June 1, 2007 — Early surgery for severe sciatica may relieve pain faster than conservative treatment with eventual surgery if needed, but 1-year outcomes are similar, according to the results of a randomized trial published in the May 31 issue of The New England Journal of Medicine. Another study reported in the same issue shows that patients with degenerative spondylolisthesis and spinal stenosis who undergo surgery have better outcomes during a 2-year period compared with those who do not have surgery.
"Lumbar-disk surgery often is performed in patients who have sciatica that does not resolve within 6 weeks, but the optimal timing of surgery is not known," write Wilco C. Peul, MD, from the Leiden University Medical Center in the Netherlands, and colleagues for the Leiden–The Hague Spine Intervention Prognostic Study Group. "Since the first successful surgical treatment in 1934, the international consensus has been that surgery should be offered only if symptoms persist after a period of conservative treatment. There is, however, no consensus on how long conservative therapy should be tried before surgery is considered."
The investigators randomized 283 patients with severe sciatica for 6 to 12 weeks to early surgery or to prolonged conservative treatment with surgery if needed. The main endpoints were the score on the Roland Disability Questionnaire for Sciatica, the score on the visual analog scale for leg pain, and the patient's report of perceived recovery during the first year after randomization. Analysis was by intent-to-treat, and repeated measures were used to estimate the outcome curves for both groups.
Of 141 patients randomized to the early surgery group, 125 (89%) underwent microdiskectomy after a mean of 2.2 weeks. Of 142 patients randomized to the conservative treatment group, 55 (39%) received surgery after a mean of 18.7 weeks.
During the first year, disability scores were similar in both groups (P = .13). However, the early surgery group had faster relief of leg pain (P < .001) and faster rate of perceived recovery (hazard ratio, 1.97; 95% confidence interval, 1.72 - 2.22; P < .001). In both groups, the probability of perceived recovery after 1 year of follow-up was 95%.
"The 1-year outcomes were similar for patients assigned to early surgery and those assigned to conservative treatment with eventual surgery if needed, but the rates of pain relief and of perceived recovery were faster for those assigned to early surgery," the authors write.
Study limitations include limited generalizability because patients assigned to conservative therapy were guided by research nurses who participated in pain management, inability to blind the patients and the nurses to the treatment assignment, and time until recovery being determined from examinations performed only at predefined times during follow-up.
"Our findings suggest that patients are more likely to choose surgery if they are not able to cope with leg pain, find the natural course of recovery from sciatica unacceptably slow, and want to minimize the time to recovery from pain," the authors conclude. "Patients whose pain is controlled in a manner that is acceptable to them may decide to postpone surgery in the hope that it will not be needed, without reducing their chances for complete recovery at 12 months. Although both strategies have similar outcomes after 1 year, early surgery remains a valid treatment option for well-informed patients."
The Netherlands Organisation for Health Research and Development (ZonMW) and the Hoelen Foundation, The Hague, supported this study. The authors have disclosed no relevant financial relationships.
"For patients with persistent sciatica, there seems to be a reasonable choice between surgical and nonsurgical treatment, which may be influenced by aversion to surgical risks, the severity of symptoms, and willingness to wait for spontaneous healing," Richard A. Deyo, MD, MPH, from the University of Washington in Seattle, writes in an accompanying perspective article. "Since patients who underwent surgery months after entering the study did as well as those who had surgery within 2 weeks, there does not seem to be a therapeutic window that closes quickly."
N Engl J Med. 2007;356:2239-2243, 2245-2256.
Showing posts with label sciatica. Show all posts
Showing posts with label sciatica. Show all posts
Saturday, June 02, 2007
Friday, June 01, 2007
Surgery Eases Pain of Spinal Stenoses and Slipped Vertebra, but Sciatica Outcomes Similar
LEBANON, N.H., May 31 -- Surgery for degenerative spondylolisthesis with spinal stenosis is significantly more effective against pain than usual nonsurgical care, confirmed one large study.
But, another study found early surgery for sciatica accelerated pain relief but there were similar outcomes at one year compared with conservative treatment.
"Surgery is widely used, but its effectiveness in comparison with that of nonsurgical treatment has not been demonstrated in controlled trials," wrote James N. Weinstein, D.O., of Dartmouth here, and colleagues, in their study of spinal stenosis and slipped vertebra treatment.
These studies are helping to refine practice in the face of steadily rising spine surgery rates, commented Richard A. Deyo, M.D., M.P.H., of the University of Washington in Seattle. His editorial accompanied both studies in the May 31 issue of the New England Journal of Medicine.
Back surgery may not be necessary to preserve life or function for these patients without major neurologic deficits, but appropriate surgery may provide valuable pain relief, Dr. Deyo wrote.
