title: Lidocaine 5% patch: an open-label naturalistic chronic pain treatment trial and prediction of response.
abstract: OBJECTIVE
  There have been a few open-label nonplacebo reports on the successful use of lidocaine 5% patch (L5P) for other types of pain besides postherpetic neuralgia, such as chronic low back pain. With the these reports, we began to utilize L5P routinely for chronic pain patients (CPPs) with various pain diagnoses. The purpose of this report was to describe the results of a retrospective review of this open-label naturalistic L5P chronic pain treatment trial and to attempt to delineate predictors of perceived clinical response.
  
  
  METHODS
  Consecutive CPPs were selected for this clinical trial according to the following inclusion criteria: the CPPs with pain greater than 6-month duration and either a hyperalgesic pain area or trigger point, which could be covered by one L5P, were offered a 3-day L5P naturalistic treatment trial. The purpose of this trial was to determine which CPPs would perceive improvement and continue using L5P. CPPs entering the trial completed the neuropathic pain scale (NPS) at entrance and completion of the trial. The senior author also completed a baseline information tool on each CPP entering this naturalistic trial. At the completion of the 3-day trial, the CPPs were asked if they perceived pain improvement with the use of L5P. In the retrospective review, the CPPs were thus segregated into two groups, those with and without perceived clinical improvement, and were statistically compared for available clinical variables. Logistic regression was then utilized to determine which significant independent variables contributed to the correct prediction of perceived improvement.
  
  
  METHODS
  Multidisciplinary pain facility.
  
  
  METHODS
  Patients with chronic pain.
  
  
  RESULTS
  Of 362 consecutive CPPs, 114 or 31.5% were deemed candidates for this naturalistic trial. None of the CPPs refused or fulfilled exclusion criteria eliminating them from the trial. The total sample (N = 114) showed statistical improvement on all 10 NPS scales (except scales 4 and 6) plus the NPS 4, NPS nonallodynic 8, and NPS 10. The perceived clinically improved group (N = 87, 76.3% of those entering the trial), also showed perceived improvement on all preceding scales except 4 and 6. The perceived clinically nonimproved group (N = 27, 23.7% of those entering the trial) showed statistical improvement on scales B and NPS 10. Perceived improvement was predicted by the following variables: pain wakes patient up, patch placement not low back, and not in litigation. These variables explained 9.8%, 20%, and 14% of the variance, respectively. Overall, 44.5% of the variance was explained.
  
  
  CONCLUSIONS
  A significant percentage of CPPs exposed to an L5P 3-day naturalistic trial perceived clinical improvement. However, this can only be concluded as an initial effect, and whether or not this effect is attributable to L5P cannot be derived from our data as the effect could have been nonspecific. The apparent CPP perceived clinical improvement was not associated with any particular useful clinical indicator. As such, at present, no variable can be recommended for use in selecting CPPs for such a naturalistic L5P clinical treatment trial. However, this study indicates that such a trial can be useful in selecting CPPs who may perceive benefit from L5P.
authors.affiliation: Department of Psychiatry, University of Miami School of Medicine, 1400 NW 10th Avenue, D-79, Florida 33136, USA. d.fishbain@med.miami.edu
authors.forename: David A
authors.initials: DA
authors.lastname: Fishbain
authors.forename: John E
authors.initials: JE
authors.lastname: Lewis
authors.forename: Brandly
authors.initials: B
authors.lastname: Cole
authors.forename: Brian
authors.initials: B
authors.lastname: Cutler
authors.forename: Hubert L
authors.initials: HL
authors.lastname: Rosomoff
authors.forename: R Steele
authors.initials: RS
authors.lastname: Rosomoff
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000779:Anesthetics, Local / Q000008:administration & dosage; D002908:Chronic Disease / Q000188:drug therapy; D005260:Female; D006801:Humans; D008012:Lidocaine / Q000008:administration & dosage*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D018710:Pain Clinics; D010147:Pain Measurement; D017288:Pain Threshold / Q000187:drug effects / Q000502:physiology; D010148:Intractable Pain / Q000188:drug therapy*; D011237:Predictive Value of Tests; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000779:Anesthetics, Local; D008012:Lidocaine