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NCT Number: NCT06260865

A Confirmatory Trial of Multidisciplinary Digital Therapeutics for 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.

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Key information

Conditions

Patellofemoral Pain Syndrome Joint Diseases Musculoskeletal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Myongji Hospital, Goyang-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

MORA Cure

Device

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 Usual

Other

In the control group, education is delivered and self-exercise is recommended.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Usual pain severity assessed by the Visual Analogue Scale (VAS)

    Time frame: 4 weeks, 12 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).

  2. Worst pain severity assessed by the Visual Analogue Scale (VAS)

    Time frame: 4 weeks, 8 weeks, 12 weeks

    Differences in worst pain severity between groups after the intervention. VAS score will be measured from 0 (no pain) to 100 (worst pain imaginable).

  3. Functional disability assessed by the Kujala Patellofemoral Scale

    Time frame: 4 weeks, 8 weeks, 12 weeks

    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).

  4. Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)

    Time frame: 4 weeks, 8 weeks, 12 weeks

    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).

  5. 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

    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).

  6. Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)

    Time frame: 4 weeks, 8 weeks, 12 weeks

    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).

  7. Flexion and extension strength of knee

    Time frame: 4 weeks, 8 weeks, 12 weeks

    Flexion and extension strength of knee are measured using a Biodex isokinetic dynamometer (peak torque (Nm) and % decrease in torque).

  8. Treatment adherence

    Time frame: 4 weeks, 8 weeks, 12 weeks

    Treatment adherence of each group, defined as percentage of days taking treament properly out of all days

Sponsors and collaborators

Lead sponsor

EverEx Inc.

Industry

Registry information

Official study title

Prospective, Randomized, Controlled Confirmatory Clinical Investigation to Evaluate the Safety and Efficacy of a Multidisciplinary Digital Therapeutics in Patients with Patellofemoral Pain Syndrome

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2024
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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