Randomisierte Pilotstudie zur Quantifizierung des patientenseitigen Nutzens der Beeinflussung primärer Wundheilungsprozesse durch Tiefenoszillation

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Abstract

BACKGROUND AND AIM OF THE INVESTIGATION: Deep oscillation refers to an electromechanical therapy method in which electrostatic attraction and friction, produced by the use of a hand-held applicator, create resonance vibrations in treated tissue. In a pilot clinical trial the impact of deep oscillation has been examined in relation to the physiological parameters of wound healing on postoperative wounds.

Material and methods: Following osteosynthesis operations (extremities and spinal column), 40 patients were stratified by operation localisation and randomised into two samples (intervention [n = 20], control [n = 20]). Aside from primary care of the operation wound, finding-oriented deep oscillation was applied for at least one week following the operation in the intervention sample. The intra-individual reduction in postoperative pain occurrence between day 2 and day 7 of the postsurgical period was quantified by means of a visual analogue scale (VAS) serving as primary clinical end point from the patient’s point of view. Confirmatory analysis of this primary endpoint was based on a two-sample Wilcoxon test at the 5 % level of significance.

Results: According to VAS pain occurrence declined in the intervention group from day 2 to day 7 in the postoperative period by a median of 3 points (P) (quartile range -4-0.25 P) and a mean of -2.3 P, the control group remained (almost) unaltered with a median difference of 0 P (-2-0 P) and a mean difference of -0.85 P; the treatment groups differed significantly in the postoperative profile of VAS-based pain sensation (Wilcoxon p = 0.006). None of the secondary endpoints showed any locally significant sample differences.

Discussion: These results demonstrate a significant pain-alleviating effect of deep oscillation. However, the exact physiological effects underpinning the impact of deep oscillation are still not completely understood.

Reinhold J., Deeva I., Korkina L., Schaper K., Krummenauer F. (2014): Randomisierte Pilotstudie zur Quantifizierung des patientenseitigen Nutzens der Beeinflussung primärer Wundheilungsprozesse durch Tiefenoszillation. Z Orthop Unfall 152(3), 260-264.
English title: Randomised Pilot Study for Quantification of Benefit from the Patient’s Point of View of Deep Oscillation Treatment in Primary Wound Healing.