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Tendinopathy Of Patella Groningen Amsterdam Maastricht ESWT study


- candidate number3833
- NTR NumberNTR1408
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-aug-2008
- Secondary IDsABR NL 19389.042.08
- Public TitleTendinopathy Of Patella Groningen Amsterdam Maastricht ESWT study
- Scientific TitleEffectiveness of Extracorporeal Shockwave Therapy in Jumping Athletes with Patellar Tendinopathy’
- ACRONYMTOPGAME-study
- hypothesisESWT treatment leads to pain reduction and improvement of kneefunction in athletes with patellar tendinopathy
- Healt Condition(s) or Problem(s) studiedPatellar tendinopathy, Jumper's knee, Shockwave therapy
- Inclusion criteriaMale and female athletes with the following criteria are eligible for inclusion:
1. History of knee pain in patellar tendon or its patellar or tibial insertion (pointed out in a anatomical drawing of the knee) in connection with training and competition
2. Symptoms for over three months in the actual season or in the second half of the previous season (January – May 2008) (to exclude acute inflammatory tendon problems and de novo partial ruptures)
3. Age 18-35 years old (to reduce the chance of other osteochondrotic diseases like Sinding-Larsen-Johanson, Osgood-Schlatter and osteoarthrosis)
4. Palpation tenderness to the corresponding painful area
5. VISA score < 80
- Exclusion criteria1. Acute knee or patellar tendon injuries
2. Chronic joint diseases
3. Signs or symptoms of other coexisting knee pathology
4. Contraindications for ESWT (pregnancy, malignancy, coagulopathy)
5. Knee surgery or injection therapy with corticosteroids in the last preceding three months
6. 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 22-sep-2008
- planned closingdate1-jul-2009
- Target number of participants60
- InterventionsExtracorporeal shockwave therapy
- Primary outcomeVISA-score
- Secondary outcome• Answer to the question: “How is your knee now as compared with before treatment?”, by marking an 11-point visual numerical scale, with +5 representing maximum improvement (no symptoms), 0 representing no change, and –5 representing maximum worsening (severe symptoms)
• Rate the pain on a Visual Analogue Scale (VAS) in which 0 represents no pain, and 100 maximal pain:
- during activities of daily living (ADL),
- during sports,
- 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 (20, 24).
- during a jumping test: the athlete performs ten maximal jumps
• Rate overall treatment satisfaction, with use of a 4-grade scale as “no symptoms”, improved, but still symptomatic”, “no change”, “worse”.
• Answer the question if they would recommend ESWT treatment to family or friends; “yes” or “no”.
• Ultrasound characteristics (hypo-echogenity, diameter, calcifications, neovascularisation)
• Side effects and adverse reactions/events
- Timepoints- pretreatment
- 1 week post treatment
- 3 months post treatment
- 6 months post treatment
- Trial web sitehttp:/www.topgamestudie.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES J. Zwerver
- CONTACT for SCIENTIFIC QUERIES J. Zwerver
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsNo Effect of Extracorporeal Shockwave Therapy on Patellar Tendinopathy in Jumping Athletes During the Competitive Season. Johannes Zwerver,*y MD, PhD, Fred Hartgens,z MD, PT, PhD, Evert Verhagen,§ PhD, Henk van der Worp,y MSc, Inge van den Akker-Scheek,y PhD, and Ron L. Diercks,y MD, PhD. AJSM PreView, published on February 1, 2011 as doi:10.1177/0363546510395492.
- Brief summaryRationale:
Patellar tendinopathy is a common overuse injury that often has a major impact on the knee function and even the career of jumping athletes. There is no consensus about the most appropriate treatment but Extracorporeal ShockWave Therapy (ESWT) appears to be a promising treatment. Until now its effectiveness has only been studied in patients with chronic recalcitrant patellar tendinopathy.

Objective:
Aim of this study is to determine the effectiveness of ESWT on pain, symptoms and function, in athletes with patellar tendinopathy (in an early stage of the disease) who are still able to train and compete.

Study design:
Double blinded, randomized controlled study using a 2 group repeated measures design with a treatment period of 2 weeks and a 6 month follow-up

Study population:
Volleyball and basketball players with (early stage) patellar tendinopathy, 18-35 yr old

Intervention:
One group will receive three ESWT treatments at a weekly interval, the other group will receive three placebo ESWT treatments at a weekly interval

Main study parameters/endpoints:
Change in VISA score. The VISA 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.
- Main changes (audit trail)29-jun-09: Changed target number of participants. Original number was 86 this is changed to 60.
- RECORD15-aug-2008 - 26-feb-2011


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