Randomised Controlled Trial for the selfBACK Project

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

461 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-08

Study Completion Date

2020-10-20

Brief Summary

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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.

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Detailed Description

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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

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study design is a multi-center randomised controlled trial with 2 parallel arms

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

The analysis of the data will be performed blindly.

Study Groups

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Usual care + selfBACK

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

Group Type EXPERIMENTAL

selfBACK

Intervention Type BEHAVIORAL

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

Usual care

Intervention Type OTHER

Participants will receive usual care

Usual care

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.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Participants will receive usual care

Interventions

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selfBACK

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

Intervention Type BEHAVIORAL

Usual care

Participants will receive usual care

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No