The RECOVER  study demonstrated significant improvements in early-morning motor function (UPDRS III) and sleep disturbances (PDSS-2) with rotigotine transdermal system. Improvements were also reported on a Likert pain scale (measuring any type of pain). This Post hoc analyses for patients reporting ‘any’ pain (pain score ≥1) at baseline, and subgroups reporting ‘mild’ (score 1–3), and ‘moderate-to-severe’ pain (score ≥4) were performed. Likert pain scale change from baseline in rotigotine-treated patients was further analyzed based on a UPDRS III/PDSS-2 responder analysis . As post hoc analyses, all p values presented are exploratory.PD patients with unsatisfactory early-morning motor impairment were randomized to optimal-dose (up to 16 mg/24 h) rotigotine or placebo, maintained for 4 weeks. Pain was assessed in the early-morning using an 11-point Likert pain scale (rated average severity of pain (of any type) over the preceding 12 hours from 0 [no pain] to 10 [worst pain ever experienced]). Of 267 patients with Likert pain data , 187 (70%) reported ‘any’ pain; of these 87 (33%) reported ‘mild’, and 100 (37%) ‘moderate-to-severe’ pain. Change from baseline pain scores decreased with rotigotine compared with placebo in patients with ‘any’ pain , and in the subgroup with ‘moderate-to-severe’ pain . UPDRS III or PDSS-2 responders showed greater improvement in pain than non-responders.post hoc analysis of the RECOVER study suggest that pain was improved in patients with PD treated with rotigotine; this may be partly attributable to benefits in motor function and sleep disturbances. Prospective studies are warranted to investigate this potential benefit and the clinical relevance of these findings.The results from this  Pain is a common and challenging non-motor symptom of Parkinson’s disease (PD), occurring in 40% to 85% of patients with PD, with a Rotigotine is a dopamine receptor agonist with activity across D1 through D5 receptors as well as select adrenergic and serotonergic sites; continupost hoc analysis of the RECOVER study further investigates the effect of rotigotine transdermal system on pain among patients with PD who reported pain at baseline as rated by a Likert pain scale. Post hoc analyses were also performed to investigate the possibility that the observed improvements in pain with rotigotine may at least in part, be directly attributable to the improvement in motor impairment and sleep disturbance.The current Enrolled patients were men and women aged 18 years or older, with PD (Hoehn and Yahr Stages I–IV), and unsatisfactory control of early morning motor symptoms as determined by the investigator. Immediate-release levodopa was permitted provided the dose was stable for at least 28 days prior to baseline. The full RECOVER  study design including complete inclusion/exclusion criteria has been published. The stuPatients were randomized 2:1 to receive transdermal patches containing rotigotine or placebo; treatment was titrated to optimal dose (defined as the dose at which both the investigator and patient felt that early morning motor impairment was adequately controlled) over 1 to 8 weeks, starting at 2 mg/24 h and increasing to a maximum of 16 mg/24 h. This dose was maintained for 4 weeks (maintenance phase), during which dose adjustments  were not permitted. Visits were scheduled at screening and baseline; every 2 weeks during dose titration; start and end of maintenance; and 30 days after treatment ended. Patients were hospitalized for two nights at baseline and at the end of maintenance. Patients who withdrew prematurely were asked to return for a withdrawal visit. All efficacy outcomes were assessed in the early morning; they were assessed at baseline before new patch application , and at the end of maintenance, or in the event that a patient was prematurely withdrawn from the trial.post hoc analysis, Likert pain scale score change from baseline to end of treatment was assessed in patients with ‘any pain’ at baseline, which was defined as those who recorded a baseline Likert pain scale score ≥1. Two further subgroups were defined from this group: patients reporting ‘mild pain’ , and those reporting ‘moderate-to-severe pain’  at baseline.Patient rating of pain was recorded in the early morning, after the second night of hospitalization, using a standard 11-point Likert pain scale. The scaSix items were identified within the other assessment scales used in RECOVER, that also provide an evaluation of pain: ‘nocturnal cramps’ (NADCS); ‘painfuThe co-primary efficacy measures in RECOVER were change from baseline in early morning motor function assessed using the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III (Motor Examination) measured in the early morning, and nocturnal sleep disturbances assessed using the modified PDSS-2 total scores. To investigate the possibility that the observed improvements in pain with rotigotine may be directly attributable to the improvement in motor function and sleep disturbance, the Likert pain scale change from baseline in rotigotine-treated patients was further analyzed based on a UPDRS III/PDSS-2 responder analysis. In RECOVER, a patient was defined as a responder if showing a ≥30% reduction,24 in eapost hoc analyses, all p values presented are exploratory and do not infer statistical significance. No adjustments were made for multiplicity due to closed test procedure for primary efficacy variables.Likert pain scale was assessed as change from baseline to end of treatment, where end of treatment was the combined results of observations from end of maintenance and early withdrawal, using data as observed. Likert pain scale analyses were performed on the full analysis set (FAS). The FAS included all randomized patients who received at least one dose of study drug and had a baseline and at least one post-baseline measurement for both co-primary efficacy variables. UPDRS Part III and PDSS-2 were performed on the FAS and were assessed as change from baseline to end of maintenance, with last observation carried forward. Differences in demographics/baseline characteristics between patients with pain and patients with no pain at baseline  were estimated using t-test for continuous data, and the Chi-square test for categorical data. Treatment differences for Likert pain score change from baseline to end of treatment were estimated using analysis of covariance (ANCOVA), with treatment and region as factors and baseline Likert pain value as the covariate. UPDRS and PDSS-2 30% responder status differences for Likert pain score change from baseline to end of treatment were estimated using ANCOVA, with responder status and region as factors and baseline Likert pain value as the covariate. As Of 287 patients randomized , 246 completed the study; 267 patients  were included in the FAS, all of whom had baseline and follow-up Likert pain scale scores. At baseline, 187 (70%) patients with a Likert pain scale score ≥1 were considered to have ‘any pain’ at baseline; 100 (37%) patients with a Likert pain scale score ≥4 were considered to have ‘moderate-to-severe’ pain  for patients reporting ‘no pain’ at baseline (pain score = 0), 11.5 ± 4.3 mg/24 h (n = 132) for patients reporting ‘any’ pain’, 12.0 ± 3.9 mg/24 h (n = 62) for patients reporting ‘mild’ pain, and 11.1 ± 4.6 mg/24 h (n = 70) for patients reporting ‘moderate-to-severe’ pain.At baseline, individual item scores from other scales used in RECOVER assessing pain, i.e., NADCS, PDQ-8, PDSS-2, and NMSS, were higher  in patients with greater severity of pain as assessed by the Likert pain scale  mean [95% CI] treatment difference of -0.88 , p = 0.013. This was also the case in the subgroup of patients with ‘moderate-to-severe’ pain , but was not observed in patients with ‘mild’ pain  between change from baseline to end of maintenance in UPDRS III and PDSS-2 with Likert pain scale score change from baseline (rotigotine-treated patients) are presented in Additional filer = 0.40 [patients with ‘mild’ pain], and r = 0.31 [patients with ‘moderate-to-severe’ pain]) and nocturnal sleep disturbances . Results were comparable for Spearman rank-order correlation coefficients (data not shown).Rotigotine-treated patients defined as UPDRS Part III 30% responders, showed a greater improvement on the Likert pain scale than the non-responders. This was the case for the patient group reporting ‘any pain’ at baseline  and for the subgroup reporting ‘moderate-to-severe’ pain at baseline   of patients who participated in the RECOVER study reported experiencing pain at baseline, in the 12 hours preceding the early-morning assessments as rated by the Likert pain scale (score ≥1). Over a third (37%) reported ‘moderate-to-severe’ pain (score ≥4), supporting prior observations documenting pain as a common non-motor symptom of PD. The effThe Likert pain scale indicates both presence and severity of pain without distinguishing different types of pain or causality. However, of note, patients who reported pain at baseline appeared to have more advanced motor symptoms of PD based on higher UPDRS Part III score (p = 0.013 in patients with ‘moderate-to-severe’ pain vs patients with ‘no’ pain), and greater nocturnal sleep disturbance, as assessed by PDSS-2 . In addition, the proportion of patients receiving levodopa was numerically larger and mean disease duration was longer than in patients who did not report ‘any’ pain at baseline (p >0.05). This would suggest that the symptoms of pain observed at baseline in these patients may, at least in part, be related to the severity of symptoms of PD. There did not appear to be any difference in mean rotigotine maintenance dose between the different pain subgroups. The most marked rotigotine treatment effect, i.e., improvement in pain, was seen in patients with the most pronounced pain, i.e., the ‘moderate-to-severe’ pain subgroup, while no relevant improvement compared with placebo was observed in the subgroup of patients with ‘mild’ pain. However, the number of patients in this subgroup with ‘mild’ pain may not have been sufficient to detect an effect for only mild symptoms. In addition, by definition, patients in this subgroup had lower baseline Likert pain scores , and there was therefore less scope to detect a treatment effect.post hoc analysis of the RECOVER study, evaluating individual items of the PDSS-2 and PDQ-8, showed that the prevalence of four items recording the presence of pain ranged from 27% (painful posturing in the morning) to 38% (painful muscle cramps or spasms), and suggested that rotigotine had a beneficial effect on ‘painful muscle cramps or spasms due to PD’, frequency of nocturnal ‘pain in arms or legs’, nocturnal ‘muscle cramps in arms or legs’, and ‘painful posturing in the morning’[Patients who responded to treatment with rotigotine with at least a 30% improvement in their early morning motor function (UPDRS Part III) or nocturnal sleep disturbances (PDSS-2) showed a greater improvement in overall pain compared with the UPDRS III/ PDSS-2 non-responders, supporting the concept that the pain reported was to some extent related to their symptoms of PD. In addition, baseline scores of the individual items of the other scales used in RECOVER that assessed pain  were higher in patients with pain as assessed by the Likert pain scale than in patients with no pain . This again suggests that the pain measured by the Likert pain scale was likely to capture types of pain assessed with these items, e.g., pain in limbs, muscle cramps due to PD, and painful