Whether this justifies surgery has to be decided jointly by well-informed patients and physicians, he added.
Dr. Weinstein's analysis was part of the larger Spine Patient Outcomes Research Trial (SPORT), which aims to provide evidence for appropriate treatment of the most common causes of back pain.
The current study included a cohort of 304 patients randomized to standard decompressive surgery (95% with bilateral single-level fusion) or usual care and an observational cohort of 303 patients who chose treatment with their physician.
Usual care included physical therapy (for 42% of patients), epidural steroid injections (45%), opioids (34%), and nonsteroidal anti-inflammatory agents (51%).
However, extensive crossover between surgical and nonsurgical groups in both cohorts hampered the study. About half of participants assigned to usual care underwent surgery within two years of the start of the study; only 64% of those assigned to surgery actually had it. Of patients who initially chose surgery, just 25% had surgery within two years.
So the researchers pooled both cohorts and did an as-treated analysis with 372 patients having undergone surgery within two years after enrollment and 235 having received only nonsurgical treatment.
All 607 patients had spinal stenosis (60% severe) and degenerative spondylolisthesis, proven by imaging, as well as neurogenic claudication (85%) or radicular leg pain (77%). Symptoms had to have persisted for at least 12 weeks. All participants were surgical candidates.
While the observational and randomized cohorts were fairly similar, there were important differences between treatment groups. So the researchers controlled for covariates, including age, sex, work status, duration of current symptoms, reflex deficit, levels of disease, and baseline scores for each of the measured indices.
The intent-to-treat analysis showed no significant differences between treatment groups in the randomized cohort.
In contrast, the as-treated effects significantly favored surgery for all primary and secondary outcomes at all time points (P<0.001). Treatment effects for surgery versus nonsurgical therapy at two years were:
18.1 for bodily pain on the Short Form-36 questionnaire (95% confidence interval 14.5 to 21.7).
18.3 for physical function on the Short Form-36 (95% CI 14.6 to 21.9).
−16.7 for disability on the Oswestry Disability Index (95% CI −19.5 to −13.9).
−4.9 for Stenosis Bothersomeness Index scores (95% CI −6.0 to −3.8).
−1.5 for Leg Pain Bothersomeness Scale scores (95% CI −1.8 to −1.1).
−1.2 for Low Back Pain Bothersomeness Scale scores (95% CI −1.3 to −0.7).
36.6% reported they were "very" or "somewhat" satisfied with their symptoms (95% CI 28.0 to 45.1).
50.0% reported "major improvement" in progress (95% CI 42.2 to 57.9).
Nearly identical results in the randomized and the observational cohorts.
Importantly, the researchers said, there appeared to be little evidence of harm for surgical or nonsurgical treatment. No patient in either group had cauda equina syndrome as a consequence of nerve root compression. Most surgical patients had no operative complications (89%).
"Often patients fear they will get worse without surgery, but the patients receiving nonsurgical treatment, on average, showed moderate improvement in all outcomes," they wrote.
They cautioned that their findings cannot be used to make direct comparisons between surgery and any specific nonsurgical treatment and vice versa.
In his editorial, Dr. Deyo likewise noted that "caution is in order," because combining the groups in an as-treated analysis essentially turned the study into a single large cohort study, which even when well designed may contradicted randomized, controlled trial results.
The "true magnitude of the surgical advantage probably lies somewhere between the two estimates" of as-treated and intent-to-treat effects, Dr. Deyo added.
As reported in November 2006, a separate analysis of the same trial found little difference between surgical and nonsurgical treatment for disk herniation with sciatica.
But because that analysis likewise suffered crossover problems that could have confounded the results, researchers in the Netherlands conducted a separate randomized, controlled trial in 283 patients with severe sciatica for six to 12 weeks.
Wilco C. Peul, M.D., of Leiden University Medical Center in Holland, and colleagues, randomized 141 patients to early microdiskectomy and 142 to prolonged conservative treatment with surgery later if needed.
Conservative treatment was provided by family doctors guided by research nurses who participated in pain management. Therapy was targeted to enable patients to resume daily activities. It included guidelines-directed prescription of pain medication and referral to a physiotherapist for patients afraid to move.
For those with sciatica persisting at six months or increasing, refractory leg pain or neurologic deficits at any point, microdiskectomy was offered. Thirty-nine percent underwent surgery at a mean of 18.7 weeks.
Most patients underwent early surgery as assigned -- 89% at a mean of 2.2 weeks. The treatment groups had similar baseline characteristics.
Among the findings, the researchers reported:
No significant difference in Roland Disability Questionnaire scores in the first year (P=0.13).
Twice as fast leg pain relief with early surgery as with conservative treatment (P<0.001).
