Back to resultsMultidisciplinary Digital Therapeutics of Patellofemoral Pain Syndrome Versus Usual Care
Primary Purpose
Patellofemoral Pain Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MORT-PFPS app
treatment as usual (TAU)
Sponsored by
About this trial
This is an interventional treatment trial for 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 long sitting cycling running going up or down stairs kneeling 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
Sites / Locations
- Seoul National University Bundang HospitalRecruiting
- Seoul Metropolitan Government-Seoul National University Boramae Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MORT-PFPS
treatment as usual (TAU)
Arm Description
Participants randomly assigned to this arm will use the app, MORT-PFPS.
Participants randomly assigned to this arm will receive their TAU only (no use of the app, MORT-PFPS).
Outcomes
Primary Outcome Measures
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).
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).
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).
Secondary Outcome Measures
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).
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).
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).
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).
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).
Changes of Knee strength
Flexion and extension strength of knee are measured using a Biodex isokinetic dynamometer (peak torque (Nm) and % decrease in torque).
Changes of hip abductor function
Hip abductor function is assessed by knee valgus angle during single leg squat (°).
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).
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).
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).
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).
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).
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).
Use of rescue medication
Differences in use of rescue medication between groups at 4, 8, 12 weeks.
Assessment of retention in treatment
Differences in retention rates between groups at 4, 8 weeks.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05614583
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EverEx Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single site, randomized controlled trial research study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MORT-PFPS
Arm Type
Experimental
Arm Description
Participants randomly assigned to this arm will use the app, MORT-PFPS.
Arm Title
treatment as usual (TAU)
Arm Type
Active Comparator
Arm Description
Participants randomly assigned to this arm will receive their TAU only (no use of the app, MORT-PFPS).
Intervention Type
Device
Intervention Name(s)
MORT-PFPS app
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
treatment as usual (TAU)
Intervention Description
In the control group, psychoeducation is delivered and self-exercise is recommended.
Primary Outcome Measure Information:
Title
Usual pain severity assessed by the Numeric Rating Scale (NRS )
Description
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).
Time Frame
8 weeks
Title
Global rating of perceived recovery
Description
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).
Time Frame
8 weeks
Title
Functional disability assessed by the Kujala Patellofemoral Scale
Description
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).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Usual pain severity assessed by the Numeric Rating Scale (NRS)
Description
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).
Time Frame
4, 12 weeks
Title
Global rating of perceived recovery
Description
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).
Time Frame
4, 12 weeks
Title
Functional disability assessed by the Kujala Patellofemoral Scale
Description
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).
Time Frame
4, 12 weeks
Title
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)
Description
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).
Time Frame
4, 8, 12 weeks
Title
Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)
Description
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).
Time Frame
4, 8, 12 weeks
Title
Changes of Knee strength
Description
Flexion and extension strength of knee are measured using a Biodex isokinetic dynamometer (peak torque (Nm) and % decrease in torque).
Time Frame
8, 12 weeks
Title
Changes of hip abductor function
Description
Hip abductor function is assessed by knee valgus angle during single leg squat (°).
Time Frame
8, 12 weeks
Title
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)
Description
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).
Time Frame
4, 8, 12 weeks
Title
Changes of functional disability assessed by the Kujala Patellofemoral Scale
Description
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).
Time Frame
4, 8, 12 weeks
Title
Changes of health-related quality of life assessed by EuroQol five-dimensional (EQ-5D) [ Time Frame: 4, 8, 12 weeks ]
Description
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).
Time Frame
4, 8, 12 weeks
Title
Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Description
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).
Time Frame
8, 12 weeks
Title
Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)
Description
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).
Time Frame
8, 12 weeks
Title
Assessment of fear avoidance behaviours measured by Fear-Avoidance Beliefs Questionnaire (FABQ)
Description
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).
Time Frame
8, 12 weeks
Title
Use of rescue medication
Description
Differences in use of rescue medication between groups at 4, 8, 12 weeks.
Time Frame
4, 8, 12 weeks
Title
Assessment of retention in treatment
Description
Differences in retention rates between groups at 4, 8 weeks.
Time Frame
4, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
cycling
running
going up or down stairs
kneeling
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taehyun Park, M.D.
Phone
82-70-7799-0812
Email
bill@everex.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chong Bum Chang, Dr.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
So-hyeon Jeon
Phone
82-10-8443-6762
Email
sohyeon6762@gmail.com
Facility Name
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
City
Dongjak
State/Province
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyewon Kim
Phone
82-10-2745-0313
Email
wol960311@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multidisciplinary Digital Therapeutics of Patellofemoral Pain Syndrome Versus Usual Care
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