Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study.

PURPOSE: To evaluate the safety and efficacy of radiofrequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of chronic low back pain (CLBP) in a Food and Drug Administration approved Investigational Device Exemption trial. The BVN has been shown to innervate endplate nociceptors which are thought to be a source of CLBP. METHODS: A total of 225 patients diagnosed with CLBP were randomized to either a sham (78 patients) or treatment (147 patients) intervention. The mean age within the study was 47 years (range 25-69) and the mean baseline ODI was 42. All patients had Type I or Type II Modic changes of the treated vertebral bodies. Patients were evaluated preoperatively, and at 2 weeks, 6 weeks and 3, 6 and 12 months postoperatively. The primary endpoint was the comparative change in ODI from baseline to 3 months. RESULTS: At 3 months, the average ODI in the treatment arm decreased 20.5 points, as compared to a 15.2 point decrease in the sham arm (p = 0.019, per-protocol population). A responder analysis based on ODI decrease ≥ 10 points showed that 75.6% of patients in the treatment arm as compared to 55.3% in the sham control arm exhibited a clinically meaningful improvement at 3 months. CONCLUSION: Patients treated with RF ablation of the BVN for CLBP exhibited significantly greater improvement in ODI at 3 months and a higher responder rate than sham treated controls. BVN ablation represents a potential minimally invasive treatment for the relief of chronic low back pain. These slides can be retrieved under Electronic Supplementary Material.

Last-male sperm precedence in Rhynchophorus ferrugineus (Olivier): observations in laboratory mating experiments with irradiated males.

The Red Palm Weevil (RPW) Rhynchophorus ferrugineus (Olivier 1790) is an invasive pest from southeastern Asia and Melanesia that in the last 30 years has spread widely in the Middle East and Mediterranean Basin. Its stem-boring larvae cause great damage to several palm species of the Arecaceae family, many of which are economically important for agricultural and ornamental purposes. Therefore, great attention has recently been focused in studying this species to identify sustainable and effective eradication strategies, such as sterile insect technique (SIT). The rapid spread of RPW is associated with its high reproductive success. To evaluate the suitability of a SIT strategy, particular physiological and behavioral aspects of RPW reproduction, such as the presence of polyandry and post-copulatory sperm selection mechanisms, were investigated. To determine paternity of progeny from multiply mated females, double-crossing experiments were carried out confining individual females with either a wild-type male or a γ-irradiated male (Co-60). Fecundity and fertility of females were scored to evaluate post-copulatory sperm selection. Results showed that progeny were almost exclusively produced by the sperm of the second male, suggesting that a last-male sperm precedence is expressed at high levels in this species, and providing interesting insights for an area-wide RPW management strategy such as the SIT.

Modeling Environmental Influences in the Psyllaephagus bliteus (Hymenoptera: Encyrtidae)-Glycaspis brimblecombei (Hemiptera: Aphalaridae) Parasitoid-Host System.

Glycaspis brimblecombei Moore (Hemiptera: Aphalaridae) is an invasive psyllid introduced into the Mediterranean area, where it affects several species of Eucalyptus. Psyllaephagus bliteus Riek (Hymenoptera: Encyrtidae) is a specialized parasitoid of this psyllid that was accidentally introduced into Italy in 2011. We developed a model of this host-parasitoid system that accounts for the influence of environmental conditions on the G. brimblecombei population dynamics and P. bliteus parasitism rates in the natural ecosystem. The Lotka-Volterra-based model predicts non-constant host growth and parasitoid mortality rates in association with variation in environmental conditions. The model was tested by analyzing sampling data collected in Naples in 2011 (before the parasitoid was present) and defining several environmental patterns, termed Temperature-Rain or T-R patterns, which correspond to the host growth rate. A mean value of the host growth rate was assigned to each T-R pattern, as well as a variation of the parasitoid mortality rate based on temperature thresholds. The proposed model was applied in simulation tests related to T-R patterns carried out with a data series sampled between June 2014 and July 2015 in five Italian sites located in Campania, Lazio, Sicily, and Sardinia regions. The simulation results showed that the proposed model provides an accurate approximation of population trends, although oscillation details may not be apparent. Results predict a 64% reduction in G. brimblecombei population density owing to P. bliteus parasitoid activity. Our results are discussed with respect to features of the host-parasitoid interaction that could be exploited in future biological control programs.

