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Great news and questions about Biacuplasty.

JessyLovestheCubsJJessyLovestheCubs Posts: 43
edited 06/11/2012 - 8:44 AM in Chronic Pain
Hey everybody I made a trip to the Cleveland Clinic this past Friday to a pain management doctor. It turns out the doctor I saw (edit) is one of the most well known pain management doctors in the world...and I definitely agree!

I brought my MRI that all my other doctors said showed nothing and guess what? He found something! My L5 is completely black with a white spec on it. My last doctor said, well this is abnormally dark but it doesn't mean anything. Well my new doctor thinks I have a fissure in my L5 and is having me do a discogram, which is what I asked my last doctor about and he yelled at me saying absolutely not (It was the same guy that told me I was faking it.) He was the first doctor I've had the explained why someone so young could have back pain. He said that usually when kids are 14 or 15 and they fall or something and get a fissure they usually start showing symptoms in their 20s. It makes so much sense because I fell all the time when I played soccer as a teenager.

The doctor was so funny. He kept looking at my charts and yelling why have you not had a discogram?! And then he looked at the names of my previous doctors and said they don't know what they're talking about. He was so eccentric and knowledgeable. He explained every thing to me in detail and kept citing recent medical journals and different things that are going on all over the world regarding low back pain.

Ok so here's the deal. After the discogram (if he shows what he think it will) he wants me to have a biacuplasty. Anyone heard of it? It's a new procedure in its early stages but so far they have had great success rates.

Well, let me know if any of you have heard of biacuplasty, edit, or have any information or advice on discograms.

Edited by tamtam doctors names not permitted on spine-health.


  • I wish my pain doctor did that!
  • Biacuplasty is a procedure that is still in its early stages of testing. Its efficacy has only been studied previously in human cadavers and pigs. Your doctor is the lead researcher on some of the literature on this new procedure and so has an interest in recruiting patients who will consent to participating in clinical trials on humans, a study sponsored by the Cleveland Clinic -- National Institutes of Health clinical trial #NCT00749554.

    See this link for details on the clinical trial:


    Please know that, in order to conduct a proper study of this procedure's effectivness in alleviating back pain, some of the study patients will receive a sham ( placebo) treatment, and you will not know if the actual radio frequency ablation was performed or not.

    No one can tell you what you should do; it's up to you to do some research and decide if a procedure is right for you given your own unique situation. But I hope your doctor did disclose to you that he has an interest in guiding you toward this procedure as opposed to other treatments that may help you.

    I wish you all the best.
  • I ma so happy for you kiddo...I know you have been through alot but it makes me feel better when I read posts like yours that with enough diligence that you can find answers and possible relief.

    I do not know much about the procedure you mention but I do know too much about a discogram. Please be prepared as it is not pleasant but I believe you like myself are willing to go through what it takes to really get to the root of it.

    This really has made my day. I was always troubled when I read your posts.

    The right doctor can make all the difference.

  • Kind of surprised as the description of it is very similar to an IDET but using radio frequency.

  • Babybubbles, that study started in 2007. Did you check pubmed for any recent research?

    eta: Indeed, here is a 2008 6 month follow-up.


    and a 12 month follow-up in 2009.


  • Is that something I should consider having?
  • So I might not even get it? I can't travel 10 hours to be in a placebo group. I want something to fix me this isn't fair.
  • Do not let these posts confuse you. Discuss this with your Doctor. I am now involved with a study but the Doctor probably would have told you this already. If he did not use the word study than I would say that he plans on just giving you the procedure.

    But again one step at a time, discuss with your Doctor and in anycase you first will have the discogram. After you have the discogram and receive the results than the Doctor will tell you your options in more detail. You can than ask him these questions concerning placebo group, difference with IDET and anything else you will have...

    First step is discogram, when is it scheduled for?

  • He did say is was a study. We don't have the discogram scheduled yet.
  • HappyHBmom, here's the start/end date listed on the NIH website:

    Estimated Enrollment: 8
    Study Start Date: September 2007
    Estimated Study Completion Date: September 2010
    Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

    So it looks like they are still recruiting. The trial paperwork states that the doctor who performs the procedure (or the sham procedure) is not the one who will be following up with the patient. So, your consulting doctor won't know which group you were in either. The study will be "unblinded" after six months -- they'll tell the patients which group they belonged to (real or sham) probably sometime after March of next year.

    Jessy, you really need to talk to your doctor, and don't be shy about getting a second opinion if you want one. This is actually a very small study (8 participants), and probably half of them will actually receive no real treatment at all (they'll put in the probes, and the machine will buzz, but they won't use any heat). The doctor/researcher involved must disclose that to you, and participants have to acknowledge that they know they may be in the placebo group. You will not know which group you were in, and they cannot tell you.

    The paperwork also states that, if after 6 months the procedure has good results for the participants who actually received it, those in the placebo group will be offered the real procedure.

