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**Cyberseminar transcript**

**Spotlight on Pain Management**

**An Internet-mediated Exercise Intervention for Veterans with Chronic Low Back Pain**

**Sarah L. Krein, PhD, RN**

**June 5, 2012**

Bob Kerns:Good morning, everybody, and welcome to this month’s spotlight on pain management. I'm Bob Kerns. I'm National Program Director for Pain Management in VA Central Office. And it’s my pleasure to welcome you to today’s spotlight on pain management. I want to take a moment to thank the Center for Information Dissemination and Education Resources, CIDER, an HSR&D funded resource center; and Heidi Schlueter, in particular, for their support of this monthly conference. 

Today it’s my pleasure to introduce Sarah Krein. Sarah is a PhD nurse and research health science specialist at the Ann Arbor VA Center for Clinical Management Research. And a research associate professor of Internal Medicine at the University of Michigan. Dr. Krein’s research interest includes chronic illness care and complex chronic disease with a specific interest in chronic pain management. The work she is presenting today was funded for a grant from the VA’s Health Services Research and Development Service. 

It is my pleasure to welcome Dr. Krein, who is going to present an Internet mediated exercise intervention for Veterans with chronic low back pain. Thank you, Sarah.

Sarah Krein:Ok, thanks a lot, Bob and I really appreciate the opportunity to share today some of the results of our recently completed study. Well, this is kind of hot off the press material. What I want to cover in the next 40 or 45 minutes is just to start out with a brief background to help you understand what motivated our research in this area. 

Then talk about the conceptual framework for the project, which I think provides a really nice overview of the intervention, the type of activity we were trying to promote. Then the outcomes that we're hoping to achieve. I will talk specifically about the intervention component. We study design and then present our six month study findings and wrap it up with a few implications.

To start out, probably no big surprise to most of the folks on the line today; low back pain is a very prevalent health condition with about a quarter of adults in the U.S. reporting low back pain in the past three months; about half of us, reporting back pain during the given year. It is also an extremely costly condition and has significant negative consequences regardless of age. 

I always find this somewhat – of some interest given that a lot of the work that I have done in chronic conditions seemed to be more selected towards older adults. But chronic back pain does not seem to be quite so selective; so, can impact younger people in terms of employment and income opportunities. It also impacts older folks in terms of mobility and social function. 

Now, in our VA primary care patients, we know that about 50 to 70 percent report chronic pain. We also have data to suggest the prevalence may be higher among female Veterans. Pain is, of course, a costly disorder in the VA as well as outside.

We also know that the number of Veterans with chronic low back pain appears to be growing steadily. I think most of us are well aware of the returning Iraqi and Afghanistan Veterans and the issues that they are facing with chronic pain, which includes chronic back pain. Given that pain is such a prevalent condition, it is good to know that we also have a number of strategies for managing chronic back pain. There is varying levels of evidence for all of these different management strategies. Of course, one is pharmacotherapy. There has been a lot of interest as of late in the use opioids, which will not be the topic today since that was covered a couple of weeks ago very nicely. 

There are also the more interventional strategies like surgery and perhaps injections or other types of intervention. Then, of course, there are strategies like exercise therapy; multidisciplinary pain programs, and psychological intervention. Given all of these strategies, my colleagues and I were interested in finding out a little bit more about what our patients use to manage their chronic low back pain. 

So, a couple of years ago we conducted a study. This was a survey of primary care patients in VA. Just to orient people a little bit to this slide, we actually had three groups of patients. One that was just a general primary care patient population. We had one group that had heart failure and another group that had diabetes. Now again, there was some overlap amongst these groups. I am sure that most of you know how a lot of our patients have multiple chronic conditions.

And of these groups, we then asked if they had chronic pain? Among our patients about 60 percent, maybe a little over 60 percent in some of these different subgroups reported chronic pain, which was defined as pain that persisted for more than six months. Of those patients, we then asked what type of strategies they used to manage their pain. Now, about 80 percent reported using pain medications. Then above that as you see on this slide, there were a number of different types of nonpharmacologic strategies that patients reported using.

You can see there is a pretty good distribution. Things such as physical therapy, relaxation therapy, injections, exercise. They are pretty evenly distributed across the different subgroups as well. A few differences with our heart failure patients. But to me the most startling part of this slide is the big bars right in the middle. The most prominent strategy that patients report using for chronic back pain or for chronic, which is what we were asking about in most of these patients who had chronic back pain was rest; which is perhaps not a recommended strategy for most patients with a chronic pain condition.

What is a recommended management strategy? Well, if you look at the VA/DoD Low Back Pain Clinical  Practice  Guideline.  I am focusing specifically here on recommendation seven. What we learned is that for patients who do not improve with self-care options, clinicians should consider the addition of nonpharmacologic therapy with proven benefits. Specifically for patients with chronic or sub-acute back pain. This includes intensive interdisciplinary rehabilitation, exercise therapy, acupuncture, and massage, spinal manipulation, and yoga, cognitive behavioral therapy, or progressive relaxation.

Exercise therapy is one of those recommended nonpharmacologic therapies. What is the evidence that goes into this recommendation? Over the past couple of years, there have been several systematic review and meta-analysis looking specifically at exercise and exercise therapies. What we have learned from all of those studies is that exercise therapy appears to be at least as effective as other conservative therapies. Maybe slightly to moderately superior to no treatment or usual care. There does appear to be some benefits with exercise therapies. But it is also a little disconcerting to know that the evidence is many cases is graded as low quality. A lot of the studies are viewed as low quality for a variety of reasons; some having to do with the way the studies are conducted. 

It is not really always that they are a bad study, but that there are some problems with how they have been conducted. How the findings have been determined. There is also some difficulty though in these studies and especially when you want to pool the evidence as you would in a meta-analysis. In that the outcomes that are looked at vary also across the different studies. In some studies, it is – the focus is really on pain and pain levels as the primary outcome. While in other studies it is really more focusing on function and functional measures. 

Then the other issue that comes into play is just the simple heterogeneity. This comes in two forms. One is heterogeneity in the study populations. The subgroups of patients that are studied vary from more occupational health types of patients to patients who are being seen in pain clinics. To perhaps just a more general population of patients in the community. Then the other thing is just the types of exercise intervention and what constitutes exercise therapy.

On this slide, I wanted to share with you a definition of exercise therapy. This came from one of the more recent systematic reviews in which defined exercise therapy as a series of specific movements with the aim of training or developing the body by routine practice or physical training to promote good physical health. I think you are beginning to see that it is a pretty broad definition. There are  a lot of different things that can fall into being considered as exercise therapy if you use this definition. 

Again, if you look at the studies and the types of things that have been evaluated, you do see quite a broad variety. There are supervised exercise programs. There are home based programs. Programs that are aimed more at general physical fitness or aerobic exercise. Then those that are more back specific. Things that focus on muscle strengthening, flexibility, or even stretching exercises. 

