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The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions

Study acronym: ASPIRE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Secondary endpoints revised (25) Study title revisedv2 Show 1 more changeShow less
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07650396
Lead Sponsor Erasmus Medical Center
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development, Amsterdam UMC, UMC Utrecht, Haaglanden Medical Centre, Gelderse Vallei Hospital, Isala, Bergman Clinics, Dutch Association of Sports Medicine (VSG), Dutch Orthopaedic Association (NOV), Dutch College of General Practitioners (NHG Musculoskeletal Care), International Trial Advisory Board, Patient Panel
Conditions Achilles Tendinopathy (AT)
Enrollment 276 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov