High-Volume Image-Guided Injection in Chronic Midportion Achilles Tendinopathy
Condition: Tendinopathy; Achilles Tendon Pain; Injection Site Fibrosis
MeSH terms: Tendinopathy
Study type: Interventional
Phase: Phase 4

Summary: 
      Overuse injury of the Achilles tendon is a common entity in athletes. Currently, the usual
      treatment for chronic midportion Achilles tendinopathy is an eccentric exercise program. In
      most cases this gives satisfactory results, however there is a significant group of patients
      in which the exercise program is not sufficient. Prior to our study, three United Kingdom
      based studies have investigated the efficacy of High-Volume Image-Guided Injections (HVIGI's)
      in chronic midportion Achilles tendinopathy. They all showed promising results. However none
      of these studies had an adequate control group. This double-blind, placebo-controlled,
      randomized clinical trial will investigate the value of a High-Volume Image-Guided Injection
      in chronic midportion Achilles tendinopathy.
    

Detailed description: 
      Background of the study - Overuse injury of the Achilles tendon is a common entity in
      athletes. Especially middle aged athletes are at risk. Elite running athletes have a lifetime
      risk of sustaining an Achilles tendon injury of 52%. At the moment the usual treatment for
      chronic midportion Achilles tendinopathy is an excentric exercise program. In most cases this
      gives great results, however there is a significant group of patients in which the exercise
      program is not sufficient. Three United Kingdom-based case series evaluated the efficacy of
      High-Volume Image-Guided Injections (HVIGI's) in chronic midportion Achilles tendinopathy.
      They all showed promising results. However none of these studies used a comparative group.
      There is consequently a lack of high-quality studies in this field and therefore the
      investigators cannot recommend this treatment yet for this indication.

      Objective of the study - To investigate the efficacy of a high-volume image guided injection
      (HVIGI) in chronic midportion Achilles tendinopathy.

      Hypothesis - The average VISA-A score is higher in the patient group treated with a
      progressive exercise program in combination with a high volume image guided injection in
      comparison with the group treated with low volume injection as a control group in combination
      with a progressive exercise program.

      Study design - A double-blind, randomized, placebo-controlled clinical trial. Randomization
      and stratification (based on activity level using the Ankle Activity Score) will be performed
      using a computer-generated model. Measurements will be performed at baseline, 2, 6, 12 and 24
      weeks post injection. At every time point both the primary and secondary outcome measurements
      will be collected. The painDETECT and the Pain Coping Inventory questionnaires will be
      derived at baseline and 24 week post injection.

      Study population - In total, 80 patients with clinically diagnosed chronic midportion
      Achilles tendinopathy will be included in this study.
    

Intervention name(s): HVIGI; LVIGI; Progressive exercise program
Intervention type(s): Drug; Drug; Other
Intervention description(s): High Volume Image-Guided Injection with a saline/lidocain solution; Placebo control with injection of a saline/lidocain solution (low volume); A 12-week during progressive exercise training program consisting of isometric, isotonic and eccentric calf exercises.
Other intervention name(s): Saline 0.9% 40 ml; Lidocain 1.0% 10 ml; Saline 0.9% 1.6 ml; Lidocain 1.0% 0.4 ml
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment