Previous reports documented abnormalities in cognitive functions and decision-making (DM) in patients with chronic pain, but these changes are not consistent across studies. Reasons for these discordant findings might include the presence of confounders, variability in chronic pain conditions, and the use of different cognitive tests. The present study was aimed to add evidence in this field, by exploring the cognitive profile of a specific type of chronic pain, i.e., chronic low back pain (cLBP). Twenty four cLBP patients and 24 healthy controls underwent a neuropsychological battery and we focused on emotional DM abilities by means of Iowa gambling task (IGT). During IGT, behavioral responses and the electroencephalogram (EEG) were recorded in 12 patients and 12 controls. Event-related potentials (ERPs) were averaged oﬄine from EEG epochs locked to the feedback presentation  separately for wins and losses and the feedback-related negativity (FRN) and P300 peak-to-peak amplitudes were calculated. Among cognitive measures, cLBP patients scored lower than controls in the modified card sorting test (MCST) and the score in this test was significantly influenced by pain duration and intensity. Behavioral IGT results documented worse performance and the absence of a learning process during the test in cLBP patients compared to controls, with no effect of pain characteristics. ERPs findings documented abnormal feedback processing in patients during IGT. cLBP patients showed poor performance in the MCST and the IGT. Abnormal feedback processing may be secondary to impingement of chronic pain in brain areas involved in DM or suggest the presence of a predisposing factor related to pain chronification. These abnormalities might contribute to the impairment in the work and family settings that often cLBP patients report. Cognition indicates the brain’s acquisition, processing, storage and retrieval of information, but is also used to describe integrative neuropsychological processes such as mental imaging, problem solving and perception, and is pertinent to emotion and affect .complex process that encompasses a range of functions through which motivational processes make contact with action selection mechanisms to express one behavioral output rather than any of the available alternatives  is a rnatives . DM depernatives . Feedbacrnatives .The anatomical substrate of DM is a complex network including the prefrontal cortex (PFC), the anterior cingulate cortex (ACC), the fronto-striatal and limbic loops, and some subcortical structures and DM abnormalities are common in patients with lesions or diseases affecting these areas .In an attempt to mimic real-life DM scenarios, Longstanding evidence indicate that chronic pain, i.e., pain persisting for 3 months or longer , may havpain matrix. They also suggest that chronic pain may impinge the PFC and the related network and could be considered a cognitive state that may compete with other cognitive abilities, especially those utilizing the PFC, such as DM (Morphometric magnetic resonance imaging (MRI) demonstrated gray matter atrophy in the dorsolateral PFC . Functioch as DM .It is important to exercise caution in interpreting these neuropsychological data, because the majority of cognitive abnormalities have been documented in patients with fibromyalgia  and cannThe goal of the present study was to add evidence in this field, by exploring the cognitive profile of a specific type of chronic pain, i.e., cLBP. cLBP patients underwent a neuropsychological battery to explore different cognitive functions and we focused on emotional DM abilities by means of IGT. Abnormalities in different tests would indicate reduced cognitive abilities secondary to the affective and attentional load of pain. At variance, changes in single cognitive functions would favor the hypothesis of specific mechanisms associated with chronic pain. What’s more, focusing on emotional DM might help understanding whether PFC changes documented in neuroimaging studies do translate into cognitive changes.To explore the cortical correlates of DM, we measured behavioral responses and recorded their neurophysiological cortical correlates with electroencephalogram (EEG) and event-related potentials (ERPs) during IGT in a subgroup of cLBP patients and controls. The monitoring of feedback during DM task evokes a large cortical response mainly localized over central electrodes, which can be separated in a feedback-related negativity (FRN) and a P300, with the former representing an early appraisal of feedback on a binary classification of good vs. bad outcome, and the latter resulting in a later top–down controlled evaluation process that is related to both the valence and the magnitude of the feedback .Table 1), for a total of 48 participants. Baseline demographical conditions  were not significantly different between patients and controls. All participants gave signed informed consent prior to participation to the study and the protocol had been explained in details to them. The study was approved by the local ethics committee of the Department of Neurological and Movement Sciences, University of Verona.We recruited 24 normal subjects, who volunteered as controls, and 24 patients with cLBP  and painThe inclusion/exclusion criteria for patients and controls were: age 18–70, normal or corrected to normal vision, absence of neurological or psychiatric disease, no drugs with psychotropic or neurological effects, mini mental state examination score MMSE;  >24.Chronic low back pain patients had a mean pain duration of 72.9 ± 55.8 months . Average pain intensity was rated before the neuropsychological and IGT evaluation and was 5.1 ± 2.7/10  on a 0–10 numerical rating scale (NRS). At the time of the evaluation, none of the patients was on chronic treatment, except non steroidal anti-inflammatory drugs when needed, but none of them took any painkiller on the day of testing. The mean score on Beck Depression Inventory (BDI) was 5.0 ± 3.5/39  which indicated minimal depression, and anxiety score on the State Trait Anxiety Inventory (STAI) Y2 was 45.1 ± 4.9/80 , which indicated mild anxiety.Neuropsychological status was assessed individually by experienced neuropsychologists with a well-validated battery of five tests. The assessment lasted 1 h, with each of the five tests being given to the patients and controls one after the other in the same order. The test list include:The digit span test, a subtest of the Wechsler memory scale , is the This test is a shorter version  of the WThis test measures sustained attention and some aspects of EFs, such as the ability to elaborate relevant and irrelevant dimensions in parallel and to inhibit an automatic response while performing a task based on conflicting stimuli .This test is divided in parts A and B and evaluates attention, motor speed and EFs .esame neuropsicologico breve 2  minus those picked from disadvantageous ones (A and B) was calculated. In this way, five learning IGT scores, one for each block, were obtained for each subject, and the comparison between these scores was considered as an index of learning. An increasing value of the learning IGT score from the first to the last block indicates a preference for advantageous decks and the learning of the right pick strategy. Finally, the total IGT score was calculated by means of the difference between overall advantageous choices minus overall disadvantageous ones.The performance in the IGT test was measured using different parameters. The  reports . To thisElectroencephalogram and ERPs were recorded in a subgroup of 12 controls and 12 cLBP patients. During the IGT, the EEG was acquired from an array of 32 Ag/AgCl electrodes through a Micromed electrode system. Electrodes were identified by brain hemisphere  and general cortical zone  and they were mounted on an elastic cap, according to the International 10–20 system . The lefElectroencephalogram data were processed oﬄine using the EEGLAB software . Epochs The FRN amplitude was calculated as the peak-to-peak amplitude difference between the maximal positivity in the 150–250 ms time window and the minimal negativity in the 250–310 ms time window after feedback presentation in the Fz channel because FRN is maximal in the fronto-central midline .The P300 amplitude was calculated as the peak-to-peak amplitude difference between the minimal negativity in the 250–310 ms time window and the maximal positivity in the 310–450 ms time window after feedback presentation, from Pz channel because P300 is maximal at the parietal midline .t-test was used for continuous variables and the Fisher’s exact test for dichotomous ones. For continuous cognitive and IGT outcomes, we used the unpaired t-test in case of normal distribution, otherwise the non parametric Mann-Whitney U test was applied. The dichotomous cognitive variables and the modal distribution of deck choices were explored with the Fisher’s exact test. The correlation between cognitive and IGT measures and clinical variables  was analyzed with the Pearson’s coefficient. Learning strategy in the IGT was analyzed with a mixed model repeated-measures ANOVA  and post hoc t-test with Bonferroni’s correction. Homogeneity of variance was analyzed with the Levene’s test. The data were transformed (logarithmic transformation) before submitting them to ANOVA in case of an inequality in the variances. The FRN and P300 amplitudes were submitted to a mixed model repeated-measures ANOVA  and post hoc t-test with Bonferroni’s correction. Results are reported as mean ± SD except when otherwise specified. P < 0.05 (two-tailed) was taken as the significance threshold for all the tests.All tests were carried with the IBM SPSS version 20.0 statistical package. For the comparison of baseline demographic conditions (patients vs. controls), the unpaired p = 0.02) and modified card sorting test (MCST) perseverative errors were significantly higher in patients vs. controls (p = 0.03), while the other cognitive scores did not significantly differ between the two groups (Table 2). The number of MCST right categories was negatively and significantly influenced by the intensity of pain . The number of perseverative errors was significantly correlated with pain duration .Modified card sorting test right categories were significantly lower  vs. controls . Depression score (BDI), anxiety score (STAI Y2), duration and intensity of pain were not significantly correlated with the total amount of money. The modal value of deck choices significantly differed between patients and controls, in that 54% of cLBP patients and 83% of controls preferred advantageous decks .The advantageous or not and, once learned, they preferred the advantageous decks. At variance, the picks of the cLBP patients did not follow a clear strategy, but they seemed to fluctuate randomly across advantageous and disadvantageous decks. Normal controls showed a learning process during the task, in that the learning IGT score progressively ameliorated throughout the five blocks of the test. At variance, no clear learning strategy was found in cLBP patients, whose learning IGT score did not improve across different blocks and fluctuated close to 0 . Repeated-measures ANOVA showed a main effect of the factors block , group  and a significant block × group interaction  on the learning IGT score. Post hoc analysis with Bonferroni’s correction showed that the learning IGT score was significantly higher in controls vs. patients in blocks 3, 4, and 5 . To rule out any possible effect of concomitant depression, patients were divided in those with and without depression according to BDI (cut-off = 5/39) and the between-subjects factor depression was submitted to repeated-measures ANOVA, which documented that neither the factor depression  nor the block × depression interaction  significantly influenced the learning IGT score.When analyzing the distribution of the picks across the experimental blocks, normal controls showed an exploratory strategy, in that at the beginning of the test they explored single blocks and continued picking cards from the same block until they learned whether the deck was total IGT score.Depression score (BDI), anxiety score (STAI Y2), duration and intensity of pain were not significantly correlated with the n = 12) and controls (n = 12) did not significantly differ for age, sex and education. Among cognitive measures, the MCST right categories were significantly lower  and MCST perseverative errors were significantly higher  in patients vs. controls, while the other outcomes did not significantly differ between the two groups. For IGT, the total amount of money was lower in cLBP patients (1460 ± 692€) vs. controls . Repeated-measures ANOVA showed a main effect of the factors block , group  and a significant block × group interaction  on the learning IGT score.The subgroups of cLBP patients  vs. losses , but this was balanced between the two groups.The grand-average ERPs in patients and controls are displayed in Figure 4). Repeated-measures ANOVA showed a significant condition × group interaction , while the factors condition  and group  did not significantly affect FRN amplitude. Post hoc analysis with Bonferroni’s correction showed that the FRN amplitude was significantly higher to losses than wins in patients. The FRN amplitude difference for the two types of feedback  was significantly different between the two groups .The FRN amplitude in the Fz channel was higher to wins than losses in controls, while the opposite happened in patients . Repeated-measures ANOVA showed a significant effect of the factor condition  and a significant condition × group interaction , while the factor group  did not significantly affect P300 amplitude. Post hoc analysis with Bonferroni’s correction showed that the P300 amplitude was significantly higher to positive than negative feedback in controls, while no difference between the two types of feedback was found in patients.The P300 amplitude in the Pz channel was higher to wins than losses in controls, while this difference was absent in patients, being the P300 amplitude similarly high for both types of feedback .The P300 amplitude difference for the two types of feedback  was significantly different between the two groups , anxiety score (STAI Y2), duration and intensity of pain.In the present study, we explored cognitive functions and DM in cLBP patients and focused on emotional DM abilities by exploring behavioral responses and their neurophysiological correlated during IGT . Our datPrevious reports on cognitive functions in chronic pain reported conflicting results, in that abnormalities were not consistent and the tasks explored differed across studies . What’s We found that the intensity and duration of pain were significantly correlated to MCST scores. Pain duration and intensity were quite variable among our patients and this may represent a bias. However, based on our findings, we may hypothesize that pain might represent a competing task leading to worse and slower functioning of the dorsolateral PFC, which is involved in MCST performance. This view is in keeping with morphological MRI studies, which showed reduced size of the dorsolateral PFC in chronic pain patients , and thaDepression and anxiety did not correlate to the MCST performance in our patients, excluding a possible role of these factors. A limitation of the present study is that we did not explore the role of other factors, such as deprivation of social contacts, agility, physical training and life style changes, which together might have also contributed to the MCST abnormalities , 2013.Iowa gambling task data showed impairment of both the total amount of money and the learning strategy. cLBP patients won significantly less money than controls and their IGT score did not change throughout the blocks indicating the absence of a learning curve during the test. The IGT is a relatively difficult task, but normal controls succeeded in keeping the initial amount of money, while patients lost on average a quarter of the sum. The different outcome in the two groups depended on the presence of a learning strategy in controls, who explored the four decks in the first two blocks of the test, then chose preferentially the advantageous ones. At variance, patients choices appeared largely random ones, and there was a higher number of disadvantageous picks in this group. Depression, anxiety and pain characteristics  did not influence IGT performance.To the best of our knowledge, only two studies explored IGT in patients with chronic pain, namely in cLBP and complex regional pain syndrome  and in cThe analysis of feedback-related ERPs offered some insight on the brain mechanisms underlying the bad IGT performance in our patients. To better explore the different stages of feedback processing, we analyzed two ERPs components, namely the FRN and P300.While FRN was slightly larger for positive vs. negative feedback in normal controls, the opposite happened in our patients, who showed a significantly higher amplitude of this component to losses than wins. The FRN reflects early feedback appraisal on a binary good vs. bad classification, is an index of the violation of the expectations of the subject rather than of the absolute valence of the feedback and is generated in the ACC . Our datpositivity effect , which is supposed to reflect a positive feedback as more task relevant, because it signals that the intended goal has been achieved  and serotonin. DA is the main neuromodulator of the fronto-striatal loop, and plays a key role  in rewarIn contrast to MCST results, IGT abnormalities were not related to any pain variable. We hypothesize that they may represent a predisposing factor for pain chronification and in predicting those patients, who are at risk for developing chronic pain after a futile peripheral tissue damage. Studies on pain chronification have recently shifted from peripheral nerve and spinal cord mechanisms to cortical and limbic phenomena . Future The present IGT abnormalities are similar to those found in pathological gamblers , as wellIn conclusion, we documented that cLBP patients show poor performance in DM, as assessed with MCST and IGT. These abnormalities might contribute to the impairment in the work and family settings that often cLBP patients report. Future studies should explore whether these changes may predict the functioning in everyday life.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


CT guided lung biopsy is a commonly performed procedure to obtain tissue for a histological diagnosis in cases of suspected lung cancer.This is a prospective cohort study to obtain information directly from patients about their experiences of the biopsy procedure, thus obtaining a more accurate picture of complications compared with previously performed retrospective reviews. Patients participated in a post-procedure telephone interview and information was gathered about any procedural complications and personal experiences. We also compared the patient reported complications with those obtained from a retrospective review of hospital databases, analogous to previously performed retrospective studies.In our patient group, reported procedural complication rates were 10% pneumothorax rate (4% requiring a chest drain) and 10% haemoptysis. Post-procedural pain and shortness of breath showed positive correlation, with one patient experiencing prolonged pain. No statistical difference was found between the patient reported complication rates and those obtained from retrospective review of the hospital database.Our study demonstrates CT guided lung biopsy is a safe procedure and is generally well tolerated. Some patients may experience significant and lasting pain and therefore should be counselled about this pre-procedure. CT guided lung biopsy is a common radiological procedure performed throughout the world. It is frequently used to obtain tissue to confirm a suspected diagnosis of lung cancer to enable the histological analysis necessary for treatment planning. The procedure may also be performed for non-malignant disease, such as to obtain a specimen for microbial analysis in suspected infection. However, the majority of biopsies are for malignant disease.Within the County Durham and Darlington Foundation Trust approximately 120 CT guided lung biopsies are performed per year across the three hospital sites. Complications of CT guided lung biopsy have been well documented and include pneumothorax (4-60%), pneumothorax requiring chest drain (5-10%), haemoptysis (10%), pain, air embolism, atrial fibrillation, tumour seeding of the biopsy tract and, on rare occasions, death (0.5%). To our What is the patient reported complication rate following CT guided lung-biopsy?Are patients adequately informed regarding the procedure and aftercare?This was a prospective cross sectional survey of 49 patients (40% recruitment rate) who underwent CT guided lung biopsy within County Durham and Darlington Foundation Trust. Ethical approval was granted by the County Durham and Tees Valley Ethics Committee and funding was provided by County Durham and Darlington Foundation Trust.Adult patients with capacity were eligible for inclusion in the study if they had previously undergone a CT examination of the chest demonstrating an abnormality within the chest that was suspected to be malignant or indeterminate. Patients were excluded from the study if they were under 18 years of age, lacked capacity or were not contactable by telephone. Patients were invited to participate in the study during a clinic appointment with the referring physician and an information leaflet was supplied. Further information about the study was given by the research nurse prior to the procedure and written and informed consent was taken to participate in the study. The patients were re-assured that they could withdraw their consent at any time without detriment to their future care. Consent for the procedure was taken by the physician performing the biopsy, separately from the consent for involvement in the study.The CT guided biopsy was performed to a standard technique by one of two Consultant Radiologists : the patient was placed within the CT scanner and a suitable position for biopsy was ascertained. Local anaesthetic was infiltrated into the sub-cutaneous tissues and an 18G core biopsy needle was placed within the lesion. Usually, one to three samples were taken, depending on radiologist preference and the subjective opinion of whether an adequate sample had been obtained. No pathology service was available to analyse the sample at the time of the biopsy to check for adequacy. Routine post-procedure care included observation within the hospital for four hours. Additionally, a post-procedure chest radiograph was obtained to determine whether the patient had sustained a pneumothorax. Patients who were well post biopsy were discharged home after four hours. If the patient was unwell, then local hospital admission was arranged.Within two weeks following the procedure, the patients were telephoned by the study nurse and a structured telephone interview was undertaken. It was made clear to the patients at the time of the biopsy that the purpose of the telephone interview was to discuss the biopsy procedure and not the biopsy results. The patients were informed that the biopsy results would be obtained from the referring physician during their next clinic appointment and that the study nurse did not have any information about the biopsy results.The questions asked during the telephone interview were standardised Table .Table 1On average, the interview lasted 20 minutes. All patients who agreed to participate in the study were contacted post-biopsy and no patients withdrew their consent. The qualitative information was initially recorded on paper and then collated into a database.http://www.statsdirect.com). The number of patients recruited into our study gives 80% power to detect a 20% difference between the two groups. The Fisher exact test was used to compare the patient reported rates of haemoptysis and pneumothorax against the rates from retrospective review of the hospital records, with no difference between the two groups evident in the results.Statistical tests were performed using StatsDirect (Spearman rank correlation test shows a strong positive correlation between the immediate pain scores and shortness of breath scores (p = 0.0022). Positive correlation is also demonstrated between the immediate and one week pain scores (p = 0.0607).In total, 49 patients were recruited to the study over 15 months. There were 28 male and 21 female patients, with ages ranging from 34 to 87.Ten out of 49 (20%) patients described the procedure as painful Figure .Fourteen out of 49 29%) patients were short of breath immediately following the procedure  patients were discharged on the same day of the biopsy following uneventful 4 hour post-procedure observation. One patient required an overnight stay, one patient stayed for two days and one patient required hospitalisation for more than two days. The patients were all admitted to Darlington Memorial Hospital, within County Durham and Darlington Foundation Trust.There were no additional complications occurring between hospital discharge and the post-procedure interview at two weeks.All forty six patients (94%) answered “yes” to the question “was the biopsy what they were expecting?” whereas 3 patients answered “no”. No patients felt that they required more information and none volunteered any additional comments.Review of the hospital records showed that 5 out of 49 (10%) patients sustained a pneumothorax. Two patients required a chest drain, in concordance with the patient reported rate. Out of this group, one patient sustained a large pneumothorax, requiring a chest drain and hospitalisation for greater than two days. A further patient had a 40% pneumothorax requiring a chest drain and an overnight stay in hospital. The three other patients sustained small apical pneumothoraces, none requiring a chest drain. One of these patients with a small apical pneumothorax required a two day in-patient admission.Five patients were recorded as having post-procedural haemoptysis (10%) and 44 as none. No patients required any active treatment of the haemoptysis (such as embolisation) and all settled with conservative management.20% of our patients answered “yes” to the question “was the procedure painful?” Therefore, 80%, or the majority, tolerated it without discomfort. Similarly, 29% of our patients were short of breath during or immediately after the procedure and, therefore, 71% tolerated it without significant dyspnoea. Our results show positive correlation between immediate pain and shortness of breath, indicating that those patients who were in painwere also short of breath. This result may be expected intuitively. If the procedures were poorly tolerated, a patient may experience more pain and dyspnoea.Of interest, in our opinion, although only 10 patients answered “yes” to the direct question about procedural pain, 25 patients scored their immediate level of pain as greater than 0 (i.e. some pain) with the majority scoring 1-2/10 for pain. This suggests that there was a group of people who experienced discomfort/low pain scores immediately following the procedure but chose not to describe the procedure overall as painful. Therefore, just under half of the patients found the procedure painful to some extent, but chose not to admit it on direct questioning. A methodological strength of our study is that it was prospective and the researchers were not part of the team providing immediate clinical care. This may have led to more honesty from the patients about the complications, particularly the peri and post procedural pain.A positive correlation is also shown between immediate pain scores and scores at one week. This could be explained on the basis of an individual’s pain threshold. Those patients who scored their pain level as > 5 immediately, also gave relatively high scores at one week. All but one patient scored their pain level as less at one week, compared with the immediate post procedure pain scores. It is relevant that the single patient who scored his pain greater at one week compared with immediately post procedure sustained a small pneumothorax, managed conservatively.Pain is subjective and a small number of patients found the procedure painful and experienced sustained pain for up to one week following the procedure.Three patients said the procedure was not what they were expecting, but did not offer further comments. No patients said they required more information and none needed to consult other medical services. No patients were admitted outside our trust and thus our data reflect the true complication rates for our institution, with no late complications. No patients offered any suggestions for improvement in the service. We can surmise from the data that overall, the day-case procedure using local anaesthetic is well tolerated by our patients.Newer techniques in image guided biopsy offer the potential to further improve the patient experience. Cone beam CT is a relatively new technique whereby a three dimensional CT image is generated with a rotating fluoroscopic C-arm. This has the advantage of allowing an open environment, rather than an enclosed bore CT scanner. It also allows greater flexibility in the imaging planes used, as it is not limited to the range of movement of the CT gantry, with options for computer aided navigation for needle placement. Recent studies have shown similar complication rates with cone beam CT guided lung biopsy compared with conventional CT guided procedures, 14, 15,The percentage of post-procedure pneumothorax in our patient cohort 10%) is below the average value cited in the literature in similar sized studies (15%). Likewise, our percentage of pneumothorax requiring chest drain (4%) is below the values quoted in multiple studies (5-10%), 22–25. 0% is belWhilst our study did not take into account specific factors regarding the biopsy procedure , we assume that our patient group is comparable to the other patient groups (non-selective inclusion) and, therefore, our results are both representative and comparable. We can be reassured that our results compare favourably with the national averages. We believe we are now able to reliably inform our patients about the risks of the procedure performed at our institutions.Our results show that there is no difference between the patient reported complication rates for pneumothorax and haemoptysis, refuting our initial hypothesis. Thus, in our patient cohort within County Durham and Darlington Foundation Trust, the hospital recorded complication rates are an accurate assessment of the true complication rates.Three patients required hospital admission for management of a pneumothorax immediately following the procedure Table . None ofOne limitation of our study is the small patient cohort, which limits the power of the study. In addition, all patients are residents of County Durham and our data may not necessarily be representative of a different patient group, for example one within an urban area with a different demographic profile.Our study confirms that the described procedure is safe to perform as a day-case and tolerated well by most patients. The majority of our patients felt adequately informed about the procedure. However, an area for development is to counsel about the potential for some patients to experience more prolonged post-procedural pain, with a strategy for managing this pain.Our complication rates are commensurate with the reported rates in the literature and there is no significant difference between the patient reported rates and those obtained from retrospective review in our patient cohort. We now know the true complication rates for our institutions and can advise our patients accordingly.


