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The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions. (ASPIRE)

10 giugno 2026 aggiornato da: Adam Weir, Erasmus Medical Center
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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

276

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Olanda
      • Rotterdam, Olanda
        • Reclutamento
        • Erasmus MC
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Corticosteroid and Lidocaine Injection + Standard Care
Participants receive 1-3 ultrasound-guided peritendinous injections of Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine, in addition to standard care consisting of education, load management advice, and a structured progressive calf-strengthening exercise programme. 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.
Altro: Standard care
Education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website.
Droga: 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.
Altri nomi:
  • Drug: Methylprednisolone acetate 40 mg + Lidocaine 10 mg
  • Depo-Medrol + Lidocaine
Comparatore placebo: Placebo Injection + Standard Care
Participants receive 1-3 ultrasound-guided peritendinous placebo injections consisting of lidocaine only, in addition to standard care consisting of education, load management advice, and a structured progressive calf-strengthening exercise programme. 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.
Altro: Standard care
Education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website.
Droga: placebo injections consisting of lidocaine only
Participants receive 1-3 ultrasound-guided peritendinous placebo injections consisting of lidocaine onl
Altri nomi:
  • Iniezione di placebo
  • Drug: Lidocaine 10 mg

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in disability and symptoms measured with the VISA-A questionnaire.
Lasso di tempo: Baseline to 1 year follow-up (timepoints: Baseline, 4 weeks, 8 weeks, 3 months, 6 months, 9 months, and 1-year).
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
Lasso di tempo: During 1-year follow-up
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Minor corticosteroid side effects / corticosteroid safety indicators
Lasso di tempo: baseline, 3 months, 6 months, 9 months, and 1 year.
Body mass (kg)
baseline, 3 months, 6 months, 9 months, and 1 year.
Tendon-related symptoms and disability
Lasso di tempo: baseline, 3 months, 6 months, 9 months, and 1 year
TENDINopathy Severity Assessment - Achilles (TENDINS-A) score. 0-100; 0= worts, 100= best
baseline, 3 months, 6 months, 9 months, and 1 year
Pain outcomes
Lasso di tempo: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
Pain during activity, measured on a VAS 0-10 scale
Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
Global perceived improvement
Lasso di tempo: Assessed at 3 months, 6 months, 9 months, and 1 year
Global Rating of Change (GROC), 11-point scale
Assessed at 3 months, 6 months, 9 months, and 1 year
Physical function / functional test outcomes
Lasso di tempo: Assessed at baseline, 3 months, and 1 year
Maximum VAS pain (0-10) during or after palpation of the Achilles tendon
Assessed at baseline, 3 months, and 1 year
Health-related quality of life
Lasso di tempo: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
EuroQol-5 Dimensions, 5 Levels questionnaire (EQ-5D-5L)
Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
Return to sport / physical activity level
Lasso di tempo: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year.
Return to desired sports participation using a 7-point scale
Assessed at baseline, 3 months, 6 months, 9 months, and 1 year.
Healthcare use
Lasso di tempo: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year

