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Occipital Nerve Stimulation Study Findings

Mayo Clinic researchers reported findings of a small study of occipital nerve stimulation at the American Academy of Neurology’s annual meeting in April. While the press release’s headline proclaims it to be a “safe and effective” treatment for chronic headache, the results aren’t so rosy. In fact, safety is never even mention in the release.

There were 16 participants in the study, nine of whom had permanent stimulators implanted. The press release doesn’t explain this, but I assume it’s because the others didn’t have sufficient relief with the trial stimulator so they didn’t have the permanent stimulator implanted.

The average pain decrease is reported as 54%, but it’s not clear whether this was the average of all 16 patients or just the nine with the permanent implant. If it includes all 16, this is pretty good, but if it’s only nine, it’s ugly.

Six patients had no change or a change of less than 50%. Is this of the nine patients with implants, those without or all of them? Eight patients reported 50 to 95% pain relief and two had complete relief. So, only nine patients had implants, but 10 reported between 50% and complete pain relief. Did one of the nine have two different scores or did one of the original 16 have relief during the trial but didn’t have the permanent implant?

You know that I got my nerve stimulator at the Mayo Clinic and I’m almost positive that this is the study that my doctors began after I had my implant. I trust and like these men. I’d like to blame Mayo’s public relations staff for this misleading press release.

I’ve worked in corporate communications and have also dissected a lot of academic journal articles and even written a few. All research results are massaged; generally the less favorable the findings, the more convoluted the presentation of those findings. Often it’s not intentional, but the researcher’s biases always influence the results.

Enough about the implications of reporting. What remains is that this press release does nothing to convince me that nerve stimulation is safe and effective.

Note: Ironically, I missed this article when it was first released because I was having trouble with my nerve stimulator. Because the leads had moved, having the device on made my headaches worse than with it off.

32 Responses to Occipital Nerve Stimulation Study Findings

  1. PamC says:

    I’m going to be a part of this study in Seattle at Swedish Pain and Headache Center. My neurologist is one of the sub-investigators.

    I don’t know if I’ll be signing an NDA. I assume not, since my health information is going to be released to the FDA, etc. If that is the case, I’ll get answers for you!

    ******
    Congratulations, Pam! That’s big news. I’d love to hear more about it. Look for an e-mail from me soon.

    K

  2. PamC says:

    It’s totally working! If I avoit my triggers, I’m at about 0-2 migraines a week!! *happybounce*

    *******
    That’s fantastic! What great news.

    Kerrie

  3. Pain in the neck says:

    Since having my occipital nerve stimulator put in in Nov., 2007, my cervicogenic headache that I had (at a pain level from 8-12, 24/7) is now minmal. I have had 90-95 % relief. I do have one loose lead that has been omited from my programming and I have some stmulation over the ipg site. All in all I am very pleased with the results. Nothing else even came close to giving me ay relief.

  4. Bob says:

    I have had pain on the rt side of my head for 4 yrs. Nothing helps. … I had beee everywhere and done everything…. From all kinds of medications, Botox shots, accupunchure…The relief is minimal and short lived… I suffer all the time– on a pain scale of 1-10 a 8-9 most days and never below a 6. I would likde to know more about the nreve stimulator. I need help and relief from PAIN!

  5. Ian says:

    I too have simptoms simular to Bob following a whiplash accident 4 years ago…does anyone know if this is likely to cure me and if there are any side effects to worry about?

  6. Rob says:

    How do I find someone to implant an occipital nerve stimulator
    needed badly….HELP!
    Have insurance etc

  7. Lori says:

    Relentless burning, agonizing, head, face, and neck pain has taken all the joy from my life. I have tried approximately 10 kinds of treatments thus far. From naturopathic physicians, to fibromyalgia clinics, chiropractic manipulations,and accupuncture are some of the treatments I have tried with no relief. 13 years I have spent battling this pain 24/7. Recently, a family friend came over and gave me an article discussing the nerve stimulator telling me her son was thinking about the procedure. I read it and thought to myself, “Another treatment that probably wont help”, however it was a nice gesture. I tossed it aside and went to my appointment with a pain clinic my neurologist had referred me to. To my surprise the doctor I saw recommended an occipital nerve stimulator. He stated we would start with the cervicogenic pain and then work on the lower back pain following addressing the head, neck, and upper back pain. I have see alot of doctor’s for my “fibromyalgia” and cluster headaches . To answer Rob’s question: The doctor I saw is at The Elliot Pain Center. It is located at The Elliot Hospital in Manchester, New Hampshire. I have decided to research this further before making the final decision to go through with this. I have a feeling I may go through with it because I know I cannot continue on in this kind of pain daily. Healthy wishes…Lori

    ********
    It certainly helps some people. I wish you the best of luck.

    Take care,
    Kerrie

  8. suzy says:

    Lori, please keep us updated with your progress. I got hit on the head with a pipe 6 years ago and suffer from head, face, neck, migraine pain. nothing has helped, now thinking of nerve stimulator. I will post my results as well.
    best of luck,
    suzy

  9. Michelle says:

    I too am looking for a Doctor to try a ONS, I have been in constant pain for 10 years, have seen no less than 20 doctors,finally spoke to my insurance company rep, have been diagnosed with Occipital Neuralgia and they will approve the proceedure, now I need to find a surgeon to do it! I live on the South Shore of MA. Anyone have a great doctor????

    Michelle

  10. Mary says:

    I am getting a ONS done on April 13th. I however can not wait. i have been officially diagnosed with occipital neuralgia along with trigeminal neuralgia. I have been having a pain scale of above a 10-12 for over 2 years 24/7.. My Dr. is Dr. Day from Lubbock, Tx. After i seen many doctors all over Dallas i was finally referred to him after being turned down help there. He has walked me through many steps with my trigeminal neuralgia and we are now working on the occipital. thank god for Dr. Miles Day. he is with the Texas Tech international pain clinic. he sees many patients all over the world. i do reccomend him in many actions.

  11. Diane says:

    Hi … Just happen to come across this website recently. I thought that some of the people here would be interested in knowing about the doctor who put in my occipital stimulator. He is Dr Thimineur in Derby,CT and he also has an office in Meriden, CT. The name of the place is called the Comprehensive Headache and Pain Center. I have had Fibromyalgia for over 30 years and it has made my life a living hell. So I can truly relate to your pain. I’ll be honest and tell you that the permanent implant was pretty bad, as far as the recovery, but you get to try a temporary one for a couple of weeks to see if it helps. The temporary one was not bad at all and really the only pain is for a couple of days in the back of your head where they put the wires in. But all in all, I’m doing better than I have in years. It’s not perfect, but it’s a lot better than it has been in years. So give the temporary one a shot and see how it goes. If you’re at the end of your rope as I was, it’s better than anything I’ve ever tried and believe me, I’ve tried everything … Good Luck … I wish you all a pain free day … Diane

  12. Emily says:

    Just got an ONS installed this week. Dr. Nagy Mekhail, a pain management specialist at the Cleveland Clinic in Cleveland Ohio, was the surgeon. A very kind and very qualified physician I would recommend to anyone. I am participating in a double blind study of ANS stimulators for headache, hoping to make it easier to get insurer’s to pay for this treatment.

    *******
    How are you doing?

    Kerrie

  13. Jane Mccormick says:

    I am 51 and I got a ONS implant 10 days ago after a positive trial last year. Have had a long history of migraine and chronic daily headache.Have been through all other treatments over 30 years including a migraine clinic.The problem with rebound headaches from acute medication means I have to limit my pain relief intake and this has really limited my life more and more each year. I also have have had adverse reactions to some of the preventative medications I have been prescribed and after becoming burnt out eventual found myself at the door of the Pain clinic and the Doctor who suggested this treatment.I know its too early to pass judgment as I am just recovering from the surgery. I did have a migraine last week and ended up taking imigran. I am told by the pain nurse that a 50% reduction could be a realistic outcome..If I got that I would consider it a great success..I am still hopeful but would love to hear from someone further down the line on how they manage their breakthrough pain….and relatives who keep asking if you are cured!

  14. Sarah K says:

    I just had my first consultation about ONS and a supra orbital nerve stimulator with the head of the Pain Clinic at Dartmouth Hitchcock Medical Center, Dr Gilbert Franciullo. I would be the first patient that they would be doing both procedures on. I have headaches behind my eyes and they think both those nerves are causing them. I am 30 years old and have not been able to work due to chronic daily headache and frequent migraines. I was very impressed with him and the facility in general. I have been to some independent pain clinics with some scary results. Anyone have stimulators around the supra orbital nerve? Good luck to all!

