title: Focal muscle vibration in the treatment of upper limb spasticity: a pilot randomized controlled trial in patients with chronic stroke.
abstract: OBJECTIVE
  To examine the clinical effect of repetitive focal muscle vibration (rMV) on the motor function of the upper extremity 1 month after treatment in patients with chronic stroke.
  
  
  METHODS
  We performed a pilot randomized controlled trial using a double-blind, parallel-group study design.
  
  
  METHODS
  Medical center.
  
  
  METHODS
  Patients with chronic stroke (N=49).
  
  
  METHODS
  Patients randomly assigned to the study group (SG) received rMV, while patients in the control group (CG) received a placebo vibratory treatment. The patients and the clinical examiner were blind to the intervention.
  
  
  METHODS
  The primary endpoint was an improvement of more than .37 points on the Functional Ability Scale of the Wolf Motor Function Test (WMFT FAS). The Modified Ashworth Scale and the visual analog scale were the secondary outcome measures. All measures were administered before the treatment (t0) and 1 week (t1) and 1 month (t2) after the treatment.
  
  
  RESULTS
  Twenty-eight patients were allocated to the SG and 21 to the CG. The analysis of variance for repeated measurements revealed a significant difference in the expression of the WMFT FAS score over time only in the SG (P=.006). The treatment was successful for 7 (33%) of 21 patients recruited in the SG and for 2 (13%) of 15 patients recruited in the CG. The relative risk was 2.5 (95% confidence interval, .60-10.39), and the number needed to treat was 5. The Wilcoxon test showed a statistically significant difference between t0 and t2 in the SG (P=.02). No adverse event was observed in the 2 groups.
  
  
  CONCLUSIONS
  Our results suggest that rMV treatment of the upper limb may improve the functional ability of chronic stroke patients, but a larger, multicenter, randomized controlled study is needed.
authors.affiliation: Institute of Neurology, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Caliandro
authors.forename: Claudia
authors.initials: C
authors.lastname: Celletti
authors.forename: Luca
authors.initials: L
authors.lastname: Padua
authors.forename: Ileana
authors.initials: I
authors.lastname: Minciotti
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Russo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Granata
authors.forename: Giuseppe
authors.initials: G
authors.lastname: La Torre
authors.forename: Enrico
authors.initials: E
authors.lastname: Granieri
authors.forename: Filippo
authors.initials: F
authors.lastname: Camerota
mesh_terms: D000328:Adult; D000368:Aged; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000534:rehabilitation*; D026741:Physical Therapy Modalities; D010865:Pilot Projects; D000071939:Stroke Rehabilitation; D034941:Upper Extremity; D014732:Vibration / Q000627:therapeutic use*