Persistent PainNCT07141108
Self-monitoring and Remote Monitoring of Chronic Pain in Primary Care - Using a Digital Tool to Improve Quality of Life
A study testing Paindrainer Care system in people with Persistent Pain and Pain Management, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Pain, Pain Management, Remote Monitoring
- What is being tested?
- Paindrainer Care system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 14 May 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Lunds Universitet Centrum för Primärvårdsforskning (CPF) Institutionen för kliniska vetenskaper, Malmö
Malmö, Skåne County, 214 28
About this study
Official title: Egenmonitorering Och Distansmonitorering av långvarig smärta i primärvården, användandet av Ett Digitalt Verktyg för Att ökad livskvalité
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.
Read the 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
- Being tested
- Paindrainer Care system
- Keywords
- chronic pain, pain management, persistent pain
- Medical subject headings
- Agnosia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paindrainer Care systemDevice
Self management digital tool for chronic pain
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Paindrainer Care system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (3)
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).
Measured: From baseline to 12 weeks
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.
Measured: From baseline to 12 weeks
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.
Measured: From baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start14 May 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent PainStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane
- Responsible party
- Sponsor
- Investigators
- Patrik Midlöv, Professor MD, Principal investigator, Lunds Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141108
- Sponsor's protocol ID
- PD 2025-1
- Status last verified
- Aug 2025
- First submitted
- 23 May 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (demographic information, primary and secondary outcomes) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Egenmonitorering Och Distansmonitorering av långvarig smärta i primärvården, användandet av Ett Digitalt Verktyg för Att ökad livskvalité
- ClinicalTrials.gov ID
- NCT07141108
- Acronym / sponsor ID
- PD 2025-1
- Conditions
- Persistent Pain, Pain Management, Remote Monitoring
- Keywords
- chronic pain, pain management, persistent pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Region Skane
- Study start
- 14 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital pain management Intervention Group | Experimental | Device: Paindrainer Care systemParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paindrainer Care systemSelf management digital tool for chronic pain | Device | Digital pain management Intervention Group |
Primary outcome
Evaluation of a Digital Self-Management Tool to Support Primary Care in Managing Persistent Pain
Time frame: 12 weeks
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (demographic information, primary and secondary outcomes) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrik Midlöv, Professor MD principal investigator
Lunds Universitet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paindrainer Care system in people with Persistent Pain and Pain Management, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrik Midlöv, Professor MD (+46040391363, patrik.midlov@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of a Digital Self-Management Tool to Support Primary Care in Managing Persistent Pain (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.