Pain Scale

That Darn Pain Measurement Scale

Let’s talk about the pain measurement scale. Oh, this is a dangerous subject, isn’t it? I feel I am bound to upset someone!

Different people experience pain differently. Bottom line, it is subjective, there is no way around that. I suggest there is double subjectiveness happening when we try to “measure” pain. There is the patient’s subjective assessment of their pain, then the clinician’s subjective interpretation of the number provided by the patient.

Medical science has given us fantastic innovations. X-rays tell us very quickly if a bone is broken. We can quantify temperature and blood pressure. But not pain. Modern MRIs, CT scanners and ultrasounds let clinicians assess things their predecessors could only dream about imaging 100 years ago. But not pain.

When nurses and doctors go through their training, they aren’t at any point hooked up to a machine that inflicts level 10 pain. So if I say 10 to a doctor, how is that interpreted? I suggest if the doctor has experienced severe pain themselves, their understanding of what that 10 means is going to be better, irrespective of training, than the understanding of a doctor who has experienced nothing more that a vaccine injection or a blood test. Yes, of course lectures cover “bad pain is really, really bad” and they see patients in excruciating pain after car accidents and fires and so on. I’m not saying they have no idea: but it is different to personal experience.

Neither, of course, are patients ever “instructed” via a machine “this is a 10, for future reference”.

For every single one of us, the zero is about the only value on that scale we can all categorically agree on.

If the most serious pain a patient has ever felt has been the prick of a blood test, a broken toe is going to be, in comparison, quite painful. We assess pain severity based on our personal experience because we have nothing else to go on. Whenever I tell a clinician my pain is an 8 or above, I qualify that statement with “for me a 10 is waking up from my hysterectomy”. I’ve related before about telling my GP on one occasion my wrist felt like someone had stuck a scalpel in it and when I saw the look of “oh yeah, right” on her face I followed up with “I stuck a pitchfork right through my foot once”. Her response was, “You know what a puncture wound feels like”. Yep, I do. My foot ended up almost the size of a football. Not fun.

Yet the scale we have is ……. what we have, at this point in time. I like to think that at some future point in time we’ll be able to measure pain using some form of medical technology. I’m completely theorising here, but maybe image brain waves or tap into nerve activity in some way.

Anyone understands that undergoing surgery, being “sliced & diced” as I call it, is going to be painful. so we have anaesthetic and let the patient “sleep” through the procedure. So even if a person has undergone surgery, they didn’t actually feel it. Post-op? Well, I know from my own experience that can either be quite painful or virtually pain-free. My bilateral foot surgery post-op recovery, for example, was virtually pain free. That was a big yippee from me, let me tell you.

Childbirth is painful. Has anyone seen those clips of men subjecting themselves to simulated contractions? Whip through to about 16:40 if you want to see just the reactions.

Maybe all clinicians could be subjected to something similar as part of their training. It is OK, I’m not serious – well, not really anyway.

A doctor said to me recently, personally experiencing pain (the doctor had hurt their back) gave a bit of a new perspective. I didn’t mean to, but I did laugh, because while I’d been thinking of this article since I was last in hospital and took the picture of the pain scale featured here, I didn’t have much experience other than mine own, or my GP’s and my chat about childbirth, to use as illustrations! That one sentence essentially supported what I am saying: experiencing pain personally provides an otherwise only imagined experience. Reminded me of a situation over forty years ago in a maternity hospital. I was lying in my post-natal ward, a new Mum arrived in the bed next to mine. Seemed very distressed. Not the usual new Mum demeanor at all. Somewhat concerned I went over to her and asked if she was alright, could I call a nurse. No, she told me, following by, in hushed tones, “I’m a midwife. I can’t believe how tough I’ve been on my patients.” That’s not verbatim, my memory is not that good after forty-odd years, but she did go on to talk about, yes, you got it, pain. Her perspective was now rather different. She swore she would be a much better midwife in future.

Even if we could technically quantify pain with a machine, that would not completely solve the problem. We all have different pain tolerances. By that I mean, if we could use a machine, it might determine that the pain is technically a 5. One person with a high pain tolerance may experience that as only a 3, while another may experience it as a 7. Think about sweetness. One teaspoon of sugar is one teaspoon of sugar. Yet to one person a teaspoon of sugar in a cup of coffee or tea would be horrendously sweet, while another would need another teaspoon. Absolutely nothing has changed about the sugar though. This is where we could run into problems in relation to pain management/pain relief. “Your pain measures as a level 5, this is what you get to reduce your pain”. That may not work. Might be too much or not enough, depending on the person. Not to mention other reactions to medications. Given the typical dose of morphine, another woman I know and I have quite different reactions. She hallucinates and sees spiders eating her legs, I’m up making coffee. Consequently she was only given the “typical” dose once.

