RCT of Home-based vs Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles … (NCT06374654) | Clinical Trial Compass
By InvitationNot Applicable
RCT of Home-based vs Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy
United States56 participantsStarted 2025-07-01
Plain-language summary
The goal of this prospective randomized controlled trial is to compare the effectiveness of a home-based exercise protocol to formal physical therapy in patients who have been diagnosed with Achilles tendinopathy. The null hypothesis is that there will be no difference in the treatment outcomes between patients with Achilles tendinopathy who participate in a home-based program versus patients with Achilles tendinopathy who undergo formal physical therapy. Participants will be randomized to a 12-week home-based or formal physical therapy protocol and asked to complete brief outcomes surveys at their initial visit, and at 6 weeks, 12 weeks, 6 months, and 1 year after their initial visit.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Must be 18 years of age
* Must have a new diagnosis of Achilles tendinopathy that has presented with pain, thickening and tenderness at the mid substance of the Achilles tendon
* Symptoms present for at least 6 weeks
Exclusion Criteria:
* Patients with insertional Achilles pain or tenderness or concomitant plantar foot pain
* Patients who have had prior treatment with home eccentric stretching or physical therapy
* Patients who have prior diagnosis and treatment for Achilles tendinopathy
* Patients with history of injection (corticosteroid or sclerosing agents) to the Achilles tendon
* Patients with inflammatory arthritis
* Recent fluoroquinolone antibiotics (these agents are known to alter Achilles tendon physiology)
* Patients who have had prior foot or ankle surgery
* Individuals that do not speak English
* Bilateral disease
* Pregnant women
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Victorian Institute of Sports Assessment self-administered Achilles questionnaire (VISA-A)
Timeframe: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment