ArticleLiterature Review

Evaluating the Correlation and Responsiveness of Patient-Reported Pain With Function and Quality-of-Life Outcomes After Spine Surgery

September 2011
Spine 36(21 Suppl):S69-74

September 2011
36(21 Suppl):S69-74

DOI:10.1097/BRS.0b013e31822ef6de

Source
PubMed

Authors:

John G Devine

Medical College of Georgia at Augusta University

Daniel C Norvell

Spectrum Research, Inc.

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Systematic review. To determine the correlation of patient-reported pain with physical function and health-related quality of life (HRQoL) after spine surgery and to determine the responsiveness of pain, physical function, and HRQoL after spine surgery. Several validated outcome instruments are available to assess the success of treatment for chronic low back pain. These patient-centered tools include measurements for pain based on numeric scales, validated condition-specific functional outcomes measures, and HRQoL outcomes measures. It is unclear whether these three types of patient-reported outcomes are measuring different constructs and whether all three should be measured after spine surgery. In addition, it is unclear which of these outcomes measures is most sensitive to change after spine surgery for low back pain. A systematic search was conducted in MEDLINE, EMBASE, and the Cochrane Collaboration Library for literature published through December 2010. The correlation between pain (visual analog scale, VAS), physical function (Oswestry Disability Index, ODI), and HRQoL (36-Item Short Form Health Survey [SF-36] and European Quality of Life [EQ-5D]) change scores was performed using the Spearman rank correlation coefficients. To compare the responsiveness of pain, function, and HRQoL scores after spine surgery, we calculated effect sizes by dividing change scores by the SD of the baseline scores. This standardized method allowed us to compare the responsiveness of each outcome measure directly and reported an effect size of 0.2 to 0.3 as a "small" effect, around 0.5 a "medium" effect and 0.8 to infinity, a "large" effect. To determine whether the differences in effect sizes measuring responsiveness were significantly different, we conducted a Wilcoxon signed-rank test between each of the three measurements of pain, function, and HRQoL scores when there was enough data to perform the test. None of the correlations exceeded 0.70 using the Spearman rank correlation coefficients, suggesting that these outcomes are measuring different constructs. The strongest correlations were between the VAS back pain change scores and the SF-36 physical composite score change scores (ρ = 0.67) and VAS back pain change scores and ODI change scores (ρ = 0.69). The pooled mean effect sizes for the five studies that reported a pain measure and the ODI were 1.4 ± 0.57 and 1.1 ± 0.39, respectively. Both are considered "large" effect sizes. The pooled mean effect sizes for the three studies reporting the SF-36 physical and mental composite scores were 0.66 ± 0.39 and 0.54 ± 0.36, respectively. Both are considered "medium" effect sizes. The pooled mean effect sizes for the single studies reporting the EQ-5D and SF-36 total score were 0.78 ± 0.12 and 0.34 ± 0.21. These were "medium" and "small," respectively. We observed little correlation between the change in pain and the change in HRQoL outcomes measures. The strongest correlation was between VAS pain and ODI but was still not considered strong (0.69). These findings suggest that these three outcomes (pain, function, and HRQoL) are measuring different constructs. With respect to responsiveness, VAS pain and ODI were the only outcomes measures that demonstrated a large effect after lumbar spine surgery. None of the HRQoL tools were as sensitive to the treatment. The EQ-5D, SF physical composite, and SF mental composite outcomes demonstrated a medium effect, while the SF-36 total score demonstrated a small effect. The responsive measure shows that the more specific the outcomes tool, the more sensitive the response. Recommendation 1: When surgically treating CLBP, we recommend administering both a VAS for pain and a condition-specific physical measure such as the ODI before and after surgical intervention as these outcomes are the most treatment specific and responsive to change. Strength of recommendation: Strong.Recommendation 2: When evaluating the surgical outcomes for CLBP in the clinical-research setting, we recommend selecting a shorter version for measuring general HRQoL (e.g., SF-12, EQ-5D) to minimize clinician and patient burden. Strength of recommendation: Strong.

Correlation of Short Form 36 Health Survey with Other Relevant Clinical Scores in Patients with Degenerative Lumbar Spinal Stenosis

Article

May 2023

Study Design: Observational study. Objectives: To investigate the correlation of Short Form Health Survey (SF-36) score with various relevant clinical scoring systems, in patients with degenerative lumbar spinal stenosis (LSS). Materials and Methods: Eighty-two patients aged more than 40 years with clinicoradiological features suggestive of degenerative LSS were enrolled. All patients completed 10 clinical scoring questionnaires, which included SF-36, Oswestry Disability Index, Swiss Spinal Stenosis(SSS) Questionnaire, Quebec Pain Disability, Visual Analog Scale (VAS) (back pain), Modified Japanese Orthopaedic Association (mJOA), Pain Disability Index (PDI), Self‑paced Walking Test (SPWT), VAS (leg pain), and Neurogenic Claudication Outcome Score. A comparison of 8 health concepts of SF-36 and health change was done with other 9 clinical scores and they were statistically analyzed and correlated. Results: The mean age was 53.02 years and included 51 females (62.2%) and 31 (37.8%) males. Out of 8 health concepts, 3 of them, pain, emotional well-being, and energy/fatigue, showed a statistically significant moderate correlation with 6 clinical scores (SSS, QPD, VAS back pain, mJOA, PDI, and SPWT) (P < 0.05, r > 0.3). The mJOA scale showed a moderate negative correlation with 4 other components also namely, role limitations due to physical health, role limitations due to emotional problems, social functioning, physical functioning as well as health change (P < 0.05, r > 0.3). Role limitations due to physical health had a moderate negative correlation with QPD scale also (P < 0.05, r > 0.3). Conclusions: Pain, emotional well-being, and energy/fatigue showed a moderate correlation with maximum number of scores and mJOA scale had a moderate negative correlation with 7 out of 8 components of SF-36 as well as Health change

Construct validity and responsiveness of commonly used patient reported outcome instruments in decompression for lumbar spinal stenosis

Article

Jan 2021

Background Validity and responsiveness of Oswestry disability index (ODI), Roland Morris disability questionnaires (RMDQ), Short Form-12 Physical Component Score (SF-12 PCS) and Short Form-12 Mental Component Score (SF-12 MCS) in patients undergoing open decompression for lumbar canal stenosis has not been previously reported. Methods Outcome assessment was prospectively evaluated using the ODI, RMDQ, SF-12 PCS and SF-12 MCS pre-intervention and at average follow-up of three months post-intervention. Pearson correlation coefficient was used to evaluate the association between change in values of ODI, RMDQ, SF-12 PCS and SF-12 MCS. Distribution based methods (Effect size [ES], standardised response mean [SRM]) and anchor based method (Area under the curve [AUC] of receiver operating curve [ROC]) were used to determine responsiveness. AUC value ≥ 0.70 is considered as adequate level of responsiveness and the outcome instrument with the largest AUC is considered to be the most responsive outcome instrument. Results This study included 77 participants. Responsiveness was assessed at a mean follow-up of 12 weeks postoperatively. There was significant strong correlation between ODI and RMDQ (r = 0.65, p < 0.0001). The ES of ODI, RMDQ, SF-12 PCS and SF-12 MCS were 1.54, 1.48, 1.85 and 0.51 respectively. The SRM of RMDQ, ODI, SF-12 PCS and SF-12 MCS were 1.22, 1.17, 1.0 and 0.47 respectively. AUC of ODI, RMDQ, SF-12 PCS and SF-12 MCS were 0.83–0.88, 0.82 to 0.86, 0.78 to 0.81 and 0.69 to 0.70 respectively. Conclusion It is recommended to use either ODI or RMDQ as region specific patient reported outcome instrument and SF-12 PCS as a health related quality of life outcome instrument to evaluate outcome after decompressive laminectomy for lumbar canal stenosis.

Article

Feb 2024

Objective: To determine the association between health-related quality of life (HRQOL) and neck pain, kinesiophobia, and modalities of physical activity in individuals with postoperative degenerative cervical myelopathy and radiculopathy (DCM/R) because postoperative pain after cervical spine surgery is likely to persist, causing kinesiophobia and avoidance of physical activity.Methods: A questionnaire was distributed to 280 individuals with DCM/R. The questionnaire comprised the following four items: HRQOL (EuroQol 5-dimensions 5-level), neck pain (numerical rating scale [NRS]), kinesiophobia (11-item Tampa Scale for Kinesiophobia [TSK-11]), and physical activity (paid work, light exercise, walking, strength training, and gardening). Hierarchical multiple regression analysis was performed using the NRS, TSK-11, and physical activity as independent variables.Results: In total, 126 individuals provided analyzable responses (45.0%). After including the NRS score as an independent variable to the multiple regression equation for participants’ background, the independent rate of the regression equation significantly improved by only 4.1% (R<sup>2</sup>=0.153). The addition of the TSK-11 score significantly improved this effect by 11.1% (R2=0.264). Finally, the addition of physical activity also significantly improved the explanatory rate by 9.9% (R2=0.363).Conclusion: Neck pain, kinesiophobia, and physical activity (specifically paid work and walking) were independently associated with HRQOL in individuals with postoperative DCM/R.

Prevalence of Chronic Pain After Spinal Surgery: A Systematic Review and Meta-Analysis

Article

Full-text available

Jul 2023

Degenerative disc disease and low back pain are common challenges that persist even after a discectomy. However, characterizations and quantifications of these illnesses from the patients' perspective are insufficient. We aimed to perform a systematic review of the literature and meta-analysis to determine the frequency of chronic pain after spinal surgery. We searched MEDLINE (PubMed), Google Scholar, and the Saudi Digital Library to retrieve research articles describing the frequency of persistent back pain, reoccurring disc herniation, and undergoing another operation following primary lumbar discectomy. We excluded articles that did not disclose the proportion of patients who experienced ongoing back or leg pain for over six months after the operation. We included 16 studies evaluating 85,643 patients. The pooled prevalence of persistent pain was 14.97% (95% confidence interval: 12.38-17.76). With all advancements in technology and operation techniques, many patients (14.97%) still have failed back surgery syndrome. Appropriate preoperative communication and multidisciplinary and coordinated treatment strategies yielded the best results.

Defining the minimal clinically important difference in smartphone-based mobility after spine surgery: correlation of survey questionnaire to mobility data

Article

May 2023
J NEUROSURG-SPINE

Objective: Patient-reported outcome measures (PROMs) are the gold standard for assessing postoperative outcomes in spine surgery. However, PROMs are also limited by the inherent subjectivity of self-reported qualitative data. Recent literature has highlighted the utility of patient mobility data streamed from smartphone accelerometers as an objective measure of functional outcomes and complement to traditional PROMs. Still, for activity-based data to supplement existing PROMs, they must be validated against current metrics. In this study, the authors assessed the relationships and concordance between longitudinal smartphone-based mobility data and PROMs. Methods: Patients receiving laminectomy (n = 21) or fusion (n = 10) between 2017 and 2022 were retrospectively included. Activity data (steps-per-day count) recorded in the Apple Health mobile application over a 2-year perioperative window were extracted and subsequently normalized to allow for intersubject comparison. PROMS, including the visual analog scale (VAS), Patient Reported Outcome Measurement Information System Pain Interference (PROMIS-PI), Oswestry Disability Index (ODI), and EQ-5D, collected at the preoperative and 6-week postoperative visits were retrospectively extracted from the electronic medical record. Correlations between PROMs and patient mobility were assessed and compared between patients who did and those who did not achieve the established minimal clinically important difference (MCID) for each measure. Results: A total of 31 patients receiving laminectomy (n = 21) or fusion (n = 10) were included. Change between preoperative and 6-week postoperative VAS and PROMIS-PI scores demonstrated moderate (r = -0.46) and strong (r = -0.74) inverse correlations, respectively, with changes in normalized steps-per-day count. In cohorts of patients who achieved PROMIS-PI MCID postoperatively, indicating subjective improvement in pain, there was a 0.784 standard deviation increase in normalized steps per day, representing a 56.5% improvement (p = 0.027). Patients who did achieve the MCID of improvement in either PROMIS-PI or VAS after surgery were more likely to experience an earlier sustained improvement in physical activity commensurate to or greater than their preoperative baseline (p = 2.98 × 10-18) than non-MCID patients. Conclusions: This study demonstrates a strong correlation between changes in mobility data extracted from patient smartphones and changes in PROMs following spine surgery. Further elucidating this relationship will allow for more robust supplementation of existing spine outcome measure tools with analyzed objective activity data.

The Prevalence of Back Pain in Patients Operated on Due to Colorectal Cancer Depending on the Type of Surgical Procedure Performed

Article

Full-text available

Apr 2023

Purpose: Low back pain presents a serious challenge for numerous medical specialties. The purpose of this study was to assess disability due to low back pain in patients operated on due to colorectal cancer depending on the type of surgery performed. Methods: This prospective observational study was carried out in the period of July 2019 through March 2020. Included in the study were patients with colorectal cancer for scheduled surgeries including anterior resection of rectum (AR), laparoscopic anterior resection of rectum (LAR), Hartmann's procedure (HART), or abdominoperineal resection of rectum (APR). The Oswestry Low Back Pain Disability Questionnaire was used as the research tool. The study patients were surveyed at three time points: before surgery, six months after surgery, and one year after surgery. Results: The analysis of study results revealed that an increase in the degree of disability and functioning impairment occurred in all groups between time points I and II, with the differences being statistically significant (p < 0.05). The inter-group comparative analysis of the total Oswestry questionnaire scores revealed statistically significant differences, with the impairment of function being most severe within the APR group and least severe within the LAR group. Conclusion: The study results showed that low back pain contributes to impaired functioning of patients operated on due to colorectal cancer regardless of the type of procedure performed. A reduction in the degree of disability due to low back pain was observed one year after the procedure in patients having undergone LAR.

The change of Roussouly classification after posterior lumbar fusion surgery

Article

Full-text available

Mar 2023

Background: Roussouly classification is an important morphologic classification which can help to determine high local stress zones of the spine. Different lumbar morphologies of Roussouly type suggest different biomechanics leading to degenerative evolution. This study aimed both to describe the change of the Roussouly classification of the human spine after posterior lumbar fusion surgery and to explore the influencing factors of postoperative Roussouly type. Methods: The study is a retrospective case-control study on preoperative and postoperative Roussouly types. A total of 167 patients with lumbar degenerative disease who had undergone short-level transforaminal lumbar interbody fusion surgery between January 2014 and December 2017 in the Department of Orthopedic Surgery, First Affiliated Hospital, Air Force Medical University, were recruited. Preoperative and postoperative general data including gender, age, follow-up time, Oswestry disability index (ODI) score, visual analogue scale (VAS) score, diagnosis, and surgical segment were recorded. Clinical parameters including pelvic incidence (PI), pelvic tilt (PT), sacral slope (SS), lumbar lordosis (LL), thoracic kyphosis (TK), and sagittal vertical axis (SVA) were measured using Surgimap software, and the Roussouly classification was assessed. Results: This study included 86 male patients and 81 female patients with a mean age of 52.0±12.4 [14-88] years. The mean follow-up time for these patients was 11.5±6.9 months. The value of sagittal alignment parameters changed after the posterior lumbar fusion surgery, except for the PI value (P=0.591). Roussouly classification changed after surgery. The preoperative Roussouly values of preoperative PI, SS, and LL were significantly different in patients of 4 postoperative Roussouly types. Conclusions: The Roussouly classification changes after posterior lumbar fusion surgery. This change is independent of gender, age, follow-up time, and the number of surgical segments. The preoperative Roussouly type and PI value are essential in predicting one's postoperative Roussouly type.

The prevalence of back pain in patients operated on due to colorectal cancer depending on the type of surgical procedure performed

Preprint

Full-text available

Jan 2023

Purpose Low back pain presents a serious challenge for numerous medical specialties. The purpose of this study was to assess disability due to low back pain in patients operated on due to colorectal cancer depending on the type of surgery performed. Methods This prospective observational study was carried out in the period of July 2019 through March 2020. Included in the study were patients with colorectal cancer for scheduled surgeries including anterior resection of rectum (AR), laparoscopic anterior resection of rectum (LAR), Hartmann’s procedure (HART), or abdominoperineal resection of rectum (APR). The Oswestry Low Back Pain Disability Questionnaire was used as the research tool. The study patients were surveyed at three time points: before surgery, six months after surgery, and one year after surgery. Results The analysis of study results revealed that an increase in the degree of disability and functioning impairment occurred in all groups between time points I and II, with the differences being statistically significant (p<0.05). The inter-group comparative analysis of the total Oswestry questionnaire scores revealed statistically significant differences, with the impairment of function being most severe within the APR group and least severe within the LAR group. Conclusion The study results show that low back pain contributes to impaired functioning of patients operated on due to colorectal cancer regardless of the type of procedure performed. A reduction in the degree of disability due to low back pain was observed one year after the procedure in patients having undergone LAR.

Comparing the effects of Bupivacaine and Ropivacaine Instillation for Postoperative Analgesia in Patients Undergoing Lumbar Spine Surgery: A Prospective Randomised Double Blind Study

Article

May 2018

The concept of recovery kinetics: an observational study of continuous post-operative monitoring in spine surgery

Article

Full-text available

Jun 2022

Background: The spine surgeon's understanding of an individual patient's burden of disease and functional disability in daily life is shaped by patient-reported outcome measures (PROMs). Although PROMs are useful in understanding the patient's perception of their disease, the use of PROMs constitutes a "snapshot" approach of single timepoint data capture, omitting day-to-day fluctuations in functional status. We introduce the concept of kinetics when considering continuous and objective postoperative patient monitoring with wearable sensors. Methods: A prospective single-centre series was performed using patients either undergoing lumbar decompression for lumbar spinal stenosis (LSS) (n=12), or posterior lumbar fusion for degenerative spondylolisthesis (n=12). The Oswestry Disability Index (PROM) was conducted preoperatively and 12-weeks postoperatively. During this timeframe, continuous measurements of step count and distance travelled were made using a wrist-based wearable accelerometer. Results: Over the 12-week study period, mean daily step count for all participants improved from 4,700 to 7,700 steps per day (P=0.013), following an initial dip in total steps taken. The mean daily distance travelled improved from 3,300 to 5,300 meters per day (P=0.003). Decompression group recovered at a faster rate than the fusion group. Conclusions: Although overall improvement was similar between the decompression and fusion groups, the recovery kinetics varied. The recovery kinetics approach of continuous postoperative monitoring provides additional insight to postoperative patient progress.

The association between different outcome measures and prognostic factors in patients with neck pain: a cohort study

Article

Full-text available

Jul 2022
BMC MUSCULOSKEL DIS

Background Health domains like pain, disability, and health-related quality of life are commonly used outcomes for musculoskeletal disorders. Most prognostic studies include only one outcome, and it is unknown if prognostic factors and models may be generic across different outcomes. The objectives of this study were to examine the correlation among commonly used outcomes for neck pain (pain intensity, disability, and health-related quality of life) and to explore how the predictive performance of a prognostic model differs across commonly used outcomes. Methods We conducted an observational prospective cohort study with data from patients with neck pain aged 18–84 years consulting Norwegian chiropractors. We used three different outcomes: pain intensity (Numeric Pain Rating Scale), the Neck Disability Index (NDI), and health-related quality of Life (EQ-5D). We assessed associations between change in outcome scores at 12-weeks follow-up with Pearson’s correlation coefficient. We used multivariable linear regression models to explore differences in explained variance and relationship between predictors and outcomes. Results The study sample included 1313 patients and 941 (72%) completed follow-up at 12 weeks. The strongest correlation was between NDI and EQ-5D (r = 0.57) while the weakest correlation was between EQ-5D and pain intensity (r = 0.39). The correlation between NDI and pain intensity was moderate (r = 0.53) In the final regression models, the explained variance ranged from adjusted R ² of 0.26 to 0.60, highest with NDI and lowest with pain intensity as outcome. The predictive contributions of the included predictors were similar across outcomes. Among the investigated predictors, pain patterns and the baseline measure of the corresponding outcome measure contributed the most to explained variance across all outcomes. Conclusions The highest correlation was found between NDI and EQ-5D and the lowest with pain intensity. The same prognostic model showed highest predictive performance with NDI as outcome and poorest with pain intensity as outcome. These results suggest that we need more knowledge on the reasons for the differences in predictive performance variation across outcomes.

Impact of Body Mass Index on Postsurgical Outcomes for Workers’ Compensation Patients Undergoing Minimally Invasive Transforaminal Lumbar Interbody Fusion

Article

Jun 2022

Background: Increased morbidity associated with obesity imposes a greater financial burden on companies that provide insurance to their employees. Few studies have investigated the relationship between body mass index (BMI) and patient-reported outcome measures (PROMs) for minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) in the workers' compensation (WC) population. Methods: WC patients who underwent a primary, single-level MIS TLIF were included/grouped according to BMI: nonobese (<30 kg/m2); obese I (≥30, <35 kg/m2); severe + morbid (≥35). PROMs were collected pre- and postoperatively: visual analog scale (VAS), Oswestry Disability Index (ODI), 12-Item Short Form (SF-12) physical composite score (PCS), and Patient-Reported Outcome Measurement Information System physical function (PROMIS-PF). BMI predictive power grouping on PROMs was evaluated using simple linear regression. Established minimum clinically important difference values were used to compute achievement rates across PROMs using logistic regression. Results: A total of 116 nonobese, 70 obese I, and 61 severe + morbid patients were included. Demographics among BMI grouping significantly differed in gender, hypertensive status, and American Society of Anesthesiologists score (P ≤ 0.037, all). Operative time was significantly different in perioperative values among BMI grouping (P ≤ 0.001). Increased BMI was significantly associated with greater VAS back at 12 weeks and 2 years (P ≤ 0.026, all), greater ODI preoperatively at 12 weeks and 6 months (P ≤ 0.015, all), and decreased PROMIS-PF at 12 weeks (P ≤ 0.011, all). Mean PROMs between obese I and severe + morbid cohorts differed in SF-12 PCS at 12 weeks, only (P = 0.050). ODI overall was the only parameter for which minimum clinically important difference was achieved among BMI cohorts (P ≤ 0.023). Conclusion: WC patients with increased BMI were more likely to develop significant back pain and disability at numerous postoperative timepoints compared with nonobese individuals. Our findings highlight the weight management importance within WC population to minimize back pain and disability following MIS TLIF, but provide a sense of reassurance with comparable clinical improvement regardless of BMI. Clinical relevance: When considering the effect of weight, surgeons may incorporate these findings in managing patient expectations in the WC population undergoing lumbar spine surgery. Level of evidence: 3:

Impact of Depression, Resilience, and Locus of Control on Adjustment of Health-Related Expectations in Aging Individuals With Chronic Illness

Article

Full-text available

Apr 2022

Objectives Quality of Life (QoL) depends on the discrepancy between desired and current experiences (referred to as the Calman gap), thus in chronic illness, adjustment of expectations and interpretation of the current situation are crucial. Depression is known to influence this gap, and the present study aims to further assess the role of resilience and health locus of control (HLC). Methods A total of 94 patients (age M = 71.8, SD = 7.7 years) with neurological disorders were screened via telephone regarding depression, resilience and HLC. Current and desired state of several life domains were assessed, such as Fitness, General Health, Pain, Daily Activities, Finances, Leisure, and Family. Elastic net regularization and analyses of variance were used to disentangle the impact of depression, resilience, HLC, and sociodemographic factors on the perception of current and desired state, and the gap between both. Results A gap was present for all domains but largest for pain. Interpretation of the current state was linked to desired state, HLC, and age. All gaps were related to depression; certain domains were in addition influenced by resilience, HLC and sociodemographic factors. Of note, for most domains, patients did not select the highest possible desired state. Conclusion Older patients with neurological disorders report a gap between current and desired state for many aspects of life. Adjusting expectations is beneficial in the face of declining health, but a reasonably increased desired state may positively influence the perception of the current situation. Depression negatively influences the interpretation of the Calman gap.

Wound Infiltration and Instillation Technique for Postoperative Analgesia Using Bupivacaine in Patients Undergoing Lumbar Spine Surgeries

Article

Full-text available

Mar 2022

Background: Pain relief after surgery continues to be a major medical challenge in clinical practice. Lumbar spine surgery is associated with significant postoperative pain. Providing optimal analgesia locally in the area of surgical wound, with little systemic side-effects, is a favourable option and has become an intrinsic part of multimodal analgesia. We aimed to assess and compare the effectiveness of local infiltration and instillation of bupivacaine for postoperative analgesia in patients undergoing lumbar spine surgery. Materials and methods: Forty-four adult patients of the American Society of Anesthesiologists (ASA) class I and II were randomly assigned into two groups, incorporating 22 patients per group. After the completion of lumbar spine surgery and after hemostasis was achieved, patients in group A received instillation of 20 ml of 0.25% bupivacaine at the surgical wound site and patients in group B received 20 ml of 0.25% bupivacaine infiltration into the paravertebral muscles on either side. Postoperative numerical rating scale (NRS) pain scores at 1, 2, 3, 4, 5, 6, 7, 8, 14, 20, and 24 hours; the time to first analgesic required, total rescue analgesic consumption, and adverse effects were recorded. Statistical analysis was done using IBM SPSS Statistics for Windows, Version 20.0 (Released 2011; IBM Corp, Armonk, New York, United States). Results: Time to the first analgesic requirement was significantly longer in group A (12.39±1.56 hours) compared to the B group (2.48±0.58 hours) (P < 0.001). The amount of rescue analgesia (diclofenac sodium) required was significantly higher in group B (135.00±46.17 milligrams) compared to A (93.75±33.32 milligrams) (P = 0.001). The number of analgesic demands was higher in the infiltration group compared to the instillation group and was observed to be statistically significant. Hemodynamic parameters remained comparable between the groups. Conclusion: Local instillation of surgical wound site provided better pain control than infiltration technique and is effective and safe postoperative analgesia in patients undergoing laminectomy surgeries.