posturing. A previous morning’. These sr = 0.31–0.40) and nocturnal sleep disturbances (r = 0.16–0.30), the pain reported by the patients may also include pain unrelated to motor function or sleep disturbance. Pain in PD should therefore be considered as a non-motor symptom in PD per se, and may also be linked to alterations in pain sensation[Pain in patients with PD has previously been described to fluctuate with motor fluctuations, with more frequent and severe pain in ‘off’ compared with ‘on’ states. Howeverensation,14,27,28ensation.post hoc exploratory analyses)[post hoc analysis.In the RECOVER study population, improvements were also observed in favor of rotigotine in scales/items assessing the neuropsychiatric symptoms of depression, apathy and anhedonia ,30. It ipost hoc analysis to consider. First, these analyses are exploratory in nature therefore the statistical significance or clinical relevance of the observed improvements in pain, following treatment with rotigotine cannot be determined from these results. Second, because patients were not selected for the RECOVER study based on symptoms of pain, post hoc selection using subjective Likert pain scales scores may have biased the results. Third, the limitation of the Likert pain scale to assess general pain, i.e., its inability to record information on the types and causes of pain, and also the retrospective observation limited to the preceding 12 hours. It is also important to note that the clinical relevance of the arbitrary categorization of patients as reporting ‘mild’ and ‘moderate-to-severe’ pain on the Likert pain scale has not been defined. However, as there is currently no validated pain scale for patients with PD, we relied on a standard Likert pain scale, accepting that this scale is not specific to PD-related or associated pain.There are several limitations of this post hoc analysis, these data support existing information that pain is a prevalent non-motor symptom associated with PD. This study has begun to characterize some of the types  and distribution of pain  that may be improved with rotigotine; our results also suggest that the improvement in pain was to some extent attributable to the benefits in motor function and nocturnal sleep disturbances, such as dystonic symptoms at night or in the early morning. Prospective studies are warranted to investigate the potential improvements in pain with rotigotine transdermal system, and to determine the clinical relevance of these findings.Despite the limitations of this Basal Ganglia, as an editorial board member of Parkinsonism and Related Disorders, and the Journal of Parkinson’s Disease, and as the Liaison and PR Committee Chairman of the Movement Disorder Society; has received honoraria for academic lectures at sponsored symposiums from UCB Pharma, Britannia, GlaxoSmithKline, Abbott, Teva, Medtronic, and Boehringer Ingelheim Pharmaceuticals, Inc.; and has received educational grants for research from UCB Pharma, Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., and Britannia. TAZ has received compensation from UCB Pharma, GlaxoSmithKline, Teva, Edison Pharmaceuticals, General Electric, and the Friedreich’s Ataxia Research Alliance (FARA). ES is an employee of UCB Pharma, Monheim am Rhein, Germany. BB is an employee of UCB Pharma, Raleigh, NC, USA and receives stock options from this employment. KM is an employee of UCB Pharma, Smyrna, GA, USA and receives stock options from this employment. LG was an employee of UCB Pharma, Brussels, Belgium, during the development of the manuscript. CT is a consultant for and/or has received honoraria/research support from Vifor Pharma, UCB Pharma, Mundipharma, Britannia, Novartis, Boehringer Ingelheim Pharmaceuticals, Inc., GlaxoSmithKline, Teva Neuroscience and Desitin.JK has received personal compensation for activities with UCB Pharma, GlaxoSmithKline, Teva, Medtronic, and Boehringer Ingelheim Pharmaceuticals, Inc. as a consultant and honoraria for academic lectures from Merz and Bayer. KRC serves as the European Editor of post hoc analyses, performed the statistical analysis, and was involved in revising the manuscript critically for important intellectual content. KM and LG participated in the design of the current post hoc analyses, participated in the analysis and interpretation of data, and were involved in revising the manuscript critically for important intellectual content. All authors read and approved the final manuscript.JK, KRC, TZ, BB, and CT participated in the analysis and interpretation of data, and were involved in revising the manuscript critically for important intellectual content. ES participated in the design of the current The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2377/14/42/prepubIndependent Ethics Committees or Institutional Review Boards of participating centres in the RECOVER study.Click here for filer) for change from baseline in Likert pain scale score with UPDRS III and PDSS-2 change from baseline in rotigotine-treated patients.Pearson correlation coefficients (Click here for file


How the research advances dissemination and implementation research: The management of chronic pain poses a significant challenge for primary care practices, particularly those caring for medically underserved patient populations. Experience in the Veterans Health Administration (VHA) has demonstrated that implementation of a Stepped Care Model for Pain Management (SCM-PM) can improve outcomes for patients with chronic pain. In this project, we advance the dissemination and implementation research by describing the use of the Promoting Action on Research Implementation in Health Services (PARIHS) Framework to guide the adaptation, implementation, and dissemination of the SCM-PM to a non-VHA setting-a large, statewide Federally Qualified Health Center.Chronic pain is extremely common in safety-net practices. The Stepped Care Model for Pain Management (SCM-PM) has been shown to improve outcomes in the Veterans Health Administration (VHA) system. To examine whether this model is transferable to non-VHA settings we undertook a three-year quality improvement project to adapt and implement the SCM-PM in a large, statewide Federally Qualified Health Center.This project used an observational mixed methods evaluation framework and used the PARIHS Framework to guide the design of the intervention. Study subjects included all patients and providers (PCPs) of the health center. The principal goals of the project were 1) to improve the screening for and management of routine pain complaints in primary care using basic tools and protocols to improve the assessment, documentation, treatment, and monitoring of pain; and 2) to provide additional resources and supports for PCPs to assist in managing more complex cases.The use of opioid treatment agreements among patients using opioids chronically (COT), increased from 49% to 64%. The number of COT patients with a urine drug test within the preceding six months increased from 867 (66%) to 1,097 (86%). Patients with a completed pain functional assessment increased from 428 (33%) to 589 (46%). The percentage of patients co-managed by an onsite behavioral health provider increased from 22.5% to 24.4%. Referrals to chiropractors also increased. There was a decline in number of patients with pain receiving any opioid prescriptions from 43% to 40%, and in those receiving COT from 17.5% to 15.9%. The percentage of patients with an episode of severe pain decreased from 74% to 61%. Surveys showed that CHCI PCPs expressed increased confidence in their ability to manage pain effectively and had an increase of 9.2% in pain management knowledge scores.To implement successfully the Stepped Care Model for Pain Management (SCM-PM) at our statewide Federally Qualified Health Center, we had to identify all patients with chronic non-cancer pain (CNCP). A straightforward method for identifying patients with CNCP solely using structured electronic health record (EHR) data does not exist. Individual data elements such as pain scores or diagnostic codes (ICD9) are not sufficiently reliable or comprehensive. Our objective was to develop and validate an accurate method to identify patients with CNCP using EHR data.We identified patients with CNCP in our EHR system using a comprehensive set of data elements including diagnostic codes, patient-reported pain scores, and prescription opioid medications. Reviews of the medical chart were used to evaluate the accuracy of these data elements in all their combinations. Based on these evaluations we developed an algorithm to more accurately identify patients with CNCP. The algorithm's results were validated by comparing them with the documentation of chronic pain by the patient's treating clinician in 381 random patient charts.The new algorithm, using pain scores, prescription medications, and ICD9 codes had a sensitivity and specificity of 84.8% and 97.7%, respectively. The algorithm was more accurate (95.0%) than pain scores (88.7%) or ICD9 codes (93.2%) alone. The Receiver Operating Characteristic was 0.981.The newly developed and validated algorithm uses a combination of readily available elements from the EHR system to accurately identify patients with CNCP. By applying the algorithm to our patient population, we were able to gain a better understanding of the extent of chronic pain and how it is managed in our health centers. This helped us to better tailor our implementation efforts to the needs of the patients with CNCP and their primary care providers.The Veterans Health Administration (VHA) has engaged in a system-wide transformational effort to implement the Stepped Care Model of Pain Management (SCM-PM) as its single standard of care for Veterans with painful conditions. Successful organizational improvement processes typically rely on reliable metrics to establish targets for improvement and to monitor progress. This project examined the utility of the measure of Pain Care Quality (PCQ) documentation in evaluating implementation of the SCM-PM at one VHA healthcare system and to explore its generalizability in a non-VHA Federally Qualified Health Center undergoing a similar organizational improvement effort.From 2009 to 2012 a comprehensive pain management performance improvement approach was implemented at the VHA. Two hundred progress notes per year (July 2008 -June 2012) were randomly sampled from VHA primary care prescribers of chronic opioid therapy (COT). Using the PCQ extraction tool, each note was reviewed and coded for the presence of key dimensions of PCQ documentation, namely pain assessment, treatment, and reassessment of outcomes. General Estimating equations (GEE) controlling for provider and facility, with post-hoc pair comparisons were used to examine changes in PCQ items over the four years. This approach was replicated in a multi-site FQHC for two consecutive years (2011-2012).Significant improvements were noted in pain reassessment and patient education, with trends in improvement noted for pain assessment and treatment planning. Several specific dimensions of pain assessment and treatment planning also improved significantly, including documentation of functional assessments (p < 0.001). Although post hoc comparisons generally documented improvements over time, some variability across the four years of observation suggest that these trends are not entirely linear. Although none of the dimensions of PCQ at the FQHC were significant, results suggest trends in a positive direction across all dimensions of PCQ.


