Tendinopathy Clinical Trial
Official title:
High Volume Injection (HVI) or Autologous Conditioned Plasma (ACP) in Chronic Achilles Tendinopathy: A Randomized Controlled Double Blinded Trial
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)
Chronic Achilles tendinopathy (AT) is a common and impairing disorder. Only sparse
scientific evidence exists for the present used treatments and no golden standard treatment
exists so far.
Aim: The aim of the study is in AT patients to examine and compare the effect of high volume
injection (HVI) or autologous conditioned plasma (ACP) in combination with eccentric
training to placebo treatment (sham treatment and eccentric exercises).
Materials and methods: Healthy males (21-59 years; n=60) with AT is 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. Participants will treated
on 4 successive occasions with 2 weeks (wks) interval (HVI will only be injected once at
baseline, the 3 following injections will be placebo). The injections will be performed
under ultrasound guidance. All subjects will undergo a 12-wk eccentric training program.
Clinical effects will be assessed as changes in symptoms and pain (VISA-A and VAS score),
tendon ultrasound thickness and muscle function (one-legged heel-rise test). All outcome
measures will be recorded at baseline and again at 6 weeks, 12 week and 6 month follow-up.
Results: Will se the changes and differences between groups (HVI, ACP and Placebo) in VISA-A
scores, VAS scores, ultrasound (tendon thickness) and muscle function.
Statistics: All data will be analyzed in SigmaPlot v11 using two-way repeated measures ANOVA
with Student-Newman-Keuls Post-hoc test. This is used to see changes over time in all groups
(time effect) and differences between groups within time-points (group effect). All data
will be presented as mean ± SEM time.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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