eVISualisation of Physical Activity and Pain (eVIS) for Patients With Chronic Pain

Recruiting now · Not applicable

Conditions studied: Chronic Pain

In brief

Introduction: Living with chronic pain often involves negative consequences. Interdisciplinary Pain Rehabilitation Programs (IPRPs), a subset of Interdisciplinary Treatment (IDT) includes physical activity and exercise and is considered superior to single-treatment measures in patients with chronic pain. However, effects emerge sub-optimal and as many as 30% of patients deteriorate in some outcomes. A novel intervention, eVISualisation (eVIS) of physical activity and pain, has been systematically developed to facilitate patients in reaching and maintaining recommended individualized physical activity levels. The aim is to transparently report on methodology, outcome assessments, and processes for a registry-based randomized controlled trial (R-RCT) initiated as an internal pilot study. 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.

Key facts

Study ID: NCT05009459
Run by: Dalarna University
People needed: 280
Starts: 2021-10-28
Expected to finish: 2026-12-31
Last updated by the study team: 2025-08-28

Who can join

Age: 18 and older, up to 67. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Swedish IPRP treatment criterias will be applied as patients entering the trial must be accepted for IPRP: Principal IPRP inclusion criteria are:
persistent or intermittent pain lasting ≥3 months
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.

You may not qualify if…

Patients who need to use a walking aid indoors.
Patients living with pain caused by systemic disease or malignancies.

Where it is running

Dalarna University — Falun, Sweden (enrolling)

Full record on ClinicalTrials.gov

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