The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions

Summary

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.

Conditions

• Achilles Tendinopathy (AT)

Interventions

OTHER

Standard care

Education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website.

DRUG

Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine

Participants receive 1-3 ultrasound-guided peritendinous injections of Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine.

DRUG

placebo injections consisting of lidocaine only

Participants receive 1-3 ultrasound-guided peritendinous placebo injections consisting of lidocaine onl

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Amsterdam UMC

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Haaglanden Medical Centre

  collaborator OTHER

• Gelderse Vallei Hospital

  collaborator OTHER

• Isala

  collaborator OTHER

• Bergman Clinics

  collaborator OTHER

• Dutch Association of Sports Medicine (VSG)

  collaborator UNKNOWN

• Dutch Orthopaedic Association (NOV)

  collaborator UNKNOWN

• Dutch College of General Practitioners (NHG Musculoskeletal Care)

  collaborator UNKNOWN

• International Trial Advisory Board

  collaborator UNKNOWN

• Patient Panel

  collaborator UNKNOWN

• Erasmus Medical Center

  lead OTHER

Principal Investigators

• Robert Jan de Vos, MD, PhD · Erasmus Medical Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-03

Primary Completion

2027-12-31

Completion

2028-10-31

Countries

• Netherlands

Study Locations