Retrospective case series.To report a novel approach to open posterior sacroiliac (SI) joint arthrodesis using a threaded titanium cage containing rhBMP-2.Twenty consecutive patients with a mean age of 57.7 years (range: 33-84) underwent posterior SI joint fusion. Two closely related novel posterior oblique approaches were employed. Enrolled subjects included 17 females and three males. The mean follow-up time for CT to assess fusion was 27 months (range: 17-45 months). Insurance included a mixture of public and private payers. One of the patients (patient 19) was on worker’s compensation. During follow-up, patients were assessed radiologically for radiographic bony union and asked to rate their satisfaction with the procedure. The Oswestry Disability Index (ODI) was applied on a one-time basis upon follow-up. All patients were diagnosed with sacroiliac joint pain based primarily on a positive response to fluoroscopically guided injections into the sacroiliac joint.Out of 20 patients, 33 SI joints were considered symptomatic and operated, and 32/33 joints successfully fused radiographically (a 96.9% fusion success rate). The average procedure satisfaction rating (PSR) was 7.25 out of a maximum 10 (range 1-10). Seventeen patients responded to post-surgery follow-up questions, and 13 patients (76%), indicated they would elect to have the surgery again as well as recommend it to others. Average estimated blood loss was less than 50 mL, and average length of stay was one day.Preliminary experiences with these novel posterior approaches to the SI joint described here seem to be safe and effective. The novel posterior approaches to the SI joint described here appear, preliminarily, to have many advantages over previously described procedures including markedly reduced surgical morbidity. Low back pain is ubiquitous, with a lifetime prevalence of 60-80% -3. It isThe SI joint was initially suggested as a source of chronic low back pain in 1905 , 12 but A comparative retrospective analysis was conducted on 20 consecutive patients who underwent sacroiliac joint fusion performed by a single neurosurgeon. After Institutional Review Board approval, patients were contacted for follow-up and medical charts were systematically reviewed.Mean age at the time of surgery was 57.7 years (range: 33-84). There were 17 females and 3 males. Out of the 20 patients studied, 16 were nonsmokers, two smoked more than 10 cigarettes a day upon follow-up, and two were former smokers  filled with INFUSE® rhBMP-2). Under general anesthesia, the patients were positioned prone on a laminectomy frame. A posterior medial oblique approach was initially employed to fixate the joint by driving a cage into the posterior ligamentous cleft between the sacrum and ilium Figure . Due to . Under gThe first six patients underwent a posterior medial oblique procedure Figure , whereasThe average estimated blood loss in this approach was 50 mL or less. Average length of stay was 0.95 days . Fusion, defined as radiographic evidence of trabecular bone bridging, was present in 32 out of 33 joints, for a fusion success rate of 96.9%. One joint approached with the posterior lateral technique did not fuse as the cage was placed too far into the ala and lost connection with the ilium.There were no other significant surgical complications. Specifically, there were no infections, no bleeding events, no reoperations, and no medical complications.The average procedure satisfaction rating (PSR)  was 7.25  who responded to the post-surgical follow-up questions, 14 patients indicated they would elect to have the surgery again, and those same 14 patients responded that they would recommend the SI joint fusion procedure to others with similar low back pain issues. The remaining four patients who responded to the post-surgical follow-up questions indicated they would not elect to have the surgery again, nor would they recommend the surgery to others.The ODI was applied to all patients on a one-time basis upon follow-up to assess overall health perceptions of patients. The average ODI was a 26.2, which falls in the moderate disability category (21-40). In total, one patient was scored in the crippling back pain category (61-80), four patients were scored in the severe disability category (41-60), seven patients were scored in the moderate disability category (21-40), and eight patients were scored in the minimal disability category (0-20).2 value of 0.3465 indicates that 35% of the variation in PSR can be explained by the corresponding ODI, while the remaining 65% must be attributed to other factors. In several cases, a high PSR was obtained despite a high ODI.Figure 2 value of 0.9252 indicates that there is little variation from the trend.Figure 2 value of 0.2129 shows that in this subset of patients, there is substantial variation from the trend of high PSR corresponding to low ODI.Figure The present case series reviews a single surgeon’s experience with novel posterior instrumented approaches to fixation of the SI joint. The results indicate surprisingly high patient satisfaction scores Table . These pPosterior approaches offer direct access to fixation of the SI joint without significant surgical morbidity. The posterior superior iliac spine provides a bony entry point whose exposure requires little dissection, the transit of no functionally significant structure and is relatively superficial even in obese patients. Virtually all muscle trauma is thus obviated. Additionally, the trajectory of the fixation device poses little risk to neighboring neural and vascular structures. When considering elective surgical procedures for pain, in what may be a relatively pain sensitive patient population, minimized surgical trauma and complication should be of paramount importance. This point is underscored by the result shown here, where in this very early experience of 20 consecutive patients, there were no surgical complications.Previous surgical approaches to SI joint fixation have met with such limited clinical success that they were essentially abandoned. Multiple explanations can be offered for this failure. Accurate diagnosis may be difficult due to the apparent absence of radiographic correlates of the pain syndrome. That is, as always, patient selection is likely very important for the successful surgical treatment of SI joint disease. These historical clinical failures of SI joint fixation procedures may in part be related to excessively traumatic surgical approaches. The relatively high patient satisfaction ratings presented here are likely due in part to the minimal surgical morbidity of the posterior instrumented approaches. There may also be a biomechanical explanation for what appear initially to be substantially improved results.The normal healthy SI joint is thought to move very little or not at all, except around the time of childbirth in women. It is likely that in painful joints some sort of ligamentous laxity could allow for an abnormal micromotion. It is also likely that the instantaneous axis of rotation (IAR) for this motion exists relatively anterior within the true synovial portion of the joint. Procedures which attempt to fixate this large joint at or near the IAR are likely at a relative mechanical disadvantage to those, such as described here, which block the motion from some distance from the IAR.The data presented in Figure The Oswestry Disability Index (ODI) data presented here is of limited value given that preoperative scales were not administered. However, even though preoperative ODI data is missing, it is still productive to examine the correlation between postoperative ODI and PSR. As can be seen in Figures Patient 14 gave a PSR of 1, the lowest possible score. The patient underwent successful bilateral SI joint fusion but reported no relief of symptoms. The clinic notes indicate that failure was expected given that she had two SI joint injections which failed to provide much relief of her pain. The physician suggested surgery as a possible but unlikely solution to this patient’s moderate back pain (ODI of 36).Patient 15 (PSR of 4), underwent successful bilateral fusion, but upon follow-up, the physician noted that she suffered from residual symptoms (aching over the L3 dermatome and numbness in her right foot) which were likely spinal in origin.Three demographic features are noted to potentially skew the results of this study positively. First, the patients in this study were mostly nonsmokers (16/20 or 80% never smoked while 2/20 had quit smoking). Furthermore, only one patient (5% of patients) was on worker’s compensation. One demographic feature which may skew the results in a negative way is that this study involved the investigator’s very early experience with a new procedure.Several limitations to this study exist. First, the size of the cohort is relatively small. Second, this report describes a surgeon’s preliminary experience with a novel surgical technique using an off-the-shelf, nonoptimized implant. Next, the ODI would have been more effective had it been applied preoperatively in addition to postoperatively in order to more effectively demonstrate changes in patients’ low back pain conditions.The present report describes a novel surgical technique with surprisingly good clinical results for a pain syndrome which has historically had an unsatisfactory response to surgical treatment. The posterior oblique surgical approaches represent a very promising avenue for treatment of sacroiliac-related pain syndromes.


The treatment of chronic pain consumes a significant share of primary care. Community and family health team pharmacists frequently see patients with chronic pain, thus have the opportunity to improve their care. To assess the knowledge, perceptions, and attitudes of Ontario pharmacists, we invited 5,324 Ontario pharmacists, to participate in an online survey we developed using Qualtrics. The 31-question survey gathered demographic information, assessed pharmacists’ knowledge of three chronic pain conditions; chronic lower back pain ; chronic headache disorder  and painful diabetic neuropathy , and their attitudes toward and perceptions of patients with these conditions, and knowledge, attitudes, and perceptions of opioids in pain management. We received 688 responses (12.9%) and 392 pharmacists completed the survey. The mean age of respondents was 48.5 years and 48.5% were male. More than 50% of respondents were in practice for more than 20 years and 58.7% worked 25–40 hours per week. The mean knowledge scores were 4.5/8, 5.5/8, and 5.3/8 for CBLP, CHD, and PDN respectively. While 95% of respondents were aware of the increasing death rates due to opioid use, only half were familiar with the Canadian guideline for safe opioid prescribing for non-cancer use. Responses were compared based on gender, time in practice and location of practice. Pharmacists with more than ten years of experience scored significantly higher than those with less experience. Fewer differences were found in comparisons of gender and location of practice. Safe and effective care of chronic pain patients, particularly with opioids, will require additional pharmacist