Thoracic surgery appears to be the treatment of choice for many lung cancers. Nevertheless, depending on the type of surgery, the chest area may be painful for several weeks to months after surgery. This painful state has multiple physical and psychological implications, including respiratory failure, inability to clear secretions by coughing, and even anxiety and depression that have negative effects on recovery.The aim of this study is to evaluate the effect of a neurofeedback-based intervention on controlling acute post-surgery pain and improving long-term recovery in patients who undergo thoracotomy for lung resection for non-small cell lung cancer (NSCLC) at an academic oncologic hospital.This study will be based on a 2-parallel group randomized controlled trial design, intervention versus usual care, with multiple in-hospital assessments and 2 clinical, radiological, and quality of life follow-ups. Participants will be randomized to either the intervention group receiving a neurofeedback-based relaxation training and usual care, or to a control group receiving only usual care. Pain intensity is the primary outcome and will be assessed using the Numeric Pain Rating Scale (NRS) in the days following the operation. Secondary outcomes will include the effect of the intervention on hospital utilization for pain crisis, daily opioid consumption, anxiety, patient engagement, blood test and chest x-ray results, and long-term clinical, radiological, and quality of life evaluations. Outcome measures will be repeatedly taken during hospitalization, while follow-up assessments will coincide with the follow-up visits. Pain intensity will be assessed by mixed model repeated analysis. Effect sizes will be calculated as mean group differences with standard deviations.We expect to have results for this study before the end of 2016.The proposed innovative, neurofeedback- and relaxation-based approach to support post-surgery pain management could lead to significant improvements in patient short and long-term outcomes. Lung cancer has been the most common cancer worldwide since 1985, both in terms of incidence and mortality , and it Cooley et al  have shoThese data highlight the importance of finding effective, early interventions in the presence of painful medical procedures ,19. SeveMany non-pharmacological interventions and interactive new technologies, such as video games and virtual reality environments, can greatly impact pain reduction. By playing a game or being immersed in a virtual environment, users experience an attentional competition between a highly salient sensation (pain) and a consciously directed focus on some other information processing activity . The conSerious games and virtual realities have been used in different contexts to modulate pain perception. In a recent review, Keefe et al  affirmedSince relaxation, distraction, and new technologies have beneficial effects on pain reduction, we propose to implement a research protocol that, by merging these factors, could help post-operative lung cancer patients to cope with acute pain generated by surgery. The technology that best suits our aim is based on the brain-computer interface (BCI) method, which enables a quick measure of brain activity while providing a neurofeedback  to help the user modulate her/his brain activity to accomplish her/his intents . One of We believe that the MindWave and its associated applications can benefit patients in the following ways (1) train them in relaxation techniques, (2) engage them in active tasks, and (3) by receiving motivation neurofeedback, push them to continuously improve their performance. Moreover, due to its ease of use, MindWave can be used by patients the precise moments they are experiencing acute pain.Our goal is to help patients with lung cancer post-operative acute pain gain better control of their symptoms using this innovative, neurofeedback-based pain-control strategy. We hypothesize that patients randomized to receive the intervention will have better pain outcomes, measured by pain intensity, and better medical and psychological outcomes compared with patients receiving usual care.Our primary aim is to evaluate the effect of neurofeedback on pain control in patients with lung cancer who have been recently operated on.Secondary outcomes include evaluating the effects of neurofeedback on (1) hospital utilization for pain crises, (2) daily opioid consumption, (3) level of anxiety, (4) participants’ pattern of engagement with the MindWave tool, and (5) blood test and chest x-ray results. Long-term outcomes also include clinical, radiological, and quality of life evaluations at the 1 and 4 month follow-ups.This study is based on a 2-parallel group randomized controlled trial design , with multiple in-hospital assessments and 2 follow-ups (at 1 and 4 months) based on clinical, radiological, and quality of life assessments. Follow-ups will coincide with the follow-up visits. The research design is shown in Participants included in this study will be recruited from the thoracic surgery unit of the European Institute of Oncology (IEO), Milan, Italy. To be considered eligible to participate, patients must fulfill all of the following inclusion criteria (1) they must be aged ≥18 years, (2) able to consent for self, (3) have a primary diagnosis of non- small cell lung cancer (NSCLC), and (4) they must have undergone a thoracotomy for lung resection <12 hours prior to the first pain assessment. Ineligible patients will be defined as those who (1) have any significant medical or psychiatric comorbidities (other than depression or anxiety), (2) cognitive impediments that would prevent them from being able to utilize the MindWave device, (3) have a known history of substance abuse, and (4) are simultaneously participating in any other research protocols that may have an impact on pain intensity.All patients who are planned to undergo a thoracotomy for lung resection at the European Institute of Oncology, thoracic surgery unit, are considered potential candidates for the present study. Once admitted in the hospital, they will be screened by a trained research assistant to verify their eligibility. Eligible patients will be asked to sign the informed consent, and then randomly assigned to the intervention or control groups. All participants will be instructed to continue to receive medical care from physicians as usual. Subjects included in the intervention arm will be trained on the use of the technology and relaxation technique prior to the operation by a research assistant. They will also receive a MindSet device and tablet with the app Focus Pocus installed on it, for the entire duration of hospitalization (5 days).This neurofeedback-based pain-management program is based on the hypothesis that a relaxation training that provides users an immediate feedback on their performance, as well as a playful environment that moves the patient’s focus from the painful sensation to a specific task can be effective in reducing acute pain perception. In fact, the use of engaging and fun mini-games encourages patients to exercise important psychological processes that underlie their ability to control their own brain responses and, consequently, their behavior.Powered by NeuroSky’s Brainwave Technology, the Mindwave headset is a slim, plastic device which fits comfortably, if not unobtrusively, over the user’s left ear see . The MinThe MindWave mobile costs approximately 100 euros (€) and comes bundled with many free and paid applications, but we limited our choice to those available for the iPad tablet specifically as it is one of the most confortable devices  that can be used by bedridden patients. After having tested all the existing iOS-based apps, we opted for the one called “Focus Pocus-BrainControl”. Focus Pocus is a mix of mini-games that uses live brain electrical activity  from the NeuroSky MindWave device to alter the circumstances of the player. What happens in the game depends on how relaxed the player is. Focus Pocus attracted our attention for the following reasons (1) ease of use, and has a very high-quality interface, yet is low in cost, (2) the games are engaging and fun with a unifying theme, (3) provides cognitive exercises designed by qualified experts, (4) can be used anywhere and anytime without specific supervision, (5) has been already used for scientific purposes ,46, (6) A screenshot of one of the of the Focus Pocus games is shown in For the present protocol, 2 provided tablets and MindWave mobile devices will be used at the same time on 2 different patients. They will be given to the patients the day before the operation and left at subjects' bedside for the duration of their hospital stay. The nurses and the patients will be asked to take care of the devices. The MindSet device and its sensor contact points will be cleaned regularly with an alcohol-based cleaner and a soft cloth included in the MindSet casing to prevent cross-infection and to guarantee good signal quality.Prior to the surgery , participants will participate in an in-hospital intensive education (45-60 minutes) training session when they are not yet experiencing post-operative pain. During the training, an expert research assistant will explain to each patient how, when, and for how long the MindWave and the Focus Pocus app should be used. After that, the patient will be encouraged to practice the use of the tool by him/herself under the supervision of the research assistant. Once the patients become autonomous with the device, the training session will end, and the MindWave and tablet to be used until their discharge from the hospital will be provided.Patients included in the intervention arm will continue to receive the standard care consisting of intercostal analgesia and intravenous pain killers. In addition to it, they will be encouraged to use the MindWave device to manage their pain on-demand and every time they think they need it. During the hospitalization period, patients assigned to the intervention group will also be asked to evaluate their pain over the past 12 hours on a daily basis until their discharge from hospital.Subjects assigned to the control arm will receive only the standard care. In adjunct, they will also be asked to evaluate their pain over the past 12 hours, every day starting from the operation until their discharge from hospital.An independent researcher with no direct contact with the participants will use a computer-generated randomization with a 1:1 ratio and permutated blocks to optimize balance in each treatment arm. Due to the nature of the study, participants, care providers, and researchers cannot be blinded for the allocated treatment. However, the data analysis will be blind, as all of the patients receive a unique study code, under which their data is stored in the database.We will assess one primary outcome and several secondary outcomes. A number of validated instruments will be used to assess the outcomes at multiple time points during the hospitalization and follow-ups. The patients, both in the treatment and in the control arms, will be asked to complete them at specific time-points without the supervision of the research assistants. Hospital nurses will be asked if they completed all the outcome measures, as requested by the protocol, at the end of each day. Demographic and clinical information of each participant will be also collected.The primary outcome measurement is pain intensity, measured as a continuous outcome. It will be assessed quantitatively with the Numeric Pain Rating Scale (NRS) . The papSeveral secondary outcomes will be measured at various time points during the hospitalization . ClinicaThe number of events in which the patient reports severe, uncontrolled, and causing distress pain that requires urgent and unplanned care visitsOpioid consumption, measured quantitatively as oral morphine equivalent daily doseAnxiety, measured by the State-Trait Anxiety Inventory (STAI) scaleThe pattern of patient engagement with the MindWave tool, assessed quantitatively by the number and length of time each subject uses it (as recorded by the software). Usability and satisfaction with the tool will be also investigated.A blood test and chest x-ray will be also performed at the end of the hospitalization period in order to determine if the intervention group shows a better x-ray outcome and fewer infections, due to more physiotherapy because of reduced paint test of difference between means, with 80% power, and a 2-sided alpha of .05. Patients in the experimental group who decide to never use the device during hospitalization will be excluded from the study.A sample size of 80 subjects, 40 per arm, is sufficient to detect a difference of 1.5 between the two groups (control vs intervention) in pain intensity scores, assuming equal standard deviation of 2.5, using a two-tailed t test and categorical variables will be compared using a chi-square test. Pain intensity, our primary outcome, measured longitudinally, will be assessed by mixed model analysis of variance with treatment assignment as the between-group factor and time as the within-subject factor. Effect sizes will be calculated as mean group differences with standard deviations. A similar approach will be used to analyze continuous secondary outcomes while categorical outcomes will be analyzed by chi-square tests.Statistical analysis will be conducted with the SPSS Software, version 22, with an alpha of .05 set a priori for all analyses. Descriptive statistics will be used to summarize baseline demographic characteristics by study arm. Continuous variables will be compared between the two groups using a The hospital internal ethical committee reviewed and approved the study protocol. Upon meeting eligibility criteria, participants will be informed about the study and asked to sign two copies of the informed consent, one for them and the other for the study team. During the enrollment visit and the entire duration of the study, trained research assistants will be available to answer the patients’ questions and to give them additional information.We expect to have results for this study before the end of 2016.The idea to implement this protocol originated from the need to find an on-demand, pain control strategy that helps lung cancer patients to better tolerate acute pain that often arises in the days immediately after surgery. A prompt reduction of pain is fundamental to reduce the risk of respiratory failure and/or the inability to clear secretions by coughing, as well as the probability to develop long-term negative physical and psychological conditions that can significantly interfere with a full recovery.Biofeedback-based training usually guarantees a persistent learning, even when the machine-guided training ends up . In otheOur main endpoint will serve to evaluate the immediate effect of neurofeedback on pain control. If our results are positive, this technique could be used in combination with traditional pharmacological treatments to improve the patients’ post-operative experience, reduce the use of analgesic, and improve long-term physical and psychological outputs.A challenge of this research protocol is the use of neurofeedback to reduce pain perception. While relaxation, virtual reality, and gaming have been demonstrated to be effective in reducing pain, there is no data on the efficacy of neurofeedback and related applications. Nevertheless, we believe that neurofeedback has great potential to reduce pain through relaxation for the following three reasons. First, receiving feedback determined by a specific mental activation can facilitate behavioral modifications and learning of relaxation techniques. Second, compared to traditional visual feedback, a more complex feedback coming from a virtual game can encourage a greater involvement of the patient, and consequently, distraction from the painful sensation. Finally the MindWave system is a cheap, user friendly device that can be easily used by patients without the supervision of the research assistant.The main limitation of the present study is the number of channels and poor precision of the MindWave device in recording the user’s brainwaves. However, since brainwave analyses are not the focus of this study, we do not consider it a critical limitation. Future studies could make use of more sophisticated devices that are currently being advertised but are not yet available on the market.Another limitation stems from our use of the Focus Pocus app on adult cancer patients, as it was originally developed to train children with specific attentive disorders. Even if the proposed mini-games are suitable for adults, it would be useful, in the future, to develop ad hoc apps tailored to adults’ preferences and abilities.To our knowledge, this is the first clinical trial evaluating the impact of a neurofeedback-based intervention on pain management. We hope that our results will lead to larger trials to demonstrate more robust evidence. If our hypotheses are confirmed, the proposed method can be applied to post-operative patients and, in general, to patients suffering from acute pain to reduce care costs and improve overall patient outcomes.


Low back pain (LBP) could be influenced by socio-cultural factors. Pain narratives are important to understand the influence of environment on patients with chronic LBP. There are few studies that have explored the experience of patients with chronic LBP in different socio-cultural environments. The aim of this study was to describe the experience of patients with chronic LBP in Spain and Brazil.A qualitative phenomenology approach was implemented. Chronic LBP patients from the University Hospital of Salamanca (Spain), and/or Federal University of São Carlos (Brazil) were included, using purposeful sampling. Data were collected from 22 Spanish and 26 Brazilian patients during in-depth interviews and using researchers’ field notes and patients' personal diaries and letters. A thematic analysis was performed and the guidelines for reporting qualitative research were applied.Forty-eight patients with a mean age of 50.7 years (SD: ± 13.1 years) were included in the study. The themes identified included: a) ways of perceiving and expressing pain—the participants focused constantly on their pain and anything outside it was considered secondary; b) the socio-familial environment as a modulator of pain—most participants stated that no one was able to understand the pain they were experiencing; c) religion as a modulator of pain—all Brazilian patients stated that religious belief affected the experience of pain; and d) socio-economic and educational status as a modulator of pain—the study reported that economic factors influenced the experience of pain.The influences of LBP can be determined based on the how a patient defines pain. Religion can be considered as a possible mechanism for patients to manage pain and as a form of solace. Low back pain (LBP) is a significant health care problem, where the 1-year prevalence for LBP ranges from 22% to 65% . There iIn Brazil, during 2002–2010, the 3-month prevalence of chronic LBP increased from 4.2% to 9.6%, which was partly due to an increase in the country’s life expectancy . In SpaiSeveral social factors may also have an influence on LBP, such as earnings, ethnicity, access to health care  and low Designing studies that reflect the perspective of a patient with LBP would considerable help in understanding the suffering associated with the disease , and theIn 2011, the Global Burden Study  reportedThe description and comparison of the different perspectives of patients with LBP, either of Spanish  or BraziA qualitative phenomenology study addressing the experiences of Spanish and Brazilian chronic LBP patients was conducted . QualitaPrevious studies –22, 41 hTo be eligible for the study, participants had to suffer from chronic non-specific LBP diagnosed by an Orthopaedic physician. LBP was defined as pain between the costal margins and the inferior gluteal folds, which is usually accompanied by painful limitation of movement and may be associated with referred pain running down the leg . Also, pA purposeful sampling strategy was employed and can be defined as the selection of individuals based on purposes associated with addressing a specific aim of the research study , 47. It The research team consisted of six members (4 women and 2 men), three from Brazil  and three from Spain . Each group was led by an expert researcher with experience in qualitative designs . The other members of the research team were working at one of the respective university . At the time the study was carried out, all of the researchers had their PhDs, except one member who had a Master’s Degree (DPRS). Four members were physiotherapists , one psychologist (LMG) and one nurse (DPC). Previous to working at the University level, 4 members of the team had clinical experience in rehabilitation and pain , one member in neurology (DPC) and one in psychology (LMG). In addition, all members of the team had research experience in chronic musculoskeletal pain. The authors had no previous contact with any of the participants.The teams from both countries met once a week via teleconference. The contents of the meeting were related to: quality control criteria, methodological aspects for data collection and analyses, and updates regarding the progress of the study. The meetings were conducted in both languages, i.e. Spanish and Portuguese.Data were acquired over a one-year period from January 2013 until December 2013. The methodology used for data acquisition is outlined in The data collection process began with an in-depth unstructured interview , always The interviews were tape-recorded and transcribed verbatim. Personal documents  provided by the patients and the researchers’ field notes were collected. The personal data collected from patients provided a rich source of information since they describe personal experiences from the patients’ point of view .During the interview, the researchers made notes, including a description of the environment, patient non-verbal responses to questions, the use of metaphors in their narratives, and other relevant points emerging in the interview.A total of 48 interviews involving 48 patients were conducted. These interviews comprised a total recording time of: 1680 minutes (28 hours) and 1335 minutes (22.25 hours), for Brazil and Spain respectively. Also, the median duration of an interview was 58 minutes, with a range of 37–102 minutes, for Brazil, and 44 minutes, with a range of 32–100 minutes for Spain. Eighteen personal letters and 8 diary entries were collected from the patients, together with the researchers’ field notes from the 48 participants. All interviews were conducted in a separate office at the Hospital and University facilities. Sociodemographic data were obtained following the interviews and were provided independently by the participants in a self-completed questionnaire.A complete and literal transcription of each of the interviews, researchers’ field notes and patient’s documents were drafted. The texts were collated to allow qualitative analysis to be performed . In ordehttp://www.equator-network.org/). Data reliability method [The guidelines for conducting qualitative studies established by the consolidated criteria for reporting qualitative research  were foly method  consisteThe quality control that was applied to the interview transcription was taken into special consideration. In the first phase, the interviews were transcribed using the language of the country of origin so that the researchers from that country could carry out the corresponding analysis. Afterwards, all transcriptions together with the analysis conducted  were translated (from Spanish to Portuguese and from Portuguese to Spanish) and sent to researchers of each country (Brazil to Spain and Spain to Brazil) in order to prepare for the joint meetings. Collecting qualitative data in one language and presenting the findings in another language forced the researchers to take translation–related decisions that had a direct impact on the trustworthiness of the research and its findings . The traThis study was approved by the Clinical Research Ethics Committee at the University of Salamanca (project number: 7-2-12). It was performed in accordance with the Declaration of Helsinki. Permission to record the interviews was always sought prior to their being performed. Written informed consent was obtained beforehand.Forty-eight LBP patients with a mean age of 50.7 years (SD: ± 13.1 years) were included within the study. The median of the age of the LBP patients was 47 years (range 38–65). The themes representing the experiences of patients of LBP were extracted from the interviews. Four specific themes emerged from the material analyzed: a) ways of perceiving and expressing pain; b) socio-familial environment as a modulator of pain; c) religion as a modulator of pain, and d) socio-economic and education status as a modulator of pain. In Regarding the experience of pain, most participants, from both countries, reported that pain had become “everything”; it was seen as a presence in itself that had in some way “taken over” the patient’s body. The participants focused constantly on their pain and anything outside it was considered secondary. This type of pain affects all levels of life: physical, psychic and social. Similarly, all patients perceived that any physical disturbance, pain, or worry seemed to take priority over everything else, and their whole lives were directed towards avoiding the appearance or any increase in their pain.like being stabbed with a knife, it eats you up, it is rabid, a deep wound) whereas the Brazilian patients described it in relation to activities and circumstances where pain arises . Most of the Brazilian patients appeared to be more positive about their pain, even in cases in which owing to their clinical condition it was chronic and constant. They showed a cheerful, positive attitude and were aware that such an attitude would be beneficial to them.On describing and expressing LBP, the Spanish patients described it as an isolated phenomenon, using specific and aggressive terms  reported that their family environment demanded extra of them; they urged that the patient make an effort to overcome pain, as if “forgetting about it” were an option. The patients reported that sometimes they were even accused by family members of being exaggerated or malingering. The lack of a clear diagnosis in some cases made them feel less well understood. They sometimes even lived their pain as though it were a scourge.In both countries, the patients’ narratives pointed to two perspectives in relation to their friendships. On the one hand there were participants who had lost friends as a result of the changes in their lifestyles brought about by the pain they were undergoing  and, on the other hand, there were individuals who struggled to keep their friends, avoiding changing their habits even though this was not to their benefit.Regarding differences between the participants from the two countries, the reports of the Brazilian patients pointed to more support from friends and family, with few changes in their daily activities due to pain. By contrast, in the Spanish patients there were more reports revealing a change in their lifestyles, together with the use of more expressions referring to how lonely they felt, how they felt rejected, or how they were suspected of malingering by their family members.All the Brazilian patients stated that religious belief affected the experience of pain. For these patients, faith and belief was a relief, a constant and necessary support that gave them the strength to cope with their pain. No accounts of pain being perceived as divine retribution or anything similar were recorded.Half of the Spanish patients stated that religion could affect pain, although with interpretations different from those of the Brazilian patients. For these Spanish patients, religion was mentioned in terms of its cognitive and mental effects in the perception of pain, where there is a rational explanation of the mechanism concerning the belief that faith helps patients. The other half of the Spanish patients did not believe that religion could help to mitigate lumbar pain, even though some of them were believers.the rich may suffer less because they have access to better