NCT05009459 eVISualisation of Physical Activity and Pain (eVIS) for Patients With Chronic Pain
| NCT ID | NCT05009459 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dalarna University |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2021-10-28 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 280 participants in total. It began in 2021-10-28 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: * Patients who need to use a walking aid indoors. * Patients living with pain caused by systemic disease or malignancies.
Contact & Investigator
Linda Vixner, Dr
PRINCIPAL INVESTIGATOR
School Health and Welfare
Frequently Asked Questions
Who can join the NCT05009459 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 67 Years, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05009459 currently recruiting?
Yes, NCT05009459 is actively recruiting participants. Contact the research team at vsj@du.se for enrollment information.
Where is the NCT05009459 trial being conducted?
This trial is being conducted at Falun, Sweden.
Who is sponsoring the NCT05009459 clinical trial?
NCT05009459 is sponsored by Dalarna University. The principal investigator is Linda Vixner, Dr at School Health and Welfare. The trial plans to enroll 280 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.