Internet-Based Exercise Therapy Using Algorithms for Conservative Treatment of Anterior Knee Pain: A Pragmatic Randomized Controlled Trial.

Abstract

BackgroundConservative treatment remains the first-line option, and there is significant medical evidence showing that home-based exercise therapy for the treatment of common causes of knee pain is effective. SimpleTherapy created an online platform that delivers Internet-based exercise therapy for common causes of knee pain. The system is driven by an algorithm that can process the user’s feedback to provide an adaptive exercise regimen. This triple-armed, pragmatic randomized pilot was designed to evaluate if this telerehabilitation platform is safe and effective.ObjectiveWe hypothesized that a home-based, algorithm-driven exercise therapy program can be safe for use and even improve compliance over the standard of care, the paper handout.MethodsAfter an independent internal review board review and approval, the website trial.simpletherapy.com was opened. Once the trial was open for enrollment, no changes to the functionality or user interaction features were performed until the trial had closed. User accrual to the website was done using website optimization and social media postings tied to existence of knee pain. Consent was obtained online through checkboxes with third-party signature confirmation. No fees were charged to any patient. Patients were recruited online from an open access website. Outcomes were self-assessed through questionnaires with no face-to-face clinician interaction. A triple-arm randomized controlled trial was used with arm 1 being a static handout of exercises, arm 2 being a video version of arm 1, and arm 3 being a video-based, algorithm-driven system that took patient feedback and changed the exercises based on the feedback. Patients used household items and were not supervised by a physical therapist or clinician. Patients were reminded at 48-hour intervals to complete an exercise session.ResultsA total of 860 users found the trial and initiated the registration process. These 860 were randomized, and the demographic distribution shows the randomization was successful. In all, 70 users completed the 6-week regimen (8.1%): 20 users were in arm 1, 33 users in arm 2, and 17 users in arm 3. There were no adverse events reported in any of the 3 arms. All outcomes were self-assessed. No adverse events were reported during or after the trial.ConclusionsBecause only 8.1% of those who enrolled completed the trial, an intent-to-treat analysis did not reach statistical significance in this pilot trial. However, the completion rates are comparable to those of previous online-only trials. Given an early phase trial, no adverse events were reported. Ongoing data collection continues and will form the basis for further data on the efficacy of this intervention.Trial RegistrationClinicaltrials.gov NCT01696162; https://clinicaltrials.gov/ct2/show/NCT01696162 (Archived by WebCite at http://www.webcitation.org/6lM8jC7Gu)