health care, while the poor must suffer more owing to their economic limitations. In the case of the Spanish patients, the results were not as patent since they considered their own health system sufficiently universal to cover lumbar pain for all sectors of the population.Nearly all the patients included in the study reported that the economic development of the country of origin influenced the experience of pain. Good health coverage and the existence of resources destined for the treatment of LBP were factors that reduced the experience of pain. Most of the Brazilian patients stated that In both countries, living in urban or rural areas was also perceived as a factor that affects the experience of pain. Thus, some Brazilian and Spanish patients reported that living in a rural setting increased the likelihood of developing LBP. In the country, the possibilities of rest or stopping work are slim, and pain must be supported as long as this allows the individual to work.Regarding the differences between the patients from both countries, most of the Brazilian patients described experience of more pain than the Spanish ones, but they were able to bear it better in their daily lives. Differently, the Spanish patients complained more and had difficulty in accepting and assimilating the pain.Some patients, from both nationalities, stated that having more education decreases the perception of lumbar pain because better educated people will have better knowledge about how to seek solutions, and understanding of the mechanisms of pain. Some Brazilian patients related a low education level to having more menial jobs, which were more likely to produce lumbar pain. By contrast, the majority of Spanish patients stated that the level of education was not related to lumbar pain or the way of coping with it.The results of this study show that for all patients pain had become the main axis of their lives. Spanish patients described pain in an aggressive manner, while the Brazilian patients’ attitude towards describing their pain was more positive. The patients manifested the difficulty in understanding their pain and recounted the conflicts that had arisen with family members. The Brazilian patients believed that having few resources and a low education level had an influence on pain. On the contrary, religion was perceived as a source of relief for these patients. Also, all of the patients related living in rural areas to more pain, as the work carried out was more manual.Culturally-specific attitudes about the role and meaning of pain can influence the perception and response of patients to their own pain . Thus, cPrevious studies , 19, 21 Our results reveal that the narratives of the Spanish patients are more aggressive and negative in comparison to the Brazilian’s. Additionally, previous studies have shown that the intensity and the duration of pain, and the associated disability have influence on how pain is expressed . HoweverOur results also show that all patients from both countries feel pressure from their families and workplace, which is a result that coincides with previous studies carried out in Spain  and BrazBaetz andBowen [Our study reveals how Brazilian patients have a strong belief in the importance of religion in LBP. In Brazil, Arcanjo and Silva  reportedndBowen  report tndBowen . In contndBowen .Socio-economic and educational factors are also perceived as modulators of pain. The manifestation of pain is inextricably linked to those factors that make up the individual´s social environment, such as social network, literacy, and socioeconomic factors –22.Sistema Único de Saúde presents a mixed healthcare model, 75% public and 25% private [Furthermore, our results have exposed the differences between Brazilian and Spanish patients with respect to their opinion as to whether healthcare coverage can have influence on LBP. In Spain, Cano et al.  have sho private , which c private , 64.Moreover, Shaw et al.  describeHolmberg andThelin [Previous studies have demonstrated a similar prevalence of LBP in both rural and urban settings . NeverthdThelin  reporteddThelin . One posdThelin .Although some authors recommend that interviews should be held alone , 46, 6 pThe influences of LBP can be determined based on an understanding of the meaning given to pain by patients and the effect of socio-cultural factors. Our results can aid health professionals in the understanding of LBP in multiethnic and multicultural areas. Religion can be considered a possible instrument for the handling of pain in some patients who are believers, although further work is still required. In both Spain and Brazil, this work provides a first step towards increasing the awareness of the perceptions regarding the quality of life of LBP patients.S1 Appendix(DOC)Click here for additional data file.


To investigate associations of pain intensity in those with long‐term back pain, with their partners' rating of key constructs of relationship quality: cohesion (activities together), consensus , satisfaction .CI) are reported.Self‐report questionnaires on relationship quality (partner‐rated), depression (partner‐rated), relationship length, and pain intensity (patient‐rated) were collected from back pain patients and their partners (N = 71). Linear regression was carried out to test for associations, standardized coefficients (β) and 95% confidence intervals . Furthermore lower ratings of consensus were reported where patient pain intensity interacted with partner depression .There was no main effect between patient pain intensity and partner rating of relationship quality. However, partner ratings of relationship quality were lower if the partner reported increasing depressive symptoms. Adjusting for the effects of partner depression show that ratings of consensus  from partners were actually higher with increasing levels of pain intensity in patients (β 0.54, 95% These findings illustrate the association of pain outcomes beyond the patient within a primary care sample. Moderators of the responses about the relationship construct of consensus generated by partners appear to be partners' own level of depressive symptoms and whether their depressive symptoms are associated with the patients' pain intensity. Consultations should consider the social context of patients with pain. Long‐term back pain is a common and major health concern, with a lifetime prevalence estimate of over 70% in industrialized nations It is generally accepted that the experience of back pain is shaped at a biopsychosocial level However, more recent research has revealed a more nuanced understanding of a complex relationship between partners where one has pain. For example Cano et al. In this current study, we consider the association between patients' reported pain intensity and their partners' rating of relationship quality  to ascertain whether patient pain intensity associates with judgements of the relationship quality in partners. Consistent with previous literature This is a cross‐sectional study nested within a larger longitudinal follow‐up study of patients seeking primary health care for low back pain (LBP).Full details of the original study can be found elsewhere Ethical approval was obtained from the North Staffordshire and Central Cheshire Research Ethics Committees for all stages of this study.Pain intensity was measured by calculating the mean of three numerical rating scales  for the patient's least, usual, and current (at the time of filling in the questionnaire) levels of LBP over the previous 2 weeks. Higher scores indicate higher levels of reported pain intensity The Hospital Anxiety and Depression Scale (HADS) was used to assess the partner's level of depressive symptoms. The HADS contained seven items of depressive symptoms; item scores ranged from 0 to 3; scale scores ranged from 0 to 21, and higher scores indicated greater levels of depressive symptoms The Revised Dyadic Adjustment Scale (RDAS) Information on gender, age, and length of relationship (years/months) were collected from both patients and their partners.Pearson's correlations were first used to describe the associations between the partner‐rated constructs of relationship quality, patient‐rated pain intensity, partner's depressive symptoms and other variables. The association of patient‐rated pain intensity and partner‐rated relationship constructs were tested using three separate hierarchical linear regression models, one for each of the relationship constructs . Each regression model contains four hierarchical analysis steps. Step one tested the direct unadjusted association of patients' rated pain intensity with the partner‐rated relationship quality construct. Step two adjusted the step one analysis for partner depressive symptoms. Step three adjusted for any interaction between partner depressive symptoms and patient's pain intensity. Finally step four carried out adjustment for partner age, gender, and the length of time (in years) of the relationship between patient and partner. This stepped model was chosen in order to consider direct associations between patient‐rated pain intensity and partner‐rated relationship quality constructs, to adjust for the potential influence of depressive symptoms on judgements of relationship quality  t‐tests showed no significant differences between patients and partners on their age , and no significant differences between patients and partners on their judgements of relationship length . Table In total, 299 patients indicated they had a current partner, and 71 (24%) partners responded. We have no information on how many patients passed on partner questionnaires to their partner. Patients with partners who responded were more likely to be female (67% vs 61%), were significantly older (57 years vs 53 years), reported a significant, longer length of relationship with their current partner (32 years vs 25 years), and reported significantly higher levels of pain intensity (mean 3.2 vs 2.4). The mean ages of partners (58.9 years) and patients (58.1 years) were similar. Gender distribution showed that 69% of patients were female, this corresponded to 69% of the partners being male; there was no same‐sex relationships reported within this cohort. Partners indicated that they had been in a relationship with the patient for a mean of 32 years. Paired sample Table P = 0.54, consensus β −0.09, P = 0.47, satisfaction β 0.14, P = 0.28). Adjustment for partner‐rated depressive symptoms at step two showed no change in the nonsignificant associations between pain intensity and the relationship quality constructs, with partner depressive symptoms being the only consistent variable to be associated with all partners' rated relationship quality variables . Results at step three  show for the cohesion model, no association of patient pain intensity and partner ratings of cohesion, and no association for the interaction between patient pain intensity and partner depressive symptoms. Only partner‐rated depressive symptoms associated with cohesion, with higher levels of depressive symptoms being associated with lower ratings of cohesion. Similar results were found for the satisfaction model. However, results for consensus indicated a significant association between patient pain intensity