If you think about all of these different approaches, it probably begins to become more clear as to why there is sort of a mixed result in some of the evidence that we currently have about the benefits of exercise therapy. But another thing that came out of some of these reviews. And especially from work done by Hayden and colleagues. This was published back in 2005, which I found quite useful. Especially as we were starting to plan the intervention that we wanted to use for our projects – was that they also identified characteristics of the types of exercise therapy that they felt would be of most benefit. Again, this was based on the evidence that they were reviewing at that point and time. 

Those characteristics included programs that seemed to be of most benefit were those that were individually designed. Had some level of supervision, whether it was at home, or in some kind of facility based program. Adherence, perhaps no big surprise, the fact that people need to actually participate in the activity. And achieve some level or some dosage is important. Then they also identified stretching as being perhaps of more benefit for pain and decreasing pain. Whereas strengthening exercises appeared to be more useful for improving function.

These are perhaps the ideal characteristics of an exercise program or an exercise therapy. But to my knowledge, no one has really evaluated the specific combination. With respect to exercise therapy, that again has kind of left us thinking more about what is it about the type of exercise therapy for a low back pain? And is there a specific type of therapy that we can provide to our patient that will be of benefit?

Just to summarize and recap very quickly as I've just described. Chronic pain is – or back pain in particular is very prevalent. The patients use a lot of different strategies to manage their chronic pain, including some such as  rest that may not be recommended. We know that exercise is a key component in the management of people with chronic back pain. And also for people with other chronic conditions. It is really I think important again for our Veteran population who have multiple conditions. That this could be a very useful type of strategy for all of their condition. Not to mention that another VA study found that a little regular exercise extends men’s lives. Perhaps another benefit as well.

But of course, the most effective exercise regimen and perhaps even more importantly, how to effectively and efficiently assist people with using exercise therapy is still to be determined. My colleagues and I thought long and hard about what we thought we could do to help remedy this situation. We thought specifically about what people can do. What people will do and what we can help them do. I suppose that the strategy depicted in this slide, which is behind the remote strategy might have been one solution. But, we kind of decided that was not very feasible. We did not want to go into people’s homes on a regular basis. 

So, from there we moved on to Veterans walk to beat back pain. So, Veterans walk to beat back pain. This slide is now showing you the conceptual framework for this study. It has a couple of different components. On the left-hand side of this slide, you can see the intervention components. I am going to go through these individually again just to give you a bit more information about what we were asking people to do. How we tried to assist them in engaging in exercise. In this case, our exercise of choice was walking. 

Walking is great there in the middle of the slide as well. Then on the right-hand side, you can see our primary outcome in this particular study was to try to improve pain-related function, or decreased disability. So, the intervention components included an enhanced pedometer, a website, and an E-community. It tried to promote walking to improve function. 

The other thing on the slide I just want to mention is we have this direct pathway that we felt might lead to improvement. But we also had a couple of things that we tried to target specifically as perhaps mediating or moderating factors that we know also are important in trying to improve or to get people to exercise and to walk. Also, perhaps reduce their functional disability.  

A couple of things that we tried to focus on during the course of this study. Some of the materials that we provided also were to improve self-efficacy so people’s confidence and their ability to engage in this particular walking program. We focused a little bit on pain-related fears since that is also something that comes up frequently for patients who have chronic pain conditions. The fear that they are going to injure themselves worse. Then that we also tried to focus a bit on knowledge and knowledge gaps. You can also see in the right-hand side in addition to pain-related disabilities, our primary outcome. We also had some secondary outcomes that we wanted to look at, including quality of life. Pain, so actually pain, it tends to be; and then depression.

This is kind of the big picture of the project itself. Now, let us look a little bit more specifically and talk a bit more about the different components. First of all walking; why did we choose walking as our form of exercise therapy? Well there is several reasons. One is it requires little skill or training. It is also generally a low cost activity except perhaps for having to purchase good walking shoes, which we did encourage people to do. Most people can walk. The injury rate with walking is generally quite low. 

It turns out luckily for us that is the physical activity of choice for most adults. It is something that can be objectively monitored. This is important for a couple of reasons. One, is it allowed us to collect data on people’s walking activity. But it also was something that the people themselves, that the participants themselves could monitor and use to try to increase and engage in this activity. I will show you a little bit more about how we tried to help them to do that.

Now, what is interesting when we first planned this study, there was not a whole lot of information out there about walking as a way to – as an intervention for low back pain. In 2010, there was a study, a review article that was published. I believe this was actually Cocharan [PH] review article that came out. The conclusion was that there was low to moderate evidence supporting walking. But I think the more important issue for me in looking at this review article was there were only four studies. Three of the four again were judged as being a poor methodological quality. The real conclusion from this was that really more research needed to be done to determine whether or not this was an effective intervention for patients with chronic back pain.

In terms of the components for the intervention. One of our key components is an enhanced pedometer. The pedometer that we use is an uploading pedometer. It has an accelerometer imbedded into it. It is a very accurate pedometer, which I think is very helpful for our participants. Anybody who has ever had a pedometer that is not very accurate knows how frustrating it can be to try to use that type of a device. The pedometer also has an internal clock and it has enough memory to store 42 days of detailed time stamped step [sic] count data. 

That was useful for us. Because again, as we were collecting those data, we could have them upload and collect 42 days of data at one upload. For the participants, it is a nice little pedometer because they could also scroll back seven days. You could see your past weeks’ worth of activities, which I think is a nice feature for anyone who has used pedometers in the past. They could also see in the readout, their total step count as well as what was called aerobic or is called aerobic step count. That is just about steps, so steps that occurred at ten minutes or more between this movement.

Another nice feature of this pedometer is that it can be worn in different places. For some participants, they could not really put it on their belt loop. Or, could tend to put it in a pocket and it seemed to work fine in that strategy as well. Then, it has for us again the nice feature is the enhancement of being an uploading pedometer. There is a USB port embedded that allows you to upload data from the pedometer. In this case, the data were uploaded to our study website. If you purchase this on the market, you can actually get a CD that comes with it and put that on your computer. Then you could upload the data to your own computer and track your step count as well. But we wanted the data uploaded to our study website. We did not give participants the CD until after the study concluded.

Now I do have to say that both the controlled participants as well as our intervention participants received this pedometer. We did ask them to upload on a regular basis. But as you are going to see as I move through the next couple of slides, those in the intervention got some more additions to the pedometer that helped them to use this information.

The next slide I am showing you is just the log in page for the study website. There are just a couple of quick features I want to point out about the login – on the login page. One thing is that we wanted to make this something that Veterans would want to use. Rather than having pictures of people with spandex and using extremely fit; and maybe not quite like our participants. We wanted people who look like them as part of their website if they looked like most of us. Just regular folks out there exercising. 

