I Do Not Believe in Medical Coincidences

"Inform study personnel about any
symptoms, changes in medications, doctor's or nurse's appointments,
or hospital admissions that you may have had."

I remember reading that line in the investigational study protocol.

I remember thinking -- No problem.  I'm healthy.

And yet, today, as I was talking with the study coordinator, who is a research nurse -- on the Week 1 call as scheduled, I was sitting on the sofa, eyeing my very newly boot-clad foot. 

We reviewed the symptoms I have been experiencing since my gluten challenge last Tuesday.  

I happily reported that the headache that started while in the post-consumption observation window of my gluten challenge, that hung on, clinging to me for days had finally gone away.  

And then I had to share the details of what has been going on with my gastrointestinal system.  I told of the bloated, full feeling, the gas, the cramping, the queasiness that sometimes rises to the level of nausea (but not yet, thankfully, vomit).  I talked about not really feeling hungry, my struggle to eat, how quickly I feel full.  I shared that, thanks to many trips to the bathroom today, I have been feeling a little less full.

I explained that while all of my symptoms are the types of symptoms I have experienced after having a suspected exposure to gluten, none of them are as bad as they have been in the past.  I haven't been (thankfully) violently ill.  I haven't, as one friend calls them, had a "potty emergency."  I tried to explain, saying that it was like I am having a low-level, longer-duration reaction.

I told the study coordinator that I have had some hot flashes, some moments of light-headedness, a few instances where the edges of my vision go sort of...gray.

I added, almost as an afterthought, that I am very tired these days.

I had this feeling that while the study coordinator was carefully recording all that I was reporting, she wasn't terribly surprised.  It wasn't that she wasn't interested -- there was just something about how she sounded that made me think she wasn't particularly surprised by any of what I had to say.

As I got toward the bottom of my list of symptoms, I hurried to assure the study coordinator that as bad as it all might sound, I am fine.  She said something about how no one wants me to be miserable.  I assured her that while I do not feel good, I am not miserable.  I explained that I actually thought if it was bad, it would be much, much worse.  She laughed -- apparently she'd heard that from other study subjects, too.  I reminded her that I am very committed to the investigative study, and that I want to see it through, despite the symptoms I reported (the symptoms that ended up feeling more like complaints).

If I thought it was uncomfortable to write about my symptoms, this -- having to talk about my symptoms in detail -- was much, much more uncomfortable.

The study coordinator -- I think recognizing my discomfort -- thanked me repeatedly for my detailed reporting of symptoms and very clear descriptions.  She called me the "ideal" study candidate.  She then shared with me that several study subjects have reported very similar symptoms.  Ah.

That gave me pause.

Should I even know that?

And what did that mean?  

Does the fact that I am clustered with others who are having symptoms mean I am in the control group?

What are the odds of THAT happening?

  (For those new to our story, my daughter was in a Phase 1 Clinical Trial for her peanut allergy called PRROTECT.  There were 9 subjects at her study site and 2 received placebo.  She was one of them.  While in the end, all is good, we learned an awful lot about anaphylaxis along the way...)

As I was wrapping up my litany of symptoms, I eyed the (new) boot.

I took a deep breath.
I knew I needed to "report" it, but it felt sort of ridiculous.


[The Backstory]
At some point relatively early yesterday morning, I realized that my left foot/ankle hurt.  I was busy getting my oldest daughter out the door to skate before school, then busy with our younger children and all that is entailed in getting them ready for school.  It wasn't until everyone was where they needed to be that I realized that my foot/ankle really hurt.  

I wasn't terribly concerned, because I hadn't done anything to my foot, so how bad could it be, really?

I sat down to look at my foot/ankle and wondered if it was maybe slightly swollen.  I wasn't sure.  I stretched it a bit, rolling it around until it started to hurt more.  I was hoping that whatever it was would just resolve, but by mid-afternoon, my foot was throbbing, and definitely swollen.  I delegated driving.  I put my foot up.  I fell asleep.  I iced my foot/ankle.  I directed my kids through homework and dinner from the sofa.  I thought about Advil, but I knew I couldn't take any medications without consulting with the study coordinator, so I held off.  I sort of wanted to keep tabs on how it was feeling anyhow.

I kept my foot elevated and iced it off and on all night long.  When I went to bed, I was vaguely aware that it was throbbing, but I was so tired that I fell asleep anyhow.

