scholarly journals Proactive Management of Intraoperative Hypotension Reduces Biomarkers of Organ Injury and Oxidative Stress during Elective Non-Cardiac Surgery: A Pilot Randomized Controlled Trial

2022 ◽  
Vol 11 (2) ◽  
pp. 392
Author(s):  
Paolo Murabito ◽  
Marinella Astuto ◽  
Filippo Sanfilippo ◽  
Luigi La Via ◽  
Francesco Vasile ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Intervention Group ◽  
Weighted Average ◽  
Organ Injury ◽  
Secondary Outcome ◽  
Control Group ◽  
Proactive Management ◽  
Intraoperative Hypotension ◽  
Time Weighted Average ◽  
And Oxidative Stress

Background: Intraoperative hypotension is associated with increased postoperative morbidity and mortality. Methods: We randomly assigned patients undergoing major general surgery to early warning system (EWS) and hemodynamic algorithm (intervention group, n = 20) or standard care (n = 20). The primary outcome was the difference in hypotension (defined as mean arterial pressure < 65 mmHg) and as secondary outcome surrogate markers of organ injury and oxidative stress. Results: The median number of hypotensive episodes was lower in the intervention group (−5.0 (95% CI: −9.0, −0.5); p < 0.001), with lower time spent in hypotension (−12.8 min (95% CI: −38.0, −2.3 min); p = 0.048), correspondent to −4.8% of total surgery time (95% CI: −12.7, 0.01%; p = 0.048).The median time-weighted average of hypotension was 0.12 mmHg (0.35) in the intervention group and 0.37 mmHg (1.11) in the control group, with a median difference of −0.25 mmHg (95% CI: −0.85, −0.01; p = 0.025). Neutrophil Gelatinase-Associated Lipocalin (NGAL) correlated with time-weighted average of hypotension (R = 0.32; p = 0.038) and S100B with number of hypotensive episodes, absolute time of hypotension, relative time of hypotension and time-weighted average of hypotension (p < 0.001 for all). The intervention group showed lower Neuronal Specific Enolase (NSE) and higher reduced glutathione when compared to the control group. Conclusions: The use of an EWS coupled with a hemodynamic algorithm resulted in reduced intraoperative hypotension, reduced NSE and oxidative stress.

scholarly journals Performance of Hypotension Prediction Index for Prevention of Hypotension and Results on Biomarkers of Organ Injury and Oxidative Stress During Elective Non-Cardiac Surgery: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Paolo Murabito ◽  
Marinella Astuto ◽  
Filippo Sanfilippo ◽  
Luigi La Via ◽  
Francesco Basile ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Reduced Glutathione ◽  
Intervention Group ◽  
Weighted Average ◽  
Organ Injury ◽  
Secondary Outcome ◽  
Control Group ◽  
Intraoperative Hypotension ◽  
Time Weighted Average ◽  
And Oxidative Stress

Abstract Background: Intraoperative hypotension is associated with increased postoperative morbidity and mortality. We tested whether the clinical application of an early warning system (EWS) in combination with an algorithm for hemodynamic management reduces the occurrence of intraoperative hypotension as well as decrease the degree of organ injury and oxidative stress. Methods: We randomly assigned patients undergoing major general surgery EWS and hemodynamic algorithm (intervention group, n=20) or standard care (n=20). The primary outcome was the difference in hypotension (defined as mean arterial pressure<65mmHg) evaluated as episodes, time and time-weighted average of hypotension. As secondary outcome we assessed surrogate markers of organ injury (neuron specific enolase -NSE), S100B protein, high-sensitive troponin, neutrophil gelatinase-associated lipocalin -NGAL) and oxidative stress (reduced glutathione). Results: The median number of hypotensive episodes was lower in the intervention group [-5.0 (95%CI:-9.0,-0.5);P<0.005], with lower time spent in hypotension [-12.8 minutes (95%CI:-38.0,-2.3 min);P<0.001], correspondent to -4.8% of total surgery time (95%CI: -12.7,0.01%; P<0.05). The median time-weighted average of hypotension was 0.12 mmHg (0.35) in the intervention group and 0.37 mmHg (1.11) in the control group, with a median difference of -0.25 mmHg (95%CI:-0.85, -0.01;P<0.05). NGAL was correlated with time-weighted average of hypotension (R=0.32;P<0.05) and S100B with all primary outcomes investigated (all P<0.001). The intervention group had lower NSE and higher reduced glutathione when compared to the control group. Conclusions: The use of an EWS coupled with an hemodynamic algorithm resulted in reduced intraoperative hypotension. This finding was coupled with a reduction of biomarkers of brain injury and oxidative stress.Trial Registration number and date: “Correlation Between Circulating Biomarkers of Organ Damage and Intraoperative Hypotension Management”, NCT03527758, registered on May 17, 2018.https://www.clinicaltrials.gov/ct2/show/NCT03527758?term=NCT03527758&draw=2&rank=1