Full endoscopic versus open discectomy for sciatica: Randomised controlled non-inferiority trial

Article

Full-text available

Feb 2022
Br Med J Int Ed

Objective To assess whether percutaneous transforaminal endoscopic discectomy (PTED) is non-inferior to conventional open microdiscectomy in reduction of leg pain caused by lumbar disc herniation. Design Multicentre randomised controlled trial with non-inferiority design. Setting Four hospitals in the Netherlands. Participants 613 patients aged 18-70 years with at least six weeks of radiating leg pain caused by lumbar disc herniation. The trial included a predetermined set of 125 patients receiving PTED who were the learning curve cases performed by surgeons who did not do PTED before the trial. Interventions PTED (n=179) compared with open microdiscectomy (n=309). Main outcome measures The primary outcome was self-reported leg pain measured by a 0-100 visual analogue scale at 12 months, assuming a non-inferiority margin of 5.0. Secondary outcomes included complications, reoperations, self-reported functional status as measured with the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery. Outcomes were measured until one year after surgery and were longitudinally analysed according to the intention-to-treat principle. Patients belonging to the PTED learning curve were omitted from the primary analyses. Results At 12 months, patients who were randomised to PTED had a statistically significantly lower visual analogue scale score for leg pain (median 7.0, interquartile range 1.0-30.0) compared with patients randomised to open microdiscectomy (16.0, 2.0-53.5) (between group difference of 7.1, 95% confidence interval 2.8 to 11.3). Blood loss was less, length of hospital admission was shorter, and timing of postoperative mobilisation was earlier in the PTED group than in the open microdiscectomy group. Secondary patient reported outcomes such as the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery, were similarly in favour of PTED. Within one year, nine (5%) in the PTED group compared with 14 (6%) in the open microdiscectomy group had repeated surgery. Per protocol analysis and sensitivity analyses including the patients of the learning curve resulted in similar outcomes to the primary analysis. Conclusions PTED was non-inferior to open microdiscectomy in reduction of leg pain. PTED resulted in more favourable results for self-reported leg pain, back pain, functional status, quality of life, and recovery. These differences, however, were small and may not reach clinical relevance. PTED can be considered as an effective alternative to open microdiscectomy in treating sciatica. Trial registration NCT02602093ClinicalTrials.gov NCT02602093 .

Physiotherapy and combined cognitive-behavioural therapy for patients with chronic pelvic pain syndrome: results of a non-randomised controlled feasibility trial

Article

Full-text available

Dec 2021

Objective To explore feasibility in terms of delivering and evaluating a combination of physiotherapy and psychotherapy for patients with chronic pelvic pain syndrome (CPPS). Design Prospective non-randomised controlled pilot study. Setting Tertiary care facility with a specialised interdisciplinary outpatient clinic for patients with CPPS. Participants A total of 311 patients was approached; 60 participated. 36 patients were included in the intervention group (mean age ±SD 48.6 years±14.8; 52.8% female) and 24 in the control group (mean age ±SD 50.6 years±14.5; 58.3% female). Fourteen participants were lost to follow-up. Interventions Participants were non-randomly allocated to the intervention group with two consecutive treatment modules (physiotherapy and cognitive behavioural therapy) with a duration of 9 weeks each or to the control group (treatment as usual). Main outcome measures Feasibility was operationalised in terms of delivering and evaluating the therapeutic combination. Regarding eligibility as the first aspect of feasibility, willingness to participate, dropout and satisfaction were assessed; for the second aspect, standardised self-report questionnaires measuring health-related quality of life, depression severity and pain were applied. Results Although eligibility and willingness-to-participate rates were low, satisfaction of the participants in the intervention group was high and dropout rates were low. Results indicated a small and non-significant intervention effect in health-related quality of life and significant effects regarding depression severity and pain. Conclusions The combination of physiotherapy and psychotherapy for patients with CPPS seems to be feasible and potentially promising with regard to effect. However, a subsequent fully powered randomised controlled trial is needed. Trial registration number German Clinical Trials Register (DRKS00009976) and ISRCTN ( ISRCTN43221600 ).

Coccygectomy for refractory coccygodynia: a systematic review and meta-analysis

Article

Full-text available

Jan 2022
EUR SPINE J

Purpose We sought to systematically assess and summarize the available literature on outcomes following coccygectomy for refractory coccygodynia. Methods PubMed, Scopus, and Cochrane Library databases were systematically searched in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data concerning patient demographics, validated patient reported outcome measures (PROMs) for pain relief, disability outcomes, complications, and reoperation rates were extracted and analyzed. Results A total of 21 studies (18 retrospective and 3 prospective) were included in the quantitative analysis. A total of 826 patients (females = 75%) received coccygectomy (720 total and 106 partial) for refractory coccygodynia. Trauma was reported as the most common etiology of coccygodynia (56%; n = 375), followed by idiopathic causes (33%; n = 221). The pooled mean difference (MD) in pain scores from baseline on a 0–10 scale was 5.03 (95% confidence interval [CI]: 4.35 to 6.86) at a 6–12 month follow-up (FU); 5.02 (95% CI: 3.47 to 6.57) at > 12–36 months FU; and 5.41 (95% CI: 4.33 to 6.48) at > 36 months FU. The MCID threshold for pain relief was surpassed at each follow-up. Oswestry Disability Index scores significantly improved postoperatively, with a pooled MD from baseline of − 23.49 (95% CI: − 31.51 to − 15.46), surpassing the MCID threshold. The pooled incidence of complications following coccygectomy was 8% (95% CI: 5% to 12%), the most frequent of which were surgical site infections and wound dehiscence. The pooled incidence of reoperations was 3% (95% CI: 1% to 5%). Conclusion Coccygectomy represents a viable treatment option in patients with refractory coccygodynia.

Smartphone GPS signatures of patients undergoing spine surgery correlate with mobility and current gold standard outcome measures

Article

Full-text available

Aug 2021
J NEUROSURG-SPINE

Objective: Patient-reported outcome measures (PROMs) are currently the gold standard to evaluate patient physical performance and ability to recover after spine surgery. However, PROMs have significant limitations due to the qualitative and subjective nature of the information reported as well as the impossibility of using this method in a continuous manner. The smartphone global positioning system (GPS) can be used to provide continuous, quantitative, and objective information on patient mobility. The aim of this study was to use daily mobility features derived from the smartphone GPS to characterize the perioperative period of patients undergoing spine surgery and to compare these objective measurements to PROMs, the current gold standard. Methods: Eight daily mobility features were derived from smartphone GPS data in a population of 39 patients undergoing spine surgery for a period of 2 months starting 3weeks before surgery. In parallel, three different PROMs for pain (visual analog scale [VAS]), disability (Oswestry Disability Index [ODI]) and functional status (Patient-Reported Outcomes Measurement Information System [PROMIS]) were serially measured. Segmented linear regression analysis was used to assess trends before and after surgery. The Student paired t-test was used to compare pre- and postoperative PROM scores. Pearson's correlation was calculated between the daily average of each GPS-based mobility feature and the daily average of each PROM score during the recovery period. Results: Smartphone GPS features provided data documenting a reduction in mobility during the immediate postoperative period, followed by a progressive and steady increase with a return to baseline mobility values 1 month after surgery. PROMs measuring pain, physical performance, and disability were significantly different 1 month after surgery compared to the 2 immediate preoperative weeks. The GPS-based features presented moderate to strong linear correlation with pain VAS and PROMIS physical score during the recovery period (Pearson r > 0.7), whereas the ODI and PROMIS mental scores presented a weak correlation (Pearson r approximately 0.4). Conclusions: Smartphone-derived GPS features were shown to accurately characterize perioperative mobility trends in patients undergoing surgery for spine-related diseases. Features related to time (rather than distance) were better at describing patient physical and performance status. Smartphone GPS has the potential to be used for the development of accurate, noninvasive and personalized tools for patient mobility monitoring after surgery.

Calculating Utilities From the Spine Oncology Study Group Outcomes Questionnaire: A Necessity for Economic and Decision Analysis

Article

Full-text available

Jul 2021

Study design: General population utility valuation study. Objective: To develop a technique for calculating utilities from the Spine Oncology Study Group Outcomes Questionnaire v2.0 (SOSGOQ2.0). Summary of background data: The ability to calculate quality-adjusted life-years (QALYs) for metastatic spine disease would enhance treatment decision making and facilitate economic analysis. QALYs are calculated using utilities. Methods: Using a hybrid concept-retention and factorial analysis shortening approach, we first shortened the SOSGOQ2.0 to eight items (SOSGOQ-8D). This was done to lessen the cognitive burden of the utility valuation exercise. A general population sample of 2730 adults was then asked to evaluate 12 choice sets based on SOSGOQ-8D health states in a Discrete Choice Experiment. A utility scoring rubric was then developed using a mixed multinomial-logit regression model. Results: We were able to reduce the SOSGOQ2.0 to an SOSGOQ-8D with a mean error of 0.003 and mean absolute error of 3.078 compared to the full questionnaire. The regression model demonstrated good predictive performance and was used to develop a utility scoring rubric. Regression results revealed that participants did not regard all SOSGOQ-8D items as equally important. Conclusion: We provide a simple technique for converting the SOSGOQ2.0 to utilities. The ability to evaluate QALYs in metastatic spine disease will facilitate economic analysis and patient counselling. We also quantify the importance of individual SOSGOQ-8D items. Clinicians should heed these findings and offer treatments that maximize function in the most important items.Level of Evidence: 3.

A novel (targeted) kinesio taping application on chronic low back pain: Randomized clinical trial

Article

Full-text available

May 2021
PLOS ONE

The aim of the present clinical trial is to evaluate the efficacy of kinesio taping on patients with chronic low back pain, when the exploration identifies skin/fascia mobilization as a factor that could modify the treatment effect. This study is a randomized controlled trial with intention-to-treat analysis. Sixty-two participants with chronic low back pain were therefore recruited from a tertiary referral hospital. Targeted kinesio taping, according to skin/fascia mobility exploration, was applied in the experimental group (17 female/13 male; 49.47 ± 11.15 years) once a week for four sessions. The control group (17 female/14 male; 48.87 ± 9.09 years) underwent a placebo taping application. At post-treatment time there was a statistically significant reduction both in disability (Roland-Morris Disability Questionnaire) and pain (Numeric Pain Rating Scale) in the experimental group (disability: −2.88, 95% confidence interval [CI] −4.56 to −1.21, P < .001; pain: −1.58, 95% CI −2.67 to −0.54 P = .001) and the control group (disability: −1.82, 95% CI −3.46 to −0.17 P = .025; pain: −1.30, 95% CI −2.32 to −0.28 P = .008) . However, at six months, these changes only remained significant in the experimental group (disability: −2.95, 95% CI −4.72 to −1.18, P < .001; pain: −1.06, 95% CI −2.07 to −0.04, P < .05). As a conclusion, the application of targeted kinesio taping produced a significant reduction in pain and disability, at 4 weeks and at 6 moths follow-up , although there were no differences between groups at any measurement time point .

Are Guidelines Important? Results of a Prospective Quality Improvement Lumbar Fusion Project

Article

Full-text available

Mar 2021
NEUROSURGERY

Background: United States (U.S.) healthcare is a volume-based inefficient delivery system. Value requires the consideration of quality, which is lacking in most healthcare disciplines. Objective: To assess whether patients who met specific evidence-based medicine (EBM)-based criteria preoperatively for lumbar fusion would achieve higher rates of achieving the minimal clinical important difference (MCID) than those who did not meet the EBM indications. Methods: All elective lumbar fusion cases, March 2018 to August 2019, were prospectively evaluated and categorized based on EBM guidelines for surgical indications. The MCID was defined as a reduction of ≥5 points in Oswestry Disability Index (ODI). Multiple logistic regression identified multivariable-adjusted odds ratio of EBM concordance. Results: A total of 325 lumbar fusion patients were entered with 6-mo follow-up data available for 309 patients (95%). The median preoperative ODI score was 24.4 with median 6-mo improvement of 7.0 points (P < .0001). Based on ODI scores, 79.6% (246/309) improved, 3.8% (12/309) had no change, and 16% (51/309) worsened. A total of 191 patients had ODI improvement reaching the MCID. 93.2% (288/309) cases were EBM concordant, while 6.7% (21/309) were not.In multivariate analysis, EBM concordance (P = .0338), lower preoperative ODI (P < .001), lower ASA (American Society of Anesthesiologists) (P = .0056), and primary surgeries (P = .0004) were significantly associated with improved functional outcome. EBM concordance conferred a 3.04 (95% CI 1.10-8.40) times greater odds of achieving MCID in ODI at 6 mo (P = .0322), adjusting for other factors. Conclusion: This analysis provides validation of EBM guideline criteria to establish optimal patient outcomes. The EBM concordant patients had a greater than 3 times improved outcome compared to those not meeting EBM fusion criteria.

The effect of pedometer-supported walking and telemonitoring after disc hernia surgery on pain and disability levels and quality of life

Article

Full-text available

Feb 2021
Int J Nurs Pract

Aim: The aim of this study was to determine the effect of pedometer-supported walking and telemonitoring after lumbar disc hernia surgery on pain and disability levels and quality of life. Methods: This was a randomized controlled trial with two randomly selected groups conducted between March 2018 and January 2019. Sixty-seven participants (33 in the intervention group and 34 in the control group) who had undergone lumbar microdiscectomy were allocated to receive and not to receive walking exercise. Pain and disability levels and quality of life of groups were tested with the McGill Pain Questionnaire, the Oswestry Disability Index and the 36-Item Short Form Survey. Measurements were taken 3 weeks after surgery and following completion of the first, second and third months. Results: Compared with the control group, pain level at the first and second months and disability level at the second and third months in the intervention group were significantly lower (p < 0.05), and in the third month, subdimension scores of quality of life (the physical role difficulty, energy and vitality, mental health, social functionality and pain) were higher (p < 0.05). Conclusions: Walking after herniated disc surgery decreased pain and disability levels and increased the quality of life; nurses can encourage adherence to walking as an effective intervention.

A Prospective Study on the Role of Neurophysiological Studies in Predicting Functional Outcome After Lumbar Discectomy

Article

Jul 2020

Background and Aim: Lumbar intervertebral discs are complex anatomical structures essential for the mobility of intervertebral joints. There is general consensus for some indications for surgery, including acute or progressive neurological deficit(s), cauda equine syndrome, or refractory pain unresponsive to conservative treatments. However, controversy exists regarding the optimal management of cases with the disparity between radiological and clinical findings, which includes a great proportion of patients. This study examines whether neurophysiological studies can be used to identify subgroups with improved post-operative outcomes. Methods and Materials/Patients: This prospective cohort study was conducted on 60 patients with clinical and imaging evidence in favor of Lumbar Disc Herniation (LDH). The pre-operative radiological assessment was the lateral X-rays in flexion and extension positions, and lumbar spine Magnetic Resonance Imaging (MRI). Pre-operative clinical assessment was done by the Oswestry Low Back Pain Disability Questionnaire and Visual Analog Scale (VAS). Neurophysiological studies were done at least one month after the onset of radiculopathy. Surgery was performed at the level suggested by neuroimaging. In all patients, we found an abnormal disc, which was removed along with any loose disc material. The patients were followed up for 1 year with intervals of 3 months for post-operative assessments. Results: In the two study arms with abnormal or normal pre-operative electrodiagnostic studies, a significant decrease was observed in the percentages of visual analog scale reduction (73.69% and 95.59%, respectively) and Oswestry disability score (65.3% and 76.2%, respectively) at the month 12 post-operative (P=0.993 to 0.002 and P=0.200 to 0.037, respectively). Conclusion: Neurophysiological studies could be regarded as helpful adjuncts to distinguish a subgroup of patients with LDH, who may experience a favorable outcome after surgical intervention.

Early postoperative physical activity and function: a descriptive case series study of 53 patients after lumbar spine surgery

Article

Full-text available

Nov 2020
BMC MUSCULOSKEL DIS

Background The purpose of this prospective case series study was to compare changes in early postoperative physical activity and physical function between 6 weeks and 3 and 6 months after lumbar spine surgery. Methods Fifty-three patients (mean [95% confidence interval; CI] age = 59.2 [56.2, 62.3] years, 64% female) who underwent spine surgery for a degenerative lumbar condition were assessed at 6 weeks and 3- and 6-months after surgery. The outcomes were objectively-measured physical activity (accelerometry) and patient-reported and objective physical function. Physical activity was assessed using mean steps/day and time spent in moderate to vigorous physical activity (MVPA) over a week. Physical function measures included Oswestry Disability Index (ODI), 12-item Short Form Health Survey (SF-12), Timed Up and Go (TUG), and 10-Meter Walk (10 MW). We compared changes over time in physical activity and function using generalized estimating equations with robust estimator and first-order autoregressive covariance structure. Proportion of patients who engaged in meaningful physical activity (e.g., walked at least 4400 and 6000 steps/day or engaged in at least 150 min/week in MVPA) and achieved clinically meaningful changes in physical function were compared at 3 and 6 months. Results After surgery, 72% of patients initiated physical therapy (mean [95%CI] sessions =8.5 [6.6, 10.4]) between 6 weeks and 3 months. Compared to 6 weeks post-surgery, no change in steps/day or time in MVPA/week was observed at 3 or 6 months. From 21 to 23% and 9 to 11% of participants walked at least 4400 and 6000 steps/day at 3 and 6 months, respectively, while none of the participants spent at least 150 min/week in MVPA at these same time points. Significant improvements were observed on ODI, SF-12, TUG and 10 MW (p < 0.05), with over 43 to 68% and 62 to 87% achieving clinically meaningful improvements on these measures at 3 and 6 months, respectively. Conclusion Limited improvement was observed in objectively-measured physical activity from 6 weeks to 6 months after spine surgery, despite moderate to large function gains. Early postoperative physical therapy interventions targeting physical activity may be needed.

Clinical outcomes of MED and iLESSYS® Delta for the treatment of lumbar central spinal stenosis and lateral recess stenosis: A comparison study

Article

Full-text available

Oct 2020

Microendoscopic discectomy (MED) is an established procedure used to treat lumbar central spinal stenosis (LCSS) and lateral recess stenosis (LRS). The Interlaminar Endoscopic Surgical System iLESSYS® Delta approach has been developed from the traditional interlaminar endoscopic technique for the treatment of LCSS and LRS. In the present study, MED was used as a reference to evaluate this newly developed approach. A total of 82 and 52 patients with radicular leg pain and/or neurogenic claudication symptoms were treated by spinal canal decompression using the MED or iLESSYS® Delta approach, respectively. The clinical outcomes of the patients were analyzed using the Modified MacNab's criteria, visual analogue scale (VAS) leg pain score, VAS back pain score and the Oswestry Disability Index (ODI) score. Finally, the effectiveness of the decompression was evaluated on a cross-sectional area of the dural sac (CSAD) at the disc level. The incision length in the iLESSYS® Delta group was significantly decreased compared with the MED group (P<0.05); however, the duration of the operation in the iLESSYS® Delta group was significantly longer compared with the MED group (P<0.05). The VAS score of the back and ODI score in the iLESSYS® Delta group were significantly decreased compared with the MED group at the 1-week follow-up (P<0.0125). The postoperative CSAD was also significantly increased in both groups compared with before the operation (P<0.05); however, there were no significant differences in the postoperative CSAD between the two groups. The good-to-excellent rates of the MED and iLESSYS® Delta approach were 89.0 and 90.4%, respectively, whereas the complication rates of the MED and iLESSYS® Delta system were 3.66 and 3.85% in the two groups, respectively. In conclusion, the iLESSYS® Delta approach was identified to be comparable with the MED approach for treating LCSS and LRS, demonstrating both precise and limited decompression. In addition, the iLESSYS® Delta approach may reduce the short-term back pain and promote faster recovery compared with the MED.

287. Early postoperative physical activity predicts clinical improvement in disability 1 year following spine surgery

Article

Full-text available

Sep 2020
SPINE J

BACKGROUND CONTEXT Walking at least 4,500 steps/day or engaging in at least 60 minutes of moderate-to-vigorous physical activity/week are known to provide multiple health benefits and prevent disability in adults with and without musculoskeletal pain. However, little is known about the impact of physical activity on outcomes following spine surgery. PURPOSE The primary objective of this study was to determine whether early postoperative physical activity is associated with clinically meaningful improvement in disability in patients undergoing spine surgery. A secondary objective was to investigate the physical activity threshold that best discriminates improvement in disability at one year following spine surgery. STUDY DESIGN/SETTING Secondary analysis of randomized controlled trial data. PATIENT SAMPLE A total of 248 participants undergoing elective surgery for a degenerative lumbar spine condition. OUTCOME MEASURES Clinically meaningful improvement in disability was considered a 30% reduction in Oswestry Disability Index (ODI) scores from baseline (6 weeks after surgery) to 1-year follow-up. METHODS Physical activity was measured using an accelerometer (Actigraph GT3X) worn for at least 10 hours/day for at least 3 days at 6-weeks following spine surgery. Physical activity was quantified as steps/day and time spent in moderate-to-vigorous physical activity (ie, at least 2,020 counts/minute). Multivariable logistic regression analysis was conducted to determine the association between steps/day at 6 weeks and clinically meaningful improvement in disability at 1 year, controlling for age, body mass index (BMI), education, race, sex, previous surgery, spinal procedure, baseline ODI score, and back and leg pain. Receiver operating characteristic curves were used to identify steps/day and moderate-to-vigorous physical activity/week that best discriminated the likelihood of achieving clinical improvement. RESULTS Of 248 participants, 216 participants (mean [SD]; age= 63[11] years, BMI= 32[7] kg/m2, 52% female) had physical activity for at least 3 valid days. Of 216 patients, 43% (n=93) achieved clinical improvement in ODI at 1-year following spine surgery. Each additional 1000 steps/day and additional 1 minute of moderate-to-vigorous physical activity/day were associated with 27% (OR=1.27, 95% CI=1.07, 1.51) and 4% (OR=1.04, 95% CI=1.01, 1.08) higher odds of achieving clinically meaningful improvement in ODI, respectively. At 6 weeks following spine surgery, walking less than 3000 steps/day (sensitivity = 68%, specificity = 52%) was associated with 66% (OR=0.34, 95% CI=0.16, 0.69) lower odds of achieving clinical improvement in disability compared to those who walked at least 3000 steps/day. In addition, engaging in less than 21 minutes of moderate-to-vigorous physical activity/week (sensitivity = 62%, specificity = 48%) was associated with a 46% (OR=0.54, 95% CI=0.29, 1.02) lower odds of achieving clinical improvement in disability at 1-year postoperative compared to those who engaged in at least 21 minutes of moderate-to-vigorous physical activity/week. CONCLUSIONS Walking at least 3,000 steps/day or engaging in at least 21 minutes of moderate-to-vigorous physical activity/week may serve as an initial recommendation for patients early after spine surgery. Results suggest that these early postoperative thresholds may optimize clinical improvement in disability at 1 year following spine surgery. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Chronic Low Back Pain

Chapter

Feb 2024

Nina Vøllestad

The Participation Assessment with Recombined Tools-Objective (PART-O): measurement properties of the Norwegian version after traumatic brain injury

Article

Jan 2024
BRAIN INJURY

Objective: To translate and evaluate the validity of the Participation Assessment with Recombined Tools-Objective (PART-O) in a Norwegian context. Methods: One hundred and twenty persons with TBI with verified intracranial lesions and persistent symptoms lasting more than 2 years, included in a randomized controlled trial, rated their participation using the PART-O at baseline. The PART-O with its three subscales (Productivity, Out and About, and Social Relations) was translated to Norwegian. Descriptive statistics, Cronbach's alpha, Rasch analysis, and correlation analysis were applied. Results: The Rasch analysis indicated a unidimensional construct of PART-O and its subscales (χ2 < 12.69, p > 0.28). The internal consistency was moderate (Cronbach's alpha 0.48-0.52) and there was a need to reduce scaling options for most of the items. The Out and About and Productivity subscales had considerable floor effects. PART-O showed moderate positive correlation to TBI-related quality of life and global functioning. Conclusions: PART-O and its subscales reflect unidimensional aspects of participation. In the present Norwegian TBI population the original scaling of PART-O was too detailed for all subscales. The floor effects and suboptimal targeting between items and subjects participation level of the Out and About subscale is a matter of concern.

The Efficacy of Bleeding Acupuncture Point UB-40 in Patients Suffering from Severe Acute Lumbago: Efficacy of Bleeding Acupuncture Point UB-40

Article

Full-text available

Dec 2023

Severe acute lumbago, or lower back pain, is a common condition that can cause sudden pain and cramping that lasts for days to weeks. The UB-40 acupuncture point, also known as the Urinary Bladder 40, is a sensitive point that provides excellent relief from spinal pain. Objective: To evaluate the efficacy of bleeding acupuncture point UB-40 in patients suffering from severe acute lumbago. Methods: An experimental pre-post study was conducted on 40 participants, recruited from the emergency department (ED) of Iffat Anwar Medical Complex Lahore from January 2021 to February 2023. All the patients were treated with bleeding at UB-40 acupuncture point technique. After the treatment, the patients were followed at baseline, 1-week and 1-month intervals. The primary outcomes of the study were to determine the improvement in acute low back pain by using the visual analogue scale (VAS) and physical impairment using Oswestry low back disability index (ODI) scale. Results: A total of 40 patients were enrolled in the current study. The mean age of patients was 38.7±12.2. Majority of the patients were females (52%). The mean pain score (VAS) at baseline was 8.00±0.751, which reduced at 4th week with a mean pain score of 2.92±1.28. Moreover, at baseline, patients had severe disability with a mean ODI score of 55.58, but after treatment it gradually decreased to (25.55). Conclusions: It was concluded that acupuncture, especially with bleeding at UB-40 point, may provide an immediate significant effect in reducing the acute pain of low back and disability.

Posttraumatic stress disorder and quality of life in patients after open thoracoabdominal aortic repair

Article

Dec 2023

Background: Open thoracoabdominal aortic aneurysm (TAAA) repair is often related to significant morbidity and complications like paraplegia or acute kidney injury. Subsequently, prolonged intensive care stay is common. However, there is a lack of research on post-traumatic stress disorder (PTSD) and the perceived quality of life (QOL) in patients undergoing complex aortic procedures, such as open TAAA repair. Therefore, our study aims to determine the prevalence of PTSD and the current QOLin these patients and whether it is associated with demographic factors or complications following open thoracoabdominal aortic repair. Patients and methods: In this retrospective study, a total of 213 adult surviving patients after open thoracoabdominal aortic repair were contacted with two questionnaires one to assess PTSD and another to evaluate current QOL after open thoracoabdominal aortic repair. 61 patients returned one or both the questionnaires, and 59 patients (97%) answered all questions of the 4-item primary care PTSD section of the survey. In addition to the PTSD screening, patients were sent an SF-36 questionnaire to assess their current quality of life. 60 patients answered the SF-36 questionnaire partially or completely (98%). Results: 27% of patients (16/59) screened positive for PTSD. Electronic medical records were matched to all responding patients. Patients who were screened positive for PTSD spent more days in intensive care (OR, 1.073; 95% CI 1.02–1.13; p=0.005), had a higher frequency of tracheotomy (OR, 6.43; 95% CI 1.87–22.06; p=0.004), sepsis (OR, 5.63; 95% CI 1.56–20.33; p=0.014), as well as postoperative paraparesis (OR, 13.23; 95% CI 1.36–129.02; p=0.019). In patients with postoperative complications, a statistically significant decrease in the overall score was observed for certain categories of the SF-36. Conclusions: The prevalence of PTSD is higher, in comparison to the general population’s prevalence, and the quality of life is affected following open thoracoabdominal aortic aneurysm repair, with a significant relation to postoperative complications as well as the length of ICU stay. Further research and screening for PTSD in relation to open TAAA repair is needed to assess its role in patient QOL during follow up.

Identifying Correlation Among Patient-Reported Outcome Measures: A Study of PROMIS-29, ODI, and VAS in Adult Spinal Deformity Patients

Article

Nov 2023

Correlation of MRI Findings with ODI and VAS Score in Patients with Lower Back Pain

Article

Full-text available

Sep 2023
Open Neuroimaging J

Background In clinical practice, there is a very common discrepancy between the clinical findings of patients with lumboischialgia and the radiological findings. Objective This research aimed to determine the degree of correlation between the ODI index and the VAS scale with degenerative changes in the lumbar spine found using MRI. Methods The study included 100 patients, who were referred for an MRI of the lumbar spine and who had a clear clinical picture of lumboischialgia. Patients underwent MRI. Degenerative changes in the lumbar spine and discs were analysed. Patients were asked to answer the questions in the questionnaire about the subjective feeling of pain and functional status, and ODI and VAS scores were calculated. Results There has been a statistically significant correlation found between the answers to the survey questions and the VAS score (p < 0.001). There was a significant correlation obtained between the level of degeneration and the disability index (p = 0.022), while the correlation with the VAS score has not been found to be significant (p = 0.325). Conclusion This study has demonstrated a significant correlation between the VAS pain score and the ODI, as well as a significant correlation between the level of degeneration on MRI scans and the disability index; however, the correlation of MRI scan results with VAS score has not been found to be significant.

Efficacy and Safety of Bilateral Ultrasound-Guided Erector Spinae Plane Block (ESPB) for Post-operative Analgesia in Spine Surgery: a Systematic Review and Meta-analysis of Randomized Controlled Trials

Article

Oct 2023

Benefits of Lumbar Spine Fusion Surgery Reach 10 Years with Various Surgical Indications

Article

Sep 2023

Background Context Lumbar spine fusion (LSF) surgery is a viable form of treatment for several spinal disorders. Treatment effects are preferably to be endorsed in real-life settings. Methods This prospective study evaluated the 10-year outcomes of LSF. A population-based series of elective LSFs performed at 2 spine centers between January 2008 and June 2012 were enrolled. Surgeries for tumor, acute fracture, or infection, neuromuscular scoliosis, or postoperative conditions were excluded. The following patient-reported outcome measures (PROMs) were collected at baseline, and 1, 2, 5, and 10 years postsurgery: VAS for back and leg pain, ODI, SF-36. Longitudinal measures of PROMs were analyzed using mixed-effects models. Results A total of 683 patients met the inclusion criteria, and 630 (92%) of them completed baseline and at least 1 follow-up PROMs, and they constituted the study population. Mean age was 61 (SD 12) years, 69% women. According to surgical indication, patients were stratified into degenerative spondylolisthesis (DS, n=332, 53%), spinal stenosis (SS, n=102, 16%), isthmic spondylolisthesis (IS, n=97, 15%), degenerative disc disease (DDD, n=52, 8%), and deformity (DF, n=47, 7%). All diagnostic cohorts demonstrated significant improvement at 1 year, followed by a partial loss of benefits by 10 years. ODI baselines and changes at 1 and 10 years were: (DS) 45, −21, and −14; (SS) 51, −24, and −13; (IS) 41, −24, and −20; (DDD) 50, −20, and −20; and (DF) 50, −21, and −16, respectively. Comparable patterns were seen in pain scores. Significant HRQoL achievements were recorded in all cohorts, greatest in physical domains, but also substantial in mental aspects of HRQoL. Conclusions Benefits of LSF were partially lost but still meaningful at 10 years of surgery. Long-term benefits seemed milder with degenerative conditions, reflecting the progress of the ongoing spinal degeneration. Benefits were most overt in pain and physical function measures.

Wearable Technology and Measurement of Outcomes from Lumbar Spondylolisthesis Surgery

Article

Aug 2023
Semin Spine Surg

Objective outcome measures may demonstrate continued change in functional recovery in patients with ceiling effects of subjective patient-reported outcome measures after surgery for lumbar degenerative disorders

Article

May 2023
SPINE J

Background context: The 6-minute walking test (6WT) has been previously shown to be a reliable and valid outcome measure. It is unclear if the 6WT may further help to detect differences in well performing patients that reach a ceiling effect in PROMs after surgery. Purpose: To evaluate changes and timing of change in objective functional impairment (OFI) as measured with the smartphone-based 6WT in relation to patient-reported outcome measures (PROMs) after surgery for degenerative lumbar disorders (DLD) STUDY DESIGN: Prospective observational cohort study PATIENT SAMPLE: 50 consecutive patients undergoing surgery for degenerative lumbar disorders OUTCOME MEASURES: Patients self-determined their objective functional impairment using the 6-minute Walking Test application (6WT-app) and completed a set of paper-based patient-reported outcome measures (PROMs) before, six weeks and 3 months after surgery. Methods: 50 patients undergoing surgery for DLD were assessed preoperatively (baseline), 6 weeks (6W) and 3 months (3M) postoperatively. Paired sample t-tests were used to establish significant changes in raw 6-minute walking distance (6WD) and standardised z-scores, as well as PROMs. Pearson correlation coefficient was used to define the relationship between 6WT and PROMs. Floor and ceiling effects were assessed for each PROM (Visual Analogue Scale - VAS, Core Outcome Measure Index - COMI, Zurich Claudication Questionnaire - ZCQ). Results: Mean 6WT results improved from 377m (standard deviation - SD 137; z-score: 1.8, SD 1.8) to 490m (SD 126; -0.7, SD 1.5) and 518m (SD 112; -0.4, SD 1.41; all p < 0.05) at 6W and 3M follow-up. No significant improvement was observed between 6W and 3M for the ZCQ, VAS back and leg pain. While correlation between 6WT and all PROMs were weak at baseline, correlation coefficient increased to moderate at 3M. A considerable ceiling effect (best possible score) was observed, most notably for the ZCQ Physical Performance, VAS back and leg pain in 24%, 20% and 16% of patient at 6W and in 30%, 24% and 28% at 3M. Conclusion: Objective functional tests can describe the continued change in the physical recovery of a patient and may help to detect differences in well performing groups as well as in cases where patients' PROM results cannot further improve because of a ceiling effect.

Determinants of Postoperative Compliance of Patient-reported Outcome Assessments Following Lumbar Spine Surgery

Article

Full-text available

Oct 2022

Introduction: This study aimed to identify demographic, clinical, and operative factors associated with increased postoperative compliance of patient-reported outcome (PRO) assessments following lumbar spine surgery. Methods: A retrospective study of prospectively collected data of 1,680 consecutive adult patients who underwent elective lumbar surgery at a single institution from 2017-2020. Digital assessment questionnaires were used to assess PROs (i.e., VAS-back, VAS-leg, Oswestry Disability Index, Short Form (SF-12) mental & physical health, VR-12 mental and physical, and VR6D scores) and patient compliance, defined as the percentage of questionnaires completed preoperatively, at 3 months and 1 year after surgery. Multivariate logistic regression was used to assess the association between PRO compliance and patient characteristics. Results: A total of 1,680 patients (53.1% male, mean age: 57.7 years) had a mean PRO compliance of 64.7%. Compliance decreased continuously from initial preoperative rates (84.5%) to lower rates at 3 months (54.4%) and 12 months (45.6%), respectively, with 33.2% of patients completing zero assessment questionnaires at 12 months, postoperatively. Factors associated with significantly increased PRO compliance included being employed (preop: odds ratio [OR] = 2.58, p = 0.002; 3-month postop: OR = 1.25, p = 0.095; 12-month postop: OR = 1.34, p = 0.028). Factors associated with decreased compliance included preoperative smoking status (3-month postop: OR = 0.63, p = 0.029; 12-month postop: OR = 0.60, p = 0.016). Conclusions: Patients who completed greater than 50% of their PROs demonstrated significantly different rates of being employed compared with those who completed less than 50% throughout 1 year of follow-up. Preoperative smoking status was associated with decreased compliance, whereas a history of employment was associated with increased compliance throughout follow-up. To validate our findings and explore additional parameters that affect postoperative compliance of PROs, further investigation is required.

Ability of Visual Analogue Scale to predict Oswestry Disability Index improvement and surgical treatment decision in patients with adult spinal deformity

Article

Full-text available

Aug 2022

Introduction: The effect of pain on HRQoL scores in ASD patients is not well studied. Disability is a major factor on decision and outcomes. On the other hand, little is known about the effect of perceived and reported pain on these parameters, especially in the elderly population. We hypothesized that baseline back and leg pain would not affect the treatment decision whereas may have a negative effect on outcomes. Research question: To determine the correlation between preoperative ODI and VAS scores; and to identify the effect of baseline VAS score on treatment decision and ODI improvement following treatment. Material and methods: In this retrospective study, patients with a follow-up duration of minimum 2 years were enrolled from a prospective multicentric ASD database. Pearson and Spearman correlation tests were used to evaluate the correlation between ODI and VAS scores; univariate binary logistic regression method was used to analyze the effect of VAS on treatment decision as well as the outcomes. Results: 1050 patients (mean age 48.2) were analyzed. Baseline ODI and back, leg pain VAS scores were significantly correlated (P < 0.001). One unit increase in baseline back and leg pain VAS scores, increased the probability of improvement in ODI by 1.219 (P = 0.016) and 1.182 times (P = 0.029), respectively in surgically treated patients; and reduced it by 0.894 times (P = 0.012) for conservatively treated patients. For patients >70 years old, one-unit increase in baseline leg pain VAS score increased the probability of deciding on surgical treatment by 1.121 times (p = 0.016). Discussion and conclusions: Preoperative back and leg pain VAS scores were found to be significantly correlated with the preoperative ODI scores. Additionally, preoperative baseline back and leg pain VAS scores were useful in predicting the improvement in disability as assessed by ODI. Another important finding was that, higher baseline leg pain (but not back pain) VAS scores increased the rate of elderly patients preferring surgical treatment.

