The Effect of High Volume Injection With and Without Steroid in Chronic Achilles Tendinopathy
Condition: Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

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.
    

Detailed description: 
      Chronic Achilles tendinopathy (AT) is a common and impairing disorder. High Volume Injection
      therapy (HVI) seems to show promising results in Achilles tendinopathy (AT). HVI consist of a
      large volume of saline with a small amount of steroid. Steroid injections is widely used for
      treating tendinopathy but we know from the literature that steroid injections only gives a
      fast and short term pain reduction in tendinopathy where HVI seems to show both a short term
      and a more prolonged effect which could contribute the volume effect (saline).

      Aim: 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).

      Materials and methods: Healthy males (21-59 years; n=60) with AT is randomly assigned to
      either 1) HVI with steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of
      Depomedrol followed by 40 mls saline) or 2) HVI without steroid (50 mls;10 mls 0.5%
      bupivacaine hydrochloride followed by 40 mls saline) The injections will be performed under
      ultrasound guidance. All subjects will undergo a 12 week eccentric training program and the
      subjects will continue eccentric training 3 times per week from week 12 to week 24.

      Clinical effects will be assessed as changes in symptoms and pain (VISA-A and VAS score),
      tendon ultrasound thickness and color Doppler. All outcome measures will be recorded at
      baseline and again at 6 weeks, 12 weeks and 24 weeks follow-up.

      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): High Volume injection without corticosteroid; High Volume injection with corticosteroid
Intervention type(s): Drug; Drug
Intervention description(s): Injection with 10 mls 0.5% bupivacaine hydrochloride and
• 40 ml saline around the tendon.; Injection with 10 mls 0.5% bupivacaine hydrochloride, 20 mg Depomedrol and 40 ml saline around the tendon.
Other intervention name(s): HVI without corticosteroid; HVI with corticosteroid
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment