Self-monitoring and Remote Monitoring of Chronic Pain in Primary Care - Using a Digital Tool to Improve Quality of Life

NCT ID: NCT07141108

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-14
• Study Completion Date: 2026-03-31

Brief Summary

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.

Conditions

Persistent Pain; Pain Management; Remote Monitoring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Digital pain management Intervention Group

Participants in this arm will use the Paindrainer® digital tool as part of their pain management strategy in primary care. Paindrainer® consists of a mobile app for self-monitoring of activity levels and symptoms, and a CARE portal for healthcare providers to support remote monitoring. The tool uses advanced neural networks to provide personalized feedback to help individuals plan and balance daily activities, aiming to enhance self-management and patient-provider communication. Standard care in primary care will continue in parallel. The study will evaluate the feasibility of implementing Paindrainer® in primary care settings and its potential to support long-term management of persistent pain conditions.

Group Type: EXPERIMENTAL

Paindrainer Care system

Intervention Type: DEVICE

Self management digital tool for chronic pain

Interventions

Paindrainer Care system

Self management digital tool for chronic pain

Intervention Type: DEVICE

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrik Midlöv, Professor MD

Role: PRINCIPAL_INVESTIGATOR

Lunds Universitet

Locations

Lunds Universitet Centrum för Primärvårdsforskning (CPF) Institutionen för kliniska vetenskaper, Malmö

Malmo, Skåne County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Patrik Midlöv, Professor MD

Role: CONTACT

patrik.midlov@med.lu.se

+46040391363

Other Identifiers

PD 2025-1

Identifier Type: -

Identifier Source: org_study_id