A Decision Support System for Self-management of Low Back Pain - PILOTSTUDY (selfBACK)

University of Southern Denmark (SDU)

Status: Completed

Conditions: Low Back Pain

Treatments: Other: Usual care + selfBACK

Study type: Interventional

Funder types: Other

Identifiers

NCT03697759

2018/791 (Other Identifier)

S-20182000-24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Usual care + selfBACK

Experimental group

Description:

Participants will use the selfBACK system and app

Treatment:

Other: Usual care + selfBACK