About this trial
Chronic pain impacts individuals, their families, and society significantly, yet specialist care resources are limited, with most patients managed in primary care. There is a need for tools that support self-management and improve resource allocation. This feasibility study evaluates the implementation of Paindrainer®, a CE-marked Class I digital tool, in primary care. Paindrainer® combines patient self-monitoring via an app with a healthcare provider portal (CARE) for remote monitoring. Using advanced neural networks, it offers personalized feedback to help patients plan and monitor daily activities and their impact on pain. The study aims to assess whether integrating this tool can enhance chronic pain management and patient quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Paindrainer Care system
DeviceSelf management digital tool for chronic pain
Treatment groups
Trial outcomes
Primary outcomes
Evaluation of a Digital Self-Management Tool to Support Primary Care in Managing Persistent Pain
Through the use of logged daily activities the overall purpose of this study is to investigate how the digital tool Paindrainer® can support primary care in assisting individuals with persistent pain, reducing the impact of pain in daily life, and improving quality of life. The study focuses on evaluating the effectiveness and usability of Paindrainer® in supporting primary care efforts to provide adequate care, enhance continuity, and increase patient confidence in managing long-term pain conditions. The primary parameter to analyse is PROMSI Pain interference 6a and usability questioners
Secondary outcomes
Change in Health-Related Quality of Life measured by the PROMIS-29 Profile
The Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS-29) is a validated questionnaire designed to assess multiple domains of health-related quality of life. It includes 29 items covering seven key domains: Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, and Pain Interference, along with a single item for Pain Intensity. Each domain consists of four items rated on a 5-point Likert scale, except for Pain Intensity, which uses an 11-point numeric rating scale (0-10). Higher scores indicate more of the concept being measured (e.g., higher fatigue, higher social participation).
Change in Pain Acceptance
The Chronic Pain Acceptance Questionnaire-9 (CPAQ-9) is a validated, shortened version of the original CPAQ, designed to measure an individual's acceptance of chronic pain. The CPAQ-9 assesses two key components: Activity Engagement (participation in life activities despite pain) and Pain Willingness (openness to experiencing pain without attempts to control or avoid it). The questionnaire consists of 9 items rated on a 7-point Likert scale, where higher scores indicate greater acceptance of chronic pain.
Change in Pain Catastrophizing measured by the Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) is a validated questionnaire used to assess catastrophic thinking related to pain, including elements of rumination, magnification, and feelings of helplessness. The scale consists of 13 items scored on a 5-point Likert scale. Higher scores indicate greater levels of pain catastrophizing.
Sponsors and contacts
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Lund University
Lead sponsor
Region Skane
Collaborator