This morning, when I got up, my foot/ankle was decidedly more swollen -- and more painful.  With a trip for work looming later in the week, I felt like I might have to actually do something about it.  I called a dear friend who is expert in matters of orthopedics and she confirmed what I was already thinking, that I should go get it seen.  

(I kept thinking -- but I didn't DO anything to my foot.)

So I took myself to IBJI Ortho Access (LOVE the concept) and within a relatively short period of time, my foot/ankle had been evaluated and x-rayed.  After poking around at the puffy joint on my ankle bone, the doctor asked me if I have gout.  I gave him a puzzled look and said something to the effect of not thinking I did.  He responded that I would definitely know if I did.  

As we reviewed my medical history and he inquired about current medications, I found myself looking down self-consciously.  I had to tell him that I didn't know what my current medications are.  I explained the investigational study, and told the doctor that since it was a double-blind study, while I was taking a daily dose of the "study drug," I did not know if what I was taking was a placebo or Montelukast.

The doctor sat down, and I could tell he was suddenly just a bit more interested in things.  He wanted to know about the investigational study, the gluten I am eating, the common uses of Montelukast.  Then he asked how much longer the investigative study would go.  He gave me a look when I said quietly "seven weeks."  (Actually, I'm at 6 weeks and 5 days, for those keeping track.)  

He said that the medication he wanted to prescribe would likely disqualify me from the study.  He went on to explain that he was going to prescribe a 6-day Medrol Dosepack (basically, a LOT of prednisone).  He said it would reduce inflammation, probably decrease pain associated with swelling and allow for better healing.  I looked steadily at him and asked, "What if I don't want to take it?"  It wasn't a challenge -- it was a real question.  I explained how invested I am -- at this point -- in the study.  I said things like "upper endoscopy" and "stool sample" at which point he suggested I take the written prescription with me, that I discuss whether or not to take it with the doctor running the investigative study, and that I be sure to take the written prescription with me on my business travel.  Relieved, I agreed to all that.

I have had a few thoughts of my own since I left the orthopedist this morning.  I am remembering the moment of unsteadiness I had yesterday morning as I got out of bed.  It passed quickly, but I have a vague memory of putting my foot down hard, maybe fast, as I waited for my head to clear, for the room to steady.  It wasn't a big deal at the time, and it didn't hurt.  But, now that my foot is as it is, and I am reflecting on what might have caused it to be that way, I cannot help but wonder...

A part of me thinks more sophisticated imaging might be in order, but for now, I am going to wait and see.  If there IS a stress fracture, or something else going on, treatment wouldn't be any different than what it is now -- just longer.

[Back to the Study]

As I was feeling ridiculous -- about to report some non-injury injury to my foot/ankle, I received a text from the dear friend who had advised me to get my foot/ankle seen.  She wondered if the inflammation was related to my gluten consumption.

With the study coordinator waiting on the other end of the line, I laughed one of those sort of uncomfortable laughs and said -- "And there's one more thing."  And then, because I still felt sort of ridiculous, I added, "My friend thinks it might be related to the fact that I am eating gluten."  (Like I needed to somehow justify what I was about to say...)

As I filled her in, I could hear her interest growing.  She listened raptly.  She asked several questions.  I concluded by telling her that I did not want to take the prednisone if doing so would disqualify me from the investigative study.  I have too much invested at this point to do that.  

The study coordinator was quiet.

I wished I could hear her thinking.

When she spoke, she was clearly choosing her words carefully.  I understood why, as she explained to me that several other subjects had reports of significant unexplained swelling and/or joint pain.

Ah.

So I am not alone.

That gave me pause.

Should I even know that?

And what did that mean?  

Does the fact that I am clustered with others who are having symptoms mean I am in the control group?

What are the odds of THAT happening?

I do not believe in medical coincidences.

I wonder what this means?

For now, I will wear that boot.  

I will rest.  I have cancelled my walking dates.  I will not be issuing any FitBit challenges any time soon.  I have no idea when my Pokemon Go! eggs will hatch.  I will rest.  I will keep my foot elevated.  I will do all that I can to allow whatever is going on to heal without further intervention.

Late this afternoon, the study coordinator texted me.  "You can take some ibuprofen.  That should alleviate some of the swelling."  It has also, thankfully, alleviated some of the pain.