Then there is the time factor. I can cope with my pain for a few days: after a few days, let me tell you it starts to get VERY draining. Tiring. Our resilience drops. Once the resilience drops, the pain may feel worse, even if it actually isn’t any more severe than it was the day before. With my current little (OK, not so little) issue, yes, I have resorted to the big guns on a couple of days this week, and probably will do so again before the new medication kicks in – assuming it will kick in. Eventually.

In my particular case, the pain rises overnight, is worst when I first wake and I can usually get rid of MOST of it by 10:30 am. The rest of my day I can do the things I need to do: walk, swim, weight training.

My brother-in-law, different conditions and much sicker than I am, has been on ever increasing serious pain medication every day for several years now. I am relatively lucky in comparison. Even so, none of us like pain, whether it be a pitchfork through the foot, post-op pain, or chronic pain. Although I juggle a few conditions, only one of those causes me pain. Other people are not so lucky, they have multiple painful conditions.

To further complicate the pain issue, what of those of us who do not feel pain when perhaps we should? I’ve mentioned that before too, as I am one of the patients considered to have some wonky pain sensors. Not all, by any means, just some. But this poses other risks, in that I do not always realise something is “bad” when it actually is, such as the infected tooth discussed in that linked article. Neuroplasticity is a major field I am not going to delve into in this article, however, wonky wiring is not an undiscussed topic. My right (unoperated) knee actually fits an example given in the below article: that knee is wrecked on imaging, but I am not in pain from that damage. The below link is to a story by Paul Biegler, author of “Why does it Still Hurt”.

Why do some people suffer constant physical agony from their injuries and conditions, while others with identical problems remain fine? The explanation may lie in the brain – and its wonky wiring.

“The brain is responsible for what we feel, but it doesn’t get it right all the time.”

https://www.smh.com.au/national/hurting-so-good-the-pain-in-the-strain-may-be-mainly-in-the-brain-20221205-p5c3r7.html

My suggestion to fellow patients is to provide some comparative or functional context if you can when describing your pain to a clinician. I use my hysterectomy: that’s not a option for everyone! Childbirth can be a useful comparative, depending on your audience (female doctor or nurse who is a mother, for example). Functional descriptions can be useful, as in “I cannot lift my arms above my chest, the pain is too severe” or “I cannot drive the car” but I find them less so. Recently I couldn’t open the coffee jar. I needed two hands to lift the milk out of the fridge. I could not put on a t-shirt as the shoulder movement required to achieve that was too painful. I should perhaps add, (usually) if I sit and do absolutely nothing, nothing hurts. That’s the nature of my disease. As soon as I move something – THAT is when it hurts. So it is a different pain pattern to that which will be experienced by many readers with different conditions.

The pain measurement scale is what it is at this point. Until science finds a different/better way, we all, patients and clinicians, have to muddle through with what we have, as imprecise as it is.

Robyn DunphyLeave a comment

Movement! Exercise! Weights! Health!

Over the last few weeks, I have noticed a few articles in various media about the general health benefits of weight training. All regular readers know I am a strong supporter (OK, advocate) of weight training for ALL adult age groups including my own and older.

The first I noticed was “How Your Muscles Affect Your Mental Health“

Muscles at work secrete tiny chemical messengers called myokines that exert powerful effects on organ function, including brain function.

Early 2018 I wrote about the importance of mental health especially when managing chronic conditions. Now it seems with resistance (weight) training, we can kill two birds with one stone! Help ourselves physically and mentally at the same time. This is very encouraging.

I’m on the Pacing UP journey at the moment. My personal best on the leg press in 160 kgs (back in 2018). I did 90 kgs today, will do 100 kgs on Saturday. No, I may not get back to the 160 kgs, but it can’t hurt to try! Plus it makes me feel better!

I’m careful though. I’m asking the gym staff to put the 20 or 25 kg weights on the leg press for me as my wrists don’t like lifting those weights onto the leg press – at the moment. Don’t be afraid to ask for help.

Then The Guardian published “Exercise with weights linked to lower risk of early death, study says“.

Adults who reported meeting the aerobic activity guidelines and weightlifting at least one or two times every week were found to have a 41% to 47% lower risk of premature death.

While many chronically ill patients are younger than I, I am in the older demographic. While I LOVE lifting weights, I do find it challenging to encourage others my age to do so. Hopefully research such as the above will help! For the record, I do weight sessions three times a week, roughly 30 minutes each time. The weights don’t have to be huge! The above photo has small weights, ankle weights, a hand weight for walking with and a resistance Thera band.

JAMA recently published “Association of Dual Decline in Cognition and Gait Speed With Risk of Dementia in Older Adults“

In this cohort study of 16 855 relatively healthy older people in Australia and the US, a dual decline in gait and cognitive function compared with nondecliners was significantly associated with increased risk of dementia. This risk was highest in those with both gait and memory decline.

No, the above article doesn’t look at weight training, but it is about movement and exercise and staying physically “on point” if we can. Something I am aiming for personally is to get back to my old walking pace of 6 kms per hour. Now, my GP kinda rolls her eyes at me given my total knee replacement, bi-lateral foot surgery, psoriatic arthritis and age. She could have left the age bit off, but she didn’t.

I’m just not quite there yet. I can do that pace, but not for long enough. Yet. Having goals is something to strive for though – while I accept I may not get back there, that doesn’t mean I should give up!

Exercise generally and the relationship to the onset of dementia is of course a big part of the study I am currently participating in. The study is still recruiting, so if you meet the criteria and are interested, contact them!

https://www.betterbrains.org.au/

This following article I do find a little worrying, given I am, technically, a complex comorbid patient. I have edited this article of mine to add this reference, as I forgot yesterday. I am far from infallible! The article is “Two or more chronic health problems in middle age ‘doubles dementia risk’.

After adjusting for factors such as socioeconomic status, diet and lifestyle, having two or more conditions aged 55 pushed up the risk of dementia almost 2.5 times compared with people who had none. Developing two or more conditions between 60 and 65 was associated with a 1.5-fold higher risk.

Retirement is working for me! Well, not being retired per se, but having the time to do more Movement As Medicine stuff WITHOUT draining my internal battery is working for me. I’ve upped my daily step goal to 7,500 every day. It was 5,500 on my weights and swimming days while I was working, 7,500 the other days. I’ve paced up.

Robyn Dunphy6 Comments

Underlying Conditions

In 2017 I wrote Why Do Our Bodies Attack Us? Like many of us, I wondered WHY did I have a chronic condition (otherwise often known as an underlying condition). Most of my working life has been about root cause analysis – naturally I apply that to myself! It is a bad move, I don’t recommend it, you can drive yourself nuts!

More recently, December 2021, I wrote Will Society Adapt? When? How? looking at society’s lack of acceptance of chronically ill people. I specifically noted I wasn’t looking at environmental impacts in that article, but we can’t ignore the impacts we ourselves, as a species, have created in the same span of the last 100 years or so. In that article I proposed society has yet to adapt to this new chronic state of health, and I referred to my generation as being the first generation of chronic people in any great number. I essentially attributed our survival to improvements in medical science keeping us alive, but why do we fall sick in the first place, in ever increasing numbers?

Regular readers will know I am a big supporter of the work of Julian Cribb, an Australian author and fantastic science communicator. He has recently released Earth Detox – How and Why We Must Clean Up Our Planet.

Every person on our home planet is affected by a worldwide deluge of man-made chemicals and pollutants – most of which have never been tested for safety. Our chemical emissions are six times larger than our total greenhouse gas emissions. They are in our food, our water, the air we breathe, our homes and workplaces, the things we use each day. This universal poisoning affects our minds, our bodies, our genes, our grandkids, and all life on Earth. 

https://www.cambridge.org/us/academic/subjects/earth-and-environmental-science/environmental-science/earth-detox-how-and-why-we-must-clean-our-planet?format=PB

I did refer to chemicals in my 2017 article cited above. I’ve also looked at plastics in Packaging Our Pills in Plastic which includes some videos – visit that article if you are interested.

So while some science is keeping us alive, our tendency as a species to misuse other science for selfish reasons is potentially, at the same time, making us sick. Why did I choose selfish in that sentence? Let’s take plastic as a classic example. When I was a child plastic was not really a thing. Shopping bags weren’t plastic. You didn’t put your fruit and vegetables in plastic at the shops. Glad Wrap? I do remember plastic bags for freezing meat. Pills were still in glass bottles.

But plastic was convenient and we started using it for EVERYTHING! Our wild life has been paying the price for years, but it seems we have too. We just didn’t want to acknowledge that fact because that would be inconvenient and if there is one thing the human species hates, it is being inconvenienced.

Of course, all of this ties in with our population growth: if there were less of us, we’d use less of all the “stuff”. Less MIGHT be manageable. That is a big “might”.

I’m going to turn 67 this year. In my first ten years of life I lived on a farm in the middle of nowhere, BUT I was still exposed to many chemicals. Sheep dip. Top dressing. Weed killers. All before the many safety tests and regulations of today were in place.

Later I moved to the city: car fumes, plastics.

“It would be naïve to believe there is plastic everywhere but just not in us,” said Rolf Halden at Arizona State University. “We are now providing a research platform that will allow us and others to look for what is invisible – these particles too small for the naked eye to see. The risk [to health] really resides in the small particles.”

https://www.theguardian.com/environment/2020/aug/17/microplastic-particles-discovered-in-human-organs

Yes, I have psoriatic arthritis (PsA) and a wonky thyroid (plus a few other things) and yes, there is a genetic component to PsA. What triggered the expression of the condition? After all, genes or no genes, my disease hasn’t been active all my life. What triggers any number of the conditions now prevalent in the chronic illness community, even if there are genes playing a role (in many cases, not yet proven)?

