The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions

NCT07650396 | Recruiting Phase 3 DMC

• 3 other identifiers: MEC-2026-02102025-524057-13-00ZonMw grant number: 1014102241
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Corticosteroid injection; Lidocaine; Placebo injection; Exercise therapy; Ultrasound-guided injection; Methylprednisolone acetate; Depo-Medrol; VISA-A

Outcome Measures

Primary Outcomes (2)

• Change in disability and symptoms measured with the VISA-A questionnaire.

  Change in disability and symptoms during 1-year follow-up, measured with the validated Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire, scored from 0 to 100.

  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

  Incidence of full-thickness Achilles tendon ruptures during 1-year follow-up, confirmed by medical records or clinical tests and imaging.

  During 1-year follow-up

Secondary Outcomes (25)

• Minor corticosteroid side effects / corticosteroid safety indicators

  baseline, 3 months, 6 months, 9 months, and 1 year.

• Tendon-related symptoms and disability

  baseline, 3 months, 6 months, 9 months, and 1 year

• Pain outcomes

  Assessed at baseline, 3 months, 6 months, 9 months, and 1 year

• Global perceived improvement

  Assessed at 3 months, 6 months, 9 months, and 1 year

• Physical function / functional test outcomes

  Assessed at baseline, 3 months, and 1 year

Study Arms (2)

Corticosteroid and Lidocaine Injection

EXPERIMENTAL

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.

Other: Standard care; Drug: Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine

Placebo Injection

PLACEBO COMPARATOR

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.

Other: Standard care; Drug: placebo injections consisting of lidocaine only

Interventions

Standard care OTHER

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

Corticosteroid and Lidocaine Injection; Placebo Injection

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

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

Also known as: Drug: Methylprednisolone acetate 40 mg + Lidocaine 10 mg, Depo-Medrol + Lidocaine

Corticosteroid and Lidocaine Injection

placebo injections consisting of lidocaine only DRUG

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

Also known as: Drug: Lidocaine 10 mg, Placebo injection

Placebo Injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• 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

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

RECRUITING

MeSH Terms

Interventions

Standard of Care; Methylprednisolone Acetate; Lidocaine

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Robert Jan de Vos, MD, PhD

  Erasmus Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristel van Abswoude, MD

CONTACT

+31 6 49326353; aspire@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description Participants, injecting physicians, investigators, and outcome assessors are blinded to treatment allocation. Randomization is performed centrally, and the injection allocation can only be revealed if medically necessary for participant safety.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary researcher

Model Details: Participants are randomly assigned in a 1:1 ratio to receive corticosteroid and lidocaine injection(s) plus standard care or lidocaine (placebo) injection(s) plus standard care. Both groups receive the same co-interventions and follow-up schedule.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 16, 2026
• Study Start: June 3, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: as yet undetermined
• Access Criteria: as yet undetermined

Locations

NL (1)