About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
• Clinical suspicion of insertional Achilles tendinopathy
Clinical suspicion of Achilles tendon rupture
Clinical suspicion of plantar flexor tenosynovitis
Clinical suspicion of sural nerve pathology
Trial design
Treatments tested in this trial
- Standard care
- Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine
- placebo injections consisting of lidocaine only
Treatment groups
Sponsors and collaborators
Erasmus Medical Center
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Amsterdam UMC
Collaborator
UMC Utrecht
Collaborator
Haaglanden Medical Centre
Collaborator
Gelderse Vallei Hospital
Collaborator
Isala
Collaborator
Bergman Clinics
Collaborator
Dutch Association of Sports Medicine (VSG)
Collaborator
Dutch Orthopaedic Association (NOV)
Collaborator
Dutch College of General Practitioners (NHG Musculoskeletal Care)
Collaborator
International Trial Advisory Board
Collaborator
Patient Panel
Collaborator