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

10. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

276

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Standard care
Education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website.
Medicin: 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.
Andre navne:
  • 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.
Andet: Standard care
Education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website.
Medicin: placebo injections consisting of lidocaine only
Participants receive 1-3 ultrasound-guided peritendinous placebo injections consisting of lidocaine onl
Andre navne:
  • Placebo injektion
  • Drug: Lidocaine 10 mg

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in disability and symptoms measured with the VISA-A questionnaire.
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Erasmus Medical Center

Samarbejdspartnere

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

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. juni 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. oktober 2028

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

upon reasonable request.

IPD-delingstidsramme

as yet undetermined

IPD-delingsadgangskriterier

as yet undetermined

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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