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

NCT07141108 | Recruiting

• 1 other identifier: PD 2025-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Pain; Pain Management; Remote Monitoring

Keywords

chronic pain; pain management; persistent pain

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (3)

• Change in Health-Related Quality of Life measured by the PROMIS-29 Profile

  From baseline to 12 weeks

• Change in Pain Acceptance

  From baseline to 12 weeks

• Change in Pain Catastrophizing measured by the Pain Catastrophizing Scale (PCS)

  From baseline to 12 weeks

Study Arms (1)

Digital pain management Intervention Group

EXPERIMENTAL

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.

Device: Paindrainer Care system

Interventions

Paindrainer Care system DEVICE

Self management digital tool for chronic pain

Digital pain management Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University: lead
• Region Skane: collaborator

Study Sites (1)

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

Malmo, Skåne County, 214 28, Sweden

RECRUITING

MeSH Terms

Conditions

Agnosia; Chronic Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Officials

• Patrik Midlöv, Professor MD

  Lunds Universitet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrik Midlöv, Professor MD

CONTACT

+46040391363; patrik.midlov@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: August 26, 2025
• Study Start: May 14, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be available starting 6 months after publication of primary results and will be accessible for 5 years thereafter.
• Access Criteria: Qualified researchers with an approved proposal can request access via the study sponsor. Data will be shared through a secure data sharing platform.

Locations

SE (1)