We have to stop blaming our chronic illness patients for being chronically ill, when it is very likely it is the path humans have chosen that has created many of us in the first place.

In our current situation in 2022, chronic illness has suddenly risen to the surface as a “reason” people die of Covid-19, so more people are aware of our existence. I myself am in four Covid-19 risk categories, the most dangerous to me being that I have an underlying inflammatory condition (PsA). We know Covid-19 can cause lots of inflammation: I’ve already got that going on, so I have this image in my mind of Covid-19 entering my body, running into PsA and my PsA saying, “Mate! Great to see ya! Let’s party!”

According to Professor Jeremy Nicholson, there are only about 10% of people in Western society that are “really, genuinely healthy”. You can find that quotation at 31:40 in the second video on Better Health, Together: Living with COVID in 2022.

I’m not suggesting 90% of us are at high risk of imminent death from either our conditions alone or our conditions plus Covid-19. We DO need to know which underlying conditions place us at higher risk of severe Covid-19 in order to be able to adequately take whatever additional protections may be necessary. The fact we are at a higher risk cannot be ignored. I see many on social media particularly suggesting the underlying conditions are irrelevant. They are relevant. We can’t ignore reality because we find it unpalatable. I most certainly think the politicians could separate the sad news of deaths from the statistics relating to underlying conditions. This is where the 90% really comes in – as in, it is potentially most of us!

As I am known to do, I have digressed – or have I? Covid-19 is perhaps a wakeup call. As a species we have created a state of ill-health as “normal”. Because we want our pollution and our chemicals and our plastics – but as Julian writes, we are paying the price. We’ve been somewhat quietly paying the price for a while, now Covid-19 has highlighted our vulnerability.

I know I have a chronic illness – many people do not yet know they have one. Conditions can take a while to be evident enough for the person to seek medical help. I am quite sure my PsA was active at least two years before I was diagnosed. In other situations, many people struggle to get a diagnosis of various conditions for years.

I am NOT suggesting that had Covid-19 come along in 1819, or 1719 that we would have been in a overall healthier state as a species. There were other considerations back then. However, we have changed our world, our environment, our living conditions, massively in the last 100 years. We’ve solved old problems, but created new problems.

I am a massive fan of science generally and medical science in particular, however I am also very aware of the human tendency to misuse anything we can if we see a personal advantage in doing so. Covid-19 gave us a shock: we were the Gods brought to our knees by the invisible.

We are not just destroying the environment of the planet we inhabit. We are not just destroying other species. We are possibly also destroying ourselves.

Robyn Dunphy3 Comments

Brain Fog? Cognitive Impairment? Which Sounds More Serious?

As a chronic illness patient, I am over the term brain fog. Let’s be honest here, it is cognitive impairment. Two years ago when I wrote “Yes, Brain Fog IS a Thing“, I was more concerned with ways to deal with it on a day-to-day basis than investigating the neurological, physiological or immunological causes or possible relief.

Cognitive impairment is a symptom experienced by MANY people with chronic conditions, irrespective of age, yet the term is more commonly associated with older people. Google cognitive impairment and nearly every result will couple cognitive impairment with “the elderly” or “in aged care” and similar phrases.

All is not lost, however – there IS recognition! And hope!

Cognitive disturbances, mood disorders and fatigue are common in SLE patients with substantial adverse effects on function and quality of life. Attribution of these clinical findings to immune-mediated disturbances associated with SLE remains difficult and has compromised research efforts in these areas. Improved understanding of the role of the immune system in neurologic processes essential for cognition including synaptic plasticity, long term potentiation and adult neurogenesis suggests multiple potential mechanisms for altered central nervous system function associated with a chronic inflammatory illness such as SLE.

Source: Lupus brain fog: a biologic perspective on cognitive impairment, depression, and fatigue in systemic lupus erythematosus

“Cognitive disturbances”. Not quite enough in my view. The title does, however refer to cognitive impairment.

Although widely used, I find brain fog to be a somewhat dismissive term – it just does not sound as serious as cognitive impairment.

Because mine was relatively minor, only really noticeable to me, I asked other patients about their experiences. Here’s what they had to say. I am sorry I couldn’t use all the responses I received!

“To me it’s like trying to fight through treacle.” ~ A

“I cant cope with multiple processes. I need things written down.” ~ J

“One recent trip [overseas] hubby went on, the flight wasn’t direct and took more than twice the time to get there. I was hysterical, and had zero recollection of the change in flight timing.” ~ N (Note, this patient does have a Functional Neurological Disorder diagnosis)

“… impossible to do more than one thing at a time. I can’t cook and carry on a conversation. I can’t wash clothes and pay bills …” ~ T

“I just don’t trust myself with details anymore. When making med appts etc I check and double check and still get things wrong. My confidence is so low when doing paperwork etc” ~ J

“I sometimes think it is more debilitating than the pain as I have learnt to push through the pain but I can’t push through the fog.” ~ M

“When my brain fog is bad I cannot process people’s speech. I describe it as words floating past me like pretty butterflies – I hear them so know they are there, but they have no meaning.” ~ F

“I wish more people understood that it’s not just being forgetful.” ~ Hannah, who writes at Sunshine and Spoons and has ehlers danlos syndrome.

