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4 Articles in this Series
Introduction
Chronic Pain and Its Companions
Opioids & The Taper Talk
Painful Diabetic Neuropathy: Could SCS Replace Pharmacologic Management?
The Links Among Peripheral Arterial Disease, Lumbar Stenosis, and Claudication

The Links Among Peripheral Arterial Disease, Lumbar Stenosis, and Claudication

with Peter G. Pryzbylkowski, MD and Jeffrey Gudin, MD

The risk of getting peripheral arterial disease, or PAD, increases substantially after age 50, in smokers, and in those with diabetes, said Peter G. Pryzbylkowski, MD, an interventional pain specialist with Relievus Pain Management in Philadelphia. Progressive disease occurs in 25%, with worsening claudication (leg pain when walking) or limb-threatening ischemia. Lumbar spinal stenosis also increases with age, and can lead to claudication.1

That was the introduction of Dr. Pryzbylkowski’s talk at the PAINWeek 2020 virtual conference. In “Flow to the Toe,” he focused on how clinicians can differentiate between neurogenic, venous, and vascular claudication (ie, intermittent leg pain), and what new treatment options are available for patients experiencing neurogenic claudication symptoms as the result of lumbar spinal stenosis.

Here, some highlights from his talk.

 

Zeroing in on the Diagnosis

Lumbar spinal stenosis (LSS) is a normal degenerative process, shared Dr. Pryzbylkowski. To detect the disorder, “It’s important to ask about functionality rather than pain.” Among the signs and symptoms of LSS are a pain in the back and legs that worsens with standing or walking, pain that gets better with lumbar flexion, and pain associated with leg weakness or numbness or tingling.

Among some key questions of your patients during assessment can shed light on their quality of life at home, he said:

  1. Can you walk to the mailbox or the end of your driveway?
  2. How long can you stand or walk before you need to rest?
  3. If you go to the grocery store, can you walk and stand a lot farther with a cart than without a cart?

When it comes to claudication, taking a patient’s history alone can miss up to 90% of cases, he said. He urged practitioners to remember the ''rule of one-thirds,” explaining that “About one-third have classic symptoms, one-third atypical, and one-third no symptoms.”  So a pain specialist and primary care provider must dig further.

Among the risk factors for increasing intermittent claudication:

  • smoking
  • type 2 diabetes
  • hypertension
  • hypercholesterolemia
  • C-reactive protein

The quality of pain and pain response differs in vascular, venous, and neurogenic claudication, he said, offering these common presentation examples:

  • vascular claudication – feels like cramping, often relieved by standing still
  • venous claudication – feels like bursting, relieved with elevation of the leg
  • neurogenic claudication – feels like an electric shock, relieved with sitting or bending

 

Traditional Treatment Approaches

Intermittent claudication is a common symptom in both LSS and PAD.In the past 5 years, treatment options for LSS have improved and expanded in this area.  Management of symptomatic patients with intermittent claudication can include a trial of risk-factor modification and exercise; those with inflow disease or unable to manage lifestyle modifications may be considered for revascularization; if ischemia is critical, that should be offered as soon as possible, Dr. Pryzbylkowski advised.

Smoking is known to increase PAD, so he also recommends immediate smoking cessation. Also helpful are lipid control antiplatelet agents, diabetes control, and blood pressure control.

Patients may be given an exercise regimen and prescribed cilostazol (100 mg orally BID) if no congestive heart failure is present.

Those with diabetes should be referred to podiatry for foot care, he said. Also: ASA 81 mg a day or clopidogrel, 75 mg a day. 

 

Newer Treatment Options

Dr. Pryzbylkowski shared two newer treatment options in his talk: MILD, designed to relieve neurogenic claudication, and the Vertiflex procedure, designed to relieve moderate stenosis. These approaches provide choices that go beyond laminectomy and epidural steroid injections, the latter of which are sometimes considered a temporary solution.  

