Aim of this study is to determine the safety and feasibility and to gain a first insight into the effects of the PRP treatment protocol on pain, symptoms and function, in athletes with chronic patellar tendinopathy.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part I
Side effects and adverse reactions/events. Experiences of the patients.
Part II
Self reported VISA-P score
The Dutch VISA-P 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. 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. The VISA-P score will be obtained for both legs separately.
Secondary outcome
• Answer to the question: *How is your knee now as compared with before
treatment?*, by marking an 11-point visual numerical scale
• Rate the pain on a Visual Analogue Scale (VAS) in which 0 represents no pain,
and 100 maximal pain:
o during activities of daily living (ADL),
o during sports,
o during a functional test: the single leg decline squat (SLDS);
o during a jump test: 3 jumps on both legs, 3 jumps on the best leg, 3 jumps on
the affected leg.
o during a triple hop test
• Rate overall treatment satisfaction, with use of a 4-grade scale
• Answer the question if they would recommend PRP injection treatment to family
or friends; *yes* or *no*.
• Ultrasound characteristics (hypo-echogenity, diameter, calcifications,
neovascularisation)
• Side effects and adverse reactions/events
• Height and distance of the jump tests.
• Number of platelets of the prepared PRP
Background summary
Despite its frequency and impact on athletic careers and in spite of decades of
research, management of patellar tendinopathy remains frustrating and
unpredictable for both athletes and clinicians. PRP appears to be a promising
treatment method in patients with chronic patellar tendinopathy, referred to a
sports medicine department after other conservative treatments had failed.
PRP treatment for chronic patellar tendinopathy is used in several medical
centers in The Netherlands and abroad. However, research on this treatment for
patellar tendinopathy is scarce and methodologically poor. Therefore it is
important to investigate the clinical effectiveness and feasibility of a non
commercial prepared PRP treatment with a better monitoring of the patients.
Study objective
Aim of this study is to determine the safety and feasibility and to gain a
first insight into the effects of the PRP treatment protocol on pain, symptoms
and function, in athletes with chronic patellar tendinopathy.
Study design
This study consists of two parts. In the first part the safety and feasibility
of the PRP treatment protocol of the Center for Sports Medicine UMCG will be
investigated in a small number of patients (n=5). The findings of the first
part will be reported to the METc. When no serious adverse events have
occurred, another 15 patients will be treated and monitored to gain a first
insight into the clinical effectiveness of the PRP treatment protocol, which
facilitates a power calculation for a future randomized controlled trial.
This prospective pilot cohort study uses one treatment group with repeated
measures. Subjects who visit the Center for Sports Medicine, who are diagnosed
having a chronic patellar tendinopathy by one of the sports medicine physicians
and who are willing to participate in the study, will receive the PRP treatment
program. This includes one PRP injection followed by a 12 week rehabilitation
and exercise program supervised by a physical therapist.
In the first part, five patients will receive a PRP injection. The feasibility
and safety of the injection will be closely monitored. The patients will be
instructed to immediately contact the Center for Sports Medicine UMCG in case
of fever, unexpected increase of pain, other side effects or signs of an
infection. Furthermore the diaries of these patients will be closely evaluated.
After 4 weeks, both patients* and our experiences will be evaluated and
reported to the METc. After the first part the treatment protocol will be
refined when necessary. In case no serious adverse events have occurred after 4
weeks, another 15 patients will be treated to gain a first insight into the
effect of this treatment protocol. Additionally, a possible learning curve will
be evened out.
In the second part, a baseline measurement will take place on the day of
injection, followed by measurements after physical therapy or regular
appointments with the sports medicine physician. These measurements will be
half way the treatment protocol (6 weeks from baseline), at the end of the
treatment protocol (12 weeks from baseline) and 4 and 14 weeks after the end of
the treatment protocol (16 and 26 weeks from baseline) (see timeline). During
these measurements, outcome parameters will be assessed by the investigator. At
these evaluation moments subjects will complete the VISA questionnaire and
perform functional loading (decline squat, triple hop test, jump test). This
questionnaire and these tests are regularly used by the physical therapist or
sports medicine physician, although now systematically recorded by the
investigator. The patients will also rate their satisfaction with the
treatment. Treatment and functional tests will take place at the Center for
Sports Medicine UMCG.
Intervention
PRP treatmen (PRP injection in patella tendon followed by a physical therapy
program)
Study burden and risks
PRP treatment seems to be an effective treatment for chronic patellar
tendinopathy so this can be of great benefit to the subjects receiving this
treatment. PRP treatments are already performed worldwide and to our knowledge
no copmlications or severe adverse events are reported. The risks for the
patients is low. The burden because of the research is low as well, all
questionnaires and physical tests occur after regular consultations with a
physiotherapist or sports medicine physician. Furthermore, it will take only
approximately 5 minutes per week to fill in the diary.
Hanzeplein 1
9713 GZ
NL
Hanzeplein 1
9713 GZ
NL
Listed location countries
Age
Inclusion criteria
• History of knee pain in the proximal section of the patellar tendon or its patellar insertion (pointed out in a anatomical drawing of the knee) in connection with training and competition
• Symptoms for over twelve months (current symptoms for at least three months)
• Age 18-40 years old
• Palpation tenderness to the corresponding painful area
• VISA score < 80
• Ultrasound characteristics showing hypoechoic zones in the corresponding area
• Recalcitrant to conservative treatment (at least eccentric training)
Exclusion criteria
• acute knee or patellar tendon injuries
• chronic joint diseases
• signs or symptoms of other coexisting knee pathology
• pregnancy
• Bleeding disorders and haematological disaeses
• Malignancy
• knee surgery
• injection of any kind in the patellar tendon in the last preceding three months
• use of NSAID*S in the last 5 days before or first 6 weeks after injection or daily use of drugs with a putative effect on patellar tendinopathy in the last year (e.g. non-steroid anti-inflammatory drugs, fluorchinolones)
• actual use of anticoagulants
Design
Recruitment
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 | NL31079.042.09 |