Language is important. The terms we use are important. Cognitive impairment is damn important.

In chatting to my gastroenterologist one day, I complained about cognitive impairment. I said to him, “If I were a doctor, I would have to give up practicing.” His eyes nearly popped out of his head. “Really?”, he asked. He and I have known each other quite some time now – he knows I am not the type to exaggerate. I knew from his reaction I had spoken in a language he understood.

The reality is I could do my accounting or IT roles in a wheelchair. True, my personal trainer hat would be more difficult in that case. I can’t do those jobs without my cognitive abilities. If I do make a mistake though, I am not risking anyone’s health outcomes. If I was a surgeon, in the middle of surgery and I forgot or could not decide where to cut next: that could be a problem. If I misread a blood test result, or prescribed the wrong dose of a medication (although pharmacists are a double check with prescribing) the impact on the patient could be negative.

Although my cognitive impairment has been very mild compared to other patients, I would still notice it. I knew it was there. In the early days of my illness, before we got things under control, it was worse. Even so, I was so ecstatic when this happened:

Remembering that number was so fantastic (to me) I emailed the clinical trial co-ordinator to tell her! I was in a meeting at the time and I was clearly excited. I was ecstatic! I have written before about brain fog – like fatigue, it is something many chronic illness patients battle with.

Source: A Clinical Trial – Patient Journey – Part III

Of course, fatigue and cognitive impairment go hand in hand in many situations. This is well known and why workers should not be driving home after very long hours. Yes, they could fall asleep at the wheel, but also their reaction times will be impaired.

The quotation above from the SLE study indicates how difficult research is into this area, as it is with fatigue. There can be SO MANY contributing factors: the underlying condition, medications, pain, fatigue, poor nutrition, lack of adequate hydration, lack of exercise, poor sleep, onset of menopause, age (MCI for example) – the list goes on. My objective is to highlight the seriousness of it. I would love to see the term brain fog done away with. When I mention it as a symptom, I want to see the reaction I got from my gastroenterologist – acknowledgement that this IS A SERIOUS ISSUE. Let’s have a serious name for it.

I have REALLY noticed the improvement, since the new medication kicked in. I feel my reaction times when driving are normal, I remember where I put my glasses, I’m writing (you can judge whether I’m writing well or poorly!), my concentration lasts well into the evening, I don’t need a shopping list.

This is great for me, but my thoughts are of the other chronic illness patients out there struggling to get their health providers to acknowledge the seriousness of this particular symptom on their quality of life – including employability. I’m also well aware that even if it IS acknowledged, we may be a long way from finding solutions – but if science don’t consider it a serious issue, science won’t look for solutions.

After I wrote the fatigue article (linked above), I had one patient say to me she has simply given up mentioning fatigue to her doctor. I understand why, but we can’t give up because then doctors don’t see it as being as important as it is. Unless, of course, they suffer one of these conditions themselves and have been through it.

In the five years I’ve had my conditions, I’ve been asked MANY times about my pain levels. About my mobility. I do not recall EVER being asked about fatigue or cognitive impairment. Now, to be fair, the generic “How are you feeling?” could be an all encompassing question, but I’ve never got the impression it was including either of these symptoms by default.

So – over to you, fellow patients!

  • Do you experience cognitive impairment/brain fog?
  • Do you prefer “cognitive impairment” (or some similar name) or “brain fog”?
  • Do you, as a chronic illness patient, feel cognitive impairment as a symptom of your underlying condition is seen as important by the medical profession?
  • What impact does cognitive impairment/brain fog have on your quality of life?
  • Do you feel in your case it results from pain, medications, fatigue or is it a separate symptom of your condition?
  • Do you think your family and friends understand your cognitive impairment/brain fog?
  • Has it impacted your career, work choices or employability?
  • If you are a family member of a chronic illness patient, do you feel you understand?
  • In your experience, is cognitive impairment/brain fog adequately recognised?
  • Anything else you would like to share?

PLEASE NOTE: Cognitive impairment can be caused by a great number of medical situations and can range from annoying to critically serious – this article is ONLY addressing where it is a symptom of an underlying condition, such as described in the SLE quotation provided above. If you are concerned about ANY change in your cognitive abilities, please consult your doctor.

