Chronic PainNCT04762329
Manage My Pain at Chronic Pain Clinics
A study testing Manage My Pain (MMP) digital pain app group in people with Chronic Pain, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The overall objective of this Early Adoption project is to gather evidence for how Managing My Pain Program (MMP), a novel digital pain management application can enable better care at home for chronic pain sufferers in the province of Ontario, Canada across 4 sites in urban, community, and rural settings Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Manage My Pain (MMP) digital pain app group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jan 2018to 8 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- New patients with chronic pain conditions referred to participating sites with pain programs to adopt the MMP tool into clinical practice.
Who cannot join
- Patients declining to consent for the study
- Patients withdrawing from the study at a later time after consenting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manage My Pain at Chronic Pain Clinics in Urban, Community, and Rural Hospitals
The overall objective of this Early Adoption project is to gather evidence for how Managing My Pain Program (MMP), a novel digital pain management application can enable better care at home for chronic pain sufferers in the province of Ontario, Canada across 4 sites in urban, community, and rural settings
Read the detailed description
Chronic pain imposes a large burden on individuals and society. A patient-centric digital chronic pain management application, Managing My Pain Program (MMP) that incorporates validated questionnaires can be used to enhance communication between providers and patients and promote self-management to evaluate the extent of patient engagement with the app when used in clinical settings.
The main objectives for this project is to evaluate the engagement in patients using MMP, and to assess improvements in clinical outcomes directly relevant for pain management, as measured by clinically-validated tools.
- Conditions
- Chronic Pain
- Being tested
- Manage My Pain (MMP) digital pain app group
- Keywords
- Pain, Psychology, Patient Oriented Research, Quality of Life, Digital Health, Chronic Pain, Pain App, Virtual Care, mHealth, Pain Management, Chronic Disease Management, Remote Monitoring
- Medical subject headings
- Chronic Pain, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manage My Pain (MMP) digital pain app groupOther
To evaluate the extent of patient engagement with the Manage My Pain (MMP) digital application when used in a clinical setting
| Study group | Role | What they receive |
|---|---|---|
| Patient group using Manage My Pain (MMP) digital application for pain data | Experimental | Participants completed pain related questionnaires on the following pain related outcomes - anxiety, depression, catastrophizing, disability, patient impression of change, and daily opioid consumption at baseline on initial visit and as a part of the first follow-up clinical visits, on the Manage My Pain (MMP) digital application Receives: Other: Manage My Pain (MMP) digital pain app group |
| Patient group using paper format for pain data | No intervention | Participants completed pain related questionnaires on the following pain related outcomes - anxiety, depression, catastrophizing, disability, patient impression of change, and daily opioid consumption at baseline on initial visit and as a part of the first follow-up clinical visits on paper format or phone interviews. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating engagement based on adoption and retention rates
Evaluating the number of patients who elected to use the Manage My Pain (MMP) application, and determining how long they used the app in the short-term (4.5 months) and long-term (4.5-7 months) follow-ups
Measured: 24 months
Secondary outcomes (6)
Change in depression as measured by the Patient Health Questionnaire 9-item (PHQ-9)
Minimum score of 0, maximum score of 27. The higher the score, the higher the severity of depression.
Measured: Short-term (4.5 months) and long-term (4.5-7 months)
Change in anxiety as measured by the General Anxiety Disorder 7-item Questionnaire (GAD-7)
Minimum score of 0, maximum score of 21. The higher the score, the higher the severity of anxiety.
Measured: Short-term (4.5 months) and long-term (4.5-7 months)
Change in pain disability as measured by the Pain Disability Index (PDI)
Minimum score of 0, maximum score of 70. The higher the score, the higher the severity of pain disability.
Measured: Short-term (4.5 months) and long-term (4.5-7 months)
Change in pain catastrophizing and measured by the Pain Catastrophizing Scale (PCS)
Minimum score of 0, maximum score of 52. The higher the score, the higher the severity of pain catastrophizing.
Measured: Short-term (4.5 months) and long-term (4.5-7 months)
Change in opioid consumption as measured by Oral Morphine Equivalents (OME)
Minimum amount of 0, no maximum amount. The higher the amount the more opioid they are taking
Measured: Short-term (4.5 months) and long-term (4.5-7 months)
Change in patient satisfaction as measured by the Patient Global Impression of Change (PGIC) scale
Minimum score of 1, maximum score of 7. The higher the score, the higher the level of patient satisfaction.
Measured: Short-term (4.5 months) and long-term (4.5-7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start8 Jan 2018
- Primary completion8 Jan 2020
- Study completion8 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Centres of Excellence
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762329
- Sponsor's protocol ID
- 17-6201
- Status last verified
- Mar 2025
- First submitted
- 26 Oct 2020
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD was collected during the study to share
Publications
Portelli P, Eldred C. A quality review of smartphone applications for the management of pain. Br J Pain. 2016 Aug;10(3):135-40. doi: 10.1177/2049463716638700. Epub 2016 Apr 19.
PubMed 27583140Alexander JC, Joshi GP. Smartphone applications for chronic pain management: a critical appraisal. J Pain Res. 2016 Sep 26;9:731-734. doi: 10.2147/JPR.S119966. eCollection 2016. No abstract available.
PubMed 27713649Salazar A, de Sola H, Failde I, Moral-Munoz JA. Measuring the Quality of Mobile Apps for the Management of Pain: Systematic Search and Evaluation Using the Mobile App Rating Scale. JMIR Mhealth Uhealth. 2018 Oct 25;6(10):e10718. doi: 10.2196/10718.
