A parallel randomized controlled trial examining the effects of rhythmic sensory stimulation on fibromyalgia symptoms
Authors: Denise Paneduro
Lee R Bartel
Thenille Braun Janzen
Allan Gordon
Larry Picard
Journal: PLoS ONE (2019)
Discipline: Multidisciplinary
Keywords: fibromyalgia; gamma-frequency rhythmic sensory stimulation; vibrotactile stimulation; chronic pain; randomized controlled trial
Affiliations: Music and Health Research Collaboratory, Faculty of Music, University of Toronto, Toronto, Ontario, Canada., Wasser Pain Management Centre, Sinai Health System, Toronto, Ontario, Canada., Faculty of Music, University of Toronto, Toronto, Ontario, Canada.

Abstract:  This double-blind, two-arm parallel randomized controlled trial investigated the effects of gamma-frequency rhythmic sensory stimulation on fibromyalgia. We were interested in whether rhythmic sensory stimulation would promote significant changes in fibromyalgia and associated symptoms, and whether treatment effects would differ between two distinct treatment parameters. Fifty patients with a formal diagnosis of fibromyalgia were randomly assigned to two test groups. One group received vibrotactile stimulation from a continuous sine wave single-frequency stimulation (40 Hz) for 30 minutes, five days per week, over five weeks, concomitant with usual care. The second group completed the same treatment protocol but received a different stimulation, consisting of random and intermittent complex wave gamma-range vibrotactile stimulation. Fibromyalgia symptoms, pain severity and interference, depression symptoms, quality of life and sleep quality were assessed at baseline and post-intervention. Results indicated that there were statistically significant changes from baseline to post-treatment in measures of fibromyalgia symptom severity, pain interference, depression, and sleep quality. However, treatment outcomes did not differ significantly between groups. These findings provide preliminary evidence that gamma-frequency rhythmic vibroacoustic stimulation may decrease fibromyalgia symptoms and ease associated comorbidities, opening new avenues for further investigation of the effects of rhythmic sensory stimulation on chronic pain conditions. 

Retracted: Yes

PubPeer comments:
 2020 retraction. https: journals.plos.org plosone article?id=10.1371 journal.pone.0230395 After this article [1] was published, concerns were raised about aspects of the study design and conclusions that prompted the PLOS ONE Editors to re-evaluate the article, together with a member of our Editorial Board. This study aimed to (1) evaluate whether the rhythmic sensory stimulation (RSS) treatments with different parameters would yield different effects on participants; and (2) evaluate the efficacy of RSS in reducing the severity of fibromyalgia symptoms. The reported experiments involved two RSS treatment groups, as described in the Methods, both of which received RSS treatment albeit with different specifications. The study did not include a true sham control treatment. The results of pre- versus post-treatment analyses reported in the article suggested that RSS stimulation may impact fibromyalgia symptoms. However, given the lack of a sham control group, one cannot distinguish effects of either treatment from placebo effects as would be needed to address the second study aim. The lack of a placebo group was raised during pre-publication peer review and was acknowledged as a limitation in the articleu2019s Discussion. However, after further consideration and post-publication input from a member of our Editorial Board, we concluded that the claims made in the article are not adequately supported by the results given the lack of the control group and the implications of this issue for the interpretation of the data. Therefore, the article does not meet PLOS ONEu2019s publication criteria, and so the PLOS ONE Editors retract this article. We regret that this issue in the study design was not fully addressed during the pre-publication peer review process. TBJ and LRB did not agree with the retraction. DP, LP, and AG either did not respond directly or could not be reached. At the time of retraction, the article [1] was republished to remove S1 Figure due to unresolved questions about copyright ownership. Reference 1.Braun Janzen T, Paneduro D, Picard L, Gordon A, Bartel LR (2019) A parallel randomized controlled trial examining the effects of rhythmic sensory stimulation on fibromyalgia symptoms. PLoS ONE 14(3): e0212021. ,