and partner ratings of consensus, with the direction being positive . As with the models for cohesion and satisfaction, partner depressive symptoms were negatively associated with consensus. There was also a significant association between the interaction term (combined effects of patient pain intensity and partner depressive symptoms) and consensus, the direction was negative . The inclusion of confounders in the final step of the regression models  did not significantly alter the reported associations. Model fit testing (ANOVA F tests for regression models) showed that all models were not significant at step 1 (inclusion of pain intensity), but all models were significant at all subsequent steps. Table Results at step one  found no direct unadjusted association between patient pain intensity and any of the partner‐rated relationship constructs  can be found for all relationship quality constructs within Table The theoretical model by Cano and Leong Even though this study has shown that relationship length did not play a significant role within the regression analyses, it may still be an important factor. This study included partners with a mean average relationship length of 32 years, the minimum relationship length being 7 years. Added to that is this cohort of patients reported the presence of LBP over 5 years previously, which is suggestive that both themselves (patients) and their partners have been exposed to, and to some extent are still exposed to the influence of pain. Research suggests that couples, where one has a chronic illness, can over time adapt and accommodate to the illness and that this can have a beneficial effect on the relationship A key strength of this study is the use of data provided by both the patient and their partner as this gives a broader view point of the potential cross‐over between patient‐rated variables and partner‐rated variables. Many previous studies have reported only patient's perspectives on relationship quality which may be influenced by the patient's mood state and level of pain A further strength of this study is the inclusion of patients and their partners from a primary care sample. Many previous studies, which have included partners, have included patients from secondary care settings  or via media advertisements which may have limited generalizibility to community samples A weakness of the study is the low response rate for partners (24%). We have no way of ascertaining how many partners actually refused to take part as we relied on the patient passing a partner questionnaire over to their partner. It may be that partners with lower relationship quality did not wish to participate. Examining the differences of patient outcomes between those who had a partner who responded and those who did not respond showed that included patients were older, had lived with their partner longer, and reported a greater level of pain intensity. This may have reduced the generalizibility of the results, and further research within different cohorts would be needed to establish if such effects are similar for couples who are younger and/or have less relationship time with their partner. This study is also cross‐sectional, and therefore, we cannot make any assumptions about cause and effect. While stratification is a valid way of investigating interaction analyses Increasing consideration has been given to the inclusion of family members  in the treatment of those with chronic illnesses In conclusion, this study has shown that patient pain intensity is associated with the relationship quality rating of their partners, significantly an effect is found for the consensus aspect  of their relationship quality. The findings show this effect is elicited and moderated by the partner's level of depressive symptoms, but when this depression is statistically controlled, the relationship between patients' pain intensity and partners' ratings of consensus is positive. The results of this study demonstrate the associations of patients' pain intensity beyond the patient, and that social context should be considered when evaluating the impact of pain.


Hydrodiscectomy is a new technique used for percutaneous spinal discectomy that employs a high-intensity stream of water for herniated disc ablation and tissue aspiration. No previous clinical study has examined the effects of percutaneous hydrodiscectomy. The aim of this study is to evaluate the outcomes of hydrodiscectomy compared to open microdiscectomy regarding pain, function, satisfaction, complications and recurrence rates.In this randomized clinical trial, patients referred to our tertiary hospital for lumbar back pain were recruited and included in the study if they had disc protrusion or small herniation in only one level, without neurological deficits and with no resolution after six weeks of conservative treatment. One group underwent open microdiscectomy, and the other group underwent percutaneous microdiscectomy via hydrosurgery. Function was evaluated using the Oswestry Disability Index and pain was assessed using a visual analog scale. Evaluations were performed preoperatively, and then during the first week and at one, three, six and twelve months postoperatively. Personal satisfaction was verified. Clinicaltrials.gov: NCT01367860.p=0.138). The rates of infection, pain, recurrence and satisfaction were similar between the two groups.During the study period, 20 patients were included in each arm and 39 completed one-year of follow-up (one patient died of unrelated causes). Both groups exhibited equal improvement on the visual analog scale and Oswestry evaluations after treatment, without any significant differences. The improvement in the lumbar visual analog scale score was not significant in the hydrodiscectomy group (Percutaneous hydrodiscectomy was demonstrated to be as effective as open microdiscectomy for reducing pain. The rates of complications and recurrence of herniation were similar between groups. Patient satisfaction with the treatment was also similar between groups. Open surgical procedures to treat spinal herniations are associated with complications such as epidural hematoma, infection, residual instability, recurrence of disc herniation and post-laminectomy syndrome, which suggests a need to develop minimally invasive treatment techniques 3versus 72% to 90% for the microdiscectomy technique, depending on the evaluation method 12The reported success rate for percutaneous lumbar discectomy ranges from 29% to 96%, Hydrodiscectomy is a new technique introduced for percutaneous discectomy. It uses a focused, high-intensity stream of water for ablation, which aspirates the tissue at the same time. It resulted in a fast, precise procedure in a study using cadavers The objective of this study was to evaluate the results of hydrodiscectomy and compare them to the gold standard procedure, open microdiscectomy, regarding pain, function, satisfaction with the surgery and complications or recurrence. The hypothesis examined was that the new technique was as safe and effective as traditional percutaneous surgery.This was a randomized, controlled, single blind study undertaken in a university at a public hospital in Brazil, comprising a convenience sample of consecutive patients admitted between June 2011 and January 2012, with follow-up until January 2013. The study was approved by the local Ethics Committee and was registered in ClinicalTrials.gov under protocol NCT01367860. It complied with the Declaration of Helsinki (1983). All patients provided signed informed consent.Patients 18 to 76 years old who were referred to our tertiary hospital for the treatment of lumbar back pain were recruited. They were included in the study if they had the following: disc protrusion or small herniation at only one level, as demonstrated by magnetic resonance imaging (MRI); MRI findings compatible with the symptoms; no neurological deficits; and no resolution after six weeks of conservative treatment. The exclusion criteria were as follows: neurological changes observed during conservative treatment, pregnancy, a clinical status that was not adequate for surgical procedures and those who did not provide informed consent. After inclusion in the study, the patients were evaluated for pain and function and were then randomly allocated to one of two groups by block randomization; one group of patients received an open microdiscectomy and the other group underwent percutaneous microdiscectomy by hydrosurgery.Randomization was performed in the operating room (OR) with opaque, sealed envelopes that were previously prepared in blocks of four each. Once the patient was admitted and prepared for surgery, one researcher (IDR) evaluated the participant for function and pain as described below. This evaluator was unaware of the treatment to be conducted and the patient undergoing the evaluations was also blind to the procedure. Then, the chief nurse (not an author) opened one envelope and disclosed the procedure to the surgeon. One experienced spine surgeon (AFC) performed all of the procedures in this study, with the help of assistants. The patient was blinded to the type of surgery before the procedure, although he/she could later observe the scar, which was larger and more centrally located in individuals who underwent open surgery.Microdiscectomy was performed with the patient under general anesthesia in a knee-chest position with hip flexion and with the aid of magnifying glasses and fluoroscopy. We created a longitudinal central opening and performed dissection up to the lamina during the small laminectomy procedure, followed by a flavectomy, hemostasis, removal of roots and a discectomy.Hydrodiscectomy was performed with the patient under sedation, which allowed the surgeon to observe the movement of the legs during the procedure. The patient was placed lying in prone position and fluoroscopy was used to locate the desired level for the operation. Blocking was performed with lidocaine . A needle was inserted percutaneously and posterolaterally, via an extrapedicular approach, below the neural foramen in the center of the disc using the traditional approach for a discectomy. Front and profile fluoroscopy were used to confirm the desired position. A dilator was introduced into the disc, followed by placement of a cannula over the dilator and into the outer annulus. The cannula was then advanced into the inner annulus. The dilator and needle were removed and the device for hydrosurgery  was introduced via the cannula access. Manual light pistoning and rotation movements were performed for approximately three to five minutes. The disc material was removed by suction.All patients underwent the same physical therapy protocol in our hospital after surgery. The physical therapists were blinded to the surgical procedure and were informed only that the patient had undergone herniated disc ablation for the treatment of low back pain.Function was evaluated using the Oswestry Disability Index (ODI) Surgical failure was considered to have occurred when radiating pain that was equal to or more intense than that experienced preoperatively was present at 30 days post-operatively. In these cases, an MRI examination was performed to evaluate the patient to determine