education. Chronic pain is a common condition affecting all age groups, ethnicities, and both sexes. It has significant impact on the quality of life for the individual, and affects their family, their employer, and society at large. Estimates of the prevalence of chronic pain vary considerably across the world. While a Canadian study conducted in 2011 found that 15% to 19% of adults 20 years of age and older reported living with chronic pain . ChronicIn primary care, an average of one out of every five persons report persistent pain . In EuroThe increase in prescription opioid abuse over the past decade is of particular concern ,15. RateGiven that pharmacists are medication experts, are among the most accessible healthcare professionals, and have frequent contact with patients living with chronic pain , those tTherefore, the overarching aim of this project was to investigate the knowledge, attitudes, perceptions, and self-reported efficacy among pharmacists as related to the management of chronic non-cancer pain, with the intent to subsequently develop a specialized training program for community pharmacists to manage chronic pain more effectively while improving the safety of opioid therapy. We defined chronic pain as pain lasting for more than three months and we focused specifically on three highly prevalent pain conditions: chronic low back pain (CLBP), chronic headache disorders (CHD), and painful diabetic neuropathy (PDN) –24. We rThe study, approved by the Institutional Review Boards at the University of Waterloo and the University of Toronto, is a cross-sectional survey of pharmacists providing primary care to patients in Ontario, Canada at community pharmacies, community health centers, and family health teams. The study population consisted of pharmacists registered in part A of the Register of Pharmacists with the Ontario College of Pharmacists (OCP), the province’s regulatory body. Part A pharmacists are those that provide active patient care, dispense, sell, and compound medications, and supervise a pharmacy where medications are kept . Of the 13,072 Part A pharmacists in Ontario, 5,324 expressed an interest in participating in research during their initial registration with the OCP or when renewing their annual license. The OCP provided a list of names and email addresses of these pharmacists to the Ontario Pharmacy Research Collaboration, a multidisciplinary pharmacy practice research program, of which the authors of this study are members.All 5,324 pharmacists in OCP’s registry were invited to participate in an online survey by email. The initial invitation and a description of the study’s objectives were sent on September 15, 2014. Two additional reminders were sent by email on September 29, 2014 and October 13, 2014. Pharmacists were given the opportunity complete the survey on paper and return it by fax or mail, but none had used this option. The link to the survey was active for 6 weeks and directed pharmacists to Qualtrics, an online survey administration tool . Respondents were anonymous; i.e., responses could not be linked to responder. At the end of the survey, respondents were provided another link to enter their name and contact details in a draw for an iPad Air in appreciation for their time, along with an opportunity to indicate interest in participating in future educational opportunities; however, this information was not linked to survey respondents.Previously published literature examining knowledge, attitudes, and perceptions toward chronic pain were reviewed –41, fromThe developed survey was pilot tested by five community and primary care pharmacists to assess wording, structure, layout, and readability, and to provide an estimate for completion time. The survey was modified based on their feedback. The instrument’s face and content validity were determined through multiple separate reviews and discussions by the study’s authors. It was estimated the survey would take 20 minutes to complete.The final survey instrument consisted of 31 questions, several of which had sub-questions. Of these questions, seven assessed pharmacists’ knowledge, five investigated attitudes and perceptions, and seven captured demographic characteristics. An additional twelve questions addressed pharmacy practice patterns, and pharmacists’ self-efficacy in managing chronic pain, but these data are not presented in this paper.Within the knowledge-assessment questions, were eight statements on CLBP, eight on CHDs and seven on PDN that responders were asked to indicate as true, false, or not sure. The other four knowledge questions were on opioid use as follows: one yes/no question asking respondents if they were familiar with the Canadian guideline for the safe and effective use of opioids in chronic non-cancer pain, one question where respondents were asked to provide the guideline’s recommended “watchful dose” of opioids per day in mg morphine equivalents, and two true/false statements assessing knowledge about the rise of overdoses related to prescription opioids in Ontario and the potential for patients with a legitimate pain problem to become addicted to prescription opioids.In two of the five questions addressing pharmacists’ attitudes and perceptions of chronic pain, participants were asked to respond to questions on the importance of incorporating complementary treatment and importance of opioids in the treatment of CLBP, CHDs, and PDN on a five-point Likert scale . The remaining three attitudes and perceptions questions asked participants to indicate how often under-dosing was the reason for