|- candidate number||9152|
|- NTR Number||NTR2774|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-feb-2011|
|- Secondary IDs||NL30637.42.09 ABR|
|- Public Title||Tendinopathy Of Patella Shockwave study.|
|- Scientific Title||Effectiveness of Radial Shockwave Therapy compared to Focused Shockwave Therapy for treating patellar tendinopathy.|
|- Healt Condition(s) or Problem(s) studied||Patellar tendinopathy, Jumper's knee, Shockwave therapy|
|- Inclusion criteria||Male and female subjects with the following criteria are eligible for inclusion:|
1. History of knee pain in patellar tendon or its patellar or tibial insertion in connection with training and competition;
2. Symptoms for over three months (to exclude acute inflammatory tendon problems and de novo partial ruptures);
3. Age 18-50 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 criteria||Subjects must not be included if one of the following applies:|
1. Acute knee or patellar tendon injuries;
2. Chronic joint diseases (including osteoartrosis);
3. Signs or symptoms of other coexisting knee pathology;
4. Contraindications for SWT (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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2010|
|- planned closingdate||1-mrt-2012|
|- Target number of participants||56|
|- Interventions||Patients receive three sessions of either focused shockwave therapy or radial shockwave therapy with a one week interval, both in combination with eccentric decline squat training.|
|- Primary outcome||VISA-P score.|
|- Secondary outcome||1. Rate the pain on a Visual Analogue Scale (VAS) in which 0 represents no pain, and 100 maximal pain:|
A. During activities of daily living (ADL);
B. During sports;
C. 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.
2. Rate overall treatment satisfaction, with use of a 4-grade scale as “no symptoms”, improved, but still symptomatic”, “no change”, “worse”;
3. Side effects and adverse reactions/events.
|- Timepoints||1. Pretreatment;|
2. 1 week post treatment;
3. 4 weeks post treatment;
4. 7 weeks post treatment;
5. 12 weeks post treatment.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| H. Worp, van der|
|- CONTACT for SCIENTIFIC QUERIES|| H. Worp, van der|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG)|
|- Brief summary||Rationale: |
Patellar tendinopathy is a chronic overuse injury of the patellar tendon. Extracorporeal Shockwave Therapy is a relative new treatment modality for treating tendinopathies. Some years ago a new kind of shockwave therapy has been introduced: radial shockwave therapy that uses radial shockwaves. Studies that investigate the effectiveness of radial shockwave therapy as treatment for patellar tendinopathy are scarce.
The aim of this study is to compare the effectiveness of focussed shockwave therapy and radial shockwave therapy as treatment for patellar tendinopathy.
The TOPSHOCK study (Tendinopathy Of Patella SHOCKwave) is a two armed randomised controlled trial. The follow up period is 3 months.
Subjects with patellar tendinopathy who visit a sports medicine physician, 18-50 years old with symptoms for over 3 months.
Patients receive three sessions of either focused shockwave therapy or radial shockwave therapy with a one week interval, both in combination with eccentric decline squat training.
Main study parameter:
The main outcome measure is the Dutch VISA-P questionnaire, that asks for pain, function and sports participation in subjects with patellar tendinopathy.
|- Main changes (audit trail)|
|- RECORD||22-feb-2011 - 4-okt-2011|