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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49833

Enrollment

Registered

2019-07-08

Start date

2019-07-09

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(Achillespees) tendinopathieën Achilles tendon pain Tendinopathy

Interventions

Shockwave treatment is a non-invasive treatment method that is effective for treating pain and improving function in mid-portion Achilles tendinopathy. The subjects are treated with shockwave a total

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)