BACKGROUND AND PURPOSE: We conducted a prospective randomized study of patients with acute low back pain and/or radiculopathy to assess the effect of knowledge of diagnostic findings on clinical outcome. The practice of ordering spinal imaging, perhaps unintentionally, includes a large number of patients for whom the imaging test is performed for purposes of reassurance or because of patient expectations. If this rationale is valid, one would expect to see a measurable effect from diagnostic information, per se. MATERIALS AND METHODS: A total of 246 patients with acute (<3 weeks) low back pain (LBP) and/or radiculopathy (150 LBP and 96 radiculopathy patients) were recruited. Patients were randomized using a stratified block design with equal allocation to either the unblinded group (MR imaging results provided within 48 hours) or the blinded group (both patient and physician blinded to MR imaging results.) After the initial MR imaging, patients followed 6 weeks of conservative management. Roland function, visual pain analog, absenteeism, Short Form (SF)-36 Health Status Survey, self-efficacy scores, andFear Avoidance Questionnaire were completed at presentation; 2, 4, 6, and 8 weeks; and 6, 12, and 24 months. Improvement of Roland score by 50% or more and patient satisfaction assessed by Cherkin symptom satisfaction measure were considered a positive outcome. RESULTS: Clinical outcome at 6 weeks was similar for unblinded and blinded patients. Self-efficacy, fear avoidance beliefs, and the SF-36 subscales were similar over time for blinded and unblinded patients, except for the general health subscale on the SF-36. General health of the blinded group improved more than for the unblinded group (P = .008). CONCLUSIONS: Patient knowledge of imaging findings do not alter outcome and are associated with a lesser sense of well-being.
RCT Entities:
BACKGROUND AND PURPOSE: We conducted a prospective randomized study of patients with acute low back pain and/or radiculopathy to assess the effect of knowledge of diagnostic findings on clinical outcome. The practice of ordering spinal imaging, perhaps unintentionally, includes a large number of patients for whom the imaging test is performed for purposes of reassurance or because of patient expectations. If this rationale is valid, one would expect to see a measurable effect from diagnostic information, per se. MATERIALS AND METHODS: A total of 246 patients with acute (<3 weeks) low back pain (LBP) and/or radiculopathy (150 LBP and 96 radiculopathypatients) were recruited. Patients were randomized using a stratified block design with equal allocation to either the unblinded group (MR imaging results provided within 48 hours) or the blinded group (both patient and physician blinded to MR imaging results.) After the initial MR imaging, patients followed 6 weeks of conservative management. Roland function, visual pain analog, absenteeism, Short Form (SF)-36 Health Status Survey, self-efficacy scores, and Fear Avoidance Questionnaire were completed at presentation; 2, 4, 6, and 8 weeks; and 6, 12, and 24 months. Improvement of Roland score by 50% or more and patient satisfaction assessed by Cherkin symptom satisfaction measure were considered a positive outcome. RESULTS: Clinical outcome at 6 weeks was similar for unblinded and blinded patients. Self-efficacy, fear avoidance beliefs, and the SF-36 subscales were similar over time for blinded and unblinded patients, except for the general health subscale on the SF-36. General health of the blinded group improved more than for the unblinded group (P = .008). CONCLUSIONS:Patient knowledge of imaging findings do not alter outcome and are associated with a lesser sense of well-being.
Authors: Jeffrey G Jarvik; William Hollingworth; Brook Martin; Scott S Emerson; Darryl T Gray; Steven Overman; David Robinson; Thomas Staiger; Frank Wessbecher; Sean D Sullivan; William Kreuter; Richard A Deyo Journal: JAMA Date: 2003-06-04 Impact factor: 56.272
Authors: Merel Wassenaar; Rogier M van Rijn; Maurits W van Tulder; Arianne P Verhagen; Danielle A W M van der Windt; Bart W Koes; Michiel R de Boer; Abida Z Ginai; Raymond W J G Ostelo Journal: Eur Spine J Date: 2011-09-16 Impact factor: 3.134
Authors: Hazel J Jenkins; Mark J Hancock; Simon D French; Chris G Maher; Roger M Engel; John S Magnussen Journal: CMAJ Date: 2015-03-02 Impact factor: 8.262