Intro

Hello and welcome to this episode of the Conference Conversations Focus 2022 Podcast Series. In this episode, Erin MacIntyre, physiotherapist and PhD candidate at the University of South Australia and Tim Austin, Specialist Pain Physiotherapist working in primary and secondary healthcare in Sydney, chat about the clinical effectiveness of a novel physiotherapy VR intervention that has direct relevance for physiotherapy practice. Before we start this series of Conference Conversations podcasts has been brought to you by the Physiotherapy Research Foundation, supporting the promotion and translation of research and supported by Pain Away platinum and content sponsor of the PRF. Let's get started.

Tim

Hi everyone. My name's Tim Austin and I'm the National Chair of the Pain Special Interest Group of the APA. I'd like to acknowledge the traditional owners of the lands on which this recording has been made, the Wurundjeri People and the lands from which you’re listening and I'd like to pay my respects to elders past, present, and emerging. So I'd like to welcome in this podcast Erin MacIntyre. Welcome Erin.

Erin

Welcome. Thank you.

Tim

Your title of your research is Getting Your Head in the Game. It's a novel virtual reality intervention for people with chronic low back pain. So getting your head in the game, what is it? What are we talking about here?

Erin

With this project, we really want to make exercise a little bit more fun. So I'm a physio, that's my background and often with physiotherapy interventions, things like exercise that we know are really good for low back pain, we know they're really good, but they're often a little bit boring. So that's what we really wanted to do with this make it a lot more engaging, entertaining, making it an intervention that patients actually want to do long-term. And so that was kind of the real basis behind this research here.

Tim

So it literally is getting your head in the game, but virtual reality. So tell us what the virtual reality is and obviously using a headset. So can you just explain what that is before we look at what this trial was all about?

Erin

In this case, we had people wear the full, full headset. So they had the headset on, they had microphones on the side or speakers on the side so they could have not just visual or imagery but also kind of the multisensory, the sound of the game. They're also holding handsets. So they had both of their hands tracked with the game and they were really able to interact with the environment. So we got them with all that equipment on and then they played three different games. Two of them are commercially available games. You can get them today on wherever platform, virtual reality platform you're using. And that was it really engaging, really fun. Have you ever tried virtual reality before?

Tim

No, I haven't. I haven't. That's why I'm delighted to do this podcast because I'm the first one to get to listen to it. Because we're going to talk as we move through this podcast about the clinical relevance of this. Now I know this just very early research, but you can already start to see where this might have its clinical application. But if we sort of get back to, I suppose the methodology of this, it'll be useful to explain to people exactly who you chose, the people with back pain, maybe if we deal with that first, who were the subjects in your trial?

Erin

Yeah, that's a really interesting thing. So I guess the methodology is a little bit complex, especially for clinicians because it's different than your kind classic randomised control trial. We did kind of a single case experimental trial. What that means is that we only look at a small number of people, but we measure their outcomes daily. So we track them daily for 35 days. Within that 35 days we give them an intervention. But because we're asking them kind constantly daily how they're going, what their pain is, we can, with a small number of people see, still see the effect of the intervention on those participants. So we only were aiming to recruit 10 people for this site because we are still able to be able to drive quite a bit of power, understand this phenomenon quite completely with a small amount of people. So we recruited 10 people, nine of them were analysed and it's kind of interesting, I guess as a woman we did consecutive sampling from a physiotherapy clinic.

Of those nine people we ended up with eight men. So not a lot of diversity, which kind of bothers me. So we'll definitely have to follow up on that. However, we did have a diversity of ages, so it was the mean age was 44 years old. We had everyone from 28 year old to 63 year olds, which is actually really cool because I think there's this kind of conception of virtual reality being for young people. But here we kind of show that, you know, lots and lots of people can participate in this intervention. It's not just for the youth of the day.

Tim

Yeah, that's an immediate application point is whilst it's a sort of early data and an early trial, just the applicability across different ages and obviously getting a bit more diversity amongst the mix would be quite helpful. We're talking about people with chronic low back pain and so amongst these nine people, their duration of symptoms were quite lengthy.

Erin

Yes. We only include people who'd had pain for at least three months. And we also had an additional inclusion criteria about their pain being relatively stable over the two weeks prior to the study. This was to make sure that we could actually kind of a little bit more definitively say the intervention was, you know, paired to their decrease in pain versus them just having, you know, an acute kind of episode of low back pain that we know will most likely resolve kind of within that six week mark anyways. So we purposely looked for people who had had relatively longstanding pain but also relatively stable pain.

