High-Volume Image-Guided Injection in chronic midportion Achilles tendinopathy

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 UK-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 we 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.

Study design

A double-blind, placebo-controlled, randomized controlled

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

Patients will be randomized into one of the two treatment

groups:

1. High-Volume Image-Guided Injection (HVIGI) – 50ml

(0.9% NaCl solution + 1% lidocaine) in combination with an

isometric/eccentric exercise program and a return to sports

program.


2. Low-Volume Image-Guided Injection (LVIGI) – 2ml (0.9%

NaCl solution + 1% lidocaine) in combination with an

eccentric exercise program. The sports physician performs

the injection in the peritendinous space of the Achilles

tendon and the amount of neovascularization is determined

with a power-doppler ultrasonography (PDU) before and

after this procedure. In the intervention group, there is 10ml

of lidocaine processed in the mixture. The placebo group

receives 2ml of the solution, of which is 0.4ml lidocaine. Both

procedures take the same amount of time and are carried

out equally. At the end of the procedure, the patient lies

prone on the investigation table for 5 minutes.



Primary study parameters/outcome of the study

- VISA-A score. This measures pain, function and activity

level. It is validated and reliable for the chronic Achilles

tendinopathy.

Secondary study parameters/outcome of the study

- PainDETECT questionnaire

- Pain Coping Inventory (PCI) questionnaire

- Physical examination: waist circumference, length, weight,

foot posture index, palpation pain (VAS 0-100), flexibility

and strength gastrocnemius and soleus muscle, jumping

height (cm) and pain during jump test (VAS 0-100) and 10

times hopping (VAS 0-100, part of the VISA-A questionnaire)

- Degree of neovascularization (determined with

standardized Power Doppler Ultrasonography examination)

- Subjective patient satisfaction (excellent / good / fair /

poor)

- Return to sports (Return to desired sport on pre-injury

level / return to desired sport but on a lower level / return to

sports but not desired sport / no return to sports)

- Compliance to the exercise program.

High-Volume Image-Guided injections will provide a

significant improvement in symptoms compared to Low-

Volume Image-Guided injections in patients suffering from

chronic midportion Achilles tendinopathy

Baseline, 2, 6, 12 and 24 weeks

High-Volume Image-Guided Injection (50 ml) in the

peritendinous space of the Achilles tendon