As you can see we have pictures of just general folks out doing exercise that we were hoping to promote as part of this study. The other feature is we tailored that the bed, based on gender. For male participants, they would get a blue background and have pictures. Again, perhaps of more male Veterans. Whereas as you are going to see on the next slide, for a female Veteran, when you would log in, you would get a pink background. And perhaps see more pictures of women, although there was a lot of mixed pictures in the way that the website was set up. But again, it was meant to be inviting as opposed to kind of a turn off if you are finding people that really do not look like you. 

Now you can begin to see a few more features of the website. The screen I am showing you now is something only their intervention participants would see. When they would log into the website, they would be able to see their walking goals. The walking goals was an important feature of the study. Rather than expecting people to just go out and set their own goals. And use the pedometer data on their own. For those in the intervention, we actually gave them goals. These goals were set on a weekly basis. They would be emailed to the participants as well as being shown on the website when you logged in. the goals were meant to encourage people to increase their walking incrementally. 

Again, rather than sending people out with the pedometer and telling them to get to 10,000 steps, we really wanted people to do this in a way that they could achieve the goals. Also, again begin to increase in a safe way their walking activity. So, the goals would be set individualized. I am thinking back a little bit to the Hayden article. Individualized to the person themselves based on their activity the prior week. We would look at their activity the prior week. There was an algorithm to then calculate a new walking goal would add some steps to what they had done the prior week and set a new goal for that next week.

As people would log in, they would be able to see again what the goal was. How well they were doing achieving that goal. They could track it using the graphs that were provided during the week. They could even drill down to an individual day to see when they were doing their activity.

The goals I think were very important. It was also nice being able to use this type of technique. Because a lot of our participants actually had a time when they were ill or had some other issue going on. Rather than starting out at a really high goal, this could actually bring them back down if they were having some problems. They could look at what their activity had been and it would again kind of recalibrate for that individual.

Another feature of the website that I want to point out is if you look below the graph, now you can begin to see some other things that we embedded in trying to encourage people to stay active and to begin to increase their activity. We have the E-community component, or the social support, which is what you see below. These were sort of a chat feature if you will. It was not a live chat that people could post messages. 

Likewise, our study staff were very active in trying to keep the conversations going. Because of this, I think people felt in some ways that they were receiving some level of supervision. Again, thinking back to what was encouraged through that article by Hayden. There was a little sense from many of our participants that they were being monitored perhaps more actively than they actually were. But again, it provided a little bit more accountability to the participants in the intervention group. 

They could post messages and they could also receive all kinds of information from our study staff. If people had issues. For example, if there was a participant who reported having a muscle strain, we could post messages to try to address that issue and how you would deal with that. But all the participants could then use the information. It was kind of a way of providing information and education as well. 

Now, unfortunately, we did not have quite enough people to make it a little vibrant community, E-community. We knew that when we started this study. But we still felt it was important to have this connection for our participants. There were some who were pretty active posting throughout their time as a study participant. Another feature that we tried to use was called in the spotlight. We really were looking for strategies to get people to come to the website and to use the website to encourage them in their activity. 

Again, provide a little level of accountability for this activity. In the spotlight was a weekly posting that was a brief summary of new research that had come out related to physical activity or lifestyle issues. It could be diet issues as well as something that might have been in the news. Then Quick Tips was another feature which changed on an every other day basis; which provided information that was pertinent again to activities. It could be how to walk when it is raining outside. Places to walk when it is raining outside. Just little tips that we tried to embed so again, people would come back and use the website on a regular basis.

Then the final feature I wanted to share with you about the website was our basic back care refresher. When we decided to do the study, one of the things that we thought was important was for all of our participants. This included both the control patients and those in intervention to have some basic knowledge and education about dealing with back pain. We were very fortunate that our physical therapy department actually had a back class that they were using in order to provide that type of information for Veterans at the Ann Arbor VA. 

We were able to work with them to use that back class to help recruit patients. But also provide what we felt was important content for those participants. About just basic back care. All of our participants control and intervention had to attend back class. This included again basic education as well as strengthening and stretching exercises that were taught during that particular class. 

For those participants in the intervention, we also posted on our website all of the materials that they received in that class as well as videos of how to do the exercises so they would have a way to go back and kind of refresh their memories. We did realize that just having that two hour class where you learn all of this material probably is not what...  You probably are not going to retain all of it at one time. This was a way of giving them another way to access that material. 

That was the basic components of the intervention. Let us move on and talk more about the study. The specific aims of our study in aim one was to determine whether the pedometer based Internet mediated intervention would reduce pain-related functional interference among Veterans with chronic back pain in the short-term, which is the six months data that I am going to be showing you today. Then over a 12 month time frame; and then the 12 month time frame, we have those data. It has just been collected and hopefully will be ready soon. 

Unfortunately, I am not going to be able to share that with you today. But I am hoping that the six months will be enough to get you interested and perhaps pique your curiosity as to how well we did at 12 months. We really also wanted to look at 12 months because we felt for many of these types of activities, it is something that people have to do on a regular basis. I think we are all pretty well aware that exercise therapy is not a quick fix. It is something that probably has to be done for a lifetime. Because this is a chronic condition. We wanted to be able to show and demonstrate that we could maintain people’s level of activity over a sustained time frame.

In aim two, we want to assess the effective intervention on some of those secondary outcomes that I mentioned earlier. This included walking, quality of life, and pain intensity. Then aim three, which I will not be talking about today. But we hope to look at in the next couple of months is to also try to identify factors that might be associated with the sustained increase in walking among those patients who are in the intervention. 

Our recruitment criteria were pretty general for the study. We again wanted to make this a program that we thought most patients with chronic back pain were being seen in primary care at our VA could use. We had two strategies for recruitment. One was through provider referrals to back class. The second was a little more of a proactive outreach to patients since we did not have quite enough volume with just the referrals. We also looked for patients who had two or more outpatient encounters in the prior 12 months with the diagnosis of back pain and no neurologic findings. 

Those were general criteria for the study. We then had some specific eligibility criteria that we would go through and screen for over the phone. We had to confirm that patients did have persistent back pain, which we defined as greater than three months. Because this was a walking program, we wanted them to be sedentary, which again, knowing that rest is a primary strategy people use, it did not seem to be too big of a barrier to overcome. Sedentary for us was defined as less than 150 minutes of physical activity per week. They did, because it was not Internet mediated. Intervention has to have at least weekly access to a computer with a USB port and Internet access. Then also, had to be able to walk at least one block. 

This next slide just shows you again kind of the flow through the study as we recruited people. We did, as I mentioned earlier have everyone attend back class. Sometimes that was a little bit of a barrier. Because some people really did not want to attend back class. But I believe again that it was very important for everyone to have some basic knowledge about managing back pain. It also served as a way for us to then go through all the study enrollment processes. Rather than people having to come in for another visit, they could come to back class and then go through the enrollment process.

