Difference In Back Pain Research Articles

Does Epidural Corticosteroid Application During Spinal Surgery Reduce Postoperative Pain?: An Adjunct to Multimodal Analgesia.

A prospective, randomized, placebo-controlled, double-blinded study. To examine the effect of intraoperative epidural administration of Depo-Medrol on postoperative back pain and radiculitis symptoms in patients undergoing Transforaminal Lumbar Interbody Fusion (TLIF). Postoperative pain is commonly experienced by patients undergoing spinal fusion surgery. Adequate management of intense pain is necessary to encourage early ambulation, increase patient satisfaction, and limit opioid consumption. Intraoperative steroid application has been shown to improve postoperative pain in patients undergoing lumbar decompression surgeries. There have been no studies examining the effect of epidural steroids on both back pain and radicular pain in patients undergoing TLIF. In all, 151 patients underwent TLIF surgery using rh-BMP2 with 3 surgeons at a single institution. Of those, 116 remained in the study and were included in the final analysis. Based on a 1:1 randomization, a collagen sponge saturated with either Saline (1cc) or Depo-Medrol (40mg/1cc) was placed at the annulotomy site on the TLIF level. Follow-up occurred on postoperative days 1, 2, 3, 7, and postoperative months 1, 2, and 3. Lumbar radiculopathy was measured by a modified symptom- and laterality-specific Visual Analog Scale (VAS) regarding the severity of back pain and common radiculopathy symptoms. The patients who received Depo-Medrol, compared with those who received saline, experienced significantly less back pain on postoperative days 1, 2, 3, and 7 ( P <0.05). There was no significant difference in back pain beyond day 7. Radiculopathy-related symptoms such as leg pain, numbness, tingling, stiffness, and weakness tended to be reduced in the steroid group at most time points. This study provides Level 1 evidence that intraoperative application of Depo-Medrol during a TLIF surgery with rh-BMP2 significantly reduces back pain for the first week after TLIF surgery. The use of epidural Depo-Medrol may be a useful adjunct to multimodal analgesia for pain relief in the postoperative period.

Comparison of minimally invasive transforaminal lumbar interbody fusion (Mis-TLIF) with bilateral decompression via unilateral approach and open-TLIF with bilateral decompression for degenerative lumbar diseases: a retrospective cohort study

ObjectivePresently, no study has compared the clinical outcomes of minimally invasive transforaminal lumbar interbody fusion (Mis-TLIF) with bilateral decompression via the unilateral approach (BDUA) and Open-TLIF with bilateral decompression for degenerative lumbar diseases (DLD). We aimed to compare the clinical outcomes of through Mis-TLIF combined with BDUA and Open-TLIF with bilateral decompression for the treatment of DLD, and reported the learning curve of the procedure of MIS-TLIF with BDUA.MethodsWe retrospectively analyzed the prospectively collected data of consecutive DLD patients in the two groups from January 2016 to January 2020.ResultsThe operative time (OT) was significantly longer in the Mis-TLIF group (n = 113) than in the Open-TLIF group (n = 135). The postoperative drainage volume (PDV) and length of stay (LOS) were significantly higher in the Open-TLIF group than in the Mis-TLIF group. Additionally, the complication rate was significantly higher in the Open-TLIF group than in the Mis-TLIF group (14.8% vs. 6.2%, P = 0.030), while there was no significant difference in the reoperation and adjacent segment disease rates between the two groups. There were no significant differences in back pain and leg pain Numerical Rating Scale (NRS) scores and Oswestry Disability Index (ODI) between the two groups preoperatively, at discharge, and 2 years postoperatively. Patients in both groups showed significant improvements in NRS scores and ODI scores after surgery. OT was negatively correlated with the number of surgeries performed (P < 0.001, r = −0.43). The learning curve of Mis-TLIF with BDUA was steep, with OT tapered to steady state in 43 cases.ConclusionCompared with Open-TLIF with bilateral decompression, Mis-TLIF with BDUA can achieve equivalent clinical outcomes, lower PDV and LOS, and lower complication rates. Although this procedure took longer, it could be a viable alternative for the treatment of DLD after a steep learning curve.

Modic Changes of the Cervical and Lumbar Spine and Their Effect on Neck and Back Pain: A Systematic Review and Meta-Analysis.