Characterization, distribution, biology and impact on Italian walnut orchards of the invasive North-American leafminer Coptodisca lucifluella (Lepidoptera: Heliozelidae).

The leafminer Coptodisca sp. (Lepidoptera: Heliozelidae), recently recorded for the first time in Europe on Italian black and common walnut trees, is shown to be the North-American Coptodisca lucifluella (Clemens) based on morphological (forewing pattern) and molecular (cytochrome oxidase c subunit I sequence) evidence. The phylogenetic relatedness of three species feeding on Juglandaceae suggests that C. lucifluella has likely shifted, within the same host plant family, from its original North-American hosts Carya spp. to Juglans spp. Over the few years since its detection, it has established in many regions in Italy and has become a widespread and dominant invasive species. The leafminer completes three to four generations per year, with the first adults emerging in April-May and mature larvae of the last generation starting hibernation in September-October. Although a high larval mortality was recorded in field observations (up to 74%), the impact of the pest was substantial with all leaves infested at the end of the last generation in all 3 years tested. The distribution of the leafminer in the canopy was homogeneous. The species is redescribed and illustrated, a lectotype is designated and a new synonymy is established.

Mature cystic teratoma of both the fallopian tube and contralateral ovary: a case report.

UNLABELLED: Intratubal teratoma is a very rare condition. The authors believe to present the first case of a completely intratubal mature cystic teratoma with a contralateral intraovarian teratoma. Preoperative ultrasound examination allowed the intraoperative diagnosis of this rare condition, hence allowing appropriate surgical management. MATERIALS AND METHODS: A 19-year-old woman presented with a history of pelvic pain and severe dysmenorrhea. Ultrasound examination initially suggested bilateral ovarian dermoids. Upon laparoscopy, the distal left fallopian tube was obstructed and contained an inflammatory mass adhered to the rectosigmoid. The left ovary was entirely normal. A contralateral intraovarian dermoid was also identified. CONCLUSION: Although rare, when an intratubal mass is identified, consideration of intratubal dermoid should be given. Preoperative ultrasound can be of critical importance to the intraoperative diagnosis.

Effects of the environment on dog semen parameters and testosterone concentration.

Whether a mammal reproduces seasonally or continuously depends mostly on the environment and its effects on the endocrine pattern. Although the dog was the first species to have been domesticated, little information is available on the changes in reproduction that have occurred since. In this study, we evaluated whether environmental stimuli can act as modulators of male gonadal activity in the dog at the latitude of Bari (Italy). Therefore, for 1 year, serum and seminal testosterone (T) concentrations, together with seminal parameters, were recorded monthly and evaluated in relation to environmental variables such as temperature, humidity, and photoperiod. We found that, in temperate regions, the annual serum T profile is not affected by environmental conditions, whereas seminal T profile peaks in October and reaches its nadir in April. The percentage of progressive motile spermatozoa is also dependent on environmental cues. The results support the intuitive idea that recorded data require a proper analysis to be meaningful. In fact, we found that, in the dog, environmental changes appear to affect male gonadal physiology, and this is clear when recorded data are analyzed monthly; in contrast, pooling data into seasonal groups hides monthly environmental variations.

Current treatments of primary sclerosing cholangitis.

Primary Sclerosing Cholangitis (PSC) is a chronic cholestatic disease characterized by hepatic inflammation and obliterative fibrosis, resulting in both intra- and extra-hepatic bile duct strictures. End-stage liver disease and bile duct carcinoma represent frequent complications. Incidence and prevalence of PSC in USA have been recently estimated as 0.9 per 100,000 person-years, and 1-6 per 100,000 person-years, respectively. Major diagnostic criteria include the presence of multifocal strictures, beadings of bile ducts, and compatible biochemical profile, once excluded secondary causes of cholangitis. Since the aetiology of PSC remains poorly defined, medical therapy is currently limited to symptom improvement and prolonged survival. Ursodeoxycholic acid (UDCA), corticosteroids and immunosuppressants have been proposed alone or in combination to improve the clinical outcome. In selected cases, surgical or endoscopic procedures need to be considered. Orthotopic liver transplantation (OLT) is at the moment the only definitive approach although disease relapse has been reported. In this article the state of the art in PSC treatment and future promises in this field are reviewed.