However, after the enrollment process, patients would then go home. Those who were enrolled with their pedometer. We would ask them to wear their pedometer blinded. We covered up the read out on it for seven days. They had to do that so we could get a baseline measurement of their activity. At the end of that seven day period, we then asked them to upload the pedometer. For those who could successfully upload seven days of data, we would then move onto randomization. They also had to complete a baseline survey.

I think there was a few people who fell out in that time frame. Some who we called just to take the pedometer and run group. Who just never really got through that process. There was one gentleman I believe who for whatever reason, his step could never get picked up with a pedometer. He also was unable to go on for the rest of this study. We also required medical clearance for this project. Mostly to screen out for any cardiovascular problem. Again, there was really very few; I believe only one or two people for whom we did not get clearance for a walking program. 

Our study outcomes as I had mentioned previously. The primary outcome is pain-related functional interference. The measure that we used for this outcome is a pretty common one in most studies. Back pain, which is the Roland-Morris back pain disability questionnaire. This is a back pain specific measure of self-perceived disability. It is a zero to 24 scale. Patients are asked when your back hurts, you may find it difficult to do some of the things you normally do. Then are asked to mark sentences that describe you today. A sentence might be I stay at home most of the time because of my back. If again, a self-reported measure. The scale runs from zero to 24. Zero means that there is no disability. They have marked the option of none of these apply to me today.

We also used, in addition to this back specific disability index,  a more generic pain measure, which came from the medical outcome study. This is a combination of the effective pain on mood and behaviors as well as severity. Then again, had a number of different secondary outcomes that we have included as part of the study as well.

For data collection, our primary mode of data collection was a survey. The survey was done on the Internet. This was done through our study website. Control participants did have some access to this study website, but only two answered surveys and to upload their pedometer data. To also let us know if they had any adverse event.

The survey was conducted at baseline six months and 12 months. We also did a six minute walk test at baseline and then at 12 months. Unfortunately, I will not be able to share any of those data today either since we are still working on that. We have also collected all of the pedometer data. We would ask our participants in the intervention group to upload on a weekly basis. Those in the control group were asked to upload on a monthly basis. We also have a lot of data about website use. We will be able to look and see who was actively using these different components of the study intervention.

We are also going to analyze some data from the electronic medical records, so utilization of VA services. Then we have some qualitative interviews that we conducted with a few of the intervention patients. Just to get their sense of their experience with this particular intervention. Things that they felt were helpful or not as helpful. Things that we might use if we want to move forward with making this a program that is available to more Veterans.

Getting down to the data; this next slide shows you that during the course of the study we assessed over 1,400 people for eligibility. Unfortunately, we had hoped to do this in about a year, but that took a bit longer as many randomized trials do. Just to find enough participants to enroll in the study, even though there are lots of patients out there with back pain. 

Whenever you are enrolling for a trial, it seems to – the numbers seem to dwindle a little bit. But in the end, we were able to randomize 229 patients. We were shooting for 230, so I am extremely proud of my study staff. How well they did, and they worked really hard to end up with 229 individuals. We then randomized to the intervention and control arm of this study.

Now, the randomization was done electronically by the compute and on a one-to-one basis. The fact that there is a little bit of an imbalance in the grouping numbers is just by chance alone. Then as you can see at six months, we were going for about 100 people in each group. What you are seeing is that we had about 90 percent of our patients in both intervention and control; in both the intervention and the control group respond with analyzable data at six months; which is – really for – again, most randomized trials, good follow-up data. I am quite excited that we were able to do quite well in getting people to stay with us and to continue on, and provide data for this study. 

We have a similar numbers at 12 months. Although there is a few who responded at six and not at 12 and vice versa. But again, I think we have done quite well with respect to our follow-up. Having at least 90 percent in both groups for whom we have data.

This next slide is showing you the baseline characteristics of our study participants. As you can see in terms of age, the mean age was about 51 to 52. This is probably pretty typical of what you see in a lot of pain studies. It is a little bit lower than our general VA population; which tends to be – have an average age. Alright, this primary care population, it is probably in the mid-60s. It is a slightly younger population. Also, I was a little surprised about gender. That we were able to see what I think of as probably a significant number of female participants. 

Again, that maybe reflects the fact that back pain is more prevalent in that population. But most of the studies that I have done previously in the VA, we usually have about 96 percent male. I was quite surprised since we were not specifically recruiting in any way to have female participants. Although they were as eligible as any of the male participants to be in the study. Health status; you can see again that there was a fair number who had poor or fair health status. And depressive symptoms, not too surprising since depression is a well known co-morbidity of pain conditions. 

The depressive symptoms score that we used was from the Cefd. A score of ten or greater was considered positive for depressive symptoms. You can see here on average our  – have a high level of depressive symptoms in both intervention and control group. It is also a number of patients who reported taking narcotic medication. If you look at Roland-Morris disability scores. This is now our main outcome measure. 

You can see that this on the scale of zero to 24, that our participants’ reporting mean scores of around nine to ten; pain severity, mean scores of around six; and baseline step counts in both groups were around 4,000 steps. The other good news for us was that our randomization worked quite well. There was the distribution of all of these characteristics between groups, if not statistically significantly different. These groups were pretty well matched with respect to intervention and control.

Moving on to our six month preliminary results. I am going to show you a couple of different results. I want to just start out with the complete case analysis. This is for those participants for whom we have six month analyzable data. Again, I think it is pretty robust in a sense of having over 90 percent of our patients in both groups responding.  I am pretty confident in these results. Also, quite pleased with the results that we are seeing. In the Roland-Morris disability score, which is our primary outcome, the functional measure; back pain-related disability measured. You can see that intervention patients are reporting lower levels of disability than control patients. 

This is a significant difference. We also see that for the more general pain effects measure, that there are also lower scores; and in this case lower is better in the intervention versus the control participants. There are intervention patients reporting less pain in terms of pain level. They are reporting higher exercise and self-efficacy compared to the control group. Now, this score – the self-efficacy measure is a little bit odd. Because what we found is that actually both groups had worse scores at baseline. 

Or, excuse me, at six months compared to baseline, but less so for the intervention group. For fear avoidance, which was measured using the FABQ for the collectivity subscale, we do not see any difference between the control and intervention patients. Then an average step count, what we found is that on average ,the control participants have a decrease in their steps and baseline by about 150. Where the intervention group had an increase in their steps by about 700.

This is the complete case analysis. It., a part of it tends to treat analysis in the sense that people were analyzed within the group to which they were randomized regardless of what they did. This is factoring in whether they actually used the website or did anything. But these are the results for that complete case. But, of course, even with 90 percent follow-up some folks get concerned about incomplete capture. 

