The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions (NCT07650396) | Clinical Trial Compass
RecruitingPhase 3
The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions
Netherlands276 participantsStarted 2026-06-03
Plain-language summary
Achilles tendinopathy is a common and often persistent tendon disorder associated with pain, impaired function, and reduced participation in physical activities. Standard care consists of education, load management advice, and progressive calf-strengthening exercises, yet about half of patients remain symptomatic. Corticosteroid injections are frequently used in clinical practice, but evidence on long-term efficacy and safety remains inconclusive. The ASPIRE trial is a multicentre, randomized, double-blind, placebo-controlled phase III trial evaluating whether 1-3 ultrasound-guided peritendinous corticosteroid injections added to standard care are safe and more effective than placebo injections plus standard care in adults with chronic midportion Achilles tendinopathy. The primary outcomes are change in VISA-A score over 1 year and incidence of full-thickness Achilles tendon rupture during 1-year follow-up.
Who can participate
Age range
18 Years – 65 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:
* Age 18-65 years
* Clinically diagnosed midportion Achilles tendinopathy confirmed by ultrasound
* Symptoms for at least 6 months
* Persistent complaints despite standard care, including education, load management advice and at least 3 months of exercise therapy / exercise programme
Exclusion Criteria:
* • Clinical suspicion of insertional Achilles tendinopathy
* Clinical suspicion of Achilles tendon rupture
* Clinical suspicion of plantar flexor tenosynovitis
* Clinical suspicion of sural nerve pathology
* Clinical suspicion of peroneal tendon subluxation or peroneal tendinopathy
* Clinical suspicion of posterior ankle impingement syndrome
* Suspected systemic/inflammatory disorder as cause of symptoms
* Any condition preventing participation in active exercise programme
* History of Achilles tendon rupture of index tendon
* Previous local corticosteroid injection on index Achilles tendon
* Previous surgery on index Achilles tendon
* Refusal to undergo one of the study treatments
* Local skin infection, suspected systemic infection with fever, or other medical condition compromising injection safety
* Vitamin K antagonist use with INR \>3.0 within 3 days before injection or unknown INR
* Current pregnancy or breastfeeding
* Medication-induced tendon pathology (quinolones or statins related to symptom onset)
* Inability to provide informed consent
* Participation in another concomitant interventional programme for Ach…
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
Change in disability and symptoms measured with the VISA-A questionnaire.
Timeframe: Baseline to 1 year follow-up (timepoints: Baseline, 4 weeks, 8 weeks, 3 months, 6 months, 9 months, and 1-year).
2
Incidence of full-thickness Achilles tendon rupture