Asset Details
Do you wish to reserve the book?
Study protocol for a prospective, randomized controlled confirmatory clinical investigation to evaluate the safety and efficacy of a multidisciplinary digital therapeutics in patients with patellofemoral pain syndrome
Hey, we have placed the reservation for you!
By the way, why not check out events that you can attend while you pick your title.
Oops! Something went wrong.
Looks like we were not able to place the reservation. Kindly try again later.
Are you sure you want to remove the book from the shelf?
Study protocol for a prospective, randomized controlled confirmatory clinical investigation to evaluate the safety and efficacy of a multidisciplinary digital therapeutics in patients with patellofemoral pain syndrome
Do you wish to request the book?
Study protocol for a prospective, randomized controlled confirmatory clinical investigation to evaluate the safety and efficacy of a multidisciplinary digital therapeutics in patients with patellofemoral pain syndrome
Please be aware that the book you have requested cannot be checked out. If you would like to checkout this book, you can reserve another copy
We have requested the book for you!
Your request is successful and it will be processed during the Library working hours. Please check the status of your request in My Requests.
Oops! Something went wrong.
Looks like we were not able to place your request. Kindly try again later.
Journal Article
Study protocol for a prospective, randomized controlled confirmatory clinical investigation to evaluate the safety and efficacy of a multidisciplinary digital therapeutics in patients with patellofemoral pain syndrome
2025
Overview
Background
Patellofemoral pain is a prevalent knee condition affecting up to 40% of individuals, especially females aged teens to 50 s. Standard treatments, including exercise therapy, often yield insufficient long-term results, partly due to low compliance and psychological factors like depression and catastrophizing of pain. A digital therapeutics “MORA Cure PFP,” which combines structured progressive exercise and cognitive behavioral therapy via an app, offers a solution to overcome the limitations of conventional treatment for patellofemoral pain patients.
Methods
To evaluate the safety and efficacy of MORA Cure PFP, a two-arm controlled trial will enroll 216 patients diagnosed with patellofemoral pain randomly assigned in a 1:1 ratio to treatment and control groups. The treatment group will use the app, while the control group will perform self-guided exercises using educational materials. This trial aims to determine if the treatment group shows greater reduction in usual pain intensity scores at 8 weeks compared to the control group. Additional assessments include worst pain, knee function, depression, and pain catastrophizing levels.
Discussion
Key design elements of the clinical trial, such as control group selection, inclusion/exclusion criteria, number of patients, and primary endpoint, were designed with consideration for not only medical perspectives but also regulatory aspects of software as a medical device, including device approval and health technology assessment.
Trial registration
ClinicalTrials.gov., NCT06260865, registered 15th February 2024.
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
Subject
/ Adult
/ Catastrophization - psychology
/ Cognitive behavioral therapy (CBT)
/ Cognitive Behavioral Therapy - methods
/ Female
/ Humans
/ Knee
/ Knee Joint - physiopathology
/ Male
/ Medicine
/ Pain
/ Patellofemoral Pain Syndrome - diagnosis
/ Patellofemoral Pain Syndrome - physiopathology
/ Patellofemoral Pain Syndrome - psychology
/ Patellofemoral Pain Syndrome - therapy
/ Patients
/ Randomized Controlled Trials as Topic
/ Software as a medical device (SaMD)
