Wirksamkeit der Extrakorporalen Stoßwellentherapie in der Behandlung der konservativ therapieresistenten Fasziitis plantaris. -Eine prospektive, randomisierte, kontrollierte, einfach blinde Multicenterstudie
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Philipps-Universität Marburg
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Abstract
Symptomatic heel spur is a common orthopedical
syndrome. In only few cases it needs differential diagnosis by
imaging methods. The aim of therapy is to treat the symptom,
not the spur. In the beginning conservative therapy modalities
(including corticoid injections) should be applied. Due to
risks the release of the fascia surgery is chosen as ultima
ratio. ESWT should be applied if conservative treatment fails
before surgery is performed. ESWT developed from ESWL in 1991
to treat peusoarthrosis. During the years positive effects in
treatment of calcaneous tendinitis, lateral epicondylopathy and
heel spur were seen. The treatment?s of insertional
tendinopathies was hyperstimulation (Melzak). Soft tissue
calcifications and bony non unions were treated with the idea
of mechanical alterations. According to basic research of the
early 2000th neurotransmitter release induced by ESWT is
thought to have major effects in all indications. Shock wave
application causes tissue damage. In clinical application only
minor and reversible side effects could be detected. In 1995
first results of ESWT in plantar fasciitis were published
followed by the first RCT in 1996. The Marburger multicenter
trial was planned in 1997 to show safety and effectiveness of
ESWT according to the criteria of EBM. Main criteria (Roles and
Maudsley Score) and side criteria (VAS pain scale and walking
distance) were investigated before treatment, at 6 weeks, 3 and
12 months follow up. In addition MRT investigation was
performed before and at 3 month follow up. Analgetics
consumption was checked through the follow up period. This
study presents the results of the Orthopaedic Clinic of Kassel
and discusses them in context of latest developments. The check
of drop outs and blindings showed satisfactory results. The
randomisation was unsatisfactory when it comes to pain
intensity and duration of symptoms. Although the consumption of
analgetics was listed as an exclusion criteria, it was not
consequently followed. The analysis of the analgetics
consumption showed that this was uncontrollable. There was no
effect measured after 6 weeks. After 3 month follow up the main
criteria improved significantly in both groups. After 12 months
follow up all tested criteria improved. Most of the patients
had no more pain. The results of the placebo group were
superior due to a lack of randomisation, the effectiveness of
ESWT could not be verified. The changes in MRT did not
correlate with the changes in patients? symptoms. Significance
and pathogenesis of bone marrow edema remain unclear. ESWT as
applied in this study shows only a few minor side effects.
There was no difference in outcome compared to the untreated
control group. Both groups had good results. The results of
placebo ESWT at 12 month follow up does hardly differ from
results achieved by surgery, which questions the effectiveness
of the fascia surgery. Patients should be informed about risks,
optimal conservative treatment and a high spontaneous healing
rate. Each center showed different success rates or even
contradicting results compared to the whole population, small
collectives should not be evaluated with effort. Due to the
great differences in sample size, main criteria and statistic
analysis different published RCTs can hardly be compared. A
possible negative influence of the use of local anaesthetics
(dilution of neurotransmitter, inhibited hyperstimulation)
should be considered. The prohibition of analgetic consumption
is not reasonable. A differenciated documentation of analgetics
is the better solution. The score of Roles and Maudsley cannot
reflect the patients? pain therefore is unsuitable to show the
effectiveness of ESWT. The patients? experience wasn?t
evaluated. The value of EBM classification has to be discussed
controversly. Level III studies for syndromes without
spontaneous healing appear reasonable. In diseases with a
spontaneous healing rate we need placebo controlled trials to
verify the therapeutic effect. The past showed that results of
uncontrolled trials may lead to expensive and inconsiderate
developments.
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Dates
Created: 2003Issued: 2004-01-14Updated: 2011-08-10
Faculty
Medizin
Publisher
Philipps-Universität Marburg
Language
ger
Data types
DoctoralThesis
Keywords
NMRsymptomatic heel spur , RCTEBMMRTsymptomatischer FersenspornESWTESWTRCTEBM
DFG-subjects
Extrakorporale Stoßwellenlithotripsie , NMR-Tomographie
DDC-Numbers
610
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Nolte, Gabriele (110124391): Wirksamkeit der Extrakorporalen Stoßwellentherapie in der Behandlung der konservativ therapieresistenten Fasziitis plantaris. -Eine prospektive, randomisierte, kontrollierte, einfach blinde Multicenterstudie. : Philipps-Universität Marburg 2004-01-14. DOI: https://doi.org/10.17192/z2004.0005.
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This item has been published with the following license: In Copyright