Systematic Review. To systematically review the current literature and perform a meta-analysis on patients with cervical or lumbar spine Modic changes to determine if their baseline axial back pain and disability are comparable to patients without Modic changes. A systematic review of the PubMed database was conducted in accordance with PRISMA guidelines. A meta-analysis was performed to compare the mean differences in back pain, leg pain, and disability based on the presence of cervical or lumbar spine Modic changes. A subgroup analysis of the different types of Modic changes was conducted to determine if Modic type affected back pain or disability. - After review of 259 articles, 17 studies were included for meta-analysis and ten studies were included for qualitative synthesis. In the lumbar spine, 10 high-quality studies analyzed Visual Analog Scale (VAS) back pain, 10 evaluated VAS leg pain, and 8 analyzed Oswestry Disability Index. VAS back pain (mean difference (MD), -.38; 95% CI, -.61 - .16) and Oswestry disability index (MD -2.52; 95% CI, -3.93 - -1.12) were significantly lower in patients without Modic changes. Modic change subtype was not associated with differences in patient-reported outcomes. Patients with cervical spine Modic changes did not experience more severe pain than those without MC. Modic changes in the lumbar spine are not associated with clinically significant axial low back pain severity or patient disability. Similar to the lumbar spine, Modic changes in the cervical spine are not associated with symptom severity, but they are associated with pain duration.

P131. Long term effectiveness of full endoscopic versus open microdiscectomy for sciatica: a 24-month RCT

<h3>BACKGROUND CONTEXT</h3> Open microdiscectomy (OM) is the current standard procedure to treat sciatica caused by lumbar disk herniation. Percutaneous transforaminal endoscopic discectomy (PTED) is an alternative procedure which is performed under local anesthesia. Here we report the long-term results. <h3>PURPOSE</h3> To assess long-term effectiveness of PTED vs OM at 24 months. <h3>STUDY DESIGN/SETTING</h3> A pragmatic, multicenter, non-inferiority, randomized controlled trial. <h3>PATIENT SAMPLE</h3> A total of 613 were randomized to either PTED (n=304) or OM (n=309). <h3>OUTCOME MEASURES</h3> The primary outcome is self-reported leg pain measured by the 0-100 Visual Analogue Scale (VAS) with a noninferiority margin of 5. Secondary outcomes include self-reported ODI, back pain, health-related quality of life and self-perceived recovery. <h3>METHODS</h3> A pragmatic, multicenter, non-inferiority, randomized controlled trial was conducted in which patients were randomized between PTED or OM in a 1:1 ratio. The primary outcome is self-reported leg pain measured by the 0-100 visual analogue scale (VAS) with a noninferiority margin of 5. Secondary outcomes include self-reported ODI, back pain, health-related quality of life and self-perceived recovery. Outcomes were measured the day following surgery, at 2, 4, and 6 weeks, and at 3, 6, 9,12 and 24 months. <h3>RESULTS</h3> At 24 months, 92% of the patients had followup data available. At 24 months, the adjusted between group difference of the VAS leg pain was 7.3 in favor of PTED (17.0 ± 22.4 vs 24.3 ± 26.5;). There was no difference in back pain at 24 months between both groups. All other secondary patient-reported outcomes showed small but statistically more favorable results for the PTED-group. Complications rates and rate of recurrent disc surgery appear similar between both groups. <h3>CONCLUSIONS</h3> At long-term, PTED remains noninferior to OM in the treatment of sciatica at 24 months of followup and clinical outcomes appear to be more favorable for PTED, albeit not exceeding established MCIDs. Therefore, based on these study results, implementation of PTED as a treatment option for sciatica is warranted. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Safety and Reoperation Rates in Non-instrumented Lumbar Fusion Surgery: Secondary Report From a Randomized Controlled Trial of ABM/P-15 vs Allograft With Minimum 5 years Follow-Up.

Randomized controlled trial with minimum of 5-years follow-up. The purpose of this study is to evaluate the peri- and postoperative complications rates, ectopic bone migration, and reoperation rates, and secondly evaluate the 5-year patient reported outcomes (PROs), in patients treated with decompression and non-instrumented posterolateral fusion with ABM/P-15 or allograft. Patients with degenerative spondylolisthesis were enrolled in a Randomized Clinical Trial and randomized 1:1 to either ABM/P-15 or allograft bone. Patient Reported Outcomes were collected at 5-year follow-up, and patients were invited to a clinical follow-up including a computed tomography scan (CT) to evaluate signs of osteolysis, ectopic bone formation, and bone migration. Of 101 subjects enrolled in the primary study, 83 patients were available for the 5-year follow-up. We found a statistically significant difference in back pain and Oswestry Disability Index between groups. Fifty-eight patients agreed to participate in the CT study. Sixty percentage in the ABM/P-15 group vs 30% in the allograft group was classified as fused (P = .037). There were no differences in complications, reoperation-, or infection rates between the 2 groups. We found 2 patients with migration of graft material. Both patients were asymptomatic at minimum 5-year follow-up. Our study indicated that complication rates are no higher in patients treated with ABM/P-15 than allograft. We found significantly higher fusion rates in the AMB/P-15 group than in the allograft group, and patients in the ABM/P-15 group reported less back pain and lower disability score at 5-year follow-up.

Efficacy and safety of unilateral biportal endoscopy compared with microscopic decompression in the treatment of lumbar spinal stenosis: A protocol for systematic review and meta-analysis.

Objective:Systematic evaluation of the efficacy and safety of unilateral biportal endoscopic decompression in the treatment of lumbar spinal stenosis.Methods:We conducted a systematic literature search and compared the randomized controlled trials (RCTs) and retrospective studies of unilateral biportal endoscopy (UBE) and microscopic decompression (MD) in the treatment of lumbar spinal stenosis from several databases.Results:Seven studies were included. The results of meta-analysis showed that the operation time of UBE was shorter than that of MD. [SMD = −0.443, 95% CI (−0.717, −0.169), P = .002]. Compared with MD, the patients’ back pain was slighter on the 1st day, 1–2 months and 6 months after UBE. During the long-term follow-up, there was no significant difference in back pain between MD and UBE [SMD = −0.519, 95% CI (−0.934, −0.104), P = .014]. There was no significant difference in lower limb visual analogue score (VAS) score between UBE decompression and MD [SMD = −0.105, 95% CI (−0.356, 0.146), P = .412]. The results of meta-analysis showed that the C-reactive protein (CRP) level of UBE was lower than that of MD [weighted mean difference = −1.437, 95% CI (−2.347, −0.527), P = .002]. There was no significant difference in other clinical effects between the 2 groups.Conclusion:The operation time of UBE was shorter than that of MD, and it was superior to micro decompression in early back VAS score, lower limb VAS score and early postoperative CRP level. There was no statistical difference between UBE and MD in other outcomes.

Effectiveness Prenatal Yoga on Back Pain of Pregnant Women in Third Trimester

Background: During pregnancy, there are usually a lot of complaints or discomforts that are common. One of them is back pain that occurs in third-trimester pregnant women. One effort to deal with back pain complaints is prenatal yoga. Prenatal yoga can flex the muscles around the spine and flexibility of the body.&#x0D; Result: The results showed that before doing Prenatal Yoga trimester III pregnant women experienced moderate pain as many as 31 people (96.9%) while after doing Prenatal Yoga became mild pain as many as 29 people (90.6%). The statistical test used in this study is the Wilcoxon test and the significance value p = 0.00 (p&gt; 0.05) means that there are significant differences in back pain before and after prenatal yoga. Using the result of this study, it is hoped that prenatal yoga techniques can be applied specifically to overcome complaints of back pain in third-trimester pregnant women.&#x0D; Method: This study uses the One Group Pre Test-Posttest design using experimental methods. The sample in this study was third-trimester pregnant women who experienced back pain with a large sample of 32 respondents. This sample was taken using the Total Sampling method and the measuring instrument used was the Visual Analog Scale (VAS).&#x0D; Conclusion: The conclusion of this study is the effectiveness of prenatal yoga on back pain in trimester III pregnant women.

