Multidisciplinary Digital Therapeutics of Patellofemoral Pain Syndrome Versus Usual Care, a Randomized Controlled Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patellofemoral Pain Syndrome
- Sponsor
- EverEx Inc.
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Usual pain severity assessed by the Numeric Rating Scale (NRS )
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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
- •long sitting
- •going up or down stairs
- •compression of the patella
- •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
Outcomes
Primary Outcomes
Usual pain severity assessed by the Numeric Rating Scale (NRS )
Time Frame: 8 weeks
The primary outcome being measure is differences in usual pain severity between groups after the intervention. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).
Functional disability assessed by the Kujala Patellofemoral Scale
Time Frame: 8 weeks
The primary outcome being measure is differences in functional disability between groups after the intervention. 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).
Global rating of perceived recovery
Time Frame: 8 weeks
The primary outcome being measure is differences in global rating of perceived recovery between groups after the intervention. Global rating of perceived recovery score was measured from 1 (very bad) to 7 (very good).
Secondary Outcomes
- Changes of health-related quality of life assessed by EuroQol five-dimensional (EQ-5D) [ Time Frame: 4, 8, 12 weeks ](4, 8, 12 weeks)
- Usual pain severity assessed by the Numeric Rating Scale (NRS)(4, 12 weeks)
- Global rating of perceived recovery(4, 12 weeks)
- Functional disability assessed by the Kujala Patellofemoral Scale(4, 12 weeks)
- 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)(4, 8, 12 weeks)
- Changes of hip abductor function(8, 12 weeks)
- 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)(4, 8, 12 weeks)
- Changes of functional disability assessed by the Kujala Patellofemoral Scale(4, 8, 12 weeks)
- Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)(4, 8, 12 weeks)
- Changes of Knee strength(8, 12 weeks)
- Assessment of retention in treatment(4, 8 weeks)
- Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)(8, 12 weeks)
- Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)(8, 12 weeks)
- Assessment of fear avoidance behaviours measured by Fear-Avoidance Beliefs Questionnaire (FABQ)(8, 12 weeks)
- Use of rescue medication(4, 8, 12 weeks)