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High-Volume Image-Guided Injection in Chronic Midportion Achilles Tendinopathy

CompletedPhase 4NCT02996409
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Overuse injury of the Achilles tendon is a common entity in athletes. Currently, the usual treatment for chronic midportion Achilles tendinopathy is an eccentric exercise program. In most cases this gives satisfactory results, however there is a significant group of patients in which the exercise program is not sufficient. Prior to our study, three United Kingdom based studies have investigated the efficacy of High-Volume Image-Guided Injections (HVIGI's) in chronic midportion Achilles tendinopathy. They all showed promising results. However none of these studies had an adequate control group. This double-blind, placebo-controlled, randomized clinical trial will investigate the value of a High-Volume Image-Guided Injection in chronic midportion Achilles tendinopathy.

Study details

Official title
The Value of a High-Volume Image-Guided Injection in Chronic Midportion Achilles Tendinopathy: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Conditions
  • Tendinopathy
  • Achilles Tendon Pain
  • Injection Site Fibrosis
Interventions
  • Drug: HVIGI
  • Drug: LVIGI
  • Other: Progressive exercise program
Sponsor
Erasmus Medical Center
Collaborators
Dutch Arthritis Association; The Anna Foundation
Start date
2016-12
Primary completion
2019-07
Sex
All
Age range
from 18 Years to 70 Years
Results posted
No results posted in this snapshot
Countries
Netherlands
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Age 18-70 years. 2. Clinical diagnosis of chronic midportion Achilles tendinopathy: Painful swelling of the Achilles tendon, 2-7 cm proximal to it's calcaneal insertion. 3. Non-response to exercise program for 6 weeks. 4. Painful Achilles tendon for more than 2 months. 5. Neovascularisation is present on Power Doppler Ultrasonography examination Exclusion Criteria: 1. Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneum) 2. Clinical suspicion of an Achilles tendon rupture (Thompson test abnormal and palpable "gap") 3. Clinical suspicion of plantar flexor tenosynovitis (posteromedial pain when the toes are plantar flexed against resistance) 4. Clinical suspicion of n.suralis pathology (sensitive disorder in the area of the sural nerve) 5. Clinical suspicion of peroneal subluxation (visible luxation of the mm. Peronea spot in combination with localized pain) 6. Suspicion of internal disorders: spondylarthropathy, gout, hyperlipidemia, Rheumatoid Arthritis and sarcoidosis. 7. Condition that prevents the patients from executing an active exercise program 8. Recently prescribed drugs (within 2 years) with a putative effect on symptoms and tendon healing (quinolone antibiotics, corticosteroids). 9. Previous Achilles tendon rupture. 10. Patient has received surgical intervention for his injury. 11. Patient does not wish, for whatever reason, to undergo one of the two treatments 12. A medical condition that would affect safety of injection (e.g. peripheral vascular disease, use of anticoagulant medication) 13. Known presence of a pregnancy 14. Condition of the Achilles tendon caused by medications (arising in relation to moment of intake), such as quinolones and statins 15. Inability to give informed consent. 16. Participation in other concomitant treatment programs. 17. Patient has already one side included in this study. 18. Allergy for lidocain.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02996409