Achilles Tendinopathy (AT)
Conditions
Keywords
Corticosteroid injection, Lidocaine, Placebo injection, Exercise therapy, Ultrasound-guided injection, Methylprednisolone acetate, Depo-Medrol, VISA-A
Brief 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. 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.
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.
Interventions
OTHERStandard care
Education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website.
DRUGDepo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine
Participants receive 1-3 ultrasound-guided peritendinous injections of Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine.
DRUGplacebo injections consisting of lidocaine only
Participants receive 1-3 ultrasound-guided peritendinous placebo injections consisting of lidocaine onl
Sponsors
Erasmus Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Amsterdam UMC
UMC Utrecht
Haaglanden Medical Centre
Gelderse Vallei Hospital
Isala
Bergman Clinics
Dutch Association of Sports Medicine (VSG)
Dutch Orthopaedic Association (NOV)
Dutch College of General Practitioners (NHG Musculoskeletal Care)
International Trial Advisory Board
Patient Panel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in disability and symptoms measured with the VISA-A questionnaire. | 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. |
| Incidence of full-thickness Achilles tendon rupture | 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
| Measure | Time frame | Description |
|---|---|---|
| Minor corticosteroid side effects / corticosteroid safety indicators | baseline, 3 months, 6 months, 9 months, and 1 year. | Body mass (kg) |
| Tendon-related symptoms and disability | baseline, 3 months, 6 months, 9 months, and 1 year | TENDINopathy Severity Assessment - Achilles (TENDINS-A) score. 0-100; 0= worts, 100= best |
| Pain outcomes | Assessed at baseline, 3 months, 6 months, 9 months, and 1 year | Pain during activity, measured on a VAS 0-10 scale |
| Global perceived improvement | Assessed at 3 months, 6 months, 9 months, and 1 year | Global Rating of Change (GROC), 11-point scale |
| Physical function / functional test outcomes | Assessed at baseline, 3 months, and 1 year | Maximum VAS pain (0-10) during or after palpation of the Achilles tendon |
| Health-related quality of life | 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 |
| Return to sport / physical activity level | 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 |
| Healthcare use | 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. |
| Imaging outcomes: tendon structure | 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 |
| Imaging outcomes: neovascularisation / Doppler flow | Assessed at baseline, 3 months, and 1 year | percentage of Doppler flow within the color box, quantified with the Surface Area Quantification (SAQ) method |
| Minor corticosteroid side effects | baseline, 3 months, and 1 year. | Visible skin abnormalities at the injection site scored as present or absent |
| productivity loss | 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 |
| Imaging outcomes: tendon structure on ultrasound | Assessed at baseline, 3 months, and 1 year | tendon volume (cubic centimeters) |
Countries
Netherlands
Contacts
CONTACTKristel van Abswoude, MD
PRINCIPAL_INVESTIGATORRobert Jan de Vos, MD, PhD
Erasmus Medical Centre
Outcome results
None listed