Surgeons Learning Curve of Transforaminal Endoscopic Discectomy for Sciatica

Article

Full-text available

Jul 2022

Objective: Full-endoscopic spine surgery is gaining interest as a less-invasive alternative to treat sciatica caused by a lumbar disc herniation. Concerns, however, exist with the learning curve as percutaneous transforaminal endoscopic discectomy (PTED) appears to be more difficult to be performed compared to other techniques. In this study, the clinical outcomes during and after the learning curve are presented of 3 surgeons naïve to PTED. Methods: In the first phase of a randomized controlled, noninferiority trial comparing PTED with microdiscectomy, 3 surgeons were trained in the PTED-procedure by a senior surgeon. After performing up to 20 cases under supervision, they started performing PTED on their own. Results of the early cases were compared to the later cases (>20). Furthermore, complications and reoperations were compared. Finally, differences in clinical outcomes between surgeons were compared. Results: At 12 months of follow-up, 87% of the patients had follow-up data available. In general, there were no significant differences in patient-reported outcomes between the early and later PTED cases. Furthermore, outcomes of the early PTED cases were comparable to the outcomes of microdiscectomy, while the later PTED cases had small, but more favorable outcomes compared to microdiscectomy. Two learning curve surgeons had substantially higher rates of reoperations within 1 year, compared to the senior surgeon or the microdiscectomy group. Duration of surgery was also longer for all learning curve surgeons. Finally, when comparing clinical outcomes of patients undergoing PTED versus microdiscectomy, there appears to be some statistically significant differences in outcomes compared between the senior and 3 learning curve surgeons. Conclusion: PTED appears to be safe to be adopted by surgeons naïve to the procedure when they are initially supervised by an experienced senior surgeon. Duration of surgery and risk of repeated surgery are increased during the learning curve, but patient-reported outcomes of the early PTED cases are similar to the outcomes of later PTED cases, and similar to the outcomes of microdiscectomy cases. This study underlines the need for an experienced mentor for surgeons to safely adopt PTED.

Outcomes of Cervical Disc Replacement in Patients With Neck Pain Greater Than Arm Pain

Article

Apr 2022
SPINE J

BACKGROUND CONTEXT Although anterior cervical discectomy and fusion (ACDF) is believed to positively impact a patient's radicular symptoms as well as axial neck pain, the outcomes of cervical disc replacement (CDR) with regards to neck pain specifically have not been established. PURPOSE Primary: to assess clinical improvement following CDR in patients with neck pain greater than arm pain. Secondary: to compare the clinical outcomes between patients undergoing CDR for predominant neck pain (pNP), predominant arm pain (pAP), and equal neck and arm pain (ENAP). STUDY DESIGN Retrospective review of prospectively collected data PATIENT SAMPLE Patients who had undergone one- or two-level CDR for the treatment of degenerative cervical pathology and had a minimum of 6-month follow-up were included and stratified into three cohorts based on their predominant location of pain: pNP, pAP, and ENAP. OUTCOME MEASURES Patient-reported outcomes (PROs): Neck Disability Index (NDI), Visual Analog Scale (VAS) neck and arm, Short Form 12-Item Physical Health Score (SF12-PHS), Short Form 12-Item Mental Health Score (SF12-MHS), minimal clinically important difference (MCID). METHODS Changes in PROs from preoperative values to early (<6 months) and late (≥6 months) postoperative timepoints were analyzed within each of the three groups. The percentage of patients achieving MCID was also evaluated. RESULTS 125 patients (52 pNP, 30 pAP, 43 ENAP) were included. The pNP cohort demonstrated significant improvements in early and late NDI and VAS-Neck, early SF-12 MCS, and late SF-12 PCS. The pAP and ENAP cohorts demonstrated significant improvements in all PROMs, including NDI, VAS-Neck, VAS-Arm, SF-12 PCS, and SF-12 MCS, at both the early and late timepoints. No statistically significant differences were found in the MCID achievement rates for NDI, VAS-Neck, SF-12 PCS, and SF-12 MCS at the late timepoint amongst the three groups. CONCLUSIONS CDR leads to comparable improvement in neck pain and disability in patients presenting with neck pain greater than arm pain and meeting specific clinical and radiographic criteria.

Bilateral lumbar ultrasound-guided erector spinae plane block versus local anesthetic infiltration for perioperative analgesia in lumbar spine surgery: a randomized controlled trial

Article

Feb 2022
MINERVA ANESTESIOL

Background: Lumbar spinal surgery is associated with severe postoperative pain. We examined the analgesic efficacy of bilateral lumbar ultrasound-guided erector spinae plane block (ESPB) with ropivacaine compared with local infiltration. Methods: Patients undergoing elective lumbar arthrodesis were randomly divided into two groups. Control group received 0.375 % ropivacaine 40 ml through the wound, and ESPB group received preoperative bilateral ESPB with 0.375 % ropivacaine 40 ml. Primary outcome was postoperative pain intensity at rest using a Numeric Rating Scale (NRS). Secondary outcomes included difference in pain intensity between pre-intervention and defined timepoints, total amount of opioid analgesic requested by the patients at the same timepoints, the incidence of any adverse event, and the length of hospital stay (LOS) after surgery. Results: Sixty patients were enrolled in the study. After surgery we detected a NRS value of 1.9 ± 1.5 in ESPB group and 5.9 ± 1.6 in Control group (p<0.001). About the opioid consumption we found a total sufentanil tablets consumption of 17 ± six and 10 ± three at 48h for Control group and ESPB group, respectively (p<0.001). Concerning LOS, 30 (100%) patients in the control group and 22(73.3%) in ESPB group were discharged after 72 hours (p=0.005). Conclusions: Bilateral ultrasound-guided ESPB offers improved postoperative analgesia compared with local infiltration in patients undergoing lumbar spinal surgery.

Pain, anesthetics and analgesics/back pain evaluation questionnaires

Chapter

Jan 2022

Jun Komatsu

As the meaning of low back pain is rather broad, no clear definition has been adopted. In addition, low back pain may represent a disease condition, as opposed to a name. Therefore, it may be necessary to quantify the clinical outcomes of low back pain considering individual differences using an objective disease-specific questionnaire to confirm the presence of pretreatment effects. Moreover, assessments of low back pain need to be multifaceted. This section discusses the importance of using subjective or objective disease-specific questionnaires to assess treatment for low back pain. For patients with low back pain, it is considered important to investigate outcomes using a patient-oriented test that assesses health-related quality of life (e.g., the Oswestry Disability Index, the Roland-Morris Disability Questionnaire, the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire). However, since it is not possible to identify changes in a patient’s medical condition using only one questionnaire, multiple questionnaires need to be administered to enable a comparison of evaluations. As each questionnaire has its own advantages and disadvantages, it is important to gain a better understanding of the characteristics of each one. Therefore, to achieve better treatment, it is important to evaluate the effects of low back pain on a patient’s social background and daily life.

Systematic Review and Meta-Analysis of 3 Treatment Arms for Vertebral Compression Fractures: A Comparison of Improvement in Pain, Adjacent-Level Fractures, and Quality of Life Between Vertebroplasty, Kyphoplasty, and Nonoperative Management

Article

Full-text available

Oct 2021

Background: Osteoporotic vertebral fractures (OVFs) have become increasingly common, and previous nonrandomized and randomized controlled trials (RCTs) have compared the effects of cement augmentation versus nonoperative management on the clinical outcome. This meta-analysis focuses on RCTs and the calculated differences between cement augmentation techniques and nonsurgical management in outcome (e.g., pain reduction, adjacent-level fractures, and quality of life [QOL]). Methods: A systematic review was performed according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines, and the following scientific search engines were used: MEDLINE, Embase, Cochrane, Web of Science, and Scopus. The inclusion criteria included RCTs that addressed different treatment strategies for OVF. The primary outcome was pain, which was determined by a visual analog scale (VAS) score; the secondary outcomes were the risk of adjacent-level fractures and QOL (as determined by the EuroQol-5 Dimension [EQ-5D] questionnaire, the Oswestry Disability Index [ODI], the Quality of Life Questionnaire of the European Foundation for Osteoporosis [QUALEFFO], and the Roland-Morris Disability Questionnaire [RDQ]). Patients were assigned to 3 groups according to their treatment: vertebroplasty (VP), kyphoplasty (KP), and nonoperative management (NOM). The short-term (weeks), midterm (months), and long-term (>1 year) effects were compared. A random effects model was used to summarize the treatment effect, including I2 for assessing heterogeneity and the revised Cochrane risk-of-bias 2 (RoB 2) tool for assessment of ROB. Funnel plots were used to assess risk of publication bias. The log of the odds ratio (OR) between treatments is reported. Results: After screening of 1,861 references, 53 underwent full-text analysis and 16 trials (30.2%) were included. Eleven trials (68.8%) compared VP and NOM, 1 (6.3%) compared KP and NOM, and 4 (25.0%) compared KP and VP. Improvement of pain was better by 1.31 points (95% confidence interval [CI], 0.41 to 2.21; p < 0.001) after VP when compared with NOM in short-term follow-up. Pain effects were similar after VP and KP (midterm difference of 0.0 points; 95% CI, -0.25 to 0.25). The risk of adjacent-level fractures was not increased after any treatment (log OR, -0.16; 95% CI, -0.83 to 0.5; NOM vs. VP or KP). QOL did not differ significantly between the VP or KP and NOM groups except in the short term when measured by the RDQ. Conclusions: This meta-analysis provides evidence in favor of the surgical treatment of OVFs. Surgery was associated with greater improvement of pain and was unrelated to the development of adjacent-level fractures or QOL. Although improvements in sagittal balance after surgery were poorly documented, surgical treatment may be warranted if pain is a relevant problem. Level of evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Comparative analysis of the quality of life of children with congenital scoliosis after surgical treatment: Extirpation of the hemivertebra from dorsal and combined access

Article

Full-text available

Jul 2021

BACKGROUND: Congenital scoliosis with disorders of the formation of the vertebrae is the most common cause of pronounced deformities of the spine in early childhood. This pathology can be treated surgically using various techniques that differ in invasiveness, severity of the condition in the postoperative period, achieved result of deformity correction, and nature of the long-term prognosis. Numerous studies have assessed the quality of life of patients who underwent surgery for acquired deformities, trauma, and degenerative and neoplastic diseases of the spine in adults. However, features of the childs quality of life following surgical technique for congenital scoliosis have not been sufficiently studied. AIM: This study aimed to compare the quality of life of children with congenital scoliosis of the thoracolumbar localization after extirpation of the hemivertebra from the dorsal and combined approaches. MATERIALS AND METHODS: An intergroup prospective analysis of the results of a survey of 60 patients with congenital deformity of the spine against the background of an isolated violation of the formation of the thoracic or lumbar vertebra was carried out. Patients underwent standard surgical treatment. Patients were divided into two groups according to the surgical approach to the abnormal vertebral body: dorsal group (n = 28) and combined group (n = 32). The average age of the patients was 75 (minmax, 26196) months. The follow-up period was 18 months after surgery. To assess the quality of life, a specialized Russian version of the PedsQL v4.0 questionnaire and a modified visual analog scale were used. RESULTS: After surgical treatment of congenital spinal deformity, quality of life indicators decreased more than two times than the results of a preoperative survey. At 18 months postoperatively, the physical activity and psychoemotional state were restored to the preoperative level, while patients of the combined group had a higher satisfaction score on the quality of life (p 0.05). CONCLUSIONS: The combined approach provides the best correction of congenital deformity of the spine and allows maintaining of the achieved result throughout the observation period. In the early postoperative period, the combined group demonstrated a significant decrease in the level of satisfaction with the quality of life, while the pain syndrome was higher than that in the dorsal group. Dynamic observation revealed the leveling of these differences and a subsequent increase in the level of satisfaction with the quality of life of these patients.

The Impact of Surgical Site Infection on Patient Outcomes After Open Posterior Instrumented Thoracolumbar Surgery for Degenerative Disorders

Article

Jun 2021

Background: Few reports in the literature have described the long-term outcome of postoperative infection from the patient perspective. The aim of the present study was to determine if complicated surgical site infection (SSI) affects functional recovery and surgical outcomes up to 2 years after posterior instrumented thoracolumbar surgery for the treatment of degenerative disorders. Methods: This retrospective cohort study involved patients who had been enrolled in a previous randomized controlled trial that examined antibiotic use for open posterior multilevel thoracolumbar or lumbar instrumented fusion procedures. In the present study, patients who had SSI (n = 79) were compared with those who did not (n = 456). Patient-reported outcome measures (PROMs) included the Oswestry Disability Index (ODI), leg and back pain scores on a numeric rating scale, Short Form-12 (SF-12) summary scores, and satisfaction with treatment at 1.5, 3, 6, 12, and 24 months. Surgical outcomes included adverse events, readmissions, and additional surgery. Results: The median time to infection was 15 days. Of the 535 patients, 31 (5.8%) had complicated infections and 48 (9.0%) had superficial infections. Patients with an infection had a higher body mass index (BMI) (p = 0.001), had more commonly received preoperative vancomycin (p = 0.050), were more likely to have had a revision as the index procedure (p = 0.004), had worse preoperative mental functioning (mental component summary score, 40.7 ± 1.6 versus 44.1 ± 0.6), had more operatively treated levels (p = 0.024), and had a higher rate of additional surgery (p = 0.001). At 6 months after surgery, patients who developed an infection scored worse on the ODI by 5.3 points (95% confidence interval [CI], 0.4 to 10.1 points) and had worse physical functioning by -4.0 points (95% CI, -6.8 to -1.2 points). Comparison between the groups at 1 and 2 years showed no difference in functional outcomes, satisfaction with treatment, or the likelihood of achieving the minimum clinically important difference (MCID) for the ODI. Conclusions: SSI more than doubled the post-discharge emergency room visit and additional surgery rates. Patients with SSI initially (6 months) had poorer overall physical function representing the delay to recovery; however, the negative impact resolved by the first postoperative year. Level of evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Bilateral lumbar Ultrasound-guided Erector Spinae Plane Block versus Local Anaesthetic Infiltration for Perioperative Analgesia in Lumbar Spine Surgery: A Randomized Controlled Trial

