Bailey, N Engl J Med 2020 - Surgery versus Conservative Care for Persistent Sciatica Lasting 4 to 12 Months

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Surgery versus Conservative Care for Persistent Sciatica Lasting 4 to 12 Months

Bailey, Urquhart, et al.·N Engl J Med·2020·208 citations·RCT

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Background

The treatment of chronic sciatica caused by herniation of a lumbar disk has not been well studied in comparison with acute disk herniation. Data are needed on whether diskectomy or a conservative approach is better for sciatica that has persisted for several months.

Methods

In a single-center trial, we randomly assigned patients with sciatica that had lasted for 4 to 12 months and lumbar disk herniation at the L4-L5 or L5-S1 level in a 1:1 ratio to undergo microdiskectomy or to receive 6 months of standardized nonoperative care followed by surgery if needed.
Surgery was performed by spine surgeons who used conventional microdiskectomy techniques.
The primary outcome was the intensity of leg pain on a visual analogue scale (ranging from 0 to 10, with higher scores indicating more severe pain) at 6 months after enrollment.
Secondary outcomes were the score on the Oswestry Disability Index, back and leg pain, and quality-of-life scores at 6 weeks, 3 months, 6 months, and 1 year.

Results

From 2010 through 2016, a total of 790 patients were screened; of those patients, 128 were enrolled, with 64 in each group.
Among the patients assigned to undergo surgery, the median time from randomization to surgery was 3.1 weeks; of the 64 patients in the nonsurgical group, 22 (34%) crossed over to undergo surgery at a median of 11 months after enrollment.
At baseline, the mean score for leg-pain intensity was 7.7 in the surgical group and 8.0 in the nonsurgical group.
The primary outcome of the leg-pain intensity score at 6 months was 2.8 in the surgical group and 5.2 in the nonsurgical group (adjusted mean difference, 2.4; 95% confidence interval, 1.4 to 3.4; P<0.001).
Secondary outcomes including the score on the Owestry Disability Index and pain at 12 months were in the same direction as the primary outcome.
Nine patients had adverse events associated with surgery, and one patient underwent repeat surgery for recurrent disk herniation.

Conclusions

In this single-center trial involving patients with sciatica lasting more than 4 months and caused by lumbar disk herniation, microdiskectomy was superior to nonsurgical care with respect to pain intensity at 6 months of follow-up. (Funded by Physicians' Services Incorporated Foundation; ClinicalTrials.gov number, NCT01335646.).

Copyright remains with the authors and publisher.

Surgery versus Conservative Care for Persistent Sciatica Lasting 4 to 12 Months

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Surgery versus Conservative Care for Persistent Sciatica Lasting 4 to 12 Months

Bailey, Urquhart, et al.·N Engl J Med·2020·208 citations·RCT

|

Background

The treatment of chronic sciatica caused by herniation of a lumbar disk has not been well studied in comparison with acute disk herniation. Data are needed on whether diskectomy or a conservative approach is better for sciatica that has persisted for several months.

Methods

In a single-center trial, we randomly assigned patients with sciatica that had lasted for 4 to 12 months and lumbar disk herniation at the L4-L5 or L5-S1 level in a 1:1 ratio to undergo microdiskectomy or to receive 6 months of standardized nonoperative care followed by surgery if needed.
Surgery was performed by spine surgeons who used conventional microdiskectomy techniques.
The primary outcome was the intensity of leg pain on a visual analogue scale (ranging from 0 to 10, with higher scores indicating more severe pain) at 6 months after enrollment.
Secondary outcomes were the score on the Oswestry Disability Index, back and leg pain, and quality-of-life scores at 6 weeks, 3 months, 6 months, and 1 year.

Results

From 2010 through 2016, a total of 790 patients were screened; of those patients, 128 were enrolled, with 64 in each group.
Among the patients assigned to undergo surgery, the median time from randomization to surgery was 3.1 weeks; of the 64 patients in the nonsurgical group, 22 (34%) crossed over to undergo surgery at a median of 11 months after enrollment.
At baseline, the mean score for leg-pain intensity was 7.7 in the surgical group and 8.0 in the nonsurgical group.
The primary outcome of the leg-pain intensity score at 6 months was 2.8 in the surgical group and 5.2 in the nonsurgical group (adjusted mean difference, 2.4; 95% confidence interval, 1.4 to 3.4; P<0.001).
Secondary outcomes including the score on the Owestry Disability Index and pain at 12 months were in the same direction as the primary outcome.
Nine patients had adverse events associated with surgery, and one patient underwent repeat surgery for recurrent disk herniation.

Conclusions

In this single-center trial involving patients with sciatica lasting more than 4 months and caused by lumbar disk herniation, microdiskectomy was superior to nonsurgical care with respect to pain intensity at 6 months of follow-up. (Funded by Physicians' Services Incorporated Foundation; ClinicalTrials.gov number, NCT01335646.).

Copyright remains with the authors and publisher.

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