ongoing pain for each condition on a five-point Likert scale , how much improvement was expected during the course of illness for each condition on a five-point Likert scale , and how they felt when approached by patients with CLBP, CHDs and PDN, each on a three-point Likert scale . Respondents were permitted to answer as many questions as they desired and to skip over questions.www.qualtrics.com; Qualtrics, Provo, UT, September 2014) and analyzed using the Statistical Package for Social Sciences . Descriptive statistics of survey respondents and survey results were calculated. Chi-square tests were used to examine the relationship between demographic variables  and pharmacists’ attitudes, knowledge, and perceptions toward treatment of chronic pain. Odds ratios and confidence intervals were estimated for statistically significant variables.Study data were recorded using Qualtrics  pharmacists responded to the survey, of whom 392 completed the survey.The mean age of responding pharmacists was 48.5 years (SD 11.5 years), 51.5% were female, 51.3% had been in practice for more than 20 years, and 80.6% worked at least 25 hours a week . As summPharmacists’ knowledge of the pathophysiology and treatment of CLBP, CHDs and PDN was assessed by 23 true/false statements: eight on CLBP, eight on CHDs, and seven on PDN . The meaOf the questions assessing knowledge of CLBP, 89.5% of responding pharmacists provided a correct answer to the true/false question on the relationship of CLBP to injury, 79.0% on whether back pain gets worse before getting better, 59.1% on the role of bed rest, and 86.5% on the effect of chronic ibuprofen use on blood pressure. Fewer than half of pharmacists provided a correct answer to the true/false question on various descriptions of chronic pain (44.3%), the appropriate dose of morphine for low back pain relief (35.4%), the role of non-prescription analgesics as a first-line treatment option (38.0%), and whether patients should avoid painful movement (13.0%) .Of the questions assessing knowledge of CHDs, 95.9% of responding pharmacists provided a correct answer to the true/false question on factors and stress that contribute to chronic tension-type headaches, 95.9% on whether migraine patients should be asked if their headaches restrict activities, 94.6% on whether headache sufferers should guard against medication overuse, and 83.7% on whether the use of prophylactic drug therapy is recommended for chronic headaches. Respondents scored less well on the true/false question on use of combination analgesics and codeine as a first-line treatment (53.52% provided a correct answer) and appropriate use of serotonin antagonists  for headaches (52.8% provided a correct answer). Less than a third of respondents (30.3%) indicated correctly whether migraine is primarily a disease of the brain with a well-established neurological basis, and less than half (42.8%) indicated correctly whether a trial of non-prescription medications should be tried first before taking prescription medications among patients who suffer from severe migraine.Of the questions assessing knowledge of PDN, 90.6% respondents provided a correct answer to the true/false question whether PDN results from damage to nerves in a hypoglycemic environment and 90.0% provided a correct answer to the question asking if all patients with diabetes will develop PDN. However, about two-thirds (65.3%) provided a correct answer to the question whether PDN results from both peripheral and central sensitization mechanisms. Most (83.6%) correctly answered the question whether optimal glycemic control is the cornerstone of treatment, but just less than half (49.0%) answered the question about tramadol being a reasonable initial treatment option correctly. Slightly more than three-quarters of respondents (77.6%) correctly answered the question whether a reasonable starting dose for gabapentin in a patient with severe renal failure is 600 mg three times a day and 78.6% correctly answered the question whether tricyclic antidepressants are effective .Slightly less than half (48%) of respondents were familiar with the Canadian guideline for safe and effective opioid use for chronic non-cancer pain. Almost all pharmacists (96%) were aware that inadvertent overdoses related to prescription opioids has been increasing in Ontario, and 72% correctly answered the question whether patients can become addicted to prescription opioids if they have a legitimate pain problem. Only 276 of 392 pharmacists who completed the survey provided responses to the request for the guideline recommended “watchful dose” of opioids per day in mg morphine equivalents. Of these respondents, 52% answered correctly that 200 mg morphine equivalents per day was the recommended dose, and 48% indicated inaccurate doses, ranging from 0 to 2000 mg morphine equivalents per day.Slightly greater than half (52%) of responding pharmacists considered complementary therapies  as “very important” to incorporate into treatment of patients with CLBP; however, only 21% and 22% of respondents indicated these complementary therapies as being very important to incorporate into treatment of patients with CHDs and PDN, respectively . Slightly more than half of respondents indicated that under-dosing with analgesics was moderately important as the reason for ongoing pain, with 52% indicating this for CLBP, 53% for CHDs and 52% for PDN. Almost half of respondents (47%) indicated that opioids were “very important” or “important” to treat CLBP, whereas 23% indicated that opioids were “very important” or “important” to treat CHDs, and 24% indicated that opioids were “very important” or “important” to treat PDN. Few pharmacists expected full improvement from CLBP, CHDs, or PDN ; however, 24%, 39%, and 20% expected major improvement and 38%, 48%, and 55% expected moderate improvement in these disorders, respectively.When asked how they feel when approached by patients with CLBP, CHDs, and PDN, most pharmacists indicated they were comfortable . In contrast, few pharmacists indicated they felt burdened .Female respondents were significantly less likely than their male counterparts to answer the following question correctly, “Appropriate dose of morphine for pain is whatever dose relieves the pain as completely as possible,”  as related to CLBP . Female Of the 23 questions on knowledge of different pain conditions, significantly more pharmacists with ten or more years of practice experience answered eight questions correctly . Among pSeventy-five percent of pharmacists whose practice location was in an urban area  correctly answered the question, “Appropriate dose of morphine for pain is whatever dose relieves the pain as completely as possible,” whereas among those who practiced in rural locations  only 25% did (p<0.001). Other responses by size of city or town in which pharmacists practiced were not significantly significant.Differences in the proportions of pharmacists who answered questions correctly on knowledge of opioid management based on gender, years of practice, or population size of practice location were not significantRespondents had a good understanding of the pathophysiology and pharmacotherapy associated with CLBP, CHDs, and PDN, with an overall score of 66%. Nevertheless, there were statistically significant differences in the overall scores obtained in PDN (76%) as compared to CHDs (69%) and CLBP respectively . The difference in the scores may indicate a greater familiarity with both headache disorders and diabetic neuropathy among pharmacists and a greater need to develop more educational content addressing the pathophysiology and pharmacotherapy of CLBP. For instance, less than 50% of the respondents answered four of eight questions correctly. In the case of the question, “Patients should avoid all painful movements”, only 13% answered correctly and only 38.0% answered the question, “Treatment with non-prescription analgesics should be first line.”Furthermore, deficiencies were also noted with respect to opioid management. Only about half the respondents were familiar with the 2010 Canadian guideline for safe and effective opioid use for chronic non-cancer pain. While 70% of the 392 who completed the survey attempted to answer the question asking the recommended “watchful dose” per day of opioids in mg morphine equivalents, only half were correct, and incorrect answers ranged widely from 0 to 2,000 mg of morphine equivalents per day. If one were to assume that the remaining 30% did not have adequate confidence to answer this question, only 36% of the pharmacists were aware of the recommended “watchful dose” per day of opioids. The concept of the watchful dose presents a fundamental change in chronic pain treatment with opioids. Previously, it was acceptable to not limit opioid dosing if patients reported continued pain. However, the Canadian guideline includes a recommendation for a watchful dose because “chronic non-cancer pain can be managed effectively in most patients with dosages at or below 200 mg/day of morphine or equivalent” and that “consideration of a higher dosage requires careful reassessment of the pain and of risk for misuse, and frequent monitoring with evidence of improved patient outcomes” . The neeThis study’s findings are consistent with previous research indicating that clinicians are generally knowledgeable about opioids but are less adept at handling questions related to their use ,43–46. TMore than half of the respondents had more than ten years of practice experience—experience that appears to be associated with greater knowledge of CLBP, CHDs and PDN. This finding is consistent with the notion that experience has a substantial direct effect on knowledge in higher complexity employment , but it About 95% of Canada is rural, but depending on the definition used, rural regions comprise 19% to 30% of the country’s population. Of the province-wide professional licensing database, 36% of respondents indicated that they practiced in regions with fewer than 100,000 people. There was largely no difference in knowledge associated with CLBP, CHDs and PDN between urban and rural practicing pharmacists, despite challenges associated with rural clinical practice, such as reduced access to educational opportunities and less peer support .Pharmacists overall were positive about managing these chronic pain conditions, with about two-thirds reporting an expectation of moderate to major improvement. Among the three conditions, complementary therapy was noted to have the strongest role in treatment of CLBP, similar to the proportion who indicated that opioids play a role in treatment. About half of the respondents indicated that under-dosing is a moderately important cause of poor pain control.This study provides insight into the state of practice of community-based pharmacists with respect to chronic pain care provision in Ontario. Despite a modest response rate, to our knowledge this is the largest survey of pharmacists’ knowledge, attitudes, and perceptions of patients with chronic pain in primary care conducted in Canada. In comparison to Lalonde et al, our study had a larger sample size (392 vs 110 