The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions (ASPIRE)
16 de junho de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
276
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Kristel van Abswoude, MD
- Número de telefone: +31 6 49326353
- E-mail: aspire@erasmusmc.nl
Locais de estudo
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Rotterdam, Holanda
- Recrutamento
- Erasmus MC
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Contato:
- k van Abswoude, MD
- Número de telefone: +31 6 49326353
- E-mail: aspire@erasmusmc.nl
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Contato:
- R.J de Vos, MD/PhD
- Número de telefone: +31 10 7040136
- E-mail: r.devos@erasmusmc.nl
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
Outros nomes:
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Comparador de Placebo: 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
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in disability and symptoms measured with the VISA-A questionnaire.
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Minor corticosteroid side effects / corticosteroid safety indicators
Prazo: baseline, 3 months, 6 months, 9 months, and 1 year.
|
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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: baseline, 3 months, and 1 year.
|
Body fat percentage
|
baseline, 3 months, and 1 year.
|
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Minor corticosteroid side effects / corticosteroid safety indicators
Prazo: baseline, 3 months, and 1 year
|
Waist circumference (cm)
|
baseline, 3 months, and 1 year
|
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Minor corticosteroid side effects / corticosteroid safety indicators
Prazo: 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.
|
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Minor corticosteroid side effects / corticosteroid safety indicators
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Assessed at baseline, 3 months, and 1 year
|
Heel Rise Endurance Test (HRET) - repetitions
|
Assessed at baseline, 3 months, and 1 year
|
|
productivity loss
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Assessed at baseline, 3 months, and 1 year
|
tendon maximum diameter (cm)
|
Assessed at baseline, 3 months, and 1 year
|
|
Pain outcomes
Prazo: 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
Prazo: 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
|
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Return to sport / physical activity level
Prazo: 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.
|
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Minor corticosteroid side effects
Prazo: baseline, 3 months, and 1 year.
|
Visible skin abnormalities at the injection site scored as present or absent
|
baseline, 3 months, and 1 year.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Robert Jan de Vos, MD, PhD, Erasmus Medical Centre
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
3 de junho de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
31 de outubro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
2 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de junho de 2026
Primeira postagem (Real)
16 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Administração de Serviços de Saúde
- Qualidade, acesso e avaliação da assistência médica
- Produtos químicos orgânicos
- Qualidade de assistência médica
- Compostos policíclicos
- Indicadores de qualidade, assistência médica
- Anilides
- Amidas
- Compostos de anilina
- Aminas
- Acetanilidas
- Pregada
- Pregnas
- Esteróides
- Compostos de anel fundido
- Pregadienetriols
- Metilprednisolona
- Prednisolona
- Acetato de Metilprednisolona
- Lidocaína
- Padrão de atendimento
Outros números de identificação do estudo
- MEC-2026-0210
- 2025-524057-13-00 (Ctis)
- ZonMw grant number: 1014102241 (Outro identificador: ZonMw)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
upon reasonable request.
Prazo de Compartilhamento de IPD
as yet undetermined
Critérios de acesso de compartilhamento IPD
as yet undetermined
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .