The primary objective is to get a first insight what the effect of FSWT and RSWT is on the tendon structure in treating patellar tendinopathy patients and on healthy tendons determined by UTC.The secondary objective is to compare the effect of FSWT…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the echo type percentage of the structure of the
patellar tendon determined by the UTC device. The UTC is an imaging technique
for tendons. It displays the density and arrangement of the collagenous matrix.
The tendon structure can be divided into four different echo types, type I,
type II, type III and type IV. Type I and II are considered as organized tendon
structure, where type III and IV are considered as degenerative tendon
structure.
Secondary outcome
The secondary study parameters are the following:
- Self reported VISA-P score: The VISA-P score is a simple, reliable instrument
for measuring the severity of patellar tendinopathy and is sensitive to small
changes in symptoms. The VISA-P was specifically designed for patellar
tendinopathy, rating pain, symptoms, simple test of function and the ability to
play sports. Six of the eight questions are scored on a VAS from 0 to 10
points, with 10 representing optimal health. The maximum VISA-P score for an
asymptomatic athlete is 100 points.
- Pain on a Visual Analogue Scale (VAS) in which 0 represents no pain, and 100
maximal pain:
during rest
during activities of daily living (ADL),
during sports
after sports
during a functional test: the single leg decline squat (SLDS); the athlete
performs one time a single leg squat to 60° of knee flexion on a 25° decline
board. This test was designed to preferentially load the patellar tendon.
during a functional test: the single leg decline squat (SLDS); the athlete
performs ten times a single leg squat to 60° of knee flexion on a 25° decline
board. This test was designed to preferentially load the patellar tendon.
- Perceived improvement, with use of a 4-grade scale as *no symptoms*,
improved, but still symptomatic*, *no change*, *worse*. (for PT subjects only)
- Sport participation, sport level and sport activity throughout the study
- Participant characteristics: Age, gender, length, weight
Background summary
Patellar tendinopathy (PT) is a commin injury, especially among athletes.
Patella tendinopathy is experienced as activity-related pain at the patellar
tendon. This injury can be a long lasting injury, can have consequences even in
daily life and can end an athletes carreer. Currently there is still no
consensus what the most appropriate treatment is for this injury. A relatively
new and common used treatment option is shockwave therapy (SWT). Several
studies showed SWT can have a positive effect on the symptoms that come with
patellar tendinopathy. There are currently two SWTs possible, focused shockwave
therapy (FSWT) and radial shockwave therapy (RSWT). A study has shown that both
SWT options seem effective on the symptoms of patellar tendinopathy and that
there seem to be no difference in effectiveness. Currently it remains unclear
what effect SWT has on the tendon strucuture in patellar tendinopathy and
healthy tendons. Until recently it was not possible to quantify the tendon
structure. With the development of the ultrasonographic tissue characterization
device, this became possible.
Study objective
The primary objective is to get a first insight what the effect of FSWT and
RSWT is on the tendon structure in treating patellar tendinopathy patients and
on healthy tendons determined by UTC.
The secondary objective is to compare the effect of FSWT and RSWT on the
symptoms in treating patellar tendinopathy patients.
Study design
The study will be a randomized controlled study with a 4 group repeated
measures design. Groups are devided in FSWT group with PT patients (N=15), FSWT
group with healthy subjects (N=15), RSWT group with PT patients (N=15) and RSWT
group with healthy subjects (N=15).
Participants will be computer randomized in either the FSWT or RSWT group. PT
patients will receive SWT on their symptomatic knee, healthy subjects will all
receive SWT on their right knee. A 2 week treatment period (3 SWT treatments
with a 1 week interval) and a 12 week follow-up for PT patients only as
exercise therapy is continued with PT patients only. UTC scans are done before
and after each shockwave treatment (T1-T3) and 1 week (T4), 6 weeks (T5) and 12
weeks (T6) after the final shockwave treatment. Healthy subjects are finished
after T4. During each evaluation the VISA-P score, VAS pain scale during rest,
ADL and during and after sports and the single leg decline squats are
determined on all subjects. Rating of subjective improvement is examined on PT
subjects only. Throughout the study the subjects will record their sport
activities. All treatments and tests are executed at the UMCG.
Study burden and risks
The amount of visits is group dependent.
Healthy subjects will be asked to visit the UMCG 4 times. During 3 visits they
will receive SWT and 2 UTC scans each visit. 1 week after the final SWT
treatment, a final UTC scan is made. During this period, subjects will be asked
not to participate in high intensity explosive sports and avoid jump related
activities/sports.
During each visit the VISA-P, VAS pain scale during rest, ADL and during and
after sports, VAS pain scale after 1 and 10 single leg decline squads will be
measured.
Possible side effect from the SWT treatment is the only risk for the healthy
subjects. But since the energy level is set low, the chances on side effects
are minimal.
Subjects from the PT group will be measured a total of 6 times. All
measurements are done when they are already expected at the UMCG. When the
subject chooses to follow physiotheraphy externally, one extra visit to the
UMCG is necessary. The same protocol as in the healthy subjects is followed.
However, PT subjects will receive an exercise program (usual care after SWT)
after their last SWT treatment, and are also measured 6 and 12 weeks after
their final SWT treatment. During each visit the VISA-P, VAS pain scale during
rest, ADL and during and after sports, VAS pain scale after 1 and 10 single leg
decline squats will be measured. Rate of perceived improvement, with use of a
4-grade scale as *no symptoms*, improved, but still symptomatic*, *no change*,
*worse" is also recorded.
The treatment protocol does not differ in any way from the regular treatment.
Therefore, no extra risks are present for the PT group during this study.
UTC scans are pain and risk free without any side effects.
Additional time is approximately 30 minutes per visit.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Male and female subjects with the following criteria are eligible for inclusion in patellar tendinopathy subject group:
- History of knee pain in patellar tendon or its patellar or tibial insertion in connection with training and competition
- Symptoms for over three months
- Age 18-45 years old
- Palpation tenderness to the corresponding painful area
- Degenerative tendon changes determined by a regular ultrasound echo
- VISA-P score < 80;Male and female subjects with the following criteria are eligible for inclusion in healthy subject group:
- Age 18-45 years old
- VISA-P score of 95 or higher
Exclusion criteria
Subjects must not be included in the patellar tendinopathy subjects group if one of the following applies:
- acute knee or patellar tendon injuries
- chronic knee joint diseases
- signs or symptoms of other coexisting knee pathology
- contraindications for SWT (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;Subjects must not be included in the healthy subjects group if one of the following applies:
- acute knee or patellar tendon injuries
- history of patellar tendinopathy
- chronic joint diseases
- contraindications for SWT (pregnancy, malignancy, coagulopathy)
- 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
- Allergy or intolerance for paracetamol
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 | NL50792.042.14 |
| OMON | NL-OMON29199 |