Closed Loop Stimulation
Closed Loop Stimulation is a “once-in-a-lifetime” medical breakthrough for the treatment of chronic pain. Low back pain, post surgical pain, neck pain, sciatica…this is a proven therapy with publications in JAMA and Lancet (two of THE most prestigious medical journals in the world).
What is Closed Loop Stimulation?
Closed Loop is a type of spinal cord stimulation that has the ability to monitor and record the cellular activity of the spinal cord, specifically pain signals, which the device analyzes to determine what needs to be done to reduce pain. In other words, the device has the ability to communicate with your nervous system and it can think!!!
As of November 2022, Closed-Loop Stimulation is FDA Approved & COVERED BY INSURANCE. It is the first & only treatment for chronic pain that has the ability to communicate with your central nervous system and treat pain at the source.
Indications
Spine surgery is not always the best option to treat pain – there is a 40% chance your pain will not respond to surgery and may even get worse.[1] This is called Failed Back Surgery Syndrome. And with each progressive surgery, the chances of success drop even more. The chance of failure with a second surgery jumped to 60%. With a third, the failure rate is as high 85%. There are many theories as to why spine surgery works for some and not in others but the 2 most widely accepted are scar tissue and something called “adjacent level disease.” Once either of these occurs, there is no way to reverse and more surgery will only make matters worse. So what is the answer?
Closed loop stimulation – a type of spinal cord stimulator that was shown to be superior to traditional methods of stimulation with durable pain relief and unparalleled patient satisfaction [2-4].
Indications include:
Low Back Pain
Sciatica
Failed Back Surgery Syndrome
Neck and/or Arm Pain
Complex Regional Pain Syndrome (CRPS) Types I & II
Post Surgical Nerve Pain
Is There Any Evidence?
Closed loop stimulation is the definition of “cutting edge.” The EVOKE trial was the world’s first double blind, randomized controlled clinical trial ever conducted on spinal cord stimulation (SCS). The doctors did not know which patients were getting closed loop stimulation and the subjects did not know what they were getting either. There were 134 subjects enrolled in the study across 13 sites across the United States – the Ainsworth Institute of Pain Management was one of them. Subjects were followed out all the way out to THREE YEARS!!!
At 12-months, 83.1% of reported statistically significant improvements in pain.[2] Subjects getting closed loop stimulation also reported statistically significant improvements in function, mood, sleep and were able to reduce their prescription opioids. Not only were these improvements sustained out to 24- and 36-months, the therapy seemed to get better over time. In fact, 100% of patients getting closed loop stimulation showed some kind of improvement at 3-years, whether it was pain relief, function, mood, or sleep…every patient getting closed loop improved. No one has ever seen anything like this before!
How Does Closed Loop Stimulation Work?
Spinal cord stimulation (SCS) is a well-established treatment for a wide variety of different types of pain, but for reasons that are not entirely understood, some people do not respond to it. Traditional stimulator systems were about 50-50 in their ability to work. In some cases, people will report “life changing” improvements in pain but then suddenly stop feeling pain relief. While no one has been able to explain why this occurs, the most commonly accepted theory is “tolerance.” Simply put, the nervous system becomes used to the stimulation and it stops being effective. That is because traditional system just keep stimulating over and over and over and over again at the same level, regardless of whether or not it is too strong. Consequently, the body adapts to the stimulation over time and tunes it out. As a result, the device fails and the pain comes back. That is where closed loop stimulation comes in.
Closed loop stimulation measures a specific signal emitted by the spinal cord called an evoke compound action potential, or ECAP for short. Just like measuring an EKG in the heart, this signal represents the flow of electrical activity moving across the spine. Not only is closed loop stimulation is the only device on Earth that can measure an ECAP, but it has the ability to analyze it and then self adjust in less than a microsecond to make sure the very next ECAP is healthy and moving the way it should.
The result is unparalleled pain relief and improvements in function, mood and sleep. Nothing even comes close.
Am I a Candidate for Closed Loop Stimulation?
If you suffer from chronic pain that has failed to resolve with conservative therapies, this treatment may be an option for you. If you had a spinal cord stimulator trial in the past that was unsuccessful, closed loop stimulation may still be an option. Contact the Ainsworth Institute to set up an initial evaluation to find out if you are a candidate for this truly amazing therapy!
The Ainsworth Institute is Here to Help
If you are suffering from chronic low back pain secondary to degenerative disc disease and want to avoid surgery, you may be a candidate for a VIA Disc Allograft. Contact the Ainsworth Institute of Pain Management today to schedule a consultation and find out if can benefit from this truly groundbreaking procedure.
[1] Deyo RA. Back surgery: who needs it? N Engl J Med. 2007;356:2239–2243.
[2] Mekhail N, Levy RM, Deer TR, et al. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial. Lancet Neurol. 2020;19(2):123-134. doi:10.1016/S1474-4422(19)30414-4.
[3] Mekhail N, Levy RM, Deer TR, et al. Durability of Clinical and Quality-of-Life Outcomes of Closed-Loop Spinal Cord Stimulation for Chronic Back and Leg Pain: A Secondary Analysis of the Evoke Randomized Clinical Trial. JAMA Neurol. 2022;79(3):251–260. doi:10.1001/jamaneurol.2021.4998.
[4] Levy R, Deer TR, Poree L, et al. Multicenter, randomized, double-blind study protocol using human spinal cord recording comparing safety, efficacy, and neurophysiological responses between patients being treated with evoked compound action potential-controlled closed-loop spinal cord stimulation or open-loop spinal cord stimulation (the Evoke study). Neuromodulation. 2019;22(3):317-326. doi:10.1111/ner.12932.
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