The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Standard care
  Education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website.
• Препарат 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.
• Препарат placebo injections consisting of lidocaine only
  Participants receive 1-3 ultrasound-guided peritendinous placebo injections consisting of lidocaine onl

Первичные конечные точки

• Change in disability and symptoms measured with the VISA-A questionnaire. [Срок оценки: 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 [Срок оценки: During 1-year follow-up]

Вторичные конечные точки (12)

• Minor corticosteroid side effects / corticosteroid safety indicators [Срок оценки: baseline, 3 months, 6 months, 9 months, and 1 year.]
• Tendon-related symptoms and disability [Срок оценки: baseline, 3 months, 6 months, 9 months, and 1 year]
• Pain outcomes [Срок оценки: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year]
• Global perceived improvement [Срок оценки: Assessed at 3 months, 6 months, 9 months, and 1 year]
• Physical function / functional test outcomes [Срок оценки: Assessed at baseline, 3 months, and 1 year]
• Health-related quality of life [Срок оценки: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year]
• Return to sport / physical activity level [Срок оценки: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year.]
• Healthcare use [Срок оценки: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year]
• Imaging outcomes: tendon structure [Срок оценки: Assessed at baseline, 3 months, and 1 year]
• Imaging outcomes: neovascularisation / Doppler flow [Срок оценки: Assessed at baseline, 3 months, and 1 year]
• Minor corticosteroid side effects / corticosteroid safety indicators [Срок оценки: baseline, 3 months, and 1 year.]
• Minor corticosteroid side effects / corticosteroid safety indicators [Срок оценки: baseline, 3 months, and 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Erasmus MC — Rotterdam

Идентификаторы

NCT: NCT07650396 · MEC-2026-0210 · 2025-524057-13-00 · ZonMw grant number: 1014102241

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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