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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
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.
Dalarna University
Falun, Sweden
RECRUITINGPhysical 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
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
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)
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)
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)
Drug name
Daily self reported data on drug name in the web application PATRON.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months follow up after IPRP
Work extension
Data on work extension will be collected from Swedish national quality registry for pain rehabilitation.
Time frame: 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
Time frame: 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
Time frame: 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 .
Time frame: 12 months follow up after IPRP
Pain duration
Days. Collected through SQRP-PC and SQRP-SC. High number of days represents longer pain duration.
Time frame: 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.
Time frame: 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".
Time frame: 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,
Time frame: 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. .
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months follow up after IPRP
Diagnosis
Demographic data on the incidence of diagnoses will be retrieved from the Patient registry.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months follow up after IPRP
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