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RECRUITING
NCT07650396
PHASE3

The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions.

Sponsor: Erasmus Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

276

Start Date

2026-06-03

Completion Date

2028-10-31

Last Updated

2026-06-16

Healthy Volunteers

No

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

Locations (1)

Erasmus MC

Rotterdam, Netherlands