Peripheral Vascular Disease & Peripheral Neuropathy

Peripheral vascular disease, or PVD, is a systemic disorder that involves the narrowing of peripheral blood vessels, most commonly caused by atherosclerosis. Peripheral Vascular Disease (PVD) is a major cause of morbidity and mortality globally, with significant financial burdens on healthcare resources 1. Peripheral Arterial Disease (PAD) affects 10-15% of the population and ~20% of people >60 years old, and a 2010 estimate was over 200 million affected globally 2.

In PVD, the diameter of the blood vessel is reduced, limiting the amount of oxygen that circulates to the arms and legs. Symptoms typically start with pain and discomfort while walking, and in severe cases, it may progress into critical limb ischemia, a severe stage of PVD that can result in ulcerations or potentially amputation.

Peripheral vascular disease is most commonly caused by smoking, high blood pressure, elevated cholesterol levels, and/or type 2 diabetes. Patients with PVD may experience no symptoms at first, and when symptoms begin to appear, they tend to be irregular and occur more often when a patient is active—especially when walking.

A patient may experience pain, cramping, and/or discomfort in their legs and feet. Other symptoms can range from achiness, to burning and fatigue, to cold, painful feet, to presenting with non-healing ulcers. If a patient’s peripheral vascular disease continues to progress, symptoms will probably occur with greater frequency and may manifest even when the patient is not walking or otherwise being active.

Other signs to watch for include

• Changes to the skin on the legs and feet, which can become thin and/or shiny
• A purplish tinge to arms and legs, or toes that become blue
• Wounds and ulcers appearing on the feet and legs
• Thinning of hair on the legs

Therapy typically includes changes to diet and exercise, smoking cessation, and, if appropriate, medications including blood thinners to dissolve clots, statins to reduce cholesterol, and vasodilators, which widen the blood vessels.

In the majority of cases, lifestyle changes, medical management, and intravascular based procedures such as stents can treat the majority of cases. However, critical limb ischemia leads to the final step in treatment, amputation.

Prior to this point, after thorough intravascular and comorbidity optimization, neurostimulation should be considered to treat symptoms, improve quality of life, and prevent limb amputation.

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DRG-S for Low Back Pain and Leg Pain

Effective treatment for chronic low back pain (LBP) is considered the ‘holy grail’ of neuromodulation. Spinal Cord Stimulation (SCS) was introduced in 1967 to treat chronic pain. Over the years it has shown mixed results for LBP, with limited improvements in pain and function, and loss of efficacy over time. Dorsal root ganglion stimulation (DRG-S) was developed as a treatment for nerve-related pain syndromes and has proven to be superior to SCS for complex regional pain syndrome (CRPS), which typically affects the hands or feet.

As utilization of DRG-S increased, so did our understanding of its underlying mechanisms of action. One such mechanism of action is a result of the stimulator device sending inhibitory signals into the spinal cord. Based on this principle, the team at the Spine & Pain Institute of NY pioneered the treatment of low back pain with DRG-S at the T12 spinal level1. Their publication on a case series of patients using DRG-S at the T12 level for intractable low back pain was better than previous studies with other forms of neurostimulation for low back pain.

The study included patients who had failed extensive treatments and included several patients who had multiple spinal surgeries. They reported not only excellent pain relief, but also great improvements in physical function and psychological testing that were not previously seen with neuromodulation therapy. The results of the study are shown on the right, here, and below. In our clinical experience, these results are readily reproducible and have been maintained over time.

After experiencing continued impressive results with DRG-S for low back pain, we decided to dive deeper into exactly why and how this device works in this manner. After a year’s long quest and an exhaustive review of the published literature relating to nerve transmission and back pain, the team authored ‘The Pathways and Processes Underlying Spinal Transmission of Low Back Pain: Observations from Dorsal Root Ganglion Stimulation Treatment’. This evidence based paper details our theory on why DRG-S works at T12 for low back pain, and more importantly outlines how low back pain is transmitted in the spinal cord2.

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After experiencing continued impressive results with DRG-S for low back pain, we decided to dive deeper into exactly why and how this device works in this manner. After a year’s long quest and an exhaustive review of the published literature relating to nerve transmission and back pain, the team authored ‘The Pathways and Processes Underlying Spinal Transmission of Low Back Pain: Observations from Dorsal Root Ganglion Stimulation Treatment’. This evidence based paper details our theory on why DRG-S works at T12 for low back pain, and more importantly outlines how low back pain is transmitted in the spinal cord2.

To better understand this complex subject, which for many may be challenging to fully grasp, the major points have been illustrated in this animated graphic. Since that time, the team has expanded the use of DRG-S by placing additional leads at S1 along with T12 as an off-label treatment for low back and associated leg pain. Our results continue be superior to our doctor’s experiences with other forms of neurostimulation for similar pain conditions. Our doctors have collectively published over 20 articles in peer reviewed medical journals on DRG-S and are considered thought leaders and pioneers of DRG-S therapy. While results from our practice with DRG-S are quite impressive and have been published and shared with the medical community, the team also recorded patient testimonials to further illustrate the great improvements seen with this therapy. The testimonials can be accessed on our Youtube page.

DRG-S LOW BACK PAIN OUTCOMESDRG-S COMPARED TO SCS FOR LBP

Multiple studies have published positive results using DRG-S therapy for low back pain. For instance, DRG-S was utilized at the L2 level to treat discogenic low back pain following failed back surgery. The graphic below shows the changes in patient reported survey scores used to measure treatment response before and after DRG-S therapy in each study. Collectively, improvements with DRG-S therapy in VAS (visual analog scale) which measures pain severity, ODI (Oswestry disability index) and SF-36 Physical which measure physical function, EQ-5 which measures quality of life, and SF-36 Mental which measures psychological improvements were consistent with or superior to prior spinal cord stimulation studies. If you are interested in learning more about DRG stimulation for low back pain and leg pain, or have failed other forms of neuromodulation, please feel free to reach out to our physicians at the Spine and Pain Institute of NY to learn more.

1. Chapman KB, Groenen PS, Patel K V., Vissers KC, van Helmond N. T12 Dorsal Root Ganglion Stimulation to Treat Chronic Low Back Pain: A Case Series. Neuromodulation Technol Neural Interface. 2020;23(2):203-212. doi:10.1111/ner.13047

2. Chapman KB, Groenen PS, Vissers KC, van Helmond N, Stanton‐Hicks MD. The Pathways and Processes Underlying Spinal Transmission of Low Back Pain: Observations From Dorsal Root Ganglion Stimulation Treatment. Neuromodulation Technol Neural Interface. Published online April 23, 2020:ner.13150. doi:10.1111/ner.13150