People with severe back pain due to a ruptured disk usually recover whether they have surgery or decide to wait it out, though an operation brings immediate pain relief. And contrary to what many people are told by their surgeons, avoiding surgery does not result in nerve damage. These findings are from a large clinical trial published in November in the Journal of the American Medical Association.
Many back surgeons criticized this trial before it began because they were convinced of disk surgery’s benefit. Some refused to refer their patients to a trial they saw as unethical because surgery would be withheld from some study participants, a necessary component to a study intended to randomly assign half to non-surgical treatment.
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But the research team led by James N. Weinstein, DO, Dartmouth Medical School, had these justifications for going ahead: 1) ruptured disks are often seen on the CT or MRI scans of people without any back symptoms and these scans also show that untreated ruptured disks can regress in time; 2) the rate of disk surgery in some regions of the U.S. is 15 times higher than that of other regions and other Western countries, thus raising suspicion that many disk operations are unnecessary.
The clinical trial went forward despite surgeons’ objections, and 2,000 people were treated at one of 13 U.S. spine clinics. All had scan-confirmed disk herniation and the persistent back and leg pain of sciatica for at least six weeks. Some of the participants agreed to be assigned randomly to receive either back surgery or non-surgical therapy (physical therapy and counseling and anti-inflammatory painkillers). Other participants, however, wanted to choose their own treatment, and they formed the basis of a separate trial called an observational study.
The results did not identify one treatment as superior to the other because so many study participants “crossed-over.” Only 50% of the people assigned to undergo surgery actually had the operation, and 30% of those assigned to non-surgical therapies decided to have the operation.
A co-author of the observational study Richard A. Deyo, MD, Professor of Medicine and of Health Services, University of Washington, Seattle, was asked for the take-home message of both trials.
“Most people got better, regardless of whether they had surgery. Surgery typically offered faster relief, but by two to four years, people are the same whether or not they had surgery,” he responded in a telephone interview. Surgery can be avoided, if the pain is tolerable and the patient is “risk averse,” he explained, referring to the small but definite risks of surgery, such as nerve injury, scarring, and anesthesia mishaps.
The risks of surgery, though small, are greater than any risk of the wait-and-see approach, he continued. “Many people have the impression they will become paralyzed or [suffer] permanent muscle weakness if they delay, but patients needn’t worry.”
Will the new findings reverse back surgeons’ opinions? “This study replicates a trial done in Norway 30 years ago with much the same results,” said Dr. Deyo, noting that many American back surgeons could be unaware of this trial.
“It might bring some surgeons up to date,” he said, answering the question of whether the findings will reduce the country’s high number of herniated disk operations, estimated to be 300,000 yearly.
“But it’s spinal fusion surgery that is now the most controversial,” said Dr. Deyo, referring to another back surgery now done in excess.
“It has exploded [in growth] over the last decade, and there is no evidence for it.” There are huge financial interests involved in terms of equipment, hospitals, and physicians, explained Dr. Deyo, and the circumstances for which the operation may be warranted, such as spondylolisthesis (vertebrae out of alignment), spinal fracture, and cancer metastasis to the spine–are all uncommon.
COPYRIGHT 2007 Center for Medical Consumers, Inc.
COPYRIGHT 2008 Gale, Cengage Learning
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