The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions (ASPIRE)
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Kristel van Abswoude, MD
- Telefonnummer: +31 6 49326353
- E-mail: aspire@erasmusmc.nl
Studiesteder
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Rotterdam, Holland
- Rekruttering
- Erasmus MC
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Kontakt:
- k van Abswoude, MD
- Telefonnummer: +31 6 49326353
- E-mail: aspire@erasmusmc.nl
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Kontakt:
- R.J de Vos, MD/PhD
- Telefonnummer: +31 10 7040136
- E-mail: r.devos@erasmusmc.nl
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Eksperimentel: 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.
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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.
Andre navne:
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Placebo komparator: 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.
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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
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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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).
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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.
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Baseline to 1 year follow-up (timepoints: Baseline, 4 weeks, 8 weeks, 3 months, 6 months, 9 months, and 1-year).
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Incidence of full-thickness Achilles tendon rupture
Tidsramme: During 1-year follow-up
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Incidence of full-thickness Achilles tendon ruptures during 1-year follow-up, confirmed by medical records or clinical tests and imaging.
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During 1-year follow-up
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Minor corticosteroid side effects / corticosteroid safety indicators
Tidsramme: baseline, 3 months, 6 months, 9 months, and 1 year.
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Body mass (kg)
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baseline, 3 months, 6 months, 9 months, and 1 year.
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Tendon-related symptoms and disability
Tidsramme: baseline, 3 months, 6 months, 9 months, and 1 year
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TENDINopathy Severity Assessment - Achilles (TENDINS-A) score.
0-100; 0= worts, 100= best
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baseline, 3 months, 6 months, 9 months, and 1 year
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Pain outcomes
Tidsramme: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
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Pain during activity, measured on a VAS 0-10 scale
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Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
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Global perceived improvement
Tidsramme: Assessed at 3 months, 6 months, 9 months, and 1 year
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Global Rating of Change (GROC), 11-point scale
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Assessed at 3 months, 6 months, 9 months, and 1 year
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Physical function / functional test outcomes
Tidsramme: Assessed at baseline, 3 months, and 1 year
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Maximum VAS pain (0-10) during or after palpation of the Achilles tendon
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Assessed at baseline, 3 months, and 1 year
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Healthcare use
Tidsramme: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
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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
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Imaging outcomes: tendon structure
Tidsramme: Assessed at baseline, 3 months, and 1 year
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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
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Assessed at baseline, 3 months, and 1 year
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Imaging outcomes: neovascularisation / Doppler flow
Tidsramme: Assessed at baseline, 3 months, and 1 year
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percentage of Doppler flow within the color box, quantified with the Surface Area Quantification (SAQ) method
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Assessed at baseline, 3 months, and 1 year
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Minor corticosteroid side effects / corticosteroid safety indicators
Tidsramme: baseline, 3 months, and 1 year.
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Body fat percentage
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baseline, 3 months, and 1 year.
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Minor corticosteroid side effects / corticosteroid safety indicators
Tidsramme: baseline, 3 months, and 1 year
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Waist circumference (cm)
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baseline, 3 months, and 1 year
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Minor corticosteroid side effects / corticosteroid safety indicators
Tidsramme: baseline, 3 months, 6 months, 9 months, and 1 year.
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Hot flushes (5-point scale)
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baseline, 3 months, 6 months, 9 months, and 1 year.
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Minor corticosteroid side effects / corticosteroid safety indicators
Tidsramme: baseline, 3 months, 6 months, 9 months, and 1 year
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Menstrual disturbances (if applicable, 5-point scale)
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baseline, 3 months, 6 months, 9 months, and 1 year
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Minor corticosteroid side effects / corticosteroid safety indicators
Tidsramme: baseline, 3 months, 6 months, 9 months, and 1 year.
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Sleep disturbances (5-point scale)
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baseline, 3 months, 6 months, 9 months, and 1 year.
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Minor corticosteroid side effects / corticosteroid safety indicators
Tidsramme: baseline, 3 months, 6 months, 9 months, and 1 year.
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Appetite (5-point scale)
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baseline, 3 months, 6 months, 9 months, and 1 year.
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Physical function / functional test outcomes
Tidsramme: Assessed at baseline, 3 months, and 1 year
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Maximum VAS pain (0-10) during or after 5 single-leg heel rises
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Assessed at baseline, 3 months, and 1 year
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Physical function / functional test outcomes
Tidsramme: Assessed at baseline, 3 months, and 1 year
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Maximum VAS pain (0-10) during or after 5 hops
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Assessed at baseline, 3 months, and 1 year
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Physical function / functional test outcomes
Tidsramme: Assessed at baseline, 3 months, and 1 year
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Heel Rise Endurance Test (HRET) - repetitions
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Assessed at baseline, 3 months, and 1 year
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productivity loss
Tidsramme: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
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Institute for Medical Technology Assessment Productivity Cost Questionnaire (iPCQ for productivity loss).
The economic evaluation will be published separately
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Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
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Imaging outcomes: tendon structure on ultrasound
Tidsramme: Assessed at baseline, 3 months, and 1 year
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tendon volume (cubic centimeters)
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Assessed at baseline, 3 months, and 1 year
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Imaging outcomes: tendon structure on ultrasound
Tidsramme: Assessed at baseline, 3 months, and 1 year
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maximum cross-sectional area (square cm)
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Assessed at baseline, 3 months, and 1 year
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Imaging outcomes: tendon structure on ultrasound
Tidsramme: Assessed at baseline, 3 months, and 1 year
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tendon maximum diameter (cm)
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Assessed at baseline, 3 months, and 1 year
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Pain outcomes
Tidsramme: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
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Pain after activity, measured on a VAS 0-10 scale
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Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
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Health-related quality of life
Tidsramme: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
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Euro Quality of life 5 Dimensions, 5 Levels questionnaire (EQ-5D-5L).
0-100 score.
0=worst, 100=best
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Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
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Return to sport / physical activity level
Tidsramme: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year.
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Return to desired sports participation using a 7-point scale.
0= worst, 7 full return to sports = best
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Assessed at baseline, 3 months, 6 months, 9 months, and 1 year.
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Minor corticosteroid side effects
Tidsramme: baseline, 3 months, and 1 year.
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Visible skin abnormalities at the injection site scored as present or absent
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baseline, 3 months, and 1 year.
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Ledende efterforsker: Robert Jan de Vos, MD, PhD, Erasmus Medical Centre
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sundhedstjenester Administration
- Sundhedsvæsenets kvalitet, adgang og evaluering
- Organiske kemikalier
- Sundhedskvalitet
- Polycykliske forbindelser
- Kvalitetsindikatorer, sundhedsvæsenet
- Anilider
- Amider
- Anilinforbindelser
- Aminer
- Acetanilider
- Gravidier
- Graviditet
- Steroider
- SMUSED-RING-forbindelser
- Gravideretrioler
- Methylprednisolon
- Prednisolon
- Methylprednisolonacetat
- Lidokain
- Standard for pleje
Andre undersøgelses-id-numre
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)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
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