Randomised Controlled Trial for the selfBACK Project

University of Southern Denmark (SDU)

Status: Completed

Conditions: Low Back Pain

Treatments: Other: Usual care; Behavioral: selfBACK

Study type: Interventional

Funder types: Other

Identifiers

NCT03798288

18/17955CDJ

Details and patient eligibility

About

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.

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 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.

Enrollment: 461 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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461 participants in 2 patient groups

Usual care + selfBACK

Experimental group

Description:

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

Treatment:

Other: Usual care

Behavioral: selfBACK

Usual care

Active Comparator group

Description:

Any 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.

Treatment:

Other: Usual care