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

10. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

276

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Kristel van Abswoude, MD
  • Telefonní číslo: +31 6 49326353
  • E-mail: aspire@erasmusmc.nl

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Jiný: Standard care
Education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website.
Lék: 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.
Ostatní jména:
  • Drug: Methylprednisolone acetate 40 mg + Lidocaine 10 mg
  • Depo-Medrol + Lidocaine
Komparátor placeba: 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.
Jiný: Standard care
Education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website.
Lék: placebo injections consisting of lidocaine only
Participants receive 1-3 ultrasound-guided peritendinous placebo injections consisting of lidocaine onl
Ostatní jména:
  • Injekce placeba
  • Drug: Lidocaine 10 mg

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in disability and symptoms measured with the VISA-A questionnaire.
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Minor corticosteroid side effects / corticosteroid safety indicators
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: baseline, 3 months, and 1 year.
Body fat percentage
baseline, 3 months, and 1 year.
Minor corticosteroid side effects / corticosteroid safety indicators
Časové okno: baseline, 3 months, and 1 year
Waist circumference (cm)
baseline, 3 months, and 1 year
Minor corticosteroid side effects / corticosteroid safety indicators
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Assessed at baseline, 3 months, and 1 year
Heel Rise Endurance Test (HRET) - repetitions
Assessed at baseline, 3 months, and 1 year
productivity loss
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Assessed at baseline, 3 months, and 1 year
tendon maximum diameter (cm)
Assessed at baseline, 3 months, and 1 year
Pain outcomes
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Erasmus Medical Center

Spolupracovníci

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

Vyšetřovatelé

  • Vrchní vyšetřovatel: Robert Jan de Vos, MD, PhD, Erasmus Medical Centre

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

3. června 2026

Primární dokončení (Odhadovaný)

31. prosince 2027

Dokončení studie (Odhadovaný)

31. října 2028

Termíny zápisu do studia

První předloženo

2. června 2026

První předloženo, které splnilo kritéria kontroly kvality

10. června 2026

První zveřejněno (Aktuální)

16. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

upon reasonable request.

Časový rámec sdílení IPD

as yet undetermined

Kritéria přístupu pro sdílení IPD

as yet undetermined

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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