Chronic PaineVISNCT05009459
eVISualisation of Physical Activity and Pain (eVIS) for Patients With Chronic Pain
A study testing eVIS in people with Chronic Pain, run by Dalarna University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- eVIS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteSweden
- Study dates
- 28 Oct 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- Patients who need to use a walking aid indoors.
- Patients living with pain caused by systemic disease or malignancies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Dalarna University
Falun, SE-791 88
Veronica Sjöberg, +4623778757, vsj@du.se
About this study
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
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
- Being tested
- eVIS
- Keywords
- Chronic pain Registry-based randomized clinical trial
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eVISBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical health
Physical health domain by RAND-36, ranging from 0 to 100, with high values indicating good health.
Measured: 12 months follow up after IPRP
Secondary outcomes (45)
Physical and mental health
RAND-36 health survey, ranging from 0 to 100, with high values indicating good health.
Measured: 6, 24, 36 months after IPRP
Objectively measured physical activity levels
Steps per day collected by Fitbit Versa 2 synchronized to web application PATRON
Measured: Data will be collected daily during study period (6 months)
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.
Measured: Data will be collected daily during study period (6 months)
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.
Measured: Data will be collected daily during study period (6 months)
Drug name
Daily self reported data on drug name in the web application PATRON.
Measured: Data will be collected daily during study period (6 months)
Drug dose
Daily self reported data on drug dose (example: 2 tablets per day) in the web application PATRON.
Measured: Data will be collected daily during study period (6 months)
Drug strenght
Daily self reported data on drug strenght (example: 500 mg/tablet) in the web application PATRON.
Measured: Data will be collected daily during study period (6 months)
Drug form
Daily self reported data on drug form (example: tablet, injection) in the web application PATRON.
Measured: Data will be collected daily during study period (6 months)
Work form
Data on work form will be collected from Swedish national quality registry for pain rehabilitation.
Measured: 12 months follow up after IPRP
Work extension
Data on work extension will be collected from Swedish national quality registry for pain rehabilitation.
Measured: 12 months follow up after IPRP
Education level
Demografic data on the dispursion of education level (elementary, gymnasium, university, other) will be collected from Swedish national quality registry for pain rehabilitation
Measured: 12 months follow up after IPRP
Pain intensity last seven days
Pain intensity ("rate your average pain during the last 7 days") will be measured daily using the Numeric Rating Scale (NRS) ranging from 0-10, with high values indicating high levels of pain. Collected through SQRP-PC and SQRP-SC
Measured: 12 months follow up after IPRP
Pain regions
Patients' ratings on a form with 36 anatomical predefined areas (18 on the left side, 18 on the right side: 1) head/face, 2) neck, 3) shoulder, 4) upper arm, 5) elbow, 6) forearm, 7) hand, 8) anterior aspect of chest, 9) lateral aspect of chest, 10) belly, 11) genitals, 12) upper back, 13) lower back, 14) hip/gluteal area, 15) thigh, 16) knee, 17) lower leg, and 18) foot collected through SQRP-PC and SQRP-SC.
Higher number of regions represents higher number of painful body regions .
Measured: 12 months follow up after IPRP
Pain duration
Days. Collected through SQRP-PC and SQRP-SC. High number of days represents longer pain duration.
Measured: 12 months follow up after IPRP
Self-rated mental health
Data will be collected by the RAND-36 health survey collected through SQRP-SC and through email administered surveys. Values are ranging from 0 to 100, with high values indicating good mental health.
Measured: baseline, 6, 12, 24 months follow up after IPRP.
Self-rated health
Data will be collected by the EuroQol-5 dimensions (EQ-5D)The Swedish version of the EuroQol-5 dimensions, (3 level version) collected routinely in SQRP-PC and SQRP-SC. The first part of EQ-5D-3L consists of a descriptive system of 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with 3 severity levels (no/some/extreme problems). The 5 dimensions can be converted into a summary index (EQ-5D Index), which ranges from
-0.594 to 1, where 1 represents "perfect health" and values below zero represent states "worse than death".
Measured: baseline, 12, 24 months follow up after IPRP.
Physical activity
Data will be collected through SQRP-PC using the National Board of Health and Welfare's question on physical activity (0 - >300 minutes/week),The outcome represents minutes spent in physical activity/week. High values represents high level of physical activity,
Measured: 12 months follow up after IPRP
Exercise
Data will be collected through SQRP-PC using the National Board of Health and Welfare's question on exercise (0 - >120 minutes/week)The outcome represents minutes spent in exercise. High values represents high level of exercise/week. .
