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 midterm 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 assigned 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

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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. Hence, one of its potential advantages is to foster 55.2% in group A and 52% in group B, while women ac- the stability of the spine as a whole in contrast to degen- counted for 44.8% of group A and 48% of group B. The erative-related instability and biomechanical impairment. mean weight of the patients was 76.6 kg in group A and As an example, corsets are routinely prescribed at least 76.3 kg in group B. The mean body mass index (BMI) in the first weeks after major spinal procedures (e.g., ar- of the patients was 25.4 in group A and 26.8 in group B. throdesis) with the rationale to support the hardware fu- Even for the distribution of the level of schooling, there sion process. However, in 2008, a randomized controlled were no differences between the 2 groups. There were no trial investigated the usefulness of postoperative bracing differences in the analysis of symptoms, level of LDH, and treatment following lumbar spinal arthrodesis, and it was anesthesiological and operative management. determined that there was neither an advantage nor a dis- No significant differences between the 2 groups were advantage in terms of fusion rates and clinical outcome.17 reported at either postoperative time point for any given The rationale for corset prescription is even less clear outcome irrespective of any scale employed (Fig. 1). In when dealing with noninstrumented lumbar surgeries be- particular, the mean (SD) VAS scores were 6.3 (0.4), 2.9 cause no data from controlled trials are available in lit- (2.3), and 2.4 (3) preoperatively and 1 and 6 months post- erature. Nonetheless, a regional survey that we performed operatively for group A, respectively, and 6.1 (0.5), 2.4 on this topic,19 which is in line with other surveys in the (0.4), and 2 (2.5), respectively, for group B. The mean (SD) literature,1,2 reported that as many as 1 of 4 spinal sur- Oswestry Disability Index scores were 50% (20%), 14% geons prescribe corset adoption with the assumption that (12%), and 16% (20%) preoperatively and 1 and 6 months it will limit the rate of early LDH relapse as well as pre- postoperatively, respectively, for group A, and 50% (20%), vent spinal instability. The results of our trial showed that 17% (15%), and 12% (16%), respectively, for group B. corset adoption has no advantages whatsoever in limiting The Roland Morris Disability Questionnaire scores were both of these events as far as the first 6-month period of 11.3 (4.6), 4.2 (4), and 3.6 (4.7) preoperatively and 1 and 6 follow-up is concerned. When dealing with LDH relapse, months postoperatively, respectively, for group A, and 11.6 in particular, no early (< 6 months) LDH relapses have (6.2), 4.4 (3.9), and 2.4 (3.3) for group B. been reported in either group. We believe, in fact, that We reported 3 surgical complications: 1 unintentional the same degree of restriction in the activities of a patient durotomy and 1 wound complication in group A and 1 through orthotic treatment could be achieved by provid- unintentional durotomy in group B. None of these patients ing simple instructions to the patients about the best post- required revision surgeries. Both patients who underwent operative behavior to follow, especially in the first weeks an unintentional durotomy had their hospital stays pro- after surgery. Specifically, besides non–activity-related longed by 1 day because of extra bed rest. LDH relapse risk factors (e.g., sex, smoking, BMI), the only modifiable factor is physical activity, we routinely instruct patients to avoid excessive load bearing and spine Discussion mobilization for at least 1 month. The definition of orthosis is “an externally applied de- Moreover, there were no differences in the reported

