Patellofemoral Pain SyndromeNCT06260865
A Confirmatory Trial of Multidisciplinary Digital Therapeutics for Patellofemoral Pain Syndrome
A study testing MORA Cure and Treatment as Usual in people with Patellofemoral Pain Syndrome, run by EverEx Inc. at 10 sites in South Korea.
Trial summary
This randomized controlled confirmatory study will be evaluating an mobile application, MORA Cure (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?
- Any age
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- MORA Cure and Treatment as Usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 26 Apr 2024to 26 Mar 2025
- 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
- Patients with peripatellar or posterior patellar pain in one or more knee joints for 3 months or longer
- Patients with peripatellar or posterior patellar pain provoked by squatting
- Patients who have pain provoked by 2 or more following activities: prolonged sitting, cycling, 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 3 or higher grade of the Kellgren-Lawrence scale
- Patients diagnosed with a fracture or dislocation around the knee within the last 3 months
- Patients who had knee surgery within the last 3 months
- Patients diagnosed with patellar tendinitis based on imaging within 3 months
- Patients taking narcotic pain medications for pain control
- Patients taking or planning to take any medication that is a contraindication within the next 16 weeks at the time of screening
Show all 9Show fewer
- Patients who are pregnant
- Patients currently participating in another clinical trial or have participated in another clinical trial within the past 3 months at the time of screening
- Patients deemed unsuitable for this study by the investigator
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Chung-Ang University Hospital
Dongjak, Seoul, 06973
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Dongjak, Seoul, 07061
Kyung Hee University Hospital at Gangdong
Gangdong, Seoul, 05278
Myongji Hospital
Goyang-si, Gyeonggi-do, 10475
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 11923
Seoul National University Bundang Hospital
Gyeonggi-do, Gyeonggi-do, 13620
Inha University Hospital
Junggu, Incheon, 22332
The Catholic University of Korea Seoul St. Mary's Hospital
Seocho, Seoul, 06591
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496
Asan Medical Center
Seoul, Seoul, 05505
About this study
Official title: Prospective, Randomized, Controlled Confirmatory Clinical Investigation to Evaluate the Safety and Efficacy of a Multidisciplinary Digital Therapeutics in Patients With Patellofemoral Pain Syndrome
This randomized controlled confirmatory study will be evaluating an mobile application, MORA Cure (ETH-01K), owned by EverEx, Inc., to examine safety and effectiveness in individuals with patellofemoral pain syndrome.
Read the detailed description
This randomized controlled confirmatory study will enroll 216 participants, where half will be randomly assigned to the digital therapeutics (S/W medical device), MORA Cure (n = 108), and half will be assigned to treatment as usual (TAU) (n = 108), 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 application 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
- MORA Cure, Treatment as Usual
- Keywords
- PFPS, DTx, SaMD, MSK
- 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.
MORA CureDevice
MORA Cure (ETH-01K), developed by EverEx, Inc., is a digital therapeutics (S/W medical device) designed to provide multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with patellofemoral pain syndrome.
Treatment as UsualOther
In the control group, education is delivered and self-exercise is recommended.
| Study group | Role | What they receive |
|---|---|---|
| MORA Cure | Experimental | Participants randomly assigned to this arm will use the digital therapeutics, MORA Cure. Receives: Device: MORA Cure |
| Treatment as Usual | Active comparator | Participants randomly assigned to this arm will receive their treatment as usual only. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usual pain severity assessed by the Visual Analogue Scale (VAS)
Differences in usual pain severity between groups after the intervention. VAS score will be measured from 0 (no pain) to 100 (worst pain imaginable).
Measured: 8 weeks
Secondary outcomes (8)
Usual pain severity assessed by the Visual Analogue Scale (VAS)
Differences in usual pain severity between groups after the intervention. VAS score will be measured from 0 (no pain) to 100 (worst pain imaginable).
Measured: 4 weeks, 12 weeks
Worst pain severity assessed by the Visual Analogue Scale (VAS)
Differences in worst pain severity between groups after the intervention. VAS score will be measured from 0 (no pain) to 100 (worst pain imaginable).
Measured: 4 weeks, 8 weeks, 12 weeks
Functional disability assessed by the Kujala Patellofemoral Scale
Differences in functional disability 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 weeks, 8 weeks, 12 weeks
Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)
Differences in health-related quality of life 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 weeks, 8 weeks, 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. 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: 4 weeks, 8 weeks, 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: 4 weeks, 8 weeks, 12 weeks
Flexion and extension strength of knee
Flexion and extension strength of knee are measured using a Biodex isokinetic dynamometer (peak torque (Nm) and % decrease in torque).