Tim

Yeah. Obviously easier to sort of research on. And I think your one person who you didn't continue with was somebody who didn't meet that criteria.

Erin

Yeah. So the one person I mentioned that we didn't analyse, they somehow snuck in. So they had a kind of a one out of 10 pain rating on the NRS scale when they came into the trials. So we exclude them, they didn't meet our inclusion criteria and I mean if you're starting a one out of 10, we can't really improve that too much

Tim

No, that's right. Maybe they just wanted to do some virtual reality. So the things you measured.

Erin

Yeah.

Tim

Share with us, I know obviously you measured pain intensity and that was, am I correct the pain intensity was the key variable primary outcome?

Erin

Exactly. That was kind of the one that we are most focused on. So we used a zero to 10 NRS scale for pain intensity. We also looked at pain catastrophizing, pain related fear and anxiety and I guess the cool thing about this methodology is that we're gaining daily outcome measures. So we only took a few items from those scales because we were asking them every single day to fill out these 10 questions on a questionnaire. So we had to be quite specific about what we were asking them.

Tim

That in itself is fascinating data, isn't it, about the consistency of asking. I think there is some research around whether those variables might change. Are there issues with regards to measuring some of these outcomes on a daily basis itself being an influence on those outcomes?

Erin

I think that's definitely a consideration. We've kind of controlled for that in two different ways. First of all, all of our participants had a baseline period. So we asked them these daily questions for a good length of time, at least five days before we start the intervention to start to control for asking the same question repeatedly. Also, if we want to get really technical in the stats, we have I guess what we call auto correlation. So if you say your pain is four of 10 Monday, the next day it's going to be more likely that you also say four of 10. What that means is that our responses are never going to be normally distributed, which is a requirement for most of our kind of statistical analyses. So we actually brought a statistician on board to help us with the analysis because it becomes quite complex and used for our modelling types of statistical tests that account for that. So I guess those two factors, it's a consideration, but because we used those two kind of factors, we were more confident that we were able to control for those potential confounders.

Tim

And like any good research project, it certainly reminds us while we need our statisticians and research methodology experts, doesn't it?

Erin

Oh, oh goodness, yes, definitely. I find this research method really, really great. Fascinating. I think it's a cool one for physiotherapy trials because you don't need huge resources to be able to get really good high-quality data. However, the downside to it is it's really, really specialised in terms of your knowledge of the study methodology, the stats, it becomes a lot more complicated kind of on that backend side of things.

Tim

Yeah. But it is the classic of an n equals one trial, isn't it? Because you’re measuring these people related to themselves.

Erin

Yeah.

Tim

And so when again, we've got our ear out for what the clinical applications are here that we are looking at, at individuals and to see how much they do actually change. Just now in terms of the actual intervention. So these are people with low back pain, their goggles are on and you get them to play some games in order to do what?

Erin

We were really trying to focus the games to encourage kind of lumbar flexion just because that seems to be, you know, I think clinically we can all agree that seems to be one of those more difficult movements for people with low back pain. So we were really encouraging them to bend further and further forward, but in a game situation. So they're not kind of consciously aware that they're bending forward repeatedly. It's more I have to hit this target, I have to reach down towards my needs to achieve that goal. So rather than it being kind of a very explicit, you must bend your back forward, you know, 50 times during this session, it's the game parameters are really getting you to do that movement repeatedly.

Tim

What's fascinating about that is I think of clinical sessions where in a sense we try and do that, but we don't have the ability of that immense amount of distraction.

Erin

Yeah.

Tim

You know, we will ask people to do various things in life. We may get them to do various things in the clinic, but in a sense it's hard for them to be blinded to what you're trying to do, whereas it's almost like the virtual reality itself is a blinded experiment.

Erin

Yeah. Maybe you could say that. Maybe you could say that. And I think that actually gets to a really fascinating thing about virtual reality. This experiment can answer this question, but something that I'm personally quite interested in, it's how virtual reality is working to change someone's pain. I think if we go in a bit of a history lesson, initially when we introduce virtual reality to treating pain, we thought that it was using it as a distraction.

