The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions. (ASPIRE)
2026년 6월 10일 업데이트: 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.
연구 개요
상태
모병
상세 설명
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.
연구 유형
중재적
등록 (추정된)
276
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Kristel van Abswoude, MD
- 전화번호: +31 6 49326353
- 이메일: aspire@erasmusmc.nl
연구 장소
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-
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Rotterdam, 네덜란드
- 모병
- Erasmus MC
-
연락하다:
- k van Abswoude, MD
- 전화번호: +31 6 49326353
- 이메일: aspire@erasmusmc.nl
-
연락하다:
- R.J de Vos, MD/PhD
- 전화번호: +31 10 7040136
- 이메일: r.devos@erasmusmc.nl
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Corticosteroid and Lidocaine Injection + Standard Care
Participants receive 1-3 ultrasound-guided peritendinous injections of Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine, in addition to standard care consisting of education, load management advice, and a structured progressive calf-strengthening exercise programme.
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.
다른 이름들:
|
|
위약 비교기: Placebo Injection + Standard Care
Participants receive 1-3 ultrasound-guided peritendinous placebo injections consisting of lidocaine only, in addition to standard care consisting of education, load management advice, and a structured progressive calf-strengthening exercise programme.
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
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in disability and symptoms measured with the VISA-A questionnaire.
기간: 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.
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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).
|
|
Incidence of full-thickness Achilles tendon rupture
기간: 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.
|
During 1-year follow-up
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Minor corticosteroid side effects / corticosteroid safety indicators
기간: baseline, 3 months, 6 months, 9 months, and 1 year.
|
Body mass (kg)
|
baseline, 3 months, 6 months, 9 months, and 1 year.
|
|
Tendon-related symptoms and disability
기간: 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
기간: 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
|
|
Global perceived improvement
기간: 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
|
|
Physical function / functional test outcomes
기간: 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
|
|
Health-related quality of life
기간: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
|
EuroQol-5 Dimensions, 5 Levels questionnaire (EQ-5D-5L)
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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
기간: 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
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Assessed at baseline, 3 months, 6 months, 9 months, and 1 year.
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Healthcare use
기간: 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
기간: Assessed at baseline, 3 months, and 1 year
|
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
|
|
Imaging outcomes: neovascularisation / Doppler flow
기간: 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
|
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Minor corticosteroid side effects / corticosteroid safety indicators
기간: baseline, 3 months, and 1 year.
|
Body fat percentage
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baseline, 3 months, and 1 year.
|
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Minor corticosteroid side effects / corticosteroid safety indicators
기간: baseline, 3 months, and 1 year
|
Waist circumference (cm)
|
baseline, 3 months, and 1 year
|
|
Minor corticosteroid side effects / corticosteroid safety indicators
기간: baseline, 3 months, and 1 year.
|
Visible skin abnormalities at the injection site
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baseline, 3 months, and 1 year.
|
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Minor corticosteroid side effects / corticosteroid safety indicators
기간: 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.
|
|
Minor corticosteroid side effects / corticosteroid safety indicators
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Assessed at baseline, 3 months, and 1 year
|
Heel Rise Endurance Test (HRET) - repetitions
|
Assessed at baseline, 3 months, and 1 year
|
|
productivity loss
기간: 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
기간: 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
기간: 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
기간: Assessed at baseline, 3 months, and 1 year
|
tendon maximum diameter (cm)
|
Assessed at baseline, 3 months, and 1 year
|
|
Pain outcomes
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Robert Jan de Vos, MD, PhD, Erasmus Medical Centre
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 6월 3일
기본 완료 (추정된)
2027년 12월 31일
연구 완료 (추정된)
2028년 10월 31일
연구 등록 날짜
최초 제출
2026년 6월 2일
QC 기준을 충족하는 최초 제출
2026년 6월 10일
처음 게시됨 (실제)
2026년 6월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 10일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MEC-2026-0210
- 2025-524057-13-00 (씨티스)
- ZonMw grant number: 1014102241 (기타 식별자: ZonMw)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
upon reasonable request.
IPD 공유 기간
as yet undetermined
IPD 공유 액세스 기준
as yet undetermined
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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