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Interview: How spasticity treatment gaps are holding back rehab outcomes

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The world of rehab medicine was last week reminded that seemingly small improvements to interventions can make significant differences to goal attainment and outcomes.

New findings about how a long-trusted treatment for spasticity should be delivered have highlighted the importance of attention to detail in the pharmacological side of neuro-rehab.

Spasticity is experienced by around 34 per cent of stroke survivors within 18 months following a stroke. It can also be a result of spinal cord injury, MS, cerebral palsy, brain or head trauma and metabolic diseases.

It is usually caused by damage to parts of the brain or spinal cord that control voluntary movement. This leads to a change in the balance of signals between the nervous system and the muscles which leads to increased activity in the muscles.

As a result, certain muscles are continuously contracted causing stiffness or tightness of the muscles which can interfere with normal movement, gait and speech.

Among treatment options for spasticity, is Dysport (abobotulinumtoxinA), an injectable form of botulinum neurotoxin type A product. It inhibits the effective transmission of nerve impulses, therefore reducing muscular contractions; and has more than 30 years of clinical experience and six million treatment years of patient experience.

A new study has found that injection guidance techniques, including ultrasound, electrical stimulation, electromyography or a combination of techniques, can dramatically improve outcomes and goal attainment.

The AboLiSh study from Ipsen found that patients subjected to injection guidance techniques before being administered with Dysport are three times more likely to achieve their goals overall.

Also, the study which assessed 430 patients across nine countries, found that almost one in four clinicians are not using injection guidance when administering a botulinum toxin type A.

These cases were associated with reduced goal attainment, which could lead to negative consequences including patient adherence to neurotoxin injections.

Dr Alberto Esquenazi, director of the Gait & Motion Analysis Laboratory at Jefferson Moss-Magee Rehabilitation in Philadelphia. “These findings highlight the current lack of consistency in how treatment is being administered to patients and underpin the importance of real-world evidence to inform clinical practice.”

NR Times spoke to Dr Esquenazi, who is also director of the Moss Rehab Center in Philadelphia, about the findings.

NR Times: What was the inspiration for the study?   

Dr Esquenazi: Some years ago we ran a study in which we only treated the upper limb but the lower limb. It was a small pilot study.

This came about from my patients who would tell me that ‘every time you inject my arm, my walking gets better’. I kept telling them ‘that’s not possible’. I had no sense of how that could be happening so we decided to study that.

We did a two-centre study [with] close to 20 patients. We measured their walking before, and then within four weeks of injection with botulinum toxin only in the upper limb. On average patients improved their walking by about 12 per cent.

We think that is linked to what we are seeing now – that when you inject the arm and the leg together, there appears to be an enhancement of results.

There has been no real-world, observational study looking at the impact of injections and the outcome of walking. That was the critical piece. If you ask a patient after a stroke or a brain injury, one of their major goals is ‘how to walk better?’ ‘How do I improve my mobility?’ So that was the trigger for the study.Please put into context the significance of your latest findings

This study is important because it’s the first time we’ve looked at the impact of botulinum toxins used in day-to-day, community-based facilities in the treatment of patients with spasticity, who had a walking problem. That was the major presenting concern. The premise was to include patients who could do at least five steps of walking to start in the study. We enabled each practitioner to choose their routine way of treatment, so this was not controlled in any way.

We wanted to [look at] how they did their procedure, how many units or what’s the dose that they used, and which muscles they selected for injection.

We gave them a little bit of freedom in the sense that they could inject one other muscle beyond the ankle musculature. We found that the great majority of the individuals who were treating these patients utilised a guidance method.

A guidance method is a way in which you can help assure that the needle that you’re using for injection is in the muscle that you want to infiltrate with a medication.

Injecting a medication is pretty simple, but knowing where you’re injecting it with certainty, and understanding why you selected that muscle and that dose of medication, are critical patterns.

We found that two thirds of individuals used some sort of a localisation method; and by doing that the outcomes were improved in the group that receive localisation mechanisms for the treatment.

Another finding was that the great majority of clinicians are not fully utilising the dose that is approved for the muscles that were treated. There’s an opportunity to further improve care by doing that. The other important finding is that when you treat the upper limb, along with the muscles of the lower limb that involve the ankle and foot, patients did better than those that only had treatments for the ankle and foot muscles.

Please elaborate on the guidance / localisation methods that may be used to help administer the treatment

There is electrical stimulation, where you place the needle into the muscle, and you can actually twitch the muscle with a little bit of electricity. You can use electromyography [EMG], where you place the needle in the muscle and, by having the patient contract the muscle, you can listen to the muscle activity. The third one, which is the newest of the techniques, at least from the point of view of utilisation for this specific procedure, is ultrasonography. You visualise the muscles and guide the needle into the muscle. I believe that combining two of those techniques – ultrasound to visualise the insertion, so you don’t end up in putting the needle in the wrong place, and then either using EMG or electrical stimulation – is the critical way to do this.

We didn’t find a specific difference between the three techniques. So it didn’t matter which technique you used, the fact that you used a technique was of a significant value to the patients. That’s the clear message – use any technique other than just thinking that anatomical guidance is good enough. By doing that, you could improve the outcomes for your patients.

What do you believe are the main barriers stopping clinicians from using these techniques?

There are two major possible reasons. One is because they were not trained in that way. Individuals who were trained some years back in general perhaps thought and perceived that using what we call ‘anatomical localisation’, meaning just guiding yourself by anatomy landmarks, was good enough. But there is now clear evidence that that’s not sufficient.

Is it likely that a lack of access to these technologies might also have been a factor?

In the countries where we did the testing the techniques were available. The cost of ultrasonography could be perceived as high. There are, however, new pieces of equipment that are fairly inexpensive – for example in the £3k to £4k region. They are not very expensive compared to the past when a machine like that would cost £25k to £30k. We have seen a decrease in cost as technology has improved.

What was your headline finding on dosage?

When we look at the approved dosages across the different countries in which we ran the study, they ranged from between 1000 and 1500 units of Dysport. But we were surprised that the mean dose was below 1000 units, in a range from about 650 to 900. There is an opportunity to use a higher approved dose that we’re currently not fully utilising.

What are your plans to take this investigation forward?

We’ve completed the collection of data, closed the study for new patients and we’ve finished the initial data analysis. We’re now going to be looking at things like differences across different countries. Also, are there differences because your training and my training were at different times or different periods in in the past?

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