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The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions

ConditionAchilles Tendinopathy (AT)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorErasmus Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

• Clinical suspicion of insertional Achilles tendinopathy

Clinical suspicion of Achilles tendon rupture

Clinical suspicion of plantar flexor tenosynovitis

Clinical suspicion of sural nerve pathology

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard care

    Other intervention

    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.

  • placebo injections consisting of lidocaine only

    Drug

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

Treatment groups

276 Participants
are divided into 2 treatment groups
Group A: Corticosteroid and Lidocaine InjectionExperimental treatment 2 interventions
Group B: Placebo InjectionPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
During 1-year follow-up

Secondary outcomes

1

Minor corticosteroid side effects / corticosteroid safety indicators

Body mass (kg)

Time frame
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

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

Pain outcomes

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

Time frame
Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
4

Global perceived improvement

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasmus Medical Center

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator

Amsterdam UMC

Collaborator

UMC Utrecht

Collaborator

Haaglanden Medical Centre

Collaborator

Gelderse Vallei Hospital

Collaborator

Isala

Collaborator

Bergman Clinics

Collaborator

Dutch Association of Sports Medicine (VSG)

Collaborator

Dutch Orthopaedic Association (NOV)

Collaborator

Dutch College of General Practitioners (NHG Musculoskeletal Care)

Collaborator

International Trial Advisory Board

Collaborator

Patient Panel

Collaborator

Source ClinicalTrials.gov
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