PAIN+ CPN

Kallewaard JW, Wintraecken VM, Geurts JW, et al. A multicenter randomized controlled trial on the efficacy of intradiscal methylene blue injection for chronic discogenic low back pain: the IMBI study. Pain. 2019 Jan 3. doi: 10.1097/j.pain.0000000000001475. (Original study)
Abstract

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.

Ratings
Discipline Area Score
Physician 5 / 7
Comments from MORE raters

Physician rater

I'd never heard of this treatment, so I'd not have thought it newsworthy. However, it seems a useful refutation for those who have heard of it.

Physician rater

This study is performed according to CONSORT statement. It concludes with a negative recommendation on the treatment of CD-LBP with MB. This result is useful for clinical practice. We need more well designed studies on CD-LBP, as this, to ascertain the efficacy of proposed treatments.

Physician rater

A useful study showing no advantage of intra spinal methyl blue injections over local anaesthetic injections.

Physician rater

This paper reports on a randomized controlled trial of the use of methylene blue injected into the intradiscal (ID) space compared with saline placebo for reduction in pain and disability scores. Both groups had 0.5 mls of 2% lidocaine also injected into the ID space. A total of 25 patients had pain reductions of 30% or greater which was considered treatment success. At 6 months, 14(35% of MB patients showed treatment success compared with 11 (26.8%) in the placebo group p = 0.426. 6 months after treatment the NRS scores dropped 1.4 points from baseline with MB and 1.2 points with placebo and lidocaine. No appreciable differences were noted in improved disability between the groups. They were unable to confirm that ID MB injections are better in reducing pain for patients with discogenic lumbar pain vs saline with lidocaine. MB did not seem to be an effective treatment of choice. This may be of interest to pain physicians but of minimal interest to clinical anesthesiologists.

Physician rater

Chronic low back pain is a common problem in society and discogenic related back pain can be a cause for this pain. A previous study in 2010 reported dramatic effects of intradiscal Methylene Blue on chronic low back pain but attempts to confirm these results in several other studies have been unsuccessful. This double blind randomised control of patients with chronic low back pain proven to be discogenic by provocative discography enrolled 81 patients from an initial cohort of 1364 to receive lignocaine intradiscal injections with or without Methylene Blue. Patients were followed up for 6 months with the main outcomes of reduction in pain intensity and patient global impression of change 6 months after the intervention. The study failed to show any significant difference between the two groups and was unable to demonstrate any significant benefit from intradiscal Methylene Blue injections. Clearly if results of a study are too good to be true, they probably aren’t true.

Physician rater

Useful article.
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