The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions (ASPIRE)
16 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
276
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Kristel van Abswoude, MD
- Número de teléfono: +31 6 49326353
- Correo electrónico: aspire@erasmusmc.nl
Ubicaciones de estudio
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Rotterdam, Países Bajos
- Reclutamiento
- Erasmus MC
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Contacto:
- k van Abswoude, MD
- Número de teléfono: +31 6 49326353
- Correo electrónico: aspire@erasmusmc.nl
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Contacto:
- R.J de Vos, MD/PhD
- Número de teléfono: +31 10 7040136
- Correo electrónico: r.devos@erasmusmc.nl
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
Otros nombres:
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Comparador de placebos: 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
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in disability and symptoms measured with the VISA-A questionnaire.
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Minor corticosteroid side effects / corticosteroid safety indicators
Periodo de tiempo: 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
Periodo de tiempo: 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
|
|
Pain outcomes
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Physical function / functional test outcomes
Periodo de tiempo: Assessed at baseline, 3 months, and 1 year
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Assessed at baseline, 3 months, and 1 year
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Minor corticosteroid side effects / corticosteroid safety indicators
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
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Minor corticosteroid side effects / corticosteroid safety indicators
Periodo de tiempo: baseline, 3 months, 6 months, 9 months, and 1 year.
|
Appetite (5-point scale)
|
baseline, 3 months, 6 months, 9 months, and 1 year.
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Physical function / functional test outcomes
Periodo de tiempo: 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
|
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Physical function / functional test outcomes
Periodo de tiempo: 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
Periodo de tiempo: Assessed at baseline, 3 months, and 1 year
|
Heel Rise Endurance Test (HRET) - repetitions
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Assessed at baseline, 3 months, and 1 year
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productivity loss
Periodo de tiempo: 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
|
Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
|
|
Imaging outcomes: tendon structure on ultrasound
Periodo de tiempo: 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
Periodo de tiempo: Assessed at baseline, 3 months, and 1 year
|
maximum cross-sectional area (square cm)
|
Assessed at baseline, 3 months, and 1 year
|
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Imaging outcomes: tendon structure on ultrasound
Periodo de tiempo: Assessed at baseline, 3 months, and 1 year
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tendon maximum diameter (cm)
|
Assessed at baseline, 3 months, and 1 year
|
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Pain outcomes
Periodo de tiempo: 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
|
Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
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Health-related quality of life
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Robert Jan de Vos, MD, PhD, Erasmus Medical Centre
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
3 de junio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de octubre de 2028
Fechas de registro del estudio
Enviado por primera vez
2 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de junio de 2026
Publicado por primera vez (Actual)
16 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Químicos orgánicos
- Calidad de la atención médica
- Compuestos policíclicos
- Indicadores de calidad, atención médica
- Aniluros
- Amidas
- Compuestos anilina
- Amina
- Acetanilidas
- Espierra
- Embarazos
- Esteroides
- Compuestos de anillo fusionado
- Esparrazadienetrioles
- Metilprednisolona
- Prednisolona
- Acetato de metilprednisolona
- Lidocaína
- Estándar de cuidado
Otros números de identificación del estudio
- MEC-2026-0210
- 2025-524057-13-00 (Ctis)
- ZonMw grant number: 1014102241 (Otro identificador: ZonMw)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
upon reasonable request.
Marco de tiempo para compartir IPD
as yet undetermined
Criterios de acceso compartido de IPD
as yet undetermined
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .