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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524057-13-00 | EU Trial (CTIS) Number | ||
| ZonMw grant number: 1014102241 | Other Identifier | ZonMw |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Amsterdam UMC | OTHER |
| UMC Utrecht | OTHER |
| Haaglanden Medical Centre |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticosteroid and Lidocaine Injection | Experimental | 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. |
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| Placebo Injection | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care | Other | Education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in disability and symptoms measured with the VISA-A questionnaire. | 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. | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Minor corticosteroid side effects / corticosteroid safety indicators | Body mass (kg) | baseline, 3 months, 6 months, 9 months, and 1 year. |
| Tendon-related symptoms and disability | TENDINopathy Severity Assessment - Achilles (TENDINS-A) score. 0-100; 0= worts, 100= best |
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Inclusion Criteria:
Exclusion Criteria:
• Clinical suspicion of insertional Achilles tendinopathy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristel van Abswoude, MD | Contact | +31 6 49326353 | aspire@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Robert Jan de Vos, MD, PhD | Erasmus Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Recruiting | Rotterdam | Netherlands |
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| Label | URL |
|---|---|
| trial website for patients | View source |
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upon reasonable request.
as yet undetermined
as yet undetermined
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2026 | Jun 2, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 9, 2026 | Jun 10, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D000077555 | Methylprednisolone Acetate |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| OTHER |
| Gelderse Vallei Hospital | OTHER |
| Isala | OTHER |
| Bergman Clinics | OTHER |
| Dutch Association of Sports Medicine (VSG) | UNKNOWN |
| Dutch Orthopaedic Association (NOV) | UNKNOWN |
| Dutch College of General Practitioners (NHG Musculoskeletal Care) | UNKNOWN |
| International Trial Advisory Board | UNKNOWN |
| Patient Panel | UNKNOWN |
Participants are randomly assigned in a 1:1 ratio to receive corticosteroid and lidocaine injection(s) plus standard care or lidocaine (placebo) injection(s) plus standard care. Both groups receive the same co-interventions and follow-up schedule.
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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.
| Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine | Drug | Participants receive 1-3 ultrasound-guided peritendinous injections of Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine. |
|
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| placebo injections consisting of lidocaine only | Drug | Participants receive 1-3 ultrasound-guided peritendinous placebo injections consisting of lidocaine onl |
|
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| baseline, 3 months, 6 months, 9 months, and 1 year |
| Pain outcomes | 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 | Global Rating of Change (GROC), 11-point scale | Assessed at 3 months, 6 months, 9 months, and 1 year |
| Physical function / functional test outcomes | Maximum VAS pain (0-10) during or after palpation of the Achilles tendon | Assessed at baseline, 3 months, and 1 year |
| Health-related quality of life | 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 |
| Return to sport / physical activity level | 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. |
| Healthcare use | 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 | 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 | Assessed at baseline, 3 months, and 1 year |
| Imaging outcomes: neovascularisation / Doppler flow | 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 | Body fat percentage | baseline, 3 months, and 1 year. |
| Minor corticosteroid side effects / corticosteroid safety indicators | Waist circumference (cm) | baseline, 3 months, and 1 year |
| Minor corticosteroid side effects | Visible skin abnormalities at the injection site scored as present or absent | baseline, 3 months, and 1 year. |
| Minor corticosteroid side effects / corticosteroid safety indicators | Hot flushes (5-point scale) | baseline, 3 months, 6 months, 9 months, and 1 year. |
| Minor corticosteroid side effects / corticosteroid safety indicators | Menstrual disturbances (if applicable, 5-point scale) | baseline, 3 months, 6 months, 9 months, and 1 year |
| Minor corticosteroid side effects / corticosteroid safety indicators | Sleep disturbances (5-point scale) | baseline, 3 months, 6 months, 9 months, and 1 year. |
| Minor corticosteroid side effects / corticosteroid safety indicators | Appetite (5-point scale) | baseline, 3 months, 6 months, 9 months, and 1 year. |
| Physical function / functional test outcomes | 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 | Maximum VAS pain (0-10) during or after 5 hops | Assessed at baseline, 3 months, and 1 year |
| Physical function / functional test outcomes | Heel Rise Endurance Test (HRET) - repetitions | Assessed at baseline, 3 months, and 1 year |
| productivity loss | 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 | tendon volume (cubic centimeters) | Assessed at baseline, 3 months, and 1 year |
| Imaging outcomes: tendon structure on ultrasound | maximum cross-sectional area (square cm) | Assessed at baseline, 3 months, and 1 year |
| Imaging outcomes: tendon structure on ultrasound | tendon maximum diameter (cm) | Assessed at baseline, 3 months, and 1 year |
| Pain outcomes | Pain after activity, measured on a VAS 0-10 scale | Assessed at baseline, 3 months, 6 months, 9 months, and 1 year |
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |