From this article:  Patients in the surgical group underwent standard microdiskectomy approaches. Nonsurgical care consisted of patient education, activity/exercise, oral analgesics, use of active physiotherapy provided at the discretion of physiotherapists not associated with the trial, and an epidural glucocorticoid injection administered by a fellowship-trained anesthesiologist. ~ Dr. Broussard

-Single-center study shows superior pain relief at 6 months
by Zeena Nackerdien PhD, CME Writer, MedPage Today 2020-04-13

Study Authors: Chris S. Bailey, Parham Rasoulinejad, et al.; Andrew J. Schoenfeld, James D. Kang

Target Audience and Goal Statement: Neurologists, neurosurgeons, orthopedic surgeons, family physicians, primary care physicians

The goal of this study was to compare surgery versus nonsurgical conservative care for persistent sciatica.

Question Addressed:

• How did surgery compare with standardized nonoperative management in patients with sciatica that had persisted for 4 to 12 months?

Study Synopsis and Perspective:

Five nerve roots — two from the lumbar spine and three from the sacrum — come together in the human body to form the right and left sciatic nerve. One sciatic nerve on each side of the body runs through the hips, buttocks, and down a leg, ending just below the knee, where it branches into other nerves. These nerves continue down the leg and into the foot and toes.

Symptomatically, sciatica presents as unilateral, well-localized leg pain, with a sharp, shooting, or burning quality that approximates to the dermatomal distribution of the sciatic nerve down the posterior lateral aspect of the leg, and normally radiates to the foot or ankle.

Lumbar disk herniation is the most common cause of sciatica. Fortunately, most cases are generally self-limited and resolve within 3 months. However, from 5% to 15% of patients with lumbar nerve root pain are surgically treated, typically involving a lumbar diskectomy.

Surgical and nonsurgical outcomes have been reported in several trials, including the Maine Lumbar Spine Study and the Spine Outcomes Research Trial (SPORT). While these studies supported a modest benefit favoring surgical intervention, they were limited by largely including patients with acute sciatica or those within 3 months after symptom onset. Therefore, there remained a need to understand how to treat patients beyond the symptomatic benchmark of 3 months.

According to outcomes from a single-center trial, microdiskectomy was superior to nonsurgical care for patients with sciatica lasting more than 4 months caused by lumbar disk herniation.

Sciatica due to acute lumbar disk herniation typically improves within 4 months with conservative therapy. Treatment options were less clear for patients with more chronic sciatica, reported Chris Bailey, MD, at Western University in London, Canada, and colleagues in the New England Journal of Medicine.

Bailey’s group screened 790 patients for trial eligibility from 2010 to 2016. Patients were informed that they would be randomized to receive surgery within 3 weeks of standardized nonsurgical care.

A total of 128 patients with lumbar radiculopathy lasting 4 to 12 months and disk herniation at the fourth and fifth lumbar vertebrae (L4-L5) or lumbosacral junction (L5-S1) level were assigned to receive either microdiskectomy (n=64) or standardized nonsurgical care followed by surgery if needed (n=64).

Patients’ average age was 38; 41% were women, and disk herniation occurred most commonly at L5-S1. The only significant between-group difference was a higher rate of antidepressant use in the surgical group.

Patients in the surgical group underwent standard microdiskectomy approaches. Nonsurgical care consisted of patient education, activity/exercise, oral analgesics, use of active physiotherapy provided at the discretion of physiotherapists not associated with the trial, and an epidural glucocorticoid injection administered by a fellowship-trained anesthesiologist.

Leg-pain intensity measured on a visual analog scale (ranging from 0 to 10, with higher scores indicating more severe pain) at 6 months after enrollment served as the primary outcome.

The score on the Oswestry Disability Index (ODI), back and leg pain, and quality-of-life scores at 6 weeks, 3 months, 6 months, and 1 year served as secondary outcomes.

Fifty-six patients underwent surgery a median of 3.1 weeks after enrollment. One patient was unable to have surgery because of cardiac arrhythmia and seven patients cancelled due to a reduction in symptoms.

The mean leg-pain intensity score at 6 months was 2.8 (down from 7.7 at baseline) in the surgery group and 5.2 (down from 8.0 at baseline) in the nonsurgical group (adjusted mean difference 2.4, 95% CI 1.4-3.4, P<0.001).

Secondary outcomes were generally in the same direction as the primary outcome, though the study design prevented clinical inferences from being drawn about secondary outcome data. Leg-pain intensity scores were 2.6 in the surgical group and 4.7 in the nonsurgical group at 12 months. The ODI scores were 22.9 and 34.7, respectively.

Of those assigned to nonsurgical care, 34% (n=22) crossed over to surgery at a median of 11 months after enrollment.

The proportion of patients reporting one or more adverse events related to surgery was similar between the surgical group (6%) and the nonsurgical group who crossed over to undergo surgery (8%). The most common adverse events were superficial wound infection and postoperative new-onset neuropathic pain.

Nine patients had adverse events associated with surgery, and one patient underwent repeat surgery for recurrent disk herniation.

Possible selection bias and the fact that the trial was conducted at only one center (hence, limited generalizability) were listed among the study limitations; additionally, 20% of primary outcome data were missing.

Source References: New England Journal of Medicine 2020; DOI: 10.1056/NEJMoa1912658

Editorial: New England Journal of Medicine 2020; DOI: 10.1056/NEJMe2000711

Study Highlights and Explanation of Findings:

“In our single-center trial involving patients with sciatica lasting 4 to 12 months caused by lumbar disk herniation at the L4-L5 or L5-S1 level, surgery resulted in less leg pain at 6 months than nonsurgical treatment,” Bailey and team wrote.

Earlier research had focused largely on treating acute or sub-acute disc herniation, Bailey noted. “We studied patients with chronic sciatica and found a significant and lasting advantage in surgery. I believe that primary care physicians may now be more supportive of surgery for this cohort of patients,” he told MedPage Today.

“Certainly, surgeons have good evidence to support what they already knew anecdotally: that although surgery is not the only option, it appears to be the best for many in this chronic sciatica population,” he added.

In an accompanying editorial, Andrew Schoenfeld, MD, and James Kang, MD, both of Brigham and Women’s Hospital and Harvard Medical School in Boston, found it reasonable that prompt surgical intervention, at a median of 3 weeks, and expeditious removal of nerve compression minimized the potential for long-term persistence of pain.

They noted that inclusion of patients who had symptoms for 4 to 12 months “did not account specifically for the effect of symptom duration in this window or other clinical factors known to influence outcome after diskectomy, such as the size of the disk herniation or the extent of nerve-root compression.”

For patients with disk herniation and persistent sciatica lasting longer than 4 months, Schoenfeld and Kang stated that it was their practice to provide information about the link between symptom duration and outcomes and to offer a decision regarding surgical or nonsurgical treatment based on the patient’s preference. Lack of benefit from nonoperative care would prompt a stronger recommendation for surgery.

“Viewed in this light, it is encouraging that the trial reported by Bailey et al. shows that surgical intervention still results in clinically meaningful improvement in patients with persistent sciatica,” they wrote.

“However, the trial does not help clinicians determine which patients are most likely to benefit from immediate surgical intervention or the duration of nonoperative care that is acceptable before surgery is recommended,” they added.