Medical Consumption Questionnaire (iMCQ) for healthcare use

The economic evaluation will be published separately.
Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
Imaging outcomes: tendon structure
Lasso di tempo: Assessed at baseline, 3 months, and 1 year
Ultrasound and ultrasound tissue characterisation of Achilles tendon where the degree of collagen disorganisation is assed using: echo types I, echo types II, echo types III, echo types IV, combined percentage echo types I + II
Assessed at baseline, 3 months, and 1 year
Imaging outcomes: neovascularisation / Doppler flow
Lasso di tempo: Assessed at baseline, 3 months, and 1 year
percentage of Doppler flow within the color box, quantified with the Surface Area Quantification (SAQ) method
Assessed at baseline, 3 months, and 1 year
Minor corticosteroid side effects / corticosteroid safety indicators
Lasso di tempo: baseline, 3 months, and 1 year.
Body fat percentage
baseline, 3 months, and 1 year.
Minor corticosteroid side effects / corticosteroid safety indicators
Lasso di tempo: baseline, 3 months, and 1 year
Waist circumference (cm)
baseline, 3 months, and 1 year
Minor corticosteroid side effects / corticosteroid safety indicators
Lasso di tempo: baseline, 3 months, and 1 year.
Visible skin abnormalities at the injection site
baseline, 3 months, and 1 year.
Minor corticosteroid side effects / corticosteroid safety indicators
Lasso di tempo: baseline, 3 months, 6 months, 9 months, and 1 year.
Hot flushes (5-point scale)
baseline, 3 months, 6 months, 9 months, and 1 year.
Minor corticosteroid side effects / corticosteroid safety indicators
Lasso di tempo: baseline, 3 months, 6 months, 9 months, and 1 year
Menstrual disturbances (if applicable, 5-point scale)
baseline, 3 months, 6 months, 9 months, and 1 year
Minor corticosteroid side effects / corticosteroid safety indicators
Lasso di tempo: baseline, 3 months, 6 months, 9 months, and 1 year.
Sleep disturbances (5-point scale)
baseline, 3 months, 6 months, 9 months, and 1 year.
Minor corticosteroid side effects / corticosteroid safety indicators
Lasso di tempo: baseline, 3 months, 6 months, 9 months, and 1 year.
Appetite (5-point scale)
baseline, 3 months, 6 months, 9 months, and 1 year.
Physical function / functional test outcomes
Lasso di tempo: Assessed at baseline, 3 months, and 1 year
Maximum VAS pain (0-10) during or after 5 single-leg heel rises
Assessed at baseline, 3 months, and 1 year
Physical function / functional test outcomes
Lasso di tempo: Assessed at baseline, 3 months, and 1 year
Maximum VAS pain (0-10) during or after 5 hops
Assessed at baseline, 3 months, and 1 year
Physical function / functional test outcomes
Lasso di tempo: Assessed at baseline, 3 months, and 1 year
Heel Rise Endurance Test (HRET) - repetitions
Assessed at baseline, 3 months, and 1 year
productivity loss
Lasso di tempo: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
Institute for Medical Technology Assessment Productivity Cost Questionnaire (iPCQ for productivity loss). The economic evaluation will be published separately
Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
Imaging outcomes: tendon structure on ultrasound
Lasso di tempo: Assessed at baseline, 3 months, and 1 year
tendon volume (cubic centimeters)
Assessed at baseline, 3 months, and 1 year
Imaging outcomes: tendon structure on ultrasound
Lasso di tempo: Assessed at baseline, 3 months, and 1 year
maximum cross-sectional area (square cm)
Assessed at baseline, 3 months, and 1 year
Imaging outcomes: tendon structure on ultrasound
Lasso di tempo: Assessed at baseline, 3 months, and 1 year
tendon maximum diameter (cm)
Assessed at baseline, 3 months, and 1 year
Pain outcomes
Lasso di tempo: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
Pain after activity, measured on a VAS 0-10 scale
Assessed at baseline, 3 months, 6 months, 9 months, and 1 year

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Erasmus Medical Center

Collaboratori

UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Isala
Gelderse Vallei Hospital
Bergman Clinics
Haaglanden Medical Centre
Amsterdam UMC
Dutch Association of Sports Medicine (VSG)
Dutch Orthopaedic Association (NOV)
Dutch College of General Practitioners (NHG Musculoskeletal Care)
International Trial Advisory Board
Patient Panel

Investigatori

  • Investigatore principale: Robert Jan de Vos, MD, PhD, Erasmus Medical Centre

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

3 giugno 2026

Completamento primario (Stimato)

31 dicembre 2027

Completamento dello studio (Stimato)

31 ottobre 2028

Date di iscrizione allo studio

Primo inviato

2 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2026

Primo Inserito (Effettivo)

16 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MEC-2026-0210
  • 2025-524057-13-00 (Ctis)
  • ZonMw grant number: 1014102241 (Altro identificatore: ZonMw)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

upon reasonable request.

Periodo di condivisione IPD

as yet undetermined

Criteri di accesso alla condivisione IPD

as yet undetermined

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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