"Cutting Edge" Ketamine for CRPS/RSD: "...no high quality evidence available..."

September 13, 2015

A RECENT LECTURE THAT I ATTENDED LEFT ME WORRYING  about what some tout as "cutting edge" treatment for Reflex Sympathetic Dystrophy (RSD, now CRPS, type I), bringing to mind Hippocrates’ admonition "...to do good or to do no harm...".  It is the perfect storm of claims: a controversial diagnosis that in many cases may be psychogenic in nature, along with an unproven and potentially toxic treatment, often being recommended in the midst of litigation.  What could go wrong?

Back in 2000 the authors of a review article entitled “Controversies surrounding reflex sympathetic dystrophy” reported “…the topic of reflex sympathetic dystrophy (RSD) has generated an increasingly significant volume of medical literature and controversy…” In my opinion, little has changed since. For example, there is no reliable rate of incidence/prevalence for RSD, in great part because there is still no consensus among experts on how to objectively and epidemiologically establish the diagnosis. There is contentious debate over what the current, often competing criteria mean, or if the diagnosis itself is actually valid except perhaps for a tiny minority of patients who assert they carry this diagnosis, if any at all. Moreover, the field is awash with diagnostic tools and treatment modalities of dubious value.

While one day mainstream medicine and perhaps even I may favor Ketamine infusion for RSD…that day is not today; because it would require a sea change in the medical literature based upon high quality clinical trials yet to be performed. According to recent review article published just a few months ago in Pain Medicine entitled A Systematic Review of Ketamine for Complex Regional Pain Syndrome "...There is no high quality evidence available evaluating the efficacy of Ketamine for CRPS and all manuscripts examined in this review were of moderate to low quality…there is clearly a rationale for definitive study..." The stated objective of the study was to examine the available literature which yielded 262 articles, of which only 45 of which met the inclusion/exclusion criteria. These findings buttressed those of the well-received article by Harden, RN, et. al., published two years earlier also in Pain Medicine, The 4th Edition of Complex Regional Pain Syndrome: Practical Diagnostic and Treatment Guidelines, 4th Edition.  That 2013  review also found only a few low level of evidence studies to support the use of Ketamine in CRPS, and concluded that caution was indicated and independent confirmation of these studies is needed, especially since Ketamine is a dissociative hallucinogenic, toxic and a drug of abuse.  

Notably, Ketamine infusion is hardly  “cutting edge” or for that matter even new, as there are case reports of its use in the medical literature as far back as the mid 1990’s. So for example, more than a decade ago, for the 2004 publication  “A Retrospective Analysis of a Novel Therapeutic Approach to Complex Regional Pain Syndrome”, records of 33 patients who underwent Ketamine infusion therapy were analyzed. The authors determined that more study was needed to further establish the safety and efficacy of this novel approach, and this is still good scientific advice.

Before that, some of you more experienced readers may recall, Lidocaine Infusion was all the rage. In 2002, I reviewed a case on appeal in which Dr. Schwartzman was the attending physician. He was an early, vigorous and longtime proponent of Ketamine and Lidocaine Infusions for CRPS/RSD, who published on the topic frequently. The patient, who carried the diagnosis, had traveled from Florida to Philadelphia to see him, as he was supposedly the only one doing it the country, something I did not doubt at the time. The denial of coverage was for IV Lidocaine, which then was supposedly the “cutting edge" treatment for RSD. The rationale I based my opinion upon then - that under the Health Plan language it was Investigational/Experimental in nature and not a covered benefit - was upheld by the self-insured Employer's Board of Directors. Although it went to some litigation, it was short lived.  These days I no longer see requests for Lidocaine infusion for RSD/CRPS type I, but I do for Ketamine. It is hard to understand why, given the status of what little we physicians know.

While I have a different attitude about studying Ketamine infusion in clinical trials for which proper Institutional Review Board approval is obtained, or perhaps even offering it out of sheer desperation to some particular individual for “humanitarian” reasons  as some proponents suggest, making a claims determination as to whether it should be paid for by some third party payer is an entirely separate issue. At this juncture, in my medical and legal opinions, not only is treating a patient with such limited data and toxic drug profile ill-advised, there is simply not sufficient reliable or credible medical evidence so as to justify recommending coverage, for what has little if any reasonable medical probability of success.  While academic chatter of this sort, such as I am writing and of course you are reading may be fun for some of us, for a more pragmatic standpoint I would turn to the healthcare industry  where litigation is rarely a factor for some guidance as to how broadly, or not, this treatment is accepted within the mainstream medical community. So for example, my admittedly incomplete survey of the Medical Policies of the major healthcare insurance carriers revealed that they considered it Experimental/Investigational in nature, and none covered it (although it is entirely possible there may be some payers that do so).

With regard to the longstanding debate over whether RSD/CRPS type I is primarily a psychogenic disorder often involving secondary gain, it is more than noteworthy that in the past decade, Ketamine has emerged as a potentially powerful and rapid acting antidepressant for certain patients with severe treatment-resistant depression. Apparently, it may also possibly be effective for chronic Post Traumatic Stress Disorder (PTSD), Obsessive Compulsive Disorder (OCD), and who knows what else around the corner (see National Institute of Health Director's Blog: Ketamine, October 1, 2014). Due to the paucity of clinical studies, for which the NIH is currently recruiting subjects, it is far too early to know. However, it certainly makes one wonder whether the RSD responders to IV Ketamine might not have a condition that is of a psychogenic etiology? If so, would it make the condition unrelated to any injury at issue?   


Feel free to contact me directly for consultation on your RSD/CRPS Type I case.

 

 

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