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Achilles Tendinopathy (AT)Phase 3ASPIRENCT07650396

The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions

A Phase 3 study testing Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine in people with Achilles Tendinopathy (AT), run by Erasmus Medical Center at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Achilles Tendinopathy (AT)
What is being tested?
Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
276 participants
Where
1 siteNetherlands
Study dates
3 Jun 2026to 31 Oct 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • • 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
Show all 20Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kristel van Abswoude, MD contact

+31 6 49326353

aspire@erasmusmc.nl

Netherlands1 site, 1 recruiting
  • Erasmus MC

    Rotterdam

    k van Abswoude, MD, +31 6 49326353, aspire@erasmusmc.nl

    R.J de Vos, MD/PhD, +31 10 7040136, r.devos@erasmusmc.nl

    Recruiting

Other trials in Netherlands

About this study

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.

Read the detailed description

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.

Being tested
Standard care, Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine, placebo injections consisting of lidocaine only
Keywords
Corticosteroid injection, Lidocaine, Placebo injection, Exercise therapy, Ultrasound-guided injection, Methylprednisolone acetate, Depo-Medrol, VISA-A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard careOther

    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 lidocaineDrug

    Also called Drug: Methylprednisolone acetate 40 mg + Lidocaine 10 mg, Depo-Medrol + Lidocaine

    Participants receive 1-3 ultrasound-guided peritendinous injections of Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine.

  • placebo injections consisting of lidocaine onlyDrug

    Also called Drug: Lidocaine 10 mg, Placebo injection

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

Study groups in NCT07650396
Study groupRoleWhat they receive
Corticosteroid and Lidocaine InjectionExperimentalParticipants 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.
Receives: Other: Standard care; Drug: Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine
Placebo InjectionPlacebo comparatorParticipants 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.
Receives: Other: Standard care; Drug: placebo injections consisting of lidocaine only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 1 year follow-up (timepoints: Baseline, 4 weeks, 8 weeks, 3 months, 6 months, 9 months, and 1-year).

  2. 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.

    Measured: During 1-year follow-up

Secondary outcomes (25)
  1. Minor corticosteroid side effects / corticosteroid safety indicators

    Body mass (kg)

    Measured: baseline, 3 months, 6 months, 9 months, and 1 year.

  2. Tendon-related symptoms and disability

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

    Measured: baseline, 3 months, 6 months, 9 months, and 1 year

  3. Pain outcomes

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

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

  4. Global perceived improvement

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

    Measured: Assessed at 3 months, 6 months, 9 months, and 1 year

  5. Physical function / functional test outcomes

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

    Measured: Assessed at baseline, 3 months, and 1 year

  6. Health-related quality of life

    Euro Quality of life 5 Dimensions, 5 Levels questionnaire (EQ-5D-5L). 0-100 score. 0=worst, 100=best

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

  7. Return to sport / physical activity level

    Return to desired sports participation using a 7-point scale. 0= worst, 7 full return to sports = best

    Measured: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year.

  8. Healthcare use

    Medical Consumption Questionnaire (iMCQ) for healthcare use

    The economic evaluation will be published separately.

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

  9. 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

    Measured: Assessed at baseline, 3 months, and 1 year

  10. Imaging outcomes: neovascularisation / Doppler flow

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

    Measured: Assessed at baseline, 3 months, and 1 year

  11. Minor corticosteroid side effects / corticosteroid safety indicators

    Body fat percentage

    Measured: baseline, 3 months, and 1 year.

  12. Minor corticosteroid side effects / corticosteroid safety indicators

    Waist circumference (cm)

    Measured: baseline, 3 months, and 1 year

  13. Minor corticosteroid side effects

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

    Measured: baseline, 3 months, and 1 year.

  14. Minor corticosteroid side effects / corticosteroid safety indicators

    Hot flushes (5-point scale)

    Measured: baseline, 3 months, 6 months, 9 months, and 1 year.

  15. Minor corticosteroid side effects / corticosteroid safety indicators

    Menstrual disturbances (if applicable, 5-point scale)

    Measured: baseline, 3 months, 6 months, 9 months, and 1 year

  16. Minor corticosteroid side effects / corticosteroid safety indicators

    Sleep disturbances (5-point scale)

    Measured: baseline, 3 months, 6 months, 9 months, and 1 year.

  17. Minor corticosteroid side effects / corticosteroid safety indicators

    Appetite (5-point scale)

    Measured: baseline, 3 months, 6 months, 9 months, and 1 year.

  18. Physical function / functional test outcomes

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

    Measured: Assessed at baseline, 3 months, and 1 year

  19. Physical function / functional test outcomes

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

    Measured: Assessed at baseline, 3 months, and 1 year

  20. Physical function / functional test outcomes

    Heel Rise Endurance Test (HRET) - repetitions

    Measured: Assessed at baseline, 3 months, and 1 year

  21. productivity loss

    Institute for Medical Technology Assessment Productivity Cost Questionnaire (iPCQ for productivity loss). The economic evaluation will be published separately

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

  22. Imaging outcomes: tendon structure on ultrasound

    tendon volume (cubic centimeters)

    Measured: Assessed at baseline, 3 months, and 1 year

  23. Imaging outcomes: tendon structure on ultrasound

    maximum cross-sectional area (square cm)

    Measured: Assessed at baseline, 3 months, and 1 year

  24. Imaging outcomes: tendon structure on ultrasound

    tendon maximum diameter (cm)

    Measured: Assessed at baseline, 3 months, and 1 year

  25. Pain outcomes

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2026
  2. Study start3 Jun 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
276 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07650396
Sponsor's protocol ID
MEC-2026-0210
Other IDs
2025-524057-13-00, ZonMw grant number: 1014102241, 2025
Acronym
ASPIRE
Status last verified
Jun 2026
First submitted
2 Jun 2026
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: upon reasonable request.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine in people with Achilles Tendinopathy (AT), run by Erasmus Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kristel van Abswoude, MD (+31 6 49326353, aspire@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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