eVISualisation of Physical Activity and Pain (eVIS) for Patients With Chronic Pain
NCT ID: NCT05009459
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
280 participants
INTERVENTIONAL
2021-10-28
2026-12-31
Brief Summary
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Methods and analysis: The R-RCT will recruit approximately 400 patients with chronic pain who are registered at primary and specialized IPRP units (n=15) in Sweden. Participants will be randomly allocated to either an IPRP + eVIS or the control group that will receive only IPRP treatment. eVIS entails objectively measured physical activity (steps) and patient-reported outcomes (pain intensity, affect on daily activities, pharmaceutical consumption) collected and visualized in the web application PATRON. Data from an initial 30 participants completing the study period (6 months) will be included in a pilot study designed to evaluate recruitment- and randomization processes, standardized effect size, sample size, characteristics of outcomes, follow-up rates of the R-RCT. Outcome variables will be extracted from PATRON and from six national registries. Multivariate statistics and repeated measures analyses will be performed. Quality Adjusted Life Years (QALYs) and Incremental Cost Effectiveness Ratio (ICER) 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-review journals.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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eVIS + Treatment as usual (interdisciplinary pain rehabilitation program)
Participant takes part of the unit´s program with an addition of eVIS. eVIS consists of objectively measured physical activity tracking using a wrist-worn activity tracker (Fitbit Versa 2) is combined with a daily activity goal (steps/day) and daily patient reports of known important clinical outcome assessments: pain intensity and its affect on daily activities and pharmaceutical consumption. Data is collected and visualized in a purpose-developed web application, Pin And TRaining ON-line (PATRON), which can be used by the patient and the IPRP-team to follow and adjust individual physical activity levels.
eVIS
To facilitate individualized physical activity levels within the Swedish IPRP setting, an eVISualisation (eVIS) of physical activity and pain intervention has been systematically developed. eVIS is designed to target facilitating mechanisms for behavior change, such as outcome expectations, self-monitoring, self-evaluation, and self-efficacy, which are theoretically framed by the Social Cognitive Theory by Bandura. In eVIS, objectively measured physical activity tracking using a wrist-worn activity tracker (Fitbit Versa 2) is combined with a daily activity goal (steps/day) and daily patient reports of known important clinical outcome assessments: pain intensity and its affect on daily activities30-34 and pharmaceutical consumption. Data is collected and visualized in a purpose-developed web application, Pin And TRaining ON-line (PATRON), which can be used by the patient and the IPRP-team to follow and adjust individual physical activity levels.
Treatment as usual (interdisciplinary pain rehabilitation program)
Participant takes part of the unit´s program with an addition of daily self-report of pain intensity (0-10), affect of pain on daily activities (0-10), and pharmacological consumption.
No interventions assigned to this group
Interventions
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eVIS
To facilitate individualized physical activity levels within the Swedish IPRP setting, an eVISualisation (eVIS) of physical activity and pain intervention has been systematically developed. eVIS is designed to target facilitating mechanisms for behavior change, such as outcome expectations, self-monitoring, self-evaluation, and self-efficacy, which are theoretically framed by the Social Cognitive Theory by Bandura. In eVIS, objectively measured physical activity tracking using a wrist-worn activity tracker (Fitbit Versa 2) is combined with a daily activity goal (steps/day) and daily patient reports of known important clinical outcome assessments: pain intensity and its affect on daily activities30-34 and pharmaceutical consumption. Data is collected and visualized in a purpose-developed web application, Pin And TRaining ON-line (PATRON), which can be used by the patient and the IPRP-team to follow and adjust individual physical activity levels.
Eligibility Criteria
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Inclusion Criteria
* pain affecting daily activities to a large extent,
* completed systematic assessment and non-pharmacological optimization is completed,
* screening for psychosocial risk factors and differential diagnosis completed
In addition the following criterias will be appled:
* Patients aged 18-67 years.
* Patients must be able to hear, see, and comprehend spoken and written Swedish
* Daily access to a computer, smartphone, or tablet.
Exclusion Criteria
* Patients living with pain caused by systemic disease or malignancies.
18 Years
67 Years
ALL
No
Sponsors
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Swedish Council for Working Life and Social Research
OTHER
The Swedish Research Council
OTHER_GOV
Dalarna University
OTHER
Responsible Party
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Linda Vixner
Docent in Medical Sciences/Deputy Head of Research Centre for Public Health and Sports (RePS)
Principal Investigators
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Linda Vixner, Dr
Role: PRINCIPAL_INVESTIGATOR
School Health and Welfare
Locations
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Dalarna University
Falun, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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Sjoberg V, Westergren J, Monnier A, Lo Martire R, Hagstromer M, Ang BO, Vixner L. Wrist-Worn Activity Trackers in Laboratory and Free-Living Settings for Patients With Chronic Pain: Criterion Validity Study. JMIR Mhealth Uhealth. 2021 Jan 12;9(1):e24806. doi: 10.2196/24806.
Sjoberg V, Tseli E, Monnier A, Westergren J, LoMartire R, Ang BO, Hagstromer M, Bjork M, Vixner L. 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. BMJ Open. 2022 Apr 15;12(4):e055071. doi: 10.1136/bmjopen-2021-055071.
Tseli E, Sjoberg V, Bjork M, Ang BO, Vixner L. Evaluation of content validity and feasibility of the eVISualisation of physical activity and pain (eVIS) intervention for patients with chronic pain participating in interdisciplinary pain rehabilitation programs. PLoS One. 2023 Mar 10;18(3):e0282780. doi: 10.1371/journal.pone.0282780. eCollection 2023.
Other Identifiers
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2017-00491
Identifier Type: -
Identifier Source: org_study_id
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