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
ID
Bron
Verkorte titel
Aandoening
Achilles tendon
Tendinopathy
Injection
Treatment
High-Volume
Achillespees
Tendinopathie
Injectie
Behandeling
Hoog-Volume
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The Victorian Institute of Sports Assessment-Achilles (VISA-A) score. This is a validated, reliable and disease-specific questionnaire to evaluate symptoms in patients with chronic midportion Achilles tendinopathy
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
Baseline, 2, 6, 12 and 24 weeks
Onderzoeksproduct en/of interventie
High-Volume Image-Guided Injection (50 ml) in the
peritendinous space of the Achilles tendon
Publiek
P.L.J. Veldhoven, van
Leidschendam 2260 AK
The Netherlands
+31 80 979 4890
sportafspraak@haaglandenmc.nl
Wetenschappelijk
P.L.J. Veldhoven, van
Leidschendam 2260 AK
The Netherlands
+31 80 979 4890
sportafspraak@haaglandenmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age 18-70 years.
- Clinical diagnosis of chronic midportion Achilles tendinopathy: Painfull swelling of the Achilles tendon, 2-7 cm proximal to it’s calcaneal insertion.
- Non-response to eccentric excercise program for 6 weeks.
- Painfull Achilles tendon for more than 2 months.
- Neovascularization is present using Power Doppler
Ultrasonography examination
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Clinical suspicion of insertional disorders.
- Clinical suspicion of Achilles tendon rupture.
- Clinical suspicion of plantar flexor tenosynovitis.
- Clinical suspicion of peroneal tendinopathy or subluxation.
- Clinical suspicion of sural nerve pathology.
- Condition of the Achilles tendon caused by medication, such as quinolones and statins.
- Known to have the following disorders: spondylarthropathy, gout, hyperlipidemia, rheumatoid arthritis and sarcoïdosis.
- Inability to perform a heavy load eccentric exercise program.
- Recently prescribed drugs (within 2 years) with a putative effect on symptoms and tendon healing (quinolone antibiotics, corticosteroids).
- Presence of pregnancy.
- Previous Achilles tendon rupture.
- Patient has received surgical intervention for his injury.
- A medical condition that would affect safety of injection (e.g. peripheral vascular disease, use of anticoagulant medication)
- Inability to give informed consent.
- Participation in other concomitant treatment programs.
- Patient has already one side included in this study.
- Patient does not wish, for whatever reason, to undergo one of the two treatments.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4686 |
NTR-old | NTR4916 |
Ander register | METC ZWH : 14 - 100 |