whether they had indications for surgical revision with microdiscectomy, allowing proper planning for the removal of herniated material.p<0.05. The statistical analysis was performed with the Statistical Package for Social Sciences (SPSS) software, version 19.0 for Windows.The statistical analysis was performed based on an intention to treat (ITT) method. Normality was examined using the Kolmogorov-Smirnov test, and if confirmed, data were analyzed with a t-test. All normally distributed continuous data were analyzed using unpaired t-tests and expressed as the means and standard deviations. Baseline categorical data were presented as proportions between groups and statistically tested with the chi-square test and, when necessary, with Fisher's exact test. Statistical significance was established at a value of During the study period, 40 patients were included in the study, 20 in each arm. Except for one patient in the hydrosurgery group who died from other causes in the sixth month after surgery, all patients completed one-year of follow up. The demographic and clinical baseline data are shown in p<0.001 for both scales) and significant differences were found for the VAS score for lumbar pain in patients who underwent open discectomy (p<0.001). The lumbar VAS score was not significantly improved (p=0.138) for the group of patients who underwent hydrodiscectomy.As shown in p>0.05), residual pain or recurrence (according to Fisher's exact test and the chi-squared test).In the open discectomy group, one case of superficial infection occurred, which was treated with antibiotics; three cases of residual pain were observed, in which a postoperative MRI investigation showed proper removal of the herniation but with residual epidural fibrosis (revision surgery was not indicated in these cases); and two cases of recurrence were observed, with revision indicated in both cases. In the group of patients who underwent hydrodiscectomy, one case of infection occurred, which was treated with antibiotics. In four patients, the pain did not improve after treatment, and these patients all underwent open microdiscectomy two months after the first procedure, with subsequent improvement of their pain. One patient in this group was HIV-positive and died six months after treatment due to pneumonia. No significant difference was observed between the groups regarding the frequency of infection (p=0.27).In the hydrosurgery group, 13 patients (68.5% of those who completed the follow-up) were satisfied with the treatment compared to 17 patients (85%) in the open discectomy group, resulting in no significant difference between the groups according to a chi-squared test (Several randomized controlled trials have compared percutaneous discectomy with microdiscectomy Some devices for percutaneous discectomy have been criticized because they cannot remove the posterior portion of the nuclear material of the herniated disc In our randomized clinical trial, significant improvements were observed in all outcome measures except the lumbar VAS score in the group of patients who underwent hydrodiscectomy. One possible explanation for this lack of significance, despite the trend toward improvement shown in In a randomized study similar to the present study, Chatterjee et al.Improvements in pain were observed in the patients treated in both groups and the use of percutaneous hydrodiscectomy was shown to be as effective as the conventional open discectomy procedure. The complication rates in both groups were similar and limited to cases of infection. The rates of recurrent herniation were also similar between the groups, as were the rates of satisfaction with the treatment.Cristante AF designed the study, collected and interpreted data, wrote the manuscript and approved the final version of the manuscript. Rocha ID and Marcon RM collected and interpreted the data, helped with manuscript writing and critical revision and approved the final version of the manuscript. de Barros TE designed the study, helped with data interpretation, critically revised the manuscript and approved the final version of the manuscript. All authors are accountable for all aspects of the work regarding the accuracy and integrity of the study data.


Post-endodontic pain is one of the main problems for both patients and dentists. The purpose of this study was to compare the effectiveness of premedication with indomethacin and ibuprofen for management of postoperative endodontic pain. In this clinical trial, mandibular molars with irreversible pulpitis were endodontically treated in 66 patients. The medicines were prepared similarly in the form of capsules containing 400 mg ibuprofen (group A), 25 mg indomethacin (group B) and placebo (group C). The patients were given one capsule 1 h before the start of treatment. Patients recorded their pain measured by a visual analogue scale (VAS) at medication time, during treatment and 8, 12 and 24 h after treatment. The data were analyzed using the chi-square, repeated measures ANOVA, paired t-test, Tamhane and Pearson correlation coefficient. Ibuprofen and indomethacin significantly reduced the postoperative pain in comparison with placebo during treatment and 8 h after treatment; however, there were no significant differences between them 12 and 24 h after treatment.  Premedication with ibuprofen and indomethacin can effectively control short term post-operative pain; the lower incidence of side effects and greater analgesic power of ibuprofen make it a superior choice. Appropriate anesthesia and successful control of postoperative endodontic pain is one of the major challenges in endodontic treatment specially in teeth with irreversible pulpitis . DespiteNon-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and indomethacin are effective in reducing the pain in endodontic treatments and are commonly prescribed for this reason . StudiesNevertheless recent investigations propose that this class of drugs has other effects embracing inhibition of cytokine synthesis or major cellular signaling pathways of inflammatory responses -9. Rudimet al. , group B [25 mg indomethacin  and group C  which were all prepared in similar capsules. The dentist and patients were not aware of the capsule contents (double-blind design).Determination of pulp status was done according to dental history, clinical findings and radiographic signs. Patients were randomly assigned to 3 equal groups . Ten min later, preoperative pain was recorded on VAS. The teeth were isolated using rubber dam and access cavities were prepared. Working length was determined with Root ZX apex locator  and confirmed with periapical radiographs. Cleaning and shaping was done using the passive step-back technique.Normal saline and 2% sodium hypochlorite were used as irrigants. Then canals were dried with paper points and obturation of the canals was accomplished by gutta-percha  and AH-26 sealer  using the lateral condensation technique within 0.5-0.1 mm of radiographic apex. Pain severity was again measured on the 100-mm VAS and was recorded. Instruction for using VAS and a questionnaire was given to the patients before medication. Patients were asked to record their pain score before administration of medicine and 10 min after local anesthesia. Furthermore postoperative pain was written down at 8, 12 and 24 h after endodontic treatment. Also the patient completed Hospital and Anxiety Depression (HAD) scale questionnaire  for evalThe data were collected and statistically analyzed using the chi-square, ANOVA, paired T-test, Tamhane and Pearson correlation coefficient using the SPSS software . The level of significance was set at 0.05.P=0.36), gender (P=0.17), background depression (P=0.29) and anxiety (P=0.11). P=0.000) but there were no significant differences between the groups before treatment (P=0.67), and 12 h (P=0.80) and 24 h (P=0.27) after treatment.ANOVA analysis showed a significant difference in pain before endodontic treatment and 8 h after treatment (P=0.23), whereas there were no significant differences in amount of pain in indomethacin group (P=0.14). Also in placebo group the severity of pain significantly increased (P=0.001). Also pairwise comparisons revealed that during the time of operation and 8 h after treatment ibuprofen (P<0.001) and indomethacin (P=0.001) groups had significantly lower pain scores than placebo. Mean VAS scores were plotted in relation to time after administration of the medicine (In fact, in ibuprofen group the severity of pain decreased after 8 and 12 h (medicine .Postoperative pain initiates a few hours after root canal therapy . For relPost-endodontic pain is often attributed to the inflammatory process as well as additional central mechanisms , 20. EndA-delta fibers as a result of continuous peripheral nociceptive barrage from inflamed pulp have been shown in animal models [A 5-fold increase in the discharge rate of dorsal horn neuron and up to a 3-fold increase in the size of the receptive field of l models , 23. Postoperative pain is the result of periapical inflammatory reactions; so NSAIDs may be useful in controlling it . PremediCOX pathway can be blocked by prophylactic prescription of NSAIDs before treatment, so pain sensation will be reduced after RCT . Becauseet al. [Ibuprofen safely blocks COX-1 and COX-2 enzymes and has analgesic and anti-inflammatory action . For redet al.  proposedet al. [et al. [Gopikrishna et al.  showed t [et al.  prophylaClinical recommendation about NSAIDs was supported by systematic reviews , 34. Theet al. [Blood level of ibuprofen increase 1 to 2 h after ingestion and its absorption occurs immediately after oral administration . Indometet al.  have evaSo in this study, according to the strong analgesic effect of indomethacin, the probability of its effect on reduction of post-endodontic pain was assessed. But, all side effects of indomethacin should be considered before its prescription .’t report side effects. This may either show a reasonable case selection or that a single dose of either medication is unlikely to cause significant problems for the patients. In this study the patients were monitored for 24 h. They didnDespite the previously mentioned efficacy of indomethacin, ibuprofen may be a better choice because it is not only a strong analgesic, but also has fewer side effects compared to indomethacin . The anaOur results showed that patients treated with ibuprofen and indomethacin significantly had lower pain ratings during treatment and at 8 h after treatment in comparison with placebo. However, the 12-h pain rating in these two groups were significantly higher than 8-h ratings. This could be attributed to the half-life of their metabolites, which is between 4 to 6 h. All groups gave similar pain ratings at 12 and 24 h after treatment.et al. [et al. [Gospikrishna et al.  and Arsl [et al.  declaredDue to the maximal analgesic effect of ibuprofen and indomethacin their effects did not last more than 8 h . MoreoveThe measurement of pain is difficult because pain perception is subjective and variable which is regulated by multiple physical and psychological factors . Many stProphylactic administration of 400 mg ibuprofen in a single-dose provides effective reduction of post-operative pain lasting for 8 h.