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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
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. (Du/Pain)ORCID iD: 0000-0002-8307-259x
Dalarna University, School of Health and Welfare, Medical Science. Military Academy Karlberg, Swedish Armed Forces. (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)Conference paper, Poster (with or without abstract) (Refereed)
Abstract [en]

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.

Place, publisher, year, edition, pages
2022.
National Category
Physiotherapy
Identifiers
URN: urn:nbn:se:du-41423OAI: oai:DiVA.org:du-41423DiVA, id: diva2:1657606
Conference
12th Congress of the European Pain Federation EFIC, Dublin, Ireland, 27-30 April 2022
Part of project
Utvärdering av eVISualisering av fysisk aktivitet och smärta (eVIS) som tillägg till multimodal smärtrehabilitering
Funder
Forte, Swedish Research Council for Health, Working Life and Welfare, 2017-00491Available from: 2022-05-11 Created: 2022-05-11 Last updated: 2023-10-03Bibliographically approved
In thesis
1. eVIS – A digital support for physical activity in patients with chronic pain
Open this publication in new window or tab >>eVIS – A digital support for physical activity in patients with chronic pain
2023 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Background: Chronic pain is a significant contemporary health challenge, exerting enormous impact on both individuals and societies. Although physical activity is the primary treatment, many patients struggle with incorporating it into their lives. In order to facilitate individualised physical activity within Interdisciplinary Pain Rehabilitation Programs (IPRP), the eVISualisation of physical activity and pain intervention was developed. This intervention consists of device-based measured physical activity, jointly visualised with patient-reported pain intensity, pain interference, and pharmaceutical consumption. 

Overall aim: To i) develop the eVIS intervention as a digital support for physical activity in IPRP, ii) to evaluate eVIS’s validity, feasibility, and acceptability as a supplementary treatment for patients taking part of IPRP, and iii) to evaluate the feasibility and acceptability of the trial design and conduct of an ongoing Registry-based Randomised Clinical Trial (R-RCT), where the effectiveness of eVIS as an addition to IPRP is evaluated.

Methods: The Medical Research Council’s updated framework for development and evaluation of complex interventions guided study designs and methodologies. This thesis contains four papers: I. Evaluation of the criterion validity of a wrist-worn activity tracker, II. Evaluation of pre-clinical content validity of eVIS, III. A study protocol outlining trial design and trial conduct of an ongoing R-RCT, and IV. Evaluation of the aforementioned trial design and trial conduct. 

Results: The wrist-worn activity tracker provided fair to acceptable measurements of SR. In collaboration with relevant stakeholders, eVIS was continuously developed and found to be relevant, simple, and safe for use by patients, clinicians, and researchers. The first real-world test of the clinical feasibility of the intervention motivated further development in the web application and procedures relating to recruitment and data collection. The evaluation of the acceptability and feasibility of the trial design and conduct provided promising results, with mainly satisfactory feasibility. However, minor revisions are required to safeguard the external validity of the ongoing R-RCT. 

Conclusions: Through continuous refinement in collaboration with stakeholders and careful consideration of the intervention’s complexity, key uncertainties, and context, indicate that the intervention is relevant, valid, feasible, and well prepared for effectiveness testing.

Place, publisher, year, edition, pages
Falun: Högskolan Dalarna, 2023
Series
Dalarna Doctoral Dissertations ; 28
Keywords
Chronic pain, Criterion validity, Content validity, Complex intervention development, Device-based measurement, Feasibility, Physical activity
National Category
Nursing
Identifiers
urn:nbn:se:du-46281 (URN)978-91-88679-55-0 (ISBN)
Public defence
2023-11-24, lecture hall Fö 5 campus Falun, 09:30 (Swedish)
Opponent
Supervisors
Available from: 2023-10-19 Created: 2023-06-22 Last updated: 2023-12-08Bibliographically approved

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

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Sjöberg, VeronicaTseli, ElenaMonnier, AndreasWestergren, JensLoMartire, RiccardoÄng, BjörnHagströmer, MariaBjörk, MathildaVixner, Linda
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