Effectiveness of the eVISualisation of physical activity and pain (eVIS) intervention in Interdisciplinary Pain Rehabilitation Programs : Study Protocol for a Registry-based Randomised Controlled Clinical Trial

• Background and aims: * Interdisciplinary Pain Rehabilitation Programs (IPRPs) are considered to be superior to single-treatment measures in chronic pain treatment. However, the effects of IPRPs are moderate and as many as 30% of patients deteriorate in some outcomes. Although physical activity and exercise are central components in IPRPs, many patients struggle to achieve and maintain the recommended levels. An intervention, entitled eVISualisation of physical activity and pain (eVIS), has now been systematically developed and designed to facilitate patients with chronic pain in achieving and maintaining recommended physical activity levels. The aim of the present study protocol is to transparently report on the methodology, outcomes, and processes for an initiated registry-based randomized controlled trial (R-RCT), which will evaluate the effectiveness of eVIS on the primary outcome physical health and defined secondary outcomes. Methods: * Participants (approximately 400) will be recruited from IPRP units and randomly allocated to either IPRP with an addition of eVIS or to treatment as usual by IPRP. eVIS entails objectively measured physical activity and patient-reported outcomes of pain intensity, effect on daily activities and pharmaceutical consumption. Data is collected and visualized in a web application, PATRON. Pilot analyses evaluating the feasibility of the R-RCT will be performed on data from initial 30 participants. Outcomes will be extracted from PATRON and from six national registries. Multivariate statistics and repeated measures analyses will be performed. Results: * Recruitment will be initiated in late 2021. ClinicalTrials.gov identifier: NCT05009459. Conclusions: * This study protocol describes a R-RCT that is designed to provide robust data on the feasibility and effectiveness of eVIS as an addition to IPRPs.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Hälsovetenskap -- Sjukgymnastik (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Health Sciences -- Physiotherapy (hsv//eng)

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