The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorErasmus Medical Center

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

276 Participants
are divided into 2 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