scholarly journals Intraoperative Hemodynamic Optimization Using The Hypotension Prediction Index And Its Impact Of Tissular Perfusion. Protocol For The Predict H Trial

2021 ◽  
Author(s):  
Juan Victor Lorente Olazábal ◽  
Ignacio Jiménez ◽  
Javier Ripollés-Melchor ◽  
Alejandra Isabel Becerra ◽  
Wilbert Wesselink ◽  
...  
Keyword(s):  
Arterial Pressure ◽  
Intervention Group ◽  
Weighted Average ◽  
Arterial Hypotension ◽  
Tissue Oxygen Saturation ◽  
Control Group ◽  
Hemodynamic Parameters ◽  
Hemodynamic Management ◽  
Intraoperative Hypotension ◽  
Multicenter Randomized Controlled Trial

Abstract Background: Intraoperative arterial hypotension is associated with poor postoperative outcomes. The Hypotension Prediction Index, developed from machine learning, predicts the occurrence of arterial hypotension from the analysis of the arterial pressure waveform. The use of this index can reduce the duration and severity of intraoperative hypotension in adults undergoing noncardiac surgery.Methods: We will conduct a multicenter, randomized, controlled trial (N=80) in high-risk surgical patients scheduled for elective major abdominal surgery. All participants will be randomly assigned to a control or intervention group. Hemodynamic management in the control group will be based on standard hemodynamic parameters. Hemodynamic management of patients in the intervention group will be based on functional hemodynamic parameters provided by the HemoSphere platform (Edwards Lifesciences Corp.), including dynamic arterial elastance, dP/dtmax and the Hypotension Prediction Index. Tissue oxygen saturation will be non-invasively and continuously recorded by using near-infrared spectroscopy technology. Biomarkers of acute kidney stress (cTIMP2 and IGFBP7) will be obtained before and after surgery. The primary outcome will be intraoperative time-weighted average of a mean arterial pressure < 65mmHg.Discussion: The aim of the study is to determine whether a goal-directed algorithm based on the prevention of arterial hypotension using the Hypotension Prediction Index reduces the duration and severity of intraoperative hypotension when compared with the recommended standard therapy and if this intraoperative strategy is associated with better tissue oxygenation and organ perfusion. Trial registration: ClinicalTrials.gov, NCT04301102. Registered on March 10, 2020.

scholarly journals Evaluation the effects of pycnogenol (French maritime pine bark extract) supplementation on the inflammatory biomarkers, nutritional and clinical status in traumatic brain injury patients, in Intensive Care Unit; A Randomized Clinical Trial protocol

2019 ◽  
Author(s):  
Mahsa Malekahmadi ◽  
Omid Moradi Moghaddam ◽  
Sheikh Mohammed Shariful Islam ◽  
Kiarash Tanha ◽  
Mohsen Nematy ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Nutritional Status ◽  
Organ Failure ◽  
Intervention Group ◽  
Control Group ◽  
Base Line ◽  
Inflammatory Status ◽  
And Oxidative Stress

Abstract Background: Traumatic brain injury (TBI) is one of the major health and socioeconomic problems in the world. Immune-enhancing enteral formula has been proven to significantly reduce infection rate in TBI patient. One of the ingredients that can be used in immunonutrition formulas to reduce inflammation and oxidative stress is pycnogenol. Objective: surveying the effect of pycnogenol on the clinical, nutritional and inflammatory status of TBI patients. Methods: This is double-blind, randomized controlled trial . Block randomization will be used. Intervention group will receive pycnogenol supplementation of 150 mg for 10 days. Control group will receive placebo for the same duration. Inflammatory status (IL-6, IL- 1β, C-reactive protein) and oxidative stress status (Malondialdehyde, total antioxidant capacity), at the base line, at the 5 th day and at the end of the study (10 th day) will be measured. Clinical and nutritional status will be assessed three times during the intervention. SOFA (sequential organ failure assessment) questionnaire for assessment of organ failure will be filled out every other day. The mortality rate will be calculated within 28 days of the start of the intervention. Weight, body mass index and body composition will be measured. All analyses will be conducted by initially assigned study arm in an intention-to-treat analysis. Discussion: We expect that supplementation of 150 mg pycnogenol for 10 days will improve clinical and nutritional status and reduce the inflammation and oxidative stress of the TBI patients.