completed surveys), higher male to female ratio (0.6:1 vs. 0.9: 1) and a greater percentage of pharmacists with substantial practice experience (34% vs. 51%).The low response rate and the possibility that participating clinicians in our study may have been a self-selecting sample because of their experience or interest in chronic pain, may not be representative of Ontario’s pharmacists overall. Furthermore, there is no possibility of assessing the nonresponse bias inherent in a voluntary participation survey. Our survey may have included a higher proportion of pharmacists who manage chronic pain actively, inflating estimates of knowledge scores. Even with pilot testing and question refinement, survey questions may still be ambiguous, result in bias, and, as with all responses that require recall or estimation, responses may have inaccurately reflected practice reality.Community pharmacists and pharmacists who are part of family health teams frequently see patients with chronic pain, thus have the opportunity to improve their care. However, this survey demonstrates that pharmacist contributions to the effective and safe treatment of these patients, particularly with opioids, appears to require additional education. Appropriate educational initiatives and pharmacist training to develop skills and provide tools may improve the care of chronic pain patients.S1 File(XLSX)Click here for additional data file.S1 Table(DOCX)Click here for additional data file.


DETECT Questionnaire (PDQ-Dlv) and the ‘Douleur Neuropathique 4 Questions’ (DN4-Dlv) for use in primary and specialist medical care settings to screen for a NePC in patients with chronic pain due to (1) LBP, (2) NSP or (3) known peripheral nerve damage (PND).The presence of nerve damage plays a key role in the development and prognosis of chronic pain states. Assessment of the presence and severity of a neuropathic pain component (NePC) is key in diagnosing chronic pain patients. Low back pain (LBP) and neck and shoulder pain (NSP) are highly prevalent and clinically important medical and societal problems in which a NePC is frequently present. The more severe the NePC, the worse the course of the pain, its prognosis and the results of treatment. Reliable and standardised diagnosis of the NePC remains difficult to achieve. Standardized and validated screening tools may help to reliably identify the NePC in individual chronic pain patients. The aim of this study is to validate the Dutch language versions of the Pain-Dlv and the DN4-Dlv with 2 weeks follow-up for test-retest reliability and 3 months follow-up for monitoring and prognosis. 438 patients with chronic pain due to (1) LBP, (2) NSP or (3) PND. will be included in this study. Based on the IASP definition of neuropathic pain, two physicians will independently assess whether the patient has a NEPC or not. This result will be compared with the outcome of the PDQ-Dlv & DN4-Dlv, the grading system for neuropathic pain, bed side examination and quantitative sensory testing. This study will further collect data regarding prevalence of NePC, general health status, mental health status, functioning, pain attribution and quality of life.The study design is cross-sectional to assess the validity of the PDQ-Dlv and DN4-Dlv in Dutch speaking countries. Our innovative multi-factorial approach should help achieve more reliable diagnosis and quantification of a NePC in patients with chronic pain.The rationale for this study is to provide detailed information on the clinimetric quality of the PDQNTR3030).The Netherlands National Trial Register ( This definition will be used in this study because of its diagnostic specificity, anatomic precision and the usefulness in clinical as well as research conditions [.The International Association for the Study of Pain IASP, 2011) defines Neuropathic Pain (NeP) as ‘pain caused by a lesion or disease of the somatosensory nervous system’ . The prevalence of chronic pain syndromes due to peripheral nerve damage (PND) is 3,3 per 1000 per year [The incidence of NeP in the Dutch general population is 0.81% or 130.000 new patients in the Netherlands per year. NeP is 63% more common in women than in men and peaks between 70 and 79 years of age [Strictly speaking, the diagnosis of neuropathic pain is a patho-anatomical diagnosis presuming knowledge regarding nerve injury which is difficult to obtain in the clinical situation. Thus in the clinical context it is better to speak of a neuropathic pain component (NePC), which is a clinical syndrome based on a typical set of clinical symptoms and signs. Clinically, a NePC is characterized by spontaneous pain and abnormal pain sensations . NeP is As a rule, a NePC has a considerable impact on the quality of daily life . Hence iDETECT-Questionnaire (PDQ) [, respectively.Because a reliable diagnosis of the neuropathic pain component is often difficult to accomplish in routine practice , it woulre (PDQ)  and the re (PDQ)  were orire (PDQ)  and Timmre (PDQ) , respect-Dlv and PDQ-Dlv will improve the identification of a NePC in Dutch primary and specialist medical care, also facilitating remote follow up evaluation by telephone, internet or post for clinical and scientific purposes. We chose an innovative approach which should lead to a more reliable identification and quantification of a NePC in patients with chronic pain. This study will help define patient groups at risk for a NePC and will help to understand and assess the variability and burden of a NePC in individual patients.Validation of the Dutch versions of DN4-Dlv and the DN4-Dlv for use in