So the classic studies are with burn patients and having their bandages changed, which is an incredibly painful and horrible experience. So they actually brought in this snow world VR experience. So they got the virtual reality goggles on, they had snowmen and snow kind of all around them, kind of the opposite of the heat and the burn in those associations. And that was actually quite effective for that acute pain relief. And then we tried to translate that across to chronic pain, but that distraction didn't seem to work so well with chronic pain because as soon as you were not immersed in that lovely environment in the virtual reality goggles, your pain came back. Right?

Tim

Yeah, yeah. What I think's interesting is in what you just said was that again, there, there's no one thing that virtual reality is, so as you said, we've seen virtual reality as a distraction. Yeah. I mean you're just like playing somebody a video of Scandinavia and feeling good about it, but we've got virtual reality where we could change the size of people's limbs or things like that. And in this, it's actually a graded activity approach. So we haven't talked about that graded activity because that's pivotal to this research, isn't it?

Erin

Yeah. And it's trying to get someone to engage in the amount of dose that we have to and long term adhere to kind of that graded activity approach.

Tim

So how exactly did the games do the graded activity approach?

Erin

Yeah, so before we got participants to do the games, we kind of graded them so that we create an easy level, a medium level, and a hard level. So in the easy level, which is where everyone started off, they only had to reach kind of small amounts, so they only had to bend a little bit forward. And then medium levels, it was, you know, the targets were more towards mid trunk and then the harder levels were even further forward. So that way we were able to kind of start them all at the easy levels and then grade them up.

Tim

And was that done individually for each person?

Erin

Yeah.

Tim

So what was a small amount for one person could have been quite different to what the small amount was for another person.

Erin

Yeah, so I guess the easy medium and hard levels were kind of pre-set and everyone did the same, easy, medium and hard. Also, when you're doing virtual reality, the headset kind of knows where it is in space. So if you put it on a taller person that's going kind of adjust it for them so it kind of works itself out in that way, if that makes sense?

Tim

Yeah, no. That, that does. So there's some, yeah, there's some degree of individualization. And then in terms of the number of sessions, am I correct, there was a different length of time before the intervention started, but everybody had two to three sessions a week for two to three weeks?

Erin

Kind of, yeah. So one of the ways that we're able to tell if the intervention influenced pain was by randomising how long their baseline was. So it wasn't just, you know, five days into the study, everyone starts the virtual reality component. We randomised them to different lengths of baselines so that if we did see a change, we could kind of pin that change to when that intervention started. Not when they started the trial.

Tim

No, that does make sense. And then the length of time of the intervention was again, a little variable, but about two to three weeks. Is that right?

Erin

Yeah, actually quite variable. I think the longest intervention period was 21 days and the shortest was 14 days, which gave us a really interesting effect where some people did, you know, six sessions and some people did nine sessions with the virtual reality. And while we didn't have, I guess, the number of people to formally test this, what we did observe is that the people who did more physiotherapy sessions, more virtual reality sessions actually tended to do better. So there may be a dose response relationship there.

Tim

Yes, yes. Which brings us to obviously results, which is why we're all here, tantalised.

Tim

You've already indicated in terms of the demographics that males were all but one and the age was quite spread. So the outcomes I know this what you really wanted to share, there were some average changes over the group, but then we'll talk a bit more about some people who might have responded better than others. So the primary outcome pain, what happened there?

Erin

Yeah, pain intensity. When we did our very fancy statistical modelling, we found that over the course of the intervention, there's an average decrease of one point on the zero to 10 NRS scale. So people's pain decreased by that point, and that was statistically significant. However, I know as well as you do one point on a 10 point scale as a clinician, as a patient, that's not super meaningful. So the exciting thing was really that four of our participants met the clinically relevant threshold, which is a drop of greater than 30% of their pain. So four people achieved that, which is a bit more exciting I think, as a clinician, as a patient.

Tim

Yeah, absolutely. This is just so important to the research that if we, spreading this out to so many other research trials over decades, if we just, I mean of course there's arguments around whether pain intensity is relevant or not, but what we're talking about here is trying to work out who's responding and how much it's actually responding to.

Erin

Yeah. Much more mixed results there. We did see statistically significant reduction in catastrophizing similar to the pain intensity, but not so much of, there wasn't as much of a clinical significance there where people had, you know, large reductions in pain catastrophizing.

Tim

So we've got 30% reduction in pain for four out of nine of the, of the people, the secondary variables. So catastrophizing, fear, anxiety.

