Sacroiliac (SI) joint pain is an under diagnosed source of low back pain due in part to lack of visible pathology on radiographs and symptoms mimicking other back-related disorders. Open SI joint fusion has been performed since the 1920s. This technique has fallen out of favor with the introduction of minimally invasive options. To date there has been no direct comparison between open and MIS SI joint fusion.We conducted a multi-center, retrospective comparative cohort study of patients who underwent SI joint fusion using either an open surgical (OS) technique using a combination of screws and cages or a minimally invasive surgical (MIS) technique with a series of titanium plasma spray (TPS) coated triangular implants. Operative measures including surgical operating time, length of hospitalization and estimated blood loss (EBL) were collected along with demographics and medical history, surgical complications, and 12- and 24-month pain scores. Improvements in pain were compared after matching for age and gender and controlling for a history of lumbar spine fusion using repeated measures analysis of variance.Data were available for 263 patients treated by 7 surgeons; 149 patients treated with OS and 114 treated with MIS SI joint fusion. Compared to OS patients, MIS patients were on average 10 years older (mean age 57 vs. 46) and 69% of all patients were female. MIS operative measures of EBL, operating time and length of hospitalization were significantly lower than open surgery (p < 0.001). Pain relief, measured as change from baseline to 12 months in VAS pain rating, was 3.5 points lower in the MIS vs. OS group . When matched for age, gender and a history of prior lumbar spinal fusion, postoperative pain scores were on average 3.0 points (95% CI 2.1 – 4.0) lower in MIS vs. OS (rANOVA p < 0.001).In this multi-center comparative study, patients who underwent either OS or MIS SI joint fusion showed postoperative improvements in pain score. Compared to OS patients, patients who underwent MIS SI joint fusion had significantly greater pain relief and more favorable perioperative surgical measures. Sacroiliac (SI) joint pain can be debilitating to patients, yet is an often-overlooked source of low back pain. Diagnosing the SI joint as the primary pain generator is difficult as patients often present with a combination of low back, groin, gluteal, and/or leg pain with signs mimicking radicular or discogenic distributions -3. Furthde novo or post lumbar spinal fusion [The number of patients under-diagnosed and/or misdiagnosed is not inconsequential. Several studies report up to 30% prevalence of SI joint disorders in patients diagnosed with low back pain ,4-6. Disl fusion . SI joinl fusion ,9. Up tol fusion . Diagnosl fusion -14. The l fusion . For patSmith-Petersen and Rogers first reported SI joint arthrodesis in 1921 . StudiesReports of minimally invasive surgical (MIS) techniques to address the SI joint began appearing in 2008. However instrumentation remained limited to threaded screws and cages that rely on autologous bone graft -24. ReceAccording to a recent survey of spine surgeons, use of the MIS approach to fuse the SI joint has recently increased in popularity compared to traditional open fusion of the SI joint; in 2012, 85% of SI joint fusion was performed using minimally invasive techniques . HoweverA retrospective multi-center comparative study was undertaken after Institutional Review Board approval was obtained. Seven (7) surgeon sites participated; 3 surgeons who perform open SIJ fusion surgery  and 4 who perform MIS SIJ fusion using triangular, titanium, TPS coated implants . A total of 263 patients were identified who underwent SIJ fusion surgery and had both pre-operative and 12- and/or 24-month postoperative pain scales documented in the medical chart; 149 in the open surgical technique cohort and 114 in the MIS technique cohort. Patients were treated between 1994 and 2012. Data extracted from the medical chart included demographics, history of prior lumbar spinal fusion, length of hospital stay (LOS), surgical operating time, estimated blood loss (EBL), complications of surgery and clinical outcomes using a 0-10 visual analog scale (VAS). Descriptive statistics are summarized as mean and standard deviation for continuous variables, and frequency charts for categorical variables.All patients were diagnosed with SI joint disorders using a combination of detailed history, clinical exam, imaging and diagnostic injections. A positive result on 3 or more pain provocation tests such as Gaenslen’s, flexion abduction external rotation (FABER), compression, distraction and thigh thrust, was used as criteria for further testing to confirm the SI joint as the primary pain generator ,31. DiagSeveral techniques for open fusion of the SI joint have been reported ,20,21,24Minimally invasive SI joint surgery using a series of triangular, titanium, TPS coated implants (iFuse Implant System) Figure  was perfPatient reported clinical outcomes were collected prospectively prior to surgery to establish baseline values and at follow up intervals per each surgeon’s routine practice. For consistency in reporting, pain scores using visual analog scale (VAS) were collected at visits close to 12 and 24 months only.Clinical improvement was defined using minimum clinically important difference (MCID) and substantial clinical benefit (SCB) values available in the literature. As there are currently no reported MCID or SCB values for SI joint fusion, values were chosen using lumbar spine criteria published by Copay et al. for MCID and Glassman et al. for SCB ,33. MCIDBaseline demographic variables were summarized with mean, standard deviation and frequency tables. Demographic characteristics were compared across cohorts using t tests for continuous variables and chi-squared tests for nominal variables. Surgical parameters  were compared using t tests.A key outcome variable was the change in pain scores on VAS. Mean baseline VAS scores, as well as mean change from baseline at 12 and 24 months, were tabulated. To account for potential differences in patient characteristics across cohorts, VAS pain scores were compared after matching, as follows. Patients in the two treatment groups were matched based on gender and age in 5-year intervals . This process led to a variable m:n matching where m ≠ n. Variable matching was due in part to missing values of the pain score as well as differences in overall age distribution between the two cohorts.A linear mixed effects model (SAS PROC MIXED) was used to estimate treatment differences using a cell means formulation with additional covariates of prior lumbar fusion and a random effect for patient. Prior lumbar fusion was included as a covariate since it may increase the risk of SI joint degeneration, and also reflects a history of serious back pain requiring surgery. The cell means formulation has a parameter for each treatment, each block , visit, and a random effect for patient. Pairwise differences between treatments for blocks of matched age-category/gender were estimated. Sparse combinations of age/gender blocks that resulted in inability of the model to provide estimates were removed from the model. The final model was estimable and converged. A final treatment effect estimate was calculated by averaging over matched age-category/gender/treatment combinations. Analysis was performed using SAS 9.0 .A total of 263 patients were identified; 149 patients treated with open surgery (OS) and 114 patients who underwent minimally invasive surgery (MIS). Demographic characteristics of patients are shown in Table Peri-operative measures were overall lower in the MIS group Table . Open suMean baseline VAS pain scores were just over 1 point higher in the MIS vs. open groups  Table . SubstanNo intraoperative complications occurred. Postoperative complications were slightly more common in the open surgery group (21% of patients) compared to the MIS group (18%) Table . The mosForty-four percent (66/149) of patients in the open surgery cohort subsequently underwent removal of spinal implants. In most cases, removal was for pain at the ilial or sacral screw. In contrast, only 3.5% of patients (4/114) undergoing MIS surgery underwent postoperative repositioning of the implants. In 3 patients, reoperation was due to nerve root impingement discovered on the postoperative CT scan. In one case, reoperation was performed at the surgeon’s discretion based on radiographic findings only.Confidently diagnosing the SI joint as a pain generator is a challenging endeavor as symptoms may mimic other conditions such as lumbar and hip pathology. A history of sleep disturbance, pain on prolonged sitting and leg instability, pain in the low back, buttock, hip and groin as well as the SI joint are common. Furthermore, imaging studies ordered to evaluate low back or hip pain typically do not include a clear view of the SI joint. Unless educated to examine the SI joint, an improper diagnosis may be made. An accurate diagnosis requires a combination of history, physical examination maneuvers that stress the SI joint, and image-guided diagnostic injections into the joint.Multiple surgical and non-surgical treatments for SI joint disorders are available. When non-surgical management fails to provide adequate relief of symptoms, surgical stabilization is an option. Published case series of various arthrodesis techniques report variable improvements in pain and function with more invasive approaches reporting moderately high complications and non-unions Table  17,19-2,29,34,35Pain and degeneration of the SI joint after lumbar spinal fusion are common occurrences, with up to 43% of these patients experiencing SI joint pain and 75% showing radiographic changes -8. Open To our knowledge, this is the first multi-center comparison of open and MIS SI joint fusion surgery. Rigorous statistical methods (age- and gender-matching as well as controlling for a history of prior lumbar fusion) were employed in an attempt to account for patient characteristics that could affect outcomes after SI joint surgery. Results of this study illustrate the advantages expected of MIS spinal surgery: reduced surgically induced tissue damage, blood loss and surgical morbidity, and length of hospitalization. These parameters have been implicated as risk factors for surgical site infections -39. AddiThis study is not without limitations. First and foremost, it is not a randomized prospective trial. As discussed by McAfee et al., randomizing patients is extremely challenging in today’s postmarket environment . Many paor MIS SI joint procedures, but not both. In an incidence rate study of data obtained from the AMA/Specialty Society Relative Value Scale Update Committee (RUC) database, less than 200 open SI joint fusion procedures were performed annually between 2001 and 2008 [This study is also not concurrent. Most surgeons interviewed during the site identification process performed either open and 2008 . In 2012Whether our results are reflective of the entire population of patients who undergo open or MIS fusion is not known. The low rate of open SI joint fusions performed annually coupled with the rapid adoption of MIS techniques with favorable safety and effectiveness profiles makes a prospective randomized controlled trial highly unlikely.The current study also lacks patient-reported outcomes typically collected in controlled trials, such as Oswestry Disability Index and SF-12 or SF-36. These outcomes instruments are labor intensive for both patients as well as office staff, hence surgeons in private practice do not typically collect them. Not all sites had complete data sets to include EBL, surgical operating time and length of stay for every patient. Finally, pain rating questionnaires, included as part of each surgeon’s standard practice, may have varied in content and been administered differently across sites.Minimally invasive SI joint fusion using a series of triangular, titanium, TPS coated implants (iFuse Implant System) results in more favorable perioperative measures, fewer reoperations and significantly improved clinical outcomes compared to traditional open surgical SI joint arthrodesis.RC and DC are employees of SI-BONE, Inc. AGS, LR, DS, MG and NS are paid consultants of SI-BONE, Inc. LR and NS are stockholders in SI-BONE, Inc. JK, MM have no competing interests.AGS, LR, DS, MG, JK, MM, NS performed patient surgeries, and contributed to manuscript draft. RC and DC drafted manuscript, performed data analysis and interpretation. All authors reviewed and provided final approval of manuscript.