The fact that maybe the people we did not have respond at six months are somewhat different than those who did. As it turns out, they may be a little bit, but it may not be exactly as we had expected. What I am showing on this next slide is looking at adjustment for this non-response. We did an analysis that includes data from all patients. Used just the physical [sic] techniques to impute missing data so that we can include everyone.

The good news, if you look on the left two columns. You can see that in the adjusted difference. Again, all of those scores are in favor of the intervention group. Suggesting a positive benefit of the intervention compared to the control group. What we see however, if you look at the statistical significance issue is that we have lost a little bit of our significance. For those who – the purists, you can see that our statistically significant result of PUS [sic]  and .05 for our primary outcome no longer exists.

But, I would suggest that this is in part because of some of the uncertainty that is introduced into the measurement by the imputation. Again, everything is in the right direction. I am pretty confident that we did have a positive impact on the folks in the intervention. But the other interesting thing that we discovered. This is admittedly post hoc. But as we were looking at this more closely, we learned that at baseline there was some percentage of our study sample. This was in both groups, who had a Roland-Morris score of zero. At baseline, they were reporting no back pain specific disability. 

Now, that is probably not all that surprising. We did not screen on that measure. Of course, for most people who do have back pain, we do know that there are certain perhaps times when it is more prevalent or more prominent for that person than at other times. But if you consider that, they really had not place to improve at six months. What we also did is look at folks who did report at least a Roland score of greater than four. It had some level of disability. If we look at that groups, and now over on the right two columns. 

You can see that again, we have pretty robust results with improvements being seen from baseline to six months  in the intervention group compared to the control group. Some pretty significant at least statistically significant results as well. For those if you think about it from a clinical perspective who were repotting at least some level of disability at baseline. We do see some pretty robust results. For the sub-analysis, it is also important to remember that now we have reduced our sample size a bit. We have about 94 folks in the control group and 84 in the intervention group. Yet, we are still seeing what appear to be some pretty significant results.

Taking that into account, I would propose that patients in the Internet  mediated intervention compared with those in the control group reported less back pain related disability and increase their physical activity. 

In this case walking; and in six months following study enrollment. Intervention patients also reported less pain and improvements in general pain-related function. We are, of course, following these enrolled patients now to see the extent to which these improvements are sustained over the subsequent six months. Those data were just collected. We are in the midst of analyzing that information now. But I am hoping to see again some continued improvement or at least sustained improvement for those in the intervention. 

But as far as implications, I believe that facilitated walking intervention that uses an enhanced development or an Internet may be an important strategy for enhancing management and improving access to an effective exercise program for Veterans with chronic back pain. Now, we may not have gone from out of shape things, but to the abdominal snowman. But I do think this type of primarily automated intervention could be an efficient way of delivering or supplementing care provided through traditional facility based programs. 

I just wanted to end by sharing with you one of the quotes from a study participant. This individual was asked about whether they would have tried walking to help manage their back pain? And said, “Probably not, but now yes. Then I didn’t know what the study or the walking could do for me. But I do now. I had a lot of back pain. And that's why I was in the study. And it seemed to alleviate my back pain. In fact, I credit it to the walking. And the true test came when I had to go off the program because of my illness and the back pain returned.” In fact, just up until recently when I had resumed walking. 

I just wanted to conclude by acknowledging all the members of the study team. This is a fabulous group of folks with whom I had the privilege of working, including Caroline Richardson, who is our family medicine physician and was the Co-PI for the study. Really was the impetus behind the Veteran’s Walk to Beat Back Pain and the Stepping Up To Health program, which was the platform for this study.

Also, I need to say thank you to the VA Ann Arbor Heath System and Physical Therapy Department since they also were instrumental in helping us with this project. With that, I would like to say thank you and would be happy to take any questions at this time. 

Moderator: Fantastic, we do definitely have some pending questions here. But I do want to let our audience know. Please submit any more questions that you have. You can use the Q&A screen, which is located on the dashboard on the right-hand side of your screen. The dashboard is at far on the right-hand side of your screen. If it has just appeared against the side of your monitor, just click on that orange arrow. And it will open it back up. 

Feel free to take your questions then right at the bottom there. Ok, and Sarah, the first question we have. Many VA investigators have encountered numerous roadblocks and problems setting up Internet space interventions or websites. They are wondering how you were able to set up the website. Wait, so many people had issues.

Sarah Krein:Yes, and us – or just like everybody else, we too had some difficulties in terms of doing this. A couple of things I have to say. This website was not housed within the VA. The website was actually something that was housed at the University of Michigan and run through the University of Michigan. We did have some challenges. We had to go through some contracting issues in order to do that. 

Of course, there are all of the security procedures that had to be set – put into place in order to do that; and used an outside approach. We’d love to figure out ways to make this something that could be done in VA within side the VA firewall to make it perhaps more accessible. But because of those challenges as was mentioned. We at this point and time had decided only to use it or to have it set up outside VA. But are hoping that we can work with some of the folks at the national level or even at our local level to see if there are ways of bringing more in-house.

Moderator: Great, thank you, the next question. What does the medical clearance consist of?

Sarah Krein: The medical clearance was pretty general. Again, our primary focus was on people who might have some cardiovascular issues that we needed to be aware of. What we would do was send a very brief form to the provider. Initially, when we started, the interesting thing about this was initially we had started out doing it on paper and having them faxed back to us. Our study – my study staff was wonderful in that they figured out a much strategy which was a way to do it through CPRS [sic]. 

They were able to get the clearance again as part of the record as opposed to having to go through this extra step for our providers. But it was a pretty general clearance form. I have to say if we did this study again, I am not sure we would do that step. At that point and time, there was always – people have some concerns about safety issues. Thinking mostly about cardiovascular issues, but we have study data from all of the monitoring that we were doing. 

Really, there was not any big issues that we observed with respect to cardiovascular problems. There was musculoskeletal conditions that came up. Not too surprising again, if you are – even with walking. But the cardiovascular issues really seem to be a non-issue. I think we can use that information now to perhaps not have to go through that process.

Moderator: Great, thank you, the next question. Any particular reason for not using the Oswestry Disability Index? Any reason for preference of RDQ versus ODI?

Sarah Krein:Yes, we did look at both of them and talked about which one to use. I think for me the reason I went with the RDQ was mostly because the studies that I was looking at and the majority of the studies that I have reviewed, that was the preferred measure. It was – I think both of them are probably good measures. But we just decided that was the one that we were going to go with. Again, mostly because it seemed that was the one preferred in most of the research that I had been reviewing. 

Moderator: Ok, great, thank you, the next question. How much do the pedometers cost and where do you get them? Will this website be available to others once the study is completed?

