Methylene Blue an Intradiscal therapy? Mohan Radhakrishna, MD, FRCPC Physical Medicine and Rehabilitation McGill University Maine study on surgery: 70% happy with outcome, 19% re-operate

Disclosure I am currently conducting a clinical trial in SCI patients through Nordic Life Science Pipeline and the US Department of Defence. I have performed many injections, taught residents, fellows and physicians.

Disclosure I work in a single payer (more or less) health care system I have more patients than I can see

Objectives Outline the evidence around the use of MB for discal pain At the end of this session the participant will be able to: Outline the evidence around the use of MB for discal pain Be able to name some of the factors implicated in starting new therapies in interventional spine practice.

Holy Grail

Discogenic pain About 40% of LBP No one physical exam maneuver. Centralization (Hancock, 2007) Statistically more common in the young (Depalma, 2011).

MRI predictors High intensity zones Modic 1 changes

Modic type 1 changes are hypointense on T1WI (A) and hyperintense on T2WI (B). R. Rahme, and R. Moussa AJNR Am J Neuroradiol 2008;29:838-842 ©2008 by American Society of Neuroradiology

Magnetic resonance findings of acute severe lower back pain. Kim SY, Lee IS, Kim BR, Lim JH, Lee J, Koh SE, Kim SB, Park SL - Ann Rehabil Med (2012)

Discography gold standard

Discogenic treatment categories Thermal Intradiscal injections Regenerative procedures

Methylene Blue?

Methylene Blue Cotton dye in 1876 1890 first use as analgesic Numerous uses in medicine since Anti-malarial Dementia etc Oz, NIH. Med Res Rev Jan 2011

Peng et al, Pain 149(2010) 124-129 36 patients in each group DBPCRCT Methylene Blue Saline Baseline Pain 7.2 6.7 Pain 6 months 2.5 6.3 Pain 12 months 2.2 6.2 Pain 24 Months 2.0 6.0

Peng, Oswestry Methylene Blue Saline Baseline 48 49 6 months 16 13

Peng et al, Pain 149(2010) 124-129 In summary: MB group improved by 52.5 on NRS and 35 points on Oswestry. No placebo response for pain or function

Gupta et al, Pain Medicine 2012

Gupta et al, Pain Medicine 2012 Case series of MB in ‘real-life’ 3 interventionalists 8 patients Success defined as 20% sustained improvement in pain

Gupta et al, Pain Medicine 2012 Results: 1 patient had improvement that was substantial (100%) and sustained. Aside from blue urine in 1 patient for 1 week, no adverse events.

Kim et al, Ann Reh Med, 2012 20 patients with intradiscal MB (no placebo) VAS, Oswestry Success defined as 2 points on VAS At 3 months, 55% met this criteria At 12 months, 20% did

Levi et al, PMR 2014 16 subject prospective trial Pain and Oswestry as outcome measures 6 month FU Success: 30% improvement in both measures Results: About 25% at 6 months

Kallewaard et al, Pain Practice 2015 15 patients Discogram positive, facet pain excluded 40% met outcome measure of 30% pain relief at 6 months. Would your patients accept this?

MB adverse effects?

Why do treatments work in trials but not ‘real life’?

Efficacy vs effectiveness Outcome measure Timeframe Inclusion criteria Hawthorne effect Author effect?

Implementing new techniques Regulatory bodies Off-label use Patient selection is key Too much of a good thing can ruin reputation

Objectives Outline the evidence around the use of MB for discal pain At the end of this session the participant will be able to: Outline the evidence around the use of MB for discal pain Be able to name some of the factors implicated in the use of new therapies in interventional spine practice.

Conclusion We have moved on from MB Balance enthusiasm with caution Appropriate consent and outcomes

References Peng et al, European Spine J, 2007. 16:33-38 Peng et al, Pain, 2010, 149:124-129. Gupta et al, Pain Physician, 2012 15:333-338 Kim et al, Annals Rehab Med 2012, 36(5): 657-664 Levi et al, PM&R 2014, 6: 1030-1038 Kallewaard et al, Pain Practice, 2015 (online)