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Low Back PainselfBACKNCT03798288

Randomised Controlled Trial for the selfBACK Project

A study testing selfBACK in people with Low Back Pain, run by University of Southern Denmark at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The intervention consists of a digital decision support system delivering a weekly plan of suggested activities that the participant can use to self-manage their low back pain (LBP) via an smartphone app. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Low Back Pain
What is being tested?
selfBACK
Could I receive a placebo?
No, everyone receives an active treatment
How many people
461 participants
Where
2 sitesin 2 countries
Study dates
8 Mar 2019to 20 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • Seeking care from primary health-care practice (general practitioners, physiotherapists, chiropractors) or a local outpatient spinecenter (DK) for non-specific LBP within the past 8 weeks
  • LBP of any duration
  • Mild-to severe pain-related disability rated as 6 or above on the Roland Morris Disability Questionnaire
  • Age: ≥18 years
  • Own and regularly use a smart phone (with at least Android 7.0 or iOS11.0) with internet access (Wi-Fi and/or mobile data)
  • Have a working email address and have access to a computer with internet access to complete questionnaires in a web browser.

Who cannot join

  • Not interested,
  • Unable to speak, read or understand the national language (Danish/ Norwegian),
  • Cognitive impairments or learning disabilities limiting participation,
  • Mental or physical illness or condition limiting participation,
  • Inability to take part in exercise/physical activity,
  • Fibromyalgia (diagnosed by a health care professional),
Show all 9Show fewer
  • Pregnancy,
  • Previous back surgery
  • Ongoing participation in other research trials for LBP management.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Denmark1 site

  • Physical Activity and Health at Work, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark

    Odense, 5230

Other trials in Denmark

Norway1 site

  • Norwegian University of Science and Technology

    Trondheim

Other trials in Norway

About this study

Official title: A Decision Support System for Self-management of Low Back Pain - a Randomized Controlled Trial for the selfBACK Project

The intervention consists of a digital decision support system delivering a weekly plan of suggested activities that the participant can use to self-manage their low back pain (LBP) via an smartphone app.

Read the detailed description

The selfBACK intervention consists of the selfBACK system, that provides the participants with an individually tailored weekly plan of suggested activities to use in their self-management of low back pain.

The selfBACK system constitutes a data-driven decision support system that uses case-based reasoning to capture and reuse participant cases to suggest the most suitable self-management plan for participants. The system is an intelligent system delivering self-management plans tailored to individual participant characteristics. Information about participant characteristics is collected via a (baseline) questionnaire, weekly self-reports via the app on symptom progression etc., and a wristband that detect daily number of steps. The weekly plans are presented in an app to participants.

The weekly plan includes three categories of content;

  1. information/education
  2. recommended daily number of steps
  3. recommended strength and flexibility exercises

Outcomes are collected as baseline, 6 weeks, 3, 6, 9 months.

Conditions
Low Back Pain
Being tested
selfBACK, Usual care
Keywords
Digital Decision Support System, App, Self-management
Medical subject headings
Low Back Pain, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • selfBACKBehavioural

    Participants will use the selfBACK system and app in addition to receiving usual care

  • Usual careOther

    Participants will receive usual care

Study groups in NCT03798288
Study groupRoleWhat they receive
Usual care + selfBACKExperimentalThe selfBACK system constitutes a data-driven decision support system that uses case-based reasoning to capture and reuse participant cases to suggest the most suitable self-management plan for participants. The system is an intelligent system delivering self-management plans tailored to individual participant characteristics. Information about participant characteristics is collected via a (baseline) questionnaire, weekly self-reports via the app on symptom progression etc., and a wristband that detect daily number of steps. The weekly plans are presented in an app to participants. The weekly plan includes three categories of content; 1. information/education 2. recommended daily number of steps 3. recommended strength and flexibility exercises
Receives: Behavioral: selfBACK; Other: Usual care
Usual careActive comparatorAny diagnostic or treatment-related pathway (e.g. receive information, advice or treatment) as instructed by their health care professional. Patients are allowed to seek care, treatment or help elsewhere as normal.
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Roland Morris Disability Questionnaire

    The primary outcome is the Roland Morris Disability Questionnaire (RMDQ) assessing pain-related disability. The questionnaire includes 24 items asking participants to indicate if they experience functional impairments by answering "yes" or "no" to a series of descriptions of functional abilities with higher scores indicating higher level of disability.

    Measured: change from baseline to 3 months

Secondary outcomes (6)

  1. Pain Self-Efficacy Questionnaire

    The questionnaire assesses the participant's level of confidence in carrying out specific activities despite their pain. The PSEQ is a 10-item questionnaire scored on an ordinal scale ranging from zero [completely disagree] to six [completely agree].

    Measured: change from baseline to 3 months

  2. The Fear Avoidance Belief Questionnaire

    The FABQ is a 5-item questionnaire, where the participants score their beliefs about their LBP on an ordinal scale ranging from zero [completely disagree] to six [completely agree]

    Measured: change from baseline to 3 months

  3. Pain intensity

    Pain intensity measured as average and worst LBP within the past week. Measured on a 0 - 10 Numerical Rating Scale with 0 being no pain and 10 being worst pain imaginable.

    Measured: change from baseline to 3 months

  4. Brief Illness Perception Questionnaire

    The questionnaire evaluates the participants' illness perception in an 8-item questionnaire. Items are scored on an ordinal scale ranging from zero [no problems] to 10 [worst severity].

    Measured: change from baseline to 3 months

  5. Saltin-Grimby Physical Activity Level Scale

    Participants indicate their amount of time per week performing leisure activities with four levels of intensity ranging from sedentary to vigorous physically active

    Measured: change from baseline to 3 months

  6. Patients Global Perceived Effect

    A single item question for Patient's Global Perceived Effect will be asked at follow-up, where participants are asked to rate improvement or deterioration of their LBP compared to before the intervention

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2019
  2. Study start8 Mar 2019
  3. Primary completion6 May 2020
  4. Study completion20 Oct 2020

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study design is a multi-center randomised controlled trial with 2 parallel arms
Masking
Single blind
Who is masked
Investigator
Enrolment
461 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03798288
Sponsor's protocol ID
18/17955CDJ
Acronym
selfBACK
Status last verified
Feb 2023
First submitted
7 Jan 2019
Last updated
17 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mork PJ, Bach K; selfBACK Consortium. A Decision Support System to Enhance Self-Management of Low Back Pain: Protocol for the selfBACK Project. JMIR Res Protoc. 2018 Jul 20;7(7):e167. doi: 10.2196/resprot.9379.

    PubMed 30030208

  • Kongstad LP, Overas CK, Skovsgaard CV, Sandal LF, Hartvigsen J, Sogaard K, Mork PJ, Stochkendahl MJ. Cost-effectiveness analysis of app-delivered self-management support (selfBACK) in addition to usual care for people with low back pain in Denmark. BMJ Open. 2024 Sep 5;14(9):e086800. doi: 10.1136/bmjopen-2024-086800.

    PubMed 39242164

  • Bardal EM, Sandal LF, Nilsen TIL, Nicholl BI, Mork PJ, Sogaard K. 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. PLOS Digit Health. 2023 Sep 22;2(9):e0000302. doi: 10.1371/journal.pdig.0000302. eCollection 2023 Sep.

    PubMed 37738237

  • Svendsen MJ, Nicholl BI, Mair FS, Wood K, Rasmussen CDN, Stochkendahl MJ. One size does not fit all: Participants' experiences of the selfBACK app to support self-management of low back pain-a qualitative interview study. Chiropr Man Therap. 2022 Oct 3;30(1):41. doi: 10.1186/s12998-022-00452-2.

    PubMed 36192724

  • Overas CK, Nilsen TIL, Nicholl BI, Rughani G, Wood K, Sogaard K, Mair FS, Hartvigsen J. Multimorbidity and co-occurring musculoskeletal pain do not modify the effect of the SELFBACK app on low back pain-related disability. BMC Med. 2022 Feb 8;20(1):53. doi: 10.1186/s12916-022-02237-z.

    PubMed 35130898

  • Sandal LF, Bach K, Overas CK, Svendsen MJ, Dalager T, Stejnicher Drongstrup Jensen J, Kongsvold A, Nordstoga AL, Bardal EM, Ashikhmin I, Wood K, Rasmussen CDN, Stochkendahl MJ, Nicholl BI, Wiratunga N, Cooper K, Hartvigsen J, Kjaer P, Sjogaard G, Nilsen TIL, Mair FS, Sogaard K, Mork PJ. Effectiveness of App-Delivered, Tailored Self-management Support for Adults With Lower Back Pain-Related Disability: A selfBACK Randomized Clinical Trial. JAMA Intern Med. 2021 Oct 1;181(10):1288-1296. doi: 10.1001/jamainternmed.2021.4097.

    PubMed 34338710

  • Rasmussen CDN, Svendsen MJ, Wood K, Nicholl BI, Mair FS, Sandal LF, Mork PJ, Sogaard K, Bach K, Stochkendahl MJ. App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation. JMIR Res Protoc. 2020 Oct 29;9(10):e20308. doi: 10.2196/20308.

    PubMed 33118959

  • Sandal LF, Stochkendahl MJ, Svendsen MJ, Wood K, Overas CK, Nordstoga AL, Villumsen M, Rasmussen CDN, Nicholl B, Cooper K, Kjaer P, Mair FS, Sjogaard G, Nilsen TIL, Hartvigsen J, Bach K, Mork PJ, Sogaard K. An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 3;8(12):e14720. doi: 10.2196/14720.

    PubMed 31793897

Questions about this trial

What is this clinical trial studying?

A study testing selfBACK in people with Low Back Pain, run by University of Southern Denmark at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. 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: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark, Norway. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Roland Morris Disability Questionnaire (time frame: change from baseline to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03798288, which also lists 8 linked publications.

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 17 Feb 2023.

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