Is there an answer for stroke patients when conventional treatment for severe spasticity doesn't yield the desired results? In a recent article in the Journal of Neurology, Neurosurgery and Psychiatry, Michael Creamer, DO, and colleagues shared results showing the effectiveness of intrathecal baclofen therapy in treating patients with severe, post-stroke spasticity. Dr. Creamer shared the findings and their implications for physiatrists in a conversation with Michael Saulino, MD, clinical director of intrathecal therapy services at MossRehab. Dr. Creamer is a spinal cord injury and pain specialist at Central Florida Pain Relief Centers and an assistant clinical professor at Florida State University involved in training medical students.
Welcome to a MossRehab conversation, part of a continuing series of discussions with pioneers in physical medicine and rehabilitation from one of America's top US-news ranked rehab facilities. In this episode, we hear from Dr Michael Creamer, specializing in spinal cord injury and spasticity management. He works in Orlando through Central Florida Pain Relief Centers and is an assistant clinical professor at Florida State University involved in medical student training. Conducting this conversation is Michael Saulino, MD. A specialist in pain management, he is director of neuromodulation at MossRehab with a special focus on intrathecal drug delivery. Dr Saulino.
Dr. Saulino: For those clinicians who might not be aware of it, talk a little bit about what spasticity is. Who gets spasticity and what are some of the treatment approaches for spasticity?
Dr. Creamer: Spasticity typically is described as an increased tightness of the muscles in the arms or legs. Usually when a person has sustained a neurologic injury. It could be from a stroke. It could be from a condition such as cerebral palsy or a spinal cord injury that may have resulted in paralysis. And then there's the uncontrolled movement of the extremity due to the lack of control from the injury to the central nervous system. Many times the spasticity acts upon itself, can be uncontrolled and sustained. Other times it may just be where the arm or leg is in a tight position, very difficult to straighten out or bend. That can result in significant limitations in a person's ability to care for themselves, to be able to walk or for others to care for them.
Dr. Saulino: As we delve a little deeper, what are some of the treatment approaches for spasticity?
Dr. Creamer: The most common treatment and the one that we as rehabilitation professionals recommend would be the use of physical therapy and occupational therapy utilizing ice and heat and stretching and splinting mechanisms to try to stretch out the tight muscles and also educating the patient and family how to do this. I would say that that's the predominant treatment approach. However, in many cases, especially in severe neurologic conditions, the use of oral antispasmodic agents becomes the next line, baclofen being the most common use for management of spasticity, but also the use of Tizanidine or Zanaflex and other medication that's used to try to suppress abnormal muscle activity. Valium is another medication that's utilized but may have some side cognitive side effects. Some of the other medications are sometimes used even though they're not usually advocated. Dantrium is another medication that is sometimes used but also has some limitations in its use because the potential side effects. Beyond the oral antispasmodic agents usually botulism toxin or botox is typically utilized and that has gained significant use and upper and lower limb spasticity. Then the last treatment that we typically utilize - may not necessarily be last that we would recommend - is the intrathecal delivery of baclofen.
Dr. Saulino: So that's really the focus of our conversation today and let's go into a little bit of detail about what intrathecal baclofen delivery is and why it has such importance in the management of spasticity.
Dr. Creamer: Well, when you think of what I just described in regards to the treatment options, most of the treatment involving physical and occupational therapy, especially in severe cases, is inadequate to control the spasticity, especially since you can't continue to stretch the limb 24 hours a day. Sometimes utilizing splints, which can be helpful, may result in pressure ulcerations or skin breakdown due to the continued pressure on that limb of a piece of metal or plastic. The oral antispasmodic agents many times have side effects of cognitive impairment and that typically is something we're trying to avoid, especially if the spasticity is due to a central nervous system insult. And then use of botulism toxin is certainly a very viable treatment, but many times we are limited in the amount of botulism neurotoxin A that we can administer through an injection into the muscles because of the potential risk of toxicity and side effects associated with high dose botulism neurotoxin A. So there are significant limitations in the use of these other treatment options and the use of intrathecal baclofen has significant advantages in that it is delivered directly into the spinal fluid, through a small tube, a catheter, and it's delivered continuously, 24 hours per day via an intrathecal pump that would be implanted. And from what we have observed has less potential side effects cognitively and is also a much more effective way of managing spasticity on a continual basis.
Dr. Saulino: Michael, you were recently involved as we were at MossRehab with a recent study involving this intrathecal baclofen therapy in the stroke population and I'd really like to focus in a little bit about that. Talk a little bit at first about how spasticity affects patients who have had a stroke.
Dr. Creamer: Well, Mike, you and I certainly have experienced patients who have presented to our office weeks, months, years down the road with spastic hemiplegia - one arm, one leg drawn up into the chest or even feet drawn up into the back of the thigh. Or even sometimes the opposite - where a leg is fully extended or an arm fully extended and wrist flexed and fingers into the palm. And we recognize the severity of the spasticity as well as the limitations that results in the patient's ability to be able to walk or to dress themselves or even for family members to care for them. And typically these are patients who have already been through the treatment approaches that I discussed earlier. So now where are we in regards to how we can help this individual? And the question arose can intrathecal baclofen, which has been used for many, many years in other populations of spinal cord injury, traumatic brain injury, can it help the stroke patients? And they really had not been any studies, at least from a standard of randomized, controlled, open label phase four studies that really looked at the use of intrathecal baclofen compared to what I described as the conventional medical management - involving physical therapy and also oral anti-spasmodic agents. We took botulism toxin out of the picture just to really gain an insight into how the comparison would be between these two treatment approaches. And that was the basis of the study. Let's look at use of intrathecal baclofen and compare to what these patients had typically been receiving and see if it made a difference in reducing tone and improving their quality of life.
