Patellofemoral Pain SyndromeNCT05614583
Multidisciplinary Digital Therapeutics of Patellofemoral Pain Syndrome Versus Usual Care
A study testing MORT-PFPS app and treatment as usual (TAU) in people with Patellofemoral Pain Syndrome, run by EverEx Inc. at 2 sites in South Korea.
Trial summary
This randomized controlled pilot study will be evaluating an app, MORT-PFPS app (ETH-01K), owned by EverEx, Inc., to examine safety and effectiveness in individuals with patellofemoral pain syndrome. Read more about this study
- Who is it for?
- Ages 19 to 50 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- MORT-PFPS app and treatment as usual (TAU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 16 Nov 2022to 19 Oct 2023
- 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 19 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female ≥ 19 and <50 years of age
- Patients who have a history of anterior knee pain in one or both knees, persisting for longer than 3months but not longer than 2 years
- Patients who have pain provoked by squatting
- Patients who have pain provoked by 2 or more following activities
- long sitting
- cycling
Show all 12Show fewer
- running
- going up or down stairs
- kneeling
- compression of the patella
- palpation of the patellar facets
- Patients who signed a written informed consent form
Who cannot join
- Patients with osteoarthritis which scored 2 or higher grade of the Kellgren-Lawrence scale
- Patients who have a history of knee pathologies or injuries (fracture, tendon injury, cartilage injury, or patella dislocation)
- Patients who had previous knee surgeries
- Patients who have patellar tendinopathy
- Patients who have Osgood-Schlatter disease, or other defined pathological conditions of the knee
- Patients who are pregnant or breastfeeding
Show all 10Show fewer
- Patients who are using anti-inflammatory medication
- Patients with known substance/alcohol use disorders
- Patients with known somatic symptom and related disorders
- Patients who are not able to participate in an exercise or strengthening program
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Dongjak, Seoul, 07061
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Multidisciplinary Digital Therapeutics of Patellofemoral Pain Syndrome Versus Usual Care, a Randomized Controlled Pilot Study
This randomized controlled pilot study will be evaluating an app, MORT-PFPS app (ETH-01K), owned by EverEx, Inc., to examine safety and effectiveness in individuals with patellofemoral pain syndrome.
Read the detailed description
This randomized controlled pilot study will enroll 40 participants, where half will be randomly assigned to the app, MORT-PFPS (n = 20), and half will be assigned to treatment as usual (TAU) (n = 20), to examine safety and effectiveness in individuals with patellofemoral pain syndrome. All subjects will be followed up in the study for a total of 12 weeks, 8-week courses of treatment with additional 4-week observation. The app provides multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with patellofemoral pain syndrome.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- MORT-PFPS app, treatment as usual (TAU)
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORT-PFPS appDevice
The MORT-PFPS, developed by EverEx, Inc., is designed to provide multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with patellofemoral pain syndrome.
In the control group, psychoeducation is delivered and self-exercise is recommended.
| Study group | Role | What they receive |
|---|---|---|
| MORT-PFPS | Experimental | Participants randomly assigned to this arm will use the app, MORT-PFPS. Receives: Device: MORT-PFPS app |
| treatment as usual (TAU) | Active comparator | Participants randomly assigned to this arm will receive their TAU only (no use of the app, MORT-PFPS). Receives: Other: treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usual pain severity assessed by the Numeric Rating Scale (NRS )
The primary outcome being measure is differences in usual pain severity between groups after the intervention. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).
Measured: 8 weeks
Global rating of perceived recovery
The primary outcome being measure is differences in global rating of perceived recovery between groups after the intervention. Global rating of perceived recovery score was measured from 1 (very bad) to 7 (very good).
Measured: 8 weeks
Functional disability assessed by the Kujala Patellofemoral Scale
The primary outcome being measure is differences in functional disability between groups after the intervention. Kujala Patellofemoral Scale, also known as Anterior Knee Pain Scale, is a patient reported assessment of patellofemoral pain syndrome-specific functional limitations. It has 13 questions, and total score ranges from 0 to 100 (higher scores meaning better outcomes).
Measured: 8 weeks
Secondary outcomes (15)
Usual pain severity assessed by the Numeric Rating Scale (NRS)
The secondary outcome being measure is differences in usual pain severity between groups at 4 and 12 weeks. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).
Measured: 4, 12 weeks
Global rating of perceived recovery
The secondary outcome being measure is differences in global rating of perceived recovery between groups at 4 and 12 weeks. Global rating of perceived recovery score was measured from 1 (very bad) to 7 (very good).
Measured: 4, 12 weeks
Functional disability assessed by the Kujala Patellofemoral Scale
The secondary outcome being measure is differences in functional disability between groups at 4 and 12 weeks. Kujala Patellofemoral Scale, also known as Anterior Knee Pain Scale, is a patient reported assessment of patellofemoral pain syndrome-specific functional limitations. It has 13 questions, and total score ranges from 0 to 100 (higher scores meaning better outcomes).
