title: Blinding effectiveness and association of pretreatment expectations with pain improvement in a double-blind randomized controlled trial.
abstract: Patient, provider, and clinical investigator expectations concerning treatments are believed to play important roles in patient response. This study examined the association of patient and research nurse/physician pretreatment expectations of pain relief with actual pain relief, the accuracy of patient and research nurse guesses about patient medication assignment, and changes in research nurse and patient pain relief expectations over the course of a randomized double-blind trial of amitriptyline versus an active placebo for patients with chronic pain and spinal cord injuries (SCI). Patient expectations of pain relief with amitriptyline were associated significantly with actual pain decrease for patients in the amitriptyline, but not placebo, condition. Research nurse/physician expectations did not predict patient pain relief. Both patients and the research nurse were able to guess patient medication assignment at a rate significantly greater than chance. The research nurse's, but not the patients', expectations of pain relief with amitriptyline decreased significantly over the course of the study. These findings have implications for future randomized controlled trials. Fully double-blind conditions are very difficult to achieve, and it is informative to assess patient and research clinician expectations and guesses regarding medication assignment.
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Box 356560, University of Washington School of Medicine, Seattle, WA 98195-6560, USA. jturner@u.washington.edu
authors.forename: Judith A
authors.initials: JA
authors.lastname: Turner
authors.forename: Mark P
authors.initials: MP
authors.lastname: Jensen
authors.forename: Catherine A
authors.initials: CA
authors.lastname: Warms
authors.forename: Diana D
authors.initials: DD
authors.lastname: Cardenas
mesh_terms: D000328:Adult; D000639:Amitriptyline / Q000008:administration & dosage*; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage*; D001291:Attitude of Health Personnel; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000523:psychology*; D017060:Patient Satisfaction; D010820:Physicians; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D013041:Specialties, Nursing; D013119:Spinal Cord Injuries / Q000150:complications
chemical_list: D018712:Analgesics, Non-Narcotic; D000639:Amitriptyline