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

Chronic Pain Clinical Trial

— eVIS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05009459
• Other study ID #: 2017-00491
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Dalarna University
• Contact: Veronica Sjöberg, Phd-student
• Phone: +4623778757
• Email: vsj[@]du.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• eVIS
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.

Locations

Country	Name	City	State
Sweden	Dalarna University	Falun

Sponsors (3)

Lead Sponsor	Collaborator
Dalarna University	Swedish Council for Working Life and Social Research, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Physical and mental health	RAND-36 health survey, ranging from 0 to 100, with high values indicating good health.	6, 24, 36 months after IPRP
Secondary	Objectively measured physical activity levels	Steps per day collected by Fitbit Versa 2 synchronized to web application PATRON	Data will be collected daily during study period (6 months)
Secondary	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.	Data will be collected daily during study period (6 months)
Secondary	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.	Data will be collected daily during study period (6 months)
Secondary	Drug name	Daily self reported data on drug name in the web application PATRON.	Data will be collected daily during study period (6 months)
Secondary	Drug dose	Daily self reported data on drug dose (example: 2 tablets per day) in the web application PATRON.	Data will be collected daily during study period (6 months)
Secondary	Drug strenght	Daily self reported data on drug strenght (example: 500 mg/tablet) in the web application PATRON.	Data will be collected daily during study period (6 months)
Secondary	Drug form	Daily self reported data on drug form (example: tablet, injection) in the web application PATRON.	Data will be collected daily during study period (6 months)
Secondary	Work form	Data on work form will be collected from Swedish national quality registry for pain rehabilitation.	12 months follow up after IPRP
Secondary	Work extension	Data on work extension will be collected from Swedish national quality registry for pain rehabilitation.	12 months follow up after IPRP
Secondary	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	12 months follow up after IPRP
Secondary	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	12 months follow up after IPRP
Secondary	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 .	12 months follow up after IPRP
Secondary	Pain duration	Days. Collected through SQRP-PC and SQRP-SC. High number of days represents longer pain duration.	12 months follow up after IPRP
Secondary	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.	baseline, 6, 12, 24 months follow up after IPRP.
Secondary	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".	baseline, 12, 24 months follow up after IPRP.
Secondary	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,	12 months follow up after IPRP
Secondary	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. .	12 months follow up after IPRP
Secondary	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.	12 months follow up after IPRP
Secondary	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.	12 months follow up after IPRP
Secondary	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.	12 months follow up after IPRP
Secondary	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.	12 months follow up after IPRP
Secondary	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.	12 months follow up after IPRP
Secondary	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	12 months follow up after IPRP
Secondary	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.	12 months follow up after IPRP
Secondary	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.	12 months follow up after IPRP
Secondary	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.	12 months follow up after IPRP
Secondary	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.	12 months follow up after IPRP
Secondary	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.	12 months follow up after IPRP
Secondary	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.	12 months follow up after IPRP
Secondary	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.	12 months follow up after IPRP
Secondary	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	12 months follow up after IPRP
Secondary	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	12 months follow up after IPRP
Secondary	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.	12 months follow up after IPRP
Secondary	Reasons for Sick leave	Demographic data on reasons for sick leave will be retrieved from the Swedish Social Insurance Agency's registry.	12 months follow up after IPRP
Secondary	Sickness benefit	Data on sickness benefit (days and hours) during the study period will be retrieved from the Swedish Social Insurance Agency's registry	12 months follow up after IPRP
Secondary	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	12 months follow up after IPRP
Secondary	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	12 months follow up after IPRP
Secondary	Diagnosis	Demographic data on the incidence of diagnoses will be retrieved from the Patient registry.	12 months follow up after IPRP
Secondary	Total number of days in care	Data on total number of days in care) will be retrieved from the Patient registry.	12 months follow up after IPRP
Secondary	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	12 months follow up after IPRP
Secondary	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.	12 months follow up after IPRP
Secondary	Pharmaceutical costs	Retrieved data from the Pharmaceutical registry will provide information on costs of prescribed and collected pharmaceuticals in SEK.	12 months follow up after IPRP
Secondary	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.	12 months follow up after IPRP
Secondary	Education	From the Population registry, data on education level and education orientation (focus) in addition to limited demographic data (sex, age) will be collected.	12 months follow up after IPRP