Effectiveness Prenatal Yoga on Back Pain of Pregnant Women in Third Trimester

Background: During pregnancy, there are usually a lot of complaints or discomforts that are common. One of them is back pain that occurs in third-trimester pregnant women. One effort to deal with back pain complaints is prenatal yoga. Prenatal yoga can flex the muscles around the spine and flexibility of the body.&#x0D; Result: The results showed that before doing Prenatal Yoga trimester III pregnant women experienced moderate pain as many as 31 people (96.9%) while after doing Prenatal Yoga became mild pain as many as 29 people (90.6%). The statistical test used in this study is the Wilcoxon test and the significance value p = 0.00 (p&gt; 0.05) means that there are significant differences in back pain before and after prenatal yoga. Using the result of this study, it is hoped that prenatal yoga techniques can be applied specifically to overcome complaints of back pain in third-trimester pregnant women.&#x0D; Method: This study uses the One Group Pre Test-Posttest design using experimental methods. The sample in this study was third-trimester pregnant women who experienced back pain with a large sample of 32 respondents. This sample was taken using the Total Sampling method and the measuring instrument used was the Visual Analog Scale (VAS).&#x0D; Conclusion: The conclusion of this study is the effectiveness of prenatal yoga on back pain in trimester III pregnant women.

EFEKTIVITAS SENAM HAMIL MENURUT MANUABA TERHADAP NYERI PUNGGUNG IBU HAMIL TRIMESTER III

Back pain is one of the most common complaints experienced by pregnant women in their third trimester of pregnancy. Of the 172 pregnant women in the third trimester of pregnancy, 80% (137 people) experienced back pain. One way to deal with back pain is to do pregnancy exercises. There are various types of pregnancy exercises, this study uses pregnancy exercises according to Manuaba. The purpose of this study is to study the effect of pregnancy training according to Manuaba on back pain in pregnant women of the third trimester in Metro City. The design of this study is a pseudo-experimental research with a single group approach. The population in this study was all third trimester pregnant women at the Puskesmas in Metro City. The sampling technique was a temporary sample with a sample of pregnant women in the third trimester with back pain complaints. Data analysis in this study uses univariate analysis with frequency and bivariate percentage analysis with t-test. The results of this study show that there is a difference in back pain before and after pregnancy training, according to Manuaba, with a mean difference of 3.06. In conclusion, there are effects of exercise, according to Manuaba, on back pain in pregnant women. These results are expected to be a source of reference for health workers to perform pregnancy exercises according to Manuaba to pregnant women to reduce back pain in pregnant women.

Patient Satisfaction Following Minimally Invasive and Open Surgeries for Adult Spinal Deformity

Patient satisfaction has become an important variable in assessing outcomes after spine surgery. Although minimally invasive surgery (MIS) techniques have become popular owing to reduced perioperative complications compared with open deformity surgery, whether patient-reported postoperative satisfaction differ between the 2 surgical approaches is unclear. The aim of this study was to characterize postoperative patient-reported outcomes (PRO) in patients who underwent open surgery or MIS for adult spinal deformity (ASD). PRO scores were prospectively collected for patients undergoing deformity correction surgery between 2016 and 2018. Inclusion criteria were age >18 years, ASD, and completed PRO surveys. Patient demographic, clinical, and radiographic data and PRO survey responses were analyzed. A post hoc analysis comparing patients who were satisfied with their outcome and those who were unsatisfied was performed. Forty patients who underwent operative management of ASD (19 in the open surgery group and 21 in the MIS group) met the criteria for inclusion in this study. Patients in the MIS group reported higher mental health and self-image scores at 6 months; however, at the 12-month follow-up, both the open surgery and MIS groups reported minimal clinically important differences in back pain, leg pain, and functional status. Patient satisfaction scores did not differ based on surgical approach or intraoperative complications. PRO after open surgery and after MIS for ASD reflected successful outcomes with significant improvements in PRO survey scores but with subtle differences in the postoperative recovery process. The MIS group reported faster recovery with earlier improvement in self-image and mental health scores, which may stem from correction of smaller deformities. At the 12-month follow-up, postoperative satisfaction was high for the majority of patients in both groups.

Clinical and Radiological Features Predicting Intervertebral Autofusion after Successful Antibiotic Therapy in Pyogenic Vertebral Osteomyelitis

