title: [Randomised pilot study for quantification of benefit from the patient's point of view of deep oscillation treatment in primary wound healing].
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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors: Institut für Medizinische Biometrie und Epidemiologie (IMBE), Universität Witten/Herdecke, Fakultät für Gesundheit, Witten.
authors: J
authors: J
authors: Reinhold
authors: Molecular Biology, Russian State Medical University, Moscow, Russian Federation.
authors: I
authors: I
authors: Deeva
authors: Molecular Biology, Russian State Medical University, Moscow, Russian Federation.
authors: L
authors: L
authors: Korkina
authors: Institut für Medizinische Biometrie und Epidemiologie (IMBE), Universität Witten/Herdecke, Fakultät für Gesundheit, Witten.
authors: K
authors: K
authors: Schaper
authors: Institut für Medizinische Biometrie und Epidemiologie (IMBE), Universität Witten/Herdecke, Fakultät für Gesundheit, Witten.
authors: F
authors: F
authors: Krummenauer
mesh_terms: D000328:Adult; D003131:Combined Modality Therapy / Q000379:methods; D059026:Diagnostic Self Evaluation; D004599:Electric Stimulation Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008405:Massage / Q000379:methods*; D010147:Pain Measurement; D010149:Postoperative Pain / Q000175:diagnosis* / Q000209:etiology / Q000517:prevention & control*; D017060:Patient Satisfaction; D010865:Pilot Projects; D016896:Treatment Outcome; D014945:Wound Healing; D055815:Young Adult