The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Change in disability and symptoms measured with the VISA-A questionnaire.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description Participants, injecting physicians, investigators, and outcome assessors are blinded to treatment allocation. Randomization is performed centrally, and the injection allocation can only be revealed if medically necessary for participant safety.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •• 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.
结局指标
主要结局
Change in disability and symptoms measured with the VISA-A questionnaire.
时间窗: 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.
Incidence of full-thickness Achilles tendon rupture
时间窗: 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.
次要结局
- Minor corticosteroid side effects / corticosteroid safety indicators(baseline, 3 months, 6 months, 9 months, and 1 year.)
- Tendon-related symptoms and disability(baseline, 3 months, 6 months, 9 months, and 1 year)
- Pain outcomes(Assessed at baseline, 3 months, 6 months, 9 months, and 1 year)
- Global perceived improvement(Assessed at 3 months, 6 months, 9 months, and 1 year)
- Physical function / functional test outcomes(Assessed at baseline, 3 months, and 1 year)
- Healthcare use(Assessed at baseline, 3 months, 6 months, 9 months, and 1 year)
- Imaging outcomes: tendon structure(Assessed at baseline, 3 months, and 1 year)
- Imaging outcomes: neovascularisation / Doppler flow(Assessed at baseline, 3 months, and 1 year)
- Minor corticosteroid side effects / corticosteroid safety indicators(baseline, 3 months, and 1 year.)
- Minor corticosteroid side effects / corticosteroid safety indicators(baseline, 3 months, and 1 year)
- Minor corticosteroid side effects / corticosteroid safety indicators(baseline, 3 months, 6 months, 9 months, and 1 year)
- productivity loss(Assessed at baseline, 3 months, 6 months, 9 months, and 1 year)
- Imaging outcomes: tendon structure on ultrasound(Assessed at baseline, 3 months, and 1 year)
- Health-related quality of life(Assessed at baseline, 3 months, 6 months, 9 months, and 1 year)
- Return to sport / physical activity level(Assessed at baseline, 3 months, 6 months, 9 months, and 1 year.)
研究者
Adam Weir
Primary researcher
Erasmus Medical Center