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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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 activ

Первичные конечные точки

• Physical health [Срок оценки: 12 months follow up after IPRP]

Вторичные конечные точки (12)

• Physical and mental health [Срок оценки: 6, 24, 36 months after IPRP]
• Objectively measured physical activity levels [Срок оценки: Data will be collected daily during study period (6 months)]
• Pain intensity last 24 hours [Срок оценки: Data will be collected daily during study period (6 months)]
• Pain interference [Срок оценки: Data will be collected daily during study period (6 months)]
• Drug name [Срок оценки: Data will be collected daily during study period (6 months)]
• Drug dose [Срок оценки: Data will be collected daily during study period (6 months)]
• Drug strenght [Срок оценки: Data will be collected daily during study period (6 months)]
• Drug form [Срок оценки: Data will be collected daily during study period (6 months)]
• Work form [Срок оценки: 12 months follow up after IPRP]
• Work extension [Срок оценки: 12 months follow up after IPRP]
• Education level [Срок оценки: 12 months follow up after IPRP]
• Pain intensity last seven days [Срок оценки: 12 months follow up after IPRP]

Критерии участия

Критерии включения

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.

Критерии исключения

• Patients who need to use a walking aid indoors.
• Patients living with pain caused by systemic disease or malignancies.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Dalarna University — Falun

Публикации

• 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. PMID 33433391
• 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. PMID 35428627
• 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. PMID 36897847

Идентификаторы

NCT: NCT05009459 · 2017-00491

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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