[Rehabilitation / Postoperative Spine Surgery Publications] Fibrin Sealant-Clinical Trial Participant

[RonM]

This is not surgery and I am not pretending to have gone through what you guys have, but I wanted to share with others who may be interested. I would also like to add that in sharing my experience I do not know if I have taken the placebo or trial drug.

I have had what I consider to be moderate back pain for about six years. I decided against surgery a couple years ago in hopes of surviving until the stem cell treatment problems were solved. I do not have the personalty type to just sit back and take what comes my way which in combination with a bit of desperation eventually led me to take the risk to volunteer for this trial.

After going through a brief sign up on their website it took about a week for them to call me back. They want basically every medical record you can possibly get that has anything to do with your back and if I am even close to typical you will have many and it takes a little time to gather them all so you may want to start this process before they even ask. I have decided it is a good idea to just go ahead from now on when I get treatments for my back to go ahead and request whatever records are generated. Of course in this trial they won't release them to you until it is completed.

About a week after I sent my records in they called me back and said I looked like a good candidate and I scheduled an appointment to talk with them in person and another appointment for a discogram and facet injections. They are very serious about seeking specific injuries for inclusion. They do hint that there may be an expansion and they did say they are seeing good results although most of the pain relief has not been permanent and they do have a theory on that but cannot move forward without more data to submit to the FDA.

I'd like to add that if you make it this far that you will go through the disco gram with no medication and while it is pretty painful it really isn't much worse than what I would consider a bad flare up. I understand everyone is different but I had this big thing built up in my mind after watching videos on youtube and after it was over while glad it was over I kind of wish I would not have stressed so much over it before hand.

The facet injections that I had really were not a big ordeal and I do not have much to add about this part as they came right before the discogram and I was so stressed over that and really not concerned about the facet injections.

I ended up having damage to more than one disc but only one disc was generating my pain which qualified me for the trial.

They require you to wait two weeks before you come back to start the trial. I had to wait three due to work obligations and it seemed like an eternity and it was then that I realized that I really have to do something to rid myself of the pain. On day one you go back and fill out numerous forms as you can imagine and I'm not gonna go into much detail but it's informed consent and baseline pain evaluations. You also get a baseline MRI and multiple X-rays done. If you have had back pain it is very routine type stuff from my point of view.

The big day follows and it was much more than I had expected. I honestly was expecting something along the lines of a steroid shot like I had many times before. They make you put on a surgical mask and roll you into a room where everyone is wearing the masks and blue things covering their hair and I was thinking what the heck is going on. I then woke up in a recovery room in fairly severe pain. I'd say my normal pain is about six out of ten and I was at at least a nine out of ten. I asked if it was supposed to hurt that bad and they were all very evasive. I am guessing it is what comes with a trial and had no real issue with it at that point. After recovery I faced a four hour car ride home and the doctors didn't offer any pain medicine and I really wish I had taken some with me. I was able to sleep some but as whatever it was they gave me before the procedure wore off the more difficult the trip got. It's all bearable so I do not want to be overly dramatic I just want to include what is involved for those that follow me that may be interested. If travel is involved it may be worth consideration to get a hotel room for an extra night. For two days I would get severe muscle cramps and as a former athlete I really mean severe with even the slightest movement. When I removed the bandage the day after whatever they did was done the bandage was fairly bloody.

The following two days walking was very difficult. I kind of have an issue with them over this and I don't know if it is because of the study but I had no warning until after the procedure that they require you to not return to work for 72 hours. Be prepared for this. It took me longer than that. I returned from a one week check up today and they said some people are more tolerant than others of the procedure and that one guy played golf the day after his was done. I intend to return to work tomorrow even though I am still in greater pain than before but I am improving daily.

I'll post updates as they come along in the possibility they may help someone else down the road but I will say that a week out and in greater pain than before I started I am glad that I at least took a chance. If you are considering this I would say that you must consider how tolerant you are of risk as there is a risk of the placebo combined with all the unknowns of an unproven drug.

I want to add that I am not trying to convince anyone to do this or not do this but I am just trying to share my experience to help you make your own decision.

[KanRunMo]

Thanks for your information. Keep us updated as you progress.

[Justin]

Ron, thank you for sharing your experience. It is most appreciated.

[RonM]

I had a four week follow up visit today. It consisted of several questionnaires on pain level and functions. Was about an eight hour drive for a twenty minute office visit. I despise sitting in a waiting room after my appointment time and was pleasantly surprised they actually called me back a couple minutes before my appointment. They said next week will end my weight restrictions. Overall I am in only slightly more pain than if I had done nothing which they seemed disappointed in but it is what it is. My hope is that after next week I can start to rebuild some core strength and get some positive results. They said to start very, very slow and gave the impression that some people had done to much to early. They said to do about half what you would think would be taking it slowly.