvement in the trial.
Overall timeline and setting:
The study will occur between May 2024 and December 2024 (8 months).
Patient Data
Once patients provide consent to the Investigative Team, they will be sent instructions on how to download and use the SelfBack app. Once installed on the participant's smartphone, the SelfBack app will ask a series of baseline questions (~ 30 min) to establish what educational advice and exercises best suit the participant.
The SelfBack app regularly asks questions of the user to determine their ability to participate in exercise and education and evaluate their progress in the program. The list of survey questions used by the app was created, approved, and distributed by Selfback and is attached to this protocol.
The SelfBack will collect two categories of data.
The first category will be related to patient demographics.
The second category is related to patient-related outcome measures, a variety of established scales, and questionnaires with known psychometric properties. These outcome measures are used to assess the participant's health status, fitness level, and psychological health. These specific outcomes are asked at baseline, 3, and 6 months.
Clinician - Patient Interaction
Chiropractors are not excluded from seeing their patients while patients are using the SelfBack app. Clinical encounters may occur for heart concerns that are unrelated to the study or require in-person evaluation to determine and evaluate their ability to continue in the study.
Clinicians are also provided with a real-time dashboard through Selfback where they can receive information about SelfBack users in real-time. Specifically, the dashboard shows if triggers have occurred which indicates the patient has entered information into the app which requires monitoring or follow-up.
Analyses
The general procedure for statistical analysis is as follows:
Descriptive statistics will be generated which will be cross-tabulated with demographic groups of interest (e.g., gender, age, community size, caregiver status, self-identification of disability, and ethnic and racial identification).
Feasibility will be judged as successful if 50% of the enrolled participants complete the education and exercise program recommended by the app.
- Conditions
- Chronic Low-back Pain
- Being tested
- SelfBack
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelfBackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Those who receive the SelfBack app Receives: Behavioral: SelfBack |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients who utilize the SelfBack app
Success will be defined as 50% of patients using the app
Measured: 8 months
Secondary outcomes (1)
The percentage of clinicians who utilize the SelfBack app
Success will be defined as 50% of clinicians using the app
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start24 May 2024
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Chiropractic Association of Alberta
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347991
- Sponsor's protocol ID
- Pro00140155
- Status last verified
- Apr 2025
- First submitted
- 17 Mar 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alberta Chiropractic SelfBack Study
- ClinicalTrials.gov ID
- NCT06347991
- Acronym / sponsor ID
- Pro00140155
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Chiropractic Association of Alberta
- Study start
- 24 May 2024 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose
This study will evaluate the feasibility of distributing the SelfBack app through members of the Chiropractic Association of Alberta and the feasibility of patients using the app.
Justification
The SelfBack app is a promising decision support system (DSS) App used globally to support and reinforce desired self-management behaviour for LBP. Selfback's program goal is to improve the self-management of nonspecific low back pain (LBP) to reduce pain-related disability. Using applications (apps) has been suggested to be a promising way to increase the effectiveness of self-management interventions.
Objectives
Our primary objective is to evaluate the feasibility of distributing and using the SelfBack app. A secondary objective is to assess patient outcomes collected by the SelfBack app.
Methodology Overview
The Chiropractic Association of Alberta (CAA) will recruit members who are interested in being enrolled in the study. Those who meet the eligibility criteria and provide consent will then be trained in the SelfBack app and then respond to a baseline survey to determine their current attitudes and beliefs regarding using the SelfBack app. Trained and enrolled chiropractors will then identify chronic LBP patients in their own practice to receive the SelfBack App. Patients who are eligible and consent to participate will be provided with the SelfBack App. The SelfBack app then collects patient data and provides patients with personalized advice regarding education and exercise for chronic LBP. De-identified group-level Selfback data will then be downloaded by the investigative team at regular intervals for analysis. Finally, chiropractors will provided with a follow-up survey to evaluate their attitudes and beliefs following their involvement in the trial.
Overall timeline and setting:
The study will occur between May 2024 and December 2024 (8 months).
Patient Data
Once patients provide consent to the Investigative Team, they will be sent instructions on how to download and use the SelfBack app. Once installed on the participant's smartphone, the SelfBack app will ask a series of baseline questions (~ 30 min) to establish what educational advice and exercises best suit the participant.
The SelfBack app regularly asks questions of the user to determine their ability to participate in exercise and education and evaluate their progress in the program. The list of survey questions used by the app was created, approved, and distributed by Selfback and is attached to this protocol.
The SelfBack will collect two categories of data.
The first category will be related to patient demographics.
The second category is related to patient-related outcome measures, a variety of established scales, and questionnaires with known psychometric properties. These outcome measures are used to assess the participant's health status, fitness level, and psychological health. These specific outcomes are asked at baseline, 3, and 6 months.
Clinician - Patient Interaction
Chiropractors are not excluded from seeing their patients while patients are using the SelfBack app. Clinical encounters may occur for heart concerns that are unrelated to the study or require in-person evaluation to determine and evaluate their ability to continue in the study.
Clinicians are also provided with a real-time dashboard through Selfback where they can receive information about SelfBack users in real-time. Specifically, the dashboard shows if triggers have occurred which indicates the patient has entered information into the app which requires monitoring or follow-up.
Analyses
The general procedure for statistical analysis is as follows:
Descriptive statistics will be generated which will be cross-tabulated with demographic groups of interest (e.g., gender, age, community size, caregiver status, self-identification of disability, and ethnic and racial identification).
Feasibility will be judged as successful if 50% of the enrolled participants complete the education and exercise program recommended by the app.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: SelfBackThose who receive the SelfBack app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelfBackThe 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. | Behavioural | Intervention |
Primary outcome
The percentage of patients who utilize the SelfBack app
Time frame: 8 months
Success will be defined as 50% of patients using the app
1 secondary outcome
The percentage of clinicians who utilize the SelfBack app
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SelfBack in people with Chronic Low-back Pain, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Greg Kawchuk, PhD (780-492-6891, greg.kawchuk@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients who utilize the SelfBack app (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.