Measured: 4, 12 weeks
Worst pain severity, pain during specific activities (running, standing up from sitting, going up or down stairs, and sleeping) assessed by the Numeric Rating Scale (NRS)
The secondary outcome being measure is differences in worst pain severity, pain during specific activities between groups at 4, 8 and 12 weeks. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).
Measured: 4, 8, 12 weeks
Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)
The secondary outcome being measure is differences in health-related quality of life between groups at 4, 8 and 12 weeks. It measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with three possible answers for each dimension (1=no problem, 2=moderate problem, 3=severe problem). The instrument also includes a visual analogue scale, which is numbered from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Measured: 4, 8, 12 weeks
Changes of Knee strength
Flexion and extension strength of knee are measured using a Biodex isokinetic dynamometer (peak torque (Nm) and % decrease in torque).
Measured: 8, 12 weeks
Changes of hip abductor function
Hip abductor function is assessed by knee valgus angle during single leg squat (°).
Measured: 8, 12 weeks
Changes of usual pain severity, worst pain severity, pain during specific activities (running, standing up from sitting, going up or down stairs, and sleeping), assessed by the Numeric Rating Scale (NRS)
The secondary outcome being measure is differences in changes of usual pain severity, worst pain severity, pain during specific activities from baseline to 4, 8, and 12 weeks between groups. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).
Measured: 4, 8, 12 weeks
Changes of functional disability assessed by the Kujala Patellofemoral Scale
The secondary outcome being measure is differences in changes of functional disability from baseline to 4, 8, and 12 weeks between groups. Kujala Patellofemoral Scale, also known as Anterior Knee Pain Scale, is a patient reported assessment of patellofemoral pain syndrome-specific functional limitations. It has 13 questions, and total score ranges from 0 to 100 (higher scores meaning better outcomes).
Measured: 4, 8, 12 weeks
Changes of health-related quality of life assessed by EuroQol five-dimensional (EQ-5D) [ Time Frame: 4, 8, 12 weeks ]
The secondary outcome being measure is differences in changes of health-related quality of life from baseline to 4, 8, and 12 weeks between groups. It measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with three possible answers for each dimension (1=no problem, 2=moderate problem, 3=severe problem). The instrument also includes a visual analogue scale, which is numbered from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Measured: 4, 8, 12 weeks
Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Differences in mental health symptoms between groups at 8, 12 weeks. The Patient Health Questionnaire-9 (PHQ-9) total score for the nine items ranges from 0 to 27 (higher scores indicating greater severity of depression).
Measured: 8, 12 weeks
Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)
Differences in levels of catastrophic thinking between groups at 8, 12 weeks. The Pain Catastrophizing Scale (PCS) is a 13-item scale, with a total range of 0 to 52 (higher scores indicating higher amounts of pain catastrophizing).
Measured: 8, 12 weeks
Assessment of fear avoidance behaviours measured by Fear-Avoidance Beliefs Questionnaire (FABQ)
Differences in fear avoidance behaviours between groups at 8, 12 weeks. The Fear-Avoidance Beliefs Questionnaire (FABQ) is a 16-item scale, with a total range of 0 to 96 (higher scores indicating higher amounts of fear avoidance behaviours).
Measured: 8, 12 weeks
Use of rescue medication
Differences in use of rescue medication between groups at 4, 8, 12 weeks.
Measured: 4, 8, 12 weeks
Assessment of retention in treatment
Differences in retention rates between groups at 4, 8 weeks.
Measured: 4, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start16 Nov 2022
- Primary completion19 Oct 2023
- Study completion19 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single site, randomized controlled trial research study
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- EverEx Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chong Bum Chang, Dr., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614583
- Sponsor's protocol ID
- E-ETH-01K-CTP-01
- Status last verified
- Jul 2024
- First submitted
- 30 Oct 2022
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee S, Yoon C, Choi CH, Park TH, Yang SJ, Cha HR, Kim TW, Park JH, Chang MJ, Chang CB. Efficacy of a Mobile Multidisciplinary Digital Therapeutics App for Patellofemoral Pain: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Oct 17;13:e69627. doi: 10.2196/69627.
PubMed 41105952
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Digital Therapeutics of Patellofemoral Pain Syndrome Versus Usual Care, a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05614583
- Acronym / sponsor ID
- E-ETH-01K-CTP-01
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- EverEx Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 14 Nov 2022 (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.
This randomized controlled pilot study will be evaluating an app, MORT-PFPS app (ETH-01K), owned by EverEx, Inc., to examine safety and effectiveness in individuals with patellofemoral pain syndrome.
