Spinal Cord Stimulators – comment on RSD

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Spinal Cord Stimulators 

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 Craig’s comment

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By no means do I mean to say that I or anyone else has better insight into how to treat pain, but I am against spinal cord stimulators [SCS’s] for treatment of pain due to CRPS, and possibly against use in other situations. I demand that the billions in profit they made be put into a retrospective and prospective study of damage caused by them in order for them to give full informed consent.

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I have 3 goals writing this.

1. SCS’s

2. Craig’s experience

3. The Only Real Answer for severe pain, not damaging the system with opioids
   

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Informed consent is never given for spinal cord stimulators because it requires truth telling, something our corporations have been reluctant to do. Business ethics are not medical ethics, as we keep being reminded daily in the headlines.

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I enclose, below, a generously expressed and detailed comment by a man who had the patience to sit down and  write the painfully gory details so you can weigh-in on your decision whether to follow your pain specialist’s opinion to give you one. I don’t want anyone to feel suckered into choosing them and if I had pain I’ll admit I’d crave relief too. Anything. I’d be in line before the doors open.

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But if you have CRPS, spinal cord stimulators will create more pain. CRPS evolves unpredictably, by a will of its own. I know some very desperate patients with CRPS everywhere including face, mouth, gums, tongue, organs, trunk, limbs. Spinal cord stimulators will create more pain. Keep in mind, I don’t see the 5 year success stories even for lumbar disc pain. They don’t need me if they are pain free.

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But if you have CRPS and desperate need for pain relief because all else has failed — every known drug in highest possible doses of ketamine, propofol, opioids for weeks in ICU fail to even touch pain— there is one thing, and only one thing to do and I will set it out below. I just sent my recommendation to a patient with CRPS in extreme pain.

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My recommendation, below, is for patients who have nowhere else to turn.

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First I’ll mention the problems Craig encountered with SCS’s. He sent his comment to the opening page of this blog, so I will reproduce below. 

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I am currently undergoing a trial Medtronic SCS. I have had to have it reprogrammed 3 times since it was installed 5 days ago. I have had sensations and issues that I have addressed with my rep and my neurosurgeon. I get a severe headache when the unit is turned on. I get the constant feeling of having to urinate. I have current running through my testicles which they can not seem to program out and I am getting little pain relief. I have had to failed back surgeries, many failed injections and I have CRPS. The leads that were inserted when I was in the table covered my mid back and both legs. After I got to my feet and waited while they programmed the unit in another room. They came in and plugged it in and I no longer had coverage on the right side. My crps is in both legs, my hands, arms and face. The lyrica helped to tamp down some of the burning but I am in pain 24/7 and this was my last resort. I have scar tissue completely surrounding my S1 nerve. By the grace of God, I am on my feet, on crutches. I seem to get a look of disbelief when I tell them the unit is causing these issues or it’s not giving me the relief I was counting on. Relief, only to cause greater issues and pain. Is not relief to me. I can not wait to get this trial out of my back. I believe the leads slipped and that is why I am not getting the full coverage I had on the table. The issues I have had are as follows: severe headache, constant feeling of having to urinate, extreme joint pain, abdominal pain, sleeplessness, involuntary jerking, surges in current even when sitting still. Intense pain around the lead insertion site. Current uncomfortably running through my testicles, regardless of setting. It is my opinion there is still not a lot known about crps and I have read evidence of people have great success with these units. Everyone reacts differently. My body obviously creates a lot of scar tissue and my orthopedic surgeon created a fair amount herself. I can’t imagine even more or being forced into a chair for yet another unlucky decision. The medication helps and I have lived this far without the optimism that it would end soon. I had high hoed for this device but I don’t think it is right for me.

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One of my patients with CRPS was hospitalized for weeks with recurring unusual abscesses and required repeated surgery of hand and forearm. Even before surgery, she had failed opioids, failed ketamine, and was in ICU for weeks and weeks while the same medications were still given along with Propofol and IV Tylenol. Nothing helps her extreme pain.

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Anesthesiologists on staff in ICU threw everything they had at the pain for weeks. Most anesthesia pain doctors would have probably done what they did because that is the limit of tools we have.

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When you have hit the limit of benefit from opioids, ketamine, propofol, we have nothing else that treats pain with one exception: drug holiday.

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Stop all analgesics including Tylenol that destroys the liver as severely as cancer, the severity of which was newly discovered and published yesterday.

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The receptors for these analgesic drugs have up-regulated to such an extent they have caused the situation. Again, I stress, everything that was done during the ICU admissions would be done by any anesthesiology pain specialist. Those are the only tools. They cause the problem. The same for opioid induced hyperalgesia. We used to do it with Parkinson’s drugs in the 80’s.