Background: Pyogenic vertebral osteomyelitis (PVO) is a bacterial infection involving the intervertebral disc, vertebral body, and paravertebral soft tissues. Damaged intervertebral structure is a major cause of persistent back pain even after successful antibiotic therapy, which can be improved by achieving autofusion or via additional surgical fixation. In this study, we analyzed the clinical and radiological features predicting intervertebral autofusion after successful antibiotic therapy in lumbar PVO. Methods: This study was retrospectively conducted with 32 patients (20 men and 12 women) diagnosed with lumbar PVO that was completely cured with no recurrences after antibiotic therapy. They were divided into two groups with (group A, n = 18) and without (group B, n = 14) intervertebral autofusion at six-month follow-up. Differences in back pain, blood inflammatory markers, and radiological features of PVO on simultaneous 18F-fluorodeoxyglucose positron emission tomography/magnetic resonance imaging (18F-FDG-PET/MRI) of the intervertebral structure between the two groups were analyzed. Results: The mean duration of antibiotic therapy was 41.44 ± 14.21 (21–89) days. Group A showed a statistically higher erythrocyte sedimentation ratio (ESR; 59.28 ± 32.33 vs. 33.93 ± 18.76 mm/h, p = 0.014; normal range of ESR < 25), maximum standardized 18F-FDG uptake (SUVmax; 5.56 ± 1.86 vs. 3.98 ± 1.40, p = 0.013), and sustained extensive edematous changes on T2-weighted fat saturation (T2FS) MRI (p = 0.015) immediately after successful antibiotic therapy. However, no significant differences were observed in back pain, C-reactive protein, or the distribution of 18F-FDG uptake/contrast enhancement on 18F-FDG-PET/MRI (p > 0.05). Conclusions: Higher ESR and SUVmax of the intervertebral structure and sustained extensive edematous change on T2FS MRI immediately after successful antibiotic therapy are related with subsequent intervertebral autofusion, which should be carefully considered when assessing therapeutic response in PVO.

Does the Predominant Pain Location Influence Functional Outcomes, Satisfaction, and Return to Work After Minimally Invasive Transforaminal Lumbar Interbody Fusion For Degenerative Spondylolisthesis?

Retrospective review of prospectively collected data. The objective of this study was to determine how different combinations of preoperative back pain (BP) and leg pain (LP) may influence functional outcomes, patient satisfaction and return to work (RTW) in patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) for degenerative spondylolisthesis. Surgical decision-making is often based on the traditional assumption that the predominance of lower extremity symptoms is a stronger indication for lumbar spine surgery. Surprisingly, there is a paucity of literature supporting this notion and the isolated impact of the preoperative pattern of pain on outcome remains unclear. Prospectively collected data for patients who underwent primary MIS-TLIF for degenerative spondylolisthesis were reviewed. Patients were categorized into 3 groups depending on predominant pain location: LP predominant (LP>BP), back pain predominant [(BPP); BP>LP] and equal pain predominance (BP=LP). Patients were prospectively followed for at least 2 years. In total, 781 patients were included: 33.4% LP predominant, 28.7% BPP and 37.9% equal pain predominance cases. The BPP group was significantly younger (P=0.005) and showed a trend towards poorer baseline Short-Form-36 Mental Component Summary (P=0.069). After adjusting for baseline differences, there was no significant difference in BP, LP, Oswestry Disability Index (ODI), SF-36 Physical Component Summary, and SF-36 Mental Component Summary between the 3 groups at all time points (P>0.05) except for poorer 1-month ODI in the BPP group (P=0.010). The rate of minimal clinically important difference attainment for ODI and SF-36 Physical Component Summary, satisfaction, expectation fulfilment and RTW were also similar (P>0.05). The functional outcomes, quality of life and satisfaction after MIS-TLIF were similar, regardless of the predominant pain location. Equal proportions of patients achieved the minimal clinically important difference and RTW. In the context of proper indications, these results suggest that MIS-TLIF can be equally effective for patients with varying combinations of BP or LP. Level III-nonrandomized cohort study.

Efektivitas Prenatal Yoga Dengan Teknik Birth Ball Pada Ibu Hamil Terhadap Nyeri Punggung

