Reduction In Leg Pain Research Articles

Patient Expectations of Adult Spinal Deformity Correction Surgery

There is a growing interest in examining preoperative expectations as a potential predictor of postoperative outcome. However, it has never been studied in the setting of adult spinal deformity (ASD). This study aims to characterize patient expectations before ASD surgery and examine the relationship between preoperative expectation and postoperative patient-reported outcomes (PROs). Analysis of prospectively collected clinical and PRO data was performed on patients who underwent ASD surgery. Inclusion criteria were age >18 years, a diagnosis of ASD, >3 vertebral level instrumentation, and completed pre- and postoperative surveys. The preoperative expectation survey included expectations of surgical outcome, pain reduction, complications, and the duration of postoperative recovery. Relationships between patient expectations and PROs were assessed. Twenty-seven patients who underwent operative management of ASD met the inclusion criteria. In their preoperative survey, 66% of patients expected highly successful surgery, whereas 22% had a moderate expectation of complications. Patients anticipated an average 71% reduction in back pain (range 42%-100%) and 68% reduction in leg pain (range 0%-100%). Patients who met their expectations of leg pain reduction had significantly greater satisfaction scores than those who did not. There were moderate-to-strong positive correlations between preoperative expectation and observed improvement in back pain, leg pain, and mental health. While substantial variability in patient expectation exists for the surgical management of ASD, patients anticipated a positive outcome with a significant reduction in pain. Greater postoperative satisfaction was associated with patients who met the expected improvement in leg pain. Preoperative expectation was positively correlated with change in pain and mental health scores.

Improvements in Back and Leg Pain Following a Minimally Invasive Transforaminal Lumbar Interbody Fusion.

Improvement in patient-reported outcomes after minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) is poorly defined. As such, the purpose of this study was to quantify improvements in Visual Analogue Scale back and leg pain, Oswestry Disability Index (ODI), and Short Form-12 (SF-12) Mental and Physical Composite scores following MIS-TLIF. A surgical registry of patients who underwent primary 1-level MIS-TLIF during 2014-2015 was reviewed. Comparisons of Visual Analogue Scale back and leg pain, ODI, and Short Form-12 Mental and Physical Composite scores were performed using paired t tests from preoperative to each postoperative time point. Analysis of variance was used to estimate the degree of improvement in back and leg pain over the first postoperative year. Subgroup analysis was performed for patients presenting with predominant back (pBP) or leg (pLP) pain. Multivariate linear regression was performed to compare patient-reported outcome scores by subgroup. A total of 106 patients were identified. Visual Analogue Scale back and leg scores, and ODI improved from preoperative scores at all postoperative time points (P < .05 for each). Patients with pBP (n = 68) and patients with pLP (n = 38) reported reductions in both back and leg pain over the first postoperative year (P < .05 for each). In the pBP cohort, patients experienced significant reductions in ODI after the first 6 postoperative weeks (P < .05 for each). In the pLP cohort, patients experienced significant reductions in ODI throughout the first postoperative year (P < .05 for each). Patients with pLP and pBP experienced similar reductions in back pain, whereas patients with pLP experienced significantly greater reductions in leg pain at all postoperative time points (P < .05 for each). The current study suggests patients experience significant improvements in back and leg pain following MIS-TLIF regardless of predominant symptom. These results can assist surgeons when counseling their patients on the magnitude of symptom improvement they may experience following MIS-TLIF.

Epidural Corticosteroid Injections for Sciatica: An Abridged Cochrane Systematic Review and Meta-Analysis.

Systematic with meta-analysis OBJECTIVES.: The aim of this study was to investigate the efficacy and safety of epidural corticosteroid injections compared with placebo injection in reducing leg pain and disability in patients with sciatica. Conservative treatments, including pharmacological and nonpharmacological treatments, are typically the first treatment options for sciatica but the evidence to support their use is limited. The overall quality of evidence found by previous systematic reviews varies between moderate and high, which suggests that future trials may change the conclusions. New placebo-controlled randomized trials have been published recently which highlights the importance of an updated systematic review. The searches were performed without language restrictions in the following databases from 2012 to 25 September 2019: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, PubMed, Embase, CINAHL, PsycINFO, International Pharmaceutical Abstracts, and trial registers. We included placebo-controlled randomized trials investigating epidural corticosteroid injections in patients with sciatica. The primary outcomes were leg pain intensity and disability. The secondary outcomes were adverse events, overall pain, and back pain intensity. We grouped similar trials according to outcome measures and their respective follow-up time points. Short-term follow-up (>2 weeks but ≤3 months) was considered the primary follow-up time point due to the expected mechanism of action of epidural corticosteroid injection. Weighted mean differences (MDs) and risk ratios (RRs) with their respective 95% confidence intervals (CIs) were estimated. We assessed the overall quality of evidence using the GRADE approach and conducted the analyses using random effects. We included 25 clinical trials (from 29 publications) providing data for a total of 2470 participants with sciatica, an increase of six trials when compared to the previous review. Epidural corticosteroid injections were probably more effective than placebo in reducing short-term leg pain (MD -4.93, 95% CI -8.77 to -1.09 on a 0-100 scale), short-term disability (MD -4.18, 95% CI: -6.04 to -2.17 on a 0-100 scale) and may be slightly more effective in reducing short-term overall pain (MD -9.35, 95% CI -14.05 to -4.65 on a 0-100 scale). There were mostly minor adverse events (i.e., without hospitalization) after epidural corticosteroid injections and placebo injections without difference between groups (RR 1.14, 95% CI: 0.91-1.42). The quality of evidence was at best moderate mostly due to problems with trial design and inconsistency. A review of 25 placebo-controlled trials provides moderate-quality evidence that epidural corticosteroid injections are effective, although the effects are small and short-term. There is uncertainty on safety due to very low-quality evidence. 1.

In persistent sciatica and lumbar disk herniation, surgery vs. conservative care reduced leg pain at 6 mo.

Bailey CS, Rasoulinejad P, Taylor D, et al. Surgery versus conservative care for persistent sciatica lasting 4 to 12 months. N Engl J Med. 2020;382:1093-102. 32187469.

Effect of information and exercise programmes after lumbar disc surgery: A randomized controlled trial

The aim of this study was to compare two physiotherapy interventions following lumber disc surgery regarding effect on pain, functioning and fear of movement. This study is a prospective randomized controlled study. When admitted to hospital for first time lumbar disc surgery, the participants were randomized to one of two post-operative intervention groups: one group received information only and the other exercise in combination with information. Outcomes were collected at baseline, 6-8 weeks and 12-months post-surgery. The primary outcome was to record changes in back/hip pain and leg pain. Secondary outcomes were evaluation of changes in function, fear-avoidance beliefs and kinesiophobia. Seventy patients completed the study and were included in the analysis, of which 37 were randomized to the group receiving information only and the remaining 33 receiving both exercise and information. For primary outcomes, at 12 months postoperatively, the group receiving both exercise and information had significantly lower leg pain compared with those receiving only information (p < .033). For secondary outcomes, at 12 months postoperatively, a significant difference (p < .027) was detected for function, which favoured those that received both exercise and information. There was no significant difference in the results for the other secondary outcomes. Both groups showed clinically important changes in relation to pain and function from baseline to 12 months. The effect of treatment showed a statistically significant difference in favour of exercise and information, but the difference was not clinically relevant. Exercise in combination with information reduced leg pain and improved function, which was statistically more evident over a period of time. Postoperative physiotherapy after lumbar disc surgery could include exercises in addition to information, but perhaps not for all patients, as both groups improved, and the difference between the two groups was not clinically relevant.

Intermediate-term clinical and radiographic outcomes with less invasive adult spinal deformity surgery: patients with a minimum follow-up of 4 years

Little information exists regarding longer-term outcomes with minimally invasive spine surgery (MISS), particularly regarding long-segment and deformity procedures. We aimed to evaluate intermediate-term outcomes of MISS for adult spinal deformity (ASD). This retrospective review of a prospectively collected multicenter database examined outcomes at 4 or more years following circumferential MIS (cMIS) or hybrid (HYB) surgery for ASD. A total of 53 patients at 8 academic centers satisfied the following inclusion criteria: age >18years and coronal Cobb > 20°, pelvic incidence-lumbar lordosis (PI-LL) > 10°, or sagittal vertical axis (SVA) > 5cm. Radiographic outcomes demonstrated improvements of PI-LL from 16.8° preoperatively to 10.8° and coronal Cobb angle from 38° preoperatively to 18.2° at 4years. The incidence of complications over the follow-up period was 56.6%. A total of 21 (39.6%) patients underwent reoperation in the thoracolumbar spine, most commonly for adjacent level disease or proximal junctional kyphosis, which occurred in 11 (20.8%) patients. Mean Oswestry Disability Index (ODI) at baseline and years 1 through 4 were 49.9, 33.1, 30.2, 32.7, and 35.0, respectively. The percentage of patients meeting minimal clinically important difference (MCID) (defined as 12% or more from baseline) decreased over time, with leg pain reduction more durable than back pain reduction. Intermediate-term clinical and radiographic improvement following MISS for ASD is sustained, but extent of improvement lessens over time. Outcome variability exists within a subset of patients not meeting MCID, which increases over time after year two. Loss of improvement over time was more notable in back than leg pain. However, average ODI improvement meets MCID at 4years after MIS ASD surgery.

Epidural corticosteroid injections for lumbosacral radicular pain.

Epidural corticosteroid injections for lumbosacral radicular pain.

Safety and Efficacy of Novel Epidural Clonidine Micropellets for Lumbosacral Radiculopathy

Background: Chronic low back and leg pain is a leading cause of disability driving significant health care expenditure and lost productivity. Treatment options such as physical therapy, corticosteroids epidural injections (ESI) or spine surgery have limited long term effectiveness, are costly, and may cause significant morbidity. Clonidine has well-known anti-neuropathic pain (analgesic) with anti-inflammatory properties. A novel, targeted-delivery formulation of slow-release biodegradable polymer (Poly (D, L-lactide) clonidine has the ability to deliver sustained, high clonidine levels in tissues to provide prolonged pain relief while minimizing systemic exposure and side effects. Methods: A pilot multicenter study was performed to investigate safety, pharmacokinetics (PK) and activity of clonidine micropellets in patients with chronic lumbosacral radiculopathy. Three sequential cohorts of 18 subjects each received a single epidural injection of clonidine 0.325 mg, 0.975 mg or 1.95 mg (1, 3 or 6 micropellets, respectively) at the interlaminar epidural level that corresponds to the painful dermatomes. Clonidine PK was evaluated at multiple time points for 84 days. Paired t-tests were performed to examine changes from baseline within each cohort, and analysis of covariance evaluated differences between dose levels. Numeric Rating Scale (NRS) and Roland Morris Disability Scale (RMS-Q) were recorded at baseline and followed up to one year postinjection. Results: The peak plasma clonidine concentration was observed 24 hours following the injection in each cohort. The mean elimination half-life ranged from 13 to 20 days. There was a statistically significant reduction in leg pain from baseline at all time points up to 1 year, in all cohorts with similar improvement in each group. All cohorts showed statistically significant improvement in the RMS-Q at all timepoints. Adverse events and rescue medications were also recorded. Conclusion: Results of this trial support the hypothesis that Clonidine Micropellets would safely and slowly deliver clonidine over a prolonged period. Clonidine’s anti-neuropathic and anti-inflammatory effects could treat the radicular pain process at the nerve root resulting in long term pain relief. Trial Registration: ClinicalTrials.gov (NCT01917825). Funding Statement: Phase II trial was funded by Medtronic Inc. Declaration of Interests: Nagy A. Mekhail: Consultant: Boston Scientific, Sollis Therapeutics, and Relievant Medsystems, Inc. Receiving research support from Mallinckrodt, Mesoblast, Halyard, and Neuros Medical Independent medical monitor for Closed-loop SCS “Evoke study” sponsored by Saluda Medical Pty. Ltd., HF10 for PDN “Senza-PDN study” sponsored by Nevro Corp. and Mild for LSS “Motion study” sponsored by Vertos Medical. Ali R. Rezai: Equity position: Sollis Therapeutics and Neurotechnology Innovation Management Board of Directors: Sollis Therapeutics Pragya B. Gupta: Nothing to disclose W Porter McRoberts: Consultant: Nalu, Abbott, Bioness, Sollis, BGT Shareholder of Nalu Gregory J. Fiore: Consultant to Sollis Therapeutics Bryan A. Jones: Employee of Sollis Therapeutics Lou-Anne G. Acevedo-Moreno: Nothing to disclose Chris J. Gilligan: Funded Research: Sollis Therapeutics, Mainstay Medical Consulting: Medtronic, Abbott, Saluda, Nuvectra Ramsin M. Benyamin: Consultant: Medtronic, Avanos, Vertiflex Ethics Approval Statement: This study was approved by the institutional review boards at 6 participating sites. The study was conducted in compliance with the Declaration of Helsinki principles for human medical research, and the principles of good clinical practice and data management. Written informed consent was obtained from all study participants.

