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The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Erasmus MC
RECRUITING
Rotterdam
Contact Information
Primary
Kristel van Abswoude, MD
aspire@erasmusmc.nl
+31 6 49326353
Time Frame
Start Date: 2026-06-03
Estimated Completion Date: 2028-10-31
Participants
Target number of participants: 276
Treatments
Experimental: Corticosteroid and Lidocaine Injection
Participants receive 1-3 ultrasound-guided peritendinous injections of Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine. All participants receive one injection at baseline; up to two additional injections may be given within the first 8 weeks at intervals of 4 weeks if predefined criteria are met.
Placebo_comparator: Placebo Injection
Participants receive 1-3 ultrasound-guided peritendinous placebo injections consisting of lidocaine only. All participants receive one injection at baseline; up to two additional injections may be given within the first 8 weeks at intervals of at least 4 weeks if predefined criteria are met.
Related Therapeutic Areas
Sponsors
Collaborators: UMC Utrecht, Patient Panel, Bergman Clinics, Dutch College of General Practitioners (NHG Musculoskeletal Care), International Trial Advisory Board, Dutch Association of Sports Medicine (VSG), Amsterdam UMC, Isala, Haaglanden Medical Centre, ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Orthopaedic Association (NOV), Gelderse Vallei Hospital
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov