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

Dalarna University

Status: Enrolling

Conditions: Chronic Pain

Treatments: Behavioral: eVIS

Study type: Interventional

Funder types: Other

Identifiers

NCT05009459

2017-00491

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 67 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

eVIS + Treatment as usual (interdisciplinary pain rehabilitation program)

Experimental group

Description:

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.

Treatment:

Behavioral: eVIS

Treatment as usual (interdisciplinary pain rehabilitation program)

No Intervention group

Description:

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.