Extracorporeal shock wave therapy (ESWT) has been used to reduce pain in patients with various musculoskeletal diseases and wounds. We investigated the effect of ESWT on scar pain after complete wound epithelialization in burn patients.2 (0.05–0.15 mJ/mm2) once per week for 3 weeks. The treatment effects were assessed using the numerical rating scale (NRS), pain threshold, Nirschl pain phase system, and Roles and Maudsley scores.A prospective, single-blind, placebo-controlled study was conducted from February 2014 to 2015. Forty patients with burn scar pain despite standard therapy  were randomized into ESWT or control (sham ESWT) groups. ESWT was administered at 100 impulses/cmP >0.05) for age, sex, and total burn surface area (%). In both groups, the NRS, pain threshold (Ib/cm2), and Nirschl pain phase system values significantly improved (P <0.05) after 3 sessions of ESWT or sham therapy, and there were significant differences between the 2 groups in terms of these 3 variables . The Roles and Maudsley scores significantly improved; among 20 patients, 17 reported a score of poor (85%) and 3 reported fair (15%) before ESWT, whereas 3 reported poor (15%), 8 reported fair (40%), 5 reported good (25%), and 4 reported excellent (20%) after ESWT (P = 0.004). The scores did not improve in the control group (P = 0.128).The characteristics of patients between the 2 study groups were balanced (ESWT significantly reduced scar pain in burn patients after wound recovery. Burn injuries over joint areas, especially in the extremities, are complicated by joint contracture as a result of long periods of immobilization for wound treatment; thus, pain modulation is very important in enabling physical therapy or occupational therapy to prevent joint contracture, and medications such as opioids, nonsteroidal anti-inflammatory drugs, and anti-psychotic drugs are presently widely used for pain modulation.In the early 1980s, extracorporeal shock wave therapy (ESWT) was used to destroy kidney stones. In the mid-1980s, it was used to treat musculoskeletal diseases, and in the 1990s, it was used in orthopedic procedures; presently, it has been widely used for noninvasive pain management and regenerative treatment of musculoskeletal diseases.[In the present study, ESWT was performed on burn patients admitted to our hospital for rehabilitation therapy following treatments for burn skin wounds at burn surgery or plastic surgery departments to evaluate the effectiveness of ESWT on residual scar pain after burn injury, and determine the clinical usefulness of ESWT as a new, noninvasive, and feasible treatment modality for scar pain.22.1The present study was a prospective, randomized, single-blind, placebo-controlled study that was conducted between February 2014 and 2015 at the Burn Center of Hallym University Hangang Sacred Heart Hospital, Seoul, South Korea. The study protocol was approved by the institutional review board of Hangang Sacred Heart Hospital, and all patients who volunteered to participate in the study provided their informed consent.2.2The participants in the study included patients with complete epithelization of open skin wounds who were admitted to our Department of Rehabilitation Medicine for the first time after undergoing aseptic treatment or skin grafting at the department of burn surgery or plastic surgery at Hangang Sacred Heart Hospital. Among these patients, those who complained of burn scar pain of ≥5 points on a numerical rating scale (NRS) despite undergoing standard therapy  for ≥1 week, had tenderness on physical examination, and had pain stemming from skin and tissues damaged by burn injuries were selected. Exclusion criteria were those with scar pain caused by psychiatric disorders such as post-traumatic stress disorder and somatoform disorder; those with symptoms suggestive of fractures around the burn scar, blood clotting disorders, anti-coagulant use, or scar area infection; those with an unstable burn scar skin condition that may lead to blistering when the skin surface is stimulated during ESWT; those with a history of hyperventilation; or pregnant patients.2.3Numbers were assigned according to the order of admission of 43 burn patients with scar pain who satisfied all of the aforementioned criteria. Then a computer program was used to divide them into the ESWT group (n = 22) and the placebo control group (n = 21). One and 2 patients in the control and ESWT groups, respectively, dropped out of the study because of transfer to another hospital; thus, 20 patients each were included in the ESWT and control groups for the final analysis (Flow Diagram).2.42) was measured using Algometer BASELINE® . The pain threshold was defined as the mean of the pressure values at which pain is first felt when the measurements were taken twice from the area with the most severe tenderness. The measurements were taken after the patients were made aware of the fact the measuring point was the pressure at which pain is first felt and not at the point when the pain is no longer tolerable.Among the burn scar areas with pain, the area in which the most severe tenderness was palpated was designated as the primary treatment site, and the pain threshold  with an electromagnetic cylindrical coil source of focused shock wave ; this is a valid and reliable method that has been extensively used for quantifying post-treatment effects in patients with soft tissue pain accompanied by tenderness.The Roles and Maudsley scores were used to assess the overall pain severity and final patient satisfaction with the treatment used, and they were determined depending on pain and the degree of restricted movement:2.6P <0.05. To examine the pretreatment homogeneity between the ESWT and control groups, the Fisher exact test, Mann–Whitney test, and independent t test were used, whereas to examine the pretest homogeneity of the NRS and Nirschl pain phase system values, the Mann–Whitney test was performed. To examine the pretest homogeneity of the pain threshold, an independent t test was used, and to examine the pretest homogeneity of the Roles and Maudsley scores, the Pearson χ2 test was used. Moreover, to determine the pretreatment and post-treatment effects within each of the treatment and control groups, the Wilcoxon signed-rank test was used to analyze the NRS and Nirschl pain phase system values, the paired t test was used to analyze the pain threshold, and the Fisher exact test was used to analyze the Roles and Maudsley scores. To determine the interaction effects of the group and time (group × time) in terms of the pretreatment and post-treatment assessment results between the 2 groups, repeated-measures analysis of variance (ANOVA) was used.Collected data were analyzed using SPSS, version 18 program , with the statistical significance level set to 33.1P >0.05), which confirmed the homogeneity of the 2 groups (Table P >0.05); thus, all assessment items before ESWT were also confirmed to be homogenous between the 2 groups  were similar between the 2 groups with no significant differences . In the assessment that was performed immediately after ESWT, immediate pain reduction effects were seen in 5 patients in the ESWT group and 0 patients in the control group, with a mean score of 7.25 ± 1.585 points, which was statistically significant (P = 0.034). In the repeated measures ANOVA, significant interactions were seen between the group and time variables (P <0.001). Thus, scar pain was reduced more significantly in the group that received 3 sessions of ESWT . In the repeated measures ANOVA, significant interactions were seen between the group and time variables (P <0.001). Thus, the treatment effects were significantly better in the ESWT group than in the control group . In the repeated measures ANOVA, significant interactions were seen between the group and time variables (P = 0.013). Thus, functional improvement was more significant in the ESWT group than in the control group (Table P = 0.004), whereas the control group showed no statistical difference (P = 0.128). Results of the Fisher exact test for the post-treatment assessments showed significant differences between the 2 groups (P = 0.04), which indicated that the final treatment satisfaction with regard to improvement in scar pain was significantly higher in the group that received 3 sessions of ESWT  was performed on those who, despite conventional treatments, had persistent pain considered to have stemmed from soft tissue below the scar. Overall, the ESWT group demonstrated significantly greater pain reduction than the control group.Therefore, we think that ESWT can be an effective alternative treatment for decreasing scar pain in burn patients, and future studies should evaluate the shock wave dose, treatment time, and interval and frequency with a greater number of patients and at various time points.We appreciate Dong Hyun Kim, PhD, Professor in the Department of Social and Preventive Medicine, Hallym University, for teaching Dr. Cho how to use theoretical and practical statistics for the purpose of this research study. This was a 2015 master's thesis for the School of Medicine at Hallym University, South Korea.


Apart from minimum pain, no other significant differences in patient reported outcomes were observed. Maximum pain scores >3 were reported from 77% (laparoscopic) and 68% (open) patients (mean ≥ 5 in both groups). Pain interference with mobilization was reported by 87–93% of patients. Both groups scored high levels of patient satisfaction. In the open group, a higher frequency of patients received a combination of general and regional anaesthesia, which had an impact of the minimum pain score. Our results from registry data indicate that surgical technique does not influence the quality of postoperative pain management during the first postoperative day if adequate analgesia is given. Postoperative pain management relevant for specific surgical procedures is debated. The importance of evaluating pain with consideration given to type of surgery and the patient's perspective has been emphasized. In this prospective cohort study, we analysed outcome data from 607 patients in the international PAIN OUT registry for assessment and comparison of postoperative pain outcome within the 24 first hours after laparoscopic and open colonic surgery. Patients from the laparoscopic group scored Providing a high quality pain treatment is a major challenge in health care. Despite the developments in pain management, postoperative pain is still a clinical problem –3. PoorlPAIN OUT started as a European commission-founded project aiming to improve clinical care of patients with postoperative pain . Today pIn the present cohort study, registry data from patients undergoing laparoscopic and open colonic surgery were included. The registry data had been collected between February 2010 and November 2012 from one to three surgical departments in each of the following countries: France, Germany, Italy, Israel, Romania, Spain, Sweden, Switzerland, and United Kingdom. Inclusion criteria were that patients had to be 16 to 18 years old or older (consenting age varies in the different countries) and could communicate. Patients were excluded if they (I) had been transferred to another ward after surgery; (II) were not present at the ward at the time of data collection; (III) had visitors at the time of data collection; (IV) refused to participate in the study; (V) were sedated or asleep; (VI) had a cognitive dysfunction that precluded complete cooperation. Process data including pre-, intra-, and postoperative variables were collected from the medical records on postoperative day one. On the same day, patients completed an outcome questionnaire, when they were back in the ward for at least 6 hours .The study was planned and implemented based on ethical principles commonly applied in clinical research. All respondents gave their informed consent to enrolment in the study and were guaranteed confidentiality. The study was approved by the institutional review board or ethics committee at all sites. Each patient's oral consent and written consent were obtained before inclusion. minimum and maximum pain intensity, physical and emotional functional interference, and perception of care are presented.Within the PAIN OUT project, the multi-item International Pain Outcomes Questionnaire (IPOQ) was developed. In the IPOQ patients' self-reported outcomes are assessed by an 11-point scale ranging from 0 to 10 (a lower score indicates less problem/difficulty). The questionnaire is presented in detail elsewhere . In thisU test. A probability of <0.05 was considered statistically significant. The statistical analyses were performed with SPSS 21 .A descriptive analysis was performed to assess the characteristics of the study sample. The demographic data were described by frequency distribution, mean and range, or mean and standard deviation (SD), respectively, when appropriate. To evaluate differences between the laparoscopic and open surgery groups in demographic variables, chi-square tests were used. Significant differences between the groups in patient outcome data were tested with the nonparametric Mann-Whitney A total of 619 patients who underwent colonic surgery were identified from the PAIN OUT registry. Twelve patients (2%) were excluded because the procedure was changed from laparoscopic to open surgery. From the remaining 607 patients, 450 (74%) had undergone open surgery and 157 (26%) had undergone laparoscopic surgery. The most frequent localization of surgery was right and left hemicolectomy. Patient demographic data and intraoperative characteristics are presented in Patient's self-assessments of pain management outcomes on the first postoperative day are presented in Figures P = 0.018). In the open surgery group, there was a higher frequency of patients receiving a combination of general and regional anaesthesia (P = 0.01)  . No sign minimum pain at a higher level than the open surgery group (P = 0.012) , but no difference if general anaesthesia was used alone (P = 0.42).Only one item in the IPO questionnaire showed a significant difference between laparoscopic and open surgery. The patients from the laparoscopic group scored= 0.012) . RepeateThe findings of this cohort study are based on data from an international pain registry. In the comparison of patient outcomes within 24 hours after laparoscopic and open colonic surgery, the laparoscopic group scored a significantly higher level of minimum pain. Although statistically significant, these values do not have much clinical importance. Apart from minimum pain, no other significant differences in patient reported outcomes were observed. Postoperative pain management relevant to specific surgical procedures is debated since the efficacy of different analgesic approaches varies between different surgical procedures . A higheGenerally, postoperative pain constitutes an important issue for patients undergoing surgery . AccordiDuring the last decade, the use of PROs has been introduced to quality registries . CompareA limitation is that we did not have access to data concerning the patients who were excluded. Given the large number of exclusion criteria, for example, patients who were not present at the ward, were in too much pain or too ill, and did not want to participate are not represented in the registry, thereby introducing a potential source of bias. Furthermore, the assessment of postoperative pain and pain management was performed only within the first 24 hours after the surgical intervention. Patients experience pain of varying levels during a number of days after colonic surgery . HoweverThe overall planning of postoperative care and nursing interventions should be performed out of a procedure specific perspective. Comparisons of laparoscopic and open colonic surgery have been performed in the nursing literature. Nurses working in a specialist colorectal unit perceived improved outcomes in terms of lower pain intensity among patients who had undergone laparoscopic surgery. They also perceived that it took less effort to care for the laparoscopic patients . In ordeMore frequent administration of analgesics for mild pain after laparoscopic surgery was reported in a retrospective study, suggesting that laparoscopic surgery is less painful . HoweverAccording to registry, clinical data surgical technique does not influence the quality of postoperative pain management during the first postoperative day if adequate analgesia for the procedure in question is given.


Our objective was to evaluate the effect of background biological disease-modifying anti-rheumatic drugs (bDMARDs) and/or corticosteroids (CS) on response to nonsteroidal anti-inflammatory drugs (NSAIDs) in rheumatoid arthritis (RA) patients.The following efficacy endpoints were evaluated using time-weighted change from baseline in a 12-week, randomized controlled clinical trial with etoricoxib: Patient Global Assessment of Pain, Swollen Joint Count, Tender Joint Count, Health Assessment Questionnaire. The following three treatment groups were evaluated: placebo, pooled etoricoxib 10/30/60 mg, and etoricoxib 90 mg. Screening values, values post flare, as well as changes after treatment were analyzed.Of the 1014 patients screened, 761 were randomized; 50% were on no background bDMARDs and/or CS therapy, 23% used bDMARDs, 34% used CS, and 8% used both bDMARDs and CS. It was demonstrated that RA patients on bDMARDs or CS had similar pain levels at screening as patients without this co-medication. They experienced flare upon NSAID withdrawal and demonstrated dose-dependent pain improvement with etoricoxib.These results support that RA patients receiving bDMARDs or CS may still require the use of concomitant analgesics to treat pain. Clinicians should continue to monitor and treat pain even after initiating a bDMARD and/or CS.NCT00264147][clinicaltrials.gov;  A majority of patients with rheumatoid arthritis (RA) list pain as a priority for improvement ,2. Advanpost-hoc analyses from a primary dose-range-finding clinical trial with etoricoxib, a COX-2 selective NSAID, in RA patients.If nonsteroidal anti-inflammatory drugs (NSAIDs) have any additive role in RA beyond the use of bDMARDs and CS, it would be predicted that three relationships should hold true: (1) patients with RA and on bDMARDs and/or CS who stop their NSAIDs should have the same degree of flare in RA symptoms as those who are not on such co-medication; ( 2) those on bDMARDs and/or CS should experience the same degree of response with the addition of another NSAID; and (3) dose–response relationships should be similar in patients on versus not on bDMARDs and/or CS. The current report addresses these relationships in post-hoc analyses are based on a randomized, placebo-controlled, double-blind, multicenter, parallel-group, 5-arm, 12-week trial of etoricoxib  [These In order to ensure that the findings were generalizable across endpoints, four responsive study endpoints were used that included physician and patient measures: 100 mm pain visual analogue scale ; swollen joint count ; tender joint count ; and health assessment questionnaire (HAQ) score .Three subpopulations were evaluated based on the dose–response relationships established in the primary trial analysis: patients on the labeled dose of etoricoxib in RA (90 mg), those on other doses of etoricoxib , and patients on placebo. Each of these three groups was further considered based on four possible combinations of bDMARDs and/or CS use . Those on DMARDs and CS before study entry were continued on the same doses throughout the trial.post-hoc analyses were not powered for non-inferiority between groups.The primary population for efficacy analyses was all randomized patients who received ≥1 dose of study medication and had valid baseline and ≥1 on-treatment measurement. Summary statistics for efficacy endpoints were reported by treatment and concomitant medication usage status. Least square means with 95% confidence intervals (CIs) of time-weighted changes from baseline over 12 weeks were generated from an ANCOVA model with terms for baseline parameter, treatment, concomitant medication status, and its interaction with treatment. Due to the limited number of patients in certain strata, the results are mainly for descriptive purposes and should be interpreted accordingly. Our study hypothesis was that etoricoxib would provide similar benefit across the four study endpoints evaluated, independent of the use of biological or corticosteroid co-medication. However, these Baseline demographics were reported in the primary publication for this study . The bDMConcomitant sDMARDs included methotrexate, sulfasalazine, hydroxycholoquine, gold salts, and leflunomide. Forty percent of patients were taking sDMARDs without bDMARDs or CS, while 19% were not taking sDMARDs, bDMARDs, or CS.Screening values  of the four endpoints were similar across the four subgroups Table . A largeImprovements in pain VAS were of similar magnitude across the four subgroups, independent of concomitant treatment with bDMARDs and/or CS Figure . In addiNo prior studies have examined whether patients with residual pain on bDMARDs benefit from treatment with NSAIDs; these analyses suggest that NSAID treatment in these patients may benefit the patient. Although remission through DMARD use is the focus of treatment in RA , pain isPrevious studies demonstrate that pain medication usage has persisted even after the introduction of bDMARDs. A study of 24,000 Medicaid patients from 1995 to 2004 showed that, despite increased bDMARDs use, additional pain medication also increased during this time period .The data reported in these analyses support a role of NSAIDs and selective COX-2 inhibitor therapy, in this case, etoricoxib, as part of a multimodal treatment strategy, alongside treatments that control inflammation in patients who continue to suffer from pain. To the historical views that pain in RA is largely related to joint inflammation or joint damage , these dpost-hoc analyses, and additional trials will be needed to confirm these data. The small number of patients in the subgroups limited appropriate sample size calculations and comparative statistical analyses across treatment groups. Particularly, the number of patients in the combined sDMARD and CS group was extremely small. We are not able to make any statements about interactions between sDMARDs and NSAIDs, but most of the patients in all groups were on sDMARDs. Additional limitations are related to the patient population. Average disease duration was 10 years; thus, our results seem to be most relevant for patients with established RA. Additionally, the percentage of patients not on any kind of DMARD or CS was 19%, which may reflect the time period (early 2006) and the multinational nature of this trial [These analyses have limitations related to the nature of is trial . Also, pDespite these limitations, the consistent trends observed across the four endpoints support that etoricoxib, as an example of an NSAID, provides symptomatic efficacy in RA patients in the presence of concomitant treatment with bDMARDs and/or CS. Given the similarity in the magnitude of flare across the subgroups, the magnitude of response to introduction of etoricoxib and the dose response across the subgroups, these data suggest that NSAIDs, and etoricoxib in particular, have a role in a multimodal treatment strategy to control RA signs and symptoms. However, prescriptions should follow a benefit-risk consideration according to current treatment recommendations.


Objectives: To examine whether patients who report orofacial pain (OP) and temporomandibular disorders (TMD) have a poorer perception of their oral health-related quality of life and, if so, to what extent, and to analyze the association between oral health perception, sociodemographic variables and reported pain duration.Study Design: 407 patients treated at the OP and TMD units in the Healthcare District of Cordoba, Spain, diagnosed following the standard criteria accepted by the scientific community – the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) – were administered the Spanish version of the Oral Health Impact Profile questionnaire (OHIP-14). Bivariate and logistic regression analyses were performed to determine the degree of association between the patients’ OHIP-14 score and pain duration, pain intensity, and various sociodemographic variables.Results: The observed distribution was 89.4% women and 10.6% men. The mean OHIP-14 score was 20.57 ± 10.73 (mean ± standard deviation). A significant association (p<0.05) was found for gender, age, marital status, chronic pain grade, self-perceived oral health status and pain duration. Conclusions: The analysis of self-perceived oral health status in patients with OP and TMD, as measured by the OHIP-14, showed that oral health is perceived more negatively by women. Moreover, a one-point increase in the Chronic Pain Grade indicator increases the OHIP-14 indicator by 4.6 points, while chronic pain, defined as pain suffered by patients for one year or more, increases the OHIP-14 indicator by 3.2 points. Key words:Orofacial pain, temporomandibular disorders, Oral Health Impact Profile, sociodemographic variables, primary care, Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Temporomandibular disorders (TMD) is a collective term used to refer to a number of clinical conditions that involve the masticatory musculature and/or temporomandibular (TM) joints and associated structures, or both . The maiThis multi-etiological approach covers a wide range of etiological causes, including macro-traumas or micro-traumas in the para-functions (i.e. bruxism), skeletal and occlusal alterations (which according to the literature have decreased in this type of disorder in recent years), systemic factors , masticatory and cervical muscle hyperactivity, alterations of the collagen matrix in temporomandibular joint (TMJ) cartilage, hormonal factors especially in women, and genetic factors, primarily catechol-o-methyltransferase (COMT).Psychological factors can also contribute to the etiological causes of TMD, particularly physical symptoms which may or may not be associated with the painful symptoms that accompany situations of emotional stress, resulting in increased excitability of the head and neck muscles. Depression is observed especially among elderly patients with limited masticatory function due to intra-artricular disorders, particularly osteoarthritis.According to two studies by Poveda et al., there is a high prevalence of TMD among the Spanish population. In their second study, the authors found that 31.4% and 18.1% of the control group presented disc displacement with reduction (DDWR) and myofascial pain (MFP), respectively , compareThe Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) is a dual-axis assessment tool used to obtain a clinical and psychological diagnosis. Axis II of the RDC/TMD, which is consistent with a biopsychosocial health model, assesses a number of items, including pain intensity, graded chronic pain and psychological variables such as depression, anxiety and physical symptoms.In the last two decades, the RDC/TMD has proven to be a highly valid and reliable instrument, which has enabled the standardization of clinical subtypes , as wellSome of the standard questionnaires used for this purpose are the Geriatric Oral Health Assessment Index (GOHAI), the Oral Health-Related Quality of Life (OHQoL), and the Oral Health Impact Profile OHIP-49). The OHIP-49 was developed and vali-dated by Slade and Spencer  and cont. The OHIThe OHIP-14 is widely used in various branches of dentistry such as caries, periodontal disease, oral medicine, prosthetics, surgery, and others. Its application in patients with signs and symptoms of orofacial pain (OP) and TMD has also been widely described by several authors  20), wh, wh20), The aim of this paper is to quantify the self-perceived health of patients with OP and TMD in order to subsequently analyze the correlation between self-perceived health and a series of variables. Furthermore, we attempt to empirically assess the relationship between self-perceived oral health and the chronification of TMD in patients seen by the Andalusian Healthcare Service primary care units.-Study group and designWe conducted a cross-sectional epidemiological study in the Healthcare District of Cordoba, Spain, in a population of 415 potential patients with signs and symptoms of OP and TMD. All the patients were informed about the examination and were asked to complete a questionnaire in accordance with the norms and guidelines previously established for the study by the ethics committee of the Reina Sofía Teaching Hospital in Cordoba, Spain. Eight patients who refused to undergo the examination or complete the questionnaire were excluded from the study. From January 2011 to November 2012, the remaining 407 patients were examined by a specialist with 27 years of experience in OP and TMD, and completed the OP and TMD primary care unit questionnaire. All of the participants in the study were aged 16 and over  and reported at least one of the following signs and symptoms: pain in the jaw or TMJs, restricted or limited range of motion when opening or closing the mouth or lateral excursions of the jaw, and joint sounds (with or without pain).In addition to refusal to participate in the study or sign the informed consent form, the following exclusion criteria were also applied: systemic rheumatic disease ; neurological or autoimmune diseases; patients who had undergone TMJ surgery or head and neck radiation treatment; patients who had suffered head and neck trauma two months prior to the study; pregnant patients; patients treated with narcotic analgesics, muscle relaxants or corticosteroids whose treatment could not be suspended one week prior to the study; patients who had been treated with antidepressants and NSAIDs at least three days prior to the study; and drug-dependent patients.We used the Spanish version of the RDC/TMD materials originally designed by Dworkin et al.  to diagnIn accordance with the RDC/TMD, patients with OP and TMD are assessed based on their clinical history and a physical examination using clinical decision algorithms in order to obtain a clinical classification. The RDC/TMD also includes sociodemographic and psychological variables.never” suffered problems or pain, and 4 is “very often”. The OHIP-14 score is obtained directly from the sum of the results of each of its 14 items (OHIP-14 = ∑ v1+ v2 +… + v14).For the qualitative analysis of self-perceived oral health in patients with OP and TMD, we used the Spanish version of the OHIP-14 questionnaire. The OHIP-14 comprises 14 items ; each wipoor”, “fair”, and “good”.After administering the OHIP-14, we asked the participants to answer a final question on self-perceived oral health status, which had three possible responses: “We also calculated the “chronic pain grade” as is habitually described in the literature . ChronicIt is also important to note that the variable pain duration used in the subsequent analyses was divided into two groups: one comprising patients who had suffered from pain for less than a year, and another composed of patients who had suffered from pain for one year or more. These groups were formed by means of a hierarchical segmentation analysis in which the dependent variable was the OHIP-14 score and the independent variable was pain duration measured in months. This analysis allowed us to statistically discriminate those groups which differed in relation to the dependent variable. It also permitted us to obtain an appropriate number of groups and establish the cutoff point taking into account only the statistical differences observed in the empirical evidence. The results are shown in figure -Statistical analysisWe first analyzed the relationship between the OHIP-14 scores and sociodemographic variables, oral health status, and pain duration. To do so, we performed a bivariate descriptive analysis. When the independent variables were categorical, we performed a contrast of means using Snedecor’s F-statistic. For the quantitative variables we performed a bilateral correlation analysis using Spearman’s rho and the Pearson correlation coefficient.In the second phase, we performed a linear regression analysis using the OHIP-14 indicator as the dependent variable and the variables that were found to be statistically significant in the bivariate analysis as explanatory variables.We tested for collinearity between the independent variables. To avoid this problem, we analyzed the partial correlations and the indicators of collinearity, as well as statistical tolerance and the variance inflation factor (VIF). By doing so, we were able to decrease the number of variables that were ultimately included in the model. This permitted us to obtain a result that was free from collinearity and fulfilled the principle of parsimony, according to which, all things being equal, when two results have the same outcome (in this case a similar R2) the simplest solution is more likely to be correct than the more complex solution. The data were analyzed using SPSS version 15.The sample comprised 365 women (89.7%) with a mean age of 42.15 ± 14.63 (mean ± standard deviation), and 42 men (10.3%) with a mean age of 41.48 ± 17.28. Hence, the ratio of women to men was 8,4 with an age range of 16 to 83. The mean OHIP-14 score obtained was 20.57 ± 10.73 .The distribution of the mean scores and standard deviations for each of the indicators are shown in In contrast, item 1, “Have you ever had trouble pronouncing certain words because of problems with your teeth, mouth or dentures?”, as well as item 2, “Have you ever felt that your sense of taste has worsened because of problems with your teeth, mouth or dentures?”, and 14, “Have you ever felt incapable of leading a normal life because of problems with your teeth, mouth or dentures?”, show significantly lower scores than the rest of the variables in the questionnaire.Figure We also observed that women had higher OHIP-14 scores than men (21.37 vs. 13.79). As regards age groups, the highest number of patients was in the 41 to 60 age range, with the lowest number of patients in the 61 and over age range. A bivariate analysis was performed on the OHIP-14 score, obtaining a value of 0.022 for a significance level of p<0.05%.As regards marital status, married patients comprise more than half of the sample, followed by single patients, while the remaining groups show practically residual values. The bivariate analysis of the OHIP-14 score showed a value of 0.046 (for p≤ 0.05), revealing that the distribution of the groups varies in relation to the OHIP-14 variable (21.08 for married patients compared to 19.10 for single patients).As regards the chronic pain grade indicator, most patients reported high pain intensity with a low level of disability (Grade II), or low pain intensity without disability (Grade I), while less than 20% of the patients reported the other situations. The bivariate analysis of chronic pain grade compared to the OHIP-14 shows a high association between patients with high pain intensity without disability, and poor perception of oral health-related quality of life.We also analyzed the association between the OHIP-14 score and self-perceived oral health status, finding as much as a 10-point difference in the OHIP-14 score between those who considered they had excellent oral health and those who rated their oral health as poor.The last variable in the analysis was “pain duration”. This variable was included in the analysis in order to assess whether it had an impact on the OHIP-14 scores, i.e. whether patients who report more months of pain obtain different scores on the OHIP-14. This hypothesis was confirmed as patients who suffered from pain for more than eleven months obtained, on average, a score that was 6.56 points higher than the mean OHIP-14 score compared to the group who suffered pain for a shorter period of time.In recent years, self-perceived oral health-related quality of life questionnaires have been widely used in different dental specialties as well as in the general population in Spain and other countries. This has led to a better and more thorough understanding of people’s perception about oral health-related quality of life. However, the use of such questionnaires in patients seen in OP and TMD primary care units in Spain and their association with these disorders has not been analyzed and reported in the scientific community.We observed higher mean OHIP-14 scores for OP and TMD patients than those reported by Montero et al.  in a samThe analysis of the association between perceived oral health-related quality of life in our patients by gender shows that the mean score for women with OP and TMD is 7.61 times higher than that for men. According to the regression model, a one-unit increase in gender, i.e. being female rather than male, increases the OHIP-14 score by almost 4 points, keeping all other variables in the regression model constant. These data are similar to those obtained by Rusanen et al.  in studiAlthough the variable marital status showed a degree of association in the chi-square bivariate analysis with p-values below 0.05, it was not found to be significant in the regression model. Although this might seem to contradict the results of Blanco et al. , who fouFurthermore, we observed that patients who rate their oral health status as poor also have a poorer perception of their oral health-related quality of life as measured by the OHIP-14, with the difference in mean scores decreasing by up to 5 percentage points in these patients. As regards self-perceived oral health status, a change in the assessment from 1 “poor” to 2 “fair” reduces the OHIP-14 score by 3.6 points, if all other variables remain constant. These results coincide consistently with those of other authors such as Montero and Bravo in a number of papers addressing this phenomenon ,19.Finally, as regards self-perceived oral health-related quality of life in terms of pain duration, where pain for “more than or less than 11 months” is taken as a cutoff point , we observed that patients who reported having suffered from pain for more than 11 months scored 3.2 points more in the OHIP-14 questionnaire than those who report having suffered from pain for less time, keeping all other variables constant.In conclusion, all the variables, with the exception of age groups and marital status, are significant in the regression model. The overall model is significant and has a high coefficient of determination (R2), which explains 31.2% of the OHIP-14 variability. This indicates that the percentage of variance of the dependent variable can be explained by the independent variables, and accounts for 100% of the variability in the OHIP-14 (in this case 31.2%). As can be observed, chronic pain grade was the independent variable that most influences variability in the OHIP-14 (explaining 48.2% of the OHIP-14 variability), followed by self-perceived oral health status, which explains 28.9% of the variability; and pain duration, which explains 13.9% of the variability in the OHIP-14. Finally, the variable gender explains 7.6% of the variability in the OHIP-14.


Familial Mediterranean fever (FMF) is an autosomal recessive disease, characterised by recurrent, self limited attacks of fever with serositis. The aim of our study was to describe the frequency of musculoskeletal complaints in children with FMF and investigate the effect of genotype on these findings.Files of patients who had been seen in our department (during routine follow-up visits) between January 2013 and January 2014 were retrospectively evaluated. Patients with two mutations were divided into 3 groups; M694V/M694V, M694V/Other mutation and patients carrying two mutations other than M694V. Patients with one mutation were divided into 2 groups; M694V and non M694V carriers.The study group comprised 317 FMF patients  with a mean age of 12.2 ± 5.7 years. The frequency of musculoskeletal complaints were as follows; arthritis 18%, arthralgia 43%, leg pain 43%, heel pain 36%, myalgia 8%, protracted arthritis 2%, protracted febrile myalgia 2%. Leg pain and heel pain were more frequently detected in patients with homozygous M694V (p<0.05). Among patients with heterozygous mutations; children with M694V mutation had more frequently artralgia, leg pain and heel pain (p<0.05).Musculoskeletal problems were common complaints in patients with FMF. Genotype seems to effect the frequency of these problems and M694V mutation is a predisposing factor for musculoskeletal complaints.


Objectives: To evaluate the efficacy of Oraqix® during scaling and root planing (SRP) in comparison with 20% benzocaine and placebo.Study Design: 15 patients requiring 4 sessions of SRP were enrolled. For each patient, Oraqix®, Hurricaine®, vaseline or no anesthetic product were randomly assigned each to a quadrant. Treatment pain was evaluated on a 100 mm Visual Analog Scale (VAS) and on a Verbal Rating Scale (VRS). The amount of product administered, the need to re-anesthetise, patient and operator satisfaction and the onset of side-effects were also recorded.Results: Oraqix® was significantly better than nothing, with a reduction of VAS score to 13.3 units, but without significant differences with Vaseline or Hurricaine®. Oraqix® was better in VRS reduction than not using any anesthetic (p=0.001) or using vaseline (p=0.024), but similar to Hurricaine® (p=0.232). Conclusions: Oraqix® effectively controls pain in SRP procedures, with few side-effects and a good acceptance on the part of patients and clinicians. Key words:Controlled clinical trial, topical anesthetic, scaling and root planing. It is estimated that about 52% of North American adult population is at risk of developing periodontal disease . Japan aNevertheless, more than 25% of adults are afraid of injections . FurtherOccasionally, topical anesthetics are used in order to reduce pain and discomfort during surgical procedures ,9. The tFor all the above mentioned reasons, an effective topical anesthetic ideally should be easy to apply, with painless administration and effective for any patient who is reluctant to receive injections ,13.Oraqix®  is a topical anesthetic agent used in periodontal treatments for pain control. It consists of an eutectic mixture of 5% lidocaine and prilocaine (each gram contains 25-mg lidocaine and 25-mg prilocaine) ,7,14. ToDifferent studies carried out with Oraqix® Donaldson et al. , JeffcoaTherefore, the objective of this split-mouth, double-blind, randomised controlled clinical trial was to determine the efficacy of Oraqix® during the SRP procedure and to compare this anesthetic material with 20% benzocaine and placebo. The secondary aims were to assess the amount of local anesthetic administered and product reapplication, to evaluate post-treatment pain using a Visual Analog Scale (VAS) and a Verbal Rating Scale (VRS), to assess patient and operator satisfaction and finally, to determine possible adverse affects.A randomised double-blind clinical trial controlled with a placebo was conducted between from January 2008 to January 2009. The protocol of the study was approved by the CREC  of the School of Dentistry of the University of Barcelona, Spain. All included patients needed periodontal treatment in 4 quadrants. Each patient had its 4 quadrants randomly assigned to one of the following 4 options for anesthetic method: topical anesthetic with Oraqix® , topical anesthetic with Hurricaine® , Vaseline cream  and no anesthetic method. Thus, all patients received the 4 treatment modalities. The sample size was calculated using the statistics program G*Power 3.0  and repeFifteen patients visiting the Pathology and Surgery Periodontal Unit of the Master’s Degree Program in Oral Surgery and Implantology  were included in the study. All participants met the inclusion criteria  and writAll SRPs were carried out by 3 third-year fellows of the Master’s Degree Program in Oral Surgery and Implantology of University of Barcelona during four sessions, separated by 1 week. All patients were seen by the same operator to eliminate interexaminer variability.Each patient was selected at random by means of a draw in each of the quadrants in order to identify the type of treatment to be used . The randomised treatment sequence was assigned to each patient before selection. The selected sequence was reported to the clinician that was in charge of each anesthetic technique prior to application.A different operator to the one who perform the SRP, anesthetised the quadrant with the specific product assigned to it after probing each tooth of the chosen quadrant at 6 points and recording whether there was any bleeding or wound suppuration. Thus, the teeth were isolated with cotton rolls or lip separators and the selected product was placed inside the periodontal pockets from distal to mesial side. Oraqix® was introduced inside the periodontal pocket using an applicator designed for such purpose Fig. . In contFollowing a waiting period of 30 to 45 seconds, a second operator started the instrumentation using universal and specific curettes from distal side to the halfway line. When reanesthesia was needed, the first operator placed more product on the painful area without the presence of a second operator so as not to loose the masking effect. After 30 seconds, the second operator entered the operating theatre and continued with the SRP procedure. In those areas that were not anesthetised, the same operator who had performed the SRP infiltrated the operating side with 4% Articaine with 1:100.000 Epinephrine  as many times as needed. The amount of Oraqix® used was recorded. Patients were prescribed analgesic medication usually oral ibuprofen 600 mg, 1 granulated sachet every 8 hours .During immediate follow-up period, within 5 minutes after treatment, the patient had to answer the following question: How much pain did you feel during the SRP procedure? The answer was marked with a vertical line on a horizontal line of 100 mm (VAS); in the far left the painless situation was found whereas the far right of the line represented the highest degree of pain. The SRP pain was also assessed using a five-point VRS  that refers to the general degree of patient’s unpleasantness during the treatment. The taste of the anesthetic used was also recorded . The ease of product application by the operator was also evaluated  as well as the possible alteration in the operator’s sense of touch when using the curettes .All patients were given a questionnaire in order to identify the following adverse effects: stinging pain, irritation, soreness, swelling, loss of feeling, alteration of taste, nausea, fatigue, cephalea at 24 and 48 hours. The questionnaire was collected after 7 days during follow up visit or before the next SRP procedure.The SPSS Inc., Chicago, IL. USA, version 15.0 statistical package was used throughout the statistical analysis (license of the University of Barcelona). A repeated-measures ANOVA design was also used for the VAS scores, the VRS scores, and the depth of the probe, in which intrasubject variability was compared across the anesthetic technique used and gender was considered a between-subjects variable. The analysis of categorical variables was carried out by χ2 tests. Analysis was intention-to-treat.A total of 10 males and 5 females, aged 29-71, were included in the study. The mean age of the participants was 51 years. Figure -Probe depth.No statistical significant differences were observed in terms of probe depth between the 4 quadrants for each patient, nor even between different participants. -VAS.With respect to the VAS scores, differences between groups were not significant, although they came very close to the statistical significance value . Oraqix® proved to be significantly better than not having anything, with a reduction of 13.3 units of VAS . Similar results were though found with Hurricaine®. There were no significant gender differences  nor interaction between gender and anesthetic type  as shown in figure -VRS.In the VRS analysis, some statistically significant differences between groups  were reported. Oraqix® proved better than not using any anesthetic method (p=0.001), with a reduction of 1.2 points (IC 95 %: -1.8 a -0.6) and better than applying vaseline (p=0.024), with a reduction of 0.6 points , but it was similar to applying Hurricaine® . There were no differences in gender  nor interaction between gender and anesthetic type . Figure -Adverse effects:Six patients treated with Oraqix® presented irritation or stinging pain at 24 hours following treatment, but it disappeared completely at 48 hour, except for one case. Four cases where no aesthetic material was administered, 4 of those treated with Hurricaine® and 3 of those who were applied Vaseline reported irritation at 24 hours. In one of the cases treated with Vaseline the irritation persisted for more than 48 hours. Only one patient reported alteration of sense of taste after the four treatment sessions, which disappeared at 48 hours.-Amount of product administered and need to re-anesthetise:The average dosage of Oraqix® used was ¾ to 1 cartridge per quadrant.3 patients needed Oraqix® reapplication; after this second administration, an infiltration anesthesia was needed for just one case. In the case of Hurricaine®, reapplication was necessary in 4 cases and in 2 of them it was also necessary to administer infiltration anesthesia. -Taste:Five out of 15 patients reported an unpleasant taste when being anesthetised with Hurricaine® in contrast with 2 out of 15, who noticed an unpleasant taste after the topical anesthetic with Oraqix®. For both topical anesthetics, there was only one case that referred a very unpleasant taste. When no anesthesia was applied or just vaseline was used, all patients claimed that the taste was not unpleasant.All patients considered that the taste would not influence their choice in future applications of these topical anesthetics during SRP maintenance. The patient who reported a very unpleasant taste with Hurricaine®, said that he would be “somewhat influenced” on being treated with this product again.Ease of application and alteration in the operator’s sense of touch when using the curette:In this study, the use of Oraqix® was associated with less intraoperative pain compared with the placebo. However no differences between the use of this anesthetic method and a 20% benzocaine dental gel were reported.Previous studies published after the market introduction of Oraqix® have proved the efficacy of the mixture of 5% lidocaine and prilocaine (EMLA®). This topical anesthetic has been mainly used to achieve pain control during sharp debridement of chronic leg ulcers of arterial, venous or arteriovenous aetiology in Dermatology as well as for soft tissues anesthesia in children -22. HoweIn Oral Surgery, EMLA® improves transepithelial transport compared with conventional topical anesthetics . McMillaIn addition, a greater efficacy of EMLA® compared with 20% benzocaine has been found in oral surgery for children. The application of EMLA® in children reduced the pain of palatal injections and placement of rubber dam clamps ,16. Abu The first studies referring to Oraqix® in scientific li-terature appeared in 2001. Friskopp et al.  conducteFriskopp and Huledal  describeThese levels were low compared to those reported to cause initial signs of toxicity (5000–l 6000 ng/ml). Side-effects were few and mild local effects of short duration. The authors concluded that there is a large safety margin with respect to systemic effects following the application of 0.9 g to 3.5 g Oraqix® (maximum 2 cartridges) .Besides,Three other multicenter studies analysed, together with our study, the efficacy of Oraqix® versus placebo as a topical anesthetic used in SRPs .In conclusion, these three multicenter studies, showed that the application of Oraqix® in periodontal pockets is well tolerated by patients and it is more effective than the placebo in reducing pain during SRP. The anesthetic gel reduced the pain by at least 50%. The median dose of active gel administered was 1 cartridge per quadrant (range from three quarters of a cartridge to 2 cartridges) ,13,18.The innovation of the present study lies in the fact that Oraqix® was compared to another topical anesthetic and vaseline administration. In addition, the “split-mouth” design (with intrasubject measures) reduced possible variability. Furthermore, as this was not a multicenter study, the variability caused by different treatment protocols and clinicians involved is reduced. Therefore, the sample size is considerably decreased. A problem connected with other trials is that concealment of treatment can be difficult, as placebo causes no numbness.In a multicenter study, Van Abu Al-Melh et al.  assessedIn the aforementioned studies ,13,18,30In conclusion, Oraqix® is an effective gel which reduces the incidence of intraoperative pain during the SRP procedures, although there were no significant statistical differences compared with Hurricaine®. Patients treated with Oraqix® did not require another type of anesthetic. Slight unpleasant taste was reported by patients and ease of application by all operators. In 2 out of 15 cases the clinician felt a slight decrease in tactile perception when using curettes.Therefore, the application of Oraqix® is an effective technique for pain reduction during SRPs, reporting few side effects and a good acceptance on the part of both patients and clinics. Furthermore it is a useful anesthetic method for individuals with dental anxiety and/or who are particularly sensitive to pain.


Pain associated with major trauma often remains uncontrolled by medical professionals in Emergency Departments (ED). This study was established in an attempt to gauge the efficacy of pain control in major traumas by determining the time taken to get patients pain under control.The study also aimed to look at the types of analgesia being used and the efficacy of pre-hospital analgesia.Only patients that triggered the activation of the Major Trauma team were included in the study.Over a 3 week period, patients meeting the inclusion criteria were questioned on arrival and initial pain score was taken. Information about the presenting complaint and en-route medication was also recorded. Patients were followed up every 10 minutes with their pain score, analgesia, procedures and treatments recorded. The patients were followed up until such a time as they reported two consecutive pain scores of 2 or until they reported that their pain was sufficiently controlled.A total of 16 people were included in the study, 8 males and 8 females.On average it took 80 minutes to achieve pain control with females reporting a higher time of 87.5 minutes compared to 74.5 minutes in males. The average time for pain control was 116 minutes for patients receiving IV morphine only, 61 minutes for patients receiving IV paracetamol only, 135 minutes for those receiving both IV paracetamol and IV morphine and 85 minutes for those receiving oral analgesia only.The average pain score on arrival to the ED was 6.06.This study highlights the need for faster and better intervention for pain control in Major Traumas.Several methods could be implemented to achieve this:•Implementing more regular pain scoring.•The possible use of alternative pain medication or nerve blocks.•Recommend a review of pain management in pre-hospital services.


Disease-specific measures of the impact of sacroiliac (SI) joint pain on back/pelvis function are not available. The Oswestry Disability Index (ODI) is a validated functional measure for lower back pain, but its responsiveness to SI joint treatment has yet to be established. We sought to assess the validity of ODI to capture disability caused by SI joint pain and the minimum clinically important difference (MCID) after SI joint treatment.n = 155) participating in a prospective clinical trial of minimally invasive SI joint fusion underwent baseline and follow-up assessments using ODI, visual analog scale (VAS) pain assessment, Short Form 36 (SF-36), EuroQoL-5D, and questions (at follow-up only) regarding satisfaction with the SI joint fusion and whether the patient would have the fusion surgery again. All outcomes were compared from baseline to 12 months postsurgery. The health transition item of the SF-36 and the satisfaction scale were used as external anchors to calculate MCID. MCID was estimated for ODI using four calculation methods: (1) minimum detectable change, (2) average ODI change of patients’ subsets, (3) change difference between patients’ subsets, and (4) receiver operating characteristic (ROC) curve.Patients (p < .0001) on all measures: SI joint pain (48.8 points), ODI (23.8 points), EQ-5D (0.29 points), EQ-5D VAS (11.7 points), PCS (8.9 points), and MCS (9.2 points). The improvement in ODI was significantly correlated (p < .0001) with SI joint pain improvement (r = .48) and with the two external anchors: SF-36 health transition item (r = .49) and satisfaction level (r = .34). The MCID values calculated for ODI using the various methods ranged from 3.5 to 19.5 points. The ODI minimum detectable change was 15.5 with the health transition item as the anchor and 13.5 with the satisfaction scale as the anchor.After SI fusion, patients improved significantly (ODI is a valid measure of change in SI joint health. Hence, researchers and clinicians may rely on ODI scores to measure disability caused by SI pain. We estimated the MCID for ODI to be 13–15 points, which falls within the range of that previously reported for lumbar back pain and indicates that an improvement in disability should be at least 15 % to be beyond random variation. Chronic lower back pain (LBP) carries a significant public health burden, with an estimated 83 million healthy years of life lost every year due to illness, disability, or early death . In highHippocrates was reported to have noted that the SI joint is mobile during pregnancy. Pain emanating from the SI joint was first described in the early 1900s , prior tTreatment options for SI joint pain include physical therapy , intra-aDisability caused by both lumbar spine and SI joint pain may be assessed with the Oswestry Disability Index (ODI). First reported in 1980, the ODI is a validated and well-accepted measure of the impact of lower back pain on disability –31. ODI The minimum clinically important difference (MCID), or the smallest change that is considered important to patients, has been calculated for ODI for patients after lumbar surgery, both in large samples of patients with mixed diagnoses and surgical procedures and in small samples with specific pathologies and surgeries. MCID calculated for ODI ranges from 7 to 15 –35. MCIDThe purpose of this study is to assess the validity of ODI to capture disability caused by SI joint pain and its sensitivity to change after treatment. The secondary purpose of this study is to calculate the MCID for ODI following minimally invasive SI joint fusion surgery using a methodology similar to the methodology used to establish MCID after lumbar surgery.An overview of the analytic methods is presented in Table ®, an FDA-cleared titanium porous-coated implant manufactured by the study’s sponsor . The study protocol was IRB-approved at all clinical sites prior to patient enrollment.Health-related quality-of-life (HRQoL) data for all calculations reported herein were derived from a cohort of patients participating in Sacroiliac Joint Fusion Investigation  who completed the 12-month postoperative visit. SIFI is a prospective, multicenter, single-arm clinical trial of minimally invasive (MIS) SI joint fusion using iFuse Implant SystemSIFI participants were patients between the ages of 21 and 70 with a diagnosis of SI joint dysfunction due to degenerative sacroiliitis and/or sacroiliac joint disruption. Diagnosis was based on a combination of history of SI joint pain with Fortin’s sign , at leasPatients were excluded for a variety of conditions, including severe back pain due to other causes , history of recent (<1 year) major trauma to the pelvis, metabolic bone disease (either induced or idiopathic), involvement in litigation, or receiving disability payments or worker’s compensation for back or SI joint pain. Exclusion criteria were designed to eliminate patients with other pathologies that could be mistaken for SIJ pain. However, the study did not exclude patients with prior lumbar fusion as this is a risk factor for SI joint degeneration . Early sPatients underwent minimally invasive SI joint fusion  and willingness to undergo the procedure again . These last two scales are very commonly used in orthopedic clinical trials even though their validity has not been established.t test. The relationship between demographic characteristics and outcome measures was assessed with Pearson’s correlation coefficient for numerical data and Chi-square for categorical data. Analysis of variance was used to compare the change in outcomes according to the subjects’ answers to the health transition item (HTI) of the SF-36 and to the satisfaction scale.All MCID analyses presented herein focus on 12-month assessments and were performed with SPSS . The changes from baseline in ODI and VAS scores for SI joint pain were calculated as the baseline score minus the 12-month score such that a positive change score corresponds to improvement. Baseline and 12-month assessments were compared with a paired sample Two measures were selected as global assessments of change and as proxy for objective measures of change : the HTI of the SF-36 and the previously mentioned satisfaction with surgery scale . The HTIThe minimum detectable change (MDC), i.e., the smallest change that can be considered above measurement error with 95 % confidence. MDC was calculated as:MDC = 1.96 × fficient –45. A refficient .average change, i.e., the average score change seen in “somewhat better” patients (for the HTI) and the “somewhat satisfied” patients .The change difference, i.e., the difference between the average change scores of the “somewhat better” and “about the same” patients (HTI) and the “somewhat satisfied” and “somewhat dissatisfied” patients .The The ROC curve approach, where MCID is the change score that differentiates between the “somewhat better” and “about the same” patients (HTI) and the “somewhat dissatisfied” and “somewhat satisfied” patients  with identical sensitivity and specificity.Four calculations were used to determine possible values for MCID .The mini2. Most subjects were women (71.0 %), and 24.5 % were smokers. Subjects had suffered from SI joint pain for an average of 5.4 (6.5) years; 43 % had undergone lumbar spinal fusion, a suspected risk factor for SI joint degeneration [Of 172 enrolled subjects at 26 centers, 155 (90.1 %) who completed the 12-month visit comprise the study cohort. Mean (SD) age was 51.5 (11.1) years, and BMI was 29.4 (6.4) kg/mneration . Both bar = 0.21, p = .0097). However, no commonly assessed demographic characteristics  were statistically associated with either baseline SIJ pain scores or ODI or the 12-month change scores. As expected, baseline ODI was correlated with the 12-month ODI change score , indicating that subjects with a higher baseline disability tended to have a greater improvement.Consistent with other reports of minimally invasive SIJ fusion, SI joint pain and all HRQoL ratings assessed in the SIFI study showed significant improvement from baseline to 12-month postoperative scores Table . BaselinThe 12-month ODI change score was strongly correlated with the change in SI joint pain Table , indicatr = .49, p < .0001), the satisfaction scale , and the willingness to undergo surgery again scale  . The correlation between changes in ODI, HTI, and satisfaction, as well as the fact that ODI change is different between the answers of the scales, indicates that the HTI and satisfaction scales are reasonable anchors [As described in methods, MCID calculations involve correlating the target measure (ODI) with various parameters of global change. ODI change score was statistically associated with the HTI  caused by SI joint pain. The ODI change score also showed a graded relationship to the three measures of patient global assessment of the outcome of the surgery: SF-36 HTI, satisfaction, and willingness to undergo surgery again , pain (neck and arm pain), physical health (PCS), mental health (MCS), and general health (EQ-5D). Hence, it is not expected that patients would report similar responses to treatment on all HRQoL . In the This study collected only limited socioeconomic and biopsychologic information and is, thus, unable to assess the influence of these factors on the patients’ perception of pain and responses to treatment. However, biopsychologic and socioeconomic characteristics have been found to influence patients’ perception of pain and response to and choice of treatments in general and in the field of spine surgery in particular –62.ODI appears to be a valid instrument to measure disability associated with SI joint pain. ODI is sensitive to the changes in disability following MIS SI joint fusion. The MCID values obtained for ODI after MIS SI joint fusion are similar to the MCID values accepted for ODI after lumbar surgeries.


A handful of studies have reported outcomes with CyberKnife radiosurgery (CKRS) for the treatment of trigeminal neuralgia. However, the follow-up has been short with no minimum follow-up required and have included patients with short duration of symptoms. Here we report our institutional experience on patients with a minimum follow-up of 1 year and a median follow-up of 28 months (mean 38.84 months).Twenty-five patients with medically and surgically intractable TN received CKRS with a mean marginal radiation dose of 64 Gy applied to an average isodose line of 86% of the affected trigeminal nerve. Follow-up data were obtained by clinical examination and telephone questionnaire. Outcome results were categorized based on the Barrow Neurological Institute (BNI) pain scale with BNI I-III considered to be good outcomes and BNI IV-V considered as treatment failure. BNI facial numbness score was used to assess treatment complications.A large proportion of patients (42.9%) reported pain relief within 1 month following CKRS treatment. The mean time to recurrence of severe pain was 27.8 months (range 1–129 months). At median follow-up of 28 months (mean 38.84 months), actuarial rate of freedom from severe pain (BNI ≥ III) was 72%. At last follow-up 2 (8%) patients had freedom from any pain and no medications (BNI I) and the majority (48%) had some pain that was adequately controlled with medications. Seven patients (28%) had no response to treatment and continued to suffer from severe pain (BNI IV or V). Patient’s diabetic status and overall post-treatment BNI facial numbness scores were statistically significant predictors of treatment outcomes.CKRS represents an acceptable salvage option for with medically and/or surgically refractory patients. Even patients with severely debilitating symptoms may experience significant and sustained pain relief after CKRS. Particularly, CKRS remains an attractive option in patients who are not good surgical candidates or possibly even failed surgical therapy. This data should help in setting realistic expectations for weighing the various available treatment options. Trigeminal neuralgia (TN) is a debilitating condition characterized by agonizing, paroxysmal, and lancinating pain . AlthougAfter institutional review board (IRB) approval by Georgetown University Hospital IRB, patient demographic characteristics, clinical presentation, treatment history, and the radiosurgical modality were retrospectively reviewed.Patients were also followed-up by a telephone questionnaire that was conducted by a medical personnel who were not involved in treatment. Patients were questioned about the time to the onset of pain relief, the degree of pain relief and treatment complications. Based on the Barrow Neurological Institute (BNI) score for TN, we classified pain relief after treatment into five grades. A BNI I score corresponded to complete pain relief without medications; BNI II score, some pain but not requiring medications; BNI III score, some pain but adequately controlled with medications; BNI IV score, some pain not adequately controlled with medication; and BNI V score, severe pain or no pain relief. The BNI facial numbness score was used to assess complications. A BNI I score corresponded to no facial numbness; BNI II score, mild facial numbness, not bothersome; BNI III, facial numbness somewhat bothersome; and BNI IV score, facial numbness, very bothersome.Between July 2002 and February 2013, 30 patients with severe refractory TN and with minimum follow-up of 12 months underwent CK at our clinic. Five patients had no follow up information and could not be contacted by phone so they were excluded for a final sample size of 25 patients. Indications for CK included intractable pain, with a pretreatment BNI score or IV or V, refractory to standard medications and failure of previous invasive procedures. The median follow-up was 28 months  and a summary of patient characteristics is provided in Table The CKRS system  uses a 6-MV X-band linear accelerator (LA) mounted on a fully articulated robotic arm. During treatment, two orthogonally positioned x-ray detectors provide real-time imaging of bony anatomy allowing for intrafraction movement correction. Treatment was generally administered on an outpatient basis with each treatment lasting ∼ 45–90 min.Patients were immobilized in the supine position with an Aquaplast facemask . All patients underwent an iopamidol-enhanced CT cisternography with 1.25-mm contiguous slices was used to visualize the segment of the trigeminal nerve in the prepontine cistern. A lumbar puncture was performed to inject 10 mL to 12 mL of contrast material. The trigeminal nerve was readily identified on the planning workstation and a segment of the nerve was marked as the target . The target included the cisternal segment of the trigeminal nerve extending to the gasserian ganglion. The radiation oncologist, neurosurgeon, and radiation physicist performed tumor delineation, dose selection, and planning. Inverse planning was used to determine the dose to the target volume while minimizing the dose to normal tissue. A mean marginal prescription dose of 64.12 Gy  was used over the course of this series. The average prescription isodose line was 86%, whereas the dose at the edge of the brainstem was kept to less than 30% of isodose line touching the brain stem, which gives about 22.5 Gy to the brain stem. Figure Treatment outcomes were assessed by patient self-reports of pain control and medication usage at last followup. A pain-free outcome was defined as BNI pain score I and pain relief or good outcome was regarded as maintaining a BNI pain score III or better without requiring further surgery. Treatment failure was defined as pain returning to a BNI level of IV or V, or the patient undergoing an invasive surgical procedure due to uncontrolled pain. A recurrence was defined as a relapse to a previous lower level after attainment of any higher level of pain relief. Patients reported the time interval for a response and pain recurrence after CK. The date of treatment failure was considered to be the date at which pain relief became a BNI IV or V score.p value <0.05 was accepted as statistically significant. All statistical calculations were performed using SPSS software, version 13.0 .Time to BNI class IV to V pain relapse was calculated with the Kaplan-Meier method. Log-rank tests were performed to determine statistical differences between pain relapse curves. We conducted a univariate analysis of several factors hypothesized to influence or predict successful treatment, using Cox regression analysis: age, gender, side of pain, duration of symptoms, prior surgery, diabetic status at diagnosis, pretreatment facial numbness, and new facial numbness. A A large proportion of patients (42.9%) reported pain relief within 1 month following CKRS treatment. Nineteen percent of patients reported relief within 6 months of treatment and another 19% reported relief no relief of symptoms. In 14.3% relief was experienced within 3 months from treatment. The median time to recurrence of severe pain was 19 months .Results of Kaplan–Meier analysis of response time after CKRS are displayed in Figure The majority of the patients 18 or 72%) did not experience any new bothersome post-treatment facial numbness , which is consistent with previous studies reporting rates between 67%  and 92% Of the patients who responded, the majority of our patients noted improvement in symptoms within 1 month and all reported improvement within 6 months. Villavicencio et al. reported a mean latency to response of 2 weeks in a series of 95 patients  and a smAdditionally, our long-term results also are consistent with other studies reporting long-term data. Our actuarial freedom from severe pain rate was 72% at 3.2 years. Other studies have reported actuarial or observed rates of sustained pain relief between 50 to 80% at around 3 years follow-up ,10. ThusA common complication associated with CKRS for TN, which was experienced by a few patients in this series, is the development of facial numbness. Previous studies have reported variable rates of bothersome facial numbness post-treatment ranging from no patients  to over An interesting finding in our study was that diabetic patients had significantly worse pain outcomes after CKRS for TN than patients who did not have a history of diabetes. In our series, 3 of the 5 diabetic patients experienced treatment failure (BNI of IV or V at last follow-up), whereas, only 4 of 20 non-diabetic patients experienced treatment failure. Another study examining factors associated with the durability of pain relief after CKRS for TN also reported that diabetes appeared to be a negative prognostic indicator . The exaLastly, SRS has long been reserved for TN patients who are not surgical candidates or have comorbidities conferring them a shorter life expectancy. However, a recent study suggested that CKRS might be preferable to surgical therapy, in particular MVD, in certain circumstances due to its economic benefits. Tarricone et al. reported that CKRS proved to be more cost-effective than MVD yet possessed equivalent clinical effectiveness as MVD did . These aThere are several limitations to this study. The small sample size and retrospective nature of this study design limit the power of our outcome observations. Additionally, although pain intensity and numbness scales are validated tools for the quantification of pain and numbness, they are subjective outcome measures because they are dependent on personal interpretations and variation. The results of this study should, however, help clinicians provide important information to patients so they can have realistic expectations and be able to weigh the risks and benefits relative to the various available treatment options.CKRS is a safe, effective, minimally invasive and potentially cost-effective treatment modality for patients with medically intractable TN or those who are ineligible or refuse open surgery. Our results demonstrate that a CKRS treatment is associated with good outcomes in the majority of patients with sustained relief of TN pain in most responding to therapy. Our observations also further support the relationship between the development of facial numbness and treatment success and suggest that diabetic status might be a negative prognostic factor in response to CKRS for TN.