Multidisciplinary Digital Therapeutics of Patellofemoral Pain Syndrome Versus Usual Care

EverEx

Status: Completed

Conditions: Patellofemoral Pain Syndrome

Treatments: Device: MORT-PFPS app; Other: treatment as usual (TAU)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05614583

E-ETH-01K-CTP-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

MORT-PFPS

Experimental group

Description:

Participants randomly assigned to this arm will use the app, MORT-PFPS.

Treatment:

Device: MORT-PFPS app

treatment as usual (TAU)

Active Comparator group

Description:

Participants randomly assigned to this arm will receive their TAU only (no use of the app, MORT-PFPS).

Treatment:

Other: treatment as usual (TAU)