scholarly journals Evaluation the effects of Pycnogenol (French maritime pine bark extract) supplementation on the inflammatory biomarkers, nutritional and clinical status in traumatic brain injury patients, in Intensive Care Unit; A Randomized Clinical Trial protocol

2019 ◽  
Author(s):  
Mahsa Malekahmadi ◽  
Omid Moradi Moghaddam ◽  
Mohsen Nematy ◽  
Safieh Firouzi ◽  
Abdolreza Norouzy
Keyword(s):  
Oxidative Stress ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Nutritional Status ◽  
Organ Failure ◽  
Intervention Group ◽  
Control Group ◽  
Base Line ◽  
Inflammatory Status ◽  
And Oxidative Stress

Abstract Background Traumatic brain injury (TBI) is one of the major health and socioeconomic problems in the world. Immune-enhancing enteral formula has been proven to significantly reduce infection rate in TBI patient. One of the ingredients that can be used in immunonutrition formulas to reduce inflammation and oxidative stress is pycnogenol. Objective surveying the effect of pycnogenol on the clinical, nutritional and inflammatory status of TBI patients. Methods This is double-blind, randomized controlled trial. Block randomization are used. Intervention group will receive pycnogenol supplement 150 mg for 10 days. Control group will receive placebo for the same duration. Inflammatory status (IL-6, IL- 1β, C-reactive protein, IL-10) and oxidative stress status (Malondialdehyde, total antioxidant capacity), at the base line, at the 5th day and at the end of the study (10th day) are measured. Clinical and nutritional status will be assessed three times during the intervention. SOFA (sequential organ failure assessment) questionnaire for assessment of organ failure filled out every other day. The mortality rate will be asked within 28 days of the start of the intervention. Weight, body mass index and body composition are measured. All analyses will be conducted by initially assigned study arm in an intention-to-treat analysis. Discussion we will expect supplementation of 150 mg pycnogenol improves clinical and nutritional status of the TBI patients and reduces inflammation and oxidative stress in the 10 days of intervention.

scholarly journals The Use of the Hypotension Prediction Index Integrated in an Algorithm of Goal Directed Hemodynamic Treatment during Moderate and High-Risk Surgery

2021 ◽  
Vol 10 (24) ◽  
pp. 5884
Author(s):  
Marina Tsoumpa ◽  
Aikaterini Kyttari ◽  
Stamo Matiatou ◽  
Maria Tzoufi ◽  
Panayota Griva ◽  
...  
Keyword(s):  
High Risk ◽  
Arterial Pressure ◽  
Intervention Group ◽  
Treatment Protocol ◽  
Group Versus ◽  
Weighted Average ◽  
Standard Of Care ◽  
Noncardiac Surgery ◽  
Control Group ◽  
Intraoperative Hypotension

(1) Background: The Hypotension Prediction Index (HPI) is an algorithm that predicts hypotension, defined as mean arterial pressure (MAP) less than 65 mmHg for at least 1 min, based on arterial waveform features. We tested the hypothesis that the use of this index reduces the duration and severity of hypotension during noncardiac surgery. (2) Methods: We enrolled adults having moderate- or high-risk noncardiac surgery with invasive arterial pressure monitoring. Participating patients were randomized 1:1 to standard of care or hemodynamic management with HPI guidance with a goal directed hemodynamic treatment protocol. The trigger to initiate treatment (with fluids, vasopressors, or inotropes) was a value of HPI of 85 (range, 0–100) or higher in the intervention group. Primary outcome was the amount of hypotension, defined as time-weighted average (TWA) MAP less than 65 mmHg. Secondary outcomes were time spent in hypertension defined as MAP more than 100 mmHg for at least 1 min; medication and fluids administered and postoperative complications. (3) Results: We obtained data from 99 patients. The median (IQR) TWA of hypotension was 0.16 mmHg (IQR, 0.01–0.32 mmHg) in the intervention group versus 0.50 mmHg (IQR, 0.11–0.97 mmHg) in the control group, for a median difference of −0.28 (95% CI, −0.48 to −0.09 mmHg; p = 0.0003). We also observed an increase in hypertension in the intervention group as well as a higher weight-adjusted administration of phenylephrine in the intervention group. (4) Conclusions: In this single-center prospective study of patients undergoing elective noncardiac surgery, the use of this prediction model resulted in less intraoperative hypotension compared with standard care. An increase in the time spent in hypertension in the treatment group was also observed, probably as a result of overtreatment. This should provide an insight for refining the use of this prediction index in future studies to avoid excessive correction of blood pressure.

Whey protein plus lipoic acid supplementation improves inflammatory and antioxidant markers of patients with acute ischemic stroke

2020 ◽  
Vol 50 (6) ◽  
pp. 1053-1062 ◽  
Author(s):  
Yalda Sadeghpour ◽  
Aliakbar Taheraghdam ◽  
Mohammad Khalili ◽  
Mazyar Hashemilar ◽  
Elyar Sadeghi Hokmabadi ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Whey Protein ◽  
Lipoic Acid ◽  
Intervention Group ◽  
Control Group ◽  
Content Type ◽  
Acid Supplementation ◽  
Stress Markers ◽  
Hs Crp ◽  
And Oxidative Stress

Purpose Although the pathogenesis of stroke is not yet completely elucidated, factors such as oxidative stress and inflammation have been shown to play an important role in this regard. The purpose of this paper is to investigate the effects of whey protein plus lipoic acid on the inflammatory and oxidative stress markers and the prognosis in acute ischemic stroke (AIS) patients. Design/methodology/approach A double-blind, randomized controlled clinical trial was conducted among 42 patients with the first episode of AIS at the Imam Reza Hospital of the Tabriz University of Medical Sciences. The blind research staff randomly assigned patients to two groups of receiving usual hospital gavage (control group) and 1,200 mg of lipoic acid plus 20 g of whey protein in addition to usual hospital gavage (intervention group) for midday meal. Levels of albumin, Interleukin-6 (IL-6), tumor necrosis factor (TNF-α), high-sensitivity C-reactive protein (hs-CRP) and clinical outcomes including severity of neurologic damage according to National Institutes of Health Stroke Scale (NIHSS) and functional state based on modified Rankin Scale (mRS) were evaluated initially and three weeks later. Findings There were no significant differences in demographic and baseline characteristics between the two groups (p > 0.05). After three weeks, hs-CRP (p <* 0.01), IL-6 (p = 0.02) and TNF-α (p = 0.01) levels significantly reduced in the intervention group, but no significant changes were observed in cases of albumin, malondialdehyde (MDA) and total antioxidant capacity (TAC) in this group (p > 0.05). Instead, only IL-6 decreased significantly in the control group (p <* 0.01). In addition, comparing changes of assessed variables between two groups showed no significant improvement in the whey protein plus lipoic acid supplementation group vs the control group (p > 0.05). While there was significant betterment in clinical prognosis parameters within groups, no significant changes were found between groups. Originality/value The investigation implied that whey protein plus lipoic acid supplementation has no significant effects on inflammatory and oxidative stress markers compared to the control group of AIS patients. More studies in this field are needed to approve the result.

Evaluation of Salivary Antioxidants and Oxidative Stress Markers in Type 2 Diabetes Mellitus: A Retrospective Cohort Study

2020 ◽  
Vol 20 (4) ◽  
pp. 584-590 ◽  
Author(s):  
Shima Fathi ◽  
Shiva Borzouei ◽  
Mohammad Taghi Goodarzi ◽  
Jalal Poorolajal ◽  
Fatemeh Ahmadi-Motamayel
Keyword(s):  
Oxidative Stress ◽  
Diabetes Mellitus ◽  
Control Group ◽  
Oxidative Stress Markers ◽  
Stress Markers ◽  
Type 2 Dm ◽  
Patients With Diabetes ◽  
The Difference ◽  
And Oxidative Stress

Background: Diabetes Mellitus (DM) is a progressive metabolic disorder. Objective: The aim of this study was to investigate the relationship between antioxidant and oxidative stress markers in the saliva of patients with type 2 DM and a healthy control group. Methods: In this study, 20 patients with diabetes and 20 healthy individuals were evaluated. Salivary antioxidants markers consisted of total antioxidant capacity (TAC), uric acid (UA), peroxidase and catalase. Oxidative stress markers included total oxidant status (TOS), malondealdehyde (MDA) and total thiol (SH). Sialochemical analysis was performed with spectrophotometric assay. All the statistical analyses were conducted using STATA software. Results: TAC decreased significantly in patients with diabetes. Although salivary UA and peroxidase were lower in patients with diabetes compared to the control group, the difference was not significant. Salivary catalase in patients with diabetes was significantly lower than that in the control group. MDA and TOS exhibited significantly higher levels in type 2 DM. SH levels were slightly higher in DM. Conclusions: According to the results of the present study, there were some changes in the salivary levels of some antioxidants and oxidative stress markers in patients with type 2 DM and could be measured as an indicator of serum changes..

scholarly journals NF-κB and FosB mediate inflammation and oxidative stress in the blast lung injury of rats exposed to shock waves

2021 ◽  
Author(s):  
Hong Wang ◽  
Wenjuan Zhang ◽  
Jinren Liu ◽  
Junhong Gao ◽  
Le Fang ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Lung Injury ◽  
Shock Waves ◽  
Time Dependent ◽  
Inflammatory Factors ◽  
Control Group ◽  
Dependent Manner ◽  
Total Antioxidant ◽  
Blast Lung Injury ◽  
And Oxidative Stress

Abstract Blast lung injury (BLI) is the major cause of death in explosion-derived shock waves; however, the mechanisms of BLI are not well understood. To identify the time-dependent manner of BLI, a model of lung injury of rats induced by shock waves was established by a fuel air explosive. The model was evaluated by hematoxylin and eosin staining and pathological score. The inflammation and oxidative stress of lung injury were also investigated. The pathological scores of rats’ lung injury at 2 h, 24 h, 3 days, and 7 days post-blast were 9.75±2.96, 13.00±1.85, 8.50±1.51, and 4.00±1.41, respectively, which were significantly increased compared with those in the control group (1.13±0.64; P&lt;0.05). The respiratory frequency and pause were increased significantly, while minute expiratory volume, inspiratory time, and inspiratory peak flow rate were decreased in a time-dependent manner at 2 and 24 h post-blast compared with those in the control group. In addition, the expressions of inflammatory factors such as interleukin (IL)-6, IL-8, FosB, and NF-κB were increased significantly at 2 h and peaked at 24 h, which gradually decreased after 3 days and returned to normal in 2 weeks. The levels of total antioxidant capacity, total superoxide dismutase, and glutathione peroxidase were significantly decreased 24 h after the shock wave blast. Conversely, the malondialdehyde level reached the peak at 24 h. These results indicated that inflammatory and oxidative stress induced by shock waves changed significantly in a time-dependent manner, which may be the important factors and novel therapeutic targets for the treatment of BLI.

Increased oxidative stress and plasma Hsp70 levels among gasoline filling station attendants

2016 ◽  
Vol 33 (2) ◽  
pp. 171-181 ◽  
Author(s):  
Bing Xia ◽  
Kangcheng Chen ◽  
Yingnan Lv ◽  
Damin Huang ◽  
Jing Liu ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Stress Protein ◽  
Weighted Average ◽  
Exposed Group ◽  
Cumulative Exposure ◽  
Enzyme Linked Immunosorbent Assay ◽  
Control Group ◽  
Gasoline Station ◽  
Filling Station ◽  
Exposed Workers

Objectives: Methylcyclopentadienyl manganese tricarbonyl (MMT) is an organic derivative of manganese (Mn) and is used as an antiknock agent and octane enhancer in gasoline. In this article, we tested the oxidative stress and heat stress protein (Hsp) 70 levels of gasoline station attendants to explore potential plasma biomarkers. Furthermore, the dose–response relationship was also identified. Methods: A total of 144 workers, including 96 petrol fillers and 48 cashiers, participated in the study. Ambient concentrations of benzene, toluene, ethylbenzene, and xylene (BTEX) and Mn were monitored at nine filling stations. During the measuring process, the individual cumulative exposure index was calculated. Plasma oxidative stress and Hsp70 levels were also analysed using enzyme-linked immunosorbent assay. Results: The BTEX time-weighted average in office areas was significantly lower than in refuelling areas ( p < 0.05). In refuelling areas, the content of Mn ranged from 6.44 μg/m3 to 127.34 μg/m3, which was much higher than that in office areas (3.16–7.22 μg/m3; p < 0.05). Exposed workers had significantly different plasma oxidative stress indicators compared with the control group, respectively: superoxide dismutase (SOD), 39.18 ± 6.05 U/mL versus 52.84 ± 3.87 U/mL; glutathione peroxidase (GSH-Px), 186.07 ± 15.63 U versus 194.38 ± 10.42 U; and malondialdehyde (MDA), 1.68 ± 0.52 nmol/L versus 1.43 ± 0.64 nmol/L (in all comparisons, p < 0.05). Plasma Hsp70 level in the exposed group (2.77 ± 0.64 ng/mL) was significantly higher than in the control group (2.32 ± 0.87 ng/mL; p < 0.05). Furthermore, Hsp70 levels were inversely correlated with the activities of SOD ( r = −0.305) and GSH-Px ( r = −0.302) in the exposed group ( p < 0.05). Moreover, a positive correlation ( r = 0.653) was found between plasma Hsp70 levels and plasma MDA levels ( p < 0.05). Conclusion: Exposure to MMT-containing gasoline may result in increasing reactive oxygen stress among filling station attendants. Plasma Hsp70 levels could be used as a sensitive responsive biomarker for exposed workers.

