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Sponsor: Erasmus Medical Center
Conditions: Achilles Tendinopathy (AT)
Interventions: Standard care, Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine, placebo injections consisting of lidocaine only
Countries: Netherlands
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.
Sex: ALL
Age: 18 Years to 65 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Rotterdam, Netherlands