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The only way to rehabilitate the up-regulation of all those receptors that have now exploded in numbers, immune to anything you throw at them, is stop the drugs.  Stop all of them for weeks, maybe months, years, no one knows, you are all the human guinea pig waiting to happen. But if we restart them, how long do we wait, how quickly will it again lead to this massive hyper-excitable state of pro-inflammatory cytokines that we know have gone wild, flooding the CNS. A flooded engine will not restart.

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Ketamine at least is known to reduce pro-inflammatory cytokines, but the system is too busy exploding, birthing new receptors that take over, and you’ve got a 55 car pile up. Well, more like millions I’d guess. No scientist here. Clnically, when can we resume something after a drug holiday, how soon and which drug? I’d avoid opioids because they create more pro-inflammatory cytokines. Choose ketamine, because they reduce pro-inflammatory cytokines, but if it works at all, stop it at first sign of tolerance, which is the need for increased dose. It becomes less effective. Walk a fine line, endure more pain because unless you do, it will no longer help. Opioids, analgesics of many kinds. 

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How do we get you through a drug holiday because we know withdrawing these drugs will trigger even more pain for possibly weeks until the system settles down?

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Pain storms, hurricanes

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This is complex regional pain syndrome where we see this insanity of pain storms. There is no other condition, unless several neuropathic pains in people with cancer, nowhere I have seen this type of pain in decades except CRPS – comparable to pain of subarrachnoid hemorrhage, blinding pain.

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No one has answers. None. One university does outpatient infusions of ketamine six hours daily for 8 to 12 weeks. Does it help? A small percentage. Outpatient, 6 hours daily, 5 days a week, staying at a hotel, 8 weeks.

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This is CRPS/RSD. No one has answers. It is futile to throw more of the drug in the system. That is my opinion. You have a choice and may choose otherwise. It is your body. You may stay on monthly opioids for decades, until you finally admit how poorly they work. A drug holiday is what we did in the 70s during my ancient training with Parkinson’s patients. They needed full 24-hour support. The American medical system has changed since then and those are not options currently available—cost.

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You need full psychological and psychiatric support.

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The Only Real Answer

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The country needs to invest $10 million to complete the clinical trials needed for an injectable, long-lasting interleukin 10 [IL-10], the anti-inflammatory cytokine. It already has full scientific and animal studies performed by and with the world’s foremost glial scientist at University of Colorado Boulder. Professor Linda Watkins has won awards from many countries. She has been the keynote speaker at the annual academy pain meetings for years. IL-10 can relieve pain for three months in animals that have intractable chronic neuropathic pain. This is not new —–NIH I’m looking at you to fund clinical trials. And those of you who care, do a Kickstarter to fund the clinical trials.

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This is the power of the innate immune system. NIH would rather fund research on the unknowns like stem cells rather than the known. It’s known for decades, NIH does not like to fund pain research. Glia are not all about pain. They are the innate immune system, the key to Alzheimer’s, neurodegenerative diseases, almost all known disease including atherosclerosis. It’s all about inflammation. We need the trials to stop giving drugs that cause inflammation, opioids —–CDC fiats are not as good as a drug that relieves pain, a drug that really works on mechanism. Where will the addicts go if the ER only has IL-10 for pain? That is one way to overspend on ER visits.  And NIH, please get us some real clinical research funding on how to use glia for our benefit. Get us some research on the entourage effect, combining medications to achieve relief especially for neuropathic pain.

Then bring on some crack negotiating teams from insurers to do some negotiation about pharmaceutical prices. Our new president has mentioned that.

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Please bring this to everyone’s attention. One way to get a grip on pain and/or depression is to build hope, help others, and energize behind a goal.

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Kickstarters work to raise tens of millions overnight. 

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IL-10 – animals have been shown to be pain free for three months, already proven in animal studies, by one of the world’s most widely acknowledged pain specialists Professor Linda Watkins, PhD. We need the final steps to fund the clinical trials in humans.

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The material on this site is for informational purposes only.
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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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This site is not for email and not for appointments.

If you wish an appointment, please telephone the office to schedule.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Dystonia with CRPS – Intrathecal Baclofen Training Needed

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People with Complex Regional Pain Syndrome (CRPS) may develop dystonia, which is a twisting, perhaps crushing, movement of the hands and feet, spine, muscles. That is called dystonia and there is a specific treatment: Baclofen given into the spinal fluid.

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All too often, people with CRPS encounter pain specialists who have little or no experience with CRPS, but they have been trained to do procedures: blocks, pumps, spinal cord stimulators. Doctors need to be trained how to diagnose dystonia and when to use a different type of pump.

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CRPS is different, and I suspect many doctors must not see enough cases to become familiar. I would plead for special education to train physicians — especially surgeons because trauma or surgery may trigger onset of this poorly understood syndrome. But we must train all PA’s, NP’s, PT’s, RN’s, pharmacists, all healthcare providers about CRPS.  For some, CRPS may be a life ending pain, and deserves early diagnosis and better treatment.

