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

Study acronym: eVIS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 31, 2025 → Dec 31, 2027
See other at-risk trials from Dalarna University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 31, 2025 to Dec 31, 2027
    • Study completion pushed from Dec 31, 2026 to Dec 31, 2027
    v7
  2. Enrollment target: 400 to 280v6
  3. Primary completion date: Jun 2024 to Dec 31, 2025
    • Study completion date: Dec 2024 to Dec 31, 2026
    v5
  4. Primary completion date: Jun 2023 to Jun 2024
    • Study completion date: Jun 2023 to Dec 2024
    • Publications: 2 to 3
    v4
  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Enrolling by Invitation to Recruiting
    • Start date changed from estimate of Sep 2021 to Oct 28, 2021
    • Site details revised
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05009459
Lead Sponsor Dalarna University
Collaborators: Swedish Council for Working Life and Social Research, The Swedish Research Council
Conditions
(from sponsor)		 Chronic Pain
Related terms Chronic Pain
Enrollment 280 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov