Clinical trial NCT05614583: Multidisciplinary Digital Therapeutics of Patellofemoral Pain Syndrome Versus Usual Care
Official title: Multidisciplinary Digital Therapeutics of Patellofemoral Pain Syndrome Versus Usual Care, a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Lead sponsor: EverEx Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single site, randomized controlled trial research study
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

  1. long sitting
  2. cycling
  3. running
  4. going up or down stairs
  5. kneeling
  6. compression of the patella
  7. palpation of the patellar facets
* Patients who signed a written informed consent form

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Usual pain severity assessed by the Numeric Rating Scale (NRS )
timeFrame: 8 weeks
measure: Global rating of perceived recovery
timeFrame: 8 weeks
measure: Functional disability assessed by the Kujala Patellofemoral Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Usual pain severity assessed by the Numeric Rating Scale (NRS)
timeFrame: 4, 12 weeks
measure: Global rating of perceived recovery
timeFrame: 4, 12 weeks
measure: Functional disability assessed by the Kujala Patellofemoral Scale
timeFrame: 4, 12 weeks
measure: 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)
timeFrame: 4, 8, 12 weeks
measure: Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)
timeFrame: 4, 8, 12 weeks
measure: Changes of Knee strength
timeFrame: 8, 12 weeks
measure: Changes of hip abductor function
timeFrame: 8, 12 weeks
measure: 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)
timeFrame: 4, 8, 12 weeks
measure: Changes of functional disability assessed by the Kujala Patellofemoral Scale
timeFrame: 4, 8, 12 weeks
measure: Changes of health-related quality of life assessed by EuroQol five-dimensional (EQ-5D) [ Time Frame: 4, 8, 12 weeks ]
timeFrame: 4, 8, 12 weeks
measure: Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 8, 12 weeks
measure: Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)
timeFrame: 8, 12 weeks
measure: Assessment of fear avoidance behaviours measured by Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: 8, 12 weeks
measure: Use of rescue medication
timeFrame: 4, 8, 12 weeks
measure: Assessment of retention in treatment
timeFrame: 4, 8 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Dongjak
country: Korea, Republic of
facility: Seoul Metropolitan Government-Seoul National University Boramae Medical Center
state: Seoul
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chong Bum Chang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: