Clinical trial NCT03697759: A Decision Support System for Self-management of Low Back Pain - PILOTSTUDY
Official title: A Decision Support System for Self-management of Low Back Pain - PILOTSTUDY
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: 2018-10-05
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a pilot study preceding a randomized controlled trial. In the pilot study all enrolled participants are offered the intervention.
Primary purpose: TREATMENT

Brief summary: The pilot study precedes a larger randomized controlled trial, to be starting in February 2019.

In this pilot study all participants are allocated to the intervention group.

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. The plan is presented to the participant in the selfBACK 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 predictive decision support system that uses Case-Based Reasoning methodology to capture and reuse participant cases in order to suggest the most suitable self-management plan for participants. The selfBACK system is an intelligent system that will adjust the suggested self-management plan to the individual participants by using the information available on the participant (baseline questionnaires), weekly self-reported of changes in health status through the app, and data on physical activity via the step-detecting wristband.

The weekly plan includes three categories of content; 1) information/education, 2) physical activity monitoring through wearing a step-detecting wristband, and 3) strength and flexibility exercises.

Eligibility criteria: Inclusion Criteria:

* Seeking care from primary health-care practice or a specialised outpatient hospital facility (DK) for non-specific LBP within the past 8 weeks
* LBP of any duration
* Mild-to severe pain-related disability rated as 16 or below on the PROMIS-PF4 function scale.
* 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 write in the national language (Danish/ Norwegian)
* Cognitive impairment or learning disabilities
* Pathology, such as fracture, cancer, inflammatory diseases, and signs of radiculopathy (severe leg pain, loss of leg strength, or loss of or altered sensation in a myotomal or dermatomal distribution)
* Serious mental illness, such as major depression, schizophrenia, and psychosis
* Terminal illness
* Unable to take part in exercise/physical activity (such as non-ambulatory patients, use of walking aids/assistance, unable to get down and up from the floor independently)
* 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 6 weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: change from baseline to 6 weeks
measure: The Fear avoidance Belief Questionnaire
timeFrame: change from baseline to 6 weeks
measure: Pain Self-Efficacy Questionnaire
timeFrame: change from baseline to 6 weeks
measure: Activity limitation
timeFrame: change from baseline to 6 weeks
measure: Workability
timeFrame: change from baseline to 6 weeks
measure: Saltin-Grimby Physical Activity Level Scale
timeFrame: change from baseline to 6 weeks
measure: Patient Specific Functional Scale
timeFrame: change from baseline to 6 weeks
measure: Sleep
timeFrame: change from baseline to 6 weeks
measure: Perceived Stress Scale
timeFrame: change from baseline to 6 weeks
measure: Health-related Quality of Life
timeFrame: change from baseline to 6 weeks
measure: Brief Illness Perception Questionnaire
timeFrame: change from baseline to 6 weeks
measure: Patient Health Questionnaire-8
timeFrame: change from baseline to 6 weeks
measure: Patients Global Perceived effect
timeFrame: 6 weeks
measure: Patient Acceptable Symptom State
timeFrame: 6 weeks.
measure: Virtual Care Climate Questionnaire
timeFrame: 6 weeks
measure: User ratings
timeFrame: 6 weeks
Other outcomes:
measure: Tailoring variables
timeFrame: Weekly for 6 weeks
measure: Physical activity
timeFrame: weekly for 6 weeks
measure: Exercise volume
timeFrame: weekly for 6 weeks
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 Techonology
Study officials:
affiliation: University of Southern Denmark
name: Karen Søgaard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bach K, Szczepanski T, Aamodt A, Gundersen OE, Mork. PJ. Case Representation and Similarity Assessment in the selfBACK Decision Support System ICCBR 2016: Case-Based Reasoning Research and Development pp 32-46
citation: Sandal LF, Overas CK, Nordstoga AL, Wood K, Bach K, Hartvigsen J, Sogaard K, Mork PJ. A digital decision support system (selfBACK) for improved self-management of low back pain: a pilot study with 6-week follow-up. Pilot Feasibility Stud. 2020 May 23;6:72. doi: 10.1186/s40814-020-00604-2. eCollection 2020.