PubMed 30361196Bhatia A, Kara J, Janmohamed T, Prabhu A, Lebovic G, Katz J, Clarke H. User Engagement and Clinical Impact of the Manage My Pain App in Patients With Chronic Pain: A Real-World, Multi-site Trial. JMIR Mhealth Uhealth. 2021 Mar 4;9(3):e26528. doi: 10.2196/26528.
PubMed 33661130
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manage My Pain at Chronic Pain Clinics in Urban, Community, and Rural Hospitals
- ClinicalTrials.gov ID
- NCT04762329
- Acronym / sponsor ID
- 17-6201
- Conditions
- Chronic Pain
- Keywords
- Pain, Psychology, Patient Oriented Research, Quality of Life, Digital Health, Chronic Pain, Pain App, Virtual Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Ontario Centres of Excellence
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 21 Feb 2021 (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.
The overall objective of this Early Adoption project is to gather evidence for how Managing My Pain Program (MMP), a novel digital pain management application can enable better care at home for chronic pain sufferers in the province of Ontario, Canada across 4 sites in urban, community, and rural settings
Detailed description
Chronic pain imposes a large burden on individuals and society. A patient-centric digital chronic pain management application, Managing My Pain Program (MMP) that incorporates validated questionnaires can be used to enhance communication between providers and patients and promote self-management to evaluate the extent of patient engagement with the app when used in clinical settings.
The main objectives for this project is to evaluate the engagement in patients using MMP, and to assess improvements in clinical outcomes directly relevant for pain management, as measured by clinically-validated tools.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group using Manage My Pain (MMP) digital application for pain data | Experimental | Other: Manage My Pain (MMP) digital pain app groupParticipants completed pain related questionnaires on the following pain related outcomes - anxiety, depression, catastrophizing, disability, patient impression of change, and daily opioid consumption at baseline on initial visit and as a part of the first follow-up clinical visits, on the Manage My Pain (MMP) digital application |
| Patient group using paper format for pain data | No intervention | –Participants completed pain related questionnaires on the following pain related outcomes - anxiety, depression, catastrophizing, disability, patient impression of change, and daily opioid consumption at baseline on initial visit and as a part of the first follow-up clinical visits on paper format or phone interviews. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- New patients with chronic pain conditions referred to participating sites with pain programs to adopt the MMP tool into clinical practice.
Key exclusion criteria (2 listed)
- Patients declining to consent for the study
- Patients withdrawing from the study at a later time after consenting
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 |
|---|---|---|
| Manage My Pain (MMP) digital pain app groupTo evaluate the extent of patient engagement with the Manage My Pain (MMP) digital application when used in a clinical setting | Other | Patient group using Manage My Pain (MMP) digital application for pain data |
Primary outcome
Evaluating engagement based on adoption and retention rates
Time frame: 24 months
Evaluating the number of patients who elected to use the Manage My Pain (MMP) application, and determining how long they used the app in the short-term (4.5 months) and long-term (4.5-7 months) follow-ups
6 secondary outcomes
Change in depression as measured by the Patient Health Questionnaire 9-item (PHQ-9)
Time frame: Short-term (4.5 months) and long-term (4.5-7 months)
Change in anxiety as measured by the General Anxiety Disorder 7-item Questionnaire (GAD-7)
Time frame: Short-term (4.5 months) and long-term (4.5-7 months)
Change in pain disability as measured by the Pain Disability Index (PDI)
Time frame: Short-term (4.5 months) and long-term (4.5-7 months)
Change in pain catastrophizing and measured by the Pain Catastrophizing Scale (PCS)
Time frame: Short-term (4.5 months) and long-term (4.5-7 months)
Change in opioid consumption as measured by Oral Morphine Equivalents (OME)
Time frame: Short-term (4.5 months) and long-term (4.5-7 months)
Change in patient satisfaction as measured by the Patient Global Impression of Change (PGIC) scale
Time frame: Short-term (4.5 months) and long-term (4.5-7 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Background: PubMed 27583140Portelli P, Eldred C. A quality review of smartphone applications for the management of pain. Br J Pain. 2016 Aug;10(3):135-40. doi: 10.1177/2049463716638700. Epub 2016 Apr 19.
- Background: PubMed 27713649Alexander JC, Joshi GP. Smartphone applications for chronic pain management: a critical appraisal. J Pain Res. 2016 Sep 26;9:731-734. doi: 10.2147/JPR.S119966. eCollection 2016. No abstract available.
- Background: PubMed 30361196Salazar A, de Sola H, Failde I, Moral-Munoz JA. Measuring the Quality of Mobile Apps for the Management of Pain: Systematic Search and Evaluation Using the Mobile App Rating Scale. JMIR Mhealth Uhealth. 2018 Oct 25;6(10):e10718. doi: 10.2196/10718.
- Derived from this study: PubMed 33661130Bhatia A, Kara J, Janmohamed T, Prabhu A, Lebovic G, Katz J, Clarke H. User Engagement and Clinical Impact of the Manage My Pain App in Patients With Chronic Pain: A Real-World, Multi-site Trial. JMIR Mhealth Uhealth. 2021 Mar 4;9(3):e26528. doi: 10.2196/26528.
- Individual participant dataSharing planned: No. No IPD was collected during the study to share
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manage My Pain (MMP) digital pain app group in people with Chronic Pain, run by University Health Network, Toronto at 1 site in Canada.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 28 Mar 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating engagement based on adoption and retention rates (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04762329, which also lists 4 linked publications.
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 28 Mar 2025.