  15. Martin R says:

    I am 65, suffered from migraine ha for 35/40 years.Have been to family drs. neurologists,Mao C. and I have been thru so many preventive drugs (elavil,topamax,blood pressure,botox, etc) I can’t remember them all.Maxalt and or Relpax seem to do the trick getting rid of the pain, depending on how long into the ha I wait to take the med. The ha’s have progressed to an almost daily occurence; I know rebound is a consideration. I recently was given steroids and muscle relaxers for a lower back problem, which interrupted the ha’s. Prior to the back issue, I had three separate steroid injections to the occipital nerve which significantly improved pain levels for four to five days subsequent to the injections, whereupon daily ha’s returned to the almost daily occurance. I’m now scheduled to undergo a trial occip.nerve electrical stimulator, which, presumably would lead to a permanent implant. However, I am having serious reservations about my dr., an interventional radiologist doing his 1st procedure on me, further complicated by the previous blogs mentioning cog. behavioral therapy,hydrocephalic,fibromyalgia,trigeminal neuralgia,supraorbital nerve, and other scary alphabet soup possibilities. Mao Clinic did suggest that my issue was “classic migraine” but now I’m not so sure. All I know is I have chronic head pain and my life doesn’t belong to me anymore. I’d like to hear from anyone who might have different thoughts, especially Jane McCormick who has had her implant about a year now.

  16. Kate W says:

    Hi I’ve suffered chronic migraines since 7yrs old am now 36 have tried everything!!! Lots of natural things have helped life magnesium but my neck is still a big factor.
    I have had 2 children and the migraines were slightly better while breast feeding I recently stoped breastfeeding and they have come back with greater frequency and severity. I’m at my wits end and considering occipital nerve stimulation and would like to hear from people who have had sucess.

  17. Jeff G. says:

    Hi. I’ve been dealing with Occipital Neuralgia for about 8 years now, and I have taken several medications. I currently take about 100mg of Lyrica 3x a day, and 300mg of Trileptal 3-4x a day. Some days the pain is very sharp in the right side of my head, running down my neck, and going down the inside of my right shoulder blade. Lately, the meds are not enough still. Does anyone else have the shoulder pain? Have you tried the decompression of the nerve root to reduce or eliminate the pain, and had success? And, how well is the nerve stimulator working? I feel like I am seeing mixed results on the pain levels after the stimulator is implanted. Thank you.

  18. Elizabeth A says:

    Hello all-
    I had my ONS implanted in Nov 2009 in Phoenix by Dr Paul Lynch. The device was a lifesaver! I was able to work FT, travel, make plans, and get rid of the black out shades in my house. Unfortunately in Aug 2010 I developed an infection of teh ONS which turned out to be MRSA. The infection probably originated from a cute or bug bite and sine I work in the health care industry I am more prone to getting infections like MRSA. The edvice was removed and now I am back to square 1. My insurance carrier changed so I am crossing my fingers that my new insurance company will approve the surgery. I have proof that I did great with it before, so that may help me. Since the removal I have been at urgent care 6 times, in the ER 1 time, and hospitalized for 5 nights due to pain, dizziness, and loss of balance.
    I am now on Fentanyl patches until I can have another stim unit placed hopefully with in 60 days or less if all goes smoothly.
    For all thinking about the procedure, at least have the trial done where the leads are temp. for 3-5 days, for me this was a great indication of how I would do with the unit. Work close with your rep from the ONS company. For me it was ANS/St. Jude and they were wonderful! It will take time for the programing to be perfected- for me it was about 8 weeks, but keep chugging along!

  19. Deb B says:

    Kerrie – Original Article Author
    ReRead the initial article better before commenting.

    AM considering this device – suffering from 6 years of Post Concussive Migraines and Post Traumatic Headaches from whiplash and Head Injury. Anyone have more info on the implantation itself and recovery and pain of it?

  20. amanda says:

    I have been having migraines since i was 3 from a head trauma as result of a dog attack, but i live in NH and am going to the pain clinic at Elliot Hospital and have Anthem for insurance and they will not cover it… what do i do ! my doctor is going to try and appeal but doesn’t know what else to do ? it is my last resort ive been suffering with migraines for 19yrs,been thru 8 neurologist, and every different kind of treatment and nothing works. ! HELP!

