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NCT Number: NCT07650396

The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions

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.

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Key information

Conditions

Achilles Tendinopathy (AT)

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard care

Other

Education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website.

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.

Other names: Drug: Methylprednisolone acetate 40 mg + Lidocaine 10 mg, Depo-Medrol + Lidocaine

placebo injections consisting of lidocaine only

Drug

Participants receive 1-3 ultrasound-guided peritendinous placebo injections consisting of lidocaine onl

Other names: Drug: Lidocaine 10 mg, Placebo injection

Primary outcomes

  1. Change in disability and symptoms measured with the VISA-A questionnaire.

    Time frame: 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.

  2. Incidence of full-thickness Achilles tendon rupture

    Time frame: 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.

Secondary outcomes

  1. Minor corticosteroid side effects / corticosteroid safety indicators

    Time frame: baseline, 3 months, 6 months, 9 months, and 1 year.

    Body mass (kg)

  2. Tendon-related symptoms and disability

    Time frame: baseline, 3 months, 6 months, 9 months, and 1 year

    TENDINopathy Severity Assessment - Achilles (TENDINS-A) score. 0-100; 0= worts, 100= best

  3. Pain outcomes

    Time frame: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year

    Pain during activity, measured on a VAS 0-10 scale

  4. Global perceived improvement

    Time frame: Assessed at 3 months, 6 months, 9 months, and 1 year

    Global Rating of Change (GROC), 11-point scale

  5. Physical function / functional test outcomes

    Time frame: Assessed at baseline, 3 months, and 1 year

    Maximum VAS pain (0-10) during or after palpation of the Achilles tendon

  6. Health-related quality of life

    Time frame: 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

  7. Return to sport / physical activity level

    Time frame: 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

  8. Healthcare use

    Time frame: 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.

  9. Imaging outcomes: tendon structure

    Time frame: 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

  10. Imaging outcomes: neovascularisation / Doppler flow

    Time frame: Assessed at baseline, 3 months, and 1 year

    percentage of Doppler flow within the color box, quantified with the Surface Area Quantification (SAQ) method

  11. Minor corticosteroid side effects / corticosteroid safety indicators

    Time frame: baseline, 3 months, and 1 year.

    Body fat percentage

  12. Minor corticosteroid side effects / corticosteroid safety indicators

    Time frame: baseline, 3 months, and 1 year

    Waist circumference (cm)

  13. Minor corticosteroid side effects

    Time frame: baseline, 3 months, and 1 year.

    Visible skin abnormalities at the injection site scored as present or absent

  14. Minor corticosteroid side effects / corticosteroid safety indicators

    Time frame: baseline, 3 months, 6 months, 9 months, and 1 year.

    Hot flushes (5-point scale)

  15. Minor corticosteroid side effects / corticosteroid safety indicators

    Time frame: baseline, 3 months, 6 months, 9 months, and 1 year

    Menstrual disturbances (if applicable, 5-point scale)

  16. Minor corticosteroid side effects / corticosteroid safety indicators

    Time frame: baseline, 3 months, 6 months, 9 months, and 1 year.

    Sleep disturbances (5-point scale)

  17. Minor corticosteroid side effects / corticosteroid safety indicators

    Time frame: baseline, 3 months, 6 months, 9 months, and 1 year.

    Appetite (5-point scale)

  18. Physical function / functional test outcomes

    Time frame: Assessed at baseline, 3 months, and 1 year

    Maximum VAS pain (0-10) during or after 5 single-leg heel rises

  19. Physical function / functional test outcomes

    Time frame: Assessed at baseline, 3 months, and 1 year

    Maximum VAS pain (0-10) during or after 5 hops

  20. Physical function / functional test outcomes

    Time frame: Assessed at baseline, 3 months, and 1 year

    Heel Rise Endurance Test (HRET) - repetitions

  21. productivity loss

    Time frame: 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

  22. Imaging outcomes: tendon structure on ultrasound

    Time frame: Assessed at baseline, 3 months, and 1 year

    tendon volume (cubic centimeters)

  23. Imaging outcomes: tendon structure on ultrasound

    Time frame: Assessed at baseline, 3 months, and 1 year

    maximum cross-sectional area (square cm)

  24. Imaging outcomes: tendon structure on ultrasound

    Time frame: Assessed at baseline, 3 months, and 1 year

    tendon maximum diameter (cm)

  25. Pain outcomes

    Time frame: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year

    Pain after activity, measured on a VAS 0-10 scale

Study contacts

Contact information is provided by the study sponsor or research team.

Kristel van Abswoude, MD

CONTACT

[email protected]

+31 6 49326353

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Amsterdam UMC
  • Bergman Clinics
  • Dutch Association of Sports Medicine (VSG)
  • Dutch College of General Practitioners (NHG Musculoskeletal Care)
  • Dutch Orthopaedic Association (NOV)
  • Gelderse Vallei Hospital
  • Haaglanden Medical Centre
  • International Trial Advisory Board
  • Isala
  • Patient Panel
  • UMC Utrecht
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Acronym: ASPIRE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 16, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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