Preprint

Full-text available

Apr 2021

Background Lumbar spinal surgery is associated with severe postoperative pain. We examined the analgesic efficacy of bilateral lumbar ultrasound-guided erector spinae plane block (ESPB) with ropivacaine compared with local infiltration of ropivacaine.Methods Twenty-four patients undergoing elective lumbar arthrodesis were randomly divided into two groups. Control group received 0.375 % ropivacaine 40 ml through the wound, and ESPB group received preoperative bilateral ESPB with 0.375 % ropivacaine 40 ml. The primary outcome was postoperative pain intensity at rest using a Numeric Rating Scale (NRS). Secondary outcomes included difference in pain intensity between pre-intervention and defined timepoints, total amount of opioid analgesic requested by the patients at the same timepoints, the incidence of any adverse event, and the length of hospital stay (LOS) after surgery.Results After surgery we detected a NRS value of 1.9 + 1.6 in ESPB group and 6.0 + 1.7 in Control group (p<0.05). In the ESPB group we found a significant decrease (from 6.3 ± 1.6 to 1.9 ± 1.7) of NRS score after surgery compared to pre-surgery values. About the opioid consumption we found a total sufentanil tablets consumption of 17 ± 9 and 10 ± 2 at 48h for Control group and ESPB group, respectively. Concerning LOS all patients in the Control group and 9 of the ESPB group were discharged after 72 hours; 3 patients in the ESPB group left the ward after 48 hours. Conclusion Bilateral ultrasound-guided ESPB offers improved postoperative analgesia compared with local infiltration in patients undergoing lumbar spinal surgery.Trial Registration Number on Clinicaltrial.gov: NCT04123106

Preoperative PROMIS Scores Predict Postoperative Outcomes in Lumbar Spine Surgery Patients

Article

Feb 2021

Study design: Retrospective case series. Objective: Our objective was to examine the ability of preoperative Patient-reported Outcomes Measurement Information System (PROMIS) scores to predict postoperative achievement of a minimum clinically important difference (MCID) in outcome scores following lumbar spine surgery. Summary of background data: PROMIS is a computer adaptive testing system that has been validated in spine surgery patients. PROMIS allows for more efficient and personalized data collection compared to legacy assessment tools. Methods: A total of 138 patients who underwent lumbar spine surgery at a single institution completed PROMIS Physical Function (PF) and Pain Interference (PI) scores preoperatively and at 3, 12, and 24 months postoperatively. Univariate and multivariate analyses of PROMIS scores and clinical factors were performed. Receiver-operating characteristic curves were calculated to determine the ability of preoperative scores to predict postoperative achievement of an MCID of 8. PF and PI t score MCID achievement threshold values with 90% specificity were calculated. Results: Preoperative PROMIS PF and PI scores were significantly correlated to achievement of postoperative MCID after multivariate analysis. Patients with worse preoperative scores were more likely to achieve MCID. Preoperative PF and PI scores showed strong predictive value in determining ability to achieve postoperative MCID with respective area under the curve of 0.85 and 0.82. A preoperative PF threshold T-score of 31.6 had a 64% chance of achieving postoperative MCID, while a preoperative PI threshold t score of 67.8 had an 86% chance of achieving postoperative MCID. Conclusion: Preoperative PROMIS PF and PI scores predicted improvement in postoperative PROMIS scores in lumbar spine surgery patients as worse preoperative scores correlated to improved PROMIS scores postoperatively. The calculated threshold t scores showed the ability to predict improvement in postoperative PROMIS scores. Preoperative PROMIS data may be useful in surgical decision-making and improved patient education regarding postoperative outcomes.Level of Evidence: 4.

Depression Symptoms Are Associated with Poor Functional Status Among Operative Spinal Deformity Patients

Article

Dec 2020

Study design: Retrospective review of prospective multicenter database. Objective: To investigate how preoperative mental status affects preoperative and postoperative disability and health scores in ASD patients. Summary of background data: The relationship between health-related quality of life (HRQOL) and depression has previously been documented. However, the influence of depression on clinical outcomes among adult spinal deformity (ASD) patients is not well understood. Methods: ASD patients with minimum 2-year follow-up were stratified based on preoperative mental health measured by Short Form 36 (SF-36) mental component score (MCS). Patients with MCS in the 25th and 75th percentile of the cohort were designated as having low and high MCS, respectively. After matching by preoperative demographics and deformity, pre and post HRQOL were compared between the two groups. Further analysis was performed to identify individualized questions on the SF-36 that could potentially screen for patients with low MCS. Results: 513 patients were assessed (58.4 yo, 79% women, mean MCS 45.5). Thresholds for low and high MCS cohorts were 35.0 and 57.3, respectively. After matching by preoperative alignment, low MCS patients had worse ODI (52.3 ± 17.0 vs 35.7 ± 14.6, p < 0.001) and SRS-22R scores for all domains (all p < 0.001) compared to high MCS patients. Similar results were maintained at 2-yr postop, with low MCS patients having a worse ODI (35.2 ± 20.2 vs 19.7 ± 18.6, p < 0.001) and MCS (42.4 ± 13.5 vs 58.6 ± 7.1, p < 0.001). Despite similar preoperative PCS, low MCS patients were less likely to reach MCID for PCS (46.1% vs 70.6%, p < 0.01) and had a lower satisfaction at 2 year follow-up (3.88 ± 1.07 vs 4.39 ± 0.94, p < 0.001). Questions 5a, 9d, and 9f on the SF-36 were found to be independent predictors of low MCS. Conclusions: ASD patients with low MCS are more likely to experience functional limitations before and after surgery and are less likely to be satisfied postoperatively, even when similar clinical goals are achieved. Incorporating psychological factors may assist in decision making.Level of Evidence: 3.

Effect of change in preoperative depression/anxiety on patient outcomes following lumbar spine surgery

Article

Dec 2020
CLIN NEUROL NEUROSUR

Objective The purpose of this study was to investigate the association between positive change in depression or anxiety within three months post-operation and clinically meaningful changes in long-term clinical outcomes after lumbar spine surgery. Methods This study included adults with preoperative diagnosis of depression or anxiety who underwent lumbar spine surgery in the Quality Outcomes Database (QOD) from 2012 to 2018 with either a 12- or 24-month follow-up. Positive change in depression and anxiety was assessed three months after surgery. Clinical outcomes measured included Numeric Rating Scale (NRS) score for back pain (BP) and leg pain (LP), Oswestry Disability Index score (ODI) for disability, EuroQol Visual Analog Scale score (EQ-VAS) for health-related quality of life (HRQOL), and North American Spine Surgery (NASS) index score for patient satiaction measured at 12- and 24 months after surgery. Results Of the 9,656 and 1,393 patients who were included in the 12- and 24-month cohort, respectively, 7,277 patients (75.4 %) and 1,089 (78.2 %) experienced a positive change in depression or anxiety within three months after surgery. At both 12- and 24-month follow-up, patients who had positive change in depression or anxiety were more likely to achieve minimal clinically important changes in NRS-BP/LP, ODI, EQ-VAS, and NASS (all p < 0.01) compared to those who did not experience improvement in depression or anxiety. Conclusion Depression and anxiety are important comorbidities to consider in patients undergoing lumbar spine surgery. Positive change in depression and anxiety are associated with improvements in pain, disability, satisfaction, and overall functioning.

Rehabilitation after Lumbar Spine Fusion: The Effectiveness of a 12-Month Home-Exercise Program

Thesis

Sep 2020

The aim of this thesis was to study the recovery of trunk muscle strength and spine function after lumbar spine fusion surgery (LSF) and standard care, and to evaluate the effectiveness of a 12-month home-exercise program in the postoperative rehabilitation after LSF. Recovery was studied in a one-year prospective cohort study in consecutive patients undergoing non-urgent LSF (N=194, 66% women, mean age 61 years). The effectiveness of rehabilitation was studied in a randomized controlled trial of 98 patients with spondylolisthesis (75% women, mean age 59 years) who were allocated three months after LSF to the exercise group (EG) or to the usual care group (UCG). The EG underwent a 12-month training that consisted of back-specific and aerobic training including six booster sessions with a physiotherapist. The UCG underwent one guided session for light home exercises. The outcomes were isometric maximal strength of abdominal and back muscles, back muscle endurance, the Oswestry Disability Index, the Visual Analogue Scale for low back and leg pain intensities the RAND-36 for health-related quality of life, the Tampa Scale for Kinesiophobia and the International Physical Activity Questionnaire. Although some improvement occurred in the one-year prospective follow-up from preoperative level, the trunk muscle strength remained low and the trunk extension and flexion strength ratio imbalanced. After a one-year rehabilitation, no between-group differences were found in any outcomes. Both groups improved their trunk muscle strength, disability and physical functioning-related dimensions of health-related quality of life and increased their physical activity. The low back and leg pain intensities as well as degree of kinesiophobia were low three months after surgery, and they remained rather unchanged during the intervention. In conclusion, LSF patients had trunk muscle strength deficits and imbalance preoperatively and at one year of follow-up after surgery with standard care. The postoperative 12-month home-exercise after LSF did not bring significant additional benefits compared to usual care. Further, individual variation in all outcomes were large in both groups. Thus, it is important to find those patients with delayed recovery who need more individualized rehabilitation. Keywords: rehabilitation, lumbar spine fusion, trunk muscle strength, pain, disability, health-related quality of life, physical activity http://urn.fi/URN:ISBN:978-951-39-8244-7

Total disc replacement compared to lumbar fusion: A randomised controlled trial with 2-year follow-up

Article

Full-text available

Jul 2009
EUR SPINE J

The study design includes a prospective, randomised controlled study comparing total disc replacement (TDR) with posterior fusion. The main objective of this study is to compare TDR with lumbar spinal fusion, in terms of clinical outcome, in patients referred to a spine clinic for surgical evaluation. Fusion is effective for treating chronic low back pain (LBP), but has drawbacks, such as stiffness and possibly adjacent level degradation. Motion-preserving options have emerged, of which TDR is frequently used because of these drawbacks. How the results of TDR compare to fusion, however, is uncertain. One hundred and fifty-two patients with a mean age of 40 years (21-55) were included: 90 were women, and 80 underwent TDR. The patients had not responded to a conservative treatment programme and suffered from predominantly LBP, with varying degrees of leg pain. Diagnosis was based on clinical examination, radiographs, MRI, and in unclear cases, diagnostic injections. Outcome measures were global assessment (GA), VAS for back and leg pain, Oswestry Disability Index, SF36 and EQ5D at 1 and 2 years. Follow-up rate was 100%, at both 1 and 2 years. All outcome variables improved in both groups between preoperative and follow-up assessment. The primary outcome measure, GA, revealed that 30% in the TDR group and 15% in the fusion group were totally pain-free at 2 years (P = 0.031). TDR patients had reached maximum recovery in virtually all variables at 1 year, with significant differences compared to the fusion group. The fusion patients continued to improve and at 2 years had results similar to TDR patients apart from numbers of pain-free. Complications and reoperations were similar in both groups, but pedicle screw removal as additive surgery, was frequent in the fusion group. One year after surgery, TDR was superior to spinal fusion in clinical outcome, but this difference had diminished by 2 years, apart from (VAS for back pain and) numbers of pain-free. The long-term benefits have yet to be examined.

A prospective, randomised controlled trial of femoral ring allograft versus a titanium cage in circumferential lumbar spinal fusion with minimum 2-year clinical results

Article

Full-text available

Nov 2005

The literature reports on the safety and efficacy of titanium cages (TCs) with additional posterior fixation for anterior lumbar interbody fusion. However, these papers are limited to prospective cohort studies. The introduction of TCs for spinal fusion has resulted in increased costs, without evidence of superiority over the established practice. There are currently no prospective controlled trials comparing TCs to femoral ring allografts (FRAs) for circumferential fusion in the literature. In this prospective, randomised controlled trial, our objective was to compare the clinical outcome following the use of FRA (current practice) to the use of TC in circumferential lumbar spinal fusion. Full ethical committee approval and institutional research and development departmental approval were obtained. Power calculations estimated a total of 80 patients (40 in each arm) would be required to detect clinically relevant differences in functional outcome. Eighty-three patients were recruited for the study fulfilling strict entry requirements (>6 months chronic discogenic low back pain, failure of conservative treatment, one- or two-level discographically proven discogenic low back pain). The patients completed the Oswestry Disability Index (ODI), Visual Analogue Score (VAS) for back and leg pain and the Short-Form 36 (SF-36) preoperatively and also postoperatively at 6, 12 and 24 months, respectively. The results were available for all the 83 patients with a mean follow-up of 28 months (range 24-75 months). Five patients were excluded on the basis of technical infringements (unable to insert TC in four patients and FRA in one patient due to the narrowing of the disc space). From the remaining 78 patients randomised, 37 received the FRA and 41 received the TC. Posterior stabilisation was achieved with translaminar or pedicle screws. Baseline demographic data (age, sex, smoking history, number of operated levels and preoperative outcome measures) showed no statistical difference between groups (p<0.05) other than for the vitality domain of the SF-36. For patients who received the FRA, mean VAS (back pain) improved by 2.0 points (p<0.01), mean ODI improved by 15 points (p=<0.01) and mean SF-36 scores improved by >11 points in all domains (p<0.03) except that of general health and emotional role. For patients who received the TC, mean VAS improved by 1.1 points (p=0.004), mean ODI improved by 6 points (p=0.01) and SF-36 improved significantly in only two of the eight domains (bodily pain and physical function). Revision procedures and complications were similar in both groups. In conclusion, this prospective, randomised controlled clinical trial shows the use of FRA in circumferential lumbar fusion to be associated with superior clinical outcomes when compared to those observed following the use of TCs. The use of TCs for circumferential lumbar spinal fusion is not justified on the basis of inferior clinical outcome and the tenfold increase in cost.

