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

NCT07785804 | Enrolling By Invitation

• 1 other identifier: 25099
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

selfback app; low back pain

Outcome Measures

Primary Outcomes (1)

• Roland Morris Disability Questionnaire

  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.

  3 months

Secondary Outcomes (15)

• 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

Study Arms (2)

SelfBack App + Usual Care

ACTIVE COMPARATOR

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.

Device: Selfback app

Usual Care Alone

PLACEBO COMPARATOR

Participants receive usual care without access to the SelfBack application during the study period.

Other: No Interventions

Interventions

Selfback app DEVICE

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.

SelfBack App + Usual Care

No Interventions OTHER

No intervention

Usual Care Alone

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Uz Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

Related Publications (14)

• Dube MO, Langevin P, Roy JS. Measurement properties of the Pain Self-Efficacy Questionnaire in populations with musculoskeletal disorders: a systematic review. Pain Rep. 2021 Dec 21;6(4):e972. doi: 10.1097/PR9.0000000000000972. eCollection 2021 Nov-Dec.

  PMID: 34963996 BACKGROUND

• Khutok K, Janwantanakul P, Jensen MP, Kanlayanaphotporn R. Responsiveness of the PROMIS-29 Scales in Individuals With Chronic Low Back Pain. Spine (Phila Pa 1976). 2021 Jan 15;46(2):107-113. doi: 10.1097/BRS.0000000000003724.

  PMID: 33347091 BACKGROUND

• Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.

  PMID: 11074683 BACKGROUND

• Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24. doi: 10.1097/00007632-200012150-00006. No abstract available.

  PMID: 11124727 BACKGROUND

• Rezaei B, Mousavi E, Heshmati B, Asadi S. Low back pain and its related risk factors in health care providers at hospitals: A systematic review. Ann Med Surg (Lond). 2021 Sep 30;70:102903. doi: 10.1016/j.amsu.2021.102903. eCollection 2021 Oct.

  PMID: 34691437 BACKGROUND

• Sandal LF, Stochkendahl MJ, Svendsen MJ, Wood K, Overas CK, Nordstoga AL, Villumsen M, Rasmussen CDN, Nicholl B, Cooper K, Kjaer P, Mair FS, Sjogaard G, Nilsen TIL, Hartvigsen J, Bach K, Mork PJ, Sogaard K. An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 3;8(12):e14720. doi: 10.2196/14720.

  PMID: 31793897 BACKGROUND

• Sandal LF, Bach K, Overas CK, Svendsen MJ, Dalager T, Stejnicher Drongstrup Jensen J, Kongsvold A, Nordstoga AL, Bardal EM, Ashikhmin I, Wood K, Rasmussen CDN, Stochkendahl MJ, Nicholl BI, Wiratunga N, Cooper K, Hartvigsen J, Kjaer P, Sjogaard G, Nilsen TIL, Mair FS, Sogaard K, Mork PJ. Effectiveness of App-Delivered, Tailored Self-management Support for Adults With Lower Back Pain-Related Disability: A selfBACK Randomized Clinical Trial. JAMA Intern Med. 2021 Oct 1;181(10):1288-1296. doi: 10.1001/jamainternmed.2021.4097.

  PMID: 34338710 BACKGROUND

• Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3.

  PMID: 29971708 BACKGROUND

• Hayden JA, Ellis J, Ogilvie R, Malmivaara A, van Tulder MW. Exercise therapy for chronic low back pain. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD009790. doi: 10.1002/14651858.CD009790.pub2.

  PMID: 34580864 BACKGROUND

• Wong AYL, Chan LLY, Lo CWT, Chan WWY, Lam KCK, Bao JCH, Ferreira ML, Armijo-Olivo S. Prevalence/Incidence of Low Back Pain and Associated Risk Factors Among Nursing and Medical Students: A Systematic Review and Meta-Analysis. PM R. 2021 Nov;13(11):1266-1280. doi: 10.1002/pmrj.12560. Epub 2021 Mar 9.

  PMID: 33492778 BACKGROUND

• Stochkendahl MJ, Kjaer P, Hartvigsen J, Kongsted A, Aaboe J, Andersen M, Andersen MO, Fournier G, Hojgaard B, Jensen MB, Jensen LD, Karbo T, Kirkeskov L, Melbye M, Morsel-Carlsen L, Nordsteen J, Palsson TS, Rasti Z, Silbye PF, Steiness MZ, Tarp S, Vaagholt M. National Clinical Guidelines for non-surgical treatment of patients with recent onset low back pain or lumbar radiculopathy. Eur Spine J. 2018 Jan;27(1):60-75. doi: 10.1007/s00586-017-5099-2. Epub 2017 Apr 20.

  PMID: 28429142 BACKGROUND

• Sang S, Wang J, Jin J. Prevalence of low back pain among intensive care nurses: A meta-analysis. Nurs Crit Care. 2021 Nov;26(6):476-484. doi: 10.1111/nicc.12646. Epub 2021 May 25.

  PMID: 34036704 BACKGROUND

• GBD 2021 Low Back Pain Collaborators. Global, regional, and national burden of low back pain, 1990-2020, its attributable risk factors, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 May 22;5(6):e316-e329. doi: 10.1016/S2665-9913(23)00098-X. eCollection 2023 Jun.

  PMID: 37273833 BACKGROUND

• Grimby G, Borjesson M, Jonsdottir IH, Schnohr P, Thelle DS, Saltin B. The "Saltin-Grimby Physical Activity Level Scale" and its application to health research. Scand J Med Sci Sports. 2015 Dec;25 Suppl 4:119-25. doi: 10.1111/sms.12611.

  PMID: 26589125 BACKGROUND

Related Links

• PROMS
• information about the app

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicentre, randomized controlled clinical trial with two parallel groups. Participants are allocated at department level to either the intervention group receiving the SelfBack application in addition to usual care, or the control group receiving usual care alone. Each participant remains in the assigned group throughout the 12-month study period. Outcomes are assessed at baseline and at 3, 6, and 12 months after study enrolment.

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 25, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 25, 2026

Record last verified: 2025-12

Locations

BE (1)