Systemin regulates both systemic and volatile signaling in tomato plants.

The prevailing reaction of plants to pest attack is the activation of various defense mechanisms. In tomato, several studies indicate that an 18 amino acid (aa) peptide, called systemin, is a primary signal for the systemic induction of direct resistance against plant-chewing pests, and that the transgenic expression of the prosystemin gene (encoding the 200 aa systemin precursor) activates genes involved in the plant response to herbivores. By using a combination of behavioral, chemical, and gene expression analyses, we report that systemin enhances the production of bioactive volatile compounds, increases plant attractivity towards parasitiod wasps, and activates genes involved in volatile production. Our data imply that systemin is involved in the systemic activation of indirect defense in tomato, and we conclude that a single gene controls the systemic activation of coordinated and associated responses against pests.

Development of humanized mice for the study of hepatitis C virus infection.

The development of a small animal model for hepatitis C virus (HCV) infection is a critical issue for the development of novel anti-HCV drugs. To this aim, we have tried many different approaches for generating mice carrying humanized liver. Main efforts were focused on the transplantation of human hepatocytes into immunocompromised mice (SCID-/-, Bg-/-) carrying a genetic lethal liver disease (Alb-uPA). Survival of homozygotic animals should largely depend on early transplantation with healthy hepatocytes. In parallel to establishing a colony of Alb-uPA/SCID/Bg mice, we developed a microsurgical procedure for intrasplenic xenotransplantation of healthy hepatocytes in 1-week-old mice. So far, we generated several chimeras by xenotransplanting human hepatocytes in Alb-uPA+/+/SCID-/-/Bg-/- mice at 1 week after birth. In a first step, identification of successfully engrafted animals is possible by quantification of human serum albumin and human alpha 1 antitrypsin in mouse sera. Additional preliminary histomorphological analysis of liver sections from chimeric animals was also carried out. One of the mice was transiently infected with HCV, reaching viremia levels of approximately 10(5) genomes/mL. However, the efficiency of this system to generate chimeric mice is still very limited. We are currently exploring the use of more robust models of hepatic disease. Moreover, we have been also exploring novel strategies for the generation of chimeric mice by xenotransplanting human adult stem cells, instead of human hepatocytes, at preimmune stages of development.

Sacroiliac joint dysfunction: a long-term follow-up study.

Sixty-nine patients with sacroiliac joint dysfunction were prospectively evaluated and treated with a structured physical therapy program. Follow-up clinical outcome was obtained from a patient questionnaire administered by an independent reviewer a minimum of 2 years after treatment. Average patient age was 40 years, and 80% were women. Ninety-five percent rated their result as good or excellent, while 5% believed their outcome was fair or poor. A structured physical therapy program can produce good long-term results in most patients; however, 5% continue to be symptomatic. This small subset may be candidates for more invasive evaluation.

A critical appraisal of the reporting of the National Acute Spinal Cord Injury Studies (II and III) of methylprednisolone in acute spinal cord injury.

