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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
276
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.
Participants receive 1-3 ultrasound-guided peritendinous placebo injections consisting of lidocaine onl
Erasmus MC
Rotterdam, Netherlands
RECRUITINGChange 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).
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
Minor corticosteroid side effects / corticosteroid safety indicators
Body mass (kg)
Time frame: 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
Time frame: baseline, 3 months, 6 months, 9 months, and 1 year
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
Global perceived improvement
Global Rating of Change (GROC), 11-point scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Assessed at baseline, 3 months, and 1 year
Minor corticosteroid side effects / corticosteroid safety indicators
Body fat percentage
Time frame: baseline, 3 months, and 1 year.
Minor corticosteroid side effects / corticosteroid safety indicators
Waist circumference (cm)
Time frame: baseline, 3 months, and 1 year
Minor corticosteroid side effects
Visible skin abnormalities at the injection site scored as present or absent
Time frame: baseline, 3 months, and 1 year.
Minor corticosteroid side effects / corticosteroid safety indicators
Hot flushes (5-point scale)
Time frame: baseline, 3 months, 6 months, 9 months, and 1 year.
Minor corticosteroid side effects / corticosteroid safety indicators
Menstrual disturbances (if applicable, 5-point scale)
Time frame: baseline, 3 months, 6 months, 9 months, and 1 year
Minor corticosteroid side effects / corticosteroid safety indicators
Sleep disturbances (5-point scale)
Time frame: baseline, 3 months, 6 months, 9 months, and 1 year.
Minor corticosteroid side effects / corticosteroid safety indicators
Appetite (5-point scale)
Time frame: 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
Time frame: Assessed at baseline, 3 months, and 1 year
Physical function / functional test outcomes
Maximum VAS pain (0-10) during or after 5 hops
Time frame: Assessed at baseline, 3 months, and 1 year
Physical function / functional test outcomes
Heel Rise Endurance Test (HRET) - repetitions
Time frame: 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
Time frame: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
Imaging outcomes: tendon structure on ultrasound
tendon volume (cubic centimeters)
Time frame: Assessed at baseline, 3 months, and 1 year
Imaging outcomes: tendon structure on ultrasound
maximum cross-sectional area (square cm)
Time frame: Assessed at baseline, 3 months, and 1 year
Imaging outcomes: tendon structure on ultrasound
tendon maximum diameter (cm)
Time frame: Assessed at baseline, 3 months, and 1 year
Pain outcomes
Pain after activity, measured on a VAS 0-10 scale
Time frame: Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
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