Progressive Achilles Loading via Clinician E-Support (PACE): Protocol for a Dual Site Randomized Controlled Trial (Preprint)

BACKGROUND Achilles tendinopathy is a widespread condition that limits activity participation in active and sedentary populations. While exercise and education are well established treatments for Achilles tendinopathy, information is lacking on the amount of intervention required and prognostic factors for responders to non-invasive treatments. OBJECTIVE This non-inferiority, randomized controlled trial will determine the efficacy of a single-visit, physical therapist initiated rehabilitation program compared to a multi-visit, physical therapist guided rehabilitation program for Achilles tendinopathy, and identify early prognostic factors for individuals who experience the greatest improvement in pain and disability by four weeks. METHODS In this single-blind, two-arm, parallel-group, trial, 160 individuals with Achilles tendinopathy will be randomized to a single visit physical therapist-initiated rehabilitation program or to a multi-visit, physical therapist-guided telehealth rehabilitation program. Primary outcomes will be the numeric rating scale for movement pain and the Victorian Institute of Sport Assessment- Achilles for disability. Secondary outcomes will include measures of tendon health, psychosocial health domain measures, and military participation. RESULTS This research was funded in July 2024. Participant enrollment began August 2025 and is expected to conclude in 2028. As of January 2025, 15 participants have been enrolled at UIHC, meeting recruitment goals. CONCLUSIONS The PACE trial will identify a rehabilitation program focused on education and exercise for Achilles tendinopathy that expands access to care and will identify factors that predict responses to exercise and education. CLINICALTRIAL ClinicalTrials.gov NCT06736795; https://clinicaltrials.gov/study/NCT06736795 and OSF Registries osf.io/sgj47; https://osf.io/sgj47