Robyn Dunphy8 Comments

A Clinical Trial – Patient Journey – Part II

I mentioned at the end of A Clinical Trial – Patient Journey – Part I that I had originally planned not to share my experience until after the placebo arm was over. On reflection, I realised that would in fact be unintentionally biased reporting, because events during, and the experience of, that first six months, when I may or may not be on the active intervention, are valid when discussing clinical trials from a patient perspective.

I had convinced myself I would get the placebo. I do not have a history of winning at chance! The lottery? Yeah, nah. Raffles? Not a hope. Scratchies (are they still a thing)? Never! I did once win $100 in a work event of some sort, but that is hardly indicative of a great winning streak. Psychologically, it is easier to plan on having a further toughish six months than be disappointed if nothing happens. Makes sense, I think!

In Part I, I also mentioned I thought I may get an early indication based on any skin improvement. This graph is from psoriasis clinical trials.

Source: http://www.medicines.org.au/files/vepskyri.pdf

As can be seen from the above, results in the skin trials were seen very quickly. Although the trial in which I am participating is for the arthritic condition, the skin condition will also be treated.

Let’s pick up where we left off, at the baseline visit.

Baseline

After dealing with all the paperwork, doctor consultation, having bloods and urine taken, temperature and blood pressure checked, joint and enthesitis assessment and answering a lengthy quality of life type questionnaire on an iPad, it was time for the injections. I remember watching it go in (yes, I watch injections, apologies to squeamish readers) and thinking, “There’s my saline solution dose for the day”. One into the abdomen, one into the thigh.

From November 2018, I had been having UV B light therapy for the psoriasis. It really works well, but one of the criteria of the trial is no light therapy. Makes sense – the aim is to test the efficacy of the drug and that would be most difficult if certain other therapies (see explanatory comment below) were being employed at the same time. So I had to stop light therapy a specific period of time prior to the baseline visit.

The following two photos I took July 6. While with UV B and methotrexate it had reduced dramatically, once off both those therapies the skin had flared again. My baseline visit was July 17. I’d stopped the UV B therapy a little earlier than I otherwise would have, because I’d stopped in preparation for one trial, then ended up on the sister trial with a later start date.

These photos are embarrassing to share, nor are they anything like “clinical quality” as I just snapped them with my phone, but they are more meaningful that quoting percentages. If my articles are to be useful to readers, I have to be prepared to drop the mask of normality so many of us wear a lot of the time. I wanted my own baseline for comparison. We forget how things looked, over time: I wanted to be able to look at my skin further down the line on the trial and be able to see (or not see) any change. As this trial is for psoriatic arthritis, not psoriasis, no photos are part of the trial documentation.

The image on the left is a patch on my leg. The image on the right is my upper chest, just below the collar bone. You can see older images of my arm on “I am Medication Free! For Now, Anyway…”

The skin makes swimming and hydrotherapy embarrassing. Rightly or wrongly, I worry other swimmers are going to think I’m contagious. It just looks…..horrid. Worth mentioning, perhaps, this sort of skin involvement is new to me – when I say new, I mean I went through MANY years of my life with the odd tiny patch which would disappear, or absolutely none. I am not used to this.

I’ve shared this swollen foot photo before, this was February, just as DMARD number two washed out of my system. This is the psoriatic arthritis aspect. The right second toe is clearly also swollen – dactylitis. Yes, you may indeed compliment me on my choice of polish!

The joint and enthesitis assessment is quite lengthy because it involves an independent assessor testing the many finger and toe joints as well as, jaw (TMJ), feet, elbows, shoulders, sternum, knees and hips (SIJ). It seems as if, if you have a joint, they will assess it! I never think of my toes being sore, aside from the big toes, yet it is surprising just how sore they are when a relatively light test pressure is applied. I knew my thumbs were sore, but all those toe joints: ouch, ouch, ouch.  My fingers, aside from the thumbs, are OK. Even the thumbs are not bad – the soreness doesn’t stop me doing anything AT THIS TIME: however my concern is disease progression. I want, if at all possible, to stop progression.

The assessor also looks at and records the percentage of the body showing skin involvement.

At the point of the above photo, I could not fit my runners on at all – that makes exercise difficult as the gym frown on bare feet for safety reasons. The swelling had reduced a bit by July, but I was still struggling to wear runners for any length of time. The assessor, using a clinical approach rather than my layperson’s visual assessment, flagged many of my toe joints as swollen as well as sore. We get used to looking at our own bits and pieces and over time the abnormal can start to look normal.

Which injections you get is controlled by a mysterious person far, far away. To that mysterious person I am just a number. My co-ordinator emails the mysterious person, who I suspect at baseline tosses a coin to decide which arm I’m in: active or placebo. Of course I am joking – it is likely much more scientific than that. Now I’m curious – I must ask next visit!

An email comes back advising which two numbered boxes are to be used for my participant number. I wanted to keep the boxes as souvenirs (main photo) but they have to be kept for the trial auditors to check I was given what I was supposed to be given.

