Integration of a Mobilisation Device into a Multidisciplinary Rehabilitation Programme for Chronic Low Back Pain: A Pilot Randomised Controlled Trial

Integration of a Mobilisation Device into a Multidisciplinary Rehabilitation Programme for Chronic Low Back Pain: A Pilot Randomised Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Integration of a Mobilisation Device into a Multidisciplinary Rehabilitation Programme for Chronic Low Back Pain: A Pilot Randomised Controlled Trial Maaiken Vander Plaetse, Sarah Meyer, Elvi Lemmens, Francis Frankenne, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8550404/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted You are reading this latest preprint version Abstract Background: Multidisciplinary rehabilitation programmes (MRPs) are recommended to reduce pain and disability in chronic low back pain (CLBP); however, their efficacy remains uncertain due to variability in study quality. This pilot study aimed to determine the effect of integrating the LumbaCure® device (ODIX s.a., Belgium), a seat designed to mobilise the lower back, into an MRP, compared with the standard MRP, on disability. Methods: In this randomised, open-label, controlled pilot study, adults with non-specific CLBP were assigned to a standard Belgian MRP or the same programme including 15 min of LumbaCure® per session. The primary outcome was the between-group difference in relative change in disability (Oswestry Disability Index, ODI) from baseline to the end of intervention period. Secondary outcomes included pain intensity, the Tampa Scale for Kinesiophobia-17, Pain Catastrophizing Scale (PCS), Patient-Specific Functional Scale, participant satisfaction, and safety. Analyses included all randomised participants. Statistical significance was set at p < 0.05; Cohen’s d effect sizes are reported as an estimate of magnitude, given the exploratory nature of this pilot study. Results: Of 50 randomised participants, 34 completed the study (16 Control, 18 LumbaCure®), with no device-related dropouts. At the intervention end, the change in ODI score did not differ significantly between groups, although it was larger in the LumbaCure® group (Cohen’s d = 0.42). Most secondary outcomes improved more in the LumbaCure® group, but the between-group difference was only significant for the PCS. Within-group improvements at the intervention end were consistently significant for all outcomes in the LumbaCure® group, but none reached significance in the Control group. No serious adverse events were identified. Conclusions: The integration of LumbaCure® into a standard Belgian MRP enhanced improvements in disability and pain catastrophising. These preliminary findings suggest that a larger, adequately powered randomised controlled trial is warranted. Trial registration: ClinicalTrials.gov: NCT06662032 on 16 October 2024, Retrospectively registered back pain chronic pain exercise therapy multidisciplinary rehabilitation programme Figures Figure 1 Figure 2 Figure 3 Figure 4 Full Text Additional Declarations Competing interest reported. S.D. serves as Project Leader at Odix. F.F. is the inventor of LumbaCure and co-founder of Odix. Professors Falla and Demoulin act as remunerated scientific advisers to Odix Supplementary Files CIV2305043012rawdata.pdf Cite Share Download PDF Status: Under Review Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8550404","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":575210242,"identity":"48bd6140-6941-4d78-9503-02d9a7a70f12","order_by":0,"name":"Maaiken Vander Plaetse","email":"","orcid":"","institution":"Jessa Hospital","correspondingAuthor":false,"prefix":"","firstName":"Maaiken","middleName":"Vander","lastName":"Plaetse","suffix":""},{"id":575210243,"identity":"d0033f8f-f934-48d0-8fa5-c3e2aed5613b","order_by":1,"name":"Sarah Meyer","email":"","orcid":"","institution":"Jessa 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S.D. serves as Project Leader at Odix. \nF.F. is the inventor of LumbaCure and co-founder of Odix. \nProfessors Falla and Demoulin act as remunerated scientific advisers to Odix","formattedTitle":"\u003cp\u003eIntegration of a Mobilisation Device into a Multidisciplinary Rehabilitation Programme for Chronic Low Back Pain: A Pilot Randomised Controlled Trial\u003c/p\u003e","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-musculoskeletal-disorders","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmsd","sideBox":"Learn more about [BMC Musculoskeletal Disorders](http://bmcmusculoskeletdisord.biomedcentral.com/)","snPcode":"","submissionUrl":"https://author-welcome.nature.com/12891","title":"BMC Musculoskeletal Disorders","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"back pain, chronic pain, exercise therapy, multidisciplinary rehabilitation programme","lastPublishedDoi":"10.21203/rs.3.rs-8550404/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8550404/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003eMultidisciplinary rehabilitation programmes (MRPs) are recommended to reduce pain and disability in chronic low back pain (CLBP); however, their efficacy remains uncertain due to variability in study quality. This pilot study aimed to determine the effect of integrating the LumbaCure® device (ODIX s.a., Belgium), a seat designed to mobilise the lower back, into an MRP, compared with the standard MRP, on disability.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eIn this randomised, open-label, controlled pilot study, adults with non-specific CLBP were assigned to a standard Belgian MRP or the same programme including 15 min of LumbaCure® per session. The primary outcome was the between-group difference in relative change in disability (Oswestry Disability Index, ODI) from baseline to the end of intervention period. Secondary outcomes included pain intensity, the Tampa Scale for Kinesiophobia-17, Pain Catastrophizing Scale (PCS), Patient-Specific Functional Scale, participant satisfaction, and safety. Analyses included all randomised participants. Statistical significance was set at \u003cem\u003ep\u003c/em\u003e \u0026lt; 0.05; Cohen’s \u003cem\u003ed\u003c/em\u003e effect sizes are reported as an estimate of magnitude, given the exploratory nature of this pilot study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults: \u003c/strong\u003eOf 50 randomised participants, 34 completed the study (16 Control, 18 LumbaCure®), with no device-related dropouts. At the intervention end, the change in ODI score did not differ significantly between groups, although it was larger in the LumbaCure® group (Cohen’s d = 0.42). Most secondary outcomes improved more in the LumbaCure® group, but the between-group difference was only significant for the PCS. Within-group improvements at the intervention end were consistently significant for all outcomes in the LumbaCure® group, but none reached significance in the Control group. 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