Functional and Patient‐Reported Outcomes in Symptomatic Lumbar Spinal Stenosis Following Percutaneous Decompression

Background: Neurogenic claudication due to symptomatic lumbar spinal stenosis (LSS) is a painful condition causing significant functional disability. While the cause of LSS is multifactorial, thickened ligamentum flavum (LF) accounts for up to 85% of spinal canal narrowing. mild percutaneous lumbar decompression allows debulking of the hypertrophic LF while avoiding the morbidities frequently associated with more invasive surgical procedures. Methods: In this prospective case series study, consecutive LSS patients presenting with neurogenic claudication were treated with percutaneous lumbar decompression. Efficacy was evaluated using the Pain Disability Index (PDI) and Roland‐Morris Disability Questionnaire. Pre‐ and postprocedure Standing Time, Walking Distance, and Visual Analog Score (VAS) were also monitored. Significant device‐ or procedure‐related adverse events were reported. Results: The mild procedure was successfully performed on forty patients. At twelve months, both PDI and Roland‐Morris showed significant improvement of 22.6 points (ANOVA, P < 0.0001) and 7.7 points (ANOVA, P < 0.0001), respectively. Walking Distance, Standing Time, and VAS improvements were also statistically significant, increasing from 246 to 3,956 feet (ANOVA, P < 0.0001), 8 to 56 minutes (ANOVA, P < 0.0001), and 7.1 to 3.6 points (ANOVA, P < 0.0001), respectively. Tukey HSD test found improvement in all 5‐outcome measures to be significant from baseline at each follow‐up interval. No significant device‐ or procedure‐related adverse events were reported. Conclusion: This study demonstrated significant functional improvement as well as decreased disability secondary to neurogenic claudication after mild procedure. Safety, cost‐effectiveness, and quality‐of‐life outcomes are best compared with comprehensive medical management in a randomized controlled fashion and, where ethical, to open lumbar decompression surgery.     

Lumbar Spinal Stenosis: Therapeutic Options Review

Lumbar spinal stenosis (LSS) functionally impacts significant numbers of Americans per year. Current estimates place the number of Americans suffering from senescent lumbar spinal stenosis at 400,000. The prevalence of this disorder in patients ranging from 60 to 69 years of age is very high. Forty‐seven percent of this age group have mild to moderate stenosis, and 19.7% have severe stenosis. As the baby boomer generation gets older, 10,000 individuals attain the age of 65 years every day in United States. LSS is becoming very common and will be a major healthcare issue as the population ages. Although LSS is not life threatening, it can cause substantial disability with limitations to performing daily activities, and thus, the associated negative impact on quality of life (QOL). This article reviews the pathophysiology and current treatment options for LSS, focusing on evidence‐based treatment options.     

Long‐Term Results of Percutaneous Lumbar Decompression mild® for Spinal Stenosis

Background: Lumbar spinal stenosis (LSS) generally occurs from a combination of degenerative changes occurring in the lumbar spine. These include hypertrophy of ligamentum flavum, facet joint arthritic changes and bulging of the intervertebral disk. Spinal stenosis leads to compression of the lumbar neural elements (cauda equina), which manifests as low back and leg pain especially on standing and walking known as “neurogenic claudication.” Current treatment options for LSS are varied. Conservative management, including physical therapy with/without epidural steroid injections, may be adequate for mild stenosis. Surgical decompression is reserved for severe cases and results in variable degrees of success. Patients with moderate‐to‐severe LSS having ligamentum flavum hypertrophy as a key contributor are generally inappropriately treated or undertreated. This is due to ineffectiveness of conservative therapy and possibility that major surgical compression might be too aggressive. Percutaneous decompression offers a possible solution for this patient population. Methods: One‐year follow‐up study was conducted at 11 U.S. sites. Study cohort included 58 mild^® percutaneous decompression patients who underwent 170 procedures, the majority treated bilaterally at one or two lumbar levels. Outcome measures included the visual analog scale (VAS), Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and SF‐12v2^® Health Survey. Results: No major mild^® device or procedure‐related complications were reported. One‐year data showed significant reduction of pain as measured by VAS. Improvement in physical functionality, mobility, and disability was significant as measured by ZCQ, SF‐12v2, and ODI. Conclusions: At 1 year this 58‐patient cohort demonstrated continued excellent safety profile of the mild^® procedure and equally important, showed long‐term pain relief and improved functionality.     

The Influence of Pain Sensitivity on the Treatment Outcome of Transforaminal Epidural Steroid Injection in Patients with Lumbar Spinal Stenosis

The aim of this study was to investigate the effect of individual pain sensitivity on the results of transforaminal epidural steroid injection (TFESI) for the patients with lumbar spinal stenosis (LSS). Seventy‐seven patients with LSS were included in this study. Prospectively planned evaluations were performed twice consecutively before and 2 months after TFESI. These included a detailed medical history, a physical examination, and completion of a series of questionnaires, including pain sensitivity questionnaire (PSQ), Oswestry disability index (ODI), and visual analog scale (VAS) for back and leg pain. The correlations were analyzed among variables between total PSQ/PSQ‐moderate/PSQ‐minor and pain and disability level measured by VAS for back/leg pain and ODI both before and 2 months after TFESI. Two months after TFESI, there were significant decreases in VAS for back/leg pain and ODI compared with those before injection. Before injection, VAS for back pain and leg pain was highly associated with the PSQ scores including total PSQ and PSQ subscores after adjustment for age, BMI, and grade of canal stenosis. However, any subscores of PSQ and total PSQ scores were not correlated with either VAS for back pain/leg pain or ODI 2 months after TFESI with adjustment made to age, BMI, gender, and grade of canal stenosis. This study highlights that individual pain sensitivity does not influence the outcomes of TFESI treatment in patients with LSS, even though pain sensitivity has a significant negative correlation with symptom severity of LSS.     

Effectiveness of Physical Therapy Combined With Epidural Steroid Injection for Individuals With Lumbar Spinal Stenosis: A Randomized Parallel-Group Trial

Objective

To examine the effectiveness of epidural steroid injection (ESI) and back education with and without physical therapy (PT) in individuals with lumbar spinal stenosis (LSS).

Evaluation of Epidurographic Contrast Patterns with Fluoroscopic-Guided Lumbar Interlaminar Ventral Epidural Injection

Background:   Targeted ventral epidural steroid injection with a transforaminal approach has been widely used for the treatment of nerve root inflammation and pain. Lumbar interlaminar approach is also commonly used; however, ventral epidural injection may not be obtained properly. Lumbar interlaminar ventral epidural (LIVE) injection can be achieved as the epidural catheter is placed at the ventrolateral side of the nerve root. The purpose of this study is to evaluate the contrast dispersal pattern with LIVE injection.
Methods:   Forty patients with lower back and L5 radicular pain were studied. LIVE injection was performed with an epidural catheter inserted toward the 9 o'clock position (for the right side) or 3 o'clock position (for the left side) of the pedicle, where the catheter tip was placed at the ventrolateral side of the nerve root. A total of 2 mL of contrast was injected to determine the epidurographic pattern.
Results:   With 1-mL injection, all patients showed excellent filling in the ventral epidural space of L5 nerve root. After a total of 2 mL injection, it showed rostral spread in 26/40 (65%) patients, and caudal spread in 34/40 (85%) patients. None of the patients showed intravascular injection, and no neural complications were reported.
Conclusions:   The data showed excellent spread of contrast into the nerve root and the ventral epidural space in all patients. There were no inadvertent vascular or neural complications. LIVE approach can be an alternative way to achieve targeted ventral epidural injection.     

The Role of Adding Hyaluronidase to Fluoroscopically Guided Caudal Steroid and Hypertonic Saline Injection in Patients with Failed Back Surgery Syndrome: A Prospective,Double‐Blinded,Randomized Study

