title: A randomized controlled study to evaluate the efficacy of noninvasive limb cover for chronic phantom limb pain among veteran amputees.
abstract: OBJECTIVE
  To assess the efficacy of a noninvasive limb cover for treating chronic phantom limb pain (PLP).
  
  
  METHODS
  Randomized, double-blind, placebo-controlled trial.
  
  
  METHODS
  Outpatient clinic.
  
  
  METHODS
  We randomly assigned 57 subjects to 2 groups: true noninvasive limb cover (n=30) and sham noninvasive limb cover (n=27). Inclusion criteria included age of 18 years or greater, upper or lower extremity amputation with healed residual limb, and 3 or more episodes of PLP during the previous 6 weeks.
  
  
  METHODS
  Subjects received 2 true or sham noninvasive limb covers to be worn over the prosthesis and residual limbs 24 hours a day for 12 weeks.
  
  
  METHODS
  Primary outcome measure was the numerical pain rating scale of PLP level (0-10). Secondary outcomes included overall pain level (0-10), PLP frequency per week, and the Veterans RAND 12-Item Health Survey (VR-12). We collected data at baseline and at 6- and 12-week follow-up visits.
  
  
  RESULTS
  Demographic and clinical characteristics were not significantly different between groups. The true noninvasive limb cover group reported nonsignificant reductions in PLP from 5.9±1.9 at baseline to 3.9±1.7 at the 12-week follow-up. The sham noninvasive limb cover group also had nonsignificant reducations in PLP from 6.5±1.8 to 4.2±2.3. PLP did not differ significantly between the 2 groups at 6 weeks (mean difference, 0.8; 95% confidence interval [CI], -1.4 to 3) or at 12 weeks (mean difference, 0.2; 95% CI, -1.9 to 2.3). Similarly, overall pain level, PLP episodes per week, and VR-12 physical and mental health component scores did not differ between the 2 groups at 6 and 12 weeks.
  
  
  CONCLUSIONS
  A true noninvasive limb cover did not significantly decrease PLP levels or the frequency of PLP episodes per week, overall bodily pain levels, or VR-12 physical and mental health component scores compared with a sham noninvasive limb cover in our veteran amputee sample.
authors.affiliation: VA Long Beach Healthcare System, Long Beach, CA, USA. anfu.hsiao@va.gov
authors.forename: An-Fu
authors.initials: AF
authors.lastname: Hsiao
authors.forename: Robyn
authors.initials: R
authors.lastname: York
authors.forename: Ian
authors.initials: I
authors.lastname: Hsiao
authors.forename: Ed
authors.initials: E
authors.lastname: Hansen
authors.forename: Ron D
authors.initials: RD
authors.lastname: Hays
authors.forename: John
authors.initials: J
authors.lastname: Ives
authors.forename: Ian D
authors.initials: ID
authors.lastname: Coulter
mesh_terms: D000368:Aged; D000674:Amputees / Q000523:psychology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010591:Phantom Limb / Q000517:prevention & control* / Q000523:psychology*; D010919:Placebos; D011481:Protective Clothing; D016896:Treatment Outcome; D014481:United States; D014728:Veterans / Q000523:psychology*
chemical_list: D010919:Placebos