Corticosteroid injections added to standard care for chronic midportion Achilles tendinopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ASPIRE trial is a multicenter, randomized, double-blind, placebo-controlled phase III study evaluating the safety and effectiveness of ultrasound-guided peritendinous methylprednisolone acetate 40 mg with lidocaine, added to standard care, versus placebo injections with lidocaine plus standard care in adults with chronic midportion Achilles tendinopathy. Eligible participants have symptoms for at least 6 months despite structured exercise therapy and are between 18 and 65 years old. Primary outcomes include change in VISA-A score over 1 year and incidence of full-thickness Achilles tendon rupture during 1-year follow-up, with additional follow-up up to 10 years via online questionnaires. All participants receive standard care consisting of education, load management, and a progressive calf-strengthening program supported by an online platform. Follow-up assessments occur at baseline, 3 months, and 1 year, with imaging and functional testing embedded in visits.

Why it matters

Who can join: the full rules

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 Achilles tendinopathy
  * Known hypersensitivity or allergy to Depo-Medrol or Lidocaine
  * Participants with unstable or poorly controlled diabetes mellitus may be excluded at investigator discretion for safety reasons.

Where it's running

• Erasmus MC
  Rotterdam, Netherlands Recruiting

Study contacts

• Principal investigator: Robert Jan de Vos, MD, PhD — Erasmus Medical Centre
• Study coordinator: Kristel van Abswoude, MD
• Email: aspire@erasmusmc.nl
• Phone: +31 6 49326353

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.