Introduction: third-trimester pregnant women will experience discomfort such as increased shortness of breath, leg cramps, and back pain. Muscle imbalance around the pelvis that causes back pain. A method to treat the back pain is through prenatal yoga by using a birth ball which can increase blood circulation to the womb, as well as the ability of the pelvic muscles when the delivery time is incoming and can reduce back pain. Objectives: The purpose of this study is to analyze the effectiveness of prenatal yoga with Birth Ball Technique to pregnant women with back pain. Methods: Experimental design methodology with unpaired two-group difference test. The prerequisite test for the metrics uses the two-sample unpaired T-Test. The difference test used is the Mann-Whitney test. Results: The results of research using birth balls for pregnant women showed no back pain namely 6 pregnant women (42.8). pregnant women with moderate pain (28.5%), 3 mild pain pregnant women (21, 3%), and 1 pregnant woman with severe pain (7.1%). The results of the study without birth ball given show that most pregnant women fall into the moderate pain category as many as 6 respondents or 42.8%, the mild category is 4 respondents (28.5%), 2 pregnant women are in the painless category (14, 2%) and 2 respondents in the severe pain category (14.2%). Conclusions: The average result of the statistical test of the difference in the use of the birth ball with the sig value of 0.378&gt; 0.05, it can be concluded that there is no difference in back pain in the birth ball technique group with the group with no birth ball.

Pelvic Tilt Exercise Against Lower Back Pain For Third Trimester Pregnant Women In Rejang Lebong Regency

Changes that occur during pregnancy may be difficult during pregnancy and during childbirth. Complications during pregnancy include back pain, low back pain, pelvic pain, and shortness of breath. One of the most common discomforts is back pain. Back pain is the most common musculoskeletal problem in pregnant women. It is estimated that 50% to 70% of pregnant women suffer from this problem. The purpose of this study was to determine the effect of pelvic tilt training on the reduction of back pain in third-trimester pregnant women in the Rejang Lebong Regency. The research variable was back pain in third-trimester pregnant women measured before and after pelvic tilt exercises. The research was conducted in May-July 2020. This type of research is Quasi-Experimental, the results of the sample calculation obtained a sample of 32 people. The statistical test used to see the reduction in back pain before and after Pelvic tilt exercise is non-parametric Wilcoxon. Results of back pain in the third trimester of pregnant women after being given pelvic tilt exercise with p &lt;0.005. There is a difference in back pain in the third trimester of pregnant women after pelvic tilt exercises.

Hippocampus shape deformation: a potential diagnostic biomarker for chronic back pain in women.

Sex differences in the quality and prevalence of chronic pain are manifold, with women generally presenting higher incidence and severity. Uncovering chronic pain-related sex differences inform neural mechanisms and may lead to novel treatment routes. In a multicenter morphological study (total n = 374), we investigated whether the shape of subcortical regions would reflect sex differences in back pain. Given the hormone-dependent functions of the hippocampus, and its role in the transition to chronic pain, this region constituted our primary candidate. We found that the anterior part of the left hippocampus (alHP) presented outer deformation in women with chronic back pain (CBP), identified in CBP in the United States (n = 77 women vs n = 78 men) and validated in a Chinese data set (n = 29 women vs n = 58 men with CBP, in contrast to n = 53 female and n = 43 male healthy controls). Next, we examined this region in subacute back pain who persisted with back pain a year later (SBPp; n = 18 women vs n = 18 men) and in a subgroup with persistent back pain for 3 years. Weeks after onset of back pain, there was no deformation within alHP, but at 1 and 3 years women exhibited a trend for outer deformation. The alHP partly overlapped with the subiculum and entorhinal cortex, whose functional connectivity, in healthy subjects, was associated with emotional and episodic memory related terms (Neurosynth, reverse inference). These findings suggest that in women the alHP undergoes anatomical changes with pain persistence, highlighting sexually dimorphic involvement of emotional and episodic memory-related circuitry with chronic pain.

Clinical Features of Sarcopenia in Patients With Lumbar Spinal Stenosis.

Cross-sectional design. To investigate the prevalence of sarcopenia and identify factors associated with sarcopenia in patients with lumbar spinal stenosis (LSS). Patients with LSS have a higher prevalence of sarcopenia compared with healthy older adults. However, the clinical features of sarcopenia in patients with LSS are poorly understood and the factors affecting sarcopenia in patients with LSS remain unclear. Patients diagnosed with LSS based on clinical examination and magnetic resonance imaging findings, and referred to physical therapy, were enrolled. Muscle mass was measured using bioelectrical impedance using InBody S10. We collected a numerical rating scale (NRS) for back pain, the 36-Item Short-Form Survey (SF-36), the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ), bone mineral density (BMD), and radiographic measurements of spinal alignment. Sarcopenia was defined according to the Asian Working Group for Sarcopenia guidelines and patients were classified into sarcopenia or nonsarcopenia groups. A total of 178 patients were enrolled: 35 in the sarcopenia group and 143 in the nonsarcopenia group. The prevalence of sarcopenia was 19.7%. The average percent of slip (% slip) among patients in the sarcopenia group was significantly higher compared with those in the nonsarcopenia group (P < 0.05). Body mass index (BMI), BMD, physical function as assessed by the SF-36, and gait disturbance as assessed by the JOABPEQ were significantly lower in the sarcopenia group compared with those in the nonsarcopenia group (P < 0.05). A trend was observed toward between-group differences in back pain on the NRS (P < 0.1). In the logistic regression analysis, significant associations were seen between sarcopenia and % slip (odds ratio 1.15, 95% CI 1.01-1.30). Patients with LSS and sarcopenia have a higher degree of slippage and lower BMI, BMD, and physical function, and reported more severe low back pain, compared with those without sarcopenia. 4.