Measured: 4 weeks, 8 weeks, 12 weeks
Treatment adherence
Treatment adherence of each group, defined as percentage of days taking treament properly out of all days
Measured: 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start26 Apr 2024
- Primary completion1 Mar 2025
- Study completion26 Mar 2025
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
- Multicenter randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- EverEx Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chong Bum Chang, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260865
- Sponsor's protocol ID
- E-ETH-01K-CI02
- Status last verified
- Oct 2026
- First submitted
- 7 Feb 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park TH, Yoon C, Park JH, Lee S, Choi CH, Chang CB, Kim JG. Study protocol for a prospective, randomized controlled confirmatory clinical investigation to evaluate the safety and efficacy of a multidisciplinary digital therapeutics in patients with patellofemoral pain syndrome. Trials. 2025 Sep 1;26(1):328. doi: 10.1186/s13063-025-09030-2.
PubMed 40890852
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled Confirmatory Clinical Investigation to Evaluate the Safety and Efficacy of a Multidisciplinary Digital Therapeutics in Patients With Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT06260865
- Acronym / sponsor ID
- E-ETH-01K-CI02
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- PFPS, DTx, SaMD, MSK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- EverEx Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 15 Feb 2024 (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 confirmatory study will be evaluating an mobile application, MORA Cure (ETH-01K), owned by EverEx, Inc., to examine safety and effectiveness in individuals with patellofemoral pain syndrome.
Detailed description
This randomized controlled confirmatory study will enroll 216 participants, where half will be randomly assigned to the digital therapeutics (S/W medical device), MORA Cure (n = 108), and half will be assigned to treatment as usual (TAU) (n = 108), 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 application 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
- Multicenter randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| MORA Cure | Experimental | Device: MORA CureParticipants randomly assigned to this arm will use the digital therapeutics, MORA Cure. |
| Treatment as Usual | Active comparator | Other: Treatment as UsualParticipants randomly assigned to this arm will receive their treatment as usual only. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with peripatellar or posterior patellar pain in one or more knee joints for 3 months or longer
- Patients with peripatellar or posterior patellar pain provoked by squatting
- Patients who have pain provoked by 2 or more following activities: prolonged sitting, cycling, running, going up or down stairs, kneeling, compression of the patella, palpation of the patellar facets
- Patients who signed a written informed consent form
Key exclusion criteria (9 listed)
- Patients with osteoarthritis which scored 3 or higher grade of the Kellgren-Lawrence scale
- Patients diagnosed with a fracture or dislocation around the knee within the last 3 months
- Patients who had knee surgery within the last 3 months
- Patients diagnosed with patellar tendinitis based on imaging within 3 months
- Patients taking narcotic pain medications for pain control
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 |
|---|---|---|
| MORA CureMORA Cure (ETH-01K), developed by EverEx, Inc., is a digital therapeutics (S/W medical device) designed to provide multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with patellofemoral pain syndrome. | Device | MORA Cure |
| Treatment as UsualIn the control group, education is delivered and self-exercise is recommended. | Other | Treatment as Usual |
Primary outcome
Usual pain severity assessed by the Visual Analogue Scale (VAS)
Time frame: 8 weeks
Differences in usual pain severity between groups after the intervention. VAS score will be measured from 0 (no pain) to 100 (worst pain imaginable).
8 secondary outcomes
Usual pain severity assessed by the Visual Analogue Scale (VAS)
Time frame: 4 weeks, 12 weeks
Worst pain severity assessed by the Visual Analogue Scale (VAS)
Time frame: 4 weeks, 8 weeks, 12 weeks
Functional disability assessed by the Kujala Patellofemoral Scale
Time frame: 4 weeks, 8 weeks, 12 weeks
Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)
Time frame: 4 weeks, 8 weeks, 12 weeks
Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 4 weeks, 8 weeks, 12 weeks
Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)
Time frame: 4 weeks, 8 weeks, 12 weeks
Flexion and extension strength of knee
Time frame: 4 weeks, 8 weeks, 12 weeks
Treatment adherence
Time frame: 4 weeks, 8 weeks, 12 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 26 Oct 2026.
- Derived from this study: PubMed 40890852Park TH, Yoon C, Park JH, Lee S, Choi CH, Chang CB, Kim JG. Study protocol for a prospective, randomized controlled confirmatory clinical investigation to evaluate the safety and efficacy of a multidisciplinary digital therapeutics in patients with patellofemoral pain syndrome. Trials. 2025 Sep 1;26(1):328. doi: 10.1186/s13063-025-09030-2.
- 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, MD, PhD principal investigator
Seoul National University Bundang Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MORA Cure and Treatment as Usual in people with Patellofemoral Pain Syndrome, run by EverEx Inc. at 10 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 4 inclusion and 9 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 Visual Analogue Scale (VAS) (time frame: 8 weeks). 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 NCT06260865, 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 26 Oct 2026.