Erin

Yeah. Yeah, definitely. One of the really cool things about having so few participants is that when we present the results, we actually plot everyone's individual, I guess course through the trial on graphs, and then we can look at them as kind of a, you know, those nine people. And so when it looked with pain intensity, you could kind of see there's clear, you know, four lovely responders to it. The others, there's two that were kind of quite low the whole trial. And then two more who just stayed quite high.

But then when we looked at our secondary variables, it was just a dog's breakfast, it was all over the shop. So it was much harder to see just with the visual analysis, any compelling trends, which was reflected in, I guess, statistical modelling as well, which is quite nice. And so I think, you know, we measured these secondary variables because we were kind of interested to almost why this is working, you know, because pain intensity is one thing, but if we see both a big drop in pain intensity, but also pain related fear, we could kind of say, oh, maybe this similar to a graded exposure intervention where we're really reducing people's pain or fear of movement and their pain.

And maybe that's how that's working. So we could further refine, I guess, the intervention to really focus on that. But we didn't really have any compelling results for our secondary variables. So yeah.

Tim

And were those changes in catastrophizing similar to pain in that the average was down, but was it quite mixed amongst the various subjects as well?

Tim

Now, you've given a part answer to something that intrigued me that this a graded activity approach, not a graded exposure approach. So there's perhaps that sort of argument that because it wasn't an overt attention to the, to the fear in terms of exposure, that there's a, there is that sense, isn't there with graded exposure that you've got to be a bit more specific to expose people. Yeah. And possibly that's something that could be included in future research, couldn't it?

Erin

Yeah, 100%. And I think it really gets back to something that really intrigues me is how these interventions work. If you think of doing a graded exposure intervention and virtual reality conceptually it actually kind of falls apart because graded exposure is you're confronting your fears, you know, really directly. It has to be really realistic and specific to something that you are really worried about.

If we're taking someone into a virtual world, you're kind transporting them away from that. And so it's not quite as realistic, you know, it's not kind of directly getting them to confront that fear. So conceptually it doesn't make as much sense. And I think as well, there's some really cool research going on about using VR as a medium to achieve different types of interventions. So we've talked about graded activity and great exposure. We've talked about the distraction. Dan Harvey's doing some really cool research, looking at different embodiments or multisensory integration, and how if we get someone to embody, say, the body of a Hulk, and they feel really strong and really powerful, does that help their pain? You know?

And then if it does, how does that actually translate back to the real world from a virtual world? So that's why I think VR as a research stream is really interesting because we can really take it down lots of different ways if we have strong kind of theoretical constructs behind what we're doing.

Tim

So Erin, one of the great things about this trial was that engagement was high. You got the subjects that they all continued with it. You must be very proud of yourself to achieve that?

Erin

Yeah. Well, I'm very proud of Mya. So Mya's the physio who actually ran the intervention, and she was fantastic. You know, she put some effort into making sure people came back and was really accommodating to schedules. But you're right, I think it's really cool to see a 100% adherence to an intervention because that's really, really hard to achieve, especially if we're thinking about this population, people with low back pain, you know, often the interventions are either painful or boring, and neither of those make them quite attractive to do. So we often find adherence to these kind of things quite low. So the fact that we had a hundred percent adherence is probably, to me, the most exciting result.

Tim

And I do wonder whether, again, we know engagement and having a good research person who's involved and our administration staff, whether we're doing research or whether we're doing clinical practise, those are the other variables that confound research.

Erin

Yeah, yeah.

Tim

But they're part of clinically how we get people better. And I was intrigued your thoughts here about, so you had 10 people, you had one in a sense, dropout, and everybody else progressed from which you got four responders. That's an incredibly high rate. When you start with 10 and you found four responders, 40% of the people who were your start point responded. That’s quite extraordinary, isn't it?

Erin

Yeah. I like that. Thank you. You're very kind right now.

Tim

But how do you think moving on from here, we can find out who those responders are. Do you have some, some thoughts? I know your research doesn't always tell us, that doesn't tell us that at the moment, but what are you feeling? Maybe it's a question about where this research goes from here.

Erin

Yeah, I think, you know, picking out who's going to respond to an intervention, that's the million-dollar question. And there's whole groups trying to research that question because currently we’ve tried subgrouping and trying to, you know, base I guess tailor our interventions to people specifically. And we haven't really figured out how to do that. We haven't had much success with it. So it would be lovely to know, but I think that's one of those questions that's going to be really, really hard. And I hope someone else answers it because, I don't like their luck.

