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Recruiting NCT07650396

The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions

Phase III Interventional Achilles Tendinopathy (AT)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard care, Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine, placebo injections consisting of lidocaine only.
Who it may be relevant to
Registry conditions: Achilles Tendinopathy (AT). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

The ASPIRE trial is designed to address uncertainty regarding peritendinous corticosteroid injections as a second-line treatment for chronic midportion Achilles tendinopathy. Participants are adults aged 18-65 years with clinically diagnosed and ultrasonographically confirmed chronic midportion Achilles tendinopathy, persistent symptoms for at least 6 months, and ongoing complaints despite standard care including at least 3 months of exercise therapy. Participants are randomized 1:1 to receive either 1-3 ultrasound-guided peritendinous injections of methylprednisolone acetate 40 mg plus lidocaine, or 1-3 ultrasound-guided placebo injections with lidocaine only. All participants receive the same standard care consisting of education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website. Follow-up includes clinical assessments, questionnaires, ultrasound imaging, and functional testing at baseline, 3 months, and 1 year, with additional online questionnaires up to 10 years.

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

Primary outcome measures

  • Change in disability and symptoms measured with the VISA-A questionnaire. [Time frame: Baseline to 1 year follow-up (timepoints: Baseline, 4 weeks, 8 weeks, 3 months, 6 months, 9 months, and 1-year).]
  • Incidence of full-thickness Achilles tendon rupture [Time frame: During 1-year follow-up]
Secondary outcome measures (12)
  • Minor corticosteroid side effects / corticosteroid safety indicators [Time frame: baseline, 3 months, 6 months, 9 months, and 1 year.]
  • Tendon-related symptoms and disability [Time frame: baseline, 3 months, 6 months, 9 months, and 1 year]
  • Pain outcomes [Time frame: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year]
  • Global perceived improvement [Time frame: Assessed at 3 months, 6 months, 9 months, and 1 year]
  • Physical function / functional test outcomes [Time frame: Assessed at baseline, 3 months, and 1 year]
  • Health-related quality of life [Time frame: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year]
  • Return to sport / physical activity level [Time frame: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year.]
  • Healthcare use [Time frame: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year]
  • Imaging outcomes: tendon structure [Time frame: Assessed at baseline, 3 months, and 1 year]
  • Imaging outcomes: neovascularisation / Doppler flow [Time frame: Assessed at baseline, 3 months, and 1 year]
  • Minor corticosteroid side effects / corticosteroid safety indicators [Time frame: baseline, 3 months, and 1 year.]
  • Minor corticosteroid side effects / corticosteroid safety indicators [Time frame: baseline, 3 months, and 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Erasmus MC — Rotterdam

Identifiers

NCT: NCT07650396 · MEC-2026-0210 · 2025-524057-13-00 · ZonMw grant number: 1014102241

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