The objective of this randomised, placebo-controlled trial is to compare a combination of eccentric training and nitroglycerin patches with a combination of eccentric training and placebo patches.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
VISA-P score
Secondary outcome
VAS score during sports, patients satisfaction, Tegner Score and time to return
to sports.
Background summary
Patellar tendinopathy is a frequent injury in sporting people. Unfortunately,
there are no clear strategies for treatment yet. Also there is no therapy with
satisfactory results. The etiology of patellar tendinopathy is not totally
clear yet and it is very important that we can offer a good treatment strategy
to our patients. Recent clinical investigation revealed good results of
eccentric training in these patients. Nitroglycerin patches gave some good
results in treatment of other kinds of tendon injuries. Probably this is the
result of stimulating the production of collagen by nitro oxid.
Study objective
The objective of this randomised, placebo-controlled trial is to compare a
combination of eccentric training and nitroglycerin patches with a combination
of eccentric training and placebo patches.
Study design
This randomised trial is double-blind. Each patient will receive a patch, but
half of them is a placebo one. Eccentric training will also be instructed by
every patient. Patients will be examinated following a standardized procedure.
The investigator is not aware about which kind of therapy the patient is
receiving.
Intervention
Eccentric training during 12 weeks. The exercises have to be done two times a
day in 3 series of 15 repetitions for everyday of the week.
De nitroglycerin patches or placebo patches have to be applicated each day at
the patellar tendon.
Study burden and risks
Everyday eccentric training with a VAS score of 4-5 on a scale of 0 to 10,
which takes 10 minutes a day.
Applicate everyday a patch at the patellar region.
There are no risks.
Burgemeester Banninglaan 1
2262 BA Leidschendam
NL
Burgemeester Banninglaan 1
2262 BA Leidschendam
NL
Listed location countries
Age
Inclusion criteria
- age 18 to 40 years
- pain of patellar tendon at least for three months and with a maximum of two years
- pain of patellar tendon during and/or after doing sports
- VISA-P < 80
- pain of patellar tendon during palpation
Exclusion criteria
- clinically suspect of other knee pathology
- knee operation or knee injection in history
- patient did eccentric exercises for the knee before
- hypersensitive for the use of nitrats
- pregnancy
- use of medication which influence the blood pressure, like anti hypertensiva
Design
Recruitment
Medical products/devices used
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 | EUCTR2008-008243-20-NL |
CCMO | NL24820.098.09 |