Our objective is to investigate the value of a HVIGI in chronic midportion Achilles tendinopathy, using a dubbel-blind, placebo-controlled, randomised clinical trial. We expect that this study design gives us the opportunity to provide solid advise…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary outcome measurement is the VISA-A score. This measures pain,
function and activity level. It is validated en reliable for the chronic
Achilles tendinopathy.
Secondary outcome
Our secundary outcome measurements are as follows:
- The painDETECT questionnaire.
- The Pain Coping Inventory (PCI) questionnaire
- Subjective function of the Achilles tendon (5-point Likert scale) and
subjective recovery (7-point Patient's Global Assessment scale)
- 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) (First 66 patients)
- Degree of neovascularisation (determined with standarised Power Doppler
Ultrasonography examination) before and after eccentric/isotonic calf exercises
or rest (First 66 patients)
- 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)
- Time to return to full training in desired sport.
- Compliance to the exercise programme and return to sports activity programme
(RPE score x duration of activity)
Background summary
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 programme. In most cases this gives great results, however there is a
significant group of patients in which the exercise programme is not
sufficient.
Prior to our study, three UK based studies have investigated the efficiancy of
High-Volume Image-Guided Injections (HVIGI*s) in chronic midportion Achilles
tendinopathy. They all showed promising results. However none of these studies
had a placebo group. Because of this, these investigations do not help in
giving advise on which treatment option to use in chronic midportion Achilles
tendinopathy.
Study objective
Our objective is to investigate the value of a HVIGI in chronic midportion
Achilles tendinopathy, using a dubbel-blind, placebo-controlled, randomised
clinical trial. We expect that this study design gives us the opportunity to
provide solid advise on how to treat this chronic injury.
Study design
A computer-generated randomisation will lead into two groups of patients:
1. High-Volume Image-Guided Injection (HVIGI) * 50ml (0,9% NaCl solution + 1%
lidocaïne) in combination with an exercise programme and gradual return to
sports activities.
2. Low-Volume Image-Guided Injection (LVIGI) * 2ml (0,9% NaCl solution + 1%
lidocaïne) in combination with an programme and gradual return to sports
activities.
There are five measurement points. These measurement points are at 0, 2, 6, 12
and 24 weeks post treatment. Every time both the primairy and secondary outcome
measurements are collected.
Intervention
Both groups receive an injection anterior to the Achilles tendon on the medial
side. The sports physician injects a mixture of 0,9% saline solution and
lidocaïne in the peritendinous space of the Achilles tendon. The sports
physician determines the amount of neovascularisation with a power-doppler
ultrasonography (PDU) while injecting the solution. When the sports physician
has injected 50ml, he stops injecting. In the intervention group, there is 10ml
of lidocaïne processed in the mixture. The placebo group receives 2ml of the
solution, of which is 0,4ml lidocaïne. Both procedures take the same amount of
time and are carried out equally. At the end of the procedure, the patiënt lies
prone on the investigation table for 5 minutes.
Study burden and risks
The exercise programme consists of 12 weeks exercise therapy. The exercises are
performed daily and start with isometric exercises, followed by concentric,
eccentric and plymetric exercises. The estimated time consumed by the exercises
is less than 15 minutes daily. The exercises can be painful, but this will only
be bothersome in the beginning.
In previous studies with HVIGI*s, no complications have been described. Even
though an anestheticum is mixed through the mixture, the initial treatment can
be painful. This pain will go away soon after treatment.|
During the investigation the patient visits the hospital five times. The first
appointment takes approximately 110 minutes. The second, third, fourth and
fifth will only takes 40 minutes. The complete follow-up will be 24 weeks.
Burgemeester Banninglaan 1
Leidschendam 2262 BA
NL
Burgemeester Banninglaan 1
Leidschendam 2262 BA
NL
Listed location countries
Age
Inclusion criteria
- 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 excercise program for 6 weeks.
- Painfull Achilles tendon for more than 2 months.
- Neovascularisation is present on Power Doppler Ultrasonography examination
Exclusion criteria
- Clinical suspicion of insertional disorders.
- Clinical suspicion of Achilles tendon rupture.
- Clinical suspicion of plantar flexor tenosynovitis.
- Clinical suspicion of peroneal tendinopathy or subluxation.
- Clicical 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 pregancy.
- 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.
- Allergy for lidocain.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-000180-13-NL |
| CCMO | NL51623.098.15 |
| Other | NTR: 4916 |