Is Diabetic Neuropathy Improved by Spinal Cord Stimulation?
I'm going to talk to you about the Senza PDN trial, which was a randomised control study . Patients with peripheral diabetic neuropathy suffer significant losses in their quality of life, and while we can treat them with painkillers, these therapies frequently aren't effective. So in this trial, what did we do well? We took 216 patients in the United States from 18 Centos a patient and divided them into two groups.
Additionally, they needed a pain scale with a 0 to 10 rating, with zero denoting no discomfort. They had to score at least 50% on the scale (10 would be Max Pain, and after that, we randomly assigned them to either continue receiving their normal medical management, in this example, analgesic medication, or to receive regular Care Plus.
In the patients we gathered, those who received the spinal cord stimulator showed significantly better levels of pain and quality of life compared to the usual Care Group, who essentially did not modify their level of pain or quality of life compared to their Baseline assessment. What transpired after that six-month period? One of the things we did in the trial's design was to allow patients to switch to another therapy if they didn't experience any therapeutic benefits from the one they were currently receiving. Given that we saw that 90 patients chose to switch from their usual care to receiving a spinal cord stimulator, we then followed up with everyone.
for an additional 18 months, so we examined their data up to 24 months. What we discovered was very intriguing: essentially, the improvements we observed at six months persisted all the way up to 24 months, and this held true for both the group that initially received spinal cord stimulation as well as those who crossed over and received a spinal cord stimulator.
one of the things that can happen when you're measuring patient reported outcomes is Placebo effects so are these improvements we're getting in the the patient reported outcomes sustained over a two-year period and and those who received a stimulator from the beginning.
What are the implications of these findings? Well, the first one is that we need to acknowledge that spinal cord stimulation is not currently a routine therapy available for people with painful diabetic neuropathy and indeed if you look across the globe whether you're in the United States, Europe, or Asia, you'll see that spinal cord stimulation is not a common treatment option.
So what does it entail? Well, it entails bringing the patient into the hospital after an initial period assessment. They will go into the OR and, similarly to a cardiac pacemaker, the technology is very similar. Implanted into their lower back under the skin is a battery that's attached to two leads, and those leads are then effectively implanted under local anaesthesia into the intra-secal space of the spinal cord. The patient is then permitted to leave before the ambulance arrives and essentially begins what we refer to as a trial period, which may last up to perhaps a month. During this time, they wear the device, are given a diary, are asked to record their pain scores, and are then asked to return. If everything goes according to plan, we then perform what we refer to as a permanent implant, complete the Implementation of the implant, and then the patient is permitted to leave before the ambulance arrives.
Over time, these folks can benefit from these devices. with about 24 months typically the battery life of these devices now is out to as long as eight to nine years, so we will undoubtedly need to bring the patient back on a yearly basis to assess them and, at some point, we may also need to change over their battery as well. However, that's a very simple procedure to do; we just do that again under a local anaesthetic.
It's important to note that although the FDA and other regulatory bodies in the United States and Europe have recognised this technology as clinically effective and safe, neither region regularly recognises it for insurance coverage or for inclusion in the UK NHS.
Comments
Post a Comment