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There should be special centers for treatment of CRPS where patients are more likely to get best care and where research can be done.

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Treatment must be better than what I saw yesterday in a new patient who has been needlessly disabled for five years with crippling dystonia.

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Dystonia is treatable but was not diagnosed, despite many interventions, pumps, stims, blocks, repeated blocks, by teams of pain specialists and rehabilitation centers in Southern California and Georgia. Crippling dystonia was not recognized.

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Without centers for treatment of CRPS,

too many will not get the care needed to return to life.

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DYSTONIA EDUCATION NEEDED

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INTRATHECAL PUMPS

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Dystonia may occur in those with CRPS.

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I don’t follow the literature on pumps, but I have not seen anesthesia pain specialists or neurosurgeons doing intrathecal (IT) pumps since I left MD Anderson Cancer Center in 1994.

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Training to diagnose and treat dystonia should be in medical education programs, especially the interdisciplinary field of pain – a field that should not be left to the interventionists.

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The only treatment for the crippling, twisting movement disorder called dystonia is intrathecal baclofen, not oral. Baclofen must be pumped into the spinal fluid.

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I told my patient the diagnosis on the telephone before I saw him. Next, there is the fight to get insurance to allow referral to the neurosurgeon to co-manage that part of his care. We cannot say if he could have been back to work five years ago, only that twisting and crushing hands and feet can cause an agony on top of the pervasive burning.

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The gift of human life from better research and training in treatment of CRPS would be the best thing for productivity, health, and well being.

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Support better health care in this country so people don’t have to be disabled for decades with treatable conditions.

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And vote for your congressperson to support compounding pharmacies that are invaluable.

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It is an beyond belief that pain management is taught in only 3% of medical schools in 2016. We don’t need training in opioids. We need training in this vast field in every medical school. I’ll bet returning veterans have more CRPS than any other group. How many go unrecognized? How many doctors know what allodynia is?

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The material on this site is for informational purposes only.
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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided

by a qualified health care provider.

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This site is not for email and not for appointments.

If you wish an appointment, please telephone the office to schedule.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Spinal Cord Stimulators – Paralysis, Adverse Effects

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In April 2014, the Wall Street Journal published an analysis of adverse events associated with spinal cord stimulators:

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When Spine Implants Cause Paralysis, Who Is to Blame?

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These events were submitted to the FDA or were obtained from medical malpractice law suits. “In many cases, the injuries occurred after patients’ spinal cords were punctured or compressed by the stimulator electrodes….The FDA’s database contains 58 unique reports of paralysis with report or event dates from 2013, compared with 48 in the prior year.” The spinal cord stimulators were made by various companies.

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“Researchers at Duke University medical center recently found that nearly one in every 100 spinal stimulator patients experienced some degree of spinal cord or spinal nerve root damage, said Shivanand P. Lad, a Duke Neurosurgeon and the study’s lead researcher. The study, based on insurance claim records of 12,300 stimulator patients has been submitted for presentation at an upcoming medical meeting.”

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“A 2011 study based on adverse event reports submitted by device makers found the rate of paralysis or motor weakness in patients implanted with a commonly used type of stimulator was considerably lower, at around 3.8 per 1000, with about 60% of patients eventually experiencing complete or partial recovery.”

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Medtronic updated its product label in February to note “that scar tissue can form around device electrodes and cause nerve damage, including progressive quadriparesis, or gradual weakening of all four limbs.”

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“Medtronic estimates that as many as 50,000 people in the U.S. are implanted with spinal stimulators each year from all device makers.”

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“Stimulators cost between $20,000 and $60,000 each and have estimated global sales of $1.5 billion annually….”

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The FDA “cautions that the agency’s database cannot be used to ascertain comprehensive rates of adverse events because the events are under reported [my emphasis] and often contain incomplete or incorrect information.”

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The article describes a man with 40 years of back pain who had a spinal cord stimulator implanted at the University of Texas Southwestern Hospital, Dallas. He complained of numbness in his legs. A blood clot was removed on an urgent basis, but damage was irreversible. He was paralyzed from the waist down and left in a wheelchair.

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Spinal cord stimulators, abbreviated SCS, can cause many more problems that paralysis. They can cause pain, tethering of the cord, scarring of the battery pack that can slide across the back, infection that may cause death, and many other complications. Electrodes may not always be able to be removed and remain permanently scarred into the cord. Deeply troubling is that an MRI can never be done again even if the patient has cancer or stroke —none of my patients remember being told about this. Where are the five year studies that show benefit? Even with no complications, how long do they continue to relieve pain? Electrodes move and/or they malfunction. There is little to no federal investment in medications that relieve pain, but these devices are garnering sales of $1.5 billion annually without showing lasting benefit. This is a very big source or income for pain specialists, but what is the gain for patients? How can we weight the pros and cons of this money generating device?