Despite the recommended guidelines, the neonatal management of pain and discomfort often remains inadequate. The purpose of the present study was to determine whether adding a pain and discomfort module to a computerized physician order entry (CPOE) system would improve pain and discomfort evaluation in premature newborns under invasive ventilation.All newborns <37 weeks gestational age (GA) and requiring invasive ventilation were included in a prospective study during two 6-month periods: before and after the inclusion of the pain and discomfort evaluation module. The main outcome measure was the percentage of patients having at least one assessment of pain and discomfort per day of invasive ventilation using the COMFORT scale.p < 0.01), and the mean number (SD) of scores recorded per day increased from 1 (1) to 3 (1) (p < 0.01). When the score was not within the established range, the nursing staff adapted analgesia/sedation doses more frequently after module inclusion . Despite higher mean doses of midazolam after module introduction , the durations of invasive ventilation and hospital stay, and the number of nosocomial infections, were not significantly modified.A total of 122 patients were included: 53 before and 69 after the incorporation of the module. The mean age was 30 (3) weeks GA. After the module was included, the percentage of patients who benefited from at least one pain and discomfort assessment per day increased from 64% to 88% (Adding a pain and discomfort tool to the CPOE system was a simple and effective way to improve the systematic evaluation of premature newborns who required ventilatory assistance. Premature newborns hospitalized in intensive care undergo many painful medical acts, with some studies signaling an average of 15 such acts per day . ManaginAlthough the message that relieving and preventing PAD in newborns has been widely disseminated to all concerned medical staff, PAD management remains inadequate ,8. In 20On our unit, many actions have been initiated since 2002: the creation of a “pain group,” biannual training courses about pain evaluation and treatment, placement of COMFORT scales in front of each incubator, and the construction of a pain management protocol available in paper and electronic form. However, during a recent audit on PAD management in our NICU, we found that the most important objective we needed to reach was the systematization of PAD evaluation. We observed that only two thirds of the neonates under invasive ventilatory assistance had benefited from at least one formalized evaluation per day; that is, with the use of a checklist. This situation prompted us to develop a software module to specifically manage PAD, which was included in our daily-use computerized physician order entry (CPOE) system. We chose this tool for two reasons. First, we assumed that the module would encourage physicians to become more directly involved in pain management, because they would have to validate an algorithm daily to evaluate PAD and adapt analgesic/sedative treatment, based on the unit protocol. Second, we assumed that this tool would encourage the nurses to score the pain objectively, because by doing so they would be able to adjust the analgesic/sedative doses on the basis of their evaluation.The purpose of this study was to evaluate whether the inclusion of a PAD evaluation module in the NICU CPOE system would be an effective strategy to improve PAD evaluation in premature newborns requiring invasive ventilation.This prospective, before-after study was conducted in the 12-bed NICU of a tertiary care university hospital in Montpellier, France. The ratio of pediatric nurses to infants is 1 to 2 and the shift rotation is every 12 hours.Since 2002, our NICU staff has followed the protocol that we collectively developed for managing pain and discomfort; this protocol can be consulted in paper form in the NICU protocol binder. A printed version of the COMFORT scale for evaluating pain and discomfort is included in all patient charts, and all medical and paramedical personnel receive training in pain and discomfort evaluation and management twice a year.http://www.pediadol.org/IMG/pdf/COMFORT.pdf). Newborns are assumed to be “pain-free and comfortable” with scores between 18 and 23. They are considered to be “in pain or uncomfortable” with scores between 24 and 40, and “excessively sedated” with scores between 8 and 17. The interrater reliability of the COMFORT scale was verified when the scale was introduced on the NICU in 2002, but it was not repeated before beginning the study.The COMFORT scale assesses several components of pain and discomfort and has been validated in premature newborns under ventilation ,12. The The protocol remained the same and was presented to all staff before each phase of the study. All newborns under invasive ventilation received an opioid  in combination with a benzodiazepine . The efficacy was evaluated every 8 hours by a pediatric nurse using the COMFORT scale and every 4 hours if a painful procedure had been performed. The objective was a score between 18 and 24. For a score >24, the first step was to determine whether there was a specific cause, such as product perfusion or respiratory obstruction, and to improve the environmental conditions, notably by changing the baby’s position and the respirator settings if necessary. Then, if the excessively high COMFORT score was judged to be directly pain-related—for example, following a painful medical act—a bolus corresponding to an hourly dose of sufentanil was administered over 10 min and the hourly dose was increased by 20% if the score remained elevated after two boluses. If the excessively high COMFORT score was judged to be the result of discomfort—for example, a hyperalert newborn without a recent medical act or stimulation who seemed to be struggling against the respirator—the hourly dose of midazolam was increased by 20%. If the score was <18, we began reducing the hourly dose of analgesia/sedation by 20% over 8 hours, usually beginning with the midazolam. All the patients also were managed according to the Neonatal Individualized Development Care and Assessment Program used on our NICU since 2004 .A CPOE system was introduced on our unit in 2001 to limit the risk of medical errors . The modAll premature newborns with GA <37 weeks and requiring invasive mechanical ventilation were eligible for study inclusion. The noninclusion criteria were the following: a decision to limit or stop life-sustaining therapy and the use of curare during invasive ventilation.The patients were prospectively enrolled in the study during two 6-month periods separated by the introduction of the computerized module for PAD evaluation and the adaptation of analgesic/sedative dosages based on the score. Two groups of patients were compared.The control group was recruited during the period before the introduction of the PAD module, between September 2008 and February 2009. The orders to evaluate PAD and then modify the medication dosages on the basis of the score followed the protocol established in our unit; this protocol was available to all staff but could be adapted by each prescribing physician.This group of patients was recruited after the introduction of the PAD evaluation module on March 1, 2009. It thus included the patients in the immediate postintervention period from March to August 2009. During this period, the protocol for PAD management remained the same on the NICU, notably regarding the nurses, who were able to adapt the analgesic/sedation dosages based on the COMFORT scores. The only modification in this period was the systematization of PAD assessment as part of the written orders given to them.2O and maximal inspiratory pressure <20 cm H2O and FiO2 <0.4; and 3) pH >7.25 and SpO2 >85% [Newborns were extubated when they presented all of the following criteria: 1) clinical stability and spontaneous autonomous ventilation on the endotracheal tube verified during routine care, such as changing diapers or modifying position; 2) positive expiratory pressure <4 cm HpO2 >85% . InfantsOnce the decision to wean the infant from invasive ventilation was made, the NICU protocol called for a daily 20% reduction in the drug dosage when analgesic/sedatives had been given for more than 5 days and 10% when the drugs had been given for more than 10 days. In addition, withdrawal syndrome was systematically evaluated by the neonatal abstinence score of Finnegan .The nurse in charge of the infant noted the exact time of PAD assessment and the therapeutic response  in the patient chart. The main outcome measure was the percentage of patients having at least one evaluation per day of ventilation using the COMFORT scale, i.e., the ratio of the number of patients having at least one evaluation per day to the number of patients ventilated. During the ventilation period, if one of the daily nursing forms for hourly surveillance did not have a COMFORT score recorded, the infant was not included in the numerator but was included in the denominator. We arbitrarily chose the compliance rate of only one evaluation per day of ventilation in the absence of firm recommendations on the rate of evaluation in these patients.The secondary outcome measures were the number of scores prescribed and assessed per day of ventilation, the mean COMFORT score, the mean dosages of analgesics and sedatives, the duration of ventilation, the duration of hospitalization, and the number of nosocomial infections.To calculate the number of subjects needed, previous data collections suggested that the prevalence of at least a daily evaluation of the COMFORT score in the control group would be 65%. Given an alpha risk of 5% and a power of 80%, 50 patients per group were needed to show an increase in this prevalence, from 65% before module inclusion to 90% after, corresponding to a 38% improvement in scoring. Considering the mean number of premature infants admitted to our NICU for invasive ventilation, we chose a 6-month inclusion period for both the pre- and postintervention phases.t test or the Mann–Whitney when distributions were not normal or the variances were unequal. Statistical significance was set at 5% for all tests. Statistical analysis was conducted with the SAS software package, version 9 .Summary statistics are given as means (SD) for continuous variables and as numbers (percentages) for categorical variables. Categorical variables were compared with the chi-squared test or Fisher’s exact test when necessary. For continuous variables, group comparisons were made with Student’s The parents of all children gave written, informed consent to care. The procedures described herein are all part of routine care on our unit and did not require approval of the institutional review board, in line with French law.From September 2008 to August 2009, 349 newborns <37 weeks GA were admitted to the NICU; 214 of them did not require invasive mechanical ventilation. Of the 135 who required invasive ventilatory assistance, 10 were excluded from analysis following the decision to limit or stop life-sustaining therapy and 3 because of missing data. No patient was treated with curare. Thus, 122 patients were included: 53 in the control group and 69 in the intervention group.p = 0.002).The percentage of patients having at least one evaluation per day of ventilation using the COMFORT scale increased from 64% before module inclusion to 88% after inclusion  of COMFORT scores ordered per newborn and per day of ventilation also increased from 1 2) before the intervention to 3 (2) after intervention ( before tThe COMFORT scores fell outside the target range 182 times of the 813 scores collected before the intervention (22%) and 310 times of the 1,380 scores after intervention .p < 0.001).When the target range of 18 to 