The purpose of the study is compare the effect excentric exercise in combination with electric shockwave therapy with excentric exercise and sham shockwave therapy. This is measured with the VISA-P score in short term, middle term and long term…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
VISA-P: Victorian Institute of Sport Assessment: This validated score evaluates
pain, function and sportspractice.A score of 100 gives an optimal knee without
symptoms (Zwerver 2009). When there is pain in both knees than the score is for
the most painful side.
Secondary outcome
Pain pressure threshold: The pain pressure threshold is determined by a
dolorimetre on the most painful part of the patellatendon. In this position the
dolorimetre is read off a qauntity of Newton.
VAS: Visual Analogue scale for pain: patient gives a number on a scale from
0-10 whereas 0= no pain and 10= terrible pain. We take this score after 10
times on a declineboard of 25 degrees, the triple hop test and the maximal jump
test (Zwerver 2010)
Likert score: functional score of improvement of symptoms.
Background summary
Tendinopathy of the patellatendon, jumper's knee, is a chronic overuse injury
of the patella tendon. It can result in ending the sportcareer.
There is pain in the inferior part of the patella tendon, which increases with
more stress. When there is a chronic tendinopathy there is a disrupted
regenerationproces. Because of that shockabsorbtion is less than normal.
Tendinopathy of the patella tendon cab be treated with excentric exercise. This
treatment was first described by Curwin and Stanish in 1884.The best results
are described when squats are done in an angle of 25 degrees. The painful leg
makes a flection of the knee, after that with bot legs up. Each day two
sessions of three sets of fifthteen repetitions. With this treatment 50-70% of
the patients improves in kneefunction and pain.
Except excentric exercise there is another treatment started in the '90,
extracorporal shockwave therapy (ESWT). Wang finded in 2007 a significant
improvement of pain, VISA-P and kneefunction. Van Leeuwen et al concluded in
2009 that ESWT is an effective and save way for treatment in patella
tendinopathy.
There are still no publications of the combination of excentric exercise and
ESWT. There are some results from other studies but it never was published. One
study was from Peers et al. But they had only a follow up period of twelf
weeks. This study showed an significant improvement of VISA-P score. Recently
this combination was already tried in treatment of midportion tendinopathy of
the achillestendon. Rompe et al (2009) compared excentric exercise with
excentric exercise and ESWT. After four months the recovery is significantly
better in the combination group than in the only excentric exercise group.
Study objective
The purpose of the study is compare the effect excentric exercise in
combination with electric shockwave therapy with excentric exercise and sham
shockwave therapy. This is measured with the VISA-P score in short term, middle
term and long term period.
Study design
The study is a randomised study looking at the effect of treatment of
patellatendinopathy with excentric exercise and shockwavetherapy comparing
excentric exercise with sham shockwavetherapy.
The diagnosis is been given bij a sports doctor with a lot of experience in
patellatendinopathy.
After inclusion there is determination of the pain pressure threshold, the VAS
score and VISA-P. After the explination of the excentric exercise they can to
the exercises at home. This will start after the first session with shockwave.
Intervention:
Excentric exercise: squats on a declineboard of 25 degrees. First you must bent
your knee, than put the other leg next to the first leg to come up again.
During three months two sessions a day of three sets fifthteen repetitions with
one minute rest between the sets. They can do the exercises upto a VAS score=4,
above that stop the exercise. When there is no pain during the exercise you can
use some weights. If the exercise is to painful than you can help yourself to
lean on the back of a chair.
shockwave: three treatments with 1000 impulses, 4 Hz and energylevel of 0,20
mJ/mm2 (Peers 2003) with a Sonocure focussed shockwave where the most painful
point must be treated. Before the treatment there is no use of anaesthetics or
analgesics. The shockwavetherapy is in week 1,2 and 3 after inclusion. An
experienced physical therapist do the shockwavetherapy.
sham shockwave: three treatments with 1000 impulses of 0,03 mJ/mm2 with a
absorbing pad. Before the treatment there is no use of anaesthetics or
analgesics. The shockwavetherapy is in week 1,2 and 3 after inclusion . An
experienced physical therapist do the sham shockwavetherapy.
Sportsactivity during treatment is possible but not above the VAS-score=4. If
it's above 4 than it is necessary to adjust the load.
Intervention
not applicable
Study burden and risks
The excentric exercise and shockwavetherapy or sham shockwavetherapy can be a
little painfull.
burgemeester Banninglaan 1
Leidschendam 2262 BA
NL
burgemeester Banninglaan 1
Leidschendam 2262 BA
NL
Listed location countries
Age
Inclusion criteria
age: >18 years
VISA-P at baseline<80
min 1 hour sports a week
min 8 weeks pain of the patella tendon
pain with palpation at the insertion of the patellatendon
one side or two sides pain
Exclusion criteria
local steroid injection in the last month
last 6 months no immunesupressiva or coricosteroids
damaged or reconstructed anterior cruciate ligament
treatment of patellatendon with excentric exercise or shockwave before
inflammatory diseases of the joints
pregnancy
surgery of the patellatendon
local infections around the patellatendon
other knee pathology
anticoagulantia
pathology of coagulation
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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In other registers
Register | ID |
---|---|
CCMO | NL36153.098.11 |