Aim of this study is to determine the effectiveness of ESWT on pain, symptoms and function, in athletes with patellar tendinopathy (in an early stage of the disease) who are still able to train and compete.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in VISA score.
The VISA score is a simple, reliable instrument for measuring the severity of
patellar tendinopathy and is sensitive to small changes in symptoms. It was
specifically designed for patellar tendinopathy, rating pain, symptoms, simple
test of function and the ability to play sports.
Secondary outcome
·Answer to the question: *How is your knee now as compared with before
treatment?*
·Rate the pain on a Visual Analogue Scale (VAS) in which 0 represents no pain,
and 100 maximal pain:
-during activities of daily living (ADL),
-during sports,
-during a functional test: the single leg decline squat (SLDS
-during a jumping test
·Rate overall treatment satisfaction
·Answer the question if they would recommend ESWT treatment to family or friends
·Ultrasound characteristics (hypo-echogenity, diameter, calcifications,
neovascularisation)
·Side effects and adverse reactions/events
.Concurrent (para)medical consumption
Background summary
Patellar tendinopathy is a common overuse injury that often has a major impact
on the knee function and even on the career of jumping athletes. There is no
consensus about the most appropriate treatment but Extracorporeal ShockWave
Therapy (ESWT) appears to be a promising treatment. Until now its effectiveness
has only been studied in patients with chronic recalcitrant patellar
tendinopathy.
Study objective
Aim of this study is to determine the effectiveness of ESWT on pain, symptoms
and function, in athletes with patellar tendinopathy (in an early stage of the
disease) who are still able to train and compete.
Study design
Double blinded, randomized controlled study using a 2 group repeated measures
design with a treatment period of 2 weeks and a 6 month follow-up
Intervention
Extracorporeal Shockwave Therapy (ESWT)
One group will receive three ESWT treatments at a weekly interval, the other
group will receive three placebo ESWT treatments at a weekly interval
Study burden and risks
ESWT appears to be an effective treatment so this can be of great benefit to
the subject receiving this treatment. Further to this subjects within the
placebo group will be offered ESWT treatment after 6 months in case of proven
effectiveness so they can benefit from this study as well. On the other hand,
the risks and the burden for the subjects both are low. Only 1 inclusion, 3
short treatment and 3 short minimally demanding evaluation visits to a sports
medicine centre are necessary during a sport season. Athletes can continue to
participate in their sporting activities during the study. There is only a
very, very small chance that (serious) side effects of ESWT will occur. So the
potential high benefit and the low risk and burden to the subject justify this
relevant study into the effectiveness of ESWT in actively playing athletes.
Postbus 30001
9700 RB Groningen
NL
Postbus 30001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Male and female athletes with the following criteria are eligible for inclusion:
•History of knee pain in patellar tendon or its patellar or tibial insertion in connection with training and competition
•Symptoms for over three months in the actual season or in the second half of the previous season (January - May 2008) (to exclude acute inflammatory tendon problems and partial ruptures)
•Age 18-35 years old (to reduce the chance of other osteochondrotic diseases like
Sinding-Larsen-Johanson, Osgood-Schlatter and osteoarthrosis)
•Palpation tenderness to the corresponding painful area
•VISA score < 80
Exclusion criteria
Athletes must not be included if one of the following applies:
•acute knee or patellar tendon injuries
•chronic joint diseases
•signs or symptoms of other coexisting knee pathology
•contraindications for ESWT (pregnancy, malignancy, coagulopathy)
•knee surgery or injection therapy with corticosteroids in the last preceding three months
•daily use of drugs with a putative effect on patellar tendinopathy in the last year (e.g. non-steroid anti-inflammatory drugs, fluorchinolones) or actual use of anticoagulants
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL19389.042.08 |