None of us, the investigator, or my co-ordinator, or I know what is in those syringes. It is a 50/50 lottery at baseline.

After the injections the trial participant (i.e. me) sits around for two hours in case of an adverse reaction.

Take a book or iPad or Kindle with you is my advice! You may have another participant, of your trial or another trial, to chat to or you may be sitting alone. Very comfy chairs, nice throw rug for colder days, but essentially a pretty boring two hours.

Then time to go home.

Please, PLEASE bear in mind that even if you were on the exact same trial as I am on, you may have a completely different experience to my experience. Your disease would not be at the exact same stage as mine, you may have more or less joints affected, you may have more or less skin involvement, you may suffer more or less fatigue than I do. So many variables. What I write is my specific experience. Your experience may be similar, or not.

The next stage in the loading dose. This happens four weeks after the baseline injections.

I know, I know, you want to know where I am on that graph! Can I fit my runners on now? Well, I gave the runner answer away in a recent article if you are paying attention. Be patient, all will be revealed in good time. I had to wait and see!

Explanation re Concurrent Therapies

Although light therapy is not allowed, participants may stay on up to two DMARDs while on the trial. After all, if the participant is in the placebo arm, if no concurrent therapies were allowed, those participants would effectively be receiving no treatment at all for six months. Each clinical trial will have restrictions specific to that trial.

I am also restricted in what other medications I can take, such as pain medications. Given I rarely take any pain meds (exercise is my pain management), that didn’t worry me. I can’t change my dietary supplements, although I can stay on the ones I started on e.g. Vitamin D as ordered by my endocrinologist, fish oil as recommended by my sports physician. There are rules around surgery during the trial.

These are all considerations when deciding whether to participate in a clinical trial.

Robyn Dunphy3 Comments

A Clinical Trial – Patient Journey – Part I

Background

After discovering last November (2018) that my second DMARD (disease-modifying antirheumatic drug) had to be retired from my treatment regime, I did two things. I tried going medication free. I also started researching drug trials. If being medication free didn’t work, what was going to be my next step? What choices did I have that might be outside the standard treatment pathway?

Why research drug trials in particular? The first DMARD I was prescribed was developed in the 1930s. The second was introduced in 1955, originally to treat malaria but was later found to have immunomodulatory properties. These drugs are as old or older than I – surely modern medical science had something better by now? Something I wouldn’t have reactions to?

Well, yes, there are newer drugs available. Biologics are available on the PBS (Pharmaceutical Benefits Scheme) – IF the patient qualifies. That qualification bar can be high. As a example, this link to the PBS has the qualification requirements for one biologic that may be used to treat psoriatic arthritis. Click on the red “Authority Required” link to see the qualification requirements. When would I qualify? When I was 80? Not really a very positive thought for me. Yes, a private script can be given, but at $1,049.69 for four injection pens that is a little outside my price range long-term. And that is one of the cheaper ones. $40.30 with PBS subsidy. The schedule is usually inject once a week, so that is a monthly cost.

After much researching I found a drug trial that appealed to me. I don’t know who thinks up drug names, but this is risankizumab. Before I learnt how to say it, I referred to it as the “Kazakhstan drug“! I had researched the drug extensively, then looked for trials in Australia. The drug had already been approved in some jurisdictions to treat the skin condition psoriasis, so there was plenty of information available. On July 23, 2019 it was announced this drug received TGA (Therapeutic Goods Administration) approval for use in Australia, but is not yet on the PBS.  Published results from those clinical trials were very informative and positive.

The trial in which I am a participant is to assess the efficacy for psoriatic arthritis.

So I had found a drug trial I was interested in for a drug that looked very promising.

What Was I Looking For?

At this point you may be asking what was I looking for by considering doing a drug trial. As odd as this may sound, I was looking for treatment stability. I am now on my fourth DMARD. Each one has not been the right medication for me. As noted above, some of these were not the newest drugs around. Plus there was this encouraging line on the patient information sheet of one: “It is not clear how [drug X] works.” Or this one: “It is not clear how [drug Y] works in inflammatory conditions; however it is thought to have an action on the immune system.”

There is my personality type to take into consideration. I’m one of those annoying yellow quadrant HBDI people – we are the experimental thinkers. This might make me a radical patient, I suspect! It means I’m always looking “outside the box”.

I’d also had the experience of having a Synvisc injection when it was very new – that experience had been extremely positive for me. Trying new stuff is not something that scares me in the slightest.

I have faith in medical science. No, we don’t always get it right, thalidomide being the classic example as I have discussed before. I don’t seem to qualify for the biologics currently on the PBS, yet I was desperate to at least try a medication younger than myself. A medication where the therapeutic action was actually known.

I wanted something that worked without the myriad of side effects I’d experienced to date. I was also looking for a medication that might address the fatigue that goes hand-in-hand with many chronic conditions, including psoriatic arthritis.