24 was not reached, the nursing staff more often adjusted the analgesic/sedative dosages after intervention . Yet despite this, PAD evaluation remains inadequate on intensive care units—whether neonatal, pediatric, or adult—with the prevalence of patients evaluated ranging from 40% to 70% ,20. InclThe durations of invasive ventilation and NICU hospitalization and the rate of nosocomial infection remained comparable before and after the intervention. The literature has shown conflicting results regarding the impact of an analgesia/sedation algorithm on the duration of invasive ventilation ,25. OnlyMethods section, we optimized the environmental conditions before proceeding to a therapeutic adaptation of either midazolam if the infant was assessed as “uncomfortable or agitated” or sufentanil if assessed as “hyperalgesic.” It was noteworthy that the more systematized evaluation of PAD, following the addition of the module, led to an increase in the prescription of sedatives and not analgesics. One explanation is that our NICU staff has become very sensitized to pain management since 2002. When a newborn is exposed to a situation likely to generate pain, evaluation and management of the pain is nearly systematic. In contrast, our results indicated that situations of discomfort were underestimated by the nursing staff and that multidimensional scales might help to better sensitize them to discomfort and its management, through medication or other means.We chose the COMFORT scale over other multidimensional PAD scales, because it has been validated for use in newborns to assess objectively the adequacy of analgesia/sedation and it is widely used ,19,31. HWhether the use of sedation and analgesia is recommended during invasive ventilation in newborns, the use of midazolam remains controversial . NeverthThe limitations of the study include the pre-post design. The CPOE system had been in use on our unit before the study began, and thus randomization with and without a computerized tool was not feasible. We therefore used a simple before–after design for the pain and discomfort module. However, this method is open to criticism and did not allow us to affirm that our results were the exclusive consequence of module introduction. Alternative explanations include unnoticed changes in the patient characteristics at inclusion or in the management protocols on the NICU. The nursing staff turnover was 6% during the study, and we also cannot exclude that some of the “new” nurses had undertaken personal training on pain. Indeed, these nurses were generally young and perhaps more sensitized to pain management. With a short period of observation, only 6 months after module introduction, we cannot assume that the observed changes were sustained over time. The limited number of infants, the monocentric nature of the study, and the specificities of our “homemade” module also are limitations for extrapolating our data to other NICUs. Nevertheless, we believe that our results will serve to encourage reflection on how to improve PAD evaluation in critically ill newborns.The addition of a PAD module to an NICU CPOE system seems to have been an effective means to improve the systematic evaluation of PAD in premature newborns under invasive ventilation. Further studies at a bigger scale are now needed to validate this type of resource in the daily management of PAD in neonatology.CPOE: computerized physician order entry; GA: gestational age; NICU: neonatal intensive care unit; PAD: pain and discomfort.The authors declare that they have no competing interests.All authors are legitimate and have actively contributed to the work as follows: NM and CM: experts in our team for pain and discomfort management: study design, data collection, and manuscript preparation. RC: international expert in pain assessment and management: technical advice about the study design, manuscript preparation, review, and correction. RM: developed the computerized physician order entry system and the pain and discomfort module on our unit. CC and ARBN: contribution to the methodological part of the study design, monitoring, management of the data, statistical analysis of the data, and reviewing the manuscript. GC: study design and interpretation of the data, wrote the paper, and is the corresponding author. All authors read and approve the final manuscript.This work was carried out in the Neonatal Intensive Care Unit (NICU) of Arnaud de Villeneuve Hospital, CHU Montpellier, F-34000 France.


Objectives. The objective was to investigate whether a treatment with a needle stimulation pad (NSP) changes perceived pain and/or sensory thresholds in patients with chronic neck (NP) and lower back pain (BP). Methods. 40 patients with chronic NP and 42 patients with chronic BP were equally randomized to either treatment or waiting list control group. The treatment group self-administered a NSP over a period of 14 days. Pain ratings were recorded on numerical rating scales (NRSs). Mechanical detection thresholds (MDTs) and pressure pain thresholds (PPTs) were determined at the site of maximal pain and in the adjacent region, vibration detection thresholds (VDT) were measured at close spinal processes. The Northwick Park Neck Pain Questionnaire (NPQ) and the Oswestry Disability Index (ODI) were utilized for the NP and BP study, respectively. Results. NRS ratings were significantly reduced for the treatment groups compared to the control groups (NP: P = .021 and BP: P < .001), accompanied by a significant increase of PPT at pain maximum (NP: P = .032 and BP: P = .013). There was no effect on VDT and MDT. The NPQ showed also a significant improvement, but not the ODI. Conclusions. The mechanical NSP seems to be an effective treatment method for chronic NP and BP. Chronic pain syndromes affecting the neck and lower back are very common and thus clinically relevant –7: the lBoth syndromes therefore have already a high socioeconomic relevance and the incidence is still increasing. It is estimated that the total costs of low-back pain in the USA exceed 100 billion US $ per year, including the direct costs for treatment and the indirect costs for work absenteeism . The totChronic pain syndromes of the back such as lumbago and/or neck pain are essentially characterised by muscle pain and thus relate to deep somatic pain. Like visceral pain, deep somatic pain is dull, difficult to localize (for an overview see ), and diFurthermore, the complaints can be very obstinate. Therefore, treatment remains challenging. The underlying cause is often not easily detected, as there is a mismatch between the patient′s complaints and suffering and the “objective” diagnostic results  –16. Thishttp://nccam.nih.gov/health/whatiscam).Since BP and NP are usually of deep somatic origin, it seems reasonable that, in order to treat these pain syndromes, naturopathic therapists often apply methods that specifically deform and manipulate somatic body structures, such as subcutaneous tissue, skeletal musculature, and fascias. Consequently, the American National Centre for Complementary and Alternative Medicine subsumes these therapies under the superordinate concept of “Manipulative and Body-Based Practices” . The NSP—with more than 1000 sharp, but nonpenetrating plastic needles, is usually placed on soft ground and the patient lies for a limited time period on top of the mat with the uncovered, painful part of the body. It is very popular in some countries (Scandinavia) and is distributed under numerous names –25. ThosA recent study investigating the effect of a NSP in healthy young volunteers showed substantial effects on cardiac autonomic responses and reactions of the sympathetic and parasympathetic nervous system, such as self-rated relaxation, blood pressure, heart rate, heart rate variability, and back temperature . In contQuantitative sensory testing (QST) is a well-established procedure and is predominantly used for the analysis of the somatosensory phenotype of patients suffering from neuropathic pain , 29. HowThe aim of the two present pilot studies was to investigate whether a two-week treatment period using the NSP changes the pain levels of participants with chronic NP and lower BP. Furthermore, possible treatment effects on mechanical sensory thresholds, in particular mechanical detection (MDT), pressure pain (PPT), and vibration detection (VDT) thresholds were investigated. The whole QST-protocol would have consumed up to an hour per location, so that the entire protocol was considered to be too time consuming for a pilot study. Therefore, these particular QST subtests were chosen for pragmatic reasons, because they are indicative for the two different pathways, which can be considered to play a role. VDT and MDT are indicative for the lemniscal and PPT for the spinothalamic pathway (for review see –44).Inclusion criteria were age between 18 and 75 and nonspecific NP or lower BP for at least three consecutive months. The patients were excluded if they reported radicular pain, showed neurological symptoms suggesting a disc prolapse, had a vertebral column surgery less than 12 months prior to the study, a chiropractic manoeuvre or infiltration at the area treated 4 weeks prior to the inclusion in the study, or a congenital deformation of the spine. Further exclusion criteria were an insulin-dependent diabetes mellitus, dermatological diseases or skin changes at the treated area, severe mental illness that required medication, a known tendency for haemorrhages, current anticoagulation, or corticosteroid medication. Pain medication with the exception of corticosteroids as well as physiotherapy were allowed, if the treatment regimen was not altered for four weeks prior to the study and continued throughout the study. Other related physical or manual therapies like acupuncture, cupping, TENS were not allowed. Participants were recruited using flyers, by announcement through the homepage of the Chair of Complementary and Integrative Medicine, Kliniken Essen-Mitte, Germany, and through a local newspaper article. Study applicants were screened twice, first by a standardized telephone interview and second by the study physician, who examined the patient at their first appointment. This “on site” assessment during the first visit was performed to ensure patient safety. All inclusion and exclusion criteria were checked again, a careful patient history was taken, and a thorough physical examination, including neurological examination, was performed to rule out a clinical suspected spinal alteration, for example, discus prolapse. All participants provided written informed consent before participating in the study.The study was planned and conducted in compliance with the Declaration of Helsinki  and the Guidelines for good clinical practice. The protocols were approved by the institutional review board of the University of Duisburg-Essen Medical Institutions, Germany (no. 08-3767 for BP and 08-3768 for NP). Both studies were carried out independently but according to a similar protocol. They were conducted as two-week open randomized controlled pilot trials at the Department of Complementary and Integrative Medicine Kliniken Essen-Mitte, Essen, Germany from October 2008 to May 2009. At the first examination, a medical history was collected and each participant was thoroughly examined. Subjective assessments on pain and function were taken, and sensory thresholds were determined. Subsequently the participants were randomly assigned to a home-based treatment either (TG) or waiting list control group (WL). The participants in the TG were thoroughly instructed how to use the NSP. All patients were asked to document medication and physiotherapy treatments in a treatment diary. Fourteen days later the evaluation of NRS ratings, the questionnaire and the sensory examination were repeated for both groups. After the second examination day, patients of the WL received the NSP.In order to rigorously ensure that at the time of enrolment, medical examination, and baseline measurement the group allocation was unknown to everybody involved in the study, randomization was performed after completion of the first (baseline) measurement. The randomization procedure itself was performed as a lottery, without stratification or sequencing. The “lottery tickets” consisted of the exact number of “treatment” or “control” tickets needed, hidden in sealed, nonmarked opaque envelopes. These envelopes were prepared before the enrolment started and kept in a “lottery box”. The envelopes were manually shuffled before each draw and the patients picked an envelope after the completion of the first measurement.The treatment consisted of a home-based, self-administered intervention with the mechanical NSP see . It is a medical device, which has been applied for years by patients with diverse pain syndromes. Different versions of this pad are available in various sizes. The same NSP was used in both studies: a 22 × 33 cm plastic mat featuring 60 hexagonic plastic discs. On each of these discs, 19 spikes are affixed with the distance between the 1140 spikes being 5 mm . Participants were instructed to apply the NSP over a period of 14 days once daily according to the following procedure: in a first step, the patients were instructed to press both hands (only NP study) or both feet (only BP study) for 10 minutes on the mat while sitting on a chair. The protocol is to treat the hands of patients with neck pain and feet of patients with lower back pain, respectively, prior to the actual painful area derived from clinical experience. The protocol represents the way the NSP is applied in our clinic. It was recommended to place the NSP afterwards on a soft base, for example, the bed and to lie on top of the mat with the uncovered painful part of the body . The patients were also instructed to place a towel or a bedroll underneath the neck, if the neck was to be treated. The participants were informed that the first 2 to 5 minutes could be painful. A daily treatment time of about 30 minutes was recommended for the painful part of the body. A numerical rating scale (NRS) ranging from 0 = no pain to 10 = worst pain imaginable was used , 46. FurSensory testing was performed in a quiet room with constant room temperature (approx. 82–84°F) and air humidity (approx. 75%) and included the MDT, PPT, and VDT according to the quantitative sensory testing protocol , 29. In All sensory tests were conducted at the point of maximum pain and 10 cm caudal paraspinal (for NP patients) or 10 cm cranial paraspinal (for lower BP patients), respectively. Furthermore, sensory tests were conducted at two control sites apart from the painful area, the right hand, and foot, serving as measures of intraobserver reliability.MDT was tested with a standardized set of von-Frey-filaments . Von-Frey-filaments are nylon filaments with a rounded tip; affixed in a rectangular manner at a handlebar. They are pressed perpendicularly with constant force onto the skin surface  until the filament bends. Using the method of limits, a psychophysical method to approximate thresholds, five threshold determinations were made, each with a series of ascending and descending stimulus intensities. The test always started with a von Frey filament that was clearly sensed by the test person. In the next step, the examiner took the next smaller filament. This procedure was repeated until the test person was unable to sense a filament. Then this particular filament was annotated as the first subliminal stimulus. Now the test was continued in ascending order, and the next bigger filament was taken again until the test person could feel a filament. This is the next value above the threshold. The final threshold is represented by the geometric mean of these 10 values.2 using three series of ascending stimulus intensities (slowly increasing ramp of ~20 kPa/s) at a muscular area . The patient was instructed to press a button, as soon as this pressure was perceived as being painful. The final threshold was the arithmetic mean out of all 3 measurements.PPT was determined by means of an algometer  with a probe area of 1 cmVDT was measured with a Rydel Seiffer tuning fork  which was placed over a bony prominence . After the tuning fork has been induced into vibrations it was placed over the tested area. The tested person was asked, if he sensed the vibration and should indicate, if the vibration had stopped. The particular value was read out of the 8/8 scale and the final threshold was the arithmetic mean out of 3 subsequent descending measurements.The control group was offered the same NSP postintervention.These trials were pilot trials not only designed to explore the effectiveness of the NSP but moreover to generate hypotheses about the potential mechanisms of action. Thus, only patients giving a complete set of data were analysed per protocol, and missing values were not imputed. According to the Quantitative Sensory Testing (QST)-protocol , 29 PPT t-tests within these models. All analyses were conducted with the SAS statistical software . P values < .05 were regarded as statistically significant.Each outcome parameter was analysed by a univariate analysis of covariance, modelling treatment as a fixed factor, and the respective baseline value as a covariate. Differences between treatment groups were tested by two-sided Forty patients were included in the NP and 42 patients were included in the BP study  years in the in the NP study and 63.9 (±11.1) years in the BP study .While there were no baseline differences in the BP study, baseline difference for NRS ratings and NPQ scores occurred in the NP study .Moreover, gender was not equally distributed across groups: 85% of the patients in the treatment group were females compared to 100% in the control group . d = −1.6 pts; with 95%-CI: −2.8 to −.3 (P = .021) and in the BP study it was d = −2.3 pts with 95%-CI: −3.2 to −1.3 (P < .001)  , Table 2d = −7.4 NPQ score points   (NP-induced disability was significantly improved after treatment compared to the control group by  = .028) , Table 2 = .878) , Table 2Test-retest correlations in the control areas (hands and feet) were high and statistically significant, indicating good reliability and accuracy see .d = .106; CI: .013 to .198, P = .032) and BP  for log PPT at the point of maximum pain . A significant group difference was seen for NP   , Table 2No statistically significant effects between patients and controls were seen for PPT at the control areas, as well as for MDT and VDT in general . Besides the discomfort or pain when lying on the pad, especially at the first minutes of the first sessions, no adverse effects of the mechanical NSP were reported.The outcome of the two studies presented here further supports the usefulness of the NSP as a representative of naturopathic therapies in the treatment of chronic pain syndromes. To our knowledge, the two studies are the first to systematically investigate the outcome of the NSP as a therapeutic agent in two highly prevalent chronic pain syndromes. The results show that the NSP significantly reduced pain ratings in patients suffering from chronic pain of the neck or the lower back. Pre- to posttreatment decreases in the NRS of 30% in the NP study and 36% in the BP study are in the range of a moderately important clinical difference , 52. TheChronification of pain may originate at the level of the nociceptor, the spinal cord, or the brain e.g., , 26). Al. Al26]).It is assumed that hyperalgesia is associated with the hyperexcitability of central neurons in the spinal cord , 54. As  Naturopathic treatments that induce controlled but clearly visible injuries of the skin, such as, for example, gua sha massage or wet cupping, markedly alter the nociceptor environment. It can be assumed that these injuries, which are often clearly visible for several days, lead to increase firing of the nociceptive fibres in the affected regions .Such an increased firing for several hours up to days may directly influence the receptive fields of spinal neurons in the affected region. If this is the case, these treatments are likely to induce specific, demonstrable effects on the somatocutaneous or viscerosomatic projection areas. Such effects can be demonstrated by measuring the patients' pain thresholds. . InBecause there were no relevant differences in VDT and MDT, a possible involvement of the lemniscal tract is not likely. Larger studies including a nontreatment control group, a healthy control group, and including further QST-tests as well as the assessment of both body sides will reveal more conclusive evidence for the pathway in question.Previous studies in which various forms of cupping therapy, for example, dry cupping , wet cupThe often reported deep relaxation induced by many of the manipulative and body-based therapies contributes to well-being and thus works through the affective-motivational component of pain  and probThere are several limitations in these studies. While there were no baseline differences and no drop outs in the BP study, a critical factor for the interpretation of the results of the NP study is the apparent baseline difference for NRS ratings, NPQ scores, QST-scores, and gender in the NP study. However, the analysis of covariance with the respective baseline value as a covariate controls in part for this difference. Moreover, the high percentage of female participants in both studies exceeds the gender-specific back or neck pain prevalences  likely sThe waiting list control strategy may be considered a potential weakness of the study. However, there is no valid inactive sham control for the needle stimulation pad available to date. Even the blunting of the sharp needle tips would still induce a rather strong mechanical stimulation. Therefore, a waiting list control seemed to be the best way to control for the effect of anticipation or for being included into a study. Furthermore, the waiting list control groups in these two studies are rather reflecting “standard treatment” since all patients were allowed to stay on their current treatment strategies, be it medication or physiotherapy, except for those treatments, which were among the exclusion criteria. Considering the fact that in clinical trials of conservative treatments for chronic nonspecific NP, changes in pain scores are generally similar between waiting-list control and placebo control groups , and theIn the two pilot studies presented here, a rather short-treatment protocol with defined treatment units was applied. However, in clinical practice, patients apply the pad typically whenever they feel intense pain and that may be several times a day. Until now no data are available, which treatment duration and frequency reveal the best therapeutic results. Because these studies were pilot studies, we used a pragmatic approach and did not change a protocol that derived from clinical experience, which means that participants pressed their hands (NP study) or their feet (BP study) in advance of the painful area. It is not clear if this protocol influences the outcome, but this question could be included in further trials. Nonetheless, it is doubtful that there is an exact dose-effect relationship, but more likely that there is an individual “optimal dose”.The needle stimulation pad revealed a substantial potential for the alleviation of chronic NP and BP. Furthermore, psychophysical data support the assumption that the pad reveals its effects at least partly on a subcortical level of the pain processing system. A further benefit of the device is the fact that it is easy to use, safe, and does not require a therapist.


Data on the potential efficacy of acupuncture (AC) in controlling intense or very intense pain in patients with Herpes Zoster (HZ) has not been so far adequately assessed in comparison with standard pharmacological treatment (ST) by a controlled trial design.Within the VZV Pescara study, pain was assessed in HZ patients on a Visual Analogue Scale (VAS) and by the McGill Pain Questionnaire (MPQ) both at the beginning and at the end of treatment. Response rates, mean changes in pain intensity, differences in total pain burden with an area-under-the-curve (AUC) method over a 1-year follow-up and differences in the incidence of Post-Herpetic Neuralgia (PHN) were evaluated.One hundred and two patients were randomized to receive either AC (n = 52) or ST (n = 50) for 4 weeks. Groups were comparable regarding age, sex, pain intensity at presentation and missed antiviral prescription. Both interventions were largely effective. No significant differences were observed in response rates , mean reduction of VAS  and MPQ scores , incidence of PHN after 3 months , and mean AUC during follow-up . No serious treatment-related adverse event was observed in both groups.This controlled and randomized trial provides the first evidence of a potential role of AC for the treatment of acute herpetic pain.ChiCTR-TRC-10001146. A significant proportion 18% to 41%) of patients suffering with Herpes Zoster (HZ) experience intense or very intense pain at presentation, frequently persisting after the healing of rash 8% to 41%-7. ThereCurrent therapeutic options include the repeated administration of paracetamol and/or other NSAIDs for the immediate relief of pain ,10, antiIn this context, the evidence that acupuncture may be efficacious in the treatment of neuropathic pain syndromes lead to the hypothesis of a potential beneficial effect of this procedure for acute HZ-related pain -29. TherHere we report on a randomized, controlled trial, comparing the efficacy of acupuncture (AC) and standard pharmacological treatment (ST) in controlling intense or very intense acute pain in patients with HZ.The present randomized clinical trial was nested within the "VZV Pescara Study", a cohort study aimed at evaluating the intensity of pain at presentation, pain persistence, overall pain burden and relative predictors in HZ patients . Final aIn the AC arm, 8 sessions of Traditional Chinese Acupuncture were administered twice weekly by 2 experienced acupuncture physicians, members of the Italian School of Acupuncture and Traditional Chinese Medicine, Boulogne, Italy. Acupuncture basic points used are shown in Figure The main outcome of the study was the reduction in pain intensity between baseline and the end of the 4-week treatment, as measured by the reduction in the VAS score ,39. SecoBecause of the recent debate on non-inferiority trials , the stuKruskal-Wallis test was used to compare VAS, McGill and AUC mean scores across groups at each time point, as well as the mean change in each score during the follow-up. Chi-squared test was used to compare the VAS response rate and the prevalence of PHN between groups. Within each group, the differences in VAS and McGill scores between baseline and the end of the 4-week treatment were evaluated using paired t-test and confirmed through the Wilcoxon matched-pairs signed ranks test. A two-tailed p-value of 0.05 was considered significant for all analyses, which were carried out using Stata 10.1 .During the 2 years of enrolment in the VZV Pescara cohort study, 451 patients were clinically and/or microbiologically diagnosed as HZ . Of themIn the initial sample of 102 randomized patients, no differences between groups were observed in mean age , male gender , pain intensity at presentation  and missed antiviral prescription (10.0% in ST and 15.4% in AC). Similarly, as shown in Table As shown in Table No significant differences were observed between the 2 therapeutic approaches in any of the outcomes under consideration  related to both treatments were observed in the 2 groups. In addition, none of the patients were hospitalized or died during the 4 week treatment. Finally, none of them discontinued treatment due to drug-related complications or procedure-related discomfort.Lack of proper efficacy evaluations, adequate statistical power and rational design of the previous studies assessing the role of Acupuncture for Zoster related acute pain is acknowledged ,37. CoghPain intensity was evaluated by the most frequently used methods in VZV-related pain studies: VAS, to obtain an easy quantification of pain intensity ,39; McGiIt should be noted that the stratification for pain resulted in a perfect match of patients with very intense pain at presentation, which could have otherwise remarkably influenced the validity of our results for all endpoints. Furthermore, the percentage of patients which did not receive antiviral therapy was identical in the 2 arms , protecting our trial from another possible confounding factor, that is a difference in potential control of acute HZ pain by antiviral therapy between groups .This study has some limitations, however, that must be considered in interpreting results. First, we decided to measure pain intensity both by VAS and McGill scales at study entrance and after 4 weeks of treatment, that is when the investigator felt that his intervention for the control of acute pain was complete. Clearly, it would have been interesting to measure ongoing pain control at intermediate time points, to better appreciate minor differences between the investigational arms. This was not feasible, however, due to study budget constraints; in any case, most of the other investigations assessing the efficacy of experimental treatments for pain control were built with very similar or identical designs ,55.Second, our trial was based upon a relatively small sample of treated patients (n = 66). However, 41 GPs and 3 hospital units were committed to recruit HZ patients for 2 years, and more than 400 HZ patients had to be enrolled to identify 129 patients with intense or very intense pain at presentation (those with the highest need of improvements in pain control). In addition, a relatively large number of the eligible patients (n = 27) refused to enter the trial. However, this was probably unavoidable because of distrust or fear of an unusual technique such as acupuncture. Notably, no differences in age, gender and pain intensity were observed between these patients and those included in our analyses. Finally, 28 patients were excluded immediately after randomization because of rapid pain reduction. However, it would clearly have been unethical to enforce these patients in a strong analgesic therapy as well as acupuncture. Notably, and expectedly, the latter patients were younger and had very intense pain in only 2 cases. This is the reason why it would have had very little sense to use an intention-to-treat analysis, which is usually the gold standard analysis for RCTs , in thisA third limitation is represented by the lack of both a control arm with short acting analgesics only, and a control arm with mock acupuncture -59. ThisWith these caveats, our study provides the first evidence from a randomized controlled design of a potential role of acupuncture in the treatment of acute herpetic pain. Patients with intense or very intense pain at presentation showed a significant and similar degree of pain relief using acupuncture and standard pharmacological therapy. Also, no differences between treatments were observed in the incidence of severe adverse events. Given that patients treated with acupuncture carry a lower risk of cumulative drug toxicity, if these findings will be confirmed by the ensuing ACUZoster trial and/or by other investigations, acupuncture might be appropriately considered among the available therapeutic options for the control of severe acute HZ related pain.AC: Acupuncture; ST: Standard Pharmacological Treatment; VAS: Visual Analogue Scale; MPQ: McGill Pain Questionnaire; AUC: Area Under the Curve; PHN: Post Herpetic Neuralgia; HZ: Herpes Zoster; GPs: General Practitioners; ID: Infectious Disease; PMC: Pain Management Clinic.The authors declare that they have no competing interests.GP, LP, TU, CR, CG CDA and MT conceived and coordinated the study; GP, LM, LP, CDA and CG designed the trial. LM, LP, GP, EP, AC, CDA and CG interpreted and discussed the results of the trial; LM, GP and EP performed the statistical analyses; CR prescribed and performed the standard pharmacological analgesic treatments; LP and GC performed acupuncture treatments; SDP, AC and GPl administered and corrected McGill Pain questionnaire; PMT and SL randomized and tracked all patients; TU, GP, MT, AC and GPl followed the clinical status of patients under observation; SL, CG and PMT cared for the online database; GP, TU, MT, EP, LM, CG and CDA wrote and revised the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6882/11/46/prepub


Objective. The present study was conducted to determine if depressive symptoms were associated with variability in pain perception and quality of life among patients with nonalcohol-related chronic pancreatitis. Methods. The research design was cross-sectional, and self-report data was collected from 692 patients with nonalcohol-related, intractable pancreatitis. The mean age of the sample was 52.6 (SD = 14.7); 41% of the sample were male. Participants completed the MOS SF12 Quality of Life Measure, the Center for Epidemiological Studies 10-item Depression Scale (CESD), and a numeric rating scale measure of “pain on average” from the Brief Pain Inventory. Results. Depressive symptoms were significantly related to participants' reports of increased pain and decreased quality of life. The mean CESD score of the sample was 10.6 (SD = 6.5) and 52% of the sample scored above the clinical cutoff for the presence of significant depressive symptomology. Patients scoring above the clinical cutoff on the depression screening measure rated their pain as significantly higher than those below the cutoff (P < 0.0001) and had significantly lower physical quality of life (P < 0.0001) and lower mental quality of life (P < 0.0001). Conclusion. Although causality cannot be determined based on cross-sectional, correlational data, findings suggest that among patients with nonalcoholic pancreatitis, the presence of depressive symptoms is common and may be a risk factor associated with increased pain and decreased quality of life. Thus, routine screening for depressive symptomology among patients with nonalcoholic pancreatitis may be warranted. Chronic pancreatitis (CP) is a long-term, often debilitating medical condition that drastically impacts the health and quality of life of affected patients. The disease involves persistent inflammation of the pancreas, causing the hallmark symptom of severe abdominal pain in 80–90 percent of patients , 2. InitImportantly, in addition to multiple distressing physical symptoms, individuals with chronic pancreatitis report significant difficulties in social and emotional functioning. The unique interplay between physical and psychosocial symptoms of CP is not well-understood. Higher rates of clinically significant depression and anxiety amongst CP patients  are documented in the literature, and various social and physical variables associated with CP likely interact to create distressing symptoms and reports of reduced quality of life –14. For Further, the etiology of patient's CP may contribute to reported emotional, social, and physical symptoms. Alcoholism is the most common cause for nonobstructive pancreatitis and is thought to account for 70% of cases of CP . TreatmeA better understanding of the relationship between depressive symptoms, pain, and quality of life in patients with nonalcohol-related CP holds promise for improving pain management and the quality of life of this unique patient population. The present study explores the frequency with which participants with nonalcohol-related CP endorse depressive symptoms and examines the relationship between depressive symptoms, pain experience, and quality of life among participants. Consistent with previous research on the relationships between depression, pain, and quality of life among patients with other chronic medical conditions, it was hypothesized that individuals with nonalcoholic intractable CP who met criteria for significant depressive symptomatology would report higher pain ratings and lower quality of life scores compared to those who did not meet criteria.All data were collected with full approval from the Institutional Review Board at the Medical University of South Carolina. Participants' personal health information was handled ethically and in accordance with Health and Human Services regulations. M = 52.6, SD = 14.7), and 59% of the sample were female. The participants in this study consisted of 692 patients with nonalcohol-related, intractable pancreatitis. Participants had been diagnosed with pancreatitis for at least 6 months. The sample on average was middle age  at a large southeastern medical university. The participants completed the measures in a private physician office while they waited for their consultation with their physician. Nursing staff was available to help participants log-in to the system and to assist with completion of the online questionnaires if necessary.(1)The Medical Outcomes Trust Short Form 12 (SF-12). Health-related quality of life was assessed by administering the SF-12 [he SF-12 . The SF-he SF-12 , and it he SF-12 , and thehe SF-12 , 23–25. (2)The Center for Epidemiologic Studies 10-Item Depression Scale (CESD-10). The CESD-10 was used to assess self-reported depressive symptoms. This is a 10-item self-report measure with a 4-point rating scale (0–3) and has been demonstrated to be as effective as the full version of the CESD in identifying significant depressive symptoms [symptoms –28. Scor(3)The Brief Pain Inventory (BPI). The Brief Pain Inventory Short Form (BPI) is a 17-item self-report, multidimensional pain questionnaire that provides information about pain history, location, and intensity [no pain) to 10 (pain as bad as you can imagine) at several time points: at its worst and its least over the past 24 hours, on average, and at the time of the assessment. For the purpose of the present study, participants only rated their pain on average. Although the BPI was first designed to evaluate cancer pain, it has since been validated in a chronic noncancer pain patient population [ntensity . Participulation .  The following measures were completed by all participants. P = 0.05. Descriptive analyses were conducted, and Pearson correlations were run among the group as a whole examining the association between depression, quality of life, and pain on average. In addition, to further explore the relationship among variables, participants were divided into two groups: those that met criteria for the presence of depressive symptoms (score of 10 or higher on CESD 10) and those who did not meet criteria for presence of depressive symptoms. Independent sample t-tests were used to explore the differences between groups in quality of life (SF-12) and their rating of pain on average. If participants skipped any items they were excluded pairwise from each relevant analysis.All study analyses were conducted with SPSS, version 12. Statistical significance was set at r = 0 .46, P < 0 .0001).The mean age of all participants was 52.6 (SD = 14.7); 41% of the sample were men. Demographic variables were not significantly related to depressive symptoms, pain, or quality of life. Correlation data for variables analyzed are summarized in r = −.22, P < 0.0001) and mental quality of life . Similarly, participants' reports of depressive symptoms were significantly and inversely related to ratings of physical quality of life (t(691) = 9.9, P < 0.0001). Moreover, participants above the cutoff on the CESD-10 rated their quality of life as significantly lower compared to participants below the cutoff, The mean physical quality of life norm-based t-score for those above the depressive symptomatology cutoff was 34.2 (SD = 7.6) on the physical quality of life subscale of the SF-12, and for those below the cutoff the mean physical quality of life was 37.6  = 5.3, P < 0.0001). Similarly, the mean mental quality of life norm-based t-score for participants who scored above the cutoff was 44.9 (SD = 8.2), and for those below the cutoff, it was 49.0  = 5.3, P < 0.0001). Results are summarized in The mean CESD-10 score of the sample was 10.6 (SD = 6.5) with 52% of participants scoring above the cutoff for clinical depressive symptomatology. The average CESD-10 score for participants who scored above the clinical cutoff for depressive symptoms was 15.76 (SD = 4.34) compared to a mean of 4.96 (SD = 2.68) among the group scoring below the cutoff for depressive symptoms. Participants who scored above the clinical depression cutoff endorsed significantly more pain on average compared to those who did not meet the criteria for depressive symptoms. Specifically, participants above the depressive symptomatology cutoff rated their pain on average as 5.5 , whereas those below the cutoff rated their pain on average as 3.4  experience depressive symptoms. Importantly, participants who endorsed significant depressive symptoms tended to also report worse pain and lower physical and psychological quality of life compared to those who did not acknowledge significant depressive symptoms. Findings lend support for the importance of assessing and treating CP patients using a biopsychosocial model. This treatment approach posits that biological, psychological, and social factors all significantly impact individuals' level of functioning within the context of chronic illness. This model has received increasing attention and support in the literature for understanding the etiology, course, and treatment planning for medical illness . Current findings highlight the importance of the treatment of depressive symptoms in improving pain experience and physical and mental quality of life. A biopsychosocial model of treatment that targets symptoms of depression may include use of antidepressants and cognitive-behavioral interventions of activity-pacing, cognitive restructuring, and relaxation strategies. Environmental interventions may focus on increased communication, utilization of social resources, and physical rehabilitation. This comprehensive approach to treatment addresses the physiological, psychiatric, and social variables that are associated with increased distress in patients with CP.The present study also highlights the potential value of early intervention and ongoing assessment of psychosocial variables in reducing depressive symptoms and improving pain and the general well-being of CP patients who are not alcohol dependent. The use of clinical interviews and self-report measures can provide valuable information to the treatment team related to the unique challenges that individual CP patients face and treatment can be tailored accordingly. Importantly, initial and ongoing psychosocial assessment provides physicians with information related to patients' needs for referrals to other specialists, such as mental health providers. There are several limitations to the present study. The current analysis was of retrospective data, limiting variables to the confines of prior data collection. Further, as this is a cross-sectional study, findings identify an association between depression, pain level, and quality of life; the direction of this relationship is unknown. Future prospective research that includes a theoretical design, experimental methods including healthy controls and participants with alcohol-related pancreatitis, and longitudinal designs are likely to further delineate the role of depression in the course of CP. The current study is also somewhat limited by the lack of examination of other psychosocial variables. It is possible that variables such as level of social support, coping style, substance use, and treatment history also play a role in patients' report of depressive symptoms, pain experience, and quality of life. Additional research that explores the possible mitigating role of these variables will provide valuable information related to the complexity of the relationship between depression, pain, and quality of life in CP patients. Further, more comprehensive measurement of the frequency, intensity, and quality of pain will offer a more nuanced picture of CP patients' experience.  In conclusion, findings suggest that among patients with nonalcohol-related CP depression is common and may be a risk factor associated with increased pain and decreased quality of life. Thus, routine screening and intervention for depression among patients with nonalcohol-related chronic pancreatitis may be warranted.


Guillain–Barré syndrome (GBS) is an acute inflammatory demyelinating polyneuropathy characterized by symmetric limb weakness. Children with GBS sometimes consult the orthopaedists because of limb pain and gait disturbance. The orthopaedists, however, are unfamiliar with GBS, since it has rarely been delineated in detail in the orthopaedic literature. In the present study, we specifically describe orthopaedic manifestations and diagnostic clues in pediatric GBS.We reviewed seven patients with pediatric GBS in regard to age, gender, clinical symptoms, department at the first medical consultation, initial diagnosis, physical and laboratory findings, medical interventions, and the latest clinical outcome.There were five boys and two girls, with a mean age at presentation of 7.2 years. Gait disturbance associated with lower limb pain and weakness was the most frequent early clinical symptom. Among the five patients who presented initially at the orthopaedic department, three were misdiagnosed. Loss of deep tendon reflexes was seen in all patients. Anti-ganglioside antibodies were positive in three and protein levels of cerebrospinal fluid were elevated in five patients. Six patients recovered completely after intravenous immunoglobulin (IVIG) treatment, while one patient who had not undergone IVIG treatment showed minor residual disability.Acute symmetrical limb pain and gait disturbance associated with loss of tendon reflexes were important clinical manifestations of pediatric GBS. Early diagnosis is essential to prevent delayed recovery, long-term weakness, and permanent functional disabilities. Campylobacter jejuni, and 30 % of infections were attributed to C. jejuni in one meta-analysis, whereas cytomegalovirus has been identified in up to 10 % [Guillain–Barré syndrome (GBS) is an acute inflammatory demyelinating polyneuropathy (AIDP) characterized by symmetric limb weakness and loss of tendon reflexes . It is a to 10 % –6. Also, to 10 % .Guillain–Barré syndrome is recognized as a heterogeneous disorder with various clinical manifestations. As well as the classical diagnostic characteristics including ascending weakness and reflex loss, pain and bladder (or bowel) involvement are often features of GBS. Extensive “mimic disorders”, including peripheral neuropathies, disorders of the neuromuscular junction, disorders of muscle, and disorders of the central nervous system, should be excluded in the differential diagnosis of GBS –10. ElecGuillain–Barré syndrome is more common in the elderly adult population but rare in children. The incidence of GBS in children less than 17 years old is estimated at 0.8 per 100,000 . In pediWe performed a retrospective study of seven children with the diagnosis of GBS between 2004 and 2009 at the authors’ institution. Medical records and laboratory data were reviewed in regard to age, gender, disease subtype, preceding illness, department at the initial medial consultation, clinical symptoms, physical findings including range of motion (ROM) and manual muscle testing (MMT) of the affected limbs, laboratory findings, initial diagnosis, time to diagnosis from onset or the initial examination, medical interventions, and the latest clinical outcome. On the basis of MMT (grades 0–5) for each muscle, a lower limb strength was calculated as the Medical Research Council (MRC) percentage = (sum of grade scores × 100)/(number of muscles tested × 5) . For