Multidisciplinary Digital Therapeutics of Patellofemoral Pain Syndrome Versus Usual Care

Patellofemoral Pain Syndrome Clinical Trial

Official title:

Multidisciplinary Digital Therapeutics of Patellofemoral Pain Syndrome Versus Usual Care, a Randomized Controlled Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05614583
• Other study ID #: E-ETH-01K-CTP-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: April 2024

Study information

• Verified date: December 2023
• Source: EverEx Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: April 2024
• Est. primary completion date: October 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Device:
• MORT-PFPS app
The MORT-PFPS, developed by EverEx, Inc., is designed to provide multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with patellofemoral pain syndrome.

Other:
• treatment as usual (TAU)
In the control group, psychoeducation is delivered and self-exercise is recommended.

Locations

Country	Name	City	State
Korea, Republic of	Seoul Metropolitan Government-Seoul National University Boramae Medical Center	Dongjak	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
EverEx Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usual pain severity assessed by the Numeric Rating Scale (NRS )	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).	8 weeks
Primary	Global rating of perceived recovery	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).	8 weeks
Primary	Functional disability assessed by the Kujala Patellofemoral Scale	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).	8 weeks
Secondary	Usual pain severity assessed by the Numeric Rating Scale (NRS)	The secondary outcome being measure is differences in usual pain severity between groups at 4 and 12 weeks. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).	4, 12 weeks
Secondary	Global rating of perceived recovery	The secondary outcome being measure is differences in global rating of perceived recovery between groups at 4 and 12 weeks. Global rating of perceived recovery score was measured from 1 (very bad) to 7 (very good).	4, 12 weeks
Secondary	Functional disability assessed by the Kujala Patellofemoral Scale	The secondary outcome being measure is differences in functional disability between groups at 4 and 12 weeks. 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, 12 weeks
Secondary	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)	The secondary outcome being measure is differences in worst pain severity, pain during specific activities between groups at 4, 8 and 12 weeks. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).	4, 8, 12 weeks
Secondary	Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)	The secondary outcome being measure is differences in health-related quality of life between groups at 4, 8 and 12 weeks. 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).	4, 8, 12 weeks
Secondary	Changes of Knee strength	Flexion and extension strength of knee are measured using a Biodex isokinetic dynamometer (peak torque (Nm) and % decrease in torque).	8, 12 weeks
Secondary	Changes of hip abductor function	Hip abductor function is assessed by knee valgus angle during single leg squat (°).	8, 12 weeks
Secondary	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)	The secondary outcome being measure is differences in changes of usual pain severity, worst pain severity, pain during specific activities from baseline to 4, 8, and 12 weeks between groups. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).	4, 8, 12 weeks
Secondary	Changes of functional disability assessed by the Kujala Patellofemoral Scale	The secondary outcome being measure is differences in changes of functional disability from baseline to 4, 8, and 12 weeks 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, 8, 12 weeks
Secondary	Changes of health-related quality of life assessed by EuroQol five-dimensional (EQ-5D) [ Time Frame: 4, 8, 12 weeks ]	The secondary outcome being measure is differences in changes of health-related quality of life from baseline to 4, 8, and 12 weeks 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).	4, 8, 12 weeks
Secondary	Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)	Differences in mental health symptoms between groups at 8, 12 weeks. 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).	8, 12 weeks
Secondary	Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)	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).	8, 12 weeks
Secondary	Assessment of fear avoidance behaviours measured by Fear-Avoidance Beliefs Questionnaire (FABQ)	Differences in fear avoidance behaviours between groups at 8, 12 weeks. The Fear-Avoidance Beliefs Questionnaire (FABQ) is a 16-item scale, with a total range of 0 to 96 (higher scores indicating higher amounts of fear avoidance behaviours).	8, 12 weeks
Secondary	Use of rescue medication	Differences in use of rescue medication between groups at 4, 8, 12 weeks.	4, 8, 12 weeks
Secondary	Assessment of retention in treatment	Differences in retention rates between groups at 4, 8 weeks.	4, 8 weeks