Clinical trial NCT06260865: A Confirmatory Trial of Multidisciplinary Digital Therapeutics for Patellofemoral Pain Syndrome
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Keywords: PFPS
DTx
SaMD
MSK
Lead sponsor: EverEx Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-15
Enrollment: 216
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients with peripatellar or posterior patellar pain in one or more knee joints for 3 months or longer
2. Patients with peripatellar or posterior patellar pain provoked by squatting
3. 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
4. Patients who signed a written informed consent form

Exclusion Criteria:

1. Patients with osteoarthritis which scored 3 or higher grade of the Kellgren-Lawrence scale
2. Patients diagnosed with a fracture or dislocation around the knee within the last 3 months
3. Patients who had knee surgery within the last 3 months
4. Patients diagnosed with patellar tendinitis based on imaging within 3 months
5. Patients taking narcotic pain medications for pain control
6. Patients taking or planning to take any medication that is a contraindication within the next 16 weeks at the time of screening
7. Patients who are pregnant
8. Patients currently participating in another clinical trial or have participated in another clinical trial within the past 3 months at the time of screening
9. Patients deemed unsuitable for this study by the investigator

Primary outcomes:
measure: Usual pain severity assessed by the Visual Analogue Scale (VAS)
timeFrame: 8 weeks
Secondary outcomes:
measure: Usual pain severity assessed by the Visual Analogue Scale (VAS)
timeFrame: 4 weeks, 12 weeks
measure: Worst pain severity assessed by the Visual Analogue Scale (VAS)
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Functional disability assessed by the Kujala Patellofemoral Scale
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Flexion and extension strength of knee
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Treatment adherence
timeFrame: 4 weeks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Myongji Hospital
state: Gyeonggi-do
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
city: Junggu
country: Korea, Republic of
facility: Inha University Hospital
state: Incheon-si
city: Dongjak
country: Korea, Republic of
facility: Chung-Ang University Hospital
state: Seoul
city: Dongjak
country: Korea, Republic of
facility: Seoul Metropolitan Government-Seoul National University Boramae Medical Center
state: Seoul
city: Gangdong
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
state: Seoul
city: Seocho
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
state: Seoul
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chong Bum Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: