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A Randomized Controlled Trial CLINICAL ARTICLE J Neurosurg Spine 28:481–485, 2018 Usefulness of corset adoption after single-level lumbar discectomy: a randomized controlled trial Cesare Zoia, MD, PhD,1 Daniele Bongetta, MD,1,2 Cristiano Alicino, MD, PhD,3 Marcella Chimenti, MD,2 Raffaelino Pugliese, MD,1 and Paolo Gaetani, MD1 1Neurosurgery Unit, IRCCS Fondazione Policlinico San Matteo, Pavia; 2Department of Clinical-Surgical, Diagnostic and Pediatric Sciences, Università degli Studi di Pavia; and 3Department of Health Sciences, University of Genoa, Italy OBJECTIVE In this paper, the authors sought to verify whether corset adoption could improve the short-term and mid- term outcome scores of patients after single-level lumbar discectomy. METHODS A monocentric, randomized controlled trial of 54 consecutive patients who underwent single-level lumbar discectomy at the authors’ institution was performed from September 2014 to August 2015. Patients were randomly as- signed to use or not use a lumbar corset in the upright position. Patients with previous interventions for disc herniation or with concomitant canal or foraminal stenosis were excluded. The visual analog scale, Oswestry Disability Index, and Roland Morris Disability Questionnaire were used to compare groups at the 1- and 6-month follow-up time points. RESULTS No significant differences between the 2 groups were reported at either time point for any given outcome irrespective of the scale used. CONCLUSIONS Corset adoption does not improve the short-term and midterm outcomes of patients after single-level lumbar discectomy. https://thejns.org/doi/abs/10.3171/2017.8.SPINE17370 KEY WORDS lumbar disc herniation; lumbar discectomy; corset; bracing OUR of 5 adults are affected by low-back pain at ported as recently summarized by Kreiner et al.,11 but no some point in their lives, and its most common unanimous consensus is reported on the need for orthotic cause, if associated with severe leg pain, is the pres- treatments.4,15,18 In particular, there are no data yet available Fence of intracanal prolapsed intervertebral disc material.9 from controlled trials on the efficacy of orthoses for the If conservative management is not successful, the most lumbar spine following stability-maintaining procedures routinely performed surgical procedure is lumbar discec- (i.e., decompression or intervertebral disc surgery).18 On tomy, which accounts for more than 280,000 procedures this subject, we recently surveyed the postoperative corol- per year in the United States.14 The outcome satisfaction lary treatment strategies of different neurosurgeons in our rates are uniformly reported as quite high in the short-term region, who reported an amazingly high percentage (25%) to midterm (up to 75% at 6–8 weeks), irrespective of the of corset adoption prescriptions for patients who under- many differences in the postoperative management of pa- went single-level lumbar discectomy (unpublished data); tients.13 Various guidelines on the diagnosis and treatment this finding mirrors other reports in literature.1,2 The aim strategies for lumbar disc herniation (LDH) have been re- of this study was to investigate whether the use of a lumbar ABBREVIATIONS BMI = body mass index; LDH = lumbar disc herniation; VAS = visual analog scale. SUBMITTED March 27, 2017. ACCEPTED August 24, 2017. INCLUDE WHEN CITING Published online February 9, 2018; DOI: 10.3171/2017.8.SPINE17370. ©AANS 2018, except where prohibited by US copyright law J Neurosurg Spine Volume 28 • May 2018 481 Unauthenticated | Downloaded 09/23/21 11:32 AM UTC C. Zoia et al. corset in patients who underwent surgery for single-level TABLE 1. Baseline and perioperative population characteristics lumbar disc herniation could improve the short-term and Group Group p midterm outcome scores. Characteristic A B Value Methods No. of patients 29 25 Mean age, yrs 44.7 (13.1) 45.6 (9) 0.75 After receiving approval from the local ethics commit- Sex 0.82 tee, we conducted a monocentric, randomized controlled trial of 54 consecutive patients who were referred to Male 16 (55.2%) 13 (52%) IRCCS Fondazione Policlinico San Matteo from Septem- Female 13 (44.8%) 12 (48%) ber 2014 to August 2015 for low-back pain with sciatica. Mean weight, kg 76.6 (16.5) 76.3 (15.5) 0.95 The inclusion criteria required the presence at a CT or Mean height, m 1.73 (0.1) 1.69 (0.1) 0.09 MRI scan of a single-level LDH with unilateral radicular Mean BMI, kg/m2 25.4 (4) 26.8 (4.7) 0.26 pain that was nonresponsive to conservative treatment. Pa- Level of education 0.69 tients with signs of instability, such as vertebral end plate Primary school 2 (6.9%) 2 (7%) or facet joint signal alterations, listhesis, osteophytes, or suspected sagittal curve imbalance, were further evaluated Secondary school 16 (55.2%) 10 (40%) using full standing and dynamic whole-spine radiographs. High school 10 (34.5%) 11 (44%) Patients were excluded from the study if instability was University 1 (3.4%) 2 (8%) confirmed. Further exclusion criteria were previous spinal Disc space involved 0.11 surgery, multiple symptomatic LDHs, or the concomitant L1–2 1 (3.4%) 0 (0%) presence of canal or foraminal stenosis. All patients under- L2–3 2 (6.9%) 0 (0%) went single-level lumbar discectomy with an interlaminar paramedian approach. All procedures were performed by L3–4 4 (13.8%) 2 (8%) a combination of the first 2 and last 2 authors (C.Z., D.B., L4–5 5 (17.2%) 12 (48%) R.P., and P.G.) with a standard microscopic technique. No L5–S1 17 (58.6%) 11 (44%) spinal canal or foraminal decompression and no hardware Radiculopathy side 0.19 implantations were performed. Because no previous data Right 19 (65.5%) 12 (48%) were available in the literature on the effects of lumbar Left 10 (34.5%) 13 (52%) corset adoption, we were not able to perform a power analysis to determine a sample size at first. Therefore, we Mean preop symptom duration, mos 10 (11.5) 15.1 (11.4) 0.11 adopted a 1-year consecutive enrollment time frame with Mean intervention length, mins 68.6 (36) 67.8 (22.8) 0.92 at least 50 patients. Mean postop hospital stay, days 2.1 (0.6) 2 (0.4) 0.47 The day after surgery, patients were mobilized and Complication >0.99 randomly assigned to either group A or group B using an No 27 (93.1%) 24 (96%) online randomizer. Patients in group A progressively re- Yes 2 (6.9%) 1 (4%) turned to their daily activities over the course of 1 month Return to normal activities at 10 28 (96.6%) 24 (96%) >0.99 with the adoption of a lumbar corset in the upright position days postop during the first 4 weeks after surgery. Patients in group B also progressively returned to daily activities but with- Values represent the number of patients (%) unless stated otherwise. Mean out corset adoption. All of the prescribed corsets were values are presented as the mean (SD). semirigid (i.e., with posterior flexible stays and abdominal straps). No other corsets were prescribed, and a shift to a less-rigid orthotic system was not allowed. Baseline char- variables. Categorical variables are summarized in the acteristics, level of education, symptom duration, symp- form of percentage proportions. The differences in the nu- tom characteristics, American Society of Anesthesiolo- meric variables were evaluated with the ANOVA test for gists Physical Status Classification System grade, length of normalized distributed variables or the Wilcoxon signed- surgery, complications, and length of stay were recorded rank test for nonparametric statistical analysis. Differ- for all patients. The visual analog scale (VAS), Oswestry ences in categorical variables were compared using the Disability Index, and Roland Morris Disability Question- chi-square or Fisher exact test when appropriate. All tests naire were employed for comparison at the 1- and 6-month were 2-tailed, and a p value < 0.05 was determined to rep- follow-up time points and collected using outpatient inter- resent statistical significance. All statistical analyses were views, telephone interviews, or email questionnaires. The performed using Epi-Info 7.0 (Centers for Disease Control outcome assessment was not blinded. Patients with acute and Prevention) and JMP 10 (SAS Institute Inc.) for Win- LDH relapse (within 6 months) or discontinuation of corset dows. adoption during the prescribed period were excluded from the study. Results We enrolled 54 consecutive patients. Twenty-nine were Statistical Analysis randomly assigned to group A (corset adoption) and 25 Continuous numeric variables are summarized as the patients were assigned to group B (no corset) (Table 1). mean and standard deviation for normalized distributed No patient in either group reported an acute LDH relapse 482 J Neurosurg Spine Volume 28 • May 2018 Unauthenticated | Downloaded 09/23/21 11:32 AM UTC C. Zoia et al. FIG. 1. Comparison of groups A and B in terms of VAS, Oswestry Disability Index, and Roland Morris Disability Questionnaire scores preoperatively and 1 and 6 months postoperatively. Data are reported as mean (columns) ± SD (bars) values. or discontinued corset adoption if in group A. There was vice used to modify the structural and functional char- no crossing between the 2 groups. No patient was lost to acteristics of the neuromuscular and skeletal system” follow-up. There were no differences in baseline charac- (ISO 8549-1:1989; https://www.iso.org/standard/15800. teristics except for a tendency for shorter patients in group html). Intuitively, a lumbar corset limits the range of mo- B (p = 0.09). The mean age was 44.7 years in group A tion of the lumbar spine and sustains the musculoskeletal and 45.6 years in group B. The percentage of men was system.
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