Sarah Krein:All good questions; so, the pedometers can actually be commercially on Amazon. Or there are probably other places. It is an Omron pedometer, so I am not promoting any particular products. But the one that we did use in an Omron product. And can, I think it is...  I looked the other day, at least commercially available on Amazon for around, I think it is like thirty-six or thirty-seven dollars. There may be other versions. I know there are other versions of this pedometer out there. But the specific one that we used, which has the uploading feature is about thirty-seven dollars. 

With respect to the website, unfortunately we have had to now take it down, at least this version that we were using for the pain study. Because we are not able to support it without the research fund. We are trying to look for other strategies that we could use to make this type of approach available to people. I know we are going to be meeting in a couple of weeks with our facility, physical medicine and rehab director to talk about some strategies that we might to use if we wanted to continue with this program. It would have to be done in a slightly different way since we do not have the study website now. 

But there are some commercial products out there that have some very similar features that we could consider using. Maybe just looking at some other options. Because we do think this is an important thing I think that our facility would like to see perhaps continue. So we could offer it to our patients. But the website that we were using is unfortunately not sustained at the moment.

Moderator: Great, thank you, the next question. Do you have any analysis that might indicate more benefits to those in the intervention group as their level of exercise increased? In trusting that you – that you got significance with only 700 steps per day difference between the groups?

Sarah Krein:Yes, and that is a great question. I mean, again, those were...  That was an average. I do suspect that as we do dig a bit more. That is that part of our next step in the analysis plan is to actually look at the behaviors. How much people did increase their walking as well website use and all of those kinds of things that might have influenced the benefit that they received. But unfortunately we have not quite gotten to that point. But that is definitely something we want to do and see who is really getting the most benefits. What pieces of the intervention might have contributed to that.

Moderator: Great, thanks. The next question; did you use or attempt to use any captured data from the data warehouse? What data did you use or would you have liked to use from the data warehouse?

Sarah Krein:I am assuming they are talking about the corporate data warehouse?

Moderator: I believe so, yes.

Sarah Krein:Yes, and we have not. Since this was only done at the Ann Arbor, VA, most of the data that we have been able to collect. Most of the data that we were using are things that are already available or were available at least when we were doing the study at the Austin Automation Center just through the staff files. Most of the data that we have gotten has come through that. But, if we do not get all the information that we needed, we probably would need to think about going to the data warehouse. If there were other things that would be available that were not when we actually started this study.

Moderator: Great, thanks. The next question; on average, how many years have these participants been dealing with low back pain?

Sarah Krein:That is a really good question. You know what? I do not know that I have that information. I know we – I am quite sure that we asked them. I will have to go back and look to find out what that is. But, my suspicion is that for most of them it has been quite awhile. I know when we had done prior work, some of our prior survey work, it was usually many years that folks had chronic back pain. I think the majority of these I would... My suspicion is that they had been dealing with it for a number of years. It was very few for whom it was probably a new onset type of condition. But that is a good and I should have those data.

Moderator: Ok, thanks. The next question; did I read the slide correctly in that there was no statistically significant difference between groups and number of steps walked?

Sarah Krein:That is correct. If you looked at in our six months that was just kind of the general comparison. There was no statistically significant difference. Part of the issue there is just because of the variability in those measures. It was such a wide variability that to achieve statistical significance can be sometimes very difficult. We do however in that slide that I showed did not have it completely adjusted for baseline; and have not really looked at a couple of other things with respect to the step counts. 

The data – the step count data are a little tougher to deal with and so some of our analysis with those data are a bit more premature than some of the survey data. We do need to look at that more. But it takes a little bit more work in order to really look at those data since it is just a lot of information. You have to figure out exactly how to put it into a measure that is interpretable and then can be analyzed. So, it was not statistically significant. But that is correct.

Moderator: Ok, thanks. We have received several additional questions. I know we went over this a couple of minutes ago. But more questions about the brand and the cost of the pedometers?

Sarah Krein:Yes, so the brand of the pedometer that we used again. No, product promotion here, but is the Omron hj-720itc speed. That is the specific product that we used. If you go on Amazon, for example it is one that pops up. If you just put in Omron pedometer. On Amazon, at least, the last time I had looked, it – the price of that pedometer was around thirty-seven dollars. I know they have a couple of other products, though that are somewhat less expensive. There might be some that are not uploading. I am not entirely certain. I have not looked at of late – too much of the different types of products. But I know they have several different brands.

Moderator: Ok, thank you, the next question. Have your  six month findings been published?

Sarah Krein:No, that is our next step. We are currently working on a manuscript and are deciding whether it is just going to be the six month results. It may actually include the 12 month results. Since we do now have those data in. just not completely analyzed, but we are hoping to get something out in the next couple of weeks.

Moderator: Great, thanks. The next question; did you use heart rate monitors for patients to monitor their exercise intensity?

Sarah Krein:We did not. We thought about that strategy, but we did not include that. We wanted to make this as simple as possible for our participants. So, we did not do that. The only time we had considered – we had also considered using heart rate monitors during our six minute walk test. I think we started out trying to do that and it just became a nightmare trying to get these things on folks. 

We did not even end up doing that. It might have been another thing to think about and perhaps for another iteration. But we really wanted to make this kind of a very simple thing that people could do. Sometimes it gets a little more complex and we try to throw in more information for them to try to monitor what their hear rate.

Moderator: Ok, thank you. The next question. Did you assess sedentary time as an outcome variable?

Sarah Krein:No, but that would have been really good. Because I know there is more and more literature coming out now about just sedentary time being a predictor for certain bad outcomes. Had we thought about that, that probably would have been a good thing to do. But unfortunately we did not.

Moderator: Ok, thank you. In the stacks we have gotten a couple of questions wondering if there is any of the web based functionality through My HealtheVet? Or, could we use this type of website for My HealtheVet?

Sarah Krein:Yes, and that was one of our initial thoughts when we had this. When this was first proposed. It was a way of could we incorporate something like this into My HealtheVet. We have not gone back to talk with the My HealtheVet folks about the possibility of doing that. But I think we probably need to do that. I know there has been lots of interest in using My HealtheVet for a variety of programs. But this would seem like something that could be well supported through that type of an approach. We probably need to have some conversations with the My HealtheVet folks. And see if they have any interest in this kind of thing. Yes, that is another great suggestion.

Moderator: I received a follow-up to the question. The gentleman who asked about the no statistically significant difference between the number of steps. He is wondering how do you interpret these findings?

Sarah Krein:The fact that there was no difference in the number of steps?

Moderator: Yes.

Sarah Krein:Well, I mean, I think there are a couple of – there could be a lot of different reasons. Again, you have to remember that is just an average there was no statistical difference between the control and intervention group. But as somebody had mentioned earlier, we have not really looked specifically to see how people – how the outcomes relate to their actual walking behavior. Remember there is lots of variability in both of those groups. 

