Multizentrische, randomisierte Studie zur Sicherheit und Wirksamkeit der Ganzkörper-Vibration als Add-on zur pharmakologischen Standard-Behandlung von Osteoporose bei Frauen nach der Menopause

Zusammenfassung

In der vorliegenden, multizentrischen, randomisierten cross-over Studie wurde die Wirkung von Ganzkörpervibration (WBV) auf Biomarker der Knochenresorption, das Sturzrisiko und die Schmerzen im unteren Rücken untersucht. Die Studie erstreckte sich über einen Zeitraum von 12 Wochen. Es wurden 58 Patientinnen mit postmenopausaler Osteoporose eingeschlossen, die mit Alendronat (n=41) oder Raloxifen (n=17) behandelt werden. Die Patientinnen wurden in 2 Gruppen randomisiert. Die erste Gruppe erhielt während des ersten 6-wöchigen Zeitraums der Studie (Periode I) WBV mit 3 Behandlungen pro Woche und mindestens 15 Behandlungen innerhalb von 6 Wochen. In den folgenden 6 Wochen (Periode II) erhielten die Patientinnen, die in Periode I nicht mit WBV behandelt wurden die Therapie und die andere Gruppe nicht mehr. Nach 3, 6, 9 und 12 Wochen wurden die Biomarker Ostase und DXP erfasst, das Sturzrisiko anhand des Tinetti-Tests „Tinetti Mobility Test“ (TMT) beurteilt und die Schmerzstärke im unteren Rückenbereich anhand der numerischen 11-Punkte-Skala ermittelt. Der statistischen Auswertung diente der Wilcoxon-Test (2-Perioden-Crossover-Analyse). Im Ergebnis stellte sich heraus, dass bezüglich der Biomarker des Knochenumbaus keine signifikante Wirkung der Vibrationstherapie (p=0,857 und 0,778) zu verzeichnen war. Im Gegensatz dazu war die Wirkung sowohl auf die Schmerzen im unteren Rücken (p=0,0049) und wie auch auf das Sturzrisiko (p=0,0023) hoch signifikant. WBV scheint eine wertvolle Ergänzung für die symptomatische Behandlung von Schmerzen im unteren Rücken und erhöhtem Sturzrisiko bei postmenopausalen Frauen mit Osteoporose zu sein.

Abstract

This 12 week, multicentered, randomized, cross-over study study investigated the effect of whole body vibration (WBV) on biomarkers of bone remodelling, fall risk and low back pain. Eligi­ble postmenopausal woman with osteoporosis (n=58) were stratified into those on treatment with alendronate (n=41) or raloxifene (n=17) and subsequently randomized to receive either WBV or no WBV during the first 6-week period of the study (period I). WBV was performed at three sessions per week with a minimum of 15 sessions within a period of 6 weeks. At 6 weeks after baseline, patients who were initially randomized to the WBV group were observed for another 6 weeks without receiving WBV in the second period (period II) of the study, whereas those who did not receive WBV in period I were now treated with WBV for the remaining 6 weeks. Treatment effects were evaluated at 3, 6, 9 and 12 weeks using the biomarkers for bone remodeling Ostase and DXP. Fall risk was evaluated by the “Tinetti Performance-Oriented Mobility Assessment”, also called the “Tinetti Mobility Test” (TMT) and low back pain was evaluated by an 11 point numerical scale. For the statistical evaluation, a 2-period crossover-analysis Wilcoxon test (2-sided test for difference) for sums, differences and crossover differences was performed. No significant treatment effects were seen for the biomarkers of bone remodelling (p=0.857 and 0.778). In contrast to this, effects on both low back pain (p=0.0049) and fall risk (p=0.0023) were highly significant. WBV appears to be a valuable addition for the symptomatic treatment of low back pain and fall risk in postmenopausal woman with osteoporosis.

Schlüsselwörter

Wirksamkeit - muskuloskeletale ­Erkrankungen - Outcomemessung - konservative Behandlung - Osteoporose - Vibration

Key words

effectiveness - musculoskeletal diseases - outcomes - conservative therapy - osteoporosis - whole-body-vibration

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