    • Mary says:

      Has your doctor/pain clinic tried a Dx of Failed Back Syndrome-cervical region? Sometimes this Dx is acceptable to insurance companies.

  21. Glynis says:

    I’m going this route after 30+ years of pain. I’m particularly committed because both my sons have inherited my CHD and migraines. My neurosurgeon is Dr Donald Smith of USF/Tampa General Hospital, Tampa Florida. I’d appreciate any comments and will send updates as things move forward.

  22. Glynis says:

    My first news is not encouraging. The surgery was a nightmare and the stimulation is no higher than the base of the skull neck area, where there is some slight prickling. There is almost no stimulation on the right at all, even though the device is maxed out. It’s a Medtronic 37743.

    Has anyone used a different device?

    I feel I did not push through the usual medical culture to ask enough questions before going through with this. Asking questions is not easy with medical professionals, but this is an area where patients do not know what they do not know.

    Another concern: they wake you up several times during the surgery, to ask you about what you feel, and I was disconcerted to find my doctor sitting on one side of the surgery room, and the technician, Lorie Montalvo, working in my neck. I don’t even know what qualifications she has, and her card merely says Clinical Specialist. When I explained exactly what I felt, my doctor said I was giving too much detail.

    Eeek – I have three psychology degrees and a lifelong interest in neuropsychology. I’m really worried that my terror of the headaches has pushed me to jump into a technology that is just not ready. The overall impression was that this is a very imprecise business.

    During the pre-op consultations, my doctor said that there was a 50-50 chance that the surgery would not help the headaches, but never that there was a real problem getting the technology to work. I mentioned that my husband massages the top of my head, and this helps my headpain, and he ran his fingers over my head from neck almost to forehead, which touched the areas where the ice-pick headaches are. He said this is where the stimulation would be, which seemed very reassuring. Except is doesn’t go higher than the base of my skull.

    I promised updates, and that’s it for the moment. I have a crashing migraine, have spent the day trying to get the right pain meds out of Tampa General, and of course the Medtronic people (“they will be your best friends”) have not followed up. Oh joy.

    50 million people have headaches in the USA. Perhaps this will help someone on their journey to a pain-free existence.

  23. Glynis says:

    Further information: The first surgery was about 2 hours. It’s not a minor procedure.
    Lorie is an RN, but does not need a clinical background for her position. It is, however, highly preferred.
    I questioned the difference between using a tens machine and this technique for limiting migraine. The explanation is that the effect of stimulating the nerve roots is different from (or more effective than) sending signals through skin and muscle layers.
    Medtronic followed up on the Monday after the surgery. The Medtronic 37743 is their latest device.
    My present thoughts are (1) that it’s really hard to know whether I want to keep this or have it out, but the decision period is from Friday to Wednesday. Today is the first day I don’t have a savage migraine, but my neck is still swollen, desperately tender and I have no idea whether this thing works or not.
    (2) This will probably work best for people who accept that medicine is often about exploration. This is not ye olde clinical culture where the doctor knows all the answers. It’s more like taking your computer to the computer geek who tries different options to get the software running properly. It’s also difficult because (continuing the metaphor) “the geek” asks you to help, and you actually don’t know what to say or how to help, even though you all want a good outcome.

  24. Gilles says:

    Hello fellow sufferers I have been suffering from migraines for the last 15yrs. I have seen a pain specialist for the last 4yrs. I have tried everything from meds to botox’s, chiropractors,acupuncture,massage, with no results. I currently take 1000mg extra strength Tylenol, 500mg of naproxen, and 1 zomig. I must take this cocktail every day as I get HA daily. My pain specialist has now recommended a occipital nerve stimulator, not sure about the surgery. I will keep researching before I come to a decision.

  25. Amy says:

    I am considering the implant for many of the same reasons above. After alot of research, Boston Scientific has the best implant. Their leads are more precise than the other options. Not sure if insurance will cover – it’s Aetna – we tried last year with no success. I’m at the end of my rope. Dr. Christopher Uchiyama – neurosurgeon – in San Diego – comes highly regarded.

  26. kelly einhorn says:

    I am 35 yrs old and have a history of migraines for 15 yrs. I have tried medication, I am currently on pain medications for my back and they don’t help for the migraines (occipital nerve migraines,cluster headaches). I just got a letter from my insurance company denying me for the trial of a spinal cord stimulator for these migraines. Is there anyone who could give me advice on how to get my insurance company to cover this?