primary care and specialist medical care settings in Dutch speaking countries for patients with chronic pain due to LBP, NSP or known peripheral nerve damage (PND). Follow-up for monitoring and prognosis properties of DN4-Dlv and PDQ-Dlv for a NePC will be done over a period of 3 months. Additional data will be collected regarding NEPC prevalence, general health status, mental health status, functioning, pain attribution and health related quality of life in patients with chronic pain.The aim of this study is to establish the clinimetric quality, including 2-weeks test-retest reliability, of the PDQThe medical and ethical review board Committee on Research Involving Human Subjects region Arnhem-Nijmegen, Nijmegen, the Netherlands, has given approval to conduct this study, Dossier number: 2008/348; NL 25343.091.08; The Netherlands National Trial Register NTR3030.-Dlv and PDQ-Dlv . Each patient will be seen by two physicians, independently of each other, working in the same institute. The medical background of the participating physicians is diverse .Inclusion criteria: Male and female adult patients (>18 years of age) with chronic (>3 months) LBP or NSP radiating into respectively leg(s) or arm(s) or patients with chronic pain due to PND. Exclusion criteria: Patients diagnosed with malignancy, compression fractures, patients with painful syndromes of unknown origin or associated with diffuse pains , severe mental illness, chronic alcoholism or substance abuse, inability to fill in the questionnaire adequately, or incapable of understanding Dutch. Subjects can leave the study at any time for any reason without any consequences. The investigator can decide to withdraw a subject from the study for urgent medical reasons. When an individual subject leaves the study all the information from the patient will be kept in the database, and possibly be used for data analysis or withdrawal analysis. Such patients will be replaced.The patients will be recruited non-selectively and consecutively in the period from September 2009 till July 2013. At the first visit, each patient will be seen by two physicians who will question and examine the patients. They will then independently classify the patients’ pain as pain with or without a NePC, based in the IASP NeP criteria and supported by a standardized assessment form. Next, the patient will complete seven questionnaires (including the PDQ and the DN4). Twenty percent of the patients will additionally undergo QST measurement following the first visit. Two weeks and three months after the initial visit three follow-up questionnaires will be sent to the patient by mail.Date of birth, gender, weight (Kg), length (m), nationality, nationality of origin, pain medication, smoking (cigarettes a day), alcohol consumption (units per day) and education level will be assessed by use of a self completed questionnaire. Pain at this moment will be assessed by use of a numeric rating scale  Medical co-morbidity, duration of complaints (years/months), presence of diabetes mellitus (yes/no), presence of HIV (yes/no), presence of herpes (yes/no) and undergoing of chemotherapy (yes/no) are based on interview by the physician and noted by the physician on the standardized assessment form.At each centre participating patients will be examined by two (rater A and B) independent and trained pain physicians, two experienced neurologists or two experienced general practitioners, working independently of each other and blinded to the diagnosis of the other physician. To achieve standardization of the history and clinical examination all participating physicians will be trained at the sites. Both physicians will classify the pain regarding the presence or absence of a NePC based on history and clinical examination. Level of certainty of the physicians regarding the pain component classification will be assessed by use of a Visual Analogue Scale . The findings are noted on the standardized assessment form by the physician. To monitor the quality of the clinical examination random quality checks, by expected/ unexpected visits, will be used.-Dlv and DN4-Dlv and with the outcome of the original pain classification by the two physicians. This system provides a working hypothesis for the origin of patients’ pain. The criteria are graded on basis of history and testing in medical examination [The grading system for neuropathic pain as proposed by Treede et al.  will be mination : 1) Pai Pai-Dlv Mechanical static allodynia  by blunt pressure with a finger at a force which normally doesn’t evoke pain; Dynamic mechanical allodynia by stroking the skin with a Soft Brush , one movement of 1-2 centimeter and three movements of 1-2 centimeters (wind-up response); Mechanical pinprick allodynia by touch of the skin with a plastic safety pin and a Von Frey hair . Heat allodynia by using TipThermR  in a baby-bottle warmer  set at 45 degrees Celsius; Cold allodynia with an ice cube placed on the skin for 2 seconds and Vibration with a Tuning fork  applied to joint, bone or soft tissue in the region of the pain.Bed-side examination of the patient is performed by both physicians. The aim of this examination is to find possible abnormalities suggestive for a relevant lesion or disease which affects the peripheral or central somatosensory system . The valPressure Pain Thresholds (PPT) will be tested by use of an pressure algometer . PPT will be measured on the left and right bodyside once at each location: Thenar (middle part), musculus trapezius pars median (middle part), musculus rectus femoral (15 cm above patella) and