Dr. Saulino: So the study was called SISTERS, spasticity in stroke study, and exactly as you mentioned, it was a randomized trial comparing individuals who are treated with intrathecal baclofen and compared them to best medical therapy. Those results have been both presented at conferences and now at least the primary outcomes have been published. Can you tell our audience what the results of the study were?
Dr. Creamer: We demonstrated statistical and clinically significant reduction of tone based on measurements of the Ashworth scale in the upper and lower extremities in regards to spasticity reduction. So we saw statistically significant and clinically significant reduction of spasticity in the involved upper and lower limbs of the stroke patients. And this was again compared to conventional medical management. We saw an improvement in functional independence measures, even though that did not reach statistical significance. We did see a statistically significant reduction of pain in several areas that were evaluated during the clinical study. And overall the potential adverse effects were consistent with what had been seen with the use of intrathecal therapies in the past. Patient satisfaction with these devices was high in the groups that had the implant, despite the fact that they did undergo a surgical procedure.
Dr. Saulino: Were there any findings of SISTERS that you found surprising?
Dr. Creamer: Working with the use of intratechal baclofen for stroke patients, it did not surprise me. It was very encouraging that we were able to demonstrate this in a very well prepared clinical study. So I was encouraged but not surprised because I see this on a daily basis and of course the patients that I treat it has significantly changed their lives, and I see that on a on a daily basis. Even today, seeing a patient who had an intrathecal baclofen pump implanted for stroke spasticity with some adjustments in medications made and we saw the effects of spastis returning and we're able to adjust the pump to return of reduction of spasticity again. So, again, this was not a surprise for me. I really was pleased that we were able to demonstrate it in a good clinical study.
Dr. Saulino: What about the effects in the upper extremity, MIke? Does that have a little bit of a surprise for you?
Dr. Creamer: Well, again, with my patients, I've been able to see an improvement throughout, so to be able to prove it clinically was very encouraging. So it didn't surprise me, but I was very happy that we actually could show that. I think that was something that would surprise a lot of individuals. I think it was fairly common knowledge that putting an intrathecal pump into a patient, especially into the intrathecal space, would help to control lower extremity spasticity. But to see it clinically reduce upper extremities spasticity was very encouraging, especially since in the past a lot of treatment for upper extremity limb spasticity was more focused on use of botulism neurotoxin, as opposed to looking toward intrathecal therapies for upper limb spasticity control.
Dr. Saulino: I believe that the primary outcomes have been published now. Do you have the citation for our audience?
Dr. Creamer: The Journal of Neurology, Neurosurgery and Psychiatry. The publication that just came out. So we were very excited to see that recognized and have the data published.
Dr. Saulino: And that's thanks to you and all the investigators. That was a hard study to do and involved a lot of effort on all the investigators parts, and it's good to see that first paper come out. In conclusion a bit, what do you think the next steps are in spasticity research in general as well as maybe some other developments that you might see specifically for spasticity and the stroke population?
Dr. Creamer: Well, I, I'm always a big advocate to demonstrate the financial impact that this can have on patients with spasticy. We know that in the patients that have sustained a stroke, that upwards of 40 percent of these patients can have significant spasticity and up to, I think, 13 percent can have severe spasticity. We also know that it's been stated that up to 70 percent of patients who have survived a stroke and continue to have spasticity that the patient and their caregiver ranks best, he has a significant impact on their quality of life. We certainly know that it impacts their ability dress and to bathe and to walk. So the question is how does a reduction of tone impact the caregiver burden and what impact does that have on financial gain in reducing overall cost of caring for these individuals? And then also how does it compare to other alternative treatments? Botulism toxin is certainly being used consistently for spasticity control, but it's expensive, it requires injections typically every three to four months, it may not be adequate. So you know, can we really look at what is the overall financial benefit? I would expect for an intrathecal therapy, baclofen, for management of these patients. So the study was fairly limited. It was only a six month study when the patients were enrolled and when they finished. So we really need to look at a longer term study to see how this impacts the person clinically over a much longer period of time. So those are some things that I would like to see. And then also can we also incorporate botulism neurotoxin? How does that impact any residual spasticity or focal spasticity that may not be controlled with the use of intrathecal baclofen, as well. So those are just some thoughts on my mind in regards to these future studies.
Thank you for taking the time to talk with us Dr. Creamer and many thanks for helping MossRehab educate the physical medicine and rehabilitation community. Michael Creamer specializes in spinal cord injury and spasticity management, working in Orlando through Central Florida Pain Relief Centers, and he is an assistant clinical professor at Florida State University. And for conducting this conversation, thanks also to Michael Saulino, MD, specialist in pain management and the director of neuromodulation at MossRehab with a special focus on intrathecal drug delivery. Look for more conversations to come on our website at MossRehab.com/conversations. I'm Bill Fantini. Thanks for listening.
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