Background:The beneficial treatment effect surgery demonstrates over conservative care for radiculopathy secondary to acute lumbar disc herniation (LDH), occurs in the first 3 to 6 months; thereafter outcomes are recognized to be similar. This is not surprising given the favourable natural history; 90% will experience gradual resolution of their symptoms within 4 months. In Canada, owing to the inherent wait time to see a surgeon and the referring physician's expectation that most patients will improve without surgery, symptomatic patients presenting to surgeons are often the 10% that have remained symptomatic longer than the expected 4 months. The purpose is to determine whether surgery is superior to conservative care in a patient population that has had persistent symptoms for more than 4 months, and therefore create a study population which is generalizable to the Canadian health care experience. Methods: This single blinded (assessor) RCT enrolled 18-to 60-year-old patients with a unilateral, single radiculopathy from a posterolateral L4-5 or L5-S1 disc herniation. Radiculopathy duration was longer than 4 months but less than 12 months. Patients on a waiting list to see surgeons at 1 academic hospital centre were randomized to early microdiscectomy or standardized nonoperative care, including medications, education, physiotherapy and steroid injections. Patients were excluded if they had previously received these conservative modalities. The primary outcome was intensity of sciatica (scale 0-10) measured at 6 months following randomization. Secondary outcome measures included back pain, Oswestry Disability Index (ODI), SF-36, work status and satisfaction. Results: This interim analysis reports on 40 nonoperative and 39 surgical patients. No difference existed between their demographic or preoperative data. At 6 months follow-up 32 of 39 surgical patients and 36 of 40 nonoperative patients had data available. Treatment effect for all outcome measures favoured surgery for the intent-to-treat, as-treat and last-value carried forward analysis (p < 0.05). To date 13 of 40 nonoperative patients have undergone microdiscectomy (performed after the primary outcome measure of 6 mo); they have had persistent inferior scores than early surgical patients (p < 0.05). Conclusion: At the interim analysis microdiscectomy is superior to nonoperative care for patients presenting with sciatica secondary to LDH. This study will continue to confirm robustness and validity of results.
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