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

NCT05009459 | Recruiting

• 1 other identifier: 2017-00491
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Chronic pain Registry-based randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Physical health

  Physical health domain by RAND-36, ranging from 0 to 100, with high values indicating good health.

  12 months follow up after IPRP

Secondary Outcomes (45)

• Physical and mental health

  6, 24, 36 months after IPRP

• Objectively measured physical activity levels

  Data will be collected daily during study period (6 months)

• Pain intensity last 24 hours

  Data will be collected daily during study period (6 months)

• Pain interference

  Data will be collected daily during study period (6 months)

• Drug name

  Data will be collected daily during study period (6 months)

Study Arms (2)

eVIS + Treatment as usual (interdisciplinary pain rehabilitation program)

EXPERIMENTAL

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.

Behavioral: eVIS

Treatment as usual (interdisciplinary pain rehabilitation program)

NO INTERVENTION

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.

Interventions

eVIS BEHAVIORAL

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.

eVIS + Treatment as usual (interdisciplinary pain rehabilitation program)

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Dalarna University: lead
• Swedish Council for Working Life and Social Research: collaborator
• The Swedish Research Council: collaborator

Study Sites (1)

Dalarna University

Falun, SE-791 88, Sweden

RECRUITING

Related Publications (3)

• 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.

  PMID: 33433391 BACKGROUND

• 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.

  PMID: 35428627 BACKGROUND

• 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.

  PMID: 36897847 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Linda Vixner, Dr

  School Health and Welfare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Sjöberg, Phd

CONTACT

+4623778757; vsj@du.se

Elena Tseli, Dr

CONTACT

+4623778131; ezt@du.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Docent in Medical Sciences/Deputy Head of Research Centre for Public Health and Sports (RePS)

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: August 17, 2021
• Study Start: October 28, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: For deidentifed individual data used in publications: start date 2024-01-01. For additional files (supporting information): start date 2022-03-01.
• Access Criteria: Any data request must lie within the limits of the ethical approval for this project. In addition, to uphold data safety and other legal aspects relevant agreements must be established prior to data being available outside the research group.

Locations

SE (1)