Clinical trial NCT03798288: Randomised Controlled Trial for the selfBACK Project
Official title: A Decision Support System for Self-management of Low Back Pain - a Randomized Controlled Trial for the selfBACK Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Digital Decision Support System
App
Self-management
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: National Research Centre for the Working Environment, Denmark
name: University of Glasgow
name: Robert Gordon University
First posted: 2019-01-09
Enrollment: 461
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design is a multi-center randomised controlled trial with 2 parallel arms
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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),
* Pregnancy,
* Previous back surgery
* Ongoing participation in other research trials for LBP management.

Primary outcomes:
measure: Roland Morris Disability Questionnaire
timeFrame: change from baseline to 3 months
Secondary outcomes:
measure: Pain Self-Efficacy Questionnaire
timeFrame: change from baseline to 3 months
measure: The Fear Avoidance Belief Questionnaire
timeFrame: change from baseline to 3 months
measure: Pain intensity
timeFrame: change from baseline to 3 months
measure: Brief Illness Perception Questionnaire
timeFrame: change from baseline to 3 months
measure: Saltin-Grimby Physical Activity Level Scale
timeFrame: change from baseline to 3 months
measure: Patients Global Perceived Effect
timeFrame: 3 months
Other outcomes:
measure: Workability
timeFrame: change from baseline to 3 months
measure: Health-related Quality of Life
timeFrame: change from baseline to 3 months
measure: Activity limitation
timeFrame: change from baseline to 3 months
measure: Sleep
timeFrame: change from baseline to 3 months
measure: Perceived Stress Scale
timeFrame: change from baseline to 3 months
measure: Patient Health Questionnaire-8
timeFrame: change from baseline to 3 months
measure: Patient Specific Functional Scale
timeFrame: change from baseline to 3 months
measure: Pain duration and frequency
timeFrame: change from baseline to 3 months
measure: Virtual Care Climate Questionnaire
timeFrame: 4 months
measure: User ratings
timeFrame: 4 months
measure: Tailoring variables
timeFrame: weekly for 9 months
measure: Physical activity
timeFrame: weekly for 9 months
measure: Exercise volume
timeFrame: weekly for 9 months
Locations:
city: Odense
country: Denmark
facility: Physical Activity and Health at Work, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: University of Southern Denmark
name: Karen Søgaard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.