Detailed description
This randomized controlled pilot study will enroll 40 participants, where half will be randomly assigned to the app, MORT-PFPS (n = 20), and half will be assigned to treatment as usual (TAU) (n = 20), to examine safety and effectiveness in individuals with patellofemoral pain syndrome. All subjects will be followed up in the study for a total of 12 weeks, 8-week courses of treatment with additional 4-week observation. The app provides multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with patellofemoral pain syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single site, randomized controlled trial research study
| Arm | Type | Receives |
|---|---|---|
| MORT-PFPS | Experimental | Device: MORT-PFPS appParticipants randomly assigned to this arm will use the app, MORT-PFPS. |
| treatment as usual (TAU) | Active comparator | Other: treatment as usual (TAU)Participants randomly assigned to this arm will receive their TAU only (no use of the app, MORT-PFPS). |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Male or female ≥ 19 and <50 years of age
- Patients who have a history of anterior knee pain in one or both knees, persisting for longer than 3months but not longer than 2 years
- Patients who have pain provoked by squatting
- Patients who have pain provoked by 2 or more following activities
- Patients who signed a written informed consent form
Key exclusion criteria (10 listed)
- Patients with osteoarthritis which scored 2 or higher grade of the Kellgren-Lawrence scale
- Patients who have a history of knee pathologies or injuries (fracture, tendon injury, cartilage injury, or patella dislocation)
- Patients who had previous knee surgeries
- Patients who have patellar tendinopathy
- Patients who have Osgood-Schlatter disease, or other defined pathological conditions of the knee
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 |
|---|---|---|
| MORT-PFPS appThe MORT-PFPS, developed by EverEx, Inc., is designed to provide multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with patellofemoral pain syndrome. | Device | MORT-PFPS |
| treatment as usual (TAU)In the control group, psychoeducation is delivered and self-exercise is recommended. | Other | treatment as usual (TAU) |
Primary outcome
Usual pain severity assessed by the Numeric Rating Scale (NRS )
Time frame: 8 weeks
The primary outcome being measure is differences in usual pain severity between groups after the intervention. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).
Global rating of perceived recovery
Time frame: 8 weeks
The primary outcome being measure is differences in global rating of perceived recovery between groups after the intervention. Global rating of perceived recovery score was measured from 1 (very bad) to 7 (very good).
Functional disability assessed by the Kujala Patellofemoral Scale
Time frame: 8 weeks
The primary outcome being measure is differences in functional disability between groups after the intervention. Kujala Patellofemoral Scale, also known as Anterior Knee Pain Scale, is a patient reported assessment of patellofemoral pain syndrome-specific functional limitations. It has 13 questions, and total score ranges from 0 to 100 (higher scores meaning better outcomes).
15 secondary outcomes
Usual pain severity assessed by the Numeric Rating Scale (NRS)
Time frame: 4, 12 weeks
Global rating of perceived recovery
Time frame: 4, 12 weeks
Functional disability assessed by the Kujala Patellofemoral Scale
Time frame: 4, 12 weeks
Worst pain severity, pain during specific activities (running, standing up from sitting, going up or down stairs, and sleeping) assessed by the Numeric Rating Scale (NRS)
Time frame: 4, 8, 12 weeks
Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)
Time frame: 4, 8, 12 weeks
Changes of Knee strength
Time frame: 8, 12 weeks
Changes of hip abductor function
Time frame: 8, 12 weeks
Changes of usual pain severity, worst pain severity, pain during specific activities (running, standing up from sitting, going up or down stairs, and sleeping), assessed by the Numeric Rating Scale (NRS)
Time frame: 4, 8, 12 weeks
Changes of functional disability assessed by the Kujala Patellofemoral Scale
Time frame: 4, 8, 12 weeks
Changes of health-related quality of life assessed by EuroQol five-dimensional (EQ-5D) [ Time Frame: 4, 8, 12 weeks ]
Time frame: 4, 8, 12 weeks
Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 8, 12 weeks
Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)
Time frame: 8, 12 weeks
Assessment of fear avoidance behaviours measured by Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: 8, 12 weeks
Use of rescue medication
Time frame: 4, 8, 12 weeks
Assessment of retention in treatment
Time frame: 4, 8 weeks
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 31 Jul 2024.
- Derived from this study: PubMed 41105952Lee S, Yoon C, Choi CH, Park TH, Yang SJ, Cha HR, Kim TW, Park JH, Chang MJ, Chang CB. Efficacy of a Mobile Multidisciplinary Digital Therapeutics App for Patellofemoral Pain: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Oct 17;13:e69627. doi: 10.2196/69627.
- Individual participant dataSharing planned: No
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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.
Chong Bum Chang, Dr. principal investigator
Seoul National University Bundang Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MORT-PFPS app and treatment as usual (TAU) in people with Patellofemoral Pain Syndrome, run by EverEx Inc. at 2 sites in South Korea.
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 12 inclusion and 10 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 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
Usual pain severity assessed by the Numeric Rating Scale (NRS ) (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 NCT05614583, which also lists 1 linked publication.
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 31 Jul 2024.