A Third and Fourth DMARD

There was an event that drove me even more in the direction of being involved in a drug trial. In March this year, while I was still mulling over the prospect of being a lab rat, I suffered an adverse reaction to my third DMARD. I was prescribed a fourth DMARD. It seemed if there was a reaction to be had from these DMARDs, I was unfortunately a person who was going to react. By this stage I had lost faith in DMARDs as a treatment for me. I must stress, they work perfectly well for many, many people. I’m just not one of those people, it seems. One of the DMARDs had worked wonderfully for the arthritis, but ruined my skin, for example. There was something with each of them.

Again, I stress, all these were the standard treatment pathway. I wasn’t being “mistreated” in any way.

Next Steps

I discussed the proposal with my GP, my dermatologist, my urologist and my pharmacist. All four were very supportive. I have since also brought my gastroenterologist up to speed and he is also supportive. I must make clear I was not asking them from a rheumatological perspective of course, I was seeking any concerns they may have for me in their field of speciality and/or any concerns they may have about MABs in general.

I signed up and waited for the screening appointment. While waiting I bit the bullet and got a second opinion. This rheumatologist was also supportive of my desire to do the trial. Disclosure time. Through sheer coincidence this professor happens to be involved with the drug trial. My GP had written the referral well before I’d found the trial I was interested in. My GP had not even known I was researching drug trials, I had never mentioned it. The fact there was a connection was serendipitous.

Screening

My initial screening appointment was on my birthday! That was in June. So. Much. Blood! They do take a lot of tubes of blood, let me tell you. At least for this trial. I failed the first screening. Probably because I’d been taking prednisolone to try to control the inflammation while DMARD four ramped into gear, my CRP (C-reactive protein) had dropped 0.15 below the cut-off. A month earlier it had been way over. Luckily there was a sister trial with different patient qualification criteria and those criteria I did meet. That meant a second screening appointment. That took place in July. Of course, at this later screening my CRP was back up again, well over the cut-off for the first trial, but the rules are the rules. I am on the sister trial.

You are weighed, height measured, vitals taken, blood tested, joint and enthesitis assessments are done. The skin is assessed. There is paperwork, lots of paperwork. A medical history is taken (I took in a typed history from birth to now). A consultation with a site doctor. All up the screening process takes about two hours.

When I cite visit durations, these are for this particular trial. Other trials for other medications may be longer or shorter.

Active or Placebo?

This is a double blind clinical trial. Those wanting further information on clinical trial protocols in Australia can read this link at Australian Clinical Trials. Yes, there is a placebo arm. While the trial goes for four years, the placebo arm only goes for six months, after that all participants are on the active intervention. My rationale was six months of placebo could not be more difficult than the last six months I’d been through and I would only have to manage for six months if I lost the 50/50 lottery. I had nothing to lose.

I also knew that results from the trials for treating the skin condition showed very little placebo effect and that results had been seen quite quickly. I felt I would have a very good indication before the six months was up of whether I was on the placebo or the risankizumab, based on my skin.

Baseline

My Baseline appointment, the appointment where you actually receive the drug or the placebo, also took place in July. This was a much longer appointment. Essentially all the steps of the screening appointment are repeated, plus the injection, plus the patient has to wait for two hours post injection to ensure there is no adverse reaction. The coffee is good.

How is it going?

I was originally not going to write about this until after the six months. The fact I am writing earlier should be a slight hint. This will be a series as there is way too much information for one article! Tune in later in the week for Part II!

Robyn Dunphy6 Comments

If You Don’t Have Cancer, YOU Can Help Fight Cancer

Most of us know someone touched by cancer. I personally know four: two of my best friends, one of my sister’s best friends, and a former work colleague. All are cancer survivors due to the dedicated work of researchers.

The Cancer Council is undertaking a major study and needs your participation. Help your family and friends by helping the Cancer Council. I’ve participated. It is really easy.

Please consider helping.

I am very pleased to be granted permission to publish the Cancer Council’s invitation letter.

You don’t have to have cancer to fight cancer!

Cancer Council’s Australian Breakthrough Cancer Study aims to recruit one of the largest Australian research groups ever to help scientists uncover new risk factors for cancer and other diseases.

We need 50,000 Australians to help us to investigate how our genes, lifestyle and environment affect the development and treatment of cancer and other diseases. We will build a large set of health related information essential for making breakthroughs in disease prevention and treatment.

You can take part if you are:

The study has been designed so that you can take part at your convenience. Questionnaires are completed online. As we will need a sample of your saliva for genetic analyses, a saliva collection kit will be mailed to you, which you return to us by free post.

Please go to our website to sign up: https://www.abcstudy.com.au

For assistance, contact us on 1800 688 419 or info@abcstudy.com.au.

Please pass this information on to friends and family who might be interested.
Thanks for your support,

The ABC Study Team

Cancer3

Robyn DunphyLeave a comment