Tatsunori Ikemoto1, Takefumi Ueno2, Young-Chang Arai3,4, Norimitsu Wakao1,5, Atsuhiko Hirasawa1, Kazuhiro Hayashi4, Masataka Deie1. 1. Department of Orthopedic Surgery, Aichi Medical University, Nagakute, Japan. 2. Division of Clinical Research, National Hospital Organization Hizen Psychiatric Center, Saga, Japan. 3. Institute of Physical Fitness, Sports Medicine and Rehabilitation, Aichi Medical University, Nagakute, Japan. 4. Multidisciplinary Pain Center, Aichi Medical University, Nagakute, Japan. 5. Department of Orthopedic Surgery, National Center for Geriatrics and Gerontology, Obu, Japan.
Abstract
Background: The aim of this study was to confirm the effectiveness of open-label placebo (OLP) in Japanese patients with chronic low back pain (CLBP), similar to previous reports, and to investigate its short- and medium-term effects in this study population. Methods:Fifty-two patients with CLBP were randomized into a treatment as usual (TAU) group (n = 26) or an OLP + TAU group (n = 26) for 12 weeks. The TAU included advice to remain active and exercise in conjunction with recent psychological education based on a self-management strategy. In contrast, participants in the OLP + TAU group were instructed to take two OLP capsules a day. Outcome measures were assessed at baseline and at weeks 3 and 12 using the Roland-Morris Disability Questionnaire (RMDQ), Numerical Rating Scale (NRS) for pain intensity, and the Timed-Up-and-Go (TUG) test. Difference in outcomes between the two groups was compared at the two follow-up points. Results: Although all participants completed the 3-week follow-up, four patients (two in each group) were lost to follow-up beyond week 3. There were no significant intergroup differences in changes in the RMDQ score (p=0.40), pain-NRS score (p=0.19), and TUG time (p=0.98) at week 3. Two-way repeated measure analyses of covariance showed significant time-course effects but did not show group effects or any interactions between the time-course and group in terms of the RMDQ score. However, it did not show any effects in the pain-NRS score and TUG time at week 12. Conclusions: The OLP + TAU group showed no superior findings in comparison with the TAU group after 3 weeks and 12 weeks for Japanese patients with CLBP. Nonetheless, significant improvements in functional disability were observed in both groups.
RCT Entities:
Background: The aim of this study was to confirm the effectiveness of open-label placebo (OLP) in Japanese patients with chronic low back pain (CLBP), similar to previous reports, and to investigate its short- and medium-term effects in this study population. Methods: Fifty-two patients with CLBP were randomized into a treatment as usual (TAU) group (n = 26) or an OLP + TAU group (n = 26) for 12 weeks. The TAU included advice to remain active and exercise in conjunction with recent psychological education based on a self-management strategy. In contrast, participants in the OLP + TAU group were instructed to take two OLP capsules a day. Outcome measures were assessed at baseline and at weeks 3 and 12 using the Roland-Morris Disability Questionnaire (RMDQ), Numerical Rating Scale (NRS) for pain intensity, and the Timed-Up-and-Go (TUG) test. Difference in outcomes between the two groups was compared at the two follow-up points. Results: Although all participants completed the 3-week follow-up, four patients (two in each group) were lost to follow-up beyond week 3. There were no significant intergroup differences in changes in the RMDQ score (p=0.40), pain-NRS score (p=0.19), and TUG time (p=0.98) at week 3. Two-way repeated measure analyses of covariance showed significant time-course effects but did not show group effects or any interactions between the time-course and group in terms of the RMDQ score. However, it did not show any effects in the pain-NRS score and TUG time at week 12. Conclusions: The OLP + TAU group showed no superior findings in comparison with the TAU group after 3 weeks and 12 weeks for Japanese patients with CLBP. Nonetheless, significant improvements in functional disability were observed in both groups.
Authors: Nadine E Foster; Johannes R Anema; Dan Cherkin; Roger Chou; Steven P Cohen; Douglas P Gross; Paulo H Ferreira; Julie M Fritz; Bart W Koes; Wilco Peul; Judith A Turner; Chris G Maher Journal: Lancet Date: 2018-03-21 Impact factor: 79.321
Authors: Trevor Thompson; Sofia Dias; Damian Poulter; Sharon Weldon; Lucy Marsh; Claire Rossato; Jae Il Shin; Joseph Firth; Nicola Veronese; Elena Dragioti; Brendon Stubbs; Marco Solmi; Christopher G Maher; Andrea Cipriani; John P A Ioannidis Journal: Syst Rev Date: 2020-06-05