Wirksamkeit der Extrakorporalen Stoßwellentherapie in der Behandlung der konservativ therapieresistenten Fasziitis plantaris. -Eine prospektive, randomisierte, kontrollierte, einfach blinde Multicenterstudie
Der symptomatische Fersensporn ist ein häufiges orthopädisches Krankheitsbild. Seine charakteristische Klinik erfordert nur in wenigen Fällen eine bildgebende Differentialdiagnostik. Nicht der Sporn selbst, sondern der Schmerz, ist Gegenstand der Therapie. Das konservative Vorgehen...
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- 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.