  27. Sandy says:

    I have been suffering from migraines for over 22 years. I am on my third appeal for an ONS through Anthem but I’m told my chances are slim to none in getting this approved. I too, live in New Hampshire and use Elliot Hospital Pain Management as well as having a terrific neurologist up at Dartmouth Hitchcock. If there is anyone out there that has won an appeal, particularly with Anthem, I would love to know how they went about it. I’m at my wits end and would just love it if the ONS became FDA approved today!

  28. R. Nelson says:

    It is 12:30am and I just read through the 27 comments. Normally I would not post a comment, however there is a couple of things that need to be said. 1st: The ONS is not FDA approved approved for treatment for head pain. NO private insurance is going to pay for it. PERIOD. In fact there was a case that went to court in NH (look it up) and the case sided with the insurance company. All of the insurance companies have it in their contracts that they will not cover it for this use. You are wasting time with your appeals. (I speak from experience-I wasted valuable time, money, etc.) HOWEVER medicare part b will cover this procedure. If you are disabled, and many of us are, because of headaches/migraines and this procedure is the last possible option-this may work for you. Obviously, you would have to be under the care of a neurologist. You would have had to go through all of the medications, other modalities, psych evalutions, then a trial, etc.
    I just had the permanent stimulator implanted on June 26th. The road to get here was very, very difficult. I have to have the stimulator reprogrammed on Monday. My expectations are that this is not going to take away my pain…but at least give me quality of life. There are many issues with the ONS (thats why there is no FDA approval yet!!)so work with your doctor and keep moving forward! Good luck!

  29. R says:

    Two years ago, I realized when I turned my head, a shooting chronic pain started from the base of my left side of my neck, and followed a path up into the left internal mid scalp, with constant headaches only on my left side. I kept telling the doctors that I had a serious auto accident when I was younger, where I was ejected through the windshield, head first, onto a cement edge of the road. The pain made it impossible to drive, and no medicine, heat or cold, physical therapy or exercise affected the pain in any way.

    The doctors dismissed this history, although I was told by the treating doctors who saved my life, that later in life I would have increasing cervical and lumbar problems related to these significant injuries. I was finally referred to a neuro-opthomologist, who assured me nothing was wrong. Then, by chance, I found his final report on my website chart (he did not reveal his NAME on the chart). Obviously, the tests he performed indicated that my diagnosis was “occipital neuralgia”. I read about this condition, and it was consistent with the symptoms I had for almost two years., with educed the pain, which was crippling. thrown threw the windshield, my head .

    I spent the last two years going to multiple top specialists at the best teaching hospitals in NYC, who could not find anything wrong. (I think they thought I was a hypochondriac, who just wanted attention. I was sent to the Mayo Clinic in Rochester, MI, and no specialist diagnosed any specific condition. (It might have helped if I had known about the potential diagnosis which was made before my stay at Mayo.
    When I returned to NY, I saw a pain management specialist, triple board certified, who told me I did not have “occipital neuralgia”, because the pain was in the wrong areas. She gave me an extra strength aspirin, and another RX, which immediately gave me blurred, double vision. The package insert stated to immediately stop the RX, and call your doctor if this occurred. I had no intention of going back to her.

    I have read about the dangers of a spinal block in the location where my pain starts on my neck. But I can not endure this pain any more. It never goes away.

    Does anyone have any suggestions about what I should try next, without invasive surgery? I feel compassion for any one who has lived with this type of pain. Medicine is an art, but eventually I believe there is a doctor somewhere who has exceptional skills in diagnosing – probably the most challenging issue in being a physician.

  30. debbie says:

    How come all your comments are positive ones ? what about the many people who has had to have the device removed after spending 3 mths in hospital with a VERY serious infection , (RARE IN FACT) . I will be left wondering if my article will be printed for others to see ????

    • Debbie, the comments are all that I’ve received on the post. I (the blogger) am very skeptical about implanted nerve stimulators. I had one and had it removed. I’ve heard from a handful of readers who love them (though some who have gotten relief have had them removed for infection or because they just stopped working). But the research isn’t very strong for them and the more research that is published, the more problematic and less effective they seem. I’d love to hear your story.

      Take care,
      Kerrie

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