Primary Objective: Determining the effect of a patellar strap and sports tape on pain and sport participation in subjects with patellar tendinopathy. Secondary Objective(s): Determining the relationship between injury specific, sports related and…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Visual Analogue Scale (VAS) for pain will be used as the main study outcome
in both parts of the study. With this measure subjects indicate on a continuous
line between two end points their level of pain. The VAS pain scale is a valid
and reliable measure of chronic and acute pain intensity (Bijur, Silver, &
Gallagher, 2001) (Downie et al., 1978).
In the first part, the primary study parameter is the VAS pain score after ten
single leg decline squats. In the second part of the study, the primary study
parameter is the difference between the baseline and the intervention week in
the average score on the VAS pain scale during sports.
Secondary outcome
In the first part of the study, the secondary study parameter is the VAS pain
score after the maximal vertical jump test and the triple hop test.
Furthermore, the height in meters of the highest jump during the maximal
vertical jump test for each condition and the distance in meters that is
covered by three jumps during the triple hop test are considered secondary
study outcomes.
In the second part of the study, the difference in average VAS pain score
between the baseline week and the intervention week in the two hours after
sports and the next morning are secondary study parameters. The difference in
sports participation (the number and duration of training/matches and missed
training/matches a week) between the baseline week and the intervention week is
also a secondary study outcome.
Background summary
Patellar tendinopathy (jumper*s knee) is a clinical condition of gradually
progressive activity related pain at the insertion of the patellar tendon at
the apex patellae (Blazina, Kerlan, Jobe, Carter, & Carlson, 1973). Prolonged
repetitive stress of the knee-extensor apparatus can lead to this common
overuse tendinopathy in athletes from different sports. The overall prevalence
of patellar tendinopathy among elite and non-elite athletes is high and varies
between 3 and 45% (Lian, Engebretsen, & Bahr, 2005) (Zwerver & Bredeweg, 2006).
In sports characterized by high demands on speed and power for the leg
extensors, such as volleyball and basketball, a prevalence has been reported of
45% and 32% respectively (Lian et al., 2005). Patellar tendinopathy is one of
the leading causes for athletes to consult physicians or physical therapists at
sports medicine departments. Patellar tendinopathy commonly contributes to the
decision to quit an athletic career and also causes mild but long lasting
symptoms after the end of an athletic career (Kettunen, Kvist, Alanen, &
Kujala, 2002). The high prevalence, low function scores, and chronic nature of
the condition result in the fact that patellar tendinopathy can cause at least
as much impairment in athletic performance as acute knee injuries (Lian et al.,
2005).
A patellar strap or sports tape is used by numerous athletes to reduce pain and
to remain active in sports. There are several theories of how such orthoses
might work: a patellar strap or tape could increase the patella-patellar tendon
angle and hereby reduce the effective length of the patellar tendon (Lavagnino,
Arnoczky, Dodds, & Elvin, 2011). This might reduce the load on the tendon.
Others think it improves the proprioception (Callaghan, Selfe, Bagley, &
Oldham, 2002) or desentisation (Boetje et al, submitted), and therefore
decreases the amount of pain that is perceived.
However, there is currently no scientific evidence for the effectiveness of the
patellar strap and sports tape in a jumper*s knee. A small pilot study
investigated recently the effect of the patellar strap on pain in patellar
tendinopathy subjects and showed that the strap possibly has a positive effect
on pain (Boetje et al, submitted). However, this study only measured the acute
effect on pain in a small group of athletes and no placebo group was included.
Furthermore, the effect of sports tape in jumper*s knee is never studied.
Larger and more extended research is necessary to determine the actual effect
of both orthoses. In addition, it is interesting to study the effect of the
strap or tape in the different severity stages of the injury (Cook & Purdam,
2009). It might be that the orthoses are helpful in the first phase of the
injury, but are not effective anymore in a more chronic phase.
