Self-monitoring and Remote Monitoring of Chronic Pain in Primary Care - Using a Digital Tool to Improve Quality of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Paindrainer Care system.
- Who it may be relevant to
- Registry conditions: Persistent Pain, Pain Management, Remote Monitoring. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Egenmonitorering Och Distansmonitorering av långvarig smärta i primärvården, användandet av Ett Digitalt Verktyg för Att ökad livskvalité
Overview
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.
Detailed description
Long-term pain causes significant suffering to the individual, their loved ones and also entails high societal costs. In specialist care, constant development is underway through the implementation of new research and clinical findings. Patients' own efforts, decisions and strategies are a central and effective part of today's pain management. The importance of strengthening communication between patient and healthcare professionals is increasingly emphasised, as well as promoting the patient's ability to self-manage their situation.
More recently, behavior-modifying techniques have been integrated as complementary measures in the treatment of chronic pain. Despite this, a challenge remains for the healthcare system to create long-term sustainable outcomes for people with chronic pain.
The proportion of people with long-term pain who currently receive treatment in specialist care is very small, and the majority are treated in primary care instead. Resources for this patient group are insufficient and there is a great need for new tools for self- and remote monitoring that could improve the allocation of resources for this group.
This feasibility study aims to investigate whether a digital remote monitoring tool, Paindrainer®, can be implemented in primary care. The tool contains two parts, an app for the patient to use for their own monitoring of activity levels and symptoms, and the CARE portal, which is a remote monitoring tool for healthcare. The study will further explore how the implementation of this digital app in the existing treatment strategy can help address these challenges and improve care for people with chronic pain.
Paindrainer® is a CE marked class 1 product according to MDR and is based on advanced neural networks, which enables sophisticated calculations and takes into account more variables that affect the individual's pain experience and function than the human brain can handle. By using advanced calculations, Paindrainer provides continuous feedback to the patient, giving them a tool to plan and monitor their activities and understand how they affect each other.
This study will further investigate how Paindrainer® can support the individual to plan their activities in both "necessary" areas (such as daily chores, work, sleep) and other areas that are valuable to the individual (e.g. extracurricular activities, social and physical activities). By strengthening the patient's own role, Paindrainer is expected to increase the individual's quality of life and perceived health in both the short and long term.
Interventions
- Device Paindrainer Care system
Self management digital tool for chronic pain
Primary outcome measures
- Evaluation of a Digital Self-Management Tool to Support Primary Care in Managing Persistent Pain [Time frame: 12 weeks]
Secondary outcome measures (3)
- Change in Health-Related Quality of Life measured by the PROMIS-29 Profile [Time frame: From baseline to 12 weeks]
- Change in Pain Acceptance [Time frame: From baseline to 12 weeks]
- Change in Pain Catastrophizing measured by the Pain Catastrophizing Scale (PCS) [Time frame: From baseline to 12 weeks]
Eligibility criteria
Inclusion criteria
Has pain that affects daily life and has lasted for more than 3 months
Is over 18 years old
Understands Swedish or English
Is motivated and willing to use a digital tool for self-monitoring of activity level and symptoms
Has no planned surgeries during the study period
Has knowledge of and access to using a smartphone or tablet
Exclusion criteria
Severe or acute mental illness, severe anxiety, or depression
Ongoing history of substance use disorder
Serious illness under active treatment
Pain related to malignancy
Currently involved in legal proceedings or ongoing litigation related to low back or neck pain
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Sweden · 1 center
- Lunds Universitet Centrum för Primärvårdsforskning (CPF) Institutionen för kliniska vetens — Malmö
Identifiers
NCT: NCT07141108 · PD 2025-1