Clinical trial NCT05009459: eVISualisation of Physical Activity and Pain (eVIS) for Patients With Chronic Pain
Official title: eVISualisation of Physical Activity and Pain (eVIS) for Patients With Chronic Pain Participating in Swedish Interdisciplinary Pain Rehabilitation Programs: a Registry-based Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic pain Registry-based randomized clinical trial
Lead sponsor: Dalarna University
Sponsor class: OTHER
Collaborators: name: Swedish Council for Working Life and Social Research
name: The Swedish Research Council
First posted: 2021-08-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Physical health
timeFrame: 12 months follow up after IPRP
Secondary outcomes:
measure: Physical and mental health
timeFrame: 6, 24, 36 months after IPRP
measure: Objectively measured physical activity levels
timeFrame: Data will be collected daily during study period (6 months)
measure: Pain intensity last 24 hours
timeFrame: Data will be collected daily during study period (6 months)
measure: Pain interference
timeFrame: Data will be collected daily during study period (6 months)
measure: Drug name
timeFrame: Data will be collected daily during study period (6 months)
measure: Drug dose
timeFrame: Data will be collected daily during study period (6 months)
measure: Drug strenght
timeFrame: Data will be collected daily during study period (6 months)
measure: Drug form
timeFrame: Data will be collected daily during study period (6 months)
measure: Work form
timeFrame: 12 months follow up after IPRP
measure: Work extension
timeFrame: 12 months follow up after IPRP
measure: Education level
timeFrame: 12 months follow up after IPRP
measure: Pain intensity last seven days
timeFrame: 12 months follow up after IPRP
measure: Pain regions
timeFrame: 12 months follow up after IPRP
measure: Pain duration
timeFrame: 12 months follow up after IPRP
measure: Self-rated mental health
timeFrame: baseline, 6, 12, 24 months follow up after IPRP.
measure: Self-rated health
timeFrame: baseline, 12, 24 months follow up after IPRP.
measure: Physical activity
timeFrame: 12 months follow up after IPRP
measure: Exercise
timeFrame: 12 months follow up after IPRP
measure: Sedentary activities
timeFrame: 12 months follow up after IPRP
measure: Strenous exercise
timeFrame: 12 months follow up after IPRP
measure: Moderate exercise
timeFrame: 12 months follow up after IPRP
measure: Light exercise
timeFrame: 12 months follow up after IPRP
measure: Overall emotional distress
timeFrame: 12 months follow up after IPRP
measure: Pain catastrophizing
timeFrame: 12 months follow up after IPRP
measure: Psychosocial consequences - Pain intensity
timeFrame: 12 months follow up after IPRP
measure: Psychosocial consequences - Interference
timeFrame: 12 months follow up after IPRP
measure: Psychosocial consequences - Life control
timeFrame: 12 months follow up after IPRP
measure: Psychosocial consequences - Affective distress
timeFrame: 12 months follow up after IPRP
measure: Psychosocial consequences - Social support
timeFrame: 12 months follow up after IPRP
measure: Pain acceptance
timeFrame: 12 months follow up after IPRP
measure: Life satisfaction
timeFrame: 12 months follow up after IPRP
measure: Work ability
timeFrame: 12 months follow up after IPRP
measure: Functional levels
timeFrame: 12 months follow up after IPRP
measure: Sleep quality
timeFrame: 12 months follow up after IPRP
measure: Reasons for Sick leave
timeFrame: 12 months follow up after IPRP
measure: Sickness benefit
timeFrame: 12 months follow up after IPRP
measure: Days in work before new sick leave period
timeFrame: 12 months follow up after IPRP
measure: Total sick leave
timeFrame: 12 months follow up after IPRP
measure: Diagnosis
timeFrame: 12 months follow up after IPRP
measure: Total number of days in care
timeFrame: 12 months follow up after IPRP
measure: Quality Adjusted Life Years
timeFrame: 12 months follow up after IPRP
measure: Defined pharmaceutical doses per day
timeFrame: 12 months follow up after IPRP
measure: Pharmaceutical costs
timeFrame: 12 months follow up after IPRP
measure: Income
timeFrame: 12 months follow up after IPRP
measure: Education
timeFrame: 12 months follow up after IPRP
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Dalarna University
Study officials:
affiliation: School Health and Welfare
name: Linda Vixner, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.