Combining scores from different patient reported outcome measures in meta-analyses: When is it justified?

Article

Full-text available

Dec 2006
HEALTH QUAL LIFE OUT

Combining outcomes and the use of standardized effect measures such as effect size and standardized response mean across instruments allows more comprehensive meta-analyses and should avoid selection bias. However, such analysis ideally requires that the instruments correlate strongly and that the underlying assumption of similar responsiveness is fulfilled. The aim of the study was to assess the correlation between two widely used health-related quality of life instruments for patients with chronic obstructive pulmonary disease and to compare the instruments' responsiveness on a study level. We systematically identified all longitudinal studies that used both the Chronic Respiratory Questionnaire (CRQ) and the St. George's Respiratory Questionnaire (SGRQ) through electronic searches of MEDLINE, EMBASE, CENTRAL and PubMed. We assessed the correlation between CRQ (scale 1-7) and SGRQ (scale 1-100) change scores and compared responsiveness of the two instruments by comparing standardized response means (change scores divided by their standard deviation). We identified 15 studies with 23 patient groups. CRQ change scores ranged from -0.19 to 1.87 (median 0.35, IQR 0.14-0.68) and from -16.00 to 3.00 (median -3.00, IQR -4.73-0.25) for SGRQ change scores. The correlation between CRQ and SGRQ change scores was 0.88. Standardized response means of the CRQ (median 0.51, IQR 0.19-0.98) were significantly higher (p < 0.001) than for the SGRQ (median 0.26, IQR -0.03-0.40). Investigators should be cautious about pooling the results from different instruments in meta-analysis even if they appear to measure similar constructs. Despite high correlation in changes scores, responsiveness of instruments may differ substantially and could lead to important between-study heterogeneity and biased meta-analyses.

Statistical power analysis for the behavioral sciences

Book

Jan 1988

J. Cohen

In Statistical Power Analysis for the Behavior Sciences (Revised Edition)

Book

Jan 1988

Jacob Cohen

Evaluating Common Outcomes for Measuring Treatment Success for Chronic Low Back Pain

Article

Oct 2011
SPINE

Systematic review. To identify, describe, and evaluate common outcome measures in patients with chronic low back pain (CLBP). The treatment of CLBP has been associated with multiple clinical challenges. Further complicating this is the myriad of outcome scores used to assess treatment of CLBP. These scores have been used to examine different domains of patient satisfaction and quality of life in the literature. Critical assessment of the frequency, parity, and the quality of these outcomes are essential to improve our understanding of CLBP. A systematic review of the English-language literature was undertaken for articles published from January 2001 through December 31, 2010. Electronic databases and reference lists of key articles were searched to identify measures used to evaluate outcomes in six different domains in patients with CLBP. The titles and abstracts of the peer-reviewed literature of LBP were searched to determine which of these measures were most commonly reported in the literature and which have been validated in populations with CLBP. We identified 75 outcome measures cited to evaluate CLBP. Twenty-nine of these outcome measures were excluded because of only a single citation leaving 46 measures for the evaluation. The most commonly used functional outcomes were the Oswestry Disability Index, Roland Morris Disability Index, and range of motion. For pain, the Numeric Pain Rating Scale, Brief Pain Inventory, Pain Disability Index, McGill Pain Questionnaire, and visual analog scale were most commonly cited. For psychosocial function, the Fear Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, and Beck Depression Inventory were most commonly used. For generic quality of life, short form 36, Nottingham Health Profile, short form 12, and Sickness Impact Profile were the most common measures. For objective measures, the work status/return to work, complications or adverse events, and medications used were the most commonly cited. For preference-based measures, the Euro-Quol 5 dimensions and short form 6 dimensions were most commonly cited. The validity, reliability, responsiveness, universality, and potential proprietary requirements are summarized for each. Outcome measures should be routinely assessed in patients with CLBP. The choice of appropriate outcome measure should be influenced by the study objectives and design, as well as properties of the particular measure within the context of CLBP. Recommendation 1: When selecting the appropriate outcome measures for clinical or research purposes, consider domains that best measure what are most important to patients. Measures that are valid, reliable, and responsive to change should be considered first. Other considerations include the number of items required (especially in the context of multiple measures), whether the measure is validated in the relevant language, and the associated costs or fees. Strength: Strong Recommendation 2: Domains of greatest importance include pain, function, and quality of life. If cost utilization is a priority, then preference-based measures should be considered. For pain, we recommend the VAS and NRPS because of their ease of administration and responsiveness. For function, we recommend the ODI and RMDQ. The SF-36 and its shorter versions are most commonly used and should be considered if quality of life is important. If cost utility is important, consider the EQ-5D or SF-6D. Psychosocial tests are best used as screening tools prior to surgery because of their lack of responsiveness. Complications should always be assessed as a standard of clinical practice. Return to work and medication use are complicated outcome measures and not recommended unless the specific study question is focused on these domains. Consider staff and patient burden when prioritizing one's battery of measures.

Low Back Pain in Primary Care Costs of Care and Prediction of Future Health Care Utilization

Article

Aug 2010
SPINE

Cost of illness study alongside a randomized controlled trial. To describe the costs of care for patients with low back pain (1) and to identify patient characteristics as predictors for high health care cost during a 1-year follow-up (2). Low back pain (LBP) is one of the leading causes of high health care costs in industrialized countries (Life time prevalence, 70%). A lot of research has been done to improve primary health care and patients' prognosis. However, the cost of health care does not necessarily follow changes in patient outcomes. General practitioners (n = 126) recruited 1378 patients consulting for LBP. Sociodemographic data, pain characteristics, and LBP-related cost data were collected by interview at baseline and after 6 and 12 months. Costs were evaluated from the societal perspective. Predictors of high cost during the subsequent year were studied using logistic regression analysis. Mean direct and indirect costs for LBP care are about twice as high for patients with chronic LBP compared to acutely ill patients. Indirect costs account for more than 52% to 54% of total costs. About 25% of direct costs refer to therapeutic procedures and hospital or rehabilitational care. Patients with high disability and limitations in daily living show a 2- to 5-fold change for subsequent high health care costs. Depression seems to be highly relevant for direct health care utilization. Interventions designed to reduce high health care costs for LBP should focus on patients with severe LBP and depressive comorbidity. Our results add to the economic understanding of LBP care and may give guidance for future actions on health care improvement and cost reduction.

Statistical power ANALYSIS for the Behavioral sciences

Article

Jan 1988
J AM STAT ASSOC

Jacob Cohen

Incluye bibliografía e índice

Life Quality After Instrumented Lumbar Fusion in the Elderly

Article

Apr 2010
SPINE

Retrospective cohort study. To review the clinical outcome on elderly patients after spinal instrumented fusion. Although lumbar fusion in elderly patients has increased rapidly, there are only few and conflicting results regarding the clinical outcome. This retrospective review evaluated 195 patients aged 70 to 89 who underwent lumbar spinal fusion. All 195 patients had follow-ups after 6 weeks, 1 year, and 2 years, including clinical evaluation as well as visual analog scale score, Oswestry Disability Index, and Short Form health survey. Elderly patients benefit from spinal fusion. Back and leg pains were initially reduced by >50%, with a slight deterioration over a 2-year period. Pain medication was reduced in 69% of the patients, and 89.7% of the patients were satisfied. Age itself cannot be considered a contraindication.

Are Preoperative Health-Related Quality of Life Scores Predictive of Clinical Outcomes After Lumbar Fusion?

Article

May 2009
SPINE

Prospective longitudinal cohort. This study evaluated the effect of preoperative Mental Component Summary (MCS), preoperative Physical Component Summary (PCS), preoperative Oswestry Disability Index (ODI), back pain predominance, body mass index (BMI), age, smoking status, and workers' compensation on health-related quality of life after lumbar fusion. These factors were selected as they are readily available and may influence a surgeon's decision-making process. Measures of health-related quality of life are increasingly used to evaluate treatment effectiveness. However, their use as a predictive tool to determine which patients will improve has been limited. The Short Form 36 (SF-36) and ODI were collected before surgery and two years after surgery in 489 patients undergoing lumbar fusion for degenerative disorders. Linear regression modeling was used to determine the effect of preoperative MCS, preoperative PCS, preoperative ODI, back pain predominance, BMI, age, smoking status, and workers' compensation on the change in ODI and change in SF-36 PCS two years after lumbar fusion. Patients with better preoperative MCS (P = 0.008) and worse preoperative ODI scores (P < 0.0001) achieved greater ODI improvement. Workers' compensation patients did significantly worse (P = 0.03). Patients with better preoperative MCS (P = 0.0004), better preoperative PCS (P = 0.0155), and worse preoperative ODI scores (P = 0.0210) achieved greater PCS improvement. Those on workers' compensation had lower changes in PCS, an effect that was nearly significant (P = 0.0644). There were no significant correlations between PCS and ODI improvement and back pain predominance, BMI, age, and smoking status. Attempts at determining threshold values for MCS, PCS, and ODI that are predictive of a patient achieving minimum clinically important difference for PCS and ODI were unsuccessful. Patients with good preoperative MCS and poor preoperative ODI scores who are not on workers' compensation are more likely to improve after lumbar fusion. Threshold values for MCS, PCS, and ODI predictive of a patient achieving minimum clinically important difference for PCS and ODI could not be determined.

A prospective study of Autologous Growth Factors (AGF) in lumbar interbody fusion

Article

Feb 2006
SPINE J

Numerous preclinical and clinical studies have reported on the use of platelet concentrates to promote tissue healing. The results in spinal fusion applications are limited and controversial. The purpose of the current prospective clinical cohort study is to assess the effect of Autologous Growth Factors (AGF) on lumbar interbody fusion with specific attention paid to determination of clinical and radiographic outcomes. Prospective clinical study Candidates for anterior-posterior lumbar fusion with diagnosis of degenerative disc disease and/or up to grade I spondylolytic spondylolisthesis based on positive provocative discography. Clinical (visual analogue pain scale/functional outcome assessment) and radiographic outcomes (fusion on computed tomography at 6 months and plain radiographs at 12 and 24 months). Thirty-seven patients were assigned to standard anterior-posterior interbody fusion L2-S1 (single or two-level) using iliac crest bone graft (autograft group: 22 patients with 32 levels operated) or allograft combined with autogenous growth factors (AGF group: 15 patients with 25 levels operated). Radiographic outcomes were collected at 6 months postsurgery with computed tomography and at 12 and 24 months with plain radiographs. Pre- and postoperative clinical outcome measures included visual analog scores (VAS) for back and leg pain (0-10), SF-36 scores, and Oswestry disability determination. Average clinical and radiographic follow-up for the autograft group was 24.3+/-5.6 months (12-36 months) and AGF was 25.7+/-7.5 (6-40 months). Fusion incorporation at each end plate was determined at 56% in both autograft and AGF (p=NS) patients based on computed tomography at 6 months with minimal subsidence noted and no direct correlation between the incidence or degree of cage subsidence and bone graft technique. The 12- and 24-month radiographic results confirmed an 85% arthrodesis rate for the autograft patients, whereas the AGF patients had an 89% fusion rate (p=NS). Clinical outcomes were similar for both groups and no significant differences were noted for pain or functional outcome improvements. AGF combined with an allograft carrier is equivalent in radiographic and clinical outcomes to autograft in one- or two-level lumbar interbody fusion with supplemental posterior fixation and, thus, eliminates any morbidity from iliac crest bone graft harvesting. AGF combined with an appropriate carrier is a reasonable alternative to autograft and expensive bone induction technologies. Further research is still required to examine the optimum carriers, preparation and formulation, and platelet concentrations for this technology.

Version 9.1 . College Station, TX : Stata Corporation LP

Jan 2005

Stata Statistical Software

Stata Statistical Software. Version 9.1. College Station, TX : Stata Corporation LP ; 2005.

Evaluating the Correlation and Responsiveness of Patient-Reported Pain With Function and Quality-of-Life Outcomes After Spine Surgery

Abstract

No full-text available

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