NCT06736795

Progressive Achilles Loading Via Clinician E-support

Progressive Achilles Loading Via Clinician E-support (PACE)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Ruth Chimenti · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled trial with individuals who have Achilles tendon pain. This study is designed to identify an effective rehabilitation program for Achilles tendon pain that expands access to care for military personnel and to predict treatment response. Limited or delayed access to healthcare can exacerbate the severity of pain and duration of disability due to AT. This is particularly relevant for individuals deployed to battlefield settings or are being seen in busy military treatment facilities. Therefore, it is crucial to identify efficient and effective treatment pathways that maximize healthcare access and facilitate a rapid and pain-free return to full duty.

Detailed description

The objectives of this non-inferiority trial are to identify a rehabilitation program focused on education and exercise for AT that expands access to care for military personnel and to identify factors that predict responses to rehabilitation. The following aims will test our central hypothesis that a single-visit, PT-initiated rehabilitation program will be as effective in improving pain and reducing disability as a multi-visit, PT-guided rehabilitation program for AT and that within two weeks of initiating exercise treatment, early changes in patient-reported outcomes can identify responders. Specific Aim 1. Determine the efficacy of a single-visit, PT-initiated rehabilitation program vs. a multi-visit, PT-guided rehabilitation program for AT. Specific Aim 2. Identify early prognostic factors for individuals who experience the greatest improvement in pain and disability by four weeks. Study Design. A single-blind, two-arm, parallel phase 2 randomized controlled trial is the study approach. Individuals with AT will be randomized to one of two rehabilitation programs: 1) self-guided intervention initiated with a single visit with a physical therapist (PT) via telehealth followed by modules that the participant can complete asynchronously, or 2) PT-guided intervention (standard of care) with six one-on-one telehealth visits. Study will enroll 160 individuals with AT across two sites (University of Iowa Hospitals \& Clinics; Carl R. Darnall Army Medical Center, Fort Cavazos) and obtain baseline variables and immediate response at 2-weeks to characterize the sample. Outcomes will be assessed at 4 weeks (primary endpoint), 8 weeks, 26 weeks, and 1 year.

Conditions

• Achilles Tendon Pain
• Achilles Tendinopathy

Interventions

Type	Name	Description
OTHER	Exercise	All participants will be instructed in a progressive Achilles tendon loading exercise program.
OTHER	Education	All participants will receive education on Achilles tendinopathy terminology, common symptoms, diagnosis, expected recovery timeline, importance of physical activity, self-management strategies, multiple factors influencing pain, alternative and adjunct treatment options.

Timeline

• Start date: 2025-08-20
• Primary completion: 2028-06-01
• Completion: 2028-07-01
• First posted: 2024-12-17
• Last updated: 2025-10-07

Locations

2 sites across 1 country: United States