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Less Invasive Sciatica Surgery Does Not Improve Outcomes (CME/CE)

Posted by admin in Prescription Pain Killers on August 09th, 2009

SAN FRANCISCO, July 7 — Sciatica patients fare no better with minimally invasive surgical treatment than with conventional open surgery, a clinical trial revealed.

Explain to interested patients that surgery is typically offered for persistent sciatica that does not respond to conservative treatment.
Note that the study did not include comparison with nonsurgical management and was limited to patients with clear evidence of nerve root compression on MRI.

Functional status was no better with transmuscular tubular diskectomy than open microdiskectomy either in the early recovery phase at eight weeks or later at one year, Mark P. Arts, MD, of Medical Center Haaglanden in the Hague, and colleagues found.

Even more surprising were the recovery rates and pain levels favoring open surgery, they reported in the July 8 issue of the Journal of the American Medical Association.

The reason for the differences favoring open surgery were unclear, Dr. Arts’ group said.

But they cautioned that none of the difference met the required minimum for clinically important effect “and thus we cannot conclude that one surgical treatment is clinically superior to the other.”

Although tubular diskectomy is billed as a less invasive procedure, this is debatable according to the findings, the investigators said.

In their study, skin incisions were equally small, the amount of disk material removed was similar, and the rate of recurrent disk herniation did not differ between procedure groups.

Splitting, rather than slicing, the muscles to get to the offending vertebral disk was expected to have reduced postoperative back pain, the researchers said, “thus allowing quicker mobilization and contributing to shorter hospitalization and faster resumption of work and daily activities.”

Prior randomized trials had likewise shown similar resolution of pain with the two procedures, but this was explained by the low statistical power to detect anything but large effect sizes.

So, Dr. Arts’ group designed a larger, double-blind, multicenter study — the Sciatica Micro-Endoscopic Diskectomy trial.

It included 328 patients ages 18 to 70 with persistent leg pain for more than eight weeks due to lumbar disk herniations who were randomized to tubular diskectomy or open microdiskectomy.

Right from the start, there was an unexpected similarity between procedures.

The intraoperative complications were no different between groups (12% with tubular diskectomy versus 8% with conventional surgery, P=0.27), including dural tears (P=0.18).

Minimally invasive surgery didn’t reduce the mean hospital stay, nor did it bring an earlier day of mobilization.

Patients reported complete recovery at an average 2.0 weeks with tubular diskectomy and 2.1 weeks with conventional surgery (P=NS).

For the primary outcome measure of patient-reported functional disability, the early, eight-week mean on the Roland-Morris Disability Questionnaire actually tended to be higher with tubular diskectomy (5.8, 95% confidence interval 5.0 to 6.6, versus 4.9, 95% CI 3.9 to 5.9).

At one year, the functional outcome measure significantly favored conventional surgery with a mean RDQ score of 3.4 versus 4.7 with the minimally invasive surgery (difference 1.3, 95% CI 0.03 to 2.6).

For the entire one-year follow-up period, though, the mean scores were not significantly different for tubular diskectomy and open microdiskectomy (6.2 versus 5.4, difference 0.8, 95% CI -0.2 to 1.7).

At 52 weeks the number of patient who had a “good” recovery tended to be higher with the open surgery both by patient report (79% versus 69%, P=0.05) and as judged by research nurses (85% versus 76%, P=0.06).

Pain scores also tended to favor the more invasive surgery.

The visual analog scale score during the first year after surgery was lower with the conventional procedure for leg pain (mean 14.1 versus 18.3 mm, difference 4.2 mm, 95% CI 0.9 to 7.5 mm) and for back pain (mean 19.7 versus 23.2 mm, difference 3.5 mm, 95% CI 0.1 to 6.9 mm).

The researchers noted that the study excluded patients with less distinct nerve root compression on MRI, “but there is no reason to assume that the results of this study are not valid for these patients.”

The study was funded by the Dutch Health Care Insurance Board. The researchers reported no conflicts of interest.

Primary source: Journal of the American Medical Association

Source reference:

Arts MP, et al “Tubular diskectomy vs conventional microdiskectomy for sciatica: A randomized controlled trial” JAMA 2009; 302: 149-158.

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