Measured: 12 months follow up after IPRP
Sedentary activities
Data will be collected through SQRP-PC using the National Board of Health and Welfare's question on, and sedentary behavior (0 - 15 hours/day).The outcome represents minutes spent in sedentary activities/week. High values represents high level of sedentary behavior.
Measured: 12 months follow up after IPRP
Strenous exercise
In SQRP-SC, data is collected by the Godin-Shepard leisure-time physical activity questionnaire (number of times/week that strenuous exercise is performed). High values represents high levels of strenuous exersise per week.
Measured: 12 months follow up after IPRP
Moderate exercise
In SQRP-SC, data is collected by the Godin-Shepard leisure-time physical activity questionnaire (number of times/week that moderate exercise is performed). High values represents high levels of moderate exersise per week.
Measured: 12 months follow up after IPRP
Light exercise
In SQRP-SC, data is collected by the Godin-Shepard leisure-time physical activity questionnaire (number of times/week that light exercise is performed). High values represents high levels of light exersise per week.
Measured: 12 months follow up after IPRP
Overall emotional distress
Data will be collected by the Hospital Anxiety and Depression Scale (HADS) in both SQRP-PC and SQRP-SC. HADS is a 14-item self-assessment questionnaire in which 7 items address anxiety and 7 items address depression (subscales; HADS-D - depression and HADS-A - anxiety).
The subscale scores can range from 0 to 21, with lower scores indicating better function.
Measured: 12 months follow up after IPRP
Pain catastrophizing
Data will be collected by the Pain Catastrophizing Scale (PCS) in both SQRP-PC and SQRP-SC. The PCS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness. The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. Higher values indicating higher levels of catastrophizing
Measured: 12 months follow up after IPRP
Psychosocial consequences - Pain intensity
Data will be collected by the Multidimensional Pain Inventory Scale Swedish version (MPI-S) in both SQRP-PC and SQRP-SC. The construct "psychosocial consequences" is measured by five subscales (total 22 items) where "pain intensity" is the first. The subscales and the index range from 0-6, with higher scores indicating better function.
Measured: 12 months follow up after IPRP
Psychosocial consequences - Interference
Data will be collected by the Multidimensional Pain Inventory Scale Swedish version (MPI-S) in both SQRP-PC and SQRP-SC. The construct "psychosocial consequences" is measured by five subscales (total 22 items) where "interference" is the the second subscale. The subscales and the index range from 0-6. In "interference" higher scores indicate higher interference.
Measured: 12 months follow up after IPRP
Psychosocial consequences - Life control
Data will be collected by the Multidimensional Pain Inventory Scale Swedish version (MPI-S) in both SQRP-PC and SQRP-SC. The construct "psychosocial consequences" is measured by five subscales (total 22 items) where "life control" is the third subscale. The subscales and the index range from 0-6, with higher scores indicating better function.
Measured: 12 months follow up after IPRP
Psychosocial consequences - Affective distress
Data will be collected by the Multidimensional Pain Inventory Scale Swedish version (MPI-S) in both SQRP-PC and SQRP-SC. The construct "psychosocial consequences" is measured by five subscales (total 22 items) where "affective distress" is the fourth subscale. The subscales and the index range from 0-6, with higher scores indicating better function.
Measured: 12 months follow up after IPRP
Psychosocial consequences - Social support
Data will be collected by the Multidimensional Pain Inventory Scale Swedish version (MPI-S) in both SQRP-PC and SQRP-SC. The construct "psychosocial consequences" is measured by five subscales (total 22 items) where "social support" is the fitth subscale. The subscales and the index range from 0-6, with higher scores indicating better function.
Measured: 12 months follow up after IPRP
Pain acceptance
Will be collected in SQRP-PC using the Chronic Pain and Acceptance Questionnaire (CPAQ-8). The items on the CPAQ are rated on a 7-point scale from 0 (never true) to 6 (always true). Higher scores indicate higher levels of acceptance.
Measured: 12 months follow up after IPRP
Life satisfaction
Will be collected by the Life Satisfaction Scale (LiSat) in both SQRP-PC and SQRP-SC. Each item is scored on a 6-point scale from 1 (very dissatisfied) to 6 (very satisfied). High values represents higher perceived life satisfaction.
