drugset / Trial / NCT02839577

The Effect of High Volume Injection With and Without Steroid in Chronic Achilles Tendinopathy

NCT02839577

Completed 28 enrolled Bispebjerg Hospital
RandomizedFactorialDouble-blindTreatment

Summary

The aim of the study is to determine the effect of steroid in High Volume Injection (HVI) compared to HVI without steroid (volume effect) in functional outcomes and ultrasound tendon thickness and Color Doppler activity in chronic Achilles tendinopathy (AT). Healthy males with AT will be randomly assigned to either 1) HVI with steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 ml saline) or 2) HVI without steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride followed by 40 ml saline). All subjects will perform a 12-wk eccentric training program with further eccentric training 3 times per week from week 12 to week 24. Clinical examinations and ultrasound will be performed at baseline (before treatment) with follow-ups after 6 weeks, 12 weeks and again after 24 weeks prior to baseline to see any possible changes and differences between the two groups.

Timeline

Start
2013-12
Primary completion
2014-07
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methylprednisolone Other / unclassified 20 mg Other
Comparator Bupivacaine Other / unclassified 0.5 % Other
Comparator Bupivacaine Other / unclassified 10 ml Other

Indications