Background: Failed back surgery syndrome (FBSS) has been reported to account for up to 40% of patients with chronic low back pain. Epidural fibrosis may be responsible for up to 30% of all cases of FBSS. Perineural fibrosis can interfere with cerebrospinal fluid‐mediated nutrition, rendering the nerve root hyperesthetic and hypersensitive to compression. Traditionally, steroid injection has been used to treat low back pain and radiculopathy. The addition of hyaluronidase to the injectate has been reported to reduce the degree of fibrosis. Aim: To evaluate the role of hyaluronidase when added to fluoroscopically guided caudal steroid and hypertonic saline in patients with FBSS. Methods: Thirty‐eight patients with back pain because of FBSS were studied. Twenty patients received fluoroscopically guided caudal epidural steroid, local anesthetic, and hypertonic saline in combination (group 1), and 18 patients received fluoroscopically guided caudal epidural steroid, hypertonic saline, local anesthetic, and hyaluronidase (group 2). Patients were asked to rate their pain using a verbal scale of 0 to 4 (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe). Lumbar spine range of motion and opioid intake were measured. Result: Significant improvement in short‐term pain relief was noted in both groups, while significant long‐term pain relief was only achieved in group 2 patients. Conclusion: The addition of hyaluronidase to fluoroscopically guided caudal epidural steroid and hypertonic saline combination improved long‐term pain relief in patients with FBSS.     

Comparison of Epidural Depo-Medrol vs. Aqueous Betamethasone in Patients with Low Back Pain

Abstract: Despite the popularity of epidural steroid injections for low back pain, there still remains a lack of consensus on which type of steroid to inject. Most comparison studies regarding epidural steroids are based on an assumption that different types of steroids are equal as long as equipotent doses are utilized. In the spring of 2002, a national shortage of all depo steroids allowed the authors to compare epidural methylprednisolone (Depo‐Medrol) to a non depo form of betamethasone in patients with low back pain. Patients who received epidural methylprednisolone (Depo‐Medrol) reported significant reduction in pain ratings as well as disability scores after 4 weeks, while patients receiving betamethasone showed no significant difference in pain or disability scores. This study shows that the aqueous steroid betamethasone is not an effective alternative to the commonly used depo‐steroid methylprednisolone (Depo‐Medrol) when injected epidurally in patients with lumbar pain. The study also shows that the anti‐inflammatory effect of a depo‐steroid can be greater than a non‐depo steroid, even at equipotent doses. This should be an important factor to consider when reviewing epidural steroid outcome studies, where the type of steroid might affect results as much as other variables such as route of administration, volume of injectate, or use of fluoroscopy.     

Needle‐Through‐Needle Technique in Lumbar Interlaminar Epidural Steroid Injection: A Case Report

When performing lumbar epidural steroid injection on obese patients, needle placement can be challenging due to the difficulty in estimating the appropriate needle length to utilize. Often times, the standard 3.5‐inch Tuohy needle is too short to reach its target. In our case report, a needle‐through‐needle technique was attempted in a lumbar interlaminar epidural steroid injection procedure after the initial needle fell short of the epidural space. To avoid removing the initial needle and restarting the procedure using a longer needle, a 20‐gauge 6‐inch Tuohy needle was inserted into the 17‐gauge 3.5‐inch Tuohy needle, successfully reaching the epidural space. This technique can facilitate quicker needle placement by avoiding the need for restarting the procedure with a longer needle. Thus, procedural time and radiation exposure may be decreased, as may patient discomfort from repeat needle insertions.     

The 2‐Year Cost‐Effectiveness of 3 options to Treat Lumbar Spinal Stenosis Patients

Lumbar spinal stenosis (LSS) may result from degenerative changes of the spine, which lead to neural ischemia, neurogenic claudication, and a significant decrease in quality of life. Treatments for LSS range from conservative management including epidural steroid injections (ESI) to laminectomy surgery. Treatments vary greatly in cost and success. ESI is the least costly treatment may be successful for early stages of LSS but often must be repeated frequently. Laminectomy surgery is more costly and has higher complication rates. Minimally invasive lumbar decompression (mild^®) is an alternative. Using a decision‐analytic model from the Medicare perspective, a cost‐effectiveness analysis was performed comparing mild^® to ESI or laminectomy surgery. The analysis population included patients with LSS who have moderate to severe symptoms and have failed conservative therapy. Costs included initial procedure, complications, and repeat/revision or alternate procedure after failure. Effects measured as change in quality‐adjusted life years (QALY) from preprocedure to 2 years postprocedure. Incremental cost‐effectiveness ratios were determined, and sensitivity analysis conducted. The mild^® strategy appears to be the most cost‐effective ($43,760/QALY), with ESI the next best alternative at an additional $37,758/QALY. Laminectomy surgery was the least cost‐effective ($125,985/QALY).