Measured: 12 months follow up after IPRP
Work ability
Will be collected by the Work Ability Index (WAI) in SQRP-SC only. The scale ranges from 0 ("cannot work at all) to 10 (my ability to work is at its best right now) where higher levels indicate higher levels of work ability
Measured: 12 months follow up after IPRP
Functional levels
Data on functional level will be collected by the Functional Rating Scale (FRI) ranging from 0-4 in each item, total score is 40 and high values represents highly affected functional levels. FRI is collected in SQRP-SC only
Measured: 12 months follow up after IPRP
Sleep quality
Data on sleep quality will be collected by the Insomnia Severity Index (ISI) in SQRP-SC.
The index consists of 10 items with response scale 0 (no difficulities) to 4 (major difficulities). High values represents major sleep difficulties.
Measured: 12 months follow up after IPRP
Reasons for Sick leave
Demographic data on reasons for sick leave will be retrieved from the Swedish Social Insurance Agency's registry.
Measured: 12 months follow up after IPRP
Sickness benefit
Data on sickness benefit (days and hours) during the study period will be retrieved from the Swedish Social Insurance Agency's registry
Measured: 12 months follow up after IPRP
Days in work before new sick leave period
Data on days in work (partial or full time) per month in total before new sick leave period will be retrieved from the Swedish Social Insurance Agency's registry
Measured: 12 months follow up after IPRP
Total sick leave
Data on length of total sick leave during the study period will be retrieved from the Swedish Social Insurance Agency's registry
Measured: 12 months follow up after IPRP
Diagnosis
Demographic data on the incidence of diagnoses will be retrieved from the Patient registry.
Measured: 12 months follow up after IPRP
Total number of days in care
Data on total number of days in care) will be retrieved from the Patient registry.
Measured: 12 months follow up after IPRP
Quality Adjusted Life Years
The outcome will be calculated as Quality Adjusted Life Years (QALYs) which is a "utility value" that ranges between 1 (perfect health), and 0 = death. The standard treatment will be used as baseline and the calculation is a cost effectiveness calculation. Data on health-related quality of life will be used. Higher values of QALYs represents higher cost effectiveness of the intervention.
The calculation formula is as follows: Years of Life x Utility Value = #QALYs
Measured: 12 months follow up after IPRP
Defined pharmaceutical doses per day
Retrieved data from the Pharmaceutical registry will provide information on prescribed and collected pharmaceutical defined doses per day (DDD) which includes names, doses, sizes that have been collected from pharmacies, their costs, and whether the pharmaceutical is included in the subsidized pharmaceutical program.
Measured: 12 months follow up after IPRP
Pharmaceutical costs
Retrieved data from the Pharmaceutical registry will provide information on costs of prescribed and collected pharmaceuticals in SEK.
Measured: 12 months follow up after IPRP
Income
Data on disposable and earned income (SEK) as well as net income will be retrieved from the Income and taxation registry. High values represents high income.
Measured: 12 months follow up after IPRP
Education
From the Population registry, data on education level and education orientation (focus) in addition to limited demographic data (sex, age) will be collected.
Measured: 12 months follow up after IPRP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start28 Oct 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalarna University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research, The Swedish Research Council
- Responsible party
- Principal investigator, Linda Vixner, Dalarna University
- Investigators
- Linda Vixner, Dr, Principal investigator, School Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009459
- Sponsor's protocol ID
- 2017-00491
- Other IDs
- 2017
- Acronym
- eVIS
- Status last verified
- Aug 2026
- First submitted
- 29 Jun 2021
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: .For all data generated during this project, the standards and guidelines set by the International Committee of Medical Journal Editors, will be followed. In detail, this statement implies the following: 1. Results from research conducted under this project will be shared and disseminated by submission for publication in high-quality peer-reviewed journals, following relevant public access guidelines. In addition, findings will be presented at relevant international and national conferences. 2. Deidentified individual data used in publications will be made available on reasonable request to principal investigator after completion of the trial, at the earliest 2024-01-01. However, such 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. 3. Supporting files will be available on reasonable request.
Publications
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.
PubMed 33433391Sjoberg 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.
PubMed 35428627Tseli 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.