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So many of my patients that have failed the small handful of medications now available for chronic pain were given only one choice by every major pain center: spinal cord stimulator. One choice. This is a very big business but where is the five year data?

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One of my patients with Complex Regional Pain Syndrome, in remission since 2010, submitted a comment on this my site:

 

06/07/2012 at 11:25 pm   I have been a surgical nurse for 40 years and have seen many patients receive SCS…and many, many fail, or return to surgery for fractured electrode wires, misplaced wires, or infected battery pockets, besides complicated problems, or “lack of positive results, or battery revisions, or electrode repositionings.” Some patients have even developed spinal fluid leaks when the spinal dura layer has been torn during implanting the electrode wires, and they develop severe headaches, and have to return to surgery for the leak to be repaired. Many pain management doctors are convincing patients that this is a great way to treat their pain, and they find out in 2-6 months that they wish they never had agreed to it. Sure, there are some patients that get some relief, but this procedure has been pushed on the population of chronic pain patients, when they are at their worse condition, and willing to try anything….at any expense, and the companies and implanting doctors are getting the money. More patients need to learn the truth about these devices! Anonymous…. and never allowed them to put one of those things in me…but many tried!

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Elsewhere on my site, Traci writes a very sad comment:

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03/29/2011 at 6:01 am I posted on your main blog, but haven’t heard back. I know you wanted information regarding issues or problems with Spinal Cord Stimulators, so here is some information that you can add to your file. I can also be contacted for additional information because this issue continue to date.

In one of your posts you asked for input from patients that currently have a SCS. I currently have a Medtronic SCS it was implanted early 2010 and I ended up having swelling in my Lt (affected) foot/ankle every time I would charge the “re-chargeable battery”. No one at Medtronic could figure out the issue. I turned into their “human lab rat”. After several months of this I was told to switch from a rechargeable battery to a non-rechargeable batter. Thus another operation… which I did. After this surgery (I have a paddle with 16 electrodes) all 8 electrodes on the Lt side that used to supply stimulation to my Lt foot/ankle now hit my pelvic area – thus I can no longer utilize these electrodes. And out of the 8 electrodes on the Rt 2 are providing stimulation to my Lt foot and the other 6 are hitting the wrong areas. In addition to this I have had continual instances where I am getting a very sharp pain/ sharp twinge (like a jolt) around where the electrodes area. When this happens if I turn off the SCS the pain immediately stops. I’ve been on a conference call with a Senior Engineer of Medtronic and a local Rep in person with me to do reprogramming… The Engineer only wanted to know if the electrodes were putting out stimulation. He didn’t want to know what the amperage was at before I could feel it or in what part of the body the stimulation was felt. These should have been critical pieces of information. All he wanted to state was that the electrodes were working. As for the Sharp Pain / Sharp Twinges that continue to occur in the electrode area their Senior Engineer has no idea what is causing this. He asked me to run an experiment the next time it happened – I did exactly what he wanted and reported back the findings. I have yet to hear back from Medtronic. They do not want to back up their product and they are not willing to admit that their is a problem. Although I have 2 doctors including a Neurosurgeon that feel there is some type of fault in their product or that it is faulty. Hopefully this gives you some additional information you were seeking. Please feel free to email me if you would like to discuss further. I am continuing my uphill battle with Medtronic.

I have spoke with Medtronic as recently as yesterday and they can not explain the continual sharp pain/sharp twinge that I continue to get where the paddle that holds the electrodes is placed. The “Patient Relations Rep” that has been assigned to me, (at one point she tried to tell me she was from their “Legal Department” and she was later introduced by a team member as a “Patient Relations Representative”), doesn’t feel this is a big issue. She told me yesterday that this is “just medicine” and sometime they can get it right and other times it just doesn’t work out… The Senior Engineer at their company can not figure out what the problem is, so he just wants to reset the “INS”. I asked exactly what the “INS” was and the Patient Relations Rep couldn’t answer that question. I have already had my system reset numerous times (too many to count) and reprogrammed numerous times.

The trial was aproximately $25,000; the hospital expenses alone and cost for the SCS implant were over $150,000 and the secondary surgery to replace the rechargeable battery with a non-rechargeable battery was aproximately $53,000. This is all for a system the now has 2 out of 16 electrodes that hit the correct area, creates an intermitent sharp pain/sharp twinge in the spinal area where the electrodes/paddle is placed, and they aren’t sure how to resolve this issue. But I was told yesterday that their system was working properly by their rep.

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The material on this site is for informational purposes only.

It is not a substitute for medical advice,

diagnosis or treatment provided by a qualified health care provider.

~~~~~

Please understand that it is not legal for me

to give medical advice without a consultation.

If you wish an appointment, please telephone my office.

.

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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