This research is part of the evaluation of regular care.Primary objective:(1) to investigate whether 4 weekly shockwave treatments for soldiers with mid-portion Achilles tendon endopathy result in an improvement in Achilles tendon structure after 8…
ID
Source
Brief title
Condition
- Other condition
- Tendon, ligament and cartilage disorders
Synonym
Health condition
(Achillespees) tendinopathieën
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(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.
Secondary outcome
(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).
Background summary
Trainingsgeneeskunde & Trainingsfysiologie (TGTF) is the sports medical center
of the Royal Netherlands Army. With TGTF, shockwave treatment is part of the
regular care for soldiers who are referred with mid-portion Achilles
tendinopathy.
Mid-portion Achilles tendinopathy is a painful condition that occurs frequently
in physically highly active populations, including soldiers and athletes. The
condition is characterized morphologically mainly by tendon degeneration, and
can result in significant limitations in sport and employability. Shockwave
treatment has been shown to be effective for treating pain and function in
various chronic tendinopathies. Results from in vitro and in vivo studies
suggest that shockwave treatment promotes the regenerative properties of
tendinopathic Achilles tendons.
As far as we know, this phenomenon has not been quantitatively investigated in
a clinical setting.
We hypothesize that shockwave treatment improves the tendon structure of the
mid-portion of the Achilles tendons.
Study objective
This research is part of the evaluation of regular care.
Primary objective:
(1) to investigate whether 4 weekly shockwave treatments for soldiers with
mid-portion Achilles tendon endopathy result in an improvement in Achilles
tendon structure after 8 and 26 weeks.
Secondary objectives:
We also try to evaluate the effects of shock wave treatment on:
(2) pain
(3) the severity of the mid-portion Achilles tendonopathy
(4) the patient's opinion about the recovery
Study design
This is a prospective cohort study.
Intervention
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 of four times for four
consecutive weeks. 2000 shocks are distributed per treatment over the painful
area of the mid-portion of the affected Achilles tendon. Studies indicate that
the effectiveness of shockwave therapy appears to be dependent on intensity,
with the highest possible intensity appearing more effective in treating
mid-portion Achilles tendinopathy.
In this study, after the start of treatment, the intensity is quickly increased
to an intensity that the subject can tolerate during the treatment period of
approximately 4 minutes.
Study burden and risks
The risks of both diagnosis and intervention are minimal.
In addition to short-term redness of the skin, no adverse reactions have been
reported in the literature from shockwave treatment for mid-portion Achilles
tendinopathy.
Making a UTC scan is also safe. UTC falls under ultrasound imaging, making no
use of ionizing radiation. There is therefore no radiation tax (RIVM) either.
Herculeslaan 1
Utrecht 3584AB
NL
Herculeslaan 1
Utrecht 3584AB
NL
Listed location countries
Age
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:
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69527.028.19 |