AAPM&R Annual Assembly October 3 rd, 2015 Matthew Smuck, MD Chief, Physical Medicine & Rehabilitation Associate Professor, Department of Orthopaedics Director,

AAPM&R Annual AssemblyOctober 3rd, 2015

Matthew Smuck, MDChief, Physical Medicine & Rehabilitation

Associate Professor, Department of OrthopaedicsDirector, Wearable Health Lab

Stanford University

The Utility of Epidural Steroid Injections: Point - Counterpoint

DISCLOSURES

Cytonics - Research support ($ - paid to institution)

Lumo BodyTech - Advisor (stock options)

BlueJay Mobile Health - Advisor (stock options)

Vivametrica - Founder (20% owner)

State Farm Auto Insurance - Expert Witness ($ - hourly)

SIS - Board of Directors ($ - travel/honoraria)

The Spine Journal - Executive Editorial Board ($ - travel)

April 23, 2014 - the FDA released a Drug Safety Communication warning on risks of ESI, stating safety and effectiveness have not been established

EPIDURAL STEROID INJECTIONS AND THE FDA


› At this same time a multiple pain society workgroup (MPW) was working with another branch of the FDA on an “FDA Safe Use Initiative” regarding safe injection practices


The MPW includes the following 13 societies:› American Association of Neurological Surgeons› American Academy of Pain Medicine › American Academy of Physical Medicine and Rehabilitation › American Association of Neurological Surgeons › American College of Radiology › American Pain Society › American Society of Anesthesiologists › American Society of Regional Anesthesia and Pain Medicine › Congress of Neurological Surgeons › North American Neuromodulation Society › North American Spine Society › Spine Intervention Society › Society of Interventional Radiology



› At this same time a multiple pain society workgroup (MPW) was working with another branch of the FDA on an “FDA Safe Use Initiative” regarding safe injection practices

November 7, 2014 - the MPW mailed a response to the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee to explain the following:


A summary of MPW response to the FDA:› Safety is well established including studies of >16,000 consecutive ESIs


A summary of MPW response to the FDA:› Safety is well established including studies of >16,000 consecutive ESIs› Serious complications are reported, related to use of particulate steroids in TFESIs


A summary of MPW response to the FDA:› Safety is well established including studies of >16,000 consecutive ESIs› Serious complications are reported, related to use of particulate steroids in TFESIs› Risks of alternative medications are also well known (Opioids, NSAIDS)


A summary of MPW response to the FDA:› Safety is well established including studies of >16,000 consecutive ESIs› Serious complications are reported, related to use of particulate steroids in TFESIs› Risks of alternative medications are also well known (Opioids, NSAIDS)› There is ample evidence on the effectiveness of ESIs to:

• Improve pain and disability• Reduce rates of surgery




› Evidence best for disc herniation & radicular pain, may be less for other pathology




› Evidence best for disc herniation & radicular pain, may be less for other pathology› Evidence is not reliable from studies involving heterogeneous populations (ie. back pain)

and using inappropriate statistical analysis (group means instead of categorical data)




› Evidence best for disc herniation & radicular pain, may be less for other pathology› Evidence is not reliable from studies involving heterogeneous populations (ie. back pain)

and using inappropriate statistical analysis (group means instead of categorical data)› RCTs showing equivalence between epidural injection of anesthetic vs steroid should be

interpreted to show that neither option works


Meanwhile, the MPW publishes the results of the Safe Use Initiative with unanimous agreement of the boards of each of the involved societies.

Anesthesiology, 2015, V 122 • No 5


Highlights of the Safe Use Initiative recommendations: UNANIMOUS SUPPORT

› Use only non-particulate steroids for Cervical TF ESIs• Recommended for lumbar TF ESIs (circumstances may call for alternatives)

› Image guidance with appropriate views › Review prior imaging before injection› Use facemask and sterile gloves› Avoid heavy sedation

NEAR UNANIMOUS SUPPORT › Injection of contrast under real-time fluoroscopy (1 against)› Use extension tube (1 against)


Drs. Manchikanti and Falco published a rebuttal to the Safe Use Initiative.



› Describes withdrawal of ASIPP from the MPW



› Describes withdrawal of ASIPP from the MPW› Claims a lack of consensus among the remaining MPW societies



› Describes withdrawal of ASIPP from the MPW› Claims a lack of consensus among the remaining MPW societies› Suggests a role for blunt needles and alternate needle placement



› Describes withdrawal of ASIPP from the MPW› Claims a lack of consensus among the remaining MPW societies› Suggests a role for blunt needles and alternate needle placement› Argues against the mandated use of dexamethasone



› Describes withdrawal of ASIPP from the MPW› Claims a lack of consensus among the remaining MPW societies› Suggests a role for blunt needles and alternate needle placement› Argues against the mandated use of dexamethasone› Suggests that anesthetics may be as good as steroids



› Describes withdrawal of ASIPP from the MPW› Claims a lack of consensus among the remaining MPW societies› Suggests a role for blunt needles and alternate needle placement› Argues against the mandated use of dexamethasone› Suggests that anesthetics may be as good as steroids› Argues against use of lateral and oblique views in IL ESIs for reasons including

that:

“many physicians have not been trained in these techniques and are unaware of them.”


A question for Dr. Manchikanti ?


Publications and guidelines often recommend “conservative” treatments before considering invasive treatments such as ESIs

While this initially appears rational, there are 3 problems that authors of these publications and guidelines rarely address

ALTERNATIVES TO EPIDURAL STEROID INJECTIONS

Problem #1 – How well do these alternatives work?

› Randomized trials and systematic reviews of conservative treatments (physical therapy, mobilization, oral medications, etc.) often describe statistically significant differences between treatments groups, however the effect sizes are universally small

› Not only are effect sizes small, most are below thresholds of clinical relevance, so more correctly interpreted to have no clinical benefit


Problem #2 – Are these alternatives safer?

› Rates of serious complications from therapeutic ESI are very low• less than the 1/100,000 for hematoma from epidural anesthesia

› Serious risks of alternative medications are well known as documented in the following US annual rates:• >15,000 opioid related deaths• >16,000 NSAID-related deaths • >100,000 hospitalized for serious GI complications from NSAIDS


Problem #3 – What alternatives?

› Due to current dogma, most practitioners only consider ESIs after the “more conservative” alternatives have already failed.

› For many, the alternatives have already been exhausted


A question for Dr. Friedly ?


Documents

AAPM&R Annual Assembly October 3 rd, 2015 Matthew Smuck, MD Chief, Physical Medicine & Rehabilitation Associate Professor, Department of Orthopaedics Director,