Study objective
Primary Objective: Determining the effect of a patellar strap and sports tape
on pain and sport participation in subjects with patellar tendinopathy.
Secondary Objective(s): Determining the relationship between injury specific,
sports related and personal factors and the effectiveness of patellar strap and
sports tape.
Study design
This study is divided into two parts.
The first part is a randomized controlled crossover experiment in a controlled
situation in which the effect of the patellar strap and sports tape is examined
during several functional tests.
The second part of this study is a randomized controlled trial (parallel group
design). After one baseline week subjects will be divided into four different
groups.
Intervention
In the first part of the study, all subjects perform three functional tests
under four different conditions. The order of the conditions is balanced
between subjects. The four conditions are:
- A patellar strap. The strap will be adjusted to the knee according to
manufacturer* instructions.
- Sports tape. The tape will be administered by the researcher at the specific
site between the patella and the bumb at the start of the tibia (tuberositas
tibia).
- Placebo tape. Kinesiotape will be administered by the researcher also at the
specific site between the patella and the bumb at the start of the tibia
(tuberositas tibia). Because of the characteristics of the kinesiotape (very
elastic), this tape gives no support to the patella tendon in contrary to the
sports tape.
- Control condition. No intervention is used in this condition.
The three functional tests are shown and explained to the subject. The
execution of the tests is preceded by a warming up period of five minutes. The
three functional tests are: ten single leg decline squats, the maximal vertical
jump test and the triple hop test.
Directly after each test, the participant scores on a VAS pain scale the
experienced pain during the test. In addition, the height of the jumps of the
maximal vertical jump test and the covered distances of the triple hop test
will be documented for each subject.
In the second part of this study subjects are randomly divided into four groups
of 35 subjects after stratification for phase. The first week all participants
document in a log (in the normal situation) the experienced pain during and
after training and matches and the amount of pain the next morning. Further,
they document the number and duration of (missed) training and matches. After
this week, subjects do the same, but now with one of the following
interventions:
1) A patellar strap. Subjects will receive a patellar strap and will be asked
to use it for one week during training and matches.
2) Sports tape. Subject will receive sports tape and instructions how to use
it. The subject is asked to use it for one week during training and matches.
3) Placebo tape. Subjects receive kinesiotape and instructions how to use it.
These instructions are theoretically not effective.
4) Control. The control group will not receive an intervention.
Study burden and risks
The burden associated with participation in this study is small. Subjects only
need to visit the sport medical centre once for the first part of the study. In
this session, at first the subjects' characteristics (age, length, weight),
injury specific characteristics (duration of complaints and phase) and sport
related factors (sports, hours performance of sports and duration of
participation in sports), are obtained through a baseline questionnaire. Also
the VISA-P questionnaire is administered on forehand. After a warming up period
of 5 minutes, the tests are executed. After each test the subject indicates on
the VAS pain scale the amount of pain that was experienced. In total, this
session takes about one hour and 15 minutes.
For the second part of the study, subjects document in a log to what extend
they could participate in sports and how much pain they had during and after
sports. In addition, at the end of each week they answer a few general
questions about the week. The documentation in the log takes every time
maximally 5 minutes.
It is necessary to do this study with patellar tendinopathy subjects, because
it is impossible to study the effectiveness of the patellar strap and sports
tape on this injury in healthy subjects.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
-Age 18-50 years
-Current symptoms of knee pain in the patellar tendon or its patellar or tibial insertion in connection with training and competition in one or both knees.
-Duration of symptoms for over three months (to exclude acute inflammatory tendon problems and de novo partial ruptures).
-VISA- P score < 80
-Palpation sensitivity in the patellar knee area
-Participating athlete
Exclusion criteria
-Acute knee and patellar tendon problems
-Chronic joint disease(s)
-Signs or symptoms of other knee pathologies
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL42287.042.12 |
| Other | NTR TC=3660 |
| OMON | NL-OMON22717 |