Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07141108

Self-monitoring and Remote Monitoring of Chronic Pain in Primary Care Using the Paindrainer4 Digital Tool to Improve Quality of Life

Led by Lund University · Updated on 2025-08-26

30

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

Sponsors

L

Lund University

Lead Sponsor

R

Region Skane

Collaborating Sponsor

AI-Summary

What this Trial Is About

Chronic pain significantly affects individuals, their families, and society, yet most patients receive care in primary care settings where resources are limited. This research aims to evaluate the implementation of Paindrainer4, a CE-marked Class I digital tool designed to support self-management and improve chronic pain care in primary settings. The study explores whether integrating this tool can enhance pain management and improve patients' quality of life. Paindrainer4 consists of a mobile app for patients to self-monitor activity levels and symptoms, combined with a CARE portal for healthcare providers to remotely monitor patients. Using advanced neural networks, the tool provides personalized feedback to help users plan and balance daily activities affecting their pain. Participants will use Paindrainer4 alongside standard primary care treatment during the study. Participants will engage with the app to track their activities and symptoms, while healthcare providers use the CARE portal for remote monitoring. The study will measure outcomes over 12 weeks, including evaluation of the digital tool's support for managing persistent pain, changes in health-related quality of life, pain acceptance, and pain catastrophizing. The study aims to assess feasibility and potential benefits of this remote monitoring tool in routine primary care.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Implementation

Duration - 12 weeks

Participants use the Paindrainer® digital tool for self-monitoring of activity levels and symptoms as part of their pain management strategy in primary care. This includes the mobile app for self-monitoring and the CARE portal used by healthcare providers for remote monitoring.

Regular use of the digital tool with periodic check-ins as part of primary care

Long-term Monitoring

Duration - Up to 12 weeks from baseline

Participants continue to be observed for changes in health-related quality of life, pain acceptance, and pain catastrophizing during and after use of the digital tool.

Follow-up assessments at baseline and at 12 weeks

Trial Site Locations

Total: 1 location

1

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

Malmö, Skåne County, Sweden, 214 28

Actively Recruiting

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Research Team

P

Patrik Midlöv, Professor MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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Frequently Asked Questions

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