Does extracorporal shockwave therapy result in short term improvement of tendon structure in symptomatic midportion Achilles tendinopathy? An ultrasound tissue characterisation study

Completed

Conditions: (Achillespees) tendinopathieën
Achilles tendon pain
Tendinopathy
10043237

Registration Number: NL-OMON49833

Lead Sponsor: Koninklijke Landmacht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1. mid-portion Achilles tendon pain for more than two months, whereby the
complaints are of such a nature that a doctor is visited due to pain or
functional discomfort
2. active military personnel

Exclusion Criteria

1. prior Achilles tendon surgery
2. insertional (in stead of mid-portion related) symptoms
3. signs of a Complete Achilles tendon rupture
4. use of specific medications: statins, fluorquinolones or corticosteroids
5. individuals suffering from specific diseases: rheumatoid arthritis, diabetes
mellitus, psoriasis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>(1) The primary outcome measure is the quantitative improvement / change of<br /><br>Achilles tendon structure.<br /><br>This is objectified with Ultrasound Tissue Characterization (UTC).<br /><br><br /><br>UTC is a variant of ultrasound, in which a validated algorithm analyzes the<br /><br>three-dimensional stability of the echo pattern over several, successive, axial<br /><br>grayscale images. The echotypes vary from organized matrix (echotypes I and II)<br /><br>to disorganized matrix (echotypes III and IV):<br /><br>- Echotype I: (green colored) very stable; intact and aligned tendon bundles<br /><br>- Echotype II: (blue colored) moderately stable: discontinuous or more wavy<br /><br>tendon bundles<br /><br>- Echotype III: (red colored) high variability: fibrilar matrix<br /><br>- Echotype IV: (black colored) constant low intensity and variable<br /><br>distribution: complete disintegration of the matrix; amorphous tissue and<br /><br>fluid.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(2) Pain is expressed in a numeric rating scale (NRS), 0: no pain - 10:<br /><br>worst pain ever.<br /><br>(3) The severity of the mid-portion Achilles tendinopathy is objectified with<br /><br>the VISA-A questionnaire (results range from 0-100, where 100 equals a perfect<br /><br>asymptomatic score (Robinson et al., 2001).<br /><br>(4) The patient's opinion on recovery is made clear with the help of the Global<br /><br>Experienced Effect Score (GEE, 0: much better - 7: very much worse) (Hudak<br /><br>& Wright, 2000).</p><br>