No registrations found.
ID
Source
Brief title
Health condition
Patellar tendinopathy, Jumper's knee, Shockwave therapy
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
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.
Study objective
N/A
Study design
1. Pretreatment;
2. 1 week post treatment;
3. 4 weeks post treatment;
4. 7 weeks post treatment;
5. 12 weeks post treatment.
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.
H. Worp, van der
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 3613366
h.van.der.worp@sport.umcg.nl
H. Worp, van der
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 3613366
h.van.der.worp@sport.umcg.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2646 |
| NTR-old | NTR2774 |
| CCMO | NL30637.042.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON34962 |