 I think my interpretation again is that the fact that people were actually maybe moving; and even if it did not increase their steps dramatically. The fact that they were perhaps more cognizant and out there moving around was a benefit to these folks. I think part of it was related to just getting more active. Whether or not that meant a huge increase in step counts may not have been the case. But the fact that they were more active in some respect may have been of benefit. 

I also think that there was other things in the website. Maybe it was not just the walking that really promoted this. But also the fact that they were getting other content and other encouragement could have been useful. It was kind of a multi-modal intervention so it could have been different things that contributed to what I still interpret as being benefits with respect to improvements in function and reduction at least to some extent in pain for the intervention group. What it was, there was something about it that seemed to, in my opinion, lead to some benefits. How much of it was just walking per se, I think is still to be determined.

Moderator: Great, thank you. We have gotten a couple of questions from people wondering about the diagnostic breakdown for your group of participants?

Sarah Krein:We do not have all those data as of yet. To do that we would have to probably go into more of the administrative data that we have been collecting to look at what their actual diagnosis were. We did not do a lot of screening about specific diagnosis. Because again, we wanted just to be pretty generic to what we see here at the VA Ann Arbor. At least with respect to back pain patients. So, it was pretty much anybody was eligible if they were referred to back class. Or had as I mentioned earlier been seen for back pain without neurologic findings. That was really the only thing that we tried to screen out a little bit. But other than that we kind of took all comers and have not really specifically broken it down by diagnosis of yet.

Moderator: Great, thank you, the next question. Did participants both control and intervention walk alone or with a significant other? Did you control for this or did you see a walking partner effect?

Sarah Krein:We did not. I do not know that we even asked them specifically about if they walked with somebody. I know in our survey we did ask. Well, we do a little bit ask about – have some questions about support and if they have people supporting them in their activities. We may be able to get at that question a little bit in some of our survey data. 

But it is interesting. Because we had, when we were initially planning the study, discussed whether or not we wanted to also consider giving pedometers and enrolling spouses, or friends, or care partners of some sort in the intervention; as well for those in the intervention group. And it kind of went around a couple of times thinking about how that might be of benefit. 

I guess just decided for feasibility reasons not to go that route since it has meant more concerns and all kinds of other issues as far as being a study. But I think that would be really interesting as well to see if we could maybe even bump the benefits a bit more if you start to get other engaged in a more active way; and see if that would help people as well.

Moderator: Great, thank you. We are just past the top of the hour. We do still have nine pending questions. Sarah, do you have time to take these questions? Do you want to deal with them offline? I know I told you this is something that might happen, but I want to check in with you.

Sarah Krein:That is fine. I can answer a few more questions. 

Moderator: Ok.

Moderator: Ok, so, you are getting through them fairly quickly. Well, hopefully this should not take too long. The next question; was there any reduction of opioid use in patients who had benefited from the intervention compared to the control group?

Sarah Krein:Boy, everybody is ahead of us. So, yes, we do not know yet, but that is one of the analysis that we do have planned. That was why we are collecting medication data and are hoping to look at that issue. Again, hope to see some benefits in that direction as well. 

Moderator: Everybody is going to want to read the report that you have coming out. Thank you, the next question. This seems like an amazing adjunct to offer in primary care for interested patients or to encourage for not so interested patients. Can you comment how you think implementation will occur?

Sarah Krein:Yes, that is...  I mean, I guess for me the million dollar question; and I think our next step is trying to figure out how we would do that. I mean, and again there is a lot that goes into enrolling patients. And getting patients into this kind of an intervention. Then, there is a lot of the behind the scenes that – things that were going on with respect to keeping it moving that would have to be taken into account. But we are definitely going to be looking at that. Because 

I think given the results we have seen today, we feel that is an important next step and want to work with folks here at least at the Ann Arbor VA to see if there are ways we can make this a program that can actually be implemented in a VA on an ongoing basis. But I have to admit that right now, I am pretty early in that kind of thought process. So, if people do have suggestions, I would be happy to hear that as well. Because I do think it is important for us to try to do that.

Moderator: Great, thank you, the next question. You mentioned at the onset of the presentation, your intention of analyzing mechanism variables. I do not recall you recording those results. Did you happen to find that change in mechanism variables accounted at least partially for differences in outcome?

Sarah Krein:Yes, again that is a little bit more for the future. It is definitely something we are pursuing now that we have all the data in. I hope people will stay posted. And I can maybe do another session at some point and time to share some of those kinds of results as well. Since there is still a lot to be done with these data. Hopefully we will see some more interesting things popping up. 

Moderator: Great, thank you, the next question. Since your website was housed on outside server, did you have any issues with accessing your website from the VA computers?

Sarah Krein:No, except; and I have to remember if we ever got this result or not? The only problem that we had from the VA computes. There were two problems that came up. One was you have to have, in order to upload we had this little installer program that had to be loaded off the computer. And so for those of us who do not have administrative privileges on our VA computers, we had to have somebody do that for us; and had to get permission for that. 

That was one issue. The second issue that we ran into was the video itself. Trying to – the back class video that we had posted, we were unable to view at least initially on VA computers. I have – I do not remember if we ever got that completely resolved or not. I know there have been some improvements because VA has let more types of video programs stream than they did at least when we started the study. 

But that was another issue that we had. Luckily for us most of our participants were not accessing it from the VA. But for those that did, we had a few that were coming to the library. We did have a few little issues that we had to work through. 

Moderator: Ok, great, thank you, the next question. The actual improvement in step count seemed low. Were you expecting a more robust increase in regular exercise?

Sarah Krein:Yes, at least I was. I know from prior work that Caroline had done. She had used this program for other types of patient populations. I believe she was being more along the lines of like a 2000 increase in step count. I was a little surprised at how low the steps were. But again, some of that can be some measurement issues that we have not yet dealt with. But it could also be again that we just did not increase as much in terms of actual step counts. I am hoping that again people were somewhat more active even if it did not accrue to a huge number of steps over the course of the day. 

I mean, again, one of the things you just wanted to do was to get people out of their chairs and maybe move around their house a little bit more, if anything. That is probably not going to lead to a ton of extra steps. But I suspect again we have a pretty good distribution that we need to look at just a little bit more carefully of those who probably did increase quite dramatically and those who didn’t; and explore that a little bit more.

Moderator: Great, thank you, the next question. What are your thoughts regarding using telemedicine for the ongoing support to the Veterans?

Sarah Krein:I think it is incredibly important that we use these kinds of strategies for our Veteran population. To reach out to where they are at and allow them to do these kinds of things in their own homes at their own time. Make it more convenient for those participants wherever they are at. We have actually been doing some other work here at the VA Ann Arbor through our PACT Demo Lab and asking patients about their preferences. Or different types of programs and care delivery; and perhaps not too surprisingly. 

But a little surprising is the number that really do not want to come to the VA for programs and for care. I think the more that we can deliver to them remotely is really important. I know there is concerns still about lack of access to computers for some patients. I think that too is starting to diminish. A lot of people do have access. We could be doing more in this area. I think it is important that we do. 

