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Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
ID07650396

ASPIRE Trial Evaluating Corticosteroid Injections Plus Standard Care for Adults with Chronic Midportion Achilles Tendinopathy

Led by Erasmus Medical Center · Updated on 2026-06-18

276

Participants Needed

1

Research Sites

43 weeks

Total Duration

AI-Summary

What this Trial Is About

Achilles tendinopathy is a common and often persistent condition causing pain and reduced ability to participate in physical activities. This trial evaluates whether adding 1 to 3 ultrasound-guided corticosteroid injections to standard care improves symptoms and safety compared to placebo injections plus standard care in adults with chronic midportion Achilles tendinopathy. The study is a multicentre, randomized, double-blind, placebo-controlled phase III trial designed to address uncertainty about corticosteroid injections as a second-line treatment. Participants aged 18 to 65 with confirmed chronic midportion Achilles tendinopathy and symptoms lasting at least 6 months despite standard care are randomly assigned to receive either methylprednisolone acetate injections combined with lidocaine or placebo injections of lidocaine only. All receive education, load management advice, and a structured progressive calf-muscle strengthening exercise program supported by an online website. Participants get one injection at baseline and may receive up to two additional injections within 8 weeks if criteria are met. During the study, participants are assessed at baseline, 3 months, and 1 year with clinical evaluations, questionnaires, ultrasound imaging, and functional tests. Additional online questionnaires will be collected up to 10 years. Researchers measure changes in disability and symptoms using the VISA-A score over one year and monitor tendon ruptures. Safety indicators and multiple secondary outcomes including pain, quality of life, and tendon structure are also tracked throughout the follow-up.

CONDITIONS

Brief Title

The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions

Research Team

K

Kristel van Abswoude, MD

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