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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Side Effects of Neridronic Acid – Neridronate

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Neridronate

Neridronic acid

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This is a long response to detailed comments from Julie who had a reaction to the neridronic acid protocol for CRPS.

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The clinical trial on neridronic acid is extremely important and unique. It is important because it does not just cover symptoms, it actually may put CRPS into remission.

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If I had CRPS, I would not hesitate to accept short term side effects if I thought I could get long term benefit, even possibly remission. We need this study. It will not be available for anyone unless many enroll in the double blind study and hopefully soon so that results can be submitted to the FDA for approval.

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Please read her comments first, at the end of my post. And then my comments below.

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And because neridronic acid relates to bone metabolism, much later I will mention an area of research that is likely to be be valuable because it is the largest receptor system in the body, the endocannabinoid receptor system, the body’s own cannabinoid system.  Two ideas from Raphael Mechoulam, professor of Medicinal Chemistry at the Hebrew University of Jerusalem in Israel are keenly interesting:

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The Skeletal Endocannabinoid System

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The Entourage Effect

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Glia make one of the cannabinoids in the brain, and glial research is where I suspect some of the best research will come

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Hopefully these ideas will stimulate  research.

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In response to Julie, I wrote:

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Julie, I am so sorry to hear of the difficulty you had to go through for such a long time. And relieved that you got through it. I and, I’m sure everyone else, thanks you for volunteering. We will all benefit. And we all hope that if any reaction is to occur, please let it be rare. It appears that yours is rare.

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I know everyone is with you, and we bring all our hopes for the unknown. No one has the answer of what to do with intractable pain of any kind, not just CRPS pain. We must, MUST, begin to do more research on intractable pain in humans. Neridronic acid is an important beginning to look at a new mechanism.

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CRPS has, in some people, escaped every known rational approach to treatment. Neridronate may be the best thing we can get. It takes time to learn how new medications work, and they have chosen wisely, I am sure.

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Be assured, I think good minds are working on the best. But it is unknown territory.  Numbers are needed – CRPS can be very dynamic. Flares and remissions wax and wane, so long term study must be done.

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We all see patients after CRPS flares and there is nothing more to offer. Not one thing. We urgently need something that works. We are hoping neridronic acid will be that rescue.

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Will remission last 12 months or 3 months or less?

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What are long term risks?

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How often could it potentially be given, or will remission really last for years in some? We all need to see numbers.

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Huge hopes are on this drug.

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We must balance hopes and fears.

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We recognize it is a new drug for a new purpose. We hope this research will drive many more studies on CRPS and/or intractable pain.

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Julie, thank you for allowing others to see details. It may help other volunteers to set aside time to recover any post infusion effects, if needed. Hope for the best, plan for the worst is the saying.

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No one yet knows how good the potential is for duration of effect. Remission could potentially be total, in some. How many?

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We are all learning how to treat chronic intractable pain.

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Skeletal Endocannabinoid System

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The highly decorated scientist who discovered THC and the body’s endocannabinoid system, Raphael Mechoulam, professor of Medicinal Chemistry at the Hebrew University of Jerusalem, recently mentioned the SKELETAL CANNABINOID SYSTEM in a 2014 documentary on his discoveries.

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The cannabinoid system interacts powerfully with the immune system in ways not yet studied. Why does your CRPS immune system affect the skeletal system and create pain?

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Cannabinoids are anti-inflammatory, analgesic, healing. The body makes its own. We need to study the biggest receptor system in the body. It is a gaping hole that is left out of existing work on the immune system.

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And how much are glia and our innate immune system in CNS— how much are they studied?

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Please let there somehow be funding for many studies on humans – but let’s begin one study, guided by Distinguished Professor Linda Watkin’s lab. She is the only scientist who is doing translational work from  basic research in the lab to humans.

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Professor Watkins has the best clinical solution I have seen: IL-10 has remarkable potential to bring your pain to zero for 3 months or more at a times. Your brain makes it. It is *the* anti-inflammatory cytokine. Her lab has been the world leader in glial research. Where is the funding for what may be the most important area of work for intractable mood disorders and treatment resistant depression?

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Glia

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How do hundreds of now usable drugs create pro-inflammatory cytokines thus make more pain or more major mood disorder?

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And which of these hundreds of drugs on our formulary reduce inflammatory cytokines?

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What is the role, if any, of some of the medications used by rheumatologists to dampen the hyperactive immune system in autoimmune disease? Risks, but possible gain. We will never have all the answers. ALL the answers for everyone is hard to imagine.

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How do hundreds of existing drugs affect the balance of CNS cytokines?

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Skeletal Endocannabinoid System – see Raphael Machoulam’s lab in Israel. May be critical for CRPS and for osteoporosis in seniors.

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Mechoulam’s lab would bite at the chance to get funded to work with the Italian and USA CRPS study.

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Julie — I am heartened that you may be able to see Professor Ott who may be one of the foremost researchers on bone metabolism if not number one.

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I posted three times on bisphosphonates last year and hope they are a good review for others.

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The Entourage Effect

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Mechoulam also has an important concept that probably applies to my method of trying to modulate these powerful intractable pain syndromes.

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Simple concept – brilliant:

The Entourage Effect. Drugs are like politicians. A famous politician may walk unrecognized, but when you surround him or her with many people, even of lesser status, the politician has a far more powerful effect.

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I don’t know how you guys do it.

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Respectful best wishes.

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I know some of you ignore this, but I have to repeat:

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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.

.
This material is not a substitute for medical advice, diagnosis or treatment provided

by a qualified health care provider.

~~
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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