Acute iliofemoral deep vein thrombosis: does catheter-directed thrombolysis affect outcomes?

Purpose The aim was to assess the role of catheter-directed thrombolysis (CDT) in improving patency of the treated venous segments and to examine the correlation of residual thrombus with post-thrombotic syndrome (PTS). Background Iliofemoral deep vein thrombosis (DVT) is associated with severe post-thrombotic morbidity when treated with anticoagulation alone. CDT allows early removal of thrombus and reduce valvular reflux and PTS. Patients and methods This prospective randomized controlled two-arm study was conducted on 42 patients with iliofemoral DVT. The patients were randomly allocated into two groups according to the intervention performed. Group A: CDT followed by oral anticoagulants [N=21 (50%)], group B: standard DVT therapy [N=21 (50%)]. The follow-up period was 24 months. Results Patients of group A complained of less pain at 10 and 30 days (P=0.02 and 0.04, respectively). Also, there was significant decrease in leg circumference in group A at 10 and 30 days (P=0.001 and 0.03, respectively). A total of three (15%) clinically relevant nonmajor bleeding complications were reported in the CDT group. Using CDT is associated with less PTS at sixth month, 1 year, and 2 years; six (27.3%), seven (31.8%), and nine (40.9%), respectively, as compared with group B; 11 (47.8%), 13 (56.5%), and 15 (65.2%), respectively (P=0.024, 0.017, and 0.035, respectively). Conclusion Addition of CDT in the treatment of acute iliofemoral DVT was safe and tolerated by most of the patients with better effect to reduce leg pain and circumference. It was considered a protecting weapon to prevent PTS and thereby improving the quality of life and was related to achievement of higher iliac vein patency and less reflux.

Surgical Management of Lumbar Radiculopathy: a Systematic Review.

Lumbar radiculopathy is characterized by radiating pain with or without motor weakness or sensory disturbances; the point prevalence ranges from 1.6 to 13.4%. The objective of this review was to determine the efficacy, safety, and cost of surgical versus nonsurgical management of symptomatic lumbar radiculopathy in adults. We searched PubMed from January 1, 2007, to April 10, 2019 with hand searches of systematic reviews for studies prior to 2007. One reviewer extracted data and a second checked for accuracy. Two reviewers completed independent risk of bias and strength of evidence ratings. We included seven RCTs (N = 1158) and three cost-effectiveness analysis. Surgery reduced leg pain by 6 to 26 points more than nonsurgical interventions as measured on a 0- to 100-point visual analog scale of pain at up to 26 weeks follow-up; differences between groups did not persist at 1 year or later. The evidence was somewhat mixed for function and disability in follow-up through 26 weeks (standardized mean difference [SMD] - 0.16 (95% CI, - 0.30 to - 0.03); minimal differences were observed at 2 years (SMD - 0.06 (95% CI, - 0.20 to 0.07). There were similar improvements in quality of life, neurologic symptoms, and return to work. No surgical deaths occurred and surgical morbidity was infrequent. The incidence of reoperations ranged from 0 to 10%. The average cost per quality-adjusted life year gained from a healthcare payor perspective ranged from $51,156 to $83,322 for surgery compared to nonsurgical interventions. Most findings are based on a body of RCT evidence graded as low to very low certainty. Compared with nonsurgical interventions, surgery probably reduces pain and improves function in the short- and medium-term, but this difference does not persist in the long-term. Although surgery appears to be safe, it may or may not be cost-effective depending on a decision maker's willingness to pay threshold.

Treatment of Acute Iliofemoral Deep Vein Thrombosis; Does Catheter Directed Thrombolytic Therapy Change Outcomes?

Background: Iliofemoral deep vein thrombosis (DVT) is associated with severe post-thrombotic morbidity when treated with anticoagulation alone. Catheter- directed thrombolysis (CDT) allows early removal of thrombus and reduces valvular reflux and Post-thrombotic Syndrome (PTS). Patients and methods: This prospective randomized multi-center controlled two- arm blind study was conducted in 6 centers on 252 patients with iliofemoral DVT. Patients were randomly allocated by using simple random allocation cards method into two groups; Group (A): CDT followed by oral anticoagulation (N=126 (50%)), Group (B): Standard DVT therapy (N=126 (50%)). Follow-up was for 24 months. Results: Patients of group (A) significantly complained less pain at 10 &amp; 30 days (P-Value: 0.02 &amp; 0.04 respectively). Also there was significant decrease in leg circumference in group (A) at 10 &amp; 30 days (P-Value: 0.001 &amp; 0.03 respectively). Patency of iliac vein segment was significantly higher in group (A) during the 24 months follow up (P-Value &lt;0.001 (HS)). Patients in group (A) developed less PTS at six months, at one year and at two years (P-Value: 0.024, 0.017 and 0.035 respectively). Better Quality of life was observed in group (A) (P-Value: 0.003). Conclusion: Addition of catheter-directed thrombolysis in the treatment of acute iliofemoral DVT; was safe and tolerated by most of the patients with better effect to reduce leg pain &amp; circumference. It was considered a protecting weapon to prevent post-thrombotic syndrome and so improve quality of life and was related to achievement of higher iliac vein patency and less reflux.

Comparison of Tonic vs. Burst Spinal Cord Stimulation During Trial Period

Spinal cord stimulation (SCS) is a well-known treatment in patients with failed back surgery syndrome (FBSS). Burst stimulation is a recently developed stimulation modality that seems to be superior to tonic stimulation. This observational multicenter study compared tonic and burst stimulation during a trial period in patients with FBSS or radiculopathy. All the patients enrolled underwent two weeks of tonic stimulation followed by another two weeks of BurstDR stimulation, without randomization. The primary outcome was the reduction of pain in the legs and back. Health-related quality of life (EQ-5D) and the pain catastrophizing scale (PCS) were assessed before and after the trial. Patients were reevaluated after 12 months. We recruited 23 patients, 57% of whom had FBSS and 43% had radiculopathies. Five patients failed both the tonic and burst stimulation trials. While tonic stimulation reduced leg pain (p < 0.05), the burst mode added an extra pain reduction (ΔNRS 1.2 ± 1.5) (p < 0.01). No significant reduction in back pain was found (p 0.29). Pain on movement was reduced only by BurstDR (p < 0.01). Both stimulation modalities increased EQ-5D and reduced PCS from the baseline (p < 0.0001). At the end of the SCS trial phase, 26% patients chose tonic SCS, while 74% preferred burst. On 12-month follow-up examination, the benefits recorded at the end of the trial were maintained. Burst stimulation confers a greater reduction in leg pain intensity at rest and on movement. Reducing axial pain is still a challenge. Further studies are needed in order to provide each patient with the most appropriate stimulation paradigm.

Comparison of treatments for lumbar disc herniation: Systematic review with network meta-analysis.

Systematic review with network meta-analysis. To compare patient outcomes of lumbar discectomy with bone-anchored annular closure (LD + AC), lumbar discectomy (LD), and continuing conservative care (CC) for treatment of lumbar disc herniation refractory to initial conservative management. Several treatment options are available to patients with refractory symptoms of lumbar disc herniation, but their comparative efficacy is unclear. A systematic review was performed to compare efficacy of LD + AC, LD, and CC for treatment of lumbar disc herniation. Outcomes included leg pain, back pain, disability (each reported on a 0-100 scale), reherniation, and reoperation. Data were analyzed using random effects network meta-analysis. This review included 14 comparative studies (8 randomized) involving 3947 patients-11 studies of LD versus CC (3232 patients), 3 studies of LD + AC versus LD (715 patients), and no studies of LD + AC versus CC. LD was more effective than CC in reducing leg pain (mean difference [MD] -10, P < .001) and back pain (MD -7, P < .001). LD + AC was more effective than LD in reducing risk of reherniation (odds ratio 0.38, P < .001) and reoperation (odds ratio 0.33, P < .001). There was indirect evidence that LD + AC was more effective than CC in reducing leg pain (MD -25, P = .003), back pain (MD -20, P = .02), and disability (MD -13, P = .02) although the treatment effect was smaller in randomized trials. Results of a network meta-analysis show LD is more effective than CC in alleviating symptoms of lumbar disc herniation refractory to initial conservative management. Further, LD + AC lowers risk of reherniation and reoperation versus LD and may improve patient symptoms more than CC.

Clinical efficacy of once-daily micronized purified flavonoid fraction 1000 mg tablet in patients with symptomatic chronic venous disease

Aim: To investigate the clinical efficacy of micronized purified flavonoid fraction (MPFF) 1000 mg given as a single 1000 mg tablet once daily in patients suffering from chronic venous disease (CVD) vs MPFF 500 mg twice daily.Methods: In an international, randomized, double-blind, parallel-group study, patients classified C0s to C4 according to Clinical Etiological Anatomic Pathophysiologic [CEAP] classification and with leg pain graded as superior to 4 cm on a 10-cm visual analog scale (VAS), were treated for 8 weeks with either MPFF 1000 mg once daily or MPFF 500 mg twice daily. The present post-hoc analysis focuses on the effect of treatment over time in patients randomized to the MPFF 1000 mg group. Leg pain was assessed at each follow-up visit by VAS. VAS scores over time were compared between each visit using paired Student t-tests.Results: In total, 87 patients out of 174 were randomized to the MPFF 1000 mg group. Mean age ± SD was 49.1 ± 12.2 years, most of the patients were female (81.6%), the main CEAP classes of the most affected leg were C1 (20.7%), C2 (39.1%), C3 (33.33%), and the mean duration of CVD was 14.6 ± 10.9 years. Patients with previous CVD treatment represent 27.6% of the patients. A MPFF 1000 mg tablet once daily was associated with a significant and continuous reduction in leg pain throughout the treatment period: –1.54 cm (±1.45) from baseline to week 2 (p < .01), –1.11 cm (±1.06) from week 2 to week 4 (p < .01), –1.57 cm (±1.05) from week 4 to week 8 (p < .01).Conclusions: The new MPFF 1000 mg dose regimen in once daily tablets was associated with a rapid and continuous reduction in leg pain throughout the 8-week treatment period.

Treatment of the Fractional Curve of Adult Scoliosis With Circumferential Minimally Invasive Surgery Versus Traditional, Open Surgery: An Analysis of Surgical Outcomes.

Study Design:Retrospective, multicenter review of adult scoliosis patients with minimum 2-year follow-up.Objective:Because the fractional curve (FC) of adult scoliosis can cause radiculopathy, we evaluated patients treated with either circumferential minimally invasive surgery (cMIS) or open surgery.Methods:A multicenter retrospective adult deformity review was performed. Patients included: age >18 years with FC >10°, ≥3 levels of instrumentation, 2-year follow-up, and one of the following: coronal Cobb angle (CCA) > 20°, pelvic incidence and lumbar lordosis (PI-LL) > 10°, pelvic tilt (PT) > 20°, and sagittal vertical axis (SVA) > 5 cm.Results:The FC was treated in 118 patients, 79 open and 39 cMIS. The FCs had similar coronal Cobb angles preoperative (17° cMIS, 19.6° open) and postoperative (7° cMIS, 8.1° open), but open had more levels treated (12.1 vs 5.7). cMIS patients had greater reduction in VAS leg (6.4 to 1.8) than open (4.3 to 2.5). With propensity matching 40 patients for levels treated (cMIS: 6.6 levels, N = 20; open: 7.3 levels, N = 20), both groups had similar FC correction (18° in both preoperative, 6.9° in cMIS and 8.5° postoperative). Open had more posterior decompressions (80% vs 22.2%, P < .001). Both groups had similar preoperative (Visual Analogue Scale [VAS] leg 6.1 cMIS and 5.4 open) and postoperative (VAS leg 1.6 cMIS and 3.1 open) leg pain. All cMIS patients had interbody grafts; 35% of open did. There was no difference in change of primary CCA, PI-LL, LL, Oswestry Disability Index, or VAS Back.Conclusion:Patients’ FCs treated with cMIS had comparable reduction of leg pain compared with those treated with open surgery, despite significantly fewer cMIS patients undergoing direct decompression.

Efficacy of micronized purified flavonoid fraction (Daflon®) on improving individual symptoms, signs and quality of life in patients with chronic venous disease: a systematic review and meta-analysis of randomized double-blind placebo-controlled trials

The use of a venoactive drug is considered an important component of medical treatment of chronic venous disease (CVD), although the efficacy of certain venoactive drugs (VADs) on one or more individual leg symptoms or signs may have not been extensively studied to justify a strong recommendation in guidelines on CVD. The aim of this systematic review and meta-analysis was to study the effectiveness of the micronized purified flavonoid fraction (MPFF, Daflon®) across the spectrum of defined venous symptoms, signs, quality of life (QoL) and treatment assessment by the physician. On September 9, 2017, a systematic review of the databases MEDLINE, Scopus and Cochrane Central was performed, supplemented by hand searching, to identify randomized double-blind placebo-controlled trials on MPFF in patients with CVD. The main outcome measures were the individual and global symptoms, leg edema and redness, skin changes, QoL and evaluation of the overall effectiveness of the treatment by the physician. The effectiveness of MPFF compared with placebo was expressed as risk ratio (RR) or standardized mean difference (SMD) with 95% confidence interval (CI). Trial quality of evidence was graded using the GRADE system. We identified 7 trials, mostly with low risk of bias, involving 1,692 patients. On qualitative analysis, MPFF significantly improved nine defined leg symptoms, including pain, heaviness, feeling of swelling, cramps, paresthesia, burning sensation, and pruritus (itching), but also functional discomfort compared with placebo, leg redness, skin changes and QoL. On quantitative analysis, MPFF compared with placebo, assessed as a categorical variable, reduced leg pain (RR 0.53, P=0.0001, NNT=4.2), heaviness (RR 0.35, P<0.00001, NNT=2.0), feeling of swelling (RR 0.39, P<0.00001, NNT=3.1), cramps (RR 0.51, P=0.02, NNT=4.8), paresthesia (RR 0.45, P=0.03, NNT=3.5), and functional discomfort (RR 0.41, P=0.0004, NNT=3.0). Similarly, MPFF compared with placebo, assessed as a continuous variable reduced pain (SMD -0.25, 95% CI -0.38 to -0.11), heaviness (SMD -0.80, 95% CI -1.05 to -0.54), feeling of swelling (SMD -0.99, 95% CI -1.25 to -0.73), burning sensation (SMD -0.46, 95% CI -0.78 to -0.14), cramps (SMD -0.46, 95% CI -0.78 to -0.14), and functional discomfort (SMD -0.87, 95% CI -1.13 to -0.61). Regarding objective assessments of leg edema, the use of MPFF compared with placebo reduced ankle circumference (SMD -0.59, 95% CI -1.15 to -0.02), and leg redness (SMD -0.32, 95% CI -0.56 to -0.07, RR 0.50, P=0.03, NNT=3.6), improved skin changes (RR 0.18, P=0.0003, NNT=1.6) and quality of life (SMD -0.21, 95% CI -0.37 to -0.04) and was associated with clinical improvement as assessed by the physician (RR 0.28, P<0.00001, NNT=2.5). Heterogeneity was mostly minimal. The existing evidence where sufficient was mostly of high quality. Based on high quality evidence, MPFF is highly effective in improving leg symptoms, edema and quality of life in patients with CVD.

Complication rates associated with open versus percutaneous pedicle screw instrumentation among patients undergoing minimally invasive interbody fusion for adult spinal deformity.

OBJECTIVE High-quality studies that compare outcomes of open and minimally invasively placed pedicle screws for adult spinal deformity are needed. Therefore, the authors compared differences in complications from a circumferential minimally invasive spine (MIS) surgery and those from a hybrid surgery. METHODS A retrospective review of a multicenter database of patients with spinal deformity who were treated with an MIS surgery was performed. Database inclusion criteria included an age of ≥ 18 years and at least 1 of the following: a coronal Cobb angle of > 20°, a sagittal vertical axis of > 5 cm, a pelvic incidence-lumbar lordosis angle of > 10°, and/or a pelvic tilt of > 20°. Patients were propensity matched according to the levels instrumented. RESULTS In this database, a complete data set was available for 165 patients, and after those who underwent 3-column osteotomy were excluded, 137 patients were available for analysis; 76 patients remained after propensity matching (MIS surgery group 38 patients, hybrid surgery group 38 patients). The authors found no difference in demographics, number of levels instrumented, or preoperative and postoperative radiographic results. At least 1 complication was suffered by 55.3% of patients in the hybrid surgery group and 44.7% of those in the MIS surgery group (p = 0.359). Patients in the MIS surgery group had significantly fewer neurological, operative, and minor complications than those in the hybrid surgery group. The reoperation rates in both groups were similar. The most common complication category for the MIS surgery group was radiographic and for the hybrid surgery group was neurological. Patients in both groups experienced postoperative improvement in their Oswestry Disability Index and visual analog scale (VAS) back and leg pain scores (all p < 0.05); however, MIS surgery provided a greater reduction in leg pain according to VAS scores. CONCLUSIONS Overall complication rates in the MIS and hybrid surgery groups were similar. MIS surgery resulted in significantly fewer neurological, operative, and minor complications. Reoperation rates in the 2 groups were similar, and despite complications, the patients reported significant improvement in their pain and function.

