High Volume Injection or Autologous Conditioned Plasma (ACP) in Chronic Achilles Tendinopathy
Condition: Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

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)
    

Detailed description: 
      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.
    

Intervention name(s): Placebo; High Volume injection; Autologous conditioned plasma (ACP)
Intervention type(s): Other; Drug; Biological
Intervention description(s): The skin was penetrated with a needle and few drops of saline injected in the soft tissue away from the tendon; Injection with10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol 40 mls saline (NaCl) around the tendon; Injection with 4 mls of ACP around the tendon
Other intervention name(s): Sham treatment; HVI; Platelet-rich plasma (PRP)
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment