Health TrialsbyHealthPanel

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

ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-67
SponsorDalarna University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients who need to use a walking aid indoors.

Patients living with pain caused by systemic disease or malignancies.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: eVIS + Treatment as usual (interdisciplinary pain rehabilitation program)Experimental treatment 1 intervention
Group B: Treatment as usual (interdisciplinary pain rehabilitation program)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Physical health

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

Time frame
12 months follow up after IPRP

Secondary outcomes

1

Physical and mental health

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

Time frame
6, 24, 36 months after IPRP
2

Objectively measured physical activity levels

Steps per day collected by Fitbit Versa 2 synchronized to web application PATRON

Time frame
Data will be collected daily during study period (6 months)
3

Pain intensity last 24 hours

Pain intensity ("rate your average pain during the last 24 hours") by the Numeric Rating Scale (NRS), ranging from 0-10 with high values indicating high levels of pain. The scale is incorporated in the web application PATRON.

Time frame
Data will be collected daily during study period (6 months)
4

Pain interference

Data on self percieved pain interference on daily activities will be collected daily during study period ("rate how much your daily activities are affected by pain"). The scale is ranging from 0-10 with high values indicating high levels of interference. The scale is incorporated in the web application PATRON.

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

Other outcomes

Sponsors and contacts

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Dalarna University

Lead sponsor

Swedish Council for Working Life and Social Research

Collaborator

The Swedish Research Council

Collaborator

Source ClinicalTrials.gov
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