drugset / Trial / NCT02417987

High Volume Injection or Autologous Conditioned Plasma (ACP) in Chronic Achilles Tendinopathy

NCT02417987

Completed 60 enrolled Bispebjerg Hospital
RandomizedFactorialDouble-blindTreatment

Summary

The aim of the study is to examine patients with chronic Achilles Tendinopathy (AT) and to compare the effect of high volume injection (HVI) or autologous conditioned plasma (ACP) in combination with eccentric training to placebo treatment (sham treatment combined with eccentric exercises). Healthy males with AT will be randomly assigned to either 1) HVI (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 mls saline), 2) ACP (\~ 4 mls) or 3) Placebo (Plc) treatment. All subjects will perform a 12-wk eccentric training program and examinations will be done 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 groups (HVI, ACP and Plc)

Timeline

Start
2012-05
Primary completion
2014-08
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.5 % Other
Subject Hydrocortisone Other / unclassified 20 mg Other
Comparator Platelet Rich Plasma Other / unclassified 4 ml Other

Indications