title: Effectiveness and cost-effectiveness analysis of neuroreflexotherapy for subacute and chronic low back pain in routine general practice: a cluster randomized, controlled trial.
abstract: METHODS
  A cluster randomized, controlled trial was performed.
  
  
  OBJECTIVE
  To assess the clinical effectiveness and cost-effectiveness of adding patients' referral to neuroreflexotherapy intervention to the usual management of subacute and chronic low back pain in routine general practice.
  
  
  BACKGROUND
  Neuroreflexotherapy consists of the temporary implantation of epidermal devices in trigger points in the back and referred tender points in the ear. The efficacy of this procedure for treating subacute and chronic low back pain has been demonstrated in previous randomized, double-blind, controlled clinical trials.
  
  
  METHODS
  Twenty-one primary care physicians working in seven primary care centers of the Spanish National Health Service in Palma de Mallorca, Spain, were randomly assigned to the intervention group (n = 11) or the control group (n = 10). The physicians recruited patients who had low back pain that had lasted for 14 or more days despite drug treatment and who did not meet criteria for surgery. The 45 patients recruited by physicians from the control group were treated according to the standard protocol, whereas the 59 patients recruited by physicians from the intervention group were, in addition, referred to neuroreflexotherapy intervention. The analysis of variables was performed taking into account that physicians, not patients, were randomly assigned.
  
  
  RESULTS
  Patients underwent clinical evaluations at baseline and 15, 60, and 365 days later. At baseline, median intensity of pain was higher in patients undergoing neuroreflexotherapy than in control patients (visual analogue scale, 6.07; range, 4.67-8.80 vs. 5.15, range 4.11-8.00) and median duration of pain was also higher (48.1, range 28.4-211.1 vs. 17.5, range 15.0-91.5 days). At the last follow-up visit, patients treated with neuroreflexotherapy showed greater improvement than did control patients in low back pain (visual analogue scale, 5.5; range, 3.7-8.8 vs. 1.9; range, -1.2-3.0; P < 0.001); referred pain (visual analogue scale, 3.6; range, 2.7-7.3 vs. 0.6; range, -1.5-2.0; P = 0.001); and disability (Roland-Morris scale, 8.7; range, 2.0-13.3 vs. 2.0; range, -1.5-6.7; P = 0.007). Moreover, neuroreflexotherapy intervention was associated with a significantly (P < 0.035) lower number of consultations to private or public specialists, fewer indications of radiographs by primary care physicians, lower cost of drug treatment, and less duration of sick leave throughout the follow-up period. There were also differences in favor of neuroreflexotherapy intervention in the cost-effectiveness ratio for pain, disability, and quality of life that persisted in the most optimistic, the most conservative, and the average (break-even case) assumptions.
  
  
  CONCLUSIONS
  Referral to neuroreflexotherapy intervention improves the effectiveness and cost-effectiveness of the management of nonspecific low back pain.
authors.affiliation: Departamento Científico, Fundación Kovacs, Unidad de Investigación, Gerencia de Atención Primaria, INSALUD Balears, Palma de Mallorca, Spain. kovacs@kovacs.org
authors.forename: Francisco M
authors.initials: FM
authors.lastname: Kovacs
authors.forename: Joan
authors.initials: J
authors.lastname: Llobera
authors.forename: Victor
authors.initials: V
authors.lastname: Abraira
authors.forename: Pablo
authors.initials: P
authors.lastname: Lázaro
authors.forename: Francisco
authors.initials: F
authors.lastname: Pozo
authors.forename: David
authors.initials: D
authors.lastname: Kleinbaum
mesh_terms: D000208:Acute Disease; D000328:Adult; D002908:Chronic Disease; D003362:Cost-Benefit Analysis; D019468:Disease Management; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017116:Low Back Pain / Q000150:complications / Q000191:economics* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009209:Myofascial Pain Syndromes / Q000150:complications / Q000601:surgery; D010146:Pain / Q000209:etiology; D059408:Pain Management; D010147:Pain Measurement; D012028:Reflexotherapy / Q000009:adverse effects / Q000191:economics*; D016896:Treatment Outcome