Effectiveness of the SelfBack-App in Preventing and Treating Low Back Pain Versus no Intervention: a Non-randomized Clinical Trial

Summary

Low back pain (LBP) is the leading cause of disability worldwide and represents a major burden for both individuals and healthcare systems. In Belgium, more than one in five adults experiences an episode of low back pain each year. Healthcare workers, including nurses, nursing assistants, and logistical staff, are particularly vulnerable because of the physical demands of their profession. Daily activities such as patient handling, prolonged standing, repetitive movements, and manual lifting increase their risk of developing low back pain. As a result, these complaints can affect not only the health and well-being of employees but also their work ability, sickness absence, and, ultimately, the continuity and quality of patient care.

The present study evaluates the effectiveness of the SelfBack app, a digital self-management tool developed to support people with non-specific low back pain. The application uses information provided by the user, together with data recorded by a step counter, to create a personalised weekly programme. This programme includes exercises, walking goals, and educational material, all of which are adapted to the user's symptoms, progress, and individual needs.

The study will be conducted at Universitair Ziekenhuis Brussel and Valida and will include nurses, nursing assistants, and logistical staff who experience non-specific low back pain. Hospital departments will be assigned to either the intervention group or the control group. Participants in the intervention group will receive access to the SelfBack app in addition to their usual care, while those in the control group will continue to receive usual care only.

The main objective is to determine whether the use of the SelfBack app improves low back pain-related functional disability after three months. Functional disability will be assessed using the Roland-Morris Disability Questionnaire (RMDQ), a widely used and validated questionnaire for people with low back pain.

In addition to the primary outcome, the study will examine the effects of the intervention on pain intensity, work ability, physical activity, health-related quality of life, and psychological factors such as fear of movement and self-efficacy. Participants' experiences with the application will also be explored. Data will be collected through online questionnaires at baseline and after 3, 6, and 12 months.

The SelfBack app is a CE-marked Class I medical device, and no serious adverse events are expected. All personal data will be handled in compliance with the General Data Protection Regulation (GDPR).

The results of this study will help determine whether a personalised digital self-management programme can provide additional benefits when used alongside standard care for people with non-specific low back pain.

Conditions

• Low Back Pain

Interventions

DEVICE

Selfback app

The SelfBack intervention consists of a digital decision-support system delivered through a smartphone application and is evaluated in healthcare workers (nurses, assistant nurses, and logistical staff) working at Universitair Ziekenhuis Brussel and Ziekenhuis Valida. The application is designed to support the prevention and self-management of non-specific low back pain. The SelfBack application provides participants with personalized weekly self-management plans based on individual characteristics, baseline information, weekly self-reported symptoms, and activity data collected through a step counter. Participants allocated to the intervention group receive access to the SelfBack application in addition to usual care. Exercise adherence and activity levels are monitored through self-reported information within the application. The intervention is provided during the study period, with outcome assessments performed at 3, 6, and 12 months.

OTHER

No Interventions

No intervention

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2026-11-01

Completion

2027-11-01

Countries

• Belgium

Study Locations