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Tendinopathy Of Patella Shockwave study.


- candidate number9152
- NTR NumberNTR2774
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-feb-2011
- Secondary IDsNL30637.42.09 ABR
- Public TitleTendinopathy Of Patella Shockwave study.
- Scientific TitleEffectiveness of Radial Shockwave Therapy compared to Focused Shockwave Therapy for treating patellar tendinopathy.
- ACRONYMTOPSHOCK-study
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedPatellar tendinopathy, Jumper's knee, Shockwave therapy
- Inclusion criteriaMale 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 criteriaSubjects 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2010
- planned closingdate1-mrt-2012
- Target number of participants56
- InterventionsPatients 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 outcomeVISA-P score.
- Secondary outcome1. 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.
- Timepoints1. Pretreatment;
2. 1 week post treatment;
3. 4 weeks post treatment;
4. 7 weeks post treatment;
5. 12 weeks post treatment.
- Trial web siteN/A
- statusinclusion 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)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryRationale:
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.

Objective:
The aim of this study is to compare the effectiveness of focussed shockwave therapy and radial shockwave therapy as treatment for patellar tendinopathy.

Study design:
The TOPSHOCK study (Tendinopathy Of Patella SHOCKwave) is a two armed randomised controlled trial. The follow up period is 3 months.

Study population:
Subjects with patellar tendinopathy who visit a sports medicine physician, 18-50 years old with symptoms for over 3 months.

Intervention:
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)
- RECORD22-feb-2011 - 4-okt-2011


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