From the beginning, the reporting of the results of National Acute Spinal Cord Injury Studies (NASCIS) II and III has been incomplete, leaving clinicians in the spinal cord injury (SCI) community to use or avoid using methylprednisolone in acute SCI on the basis of faith rather than a publicly developed scientific consensus. NASCIS II was initially reported by National Institutes of Health announcements, National Institutes of Health facsimiles to emergency room physicians, and the news media. The subsequent report in the New England Journal of Medicine implied that there was a positive result in the primary efficacy analysis for the entire 487 patient sample. However, this analysis was in fact negative, and the positive result was found only in a secondary analysis of the subgroup of patients who received treatment within 8 hours. In addition, that subgroup apparently had only 62 patients taking methylprednisolone and 67 receiving placebo. The NASCIS II and III reports embody specific choices of statistical methods that have strongly shaped the reporting of results but have not been adequately challenged or or even explained. These studies show statistical artifacts that call their results into question. In NASCIS II, the placebo group treated before 8 hours did poorly, not only when compared with the methylprednisolone group treated before 8 hours but even when compared with the placebo group treated after 8 hours. Thus, the positive result may have been caused by a weakness in the control group rather than any strength of methylprednisolone. In NASCIS III, a randomization imbalance occurred that allocated a disproportionate number of patients with no motor deficit (and therefore no chance for recovery) to the lower dose control group. When this imbalance is controlled for, much of the superiority of the higher dose group seems to disappear. The NASCIS group's decision to admit persons with minor SCIs with minimal or no motor deficit not only enables statistical artifacts it complicates the interpretation of results from the population actually sampled. Perhaps one half of the NASCIS III sample may have had at most a minor deficit. Thus, we do not know whether the results of these studies reflect the severely injured population to which they have been applied. The numbers, tables, and figures in the published reports are scant and are inconsistently defined, making it impossible even for professional statisticians to duplicate the analyses, to guess the effect of changes in assumptions, or to supply the missing parts of the picture. Nonetheless, even 9 years after NASCIS II, the primary data have not been made public. The reporting of the NASCIS studies has fallen far short of the guidelines of the ICH/FDA and of the Evidence-based Medicine Group. Despite the lucrative "off label" markets for methylprednisolone in SCI, no Food and Drug Association indication has been obtained. There has been no public process of validation. These shortcomings have denied physicians the chance to use confidently a drug that many were enthusiastic about and has left them in an intolerably ambiguous position in their therapeutic choices, in their legal exposure, and in their ability to perform further research to help their patients.

Postoperative drains at the donor sites of iliac-crest bone grafts. A prospective, randomized study of morbidity at the donor site in patients who had a traumatic injury of the spine.

A prospective, randomized study was performed to assess the effectiveness of postoperative closed suction drainage. One hundred and twelve consecutive procedures involving autologous iliac-crest bone graft were performed, from December 29, 1992, to July 1, 1993, following a traumatic injury of the spine in 108 patients. Sixty of the sites from which the bone graft had been obtained were drained with a single large Hemovac device. The drains were maintained for two to five days postoperatively. The remaining fifty-two incisions were closed without a drainage device. All patients were evaluated clinically for problems with wound-healing. The incisions were considered to be healed when they had been asymptomatic for one year. Of eleven patients who had problems with wound-healing, six had been managed with a drain and five had not. The findings of this study do not support the routine use of drainage at the donor sites of iliac-crest bone grafts.

Seat-belt use and relation to neurologic injury in motor vehicle crashes.

The relation between seat-belt use and neurologic injury was examined for the 1,352 patients who had spinal injuries as the result of motor vehicle crashes and were subsequently admitted to the Midwest Regional Spinal Cord Injury Center at Northwestern University between 1971 and 1993. Intact lesions were observed in 44% of patients (Frankel level E), complete lesions in 28% (Frankel A), sensory intact lesions in 8% (Frankel B), motor intact lesions in 5% (Frankel C), and functional motor lesions in 14% (Frankel D). Whereas only 14% of the sample were wearing seat belts, 60% of the belted and 41% of the unbelted vehicle occupants had intact lesions. The odds of surviving a motor vehicle crash with an intact injury were greater for patients who were wearing a lap or shoulder belt (odds = 1.57) for women (odds = 0.63) and for patients whose injury occurred more recently (odds = 1.05). The relation between position in the vehicle and extent of injury was strongest for rear passengers: intact lesions were sustained by 73% of belted and 35% of unbelted rear passengers, whereas complete lesions were sustained by 9% of the belted and 21% of the unbelted rear passengers. In conclusion, seat belts appear to be an effective means of decreasing the extent of neurologic deficit in those sustaining spinal injuries caused by motor vehicle crashes. The results of this study support injury-prevention efforts that emphasize lap- and shoulder-belt use.

Adult spondylolisthesis treated with posterolateral lumbar fusion and pedicular instrumentation with AO DC plates.