MILD Procedure

MILD (a minimally invasive lumbar micro-decompression outpatient procedure from Vertos Medical), relieves pressure in the spinal canal by removing the excess tissue in the ligamentum flavum. It has been compared to removing a kink in a straw. The thickened ligament ''chokes” the canal and leads to the pain and numbness.

Using an epidurogram to visualize the area, the physician makes a 5.1 mm incision (the size of a baby aspirin), and uses the proprietary instruments to decompress the ligament. The devices are withdrawn and a Steri-strip closes the incision.

Dr. Pryzbylkowski discussed several case histories. Among them: a patent with a VAS of 9/10, able to stand and walk less than 5 minutes, with a history of ESIs and GTB injections and poor quality of life. Fifteen weeks post-op, the patient could stand and walk for 25 minutes, was off all PRN Tramadol and Mobic medications, and reported significant quality of life improvement.

“We should see a much better flow pattern [compared to before the procedure],” he said. “It's truly minimally invasive.” Published outcomes show that the procedure2 is safe in the hands of experienced pain doctors, he said. 

Interspinous Spacer

The Vertiflex Procedure, also called the Superion Indirect Decompression System, from Boston Scientific “kind of opens up or jacks up the spinal canal to a more normal width,” explained Dr. Pryzbylkowski. A 12 to 15 mm incision is made to expose the supraspinous ligament. The dilator and cannula assembly are inserted. The measurement of the interspinous pace is indicated on the gauge, which corresponds with one of five implant sizes, ranging from 8 to 16 mm.

Dr. Pryzbylkowski also cited results from the Superion procedure clinical trial.3 That study enrolled 470 patients at 29 US sites. Follow-up occurred at 24-months and through 60 months. Retention was more than 94%. The Oswestry Disability Index score went from 40 to about 30, with more than 50% improvement in scores from baseline to 5 years. Subjects reported improvement in leg pain from baseline to 5 years of 75%. And nearly 90% said they would repeat the procedure, when asked 5 years later. 

Perspective & Practical Takeaways

“Understanding the hallmark signs of neurogenic claudication is critical to appropriate treatment,” said Jeffrey Gudin, MD, a pain specialist at Englewood (NJ) Hospital and Medical Center and PPM co-editor-at-large. As mentioned, epidurals are temporary solutions, but Dr. Gudin said he has had patients who have gotten years of relief from them if done early. As for advances, “MILD is a much less invasive procedure” than surgical decompression and the outcome data look favorable to support its use for select cases of LSS. Less data is available, he said, on the implantable device.

After his talk, Dr. Pryzbylkowski shared with PPM what he sees as the most important takeaway. “It is important to remember that pain in the lower extremity could be due to either vascular or neurogenic claudication,” he said. Also important to be aware of are the other options beyond epidurals. “The MILD procedure and the Vertiflex help 'bridge the gap' between epidurals and laminectomy.”

 

Disclosures: Dr. Pryzbylkowski is a consultant for Vertos (developer of the MILD procedure) and for Nevro and Abbott (which manufacture spinal cord stimulators). Dr. Gudin consults for AcelRx, AstraZeneca, BDSI, Collegum, Daiichi Sankyo, Kaleo, Kempharm, Mallinckrodt, Nektar, Noven, Pernix, Purdue, Salix and Scilex and is a medical advisor for Quest Diagnostics. He is an owner, investor and senior medical consultant for Virpax Pharmaceuticals.

 

Sources

1.     Uesugi K, Sekiguchi M, Kikuch S, et al. Lumbar spinal stenosis associated with peripheral arterial disease: a prospective multicenter observational study. J Orthop Sci.2012;17(6):673-681.

2.     Benyamn RM, Staats PS. MILD I an Effective Treatment for lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician. 2016;19(4): 229-41.

3.     Patel VV, Whang PG, Haley TR, et al. Superion interspinous process spacer for intermittent neurogenic claudication secondary to moderate lumbar spinal stenosis: two-year results from a randomized controlled FDA-IDE pivotal trial. Spine. 2015;1:40(5):275-82.

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