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Unauthenticated | Downloaded 09/23/21 11:32 AM UTC C. Zoia et al. instability-related symptoms at follow-up (e.g., pain in a specific biomechanical analysis of each patient. Even the vertebral facets or local back pain). In our opinion, though we ruled out spinal instability in all patients, we this may be due to the fact that our population was cho- did not perform a systematic subanalysis of their pelvic sen to exclude joint-violating procedures. In particular, parameters to assess their sagittal balance. Moreover, we avoided breaching the intervertebral facets as well although there is a definitive prevalence of involvement as bilateral discontinuation of the posterior tension band of the L5–S1 space, in the same analysis we have none- (i.e., contralateral musculature and interspinous liga- theless considered all of the lumbar disc spaces with no ments). These precautions seem to limit the events of distinction. Therefore, we cannot rule out that biome- postoperative instability even in patients who have un- chanical differences in the lumbar spine disc spaces may dergone more-invasive lumbar procedures.5 Therefore, play a role in the usefulness of an external orthotic sys- we believe that the role of corset adoption on instability tem. Another issue is that our final follow-up examina- may be trivial. tion took place after just 6 months and thus did not allow The most relevant result from our trial, however, is the for evaluations of long-term LDH relapse and instability fact that no differences were determined between the 2 rates. groups at any given time point, irrespective of the scale used to the evaluate clinical outcome (VAS, Roland Mor- Conclusions ris Disability Questionnaire, or Oswestry Disability In- dex). This implies that there are no sufficiently relevant Corset adoption does not improve the short-term and elements that favor the use of a lumbar corset after con- midterm outcomes of patients after single-level lumbar sidering analyses of outcomes that focus on both pain discectomy. Its adoption should not be advised, at least in control and disability during daily activities. Interestingly, the period following this kind of lumbar surgery, given the even when we considered only the outcome evaluation economic and potential muscular burden. performed at the 1st month, which represents the period of actual treatment difference, we could not identify any References advantage of bracing. 1. Agabegi SS, Asghar FA, Herkowitz HN: Spinal orthoses. J As for the factors against the use of corsets, the main Am Acad Orthop Surg 18:657– 667, 2010 question is related to the muscular response to bracing. 2. Bible JE, Biswas D, Whang PG, Simpson AK, Rechtine In this regard, there are controversial data in the lit- GR, Grauer JN: Postoperative bracing after spine surgery erature because different reports state that bracing may for degenerative conditions: a questionnaire study. Spine J strengthen,8,10 weaken,7 or have no effect16 on the lumbar 9:309–316, 2009 muscles. None of these studies, however, were specifically 3. Carragee EJ, Han MY, Yang B, Kim DH, Kraemer H, Billys J: Activity restrictions after posterior lumbar discectomy. A designed to study the effect of bracing on patients who prospective study of outcomes in 152 cases with no postop- underwent spinal surgery. In nonoperated patients, it is erative restrictions. Spine (Phila Pa 1976) 24:2346–2351, widely accepted that there is no benefit from prolonged 1999 activity restriction, while early corset adoption may help 4. 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A rehabilitation-oriented thereby resulting in an unnecessary limitation on the non- approach in insurance medicine. Spine (Phila Pa 1976) operated side. Specifically, patients may rely more on the 24:872–876, 1999 support from the orthesis rather than activating their own 7. Eisinger DB, Kumar R, Woodrow R: Effect of lumbar or- muscles, thereby resulting in an overall weakening of their thotics on trunk muscle strength. Am J Phys Med Rehabil muscular support of the spine. Moreover, even if we have 75:194–197, 1996 8. Holmström E, Moritz U: Effects of lumbar belts on trunk not performed a systematic review, corset adoption may muscle strength and endurance: a follow-up study of con- induce contact dermatitis, in particular in sensitive areas struction workers. J Spinal Disord 5:260–266, 1992 such as the fresh surgical wound. As a matter of fact, pa- 9. Hoy D, Brooks P, Blyth F, Buchbinder R: The epidemiology tients often report discomfort due to corset adoption, in of low back pain. Best Pract Res Clin Rheumatol 24:769– particular during warmer seasons. In the end, it should not 781, 2010 be overlooked that the price of a lumbar corset varies from 10. Kawaguchi Y, Gejo R, Kanamori M, Kimura T: Quantita- €50 to €150 depending on the specific type and manu- tive analysis of the effect of lumbar orthosis on trunk muscle facturer. Whether in an insurance- or public-based health strength and muscle activity in normal subjects. J Orthop system setting, our results suggest that its adoption seems Sci 7:483–489, 2002 11. Kreiner DS, Hwang SW, Easa JE, Resnick DK, Baisden to be an unjustified use of resources. JL, Bess S, et al: An evidence-based clinical guideline for This study may be affected by relevant limitations. the diagnosis and treatment of lumbar disc herniation with First, it might be underpowered to detect any difference radiculopathy. Spine J 14:180–191, 2014 between the 2 groups. Second, the outcome assessment 12. Mannion AF, Denzler R, Dvorak J, Müntener M, Grob D: A was not blinded. Another limitation may be the lack of randomised controlled trial of post-operative rehabilitation

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after surgical decompression of the lumbar spine. Eur Spine P: Intraregional differences of perioperative management J 16:1101–1117, 2007 strategy for lumbar disc herniation: is the Devil really in the 13. Oosterhuis T, Costa LO, Maher CG, de Vet HC, van Tulder details? Int J Spine Surg 11:1, 2017 MW, Ostelo RW: Rehabilitation after lumbar disc surgery. Cochrane Database Syst Rev 14:CD003007, 2014 14. Sherman J, Cauthen J, Schoenberg D, Burns M, Reaven NL, Disclosures Griffith SL: Economic impact of improving outcomes of The authors report no conflict of interest concerning the materi- lumbar discectomy. Spine J 10:108–116, 2010 als or methods used in this study or the findings specified in this 15. van Duijvenbode IC, Jellema P, van Poppel MN, van Tulder paper. MW: Lumbar supports for prevention and treatment of low back pain. Cochrane Database Syst Rev 16:CD001823, Author Contributions 2008 16. Walsh NE, Schwartz RK: The influence of prophylactic Conception and design: Zoia. Acquisition of data: Zoia, Chimenti. orthoses on abdominal strength and low back injury in the Analysis and interpretation of data: Zoia, Bongetta, Chimenti. workplace. Am J Phys Med Rehabil 69:245–250, 1990 Drafting the article: Zoia, Bongetta. Critically revising the article: 17. Yee AJ, Yoo JU, Marsolais EB, Carlson G, Poe-Kochert C, Zoia, Bongetta, Pugliese, Gaetani. Reviewed submitted version of Bohlman HH, et al: Use of a postoperative lumbar corset manuscript: Zoia, Bongetta, Gaetani. Approved the final version after lumbar spinal arthrodesis for degenerative conditions of the manuscript on behalf of all authors: Zoia. Statistical analy- of the spine. A prospective randomized trial. J Bone Joint sis: Zoia, Alicino. Administrative/technical/material support: Surg Am 90:2062–2068, 2008 Zoia. Study supervision: Zoia. 18. Zarghooni K, Beyer F, Siewe J, Eysel P: The orthotic treatment of acute and chronic disease of the cervical and lumbar Correspondence spine. Dtsch Arztebl Int 110:737–742, 2013 Cesare Zoia: IRCCS Fondazione Policlinico San Matteo, Pavia, 19. Zoia C, Bongetta D, Poli JC, Verlotta M, Pugliese R, Gaetani Italy. [email protected].

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