Attainment of successful lumbar fusion in adults with spondylolisthesis has historically been unpredictable. Recent results and conclusions have been conflicting regarding the role of instrumentation in improving the fusion rate and clinical outcome in this patient population. In a retrospective multicenter clinical study, we assessed the outcome of 42 adults with spondylolisthesis who underwent posterolateral lumbar fusion by using pedicular instrumentation with AO DC plates. No attempt was made to reduce slippage. Follow-up clinical outcome was obtained from a patient questionnaire administered and assessed by an independent reviewer. Fusion status was assessed by anteroposterior, lateral, and oblique radiographs at the most recent follow-up examination. Spondylolisthesis was classified as degenerative in 21 patients and isthmic in 21 patients. Solid fusion was achieved in 32 (76%) patients; pseudoarthrosis occurred in two (5%) patients; the fusion mass was indeterminate in eight (19%) patients. Clinical outcome parameters rated 73% excellent to good and 27% fair to poor. Complications included four infections and two screw breakages. Poor results correlated strongly with cigarette smoking and multiple previous surgeries. In this study, fusion rate and clinical outcome were consistent with previous reports of adult spondylolisthesis. Rates of successful fusion varied according to the type of spondylolisthesis.

Intermittent partial adnexal torsion after electrosurgical tubal ligation.

Intermittent partial adnexal torsion after electrosurgical tubal ligation has been suggested as a cause of chronic pelvic pain. Little is present in the literature describing this entity or its characteristics. Unlike complete torsion of the fallopian tube, ovary, or paratubal cyst, intermittent adnexal torsion is more subtle in both clinical features and laparoscopic findings. It appears to be an underrecognized cause of pelvic pain in some women after tubal ligation. Thus these women may be subjected to many diagnostic tests and extensive evaluations with negative findings. It is not uncommon for the diagnosis to be overlooked even at the time of pelviscopic evaluation. A woman experienced the characteristic chronic, intermittent, left lower quadrant pain after electrosurgical tubal ligation. At the time of a third laparoscopic evaluation, the diagnosis of intermittent partial adnexal torsion was made, and she was treated with distal salpingectomy and ovarian fixation. She had complete resolution of her long-standing pain.

Laparoscopic diagnosis and treatment of cornual pregnancy. A case report.

An early diagnosis of interstitial pregnancy was made by serial quantitative human chorionic gonadotropin beta-subunit evaluation, transvaginal ultrasound findings and laparoscopy. Cornual resection was performed using operative endoscopic techniques; the postoperative course was unremarkable.

Occipitocervical fusion with posterior plate and screw instrumentation. A long-term follow-up study.

STUDY DESIGN: Thirty-two patients at one institution underwent occipitocervical fusions with posterior plate and screw instrumentation. The average follow-up was greater than 4 years (50 months). METHODS: AO plates and screws were used and in more than 50% of the cases, the Magerl transarticular C1-C2 screw technique enhanced the occipitocervical instrumentation. In nine patients, cement was used and thus are excluded in evaluation of fusion results. All 23 patients attained solid fusions. No pseudarthrosis occurred. The average time to fusion was 13 weeks. Halos or traction immobilization was not used postoperatively. The average time of the simple orthosis wear was 11 weeks. Patients were out of bed on an average of the second postoperative day with a range of 1-4 days postoperatively. Reduction of the atlantoaxial joint was required in 10 of the 23 patients. At follow-up, nine remain reduced. RESULTS: In one patient, the atlantodens interval approximated the preoperative distance and radiographs demonstrated one transarticular C1-C2 screw was not placed satisfactorily. The average operative time was 172 minutes, and the average blood loss was 956 cc. The neurologic status of the patients improved or remained the same. No patient deteriorated neurologically. A total of 78 occipital screws were placed. No complications resulted from any of these screws. One intraoperative complication occurred secondary to massive bleeding after a transarticular screw hole was drilled. Bone wax was placed over the drill hole and the bleeding ceased. No postoperative problems occurred in this patient. Most specifically, no central nervous system sequela was evident. CONCLUSIONS: The conclusions from this study are that posterior occipitocervical fusion can be performed very safely with plate and screw instrumentation. An extremely high fusion rate can be expected with minimal complications and minimal postoperative immobilization. This technique, however, is technically demanding.

Biomechanics of odontoid fracture fixation. Comparison of the one- and two-screw technique.

Direct anterior screw fixation of odontoid fractures has become more prevalent clinically. No biomechanical study, however, has determined whether one or two screws should be used. This study measured the stability of the odontoid process after fracture and internal fixation with one or two screws. Internal fixation of Type II odontoid fractures did not restore the original stability of the intact specimen, direct internal fixation with one or two screws provided 50% of the stability of the unfractured odontoid, and no significant differences between the one- and two-screw technique was found under loading to failure, although the two-screw technique provided increased stiffness in extension loading.