    Is your pain bad enough to consider being part of an experimental group where only some of the participants really get treatment? Can you wait until next March to know what's really going on with your condition and if you even really had the procedure at all? For some people, the answer may be "yes". Just be sure your doctor is straight with you about the fact that this is an experimental study.

    Best wishes to you.
  • But the statement "they've only done this on cadavers and pigs" was quite misleading. The outcomes so have been extremely positive.

    Jessy, I think if he said it was this study, but you weren't clear that you only have a 50% chance of actually getting the procedure then you should think very hard on this.

    However, this might not be the same study he was talking to you about- there might be other outcome studies at this point that are not placebo controlled. Discuss it with the doctor.

    This procedure looks very interesting, and the outcomes look quite positive!
  • It is actually the same study. He told me about how it was done on pigs and stuff. I already talked to my mom. I'm not going to do it. I'm going to still have my discogram but I'm not going to do any trials, I just want to get fixed. there are other things I can do besides biacuplasty.
  • Can you send me the link to this info? Thanks.
  • oops, sorry I saw you already posted it.
  • Having the discogram is good. No telling when they will get approval for that procedure, but they might (as I mentioned) have follow up studies that are not placebo-controlled since the outcomes for this study have been so good.

    But there are other methods as well, you should ask him about non-investigational techniques.
  • I haven't been posting much lately but I have been following your story. I am happy to hear that they are finally willing to do a discogram. (Sorry that it sounds like the trial won't work for you).

    I had to wait a LONG time before they finally did a discogram. Fortunately, it was positive for the disc that the doctors though might be bothering me and now I am going to have surgery.

    I just wanted to wish you luck. I will also warn you that, if it is positive, the discogram can cause a great deal of pain. The doctor actually stopped me before the procedure to make sure I fully understood this. I'm not saying this to discourage you. If your doctor wants you to get it done then you should go ahead with it. (I am happy I did) Just find out whether or not they will be able to give you some pain medication afterward and bring someone with you to drive.

    Lots of luck!

  • What kind of surgery are you having? I have been asking for a discogram for a long time and finally they are giving it to me. This is the first doctor I've had that is concerned with diagnosing me. The others have basically tried to treat something they didn't know. I'm glad I'm finally getting it. Hopefully it will be positive. I know it will hurt badly but I'm ready for a few minutes of pain if it will be able to tell me whats wrong with me.
  • I will be having spinal fusion at L4-L5 in July. The doctor felt that the discogram was the final step. He said he would only do surgery if it was positive on the one level. He did not want to do surgery on more than one level at my age (too young, too many fusions in my future, yadda, yadda).

    I won't lie - the pain was AWFUL and they ended up doing four levels because pressure built up way too quickly at the test level. But the prep was not too bad and the pain was "typical" at L4-L5. It was probably the worst pain I ever felt at that level but it was the same type of pain I had been experiencing. Afterwards I was a bit sore and very stiff.

    I hope your's is positive too, since it sounds like you have tried everything else. At the very least they should take you more seriously once they can "confirm" where the pain is. I just hope it doesn't hurt too much ;)
  • Take a step back, read your original post that demonstrates your optimism, and keep an open mind. You should not make an assumption based on what someone dug up from the internet. Talk to your new Doctor and get the scoop from the horses mouth. He obviously believes you have a problem. There are lots of studies going on out there. BB is correct that the end date for that study is Sept 2010. What she didn't mention was that was the estimated end date. It's possible that the study has ended and a new study has begun.

  • I understand that it is a study and I think you should do as Dave suggested in take a step back and really think about it and ignore all these posts. The most important things right now:

    1) You have a doctor who is listening to you and believes your pain. He is also a respected doctor and a respected facility.

    2) You are going to have discogram which means with or without your participation in the study you will get a definitive diagnosis concerning your potential pain generator at L4-L5.

    Wait for the results of the discogram and discuss with your Doctor cause at that time he may change his course of action. Mine stated with wanting an IDET right away but instead went down the epidural path first.

    So please get that Discogram, stop posting here and come back once your have your results and the course of action the Doctor recommends.

    Good luck...and stay free.

  • Clinical trials must be registered with the government (www.clinicaltrials.gov), and this is where the information was found.

    The doctor that Jessy saw at the Cleveland clinic is the lead researcher on a Phase I trial that is listed as currently recruiting. He wants to recruit her for his study, but as a treating physician he has a duty and an obligation 1) to tell her it is a experimental trial and that she might receive a placebo treatment and 2) to explain other currently approved procedures that can help her. That was the only point I was trying to make. Note that this particular study has to go through three more placebo controlled phases before completion.

    The University of Alberta and Baylis Medical Company are sponsoring a Phase IV *placebo controlled* trial of biacuplasty in Canada.

    These are the only two biacuplsty trials listed with the government.

    For anyone who doesn't know how clinical trials are conducted, see this link: http://clinicaltrials.gov/ct2/info/understand#Q19.