Tim

Part of it's those correlations that you speculate on, you speculate that was there were the people that responded, is the pain intensity related to the reduction in the catastrophizing? Were there some people who had fear that dropped and others that didn't? I mean, those are the things that all of the other research trials in all other interventions try and explore, those sort of things. For the clinician so there's plenty of clinicians listening to this podcast. What does your research say to them as they are treating people who, some of whom are getting better, some of whom aren't, what do they take from the work that you and others are doing in this space?

Erin

I think this kind of speaks to VR maybe being another tool in your clinical toolkit, right? You know, it's kind of saying, if you're having trouble, you know, engaging someone with an intervention, they maybe want to do a behavioural change intervention, they want to get a little bit more active, but they're struggling just from a peer motivation perspective, we could kind of think, ah, something like virtual reality could be something that allows them to stick with it a little bit more and it's not the only tool. It could be, you know, they want to get active, but they only like playing, you know, footy, and that’s their kind of hook into physical activity. I look at virtual reality kind of similar, you know, it's something that you could offer and play with to try to just hook them in, maintain that engagement with it. So that's what I think this study kind of says is this another option. It has been effective in this small cohort that we've looked at and yeah, have some permission to have a bit of fun and try something different and new.

Tim

All right. So we've given the listeners permission for fun. The fun police won't be out there, just as we sort of come to, I suppose that conclusion around the engagement, adherence is one of the things that's obviously been researched by lots of people with their intervention. And again, there seems that this, it was obviously highly adherent to the group and it was fun. They did get their head in the game. Is that what we're seeing here, that again, another opportunity to get people to adhere to an exercise regime or an activity regime? Is that what we're seeing?

Erin

That's what I think we're seeing. Yeah. And I think that's how I, my gut instinct is why, why we've kind of seen an effect here, but I guess it's hard to say just, I know this going to be me sounding very much like a researcher, but our study design wasn't set out to answer that question. So we have no idea.

Tim

You've been trained very well, Erin, very well. And with regards to the other ways in which we can get adherence, we also look at potentially hooking this to other known interventions. So we've got pain education as an intervention when it's done in a very individualised way. We do have exposure that you, that you talked about. Do you possibly see that we'll build different interventions, I suppose commoditizing it to some extent, but also individualising it, packaging it, might be the best way of saying it. Once our assessment sees various things that we could implement that we might need to look at that package.

Erin

Yeah, I think I understand your question. You know, I believe that no treatment should be provided in isolation. So we know, especially for persistent pain, you know, a multimodal multidisciplinary approach is almost always needed, and that's where we get the best results. So I would say something like virtual reality would be best placed in a broader treatment context where it's not just the virtual reality by itself, it is their education. It is kind of a social support intervention. It is, you know, seeing the doctor, everything together to create kind of an individualised package of care, because I think that's where we do tend to see better results rather than just one. You know, there's no magic bullet, unfortunately. There's no one thing that's going to fix everything for everyone. It's individualising it and providing that person support from lots of different angles.

Tim

Yeah, and I was thinking for myself as a clinical application, it's perhaps being more thoughtful about what is it that I'm doing that gets engagement, what am I doing that gets adherence to what I'm doing and having a bit more of a radar out for patients for whom that might be a challenge. And thinking outside the box as to what you might be able to offer them?

Erin

Yeah, I think that's absolutely fantastic. You can have the best intervention in the world, but if someone doesn't want to participate in it, it’s absolutely useless.

Tim

That’s it. That's right. And so we’re back to our responders again.

Erin

And also just thinking, you know, how can I make this fun and creative? How can I think outside the box? Because traditional tried and true methods don't always work. So where, where can we have some fun with this?

Tim

Fun. That might be a lovely place to end our podcast. So I'd like to thank again Erin MacIntyre for her research Getting your Head in the Game. It's made us think about virtual reality and how it might help our patients, particularly those with chronic low back pain. So thanks again, Erin.

Erin

No worries. I hope we had some fun with this one too.

Tim

We have indeed.

Outro

That was Erin MacIntyre, physiotherapist and PhD candidate at the University of South Australia. And Tim Austin, a Specialist Pain Physiotherapist working in primary and secondary healthcare in Sydney. You've been listening to another episode of Conference Conversations brought to you by the Physiotherapy Research Foundation and Pain Away Platinum and Content sponsor of the PRF. Thanks for listening and make sure you catch the next episode in the Conference Conversations podcast series.

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