In moderate-to-severe sciatica, pregabalin did not reduce leg pain intensity or improve quality of life

Source Citation Mathieson S, Maher CG, McLachlan AJ, et al. Trial of pregabalin for acute and chronic sciatica. N Engl J Med. 2017;376:1111-20. 28328324

Which Regional Pain Rating Best Predicts Patient-Reported Improvement in Lumbar Radiculopathy?

To determine the best regional pain score cutoff value that corresponds with patient-reported improvement in lumbosacral radiculopathy (LSR). Retrospective pooled data analysis from 3 randomized, controlled, multicenter trials using similar outcome assessments. All participants were exposed to interventions (epidural injections). Military medical centers (6 U.S.A., 1 Germany) and large tertiary care hospitals (4 urban, 1 Veterans Affairs) between 2008 and 2014. A total of 352 active duty military personnel and civilians ≥ 18 years of age with LSR. Receiver operating characteristics (ROC) with area under the curve (AUC) were calculated for 1-month outcomes for pain (numeric rating scale) using absolute and relative change in regional pain scores (back, leg) to predict clinical improvement (global perceived effect). Leg pain demonstrated greater predictive ability to identify clinical improvement compared to back pain for both absolute (ROC AUC [95% confidence interval (CI)] 0.855 [0.813, 0.896] vs. 0.753 [0.702, 0.805]; P < 0.001) and relative (AUC [95% CI]; 0.867 [0.826, 0.909] vs. 0.780 [0.729, 0.831]; P = 0.002) reduction in reported pain. Clinical improvement was best identified using a leg pain reduction threshold of ≥ 1.75 points (absolute) and ≥ 23.5% (relative). Region-specific pain cutoff ratings predicted clinical improvement for patients with LSR. Cutoff points using newly identified, smaller reductions of 1.75 points and 23.5% more accurately predicted clinical improvement for LSR than conventionally used cutoffs (2 points and 30%). LSR patients report meaningful clinical improvement with smaller reductions in pain compared to other chronic pain diagnoses, suggesting LSR patients may have different expectations.

Adjonction de ciment phosphocalcique dans les pertes de substances osseuses des fractures proximales du tibia : une étude prospective multicentrique et observationnelle

IntroductionManaging subchondral bone defects in proximal tibia fractures after plateau reduction is an important consideration. ChronOS Inject is a recently developed calcium phosphate bone substitute that shows relatively fast osteointegration. HypothesisUsing chronOS Inject during internal fixation of proximal tibial fractures provides a satisfactory treatment option that is both clinically and radiologically safe. Materials and methodsPatients enrolled in this study were treated with ChronOS Inject bone void filler, during internal fixation of proximal tibial fractures. Patients were evaluated preoperatively and at 6weeks, 6and 12months postoperative. Radiographic union was assessed using plain films supplemented by CT scans. Pain, function and adverse events were collected at all visits. A total of 36 patients were enrolled in the study and treated according to a predetermined protocol. Seven of the 36 patients (19.4 %) were lost to follow-up. ResultsSuccessful radiographic union was achieved in 27/29 (93.1 %) of patients at final follow-up. Articular subsidence of>2mm only occurred in one patient. Statistical analysis showed significant improvements both in leg pain and knee function. Progress in knee function was observed in 93.1 % (27/29) of patients from 6 weeks to 12months. No product-related complications were reported. ConclusionsSuccessful union was achieved based on radiographic criteria as well as clinical outcomes. When managing bone defects after internal fixation of proximal tibial fractures, the use of ChronOS Inject resulted in significant improvement of knee function and reduction of leg pain. Level of evidenceLevel IV, prospective observational study.