Effectiveness of the SelfBack-App in Preventing and Treating Low Back Pain Versus no Intervention: a Non-randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Roland Morris Disability Questionnaire
研究概览
简要总结
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.
详细描述
Low back pain (LBP) is a frequent condition that can affect daily functioning, physical activity, and work participation. Healthcare professionals, including nurses, assistant nurses, and logistical staff, are considered a population at increased risk because their professional activities often involve physical demands such as patient handling, repetitive movements, prolonged standing, and manual tasks.
The present study evaluates the effectiveness of the SelfBack application, a digital decision-support system designed to support the prevention and self-management of non-specific low back pain. The SelfBack system provides participants with individually adapted weekly recommendations through a smartphone application. These recommendations consist of exercise suggestions, activity goals, and educational information aimed at supporting participants in managing their symptoms and maintaining physical activity.
The study was initially designed as a single-centre clinical trial. Following an amendment dated 17/07/2026, the study was expanded into a multicentre trial to include an additional recruitment site. In addition to Universitair Ziekenhuis Brussel (UZ Brussel), Ziekenhuis Valida will participate in the recruitment of participants. This modification was introduced because recruitment was progressing more slowly than initially expected. Expanding recruitment to a second centre allows a larger number of eligible healthcare workers to be approached and improves the feasibility of completing participant inclusion within the planned timeframe.
The study compares two approaches: usual care combined with access to the SelfBack application and usual care without additional digital intervention. The aim is to determine whether the addition of a digital self-management support system can improve outcomes related to low back pain compared with usual care alone.
The SelfBack application is a digital decision-support system that provides participants with a personalized weekly self-management plan. The recommendations are generated based on information collected from the participant and are adapted according to changes in symptoms and activity levels throughout the intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 18 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently working as a nurse, assistant nurse - logistical assistance in one of the selected units of the Universitair Ziekenhuis (UZ) Brussel, Valida or Inkendaal
- •Presence or not of LBP of any duration
- •Age: ≥18 years
- •Own and regularly use a smartphone (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.
排除标准
- •Unable to speak, read or understand the national languages (Dutch/French/German) nor English
- •Presence of red flags as described in the KCE LBP guidelines
- •Work leave for medical reasons of more than 3 consecutive days during the last 6 months
- •Cognitive impairments or learning disabilities limiting participation
- •Mental or physical illness or condition limiting participation
- •Inability to take part in exercise or physical activity
- •Pregnancy
- •Previous back surgery
- •Ongoing participation in other research trials for LBP management
研究组 & 干预措施
SelfBack App + Usual Care
Participants receive access to the SelfBack application providing personalized self-management plans, including exercise recommendations, activity goals, and educational content, in addition to usual care.
干预措施: Selfback app (Device)
Usual Care Alone
Participants receive usual care without access to the SelfBack application during the study period.
干预措施: No Interventions (Other)
结局指标
主要结局
Roland Morris Disability Questionnaire
时间窗: 3 months
Roland Morris Disability Questionnaire: the questionnaire includes 24 items asking participants to indicate if they experience functional impairments. This is tested by answering to a series of descriptions of functional abilities with higher scores indicating higher level of disability. This questionnaire will be held at 3 months after the begin of the intervention.
次要结局
- Roland Morris Disability Questionnaire(6 en 12 maanden)
- Oswestry disability questionnaire(3, 6 en 12 maanden)
- PROMIS 29(This questionnaire will be held for 3, 6 and 12 months.)
- Work Ability Index (WAI)(This questionnaire will be held for 3, 6 and 12 months.)
- EQ5D - 5L(This questionnaire will be held for 3, 6 and 12 months)
- VAS score(This questionnaire will be held for 3, 6 and 12 months.)
- Tampa scale of kinesiophobia (TSK )(This questionnaire will be hold at 3, 6 and 12 months.)
- The Fear Avoidance Belief Questionnaire (FABQ)(This questionnaire will be held for 3, 6 and 12 months.)
- Pain Self-Efficacy Questionnaire:(This questionnaire will be held for 3, 6 and 12 months.)
- Physical activity([Timeframe: weekly for 9 months]. This questionnaire will be held for 3, 6 and 12 months.)
- Exercise volume(This questionnaire will be held for 3, 6 and 12 months.)
- Healthcare service use:(12 months)
- Saltin-Grimby Physical Activity Level Scale(This questionnaire will be held for 3, 6 and 12 months. (18))
- Tailoring variables:(Participants in the intervention are on a weekly basis asked a set of tailoring questions.)
- User ratings(This questionnaire will be held for 3, 6 and 12 months.)