scholarly journals Treatment of thoracolumbar burst fractures: extended follow-up of a randomized clinical trial comparing orthosis versus no orthosis

2017 ◽  
Vol 27 (1) ◽  
pp. 42-47 ◽  
Author(s):  
Jennifer C. Urquhart ◽  
Osama A. Alrehaili ◽  
Charles G. Fisher ◽  
Alyssa Fleming ◽  
Parham Rasoulinejad ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Weighted Average ◽  
Average Treatment Effect ◽  
Secondary Outcome ◽  
Thoracolumbar Burst Fractures ◽  
Treatment Comparison ◽  
Average Treatment ◽  
Burst Fractures ◽  
Time Weighted Average

OBJECTIVEA multicenter, prospective, randomized equivalence trial comparing a thoracolumbosacral orthosis (TLSO) to no orthosis (NO) in the treatment of acute AO Type A3 thoracolumbar burst fractures was recently conducted and demonstrated that the two treatments following an otherwise similar management protocol are equivalent at 3 months postinjury. The purpose of the present study was to determine whether there was a difference in long-term clinical and radiographic outcomes between the patients treated with and those treated without a TLSO. Here, the authors present the 5- to 10-year outcomes (mean follow-up 7.9 ± 1.1 years) of the patients at a single site from the original multicenter trial.METHODSBetween July 2002 and January 2009, a total of 96 subjects were enrolled in the primary trial and randomized to two groups: TLSO or NO. Subjects were enrolled if they had an AO Type A3 burst fracture between T-10 and L-3 within the previous 72 hours, kyphotic deformity < 35°, no neurological deficit, and an age of 16–60 years old. The present study represents a subset of those patients: 16 in the TLSO group and 20 in the NO group. The primary outcome measure was the Roland Morris Disability Questionnaire (RMDQ) score at the last 5- to 10-year follow-up. Secondary outcome measures included kyphosis, satisfaction, the Numeric Rating Scale for back pain, and the 12-Item Short-Form Health Survey (SF-12) Mental and Physical Component Summary (MCS and PCS) scores. In the original study, outcome measures were administered at admission and 2 and 6 weeks, 3 and 6 months, and 1 and 2 years after injury; in the present extended follow-up study, the outcome measures were administered 5–10 years postinjury. Treatment comparison between patients in the TLSO group and those in the NO group was performed at the latest available follow-up, and the time-weighted average treatment effect was determined using a mixed-effects model of longitudinal regression for repeated measures averaged over all time periods. Missing data were assumed to be missing at random and were replaced with a set of plausible values derived using a multiple imputation procedure.RESULTSThe RMDQ score at 5–10 years postinjury was 3.6 ± 0.9 (mean ± SE) for the TLSO group and 4.8 ± 1.5 for the NO group (p = 0.486, 95% CI −2.3 to 4.8). Average kyphosis was 18.3° ± 2.2° for the TLSO group and 18.6° ± 3.8° for the NO group (p = 0.934, 95% CI −7.8 to 8.5). No differences were found between the NO and TLSO groups with time-weighted average treatment effects for RMDQ 1.9 (95% CI −1.5 to 5.2), for PCS −2.5 (95% CI −7.9 to 3.0), for MCS −1.2 (95% CI −6.7 to 4.2) and for average pain 0.9 (95% CI −0.5 to 2.2).CONCLUSIONSCompared with patients treated with a TLSO, patients treated using early mobilization without orthosis maintain similar pain relief and improvement in function for 5–10 years.

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