Ramucirumab in the second-line for patients with hepatocellular carcinoma and elevated alpha-fetoprotein: patient-reported outcomes across two randomised clinical trials

BackgroundSymptoms of advanced hepatocellular carcinoma (HCC) represent a substantial burden for the patient and are important endpoints to assess when evaluating treatment. Patient-reported outcomes were evaluated in subjects with advanced HCC and baseline alpha-fetoprotein (AFP) ≥400 ng/mL treated with second-line ramucirumab.Patients and methodsPatients with AFP≥400 ng/mL enrolled in the REACH or REACH-2 phase 3 studies were used in this analysis. Eligible patients had advanced HCC, Child-Pugh A, Eastern Cooperative Oncology Group performance status 0/1 and prior sorafenib. Patients received ramucirumab 8 mg/kg or placebo once every 2 weeks. Disease-related symptoms and health-related quality of life (HRQoL) were assessed with the Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index (FHSI)-8 and EuroQoL-5-Dimensions (EQ-5D) instruments, respectively. Time to deterioration (TTD) (≥3-point decrease in FHSI-8 total score;≥0.06-point decrease in EQ-5D score, from randomisation to first date of deterioration) was determined using Kaplan-Meier estimation and the Cox proportional hazards model. Both separate and pooled analyses for REACH AFP≥400 ng/mL and REACH-2 patients were conducted.ResultsIn the pooled population with AFP ≥400 ng/mL (n=542; ramucirumab, n=316; placebo, n=226), median TTD in FHSI-8 total score was prolonged with ramucirumab relative to placebo (3.3 vs 1.9 months; HR 0.725; (95% CI 0.559 to 0.941); p=0.0152), including significant differences in back pain (0.668; (0.497 to 0.899); p=0.0044), weight loss (0.699; (0.505 to 0.969); p=0.0231) and pain (0.769; (0.588 to 1.005); p=0.0248) symptoms. TTD in EQ-5D score was not significantly different between ramucirumab and placebo groups (median 2.9 vs 1.9 months). Results in the individual trials were consistent with these findings.ConclusionsRamucirumab in second-line treatment of advanced HCC demonstrates consistent benefit in the delay of deterioration in disease-related symptoms with no worsening of HRQoL. Taken with previously demonstrated ramucirumab-driven survival benefits in this setting, these data may inform patient–clinician discussions about the benefit–risk profile of this therapy.Trial registration numberNCT01140347; NCT02435433, NCT02435433.

Does Patient Blinding Influence Clinical Outcomes After Annular Closure Device Implantation? A Propensity Score-Matched Analysis.

