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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Physical health
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients who need to use a walking aid indoors.
- •Patients living with pain caused by systemic disease or malignancies.
研究组 & 干预措施
eVIS + Treatment as usual (interdisciplinary pain rehabilitation program)
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.
干预措施: eVIS (Behavioral)
Treatment as usual (interdisciplinary pain rehabilitation program)
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.
结局指标
主要结局
Physical health
时间窗: 12 months follow up after IPRP
Physical health domain by RAND-36, ranging from 0 to 100, with high values indicating good health.
次要结局
- Objectively measured physical activity levels(Data will be collected daily during study period (6 months))
- Pain interference(Data will be collected daily during study period (6 months))
- Drug name(Data will be collected daily during study period (6 months))
- Drug dose(Data will be collected daily during study period (6 months))
- Drug form(Data will be collected daily during study period (6 months))
- Education level(12 months follow up after IPRP)
- Pain regions(12 months follow up after IPRP)
- Pain duration(12 months follow up after IPRP)
- Strenous exercise(12 months follow up after IPRP)
- Light exercise(12 months follow up after IPRP)
- Overall emotional distress(12 months follow up after IPRP)
- Psychosocial consequences - Affective distress(12 months follow up after IPRP)
- Pain intensity last seven days(12 months follow up after IPRP)
- Psychosocial consequences - Pain intensity(12 months follow up after IPRP)
- Psychosocial consequences - Interference(12 months follow up after IPRP)
- Physical and mental health(6, 24, 36 months after IPRP)
- Pain intensity last 24 hours(Data will be collected daily during study period (6 months))
- Drug strenght(Data will be collected daily during study period (6 months))
- Work form(12 months follow up after IPRP)
- Work extension(12 months follow up after IPRP)
- Self-rated health(baseline, 12, 24 months follow up after IPRP.)
- Physical activity(12 months follow up after IPRP)
- Exercise(12 months follow up after IPRP)
- Sedentary activities(12 months follow up after IPRP)
- Moderate exercise(12 months follow up after IPRP)
- Pain catastrophizing(12 months follow up after IPRP)
- Self-rated mental health(baseline, 6, 12, 24 months follow up after IPRP.)
- Psychosocial consequences - Life control(12 months follow up after IPRP)
- Pain acceptance(12 months follow up after IPRP)
- Life satisfaction(12 months follow up after IPRP)
- Sleep quality(12 months follow up after IPRP)
- Psychosocial consequences - Social support(12 months follow up after IPRP)
- Work ability(12 months follow up after IPRP)
- Functional levels(12 months follow up after IPRP)
- Reasons for Sick leave(12 months follow up after IPRP)
- Income(12 months follow up after IPRP)
- Sickness benefit(12 months follow up after IPRP)
- Pharmaceutical costs(12 months follow up after IPRP)
- Total number of days in care(12 months follow up after IPRP)
- Quality Adjusted Life Years(12 months follow up after IPRP)
- Defined pharmaceutical doses per day(12 months follow up after IPRP)
- Days in work before new sick leave period(12 months follow up after IPRP)
- Total sick leave(12 months follow up after IPRP)
- Diagnosis(12 months follow up after IPRP)
- Education(12 months follow up after IPRP)
研究者
Linda Vixner
Docent in Medical Sciences/Deputy Head of Research Centre for Public Health and Sports (RePS)
Dalarna University