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Effect of shockwave therapy on patellar tendon structure


- candidate number21782
- NTR NumberNTR5088
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-mrt-2015
- Secondary IDsNL50792.042.14 
- Public TitleEffect of shockwave therapy on patellar tendon structure
- Scientific TitleEffect of focused and radial shockwave therapy on the tendon structure of the patellar tendon in treating patellar tendinopathy patients and healthy tendons.
- ACRONYMTOPSHOCK-UTC study
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedPatellar tendinopathy, Jumper's knee
- Inclusion criteriaMale and female subjects with the following criteria are eligible for inclusion in patellar tendinopathy (PT) subject group:
• History of knee pain in patellar tendon or its patellar or tibial insertion in connection with training and competition
• Symptoms for over three months (to exclude acute inflammatory tendon problems and de novo partial ruptures)
• Age 18-45 years old (to reduce the chance of other osteochondrotic diseases like Sinding-Larsen-Johanson, Osgood-Schlatter and osteoarthrosis)
• Palpation tenderness to the corresponding painful area
• Degenerative tendon changes determined by a regular ultrasound echo
• VISA-P score < 80

Male and female subjects with the following criteria are eligible for inclusion in healthy subject group: • Age 18-45 years old
• VISA-P score of 95 or higher
- Exclusion criteriaSubjects must not be included in the PT subjects group if one of the following applies:
• acute knee or patellar tendon injuries
• chronic knee joint diseases
• signs or symptoms of other coexisting knee pathology
• contraindications for SWT (pregnancy, malignancy, coagulopathy)
• knee surgery or injection therapy with corticosteroids in the last preceding three months
• 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
• Allergy or intolerance for paracetamol

Subjects must not be included in the healthy subjects group if one of the following applies:
• acute knee or patellar tendon injuries
• history of patellar tendinopathy
• chronic knee joint diseases
• contraindications for SWT (pregnancy, malignancy, coagulopathy)
• 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
• Allergy or intolerance for paracetamol
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 13-feb-2015
- planned closingdate1-jun-2016
- Target number of participants60
- InterventionsPatients and subjects receive three sessions of either focused shockwave therapy (FSWT) or radial shockwave therapy (RSWT) with an one week interval. Patellar tendinopathy patient receive shockwave therapy in combination with eccentric decline squat training.
- Primary outcometendon structure as determined with ultrasonographic tissue characterisation (UTC)(expressed in echo type percentages)
- Secondary outcome• Self reported VISA-P score.
The 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.
• Pain on a Visual Analogue Scale (VAS) in which 0 represents no pain, and 100 maximal pain:
o during rest
o during activities of daily living (ADL),
o during sports
o during a functional test: the single leg decline squat (SLDS); the athlete performs one time a single leg squat to 60° of knee flexion on a 25° decline board. This test was designed to preferentially load the patellar tendon.
o during a functional test: the single leg decline squat (SLDS) ten times; 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.
• Perceived improvement, determined with use of a 4-grade scale as “no symptoms”, “improved, but still symptomatic”, “no change”, “worse”.
• Side effects and adverse reactions/events
- Timepoints1. Before and after first treatment (healthy and PT group)
2. Before and after second treatment (healthy and PT group)
3. Before and after third treatment (healthy and PT group)
4. 1 week after final treatment (healthy and PT group
5. 6 weeks after final treatment (PT group only)
6. 12 weeks after final treatment (PT group only)
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESPhD. I. Akker-Scheek, van den
- CONTACT for SCIENTIFIC QUERIESPhD. I. Akker-Scheek, van den
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG), Fyzzio
- PublicationsN/A
- Brief summaryRelevance:
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. FSWT and RSWT 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.
However, it remains unknown what effect FSWT and RSWT have on the tendon structure. To better understand the effect of FSWT and RSWT, it is important to evaluate the effect on the tendon structure in healthy subjects and patients with patellar tendinopathy.

Objective:
The aim of the study is to evaluate the effect of FSWT and RSWT on the tendon structure in healthy subjects and in patients with patellar tendinopathy.

Study design:
A randomized controlled pilot study using a 4 group repeated measures design. Groups are divided in FSWT group with PT patients (N=15), FSWT group with healthy subjects (N=15), RSWT group with PT patients (N=15) and RSWT group with healthy subjects (N=15). A shockwave treatment period of 2 weeks (3 treatments with a 1 week interval) will be applied and a 12 week follow-up with exercise therapy for PT patients only. Results are analyzed with a multilevel analysis

Main study parameter:
Tendon structure in echotype percentages determined by UTC.
- Main changes (audit trail)
- RECORD10-mrt-2015 - 25-apr-2015


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