Moderator: Great, thank you, the next question. I am not clear on the differences in treatment between the control and intervention groups.

Sarah Krein:Ok. The biggest difference was that for the intervention group, basically we were doing goal setting for them. Giving them specific feedback about their walking activity. Even though the control patients had a pedometer, they did not have the information to use that pedometer, which I think is pretty typical. When people get the device and pretty soon it goes in the drawer because they do not find it of use. But for the intervention group, we actually were helping them to increase their activity by providing them with reasonable goals for the walking activity. 

Giving them feedback about how they were doing on that. The other thing is that the intervention got again, were some level and some forms of social support to participate in this activity. I think the fact that they were using the website also lent some level of accountability. They felt like they were being kind of monitored in this activity; which, I think for many people is important. We were also providing them with some additional information and education and support through the website that the control participants did not receive.

Moderator: Great, thank you, the next question. What about using increase over one’s own baseline of steps as a measure instead of just number of steps?

Sarah Krein:That, yes, actually that is what we are doing. Sorry, if it was not exactly clear. Some of the results I had presented, but we are looking at the difference from baseline steps. So, I just – we were just showing averages on those slides. But in the actual analysis, we will be incorporating that baseline information. It is a difference, a change – essentially a change score for the individual patients.

Moderator: Great, thank you, the next question. How did you deal with those stating they cannot walk due to increasing their back pain? Were they included or screened out?

Sarah Krein:They were included. Well, we did not use that as  a specific screening criteria as I recall for eligibility. We do know that there were some patients who reported problems; including increasing pain or higher levels of pain through the city website. Because we collected a lot of data on any type of adverse event that was happening. 

So, we asked patients on a regular basis to report on pain levels and some other issues that might be occurring. We do know that was happening for some participants. That – that was a problem. In general, our advice would have been at least for that. Because it was a very acute period of time to perhaps decrease their activity if they needed to. But then to try to re-engage as they felt able to do so. We did not really try to screen out folks, just specifically because of that.

Moderator: Great, thank you, the next question. Were participants compensated in any way?

Sarah Krein:They were compensated in a couple of ways. One, they got a pedometer. I guess that is some form of compensation. But we also did provide compensation for basically completing the surveys. They would get at enrollment. Then for each of the surveys that they completed, there was some compensation that they would receive. But really it was more for the data collection aspects of this study. 

The other thing that we did, which I guess I had not really mentioned. Not really compensation, but for those in the intervention group, we also had gains. At various times, we would have little competitions. For the folks that would win a competition, they might also get like a little prize. But they – those were pretty much just token types of things. Sometimes it was just acknowledgement of their branch of service on the website. Or, sometimes it was – I think we had like a hat or something that people who – could win.

Moderator: Great, thank you, the next question. Did you get consent from your subjects?

Sarah Krein:Yes. This was all...  They were – we had written informed consent. That was done as part of our enrollment process. That was also...  We had the – well, we would have done that anyway because this was an intervention. But, that was one the things that helped us in terms of being able to use an outside web server. Because we were collecting some information on patients. They had to be fully informed again of where their data were being stored. That was also part of our concerned process.

Moderator: Great, thank you, the next question. On the slide with female participants, one day the person did a lot of activity. The next day, they did not achieve goal. Did you see this a lot with participants overdoing activity and then next day not being able to reach goal?

Sarah Krein:That is a good question. We have not really analyzed the data in that way. The data that I was actually showing you was one of our study staff. I will have to ask her if that was an issue for her. But we have not really looked at it in that way. We were not really specifically again monitoring patients on an individual level. That could indeed be a problem. 

We were trying to get away from that using the goal setting for people again. Rather than just kind of leaving them to their own devices. And having them go out and try to achieve this magic 10,000 steps or whatever it is all at one time. Then suffering for it for the remaining part of the week. We were trying to get them to incrementally increase activity. That was also something that was talked a lot about in back class. We would kind of reiterate that throughout the course of this study. 

But I do not know if we had a lot of that kind of activity going on just on an individual level. It could be something in our analysis. We could try to look at just a bit more carefully.

Moderator: Great, thank you, the next question. Any interest on the part of patients and, or practitioners in actually being able to refer to this program?

Sarah Krein:That is a good question. I do not know. I guess we have not really explored that as yet. I do know again that because we did not have provider referrals just to get into the study that there were a few, I think providers who specifically were referring patients to back class. Because they thought this might be of benefit to them. I think there is some interest on the provider side. 

I think that on the patient side again of the interviews that we did with our intervention patients. There were some who definitely thought this would be of benefit for other patients as well. I am kind of hopeful that this would be something that people would be interested in, both in the provider and the patient side.

Moderator: Great, what about integrating this program into a multidisciplinary pain service?

Sarah Krein:I think that would be the way to make this thing really work well. Again, I think is an adjustive program for those kinds of services, if you have them available. Not all facilities do, but I really do view this as something that is an add on to some existing infrastructure. It would really be a nice way to make this another piece that you could include in your management strategy for patients amenable to those kind of pain management strategy.

Moderator: Great, thank you, and last question. Are you considering the smartphones to do this type of study instead of computers?

Sarah Krein:Yes, that would be I think really interesting. We have not talked too much about that as yet. But that could be something that we would incorporate. We actually had done some pilot work. Some other strategies; again, with kind of a similar idea. Some of it focused more on obesity and diet and exercise for OEF [sic], OAF Veterans. That did include some smartphones components. Whether they would want to be using more of that kind of technology. 

Whereas for older Veterans, maybe it was the computer. But, I do think we have to look at some of these other options as well. It certainly has been as kind of the back of our minds as we have moved forward. Looking at all kinds of alternatives for delivering these kinds of programs. Yes, there is lots of other new technologies coming out that we could think of incorporating as well just to get people again, moving.

Moderator: Fantastic, great, thank you so much, Sarah, for taking the time to present today. And for sticking around that late, answering all of these questions that we received here. Did you have any final remarks you wanted to make before we sign off here?

Sarah Krein:No, I just wanted to say this was really a pleasure. I am glad people were interested. If there are other questions, they should feel free to e-mail me. I am happy to discuss further. 

Moderator: It sounds great. Your e-mail address is on the screen right now. Our audience can take advantage of that to their full desire. To our audience, thank you so much for those of you who stuck with us late today. We would really appreciate you sticking around. We will for the people who did leave early, we have recorded this. They can catch any answers that they missed on that recording. Sarah, thank you so much for taking the time to put this together and present today. We really do appreciate the time that you put in to this.

Sarah Krein:Great, thanks, Heddy.

Moderator: Thank you so much and we will see you hopefully all of you at a future cyber seminar. Thank you. Bye.

[END OF TAPE]

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