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A multicenter randomized controlled trial on the efficacy of intradiscal methylene blue injection for chronic discogenic low back pain

the IMBI study

Kallewaard, Jan Willema; Wintraecken, Veerle M.b; Geurts, José W.a; Willems, Paul C.c; van Santbrink, Henkd; Terwiel, Chris T.M.a; van Kleef, Maartenb; van Kuijk, Sander M.J.e,*

doi: 10.1097/j.pain.0000000000001475
Research Paper
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A study published in PAIN in 2010 showed remarkable effects of intradiscal methylene blue (MB) injections compared with placebo on pain intensity in patients with chronic discogenic low back pain (CD-LBP). Both groups received lidocaine hydrochloride injections for pain associated with the procedure. We replicated the design of the previously published study and performed a multicenter, double-blind, randomized, placebo-controlled trial to assess whether the extraordinary effects of MB on pain intensity could be confirmed. The primary outcomes were treatment success defined as at least 30% reduction in pain intensity and the Patients' Global Impression of Change 6 months after the intervention. We included 84 patients with CD-LBP of which 14 (35%) in the MB plus lidocaine group showed treatment success compared with 11 (26.8%) in the control group who received placebo plus lidocaine (P = 0.426). Twenty-seven percent of all participants treated with MB stated that their overall health improved much or very much (Patients' Global Impression of Change), vs 25.6% in the placebo group (P = 0.958). We were unable to confirm that intradiscal MB injections are better capable of significantly reducing pain in patients with CD-LBP 6 months after treatment compared with placebo. We observed that over one-quarter of patients receiving only lidocaine injections reported treatment success, which is in contrast with the previously published study. Our results do not support the recommendation of using intradiscal MB injections for patients with CD-LBP.

Intradiscal methylene blue injections compared with placebo did not result in a meaningful difference in pain or quality of life in patients with chronic discogenic low back pain.

aDepartment of Anesthesiology and Pain Management Arnhem, Rijnstate Hospital, Velp, the Netherlands

Departments of bAnesthesiology and Pain Management

cOrthopedic Surgery

dNeurosurgery and

eClinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, the Netherlands

Corresponding author. Address: Maastricht UMC+, P. Debyelaan 25, 6202 AZ Maastricht, the Netherlands. Tel.: 0031 433874374; fax: 0031 433874419. E-mail address: sander.van.kuijk@mumc.nl (S.M.J. van Kuijk).

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.painjournalonline.com).

Received July 05, 2018

Received in revised form October 05, 2018

Accepted December 13, 2018

© 2019 International Association for the Study of Pain
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