1. 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

3. 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.

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

5. 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.

6. Holy Grail

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

8. MRI predictors
High intensity zones
Modic 1 changes

9. 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:
©2008 by American Society of Neuroradiology

10. 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)

11. Discography gold standard

12. Discogenic treatment categories
Thermal
Intradiscal injections
Regenerative procedures

13. Methylene Blue?

14. 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

16. 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

17. Peng, Oswestry Methylene Blue Saline Baseline 48 49 6 months 1613

18. 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

19. Gupta et al, Pain Medicine 2012

20. 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

21. 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.

22. 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

23. 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

24. 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?

25. MB adverse effects?

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

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

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

31. 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.

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

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