PubMed 36897847
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05009459
- Acronym / sponsor ID
- eVIS / 2017-00491
- Conditions
- Chronic Pain
- Keywords
- Chronic pain Registry-based randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Dalarna UniversityUniversity, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research, The Swedish Research Council
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eVIS + Treatment as usual (interdisciplinary pain rehabilitation program) | Experimental | Behavioral: eVISParticipant 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 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. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who need to use a walking aid indoors.
- Patients living with pain caused by systemic disease or malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eVISTo 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. | Behavioural | eVIS + Treatment as usual (interdisciplinary pain rehabilitation program) |
Primary outcome
Physical health
Time frame: 12 months follow up after IPRP
Physical health domain by RAND-36, ranging from 0 to 100, with high values indicating good health.
45 secondary outcomes
Physical and mental health
Time frame: 6, 24, 36 months after IPRP
Objectively measured physical activity levels
Time frame: Data will be collected daily during study period (6 months)
Pain intensity last 24 hours
Time frame: Data will be collected daily during study period (6 months)
Pain interference
Time frame: Data will be collected daily during study period (6 months)
Drug name
Time frame: Data will be collected daily during study period (6 months)
Drug dose
Time frame: Data will be collected daily during study period (6 months)
Drug strenght
Time frame: Data will be collected daily during study period (6 months)
Drug form
Time frame: Data will be collected daily during study period (6 months)
Work form
Time frame: 12 months follow up after IPRP
Work extension
Time frame: 12 months follow up after IPRP
Education level
Time frame: 12 months follow up after IPRP
Pain intensity last seven days
Time frame: 12 months follow up after IPRP
Pain regions
Time frame: 12 months follow up after IPRP
Pain duration
Time frame: 12 months follow up after IPRP
Self-rated mental health
Time frame: baseline, 6, 12, 24 months follow up after IPRP.
Self-rated health
Time frame: baseline, 12, 24 months follow up after IPRP.
Physical activity
Time frame: 12 months follow up after IPRP
Exercise
Time frame: 12 months follow up after IPRP
Sedentary activities
Time frame: 12 months follow up after IPRP
Strenous exercise
Time frame: 12 months follow up after IPRP
Moderate exercise
Time frame: 12 months follow up after IPRP
Light exercise
Time frame: 12 months follow up after IPRP
Overall emotional distress
Time frame: 12 months follow up after IPRP
Pain catastrophizing
Time frame: 12 months follow up after IPRP
Psychosocial consequences - Pain intensity
Time frame: 12 months follow up after IPRP
Psychosocial consequences - Interference
Time frame: 12 months follow up after IPRP
Psychosocial consequences - Life control
Time frame: 12 months follow up after IPRP
Psychosocial consequences - Affective distress
Time frame: 12 months follow up after IPRP
Psychosocial consequences - Social support
Time frame: 12 months follow up after IPRP
Pain acceptance
Time frame: 12 months follow up after IPRP
Life satisfaction
Time frame: 12 months follow up after IPRP
Work ability
Time frame: 12 months follow up after IPRP
Functional levels
Time frame: 12 months follow up after IPRP
Sleep quality
Time frame: 12 months follow up after IPRP
Reasons for Sick leave
Time frame: 12 months follow up after IPRP
Sickness benefit
Time frame: 12 months follow up after IPRP
Days in work before new sick leave period
Time frame: 12 months follow up after IPRP
Total sick leave
Time frame: 12 months follow up after IPRP
Diagnosis
Time frame: 12 months follow up after IPRP
Total number of days in care
Time frame: 12 months follow up after IPRP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 33433391Sjoberg 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.
- Background: PubMed 35428627Sjoberg 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.
- Background: PubMed 36897847Tseli 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.
- Individual participant dataSharing planned: Yes. .For all data generated during this project, the standards and guidelines set by the International Committee of Medical Journal Editors, will be followed. In detail, this statement implies the following: 1. Results from research conducted under this project will be shared and disseminated by submission for publication in high-quality peer-reviewed journals, following relevant public access guidelines. In addition, findings will be presented at relevant international and national conferences. 2. Deidentified individual data used in publications will be made available on reasonable request to principal investigator after completion of the trial, at the earliest 2024-01-01. However, such 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. 3. Supporting files will be available on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linda Vixner, Dr principal investigator
School Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eVIS in people with Chronic Pain, run by Dalarna University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veronica Sjöberg, Phd (+4623778757, vsj@du.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical health (time frame: 12 months follow up after IPRP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05009459, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.