The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions (ASPIRE)
16 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
276
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Kristel van Abswoude, MD
- Telefonnummer: +31 6 49326353
- E-post: aspire@erasmusmc.nl
Studieorter
-
-
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Rotterdam, Nederländerna
- Rekrytering
- Erasmus MC
-
Kontakt:
- k van Abswoude, MD
- Telefonnummer: +31 6 49326353
- E-post: aspire@erasmusmc.nl
-
Kontakt:
- R.J de Vos, MD/PhD
- Telefonnummer: +31 10 7040136
- E-post: r.devos@erasmusmc.nl
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Corticosteroid and Lidocaine Injection
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.
|
Education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website.
Participants receive 1-3 ultrasound-guided peritendinous injections of Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine.
Andra namn:
|
|
Placebo-jämförare: Placebo Injection
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.
|
Education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website.
Participants receive 1-3 ultrasound-guided peritendinous placebo injections consisting of lidocaine onl
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in disability and symptoms measured with the VISA-A questionnaire.
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Minor corticosteroid side effects / corticosteroid safety indicators
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
|
Healthcare use
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: baseline, 3 months, and 1 year.
|
Body fat percentage
|
baseline, 3 months, and 1 year.
|
|
Minor corticosteroid side effects / corticosteroid safety indicators
Tidsram: baseline, 3 months, and 1 year
|
Waist circumference (cm)
|
baseline, 3 months, and 1 year
|
|
Minor corticosteroid side effects / corticosteroid safety indicators
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Assessed at baseline, 3 months, and 1 year
|
Heel Rise Endurance Test (HRET) - repetitions
|
Assessed at baseline, 3 months, and 1 year
|
|
productivity loss
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Assessed at baseline, 3 months, and 1 year
|
tendon maximum diameter (cm)
|
Assessed at baseline, 3 months, and 1 year
|
|
Pain outcomes
Tidsram: 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
|
|
Health-related quality of life
Tidsram: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
|
Euro Quality of life 5 Dimensions, 5 Levels questionnaire (EQ-5D-5L).
0-100 score.
0=worst, 100=best
|
Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
|
|
Return to sport / physical activity level
Tidsram: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year.
|
Return to desired sports participation using a 7-point scale.
0= worst, 7 full return to sports = best
|
Assessed at baseline, 3 months, 6 months, 9 months, and 1 year.
|
|
Minor corticosteroid side effects
Tidsram: baseline, 3 months, and 1 year.
|
Visible skin abnormalities at the injection site scored as present or absent
|
baseline, 3 months, and 1 year.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Robert Jan de Vos, MD, PhD, Erasmus Medical Centre
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
3 juni 2026
Primärt slutförande (Beräknad)
31 december 2027
Avslutad studie (Beräknad)
31 oktober 2028
Studieregistreringsdatum
Först inskickad
2 juni 2026
Först inskickad som uppfyllde QC-kriterierna
10 juni 2026
Första postat (Faktisk)
16 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Administration
- Sjukvårdskvalitet, tillgång och utvärdering
- Organiska kemikalier
- Hälsovårdskvalitet
- Polycykliska föreningar
- Kvalitetsindikatorer, hälsovård
- Anilider
- Amider
- Anilinföreningar
- Aminer
- Acetanilider
- Graviditet
- Graviditet
- Steroider
- Fusion-ringföreningar
- Graviditet
- Metylprednisolon
- Prednisolon
- Metylprednisolonacetat
- Lidokain
- Vårdstandard
Andra studie-ID-nummer
- MEC-2026-0210
- 2025-524057-13-00 (Ctis)
- ZonMw grant number: 1014102241 (Annan identifierare: ZonMw)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
upon reasonable request.
Tidsram för IPD-delning
as yet undetermined
Kriterier för IPD Sharing Access
as yet undetermined
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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