BackgroundAwareness of treatment group assignment in a clinical trial may influence patient behavior and bias outcome reporting. The objective of this study was to compare 2-year clinical outcomes in blinded vs unblinded patients who were treated with lumbar discectomy and a bone-anchored annular closure device (ACD) for prevention of lumbar disc reherniation.MethodsThis was a secondary analysis of a randomized trial comparing lumbar discectomy with (n=272) vs without (n=278) implantation of a bone-anchored ACD. Among patients who received ACD implantation, 35 (13%) were blinded and 237 (87%) were unblinded to treatment allocation. In patients treated with ACD, propensity score-matching (1:1) was performed to account for imbalances in patient characteristics between blinded and unblinded groups. Key clinical outcomes were back pain severity (0–100 scale), leg pain severity (0–100 scale), Oswestry Disability Index (ODI, 0–100 scale), symptomatic reherniation, reoperation at the treated lumbar level, and device- or procedure-related serious adverse events (AEs). Outcomes were reported through 2 years of follow-up, which coincided with the time at which blinded patients were unblinded.ResultsThere were no statistically significant differences in 2-year outcomes between propensity score-matched blinded (n=35) and unblinded (n=35) patients treated with the ACD. In blinded vs unblinded ACD patients compared to baseline, back pain severity decreased by 40 vs 37 points (P=0.61), leg pain severity decreased by 75 points in each group (P>0.99), and ODI decreased by 47 vs 43 points (P=0.19). The risks of symptomatic reherniation (5.7% vs 9.1%; P=0.59), reoperation (8.6% vs 12.2%, P=0.62), and device- or procedure-related serious AEs (5.7% vs 8.9%, P=0.63) were comparably low in blinded and unblinded patients.ConclusionIn patients treated with lumbar discectomy and a bone-anchored ACD, there were no clinically important or statistically significant differences in back pain, leg pain, ODI, symptomatic reherniation, reoperation, or serious AEs over 2 years of follow-up when comparing patients who were blinded vs unblinded to their treatment assignment. The main limitations of this study were the post hoc nature of the analysis and the potential for bias due to surgeon awareness of treatment assignment.

Surgical versus Conservative Management of Lumbar Canal Stenosis in Elderly

Background: Degenerative lumbar spinal stenosis is one of the common diseases in elderly, also may occur in younger ages. Usually presents with back pain, lower limbs pain and claudication pain. Diagnosis is confirmed by radiological studies such as plain X rays LSS, CT. LSS or MRI LSS. Objective: The aim of this prospective study was to evaluate the surgical versus conservative management of lumbar canal stenosis in old patient (age of 60 years old or more). Methods: A prospective comparative study was conducted on 100 old patients that were divide into two groups, each group 50 patients. The first 50 patients underwent surgical lumbar canal decompression and the other 50 patients underwent conservative management. Results: This study showed that elderly patients with moderate to severe lumbar stenosis without spondylolisthesis got benefit from surgery. They showed reduction in pain reported in the lower limbs (VAS Leg with p < 0.05) and improved function (Oswestry with p < 0.05) whoever there was no significance change regarding visual analogue scale (VAS) between the two groups. In addition, there was no significant difference between the result between 6 month and oneyear follow up. Conclusion: In patients with lumbar stenosis in old age, there was improvement in leg pain and function in patients underwent surgical posterior decompression but there was no difference in back pain compared to patients underwent conservative management.

Effect of spinal decompression on back pain in lumbar spinal stenosis: a Canadian Spine Outcomes Research Network (CSORN) study

Surgical decompression is usually offered for improvement of neurogenic claudication in patients with symptomatic lumbar canal stenosis. These patients often have associated low back pain (LBP) and little is known about the effect of decompression on this symptom. The goal of the present study is to specifically quantify the improvement in LBP following surgical decompression for lumbar canal stenosis and to identify factors associated with changes in LBP in this population. This is a multicenter, retrospective review of consecutive spine surgery patients enrolled by the Canadian Spine Outcomes and Research Network. Consecutive patients who underwent surgical treatment for symptomatic lumbar spine stenosis without instability between 2014 and 2017. Change in LBP on the Numeric Rating Scale (NRS). Patient-reported outcomes were collected at baseline and at 3, 12, and 24 months after surgery. The primary outcome was change in LBP on the NRS. Multivariable logistic regression was used to model the relationship between the outcome and potential factors associated with achieving minimal clinical important difference in back pain using a backward selection procedure. In all, 1,221 patients were included in the analysis. Mean age was 64 years and 58% were males. Baseline back pain scores were available in 1,133 patients and follow-up evaluations were available in 968/1,133 (85%) patients at 3 months, 649/903 (72%) patients at 12 months, and 331/454 (73%) at 24 months. LBP significantly improved 3 months after surgery and the improvement was sustained at 24 months (p<.001). We found that 74% of patients reached the minimal clinical important difference in back pain. Predictive factors for sustained improvement (12 and 24 months) in LBP after surgical intervention were absence of narcotic usage or compensation claims and increased severity of LBP before surgery (high NRS). Alleviation of clinically significant LBP was observed at 3 months after lumbar decompression surgery for neurogenic claudication and was maintained at 12 and 24 months after surgery in the majority of patients.