Chris S Bailey1, Parham Rasoulinejad1, David Taylor1, Keith Sequeira1, Thomas Miller1, Jim Watson1, Richard Rosedale1, Stewart I Bailey1, Kevin R Gurr1, Fawaz Siddiqi1, Andrew Glennie1, Jennifer C Urquhart1. 1. From the Department of Surgery (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G., J.C.U.) and Occupational Health and Safety (R.R.), London Health Sciences Centre, Schulich School of Medicine and Dentistry, Western University (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G.), Lawson Health Research Institute (C.S.B., P.R., J.C.U.), Regional Rehabilitation and Spinal Cord Injury Outpatients, Parkwood Institute (K.S.), and the Departments of Physical Medicine and Rehabilitation (T.M.) and Anesthesia and Perioperative Medicine (J.W.), St. Joseph's Hospital - all in London, ON, Canada.
Abstract
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.).
RCT Entities:
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.).
Authors: Ahmed Benzakour; Pavlos Altsitzioglou; Jean Michel Lemée; Alaaeldin Ahmad; Andreas F Mavrogenis; Thami Benzakour Journal: Int Orthop Date: 2022-07-29 Impact factor: 3.479
Authors: André Wirries; Florian Geiger; Ahmed Hammad; Martin Bäumlein; Julia Nadine Schmeller; Ingmar Blümcke; Samir Jabari Journal: Biomedicines Date: 2022-06-04
Authors: R Andrew Glennie; Jennifer C Urquhart; Prosper Koto; Parham Rasoulinejad; David Taylor; Keith Sequeira; Thomas Miller; Jim Watson; Richard Rosedale; Stewart I Bailey; Kevin R Gurr; Fawaz Siddiqi; Christopher S Bailey Journal: Clin Orthop Relat Res Date: 2022-03-01 Impact factor: 4.755