    The following is a quote from that page:

    What are the phases of clinical trials?

    Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

    In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

    In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

    In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

    In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

    It's unfortunately if some of you think I'm trying to rain on Jessy's parade, as that was not my intention. I just want her to know as much as possible, ask questions and hold out for all the answers. The one thing it breaks my heart to read is when someone says, "I didn't know!"

    Jessy, if you're reading this, I hope you keep strong and keep moving forward. I believe there is help out there for all of us, even if it seems to take far too long until we know what it is.
  • Babybubbles, we can see that you're pretty negative on the whole thing. It seems he did fully disclose that this was a clinical trial to her. There was really no reason to scare the living daylights out of the poor girl with talk about cadavers and pigs.

    It's a decision she should make with the doctor and her parents. If this turns out to be the best option for her, then great.
  • Everyone, I've done my research and talked to my parents and this is not for me. I'm not being negative, I'm getting the discogram, so there. I can't just go discuss this with my doctor because he is in Cleveland, I am in Iowa City, Iowa. I know for a fact it is the same trial, it's not that big of a deal. I'll just get something else done. My doctor has a friend at the University of Iowa Pain Management place so that is who I'm going to see.
  • Why on earth would you go to a physician you can't have a second visit with? If you're going to have a procedure, it would seem you'd want to be able to discuss it with the doctor as many times as you want! Especially if it's an investigational procedure!

    I am beyond confused by this entire thing. I think it's time for a bath.
  • The point is, HappyHBmom, someone else would do the actual procedure, not her physician. It is a double-blind study, and her physician will not know if she received real or sham treatment.

    I don't know why you continuously seem to be angered by my posts. Jessy asked for information about the procedure, and I gave her information that is available on the clinical trials website. I did not get the sense that she was frightened by my use of the words "cadaver" and "pig", I assumed she is an adult. The suggestions that I should be ignored, that I am clearly negative, that any information should be withheld because someone is "sensitive" are not only hurtful to me, as I think was intended, but do absolutely nothing to help Jessy.

    Jessy did later say she was told it was a study, but did not say if she was told about the possibility she would receive no treatment and thus, no pain relief.

    I think each of us has an obligation to become as informed as possible when it comes to our healthcare. The suggestion that *anyone* should just shut up because it might frighten someone else is simply unbelievable, if you know anything of history. I never gave advice on whether the procedure would or would not work, I simply stated facts that need to be weighed.

    Before you cast stones, please think of your own behavior. It was just a day or so ago that someone here was trying to talk a woman out of a multi-level fusion recommended by her doctor, based upon "research." It cuts both ways.

    Jessy, I'm truly sorry if this whole thread turned into something that wasn't about helping you. That was all I wanted.

    To the moderators, I apologize as well. I'm a new arrival and hope to have some things to contribute and some things to learn. But every internet community has its own special mindset, member makeup, and self-proclaimed experts (the "alpha" posters). I've learned something useful in this thread about SHs own alphas.

    As for me, no further reading, no further replies. Have at it all you want.
  • The discogram is the first step and the most important one. I do not understand though is will you be doing it in Cleveland or somewhere else.

    You will than need to find a Doctor you trust with the results.

  • I am not angry, I am annoyed- entirely unsimilar emotions. But I am also a chronic pain patient and annoyed is rather a freqent state of mind. You'll find it a lot around here.
  • Oh sheesh everyone. I am an adult by the way. I'm almost 21 so need to to talk down to me.

    I went to Cleveland to a well known doctor as a last resort because no doctor around here would listen to me. Thankfully he found something and ordered a discogram which I will have done in Iowa City by a doctor whom the doc in Cleveland recommended. He will be the one I go to to discuss things. It isn't ridiculous to go to Cleveland when I can't go back all the time. I got what I needed out of the appointment. I stopped coming to this site for a while because many people on here seem to be grouchy. Guess what, we are all in pain there is no need to bash each other. Positive attitudes do wonders.

    Thank you Babybubbles for giving me that info, I am so grateful that you posted it and so are my parents. We could have made a 10 hours trip to Cleveland only to be told I could have a chance of being in the sham group.

    Ok, so can everyone quit? How about you all take a step back a think about what you're typing and how it can be conveyed by others. This site is supposed to be a place for support, not nagging and arguing with one another. Be happy. I don't care if you're in pain, there are 100000 people out there who have it worse than we do. Using our pain as an excuse for bad attitudes gives all of us a bad name. Be happy...life isn't that bad!

  • Jessy-
    I wish you all the best, with this doc or another, with this clinical trial or another recommended procedure.

    I am just curious if the Mayo Clinic guy is helping you manage your pain between now, the discogram, and the treatment.

    We all feel a little better when our symptoms are validated by a diagnosis, but in the interim, I'm assuming you're still in pain. Were you given any help towards daily life?

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