theTable The most frequent early clinical symptom was a gait disturbance, which was associated with lower limb pain or weakness. Pain was evident in six patients during the course of illness. The distribution of pain included lower limb in five, neck in three, and back in two patients. All but two infants for whom discriminative and evaluable MMT had not been measured showed evidence of lower limb weakness, with an MRC percentage of 60–88. Three infants  refused to stand or walk because of persistent pain of various locations. The other infant (Case 1) without complaint of pain appeared to show significant distress in standing. Three older patients (Cases 4–6), who complained of severe lower limb pain, presented with unsteady crouch gait with their parents’ support. One patient (Case 3) showed 20° of flexion contracture in bilateral knees, while hip ROM was slightly limited (approximately 100° in flexion) in two patients (Cases 2 and 4). Deep tendon reflexes of the lower limbs were partially or completely diminished in all patients. In addition, two patients showed hyporeflexia of the upper extremities. The straight leg raising (SLR) test was positive in one patient (Case 6). Bladder dysfunction such as frequent urination and oliguria was seen in three patients.Routine blood investigations, including complete blood counts, erythrocyte sedimentation rate, C-reactive protein, and serum creatine kinase, were all within normal values. Magnetic resonance imaging of the brain and total spinal cord demonstrated no evidence of neurological tumors or infection. Serum anti-ganglioside antibodies and cerebrospinal fluid (CSF) were measured in all patients during the treatment period. Anti-ganglioside antibodies that are strongly associated with the AMAN form were positive in three of the five AMAN patients. CSF examination revealed elevated levels of protein in five patients and normal levels in two. Electrophysiologic examinations showed various types of abnormalities in the peripheral nerve conduction, including prolonged distal motor latency, reduced motor nerve conduction velocity, reduced compound muscle action potentials (CMAP), and reduced sensory nerve action potentials (SNAP). AIDP patients showed longer distal motor latencies and slower nerve conduction velocities than AMAN patients. Reduced CMAP amplitudes were observed in both subtypes, whereas SNAP amplitudes were almost normal in AMAN and decreased in AIDP patients.All patients were finally diagnosed as GBS by the pediatric neurologists based on the current diagnostic criteria of GBS . 1) Fea Fea1).FiSix patients who received intravenous immunoglobulin (IVIG) treatment immediately after the diagnosis of GBS demonstrated complete recovery of neurologic functions  after treatment. Glucocorticoid treatment was done in one patient before IVIG therapy. One patient (Case 3) who was already in the recovery process when definitive diagnosis was made, did not receive IVIG therapy because the pediatric neurologists concluded the therapy to be less effective. He showed limited range of bilateral ankle dorsiflexion of 5° at the latest examination .Guillain–Barré syndrome is a recognizable entity for the commonest cause of acute childhood flaccid paralysis in the field of pediatric neurology . SeveralNguyen et al. , reviewiElectrophysiologic findings are the most sensitive and specific in GBS . We finaPatients not receiving appropriate treatments sometimes provide unsatisfactory outcome, such as delayed recovery and long-term weakness. IVIG and plasmapheresis halt the progression of GBS and shorten recovery time. IVIG treatment, which has anti-inflammatory properties at the nerve root level, is preferred in childhood because of less invasive and rarer complications than plasmapheresis. Hughes et al.  describeIn conclusion, orthopaedic manifestations of pediatric GBS include: (1) gait disturbances, walking and standing difficulties; 2) symmetrical lower limb pain, back pain, and neck pain; (3) symmetrical lower limb weakness; (4) areflexia or hyporeflexia of deep tendon reflexes; and (5) less frequently positive SLR test (Fig.  symmetri


Intraspinal synovial cysts of vertebral facet joints are uncommon cause of radicular pain as well as neurological deficits. They can be managed both conservatively and surgically.A 77-year old polymorbid patient presented with bilateral low back pain which worsened during the course of time and did not respond to the conservative treatment. A diagnosis of intraspinal synovial cyst was made using the magnetic resonance imaging (MRI). Percutaneous computed tomography (CT) guided injection with installation of local anesthetic together with corticosteroid and rupture of the cyst was successfully used. A month after the procedure his pain improved, the usage of analgesics diminished and his over-all quality of life improved.Percutaneous CT guided lumbar synovial cyst treatment is safe and reliable alternative to the surgical treatment in polymorbid patients with radiculopathy who are not able to tolerate general anesthesia and operation. Radicular pain in lumbar region is a symptom which can have many causes such as herniated nucleus pulposus, migrated disc fragment, lumbar stenosis, facet joint syndrome, malignancy and/or infection.1The incidence of lumbar synovial cysts in symptomatic patients is 0.65–2.3% according to a diagnostic method.4Cysts may be asymptomatic but they usually cause radicular pain, neurogenic claudication, motor deficits, sensory and reflex disturbances or even cauda equina syndrome.5A 77-year-old patient presented with back pain in the lumbar region and both legs. Lumbar pain started 3 years ago and was primarily described as blunt and propagating along the left lower extremity. Nature of pain changed a year before the presentation into prickling in nature and spontaneous. Symptoms interfered with his daily routine. A similar type of pain affected his right lower limb. According to visual analogue scale (VAS) he evaluated his pain as 8/10. This was improved by bed rest and usage of analgesics and described as VAS 4/10.The patient had a complete occlusion of left internal carotid artery, both vertebral arteries and 70% stenosis of right internal carotid artery. He had already suffered two myocardial infarctions as well as an ischemic stroke. His other comorbidities included chronic atrial fibrillation, congestive heart failure, peripheral arterial occlusive disease, arterial hypertension, hyperlipidemia, hypercholesterolemia, benign prostatic hyperplasia and chronic renal insufficiency.MRI revealed well delineated intraspinal cystic formation compressing dural sac from the left dorsolateral side at the level of fourth and fifth lumbar facet joint. The dural sac was significantly compressed and displaced by the cyst filling more than half of the normal canal. The communication of the cyst with the left facet joint was seen. Presence of the fluid within the degenerated facet joint was additional finding that supported the diagnosis of intraspinal synovial cyst .tube technology enables an acquisition of 40 slices. The wide gantry opening ensures an easy patient access. The following CT protocol was used for CT guidance: low dose scans  with rapid 3600 gantry rotation speed (1 second) and 0.6 mm section collimation (slice thickness). A puncture point (overlying the left L4–L5 facet joint) was selected on axial CT scan. Local infiltration with 2% lydocaine 2 ml was used.Due to complex medical history the decision for non-surgical, percutaneous CT -guided intervention was made. Standard monitoring  was used. An intravenous line was inserted. The patient received cefazoline 2 g and paracetamol 1 g 30 minutes before the start of the procedure and was placed in the prone position on the CT scanner’s table. The procedure was performed under strict aseptic conditions by using CT scanner with 82 cm gantry opening . The scanner with STRATON X-ray A 22 gauge (G) atraumatic spinal needle  was advanced forward targeting the joint. The position of the needle was confirmed with subsequent CT scans. After the insertion of the needle into the facet joint space, iodine contrast media iohexol  10 ml was instilled. A communication between the joint space and the intraspinal cyst was proved, confirming the diagnosis of the synovial cyst. A mixture of local anaesthetic 1% lydocaine 1 ml and methylprednisolone 125 mg was injected into the lumen of the cyst. Additional sterile saline was installed in order to distend and rupture the cyst. The patient described pain in the spinal region and both legs during this part of the procedure, which partially responded to intravenous 0.05 mg of alfentanyl application. The loss of resistance suggested the rupture of the cyst and this was confirmed by CT scan . At the Immediately following the procedure a sterile dressing was placed over the skin entry. The patient was observed and monitored in recovery unit for two hours. A strict body rest was maintained during this period of time. The patient did not require any additional analgesics. He was discharged next day. Instructions about the wound care and observation were given to him.A short-term follow-up with the referring physician as well as with the patient himself revealed the partial relief of radicular symptoms a month after the procedure. His pain still persists but is described as blunt and without propagation. Prickling pain in both his lower extremities disappeared. His only pain therapy is weak opioid before sleep.As already mentioned, intraspinal synovial cysts are uncommon cause of radicular pain and are located on the internal and posterolateral side of the spinal canal.1Pathogenesis of synovial cysts is not well understood. A chronic degenerative process causes the protrusion of the synovial membrane through the defects of the joint capsule. Consequently formation of the cavity filled with synovial fluid occurs.The clinical presentation of the intraspinal synovial cysts depends on the size, site and relationship to the adjacent structures. Cysts may be asymptomatic but they usually cause radicular pain, neurogenic claudication, motor deficits, sensory and reflex disturbances or even cauda equina syndrome.The diagnosis of intraspinal synovial cysts is based on MRI, CT or CT myelography.Intraspinal synovial cysts can resolve spontaneously, but they usually require the treatment. The treatment  includes bed rest, analgesics, physical therapy, transcutaneous electrical stimulation (TENS), as well as minimal invasive methods such as epidural/intraarticular corticosteroid injections with or without rupture of the cyst and CT or endoscopy guided aspiration of the cyst.Non-surgical interventions include installation of corticosteroids and/or local anesthetics. The aim is to prevent the recurrence of the cyst and inflammation.3et al. confirmed a sufficient symptomatic improvement in 46% of treated patients as well as avoidance of the surgical treatment. A cyst rupture was described in all of them. Patients, who underwent surgical procedure after the minimal invasive procedure, reported the significant improvement in disability, back and leg pain.1The rupture of the cyst can be achieved with the additional injection of normal saline. An immediate complete relief is described by the majority of patients. According to reports of some authors, significant long term effect cannot be achieved.The advantage of CT over fluoroscopy is direct, reliable puncture of the cyst without dural violation and was a method of choice in our case as well. Another advantage of the procedure is that it can be repeated if necessary. Common risks include infection, bleeding or damage to nervous structures.Surgical treatment includes different procedures . The aim of these procedures is a complete resection of the cyst as well as the treatment of concomitant disease.11However, the optimal treatment strategy of synovial cysts remains controversial.Percutaneous CT- guided lumbar synovial cyst treatment is safe and reliable alternative to the surgical treatment in polymorbid patients with radiculopathy unable to tolerate general anesthesia and operation.


