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

10. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

276

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Sonstiges: Standard care
Education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website.
Arzneimittel: 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.
Andere Namen:
  • Drug: Methylprednisolone acetate 40 mg + Lidocaine 10 mg
  • Depo-Medrol + Lidocaine
Placebo-Komparator: 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.
Sonstiges: Standard care
Education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website.
Arzneimittel: placebo injections consisting of lidocaine only
Participants receive 1-3 ultrasound-guided peritendinous placebo injections consisting of lidocaine onl
Andere Namen:
  • Placebo-Injektion
  • Drug: Lidocaine 10 mg

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in disability and symptoms measured with the VISA-A questionnaire.
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Erasmus Medical Center

Mitarbeiter

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

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

3. Juni 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2027

Studienabschluss (Geschätzt)

31. Oktober 2028

Studienanmeldedaten

Zuerst eingereicht

2. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Juni 2026

Zuerst gepostet (Tatsächlich)

16. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

upon reasonable request.

IPD-Sharing-Zeitrahmen

as yet undetermined

IPD-Sharing-Zugriffskriterien

as yet undetermined

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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