Faster perceived recovery -- complete or nearly complete disappearance of symptoms -- for patients in the early surgery group (4.0 versus 12.1 weeks, hazard ratio 1.97, 95% CI 1.72 to 2.22, P<0.001).
Identical likelihood of perceived recovery at one-year follow-up (about 95% for both groups).
No difference in visual analog pain scores between groups at one year.
Similar pain, recovery, and disability score improvements for patients with early and delayed surgery at one year (P=NS).
"Thus, the major advantage of early surgical treatment is faster relief of sciatica," the researchers concluded.
They cautioned, though, that the additional support of research nurses in the conservative therapy group did not reflect usual care and may limit the generalizability of the findings.
"So who needs back surgery?" Dr. Deyo asked.
"Absent major neurologic deficits, patients with herniated disks, degenerative spondylolisthesis, or spinal stenosis do not need surgery," he concluded, "but the appropriate surgical procedures may provide valuable pain relief."
"In such situations, decisions should be made jointly by well-informed patients and their physicians," he added.
But, another study found early surgery for sciatica accelerated pain relief but there were similar outcomes at one year compared with conservative treatment.
"Surgery is widely used, but its effectiveness in comparison with that of nonsurgical treatment has not been demonstrated in controlled trials," wrote James N. Weinstein, D.O., of Dartmouth here, and colleagues, in their study of spinal stenosis and slipped vertebra treatment.
These studies are helping to refine practice in the face of steadily rising spine surgery rates, commented Richard A. Deyo, M.D., M.P.H., of the University of Washington in Seattle. His editorial accompanied both studies in the May 31 issue of the New England Journal of Medicine.
Back surgery may not be necessary to preserve life or function for these patients without major neurologic deficits, but appropriate surgery may provide valuable pain relief, Dr. Deyo wrote.
Whether this justifies surgery has to be decided jointly by well-informed patients and physicians, he added.
Dr. Weinstein's analysis was part of the larger Spine Patient Outcomes Research Trial (SPORT), which aims to provide evidence for appropriate treatment of the most common causes of back pain.
The current study included a cohort of 304 patients randomized to standard decompressive surgery (95% with bilateral single-level fusion) or usual care and an observational cohort of 303 patients who chose treatment with their physician.
Usual care included physical therapy (for 42% of patients), epidural steroid injections (45%), opioids (34%), and nonsteroidal anti-inflammatory agents (51%).
However, extensive crossover between surgical and nonsurgical groups in both cohorts hampered the study. About half of participants assigned to usual care underwent surgery within two years of the start of the study; only 64% of those assigned to surgery actually had it. Of patients who initially chose surgery, just 25% had surgery within two years.
So the researchers pooled both cohorts and did an as-treated analysis with 372 patients having undergone surgery within two years after enrollment and 235 having received only nonsurgical treatment.
All 607 patients had spinal stenosis (60% severe) and degenerative spondylolisthesis, proven by imaging, as well as neurogenic claudication (85%) or radicular leg pain (77%). Symptoms had to have persisted for at least 12 weeks. All participants were surgical candidates.
While the observational and randomized cohorts were fairly similar, there were important differences between treatment groups. So the researchers controlled for covariates, including age, sex, work status, duration of current symptoms, reflex deficit, levels of disease, and baseline scores for each of the measured indices.
The intent-to-treat analysis showed no significant differences between treatment groups in the randomized cohort.
In contrast, the as-treated effects significantly favored surgery for all primary and secondary outcomes at all time points (P<0.001). Treatment effects for surgery versus nonsurgical therapy at two years were:
18.1 for bodily pain on the Short Form-36 questionnaire (95% confidence interval 14.5 to 21.7).
18.3 for physical function on the Short Form-36 (95% CI 14.6 to 21.9).
−16.7 for disability on the Oswestry Disability Index (95% CI −19.5 to −13.9).
−4.9 for Stenosis Bothersomeness Index scores (95% CI −6.0 to −3.8).
−1.5 for Leg Pain Bothersomeness Scale scores (95% CI −1.8 to −1.1).
−1.2 for Low Back Pain Bothersomeness Scale scores (95% CI −1.3 to −0.7).
36.6% reported they were "very" or "somewhat" satisfied with their symptoms (95% CI 28.0 to 45.1).
50.0% reported "major improvement" in progress (95% CI 42.2 to 57.9).
Nearly identical results in the randomized and the observational cohorts.
Importantly, the researchers said, there appeared to be little evidence of harm for surgical or nonsurgical treatment. No patient in either group had cauda equina syndrome as a consequence of nerve root compression. Most surgical patients had no operative complications (89%).
"Often patients fear they will get worse without surgery, but the patients receiving nonsurgical treatment, on average, showed moderate improvement in all outcomes," they wrote.
They cautioned that their findings cannot be used to make direct comparisons between surgery and any specific nonsurgical treatment and vice versa.