Objective: To compare the anesthetic action of 0.5% bupivacaine in relation to 4% articaine, both with 1:200,000 epinephrine, in the surgical removal of lower third molars. As a secondary objective hemodynamic changes using both anesthetics were analyzed.Study Design: Triple-blind crossover randomized clinical trial. Eighteen patients underwent bilateral removal of impacted lower third molars using 0.5% bupivacaine or 4% articaine in two different appointments. Preoperative, intraoperative and postoperative variables were recorded. Differences were assessed with McNemar tests and repeated measures ANOVA tests. Results: Both solutions exhibited similar latency times and intraoperative efficacy. Statistical significant lower pain levels were observed with bupivacaine between the fifth (p=0.011) and the ninth (p=0.007) postoperative hours. Bupivacaine provided significantly longer lasting soft tissue anesthesia (p<0.05). Systolic blood pressure and heart rate values were significantly higher with articaine.Conclusions: Bupivacaine could be a valid alternative to articaine especially due to its early postoperative pain prevention ability. Key words:Bupivacaine, articaine, third molar, anesthesia, postoperative pain. Profuse scientific literature exists addressing different aspects of third molar treatment such as indications for extraction -3, complLocal anesthetics (LA) have been broadly compared using this model -18. A vaDue to the clinical relevance of bupivacaine’s extended postoperative analgesic effect further analysis is needed. To our knowledge only a couple of clinical trials have compared bupivacaine with articaine for lower third molar removal. ,24 ThereAll patients provided written informed consent during the recruitment period of the study. The protocol of this study was approved by the Ethics Committee of the Dental School of the University of Barcelona. Calculation of sample size was performed using G*power 3.1.0 software, assuming α error =0.05, power= 95% and estimated effect size =0.4. Sixteen patients were needed.To compensate for possible losses, study population consisted of 20 individuals with symmetrically positioned full bony impacted lower third molars, recruited from 25 eligible subjects. Eligibility criteria included ASA I or II patients, aged between 18 and 40 years, who presented bilateral impacted lower third molars, which required for their removal flap elevation, bone removal and tooth sectioning. Exclusion criteria included allergy to local anesthetics or any other medication, pregnancy or current lactation, heart rate > 110 bpm. or < 60 bpm., systolic arterial pressure > 150 mm Hg or < 100 mm Hg, diastolic arterial pressure > 100 mm Hg or < 60 mm Hg, oxygen saturation < 96%, pain, swelling or infectious signs associated to the third molar site immediately before surgery, any drug intake during the previous 15 days to the surgery, and surgeries lasting less than 15 minutes or longer than 45 minutes.The study design comprised a triple-blind scheme. All anesthetic car pules were equally manufactured and were encoded. The patient, the surgeon and the statistician who performed the data analysis did not know which anesthetic solution had been used. Each patient required a similar surgical treatment for the removal of both inferior third molars. The extraction's were carried out at two different appointments, with at least a month of wash out period. The starting time of every surgery was 9:00 am. All surgeries were performed by the same surgeon and monitored by the same person.The anesthetic technique chosen was a regional block of the inferior alveolar nerve at the mandibular foramen level with a direct technique , using aEvery patient received a leaflet where the postoperative instructions were described. Patients were prescribed 750 mg of amoxicillin  and 600 mg of ibuprofen  that had to be taken at 9:00 hours (just before surgery), 15:00 hours and 23:00 hours for 4 days. Patients were instructed to rinse with 0.12% chlorhexidine digluconate  3 times a day for 15 days, starting the day after surgery. Metamizol was prescribed as a rescue medication . Patients had to record the date and time at which the rescue medication was taken.The following data were collected:1. Onset of anesthetic action (in minutes) determined by: 1) the loss of pulpal sensibility assessed by a negative response to thermal stimuli after positioning a cotton pellet impregnated with tetrafluoroethane on the buccal aspect of the homolateral lower second molar and 2) loss of homolateral retromolar trigone mucosa, lip and tongue sensibility to pricking.2. Total volume of anesthetic solution used during surgery and need of additional anesthetic infiltration's .3. Duration of surgery after anesthetic administration (in minutes), which corresponds to the period between the first incision until placement of the last suture.4. Adverse reactions during surgery or during the first postoperative week.5. Intraoperative global pain judged by the patient and by the surgeon at the end of surgery in a 5-point scale .6. Duration of postoperative anesthesia, represented by the lack of sensibility of the lower lip and the tongue. Patients recorded the moment at which they noticed the initial recovery of lip and tongue sensibility and the time at which lip and tongue sensibility had totally returned to normality.7. Subjective pain evaluation, with the aid of a 100-mm-length visual analogue scale (VAS), with a 0 anchored by “no pain” and a 100 anchored by “worst pain imaginable”. Subjects recorded the intensity of postoperative pain at 2 hour intervals starting the surgery day at 10 am until 10 pm , and during de second, third and fourth postoperative days only at 10 am and 10 pm.8. Amount of rescue analgesic medication (magnesic metamizol) needed during the first 4 postoperative days.9. Systolic and diastolic arterial pressure, heart rate and oxygen saturation before surgery, one minute after anesthetic infiltration, at tissue incision, at start of bone removal, and after suturing. All measurements were collected using the same monitoring instrument  in a noninvasive manner.Paired t-tests were used to compare duration of surgeries and time to onset. Continuous variables were analyzed using repeated measures ANOVA. Differences between anesthetics for categorical variables were assessed with the McNemar test. Statistical significance was established at p<0.05. The results were presented as the mean ± standard deviation (SD).Twenty patients were included in the study. Two of the participants were withdrawn from the study because they did not attend the second surgical appointment, so the final sample included eighteen patients (7 men and 11 women), with a mean age of 23.8 years . No adverse reaction related to the anesthetic agent was detected during surgery or reported by any patient during the postoperative course.The onset of action for articaine and bupivacaine as referred to lip and tongue numbness was similar (p=0.789), with a mean of 1.9 minutes (SD 1.2 minutes) and 1.8 minutes (SD 1.2 minutes) respectively.Similarly, no significant differences were observed between both groups regarding number or volume of reanesthesia . IntraopDuration of surgery was also similar (p=0.185) with a mean of 23.7 minutes (SD 8.1 minutes) for bupivacaine vs. mean of 20.9 minutes (SD 4.5 minutes) for articaine. There were no statistically significant differences between solutions in pain perception, both interpreted by the surgeon or expressed by the patient . HoweverWhen considering hemodynamic changes through surgery between groups, statistically significant higher levels of systolic blood pressure were observed in the articaine group . Systolic pressure varied significantly across time , gradually increasing form the baseline until the bone removal measurement and descending again at suture placement . Interestingly, the bupivacaine group had lower pain scores during day 1, being statistically significant at 2:00 PM (p=0.011) and 4:00 PM (p=0.007) Fig. . No statOur results suggest that 4% articaine and 0.5% bupivacaine, both with 1:200,000 epinephrine, have similar clinical efficacy in third molar surgery. Time to onset, need of additional anesthetic administration, intraoperative pain and hemodynamic effects were similar for both anesthetic solutions. The main difference between both solutions was the anesthetic effect duration; granting bupivacaine longer anesthetic periods, thus reducing early postoperative pain.Even though a triple blind scheme was intended, the statistical analyzer’s blinding was jeopardized as a result of his awareness of the differences in anesthetic duration between local anesthetics. Nevertheless, the analyzer had no commercial compromise and the strategy for data analysis had been defined before the results were available.In this study, no statistically significant differences on time to onset of action were observed between both solutions. Other studies have reported faster onsets with articaine, claiming lower pKa values (7.8) than bupivacaine (8.1) ,24. Our Need of additional anesthetic administration was similar for both solutions, however unexpectedly frequent. In the study by Gregorio et al. , with a When surveying the patients on intraoperative anesthetic efficacy no statistically significant differences were found between solutions. Nonetheless, 9 patients rated their intraoperative pain awareness higher with bupivacaine, were as only 2 did so with articaine. These results could imply that bupivacaine performs slightly worse in controlling intraoperative pain, although these differences did not reach statistical significance. Intraoperative pain awareness has not been addressed directly in other studies, however indirect signs of incomplete anesthetic depth, such as need to administer additional anesthesia, could prove to some extent an inferior performance of bupivacaine as compared to articaine .Interestingly, the results suggest that surgeons are unable to interpret precisely painful situations. Surgeon’s ratings on the patients’ pain experience underestimated those expressed by patients in 25% of the surgeries performed. This should make surgeons consider improving patient-operator communication, in order to increase patient satisfaction and provide better care.An important issue when studying the application of long lasting anesthetics in surgery is their ability to reduce or delay postoperative pain. In our study statistical significant lower pain levels were observed with bupivacaine between the fifth and the ninth postoperative hours with respect to articaine. This time period extends from the point where the articaine solution starts to wear off and the bupivacaine is still acting, until the moment where the anesthetic action of the bupivacaine solution disappears. Several studies confirm the ability of bupivacaine to prolong the analgesic period for inferior alveolar nerve block anesthesia, providing analgesia during the first 8 to 12 hours, which is the period of maximum pain after third molar surgery ,10,14,26Even if bupivacaine could grant milder early postoperative periods, its extended anesthetic effect may be a drawback for some patients since prolonged periods of soft tissue anesthesia can cause soft tissue trauma as well as eating or speaking disability. Rosenquist and Nystrom  reportedOxygen saturation, heart rate and blood pressure suffered variations during stressful steps of surgery, as reported by Alemany-Martinez et al. . No signEven though bupivacaine has an overall good safety profile, it could have severe adverse effects on the central nervous system and cardiovascular system ,30. For Within the limitations of this study, it can be concluded that anesthetic success in third molar surgery is similar with 4% articaine and 0.5% bupivacaine, both with 1:200,000 epinephrine. Both solutions exhibit similar latency times and intraoperative efficacy. Bupivacaine intraoperative pain control seemed slightly worse. However, bupivacaine reduced pain scores during the early postoperative period, when the maximum intensity of pain occurs. This extended anesthetic effect entailed, nevertheless, prolonged periods of soft tissue numbness, which may be a nuisance. No significant changes were observed between anesthetic solutions with respect to diastolic blood pressure or oxygen saturation, although systolic blood pressure and heart rate were higher with articaine during incision and bone removal. Therefore, bupivacaine seems a valid alternative to articaine, particularly in the prevention of early postoperative pain.