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Effectiveness of the eVISualisation of physical activity and pain intervention (eVIS) in Swedish Interdisciplinary Pain Rehabilitation Programmes: study protocol for a registry-based randomised controlled clinical trial
Dalarna University, School of Health and Welfare, Care Sciences. Dalarna University, School of Health and Welfare, Medical Science. (DU/Pain)ORCID iD: 0000-0002-3843-0407
Dalarna University, School of Health and Welfare, Medical Science. Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden. (DU/Pain)ORCID iD: 0000-0002-8307-259x
Dalarna University, School of Health and Welfare, Medical Science. Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden; Military Academy Karlberg, Swedish Armed Forces, Solna, Sweden. (DU/Pain)ORCID iD: 0000-0001-8923-1670
Dalarna University, School of Health and Welfare, Sport and Health Science. (DU/Pain)ORCID iD: 0000-0001-8356-4669
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2022 (English)In: BMJ Open, E-ISSN 2044-6055, Vol. 12, no 4, article id e055071Article in journal (Refereed) Published
Abstract [en]

Introduction Living with chronic pain often involves negative consequences. Interdisciplinary Pain Rehabilitation Programmes (IPRP) is considered superior to single-treatment measures in patients with chronic pain. Despite this, effects emerge suboptimal and more than 20% of patients deteriorate in patientreported physical health outcomes after IPRP. A novel e-Health intervention, eVISualisation (eVIS) of physical activity and pain, was systematically developed to facilitate individualisation of physical activity levels. By adding elements of data collection, visualisation and communication of objectively measured physical activity and patient-reported outcomes (pain intensity, interference of pain, pharmaceutical consumption) to existing treatment modalities in IPRP, the IPRP team acquires prerequisites to adapt advice and physical activity prescriptions and to evaluate set activity goals. The overall aim is two fold. First, the aim is to evaluate the feasibility of the subsequent registry-based randomised controlled clinical trial (R-RCT). Second, the aim is to prospectively evaluate the effectiveness of the eVISintervention as a supplement to IPRP on our defined primary (physical health) and secondary outcomes.

Methods and analysis In the R-RCT, recruitment of 400 patients with chronic pain will be performed at 15 IPRP units. A random allocation to either IPRP + eVIS or to control group that will receive IPRP only will be performed. Data from the initial 30 participants completing the study period (6 months) will be included in a pilot study, where key feasibility outcomes (recruitment, randomisation, implementation, treatment integrity, data collection procedure, preliminary outcome measures) will be evaluated. Outcome variables will be extracted from the web application Pain And TRaining ON-line (PATRON) and from six national registries. Multivariate statistics and repeated measure analyses will be performed. Quality-adjusted life years and incremental cost-effectiveness ratio will be calculated for cost-effectiveness evaluation.

Ethics/dissemination The Swedish Ethics Review Board granted approval (Dnr 2021/02109). Results will be disseminated through peer-reviewed journals.

Trial registration number NCT05009459. Protocol V.1

Place, publisher, year, edition, pages
2022. Vol. 12, no 4, article id e055071
Keywords [en]
pain management; protocols & guidelines; telemedicine
National Category
Physiotherapy
Identifiers
URN: urn:nbn:se:du-41275DOI: 10.1136/bmjopen-2021-055071ISI: 000783842400053PubMedID: 35428627Scopus ID: 2-s2.0-85128487846OAI: oai:DiVA.org:du-41275DiVA, id: diva2:1652264
Funder
Forte, Swedish Research Council for Health, Working Life and Welfare, 2017-00491Swedish Research CouncilAvailable from: 2022-04-18 Created: 2022-04-18 Last updated: 2025-10-09Bibliographically approved

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Sjöberg, VeronicaTseli, ElenaMonnier, AndreasWestergren, JensÄng, BjörnVixner, Linda

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