In his editorial, Dr. Deyo likewise noted that "caution is in order," because combining the groups in an as-treated analysis essentially turned the study into a single large cohort study, which even when well designed may contradicted randomized, controlled trial results.
The "true magnitude of the surgical advantage probably lies somewhere between the two estimates" of as-treated and intent-to-treat effects, Dr. Deyo added.
As reported in November 2006, a separate analysis of the same trial found little difference between surgical and nonsurgical treatment for disk herniation with sciatica.
But because that analysis likewise suffered crossover problems that could have confounded the results, researchers in the Netherlands conducted a separate randomized, controlled trial in 283 patients with severe sciatica for six to 12 weeks.
Wilco C. Peul, M.D., of Leiden University Medical Center in Holland, and colleagues, randomized 141 patients to early microdiskectomy and 142 to prolonged conservative treatment with surgery later if needed.
Conservative treatment was provided by family doctors guided by research nurses who participated in pain management. Therapy was targeted to enable patients to resume daily activities. It included guidelines-directed prescription of pain medication and referral to a physiotherapist for patients afraid to move.
For those with sciatica persisting at six months or increasing, refractory leg pain or neurologic deficits at any point, microdiskectomy was offered. Thirty-nine percent underwent surgery at a mean of 18.7 weeks.
Most patients underwent early surgery as assigned -- 89% at a mean of 2.2 weeks. The treatment groups had similar baseline characteristics.
Among the findings, the researchers reported:
No significant difference in Roland Disability Questionnaire scores in the first year (P=0.13).
Twice as fast leg pain relief with early surgery as with conservative treatment (P<0.001).
Faster perceived recovery -- complete or nearly complete disappearance of symptoms -- for patients in the early surgery group (4.0 versus 12.1 weeks, hazard ratio 1.97, 95% CI 1.72 to 2.22, P<0.001).
Identical likelihood of perceived recovery at one-year follow-up (about 95% for both groups).
No difference in visual analog pain scores between groups at one year.
Similar pain, recovery, and disability score improvements for patients with early and delayed surgery at one year (P=NS).
"Thus, the major advantage of early surgical treatment is faster relief of sciatica," the researchers concluded.
They cautioned, though, that the additional support of research nurses in the conservative therapy group did not reflect usual care and may limit the generalizability of the findings.
"So who needs back surgery?" Dr. Deyo asked.
"Absent major neurologic deficits, patients with herniated disks, degenerative spondylolisthesis, or spinal stenosis do not need surgery," he concluded, "but the appropriate surgical procedures may provide valuable pain relief."
"In such situations, decisions should be made jointly by well-informed patients and their physicians," he added.
Two Studies Find Advantage of Back Surgery Over Conservative Treatment
Back problems improve more rapidly after surgery than with conservative treatment, two studies in the New England Journal of Medicine find.
In one study, 283 patients with sciatica underwent randomization either to early surgery or to conservative treatment using surgery only if needed. At 1-year follow-up, there were no significant differences between the groups in pain, disability, and recovery scores, but the early-surgery group experienced quicker pain relief and a faster rate of self-perceived recovery.
The other study involved some 600 patients with degenerative spondylolisthesis, one cohort of which underwent randomization to either decompressive laminectomy or usual nonsurgical care, and the other cohort of which chose their treatment with their physicians. As-treated analysis of the whole population (there was much crossover between treatments) revealed an advantage for surgical care both in pain relief and functional improvement; the difference persisted over 2 years. There was no such advantage found under intention-to-treat analysis.
The author of a commentary says that "caution is in order" for the second study, given the differences between the analyses. He concludes that "absent major neurologic deficits, patients with herniated disks, degenerative spondylolisthesis, or spinal stenosis do not need surgery, but the appropriate surgical procedures may provide valuable pain relief."
In one study, 283 patients with sciatica underwent randomization either to early surgery or to conservative treatment using surgery only if needed. At 1-year follow-up, there were no significant differences between the groups in pain, disability, and recovery scores, but the early-surgery group experienced quicker pain relief and a faster rate of self-perceived recovery.
The other study involved some 600 patients with degenerative spondylolisthesis, one cohort of which underwent randomization to either decompressive laminectomy or usual nonsurgical care, and the other cohort of which chose their treatment with their physicians. As-treated analysis of the whole population (there was much crossover between treatments) revealed an advantage for surgical care both in pain relief and functional improvement; the difference persisted over 2 years. There was no such advantage found under intention-to-treat analysis.
The author of a commentary says that "caution is in order" for the second study, given the differences between the analyses. He concludes that "absent major neurologic deficits, patients with herniated disks, degenerative spondylolisthesis, or spinal stenosis do not need surgery, but the appropriate surgical procedures may provide valuable pain relief."
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