m. abductor hallucis (middle part). Electrical pain thresholds (EPT) will be tested by use of the QST-3 device  on the left and right body side. Measurement locations are the musculus trapezius pars median (middle part) and the musculus rectus femoris (20 cm above patella). Electrical pain thresholds (EPT) are assessed and expressed in milli-Ampère. Single pulse evoked pain measurement is performed by one pulse at 150% of the EPT and assessed on a VAS. Summation (i.e. Electric Wind-Up response (E-WUR)) is measured by a train of five pulses at 150% of the EPT and assessed on as VAS. Conditioned Pain Modulation (CPM) [Electrical Pain Tolerance Thresholds (EPTT) (test stimulation) are assessed and expressed in milli-Ampère on the m. Rectus femoris contralateral to the dominant hand. The noxious stimulus (conditioning stimulation) is to immerse the dominant hand until the wrist in a bucket filled with water and icecubes (‘Ice water bucket test’) [Over the last two decades, QST has been developed to complement traditional neurological bedside examination in the analysis of somatosensory aberrations ,20. In ton (CPM) ,25 will t test’)  for ‘as TM, Brush-05, Somedic AB, Hörby, Sweden). The soft brush will also be used to evaluate tactile  allodynia . Examination of sensitivity to touch and pricking will be performed with the use of a Von Frey hair . Pressure allodynia  is tested by blunt pressure with a finger at a pressure that does not provoke pain in a normally sensitive area [The DN4 ,15  was developed in Germany . The PDQFunctioning: Disability Rating Index (DRI) [p = 0,0001) and a good test-retest correlation of 0,95. The inter- and Intra-rater reproducibility were respectively 0.99 and 0.98 [Mental health status: The Hospital Anxiety Depression Scale (HADS) [-Dlv[p =0.001). The correlation between the anxiety and the depression subscale was high (0.43 to 0.73) [Pain Attribution: Pain Attribution Scale (PAS) Additional questions to study the attribution of the pain in patients. On a 5-point Likert-scale the patient is asked to rate the influence of several items on the pain complaints. Rating is from ‘totally not of influence on the pain complaints’ to ‘very much of influence on the pain complaints’. Quality of life: The RAND 36-item Health Survey (RAND-36) [-Dlv was studied by van der Zee [Change : The Patients Global Impression of Change (PGIC) is a patient rated instrument which measures changes over time on a seven-points scale. Score range is from 1 (very much worse) to 7 (very much improved) [ex (DRI) . The seland 0.98 . Mental e (HADS)  will be DS) [-Dlv has a goto 0.73) . Based oto 0.73)  a cut-ofRAND-36)  is devel der Zee ,32. Chanmproved) -35.cases is 40. From the equation in the first formula by Flahault, the Ncontrols = 68 [total = 132, in each group. Thus in each group 146 patients will be included (10% drop out). It is expected that this recruitment will be achievable in the 10 general practices, 4 pain treatment centres and 2 departments of neurology chosen.In an unselected cohort of chronic LBP patients, 37% had a high probability of a NePC . Sensitiols = 68 . WithoutAll data will be collected from the patients and the physicians on paper and stored by Radboudumc. Data management and monitoring will be performed within MACRO .-Dlv and the DN4-Dlv a comparison will be made between the outcome of both the screening questionnaires and the original pain classification, the Grading system by Treede at al. [-Dlv and the DN4-Dlv will be recorded. Data analysis and statistics will be performed by use of Statistical Package for the Social Sciences . All statistical tests will be two-tailed, for all statistical analysis the type 1 error will be set on 5%.To establish the clinimetric quality of the PDQe at al. , the bedDescriptive statistics: The quantitative variables will be described using mean, standard deviation (SD) and range; Qualitative variables will be described using frequency and percentages. To assess central position, dispersion and distribution of variables, the Kolmogorov-Smirnov test will be used.Univariate analysis: Both the physicians assessments (by rater A and B) will serve as the ‘gold standard’ to assess the presence of a NePC. The internal consistency of both the physicians assessments and the physical examination tests of the DN4 will be separately established for rater A and B by calculating Cronbach’s α that assesses the contribution of each item to the precision of the measurement by both the physicians assessments and the examination items of the DN4 questionnaire.Inter-rater reliability: will be assessed by the agreement of the results obtained by raters A and B for both the physicians assessments and the examination items of the DN4. Agreement was determined by calculating the Cohen’s kappa coefficient.Test-retest reliability: will be assessed for the PDQ and DN4, after two weeks of completion of the questionnaires during the first visit. Stability of the questionnaire will be analyzed by measuring the intra-class correlation coefficient and by use of Cohen’s kappa coefficient of agreement.Prognosis and monitoring: will be assessed for the PDQ and DN4, after three months of completion of the questionnaires during the first visit. Stability of the questionnaire will be analyzed by measuring the intra-class correlation coefficient and by use of Cohen’s kappa coefficient of agreement.Correlations: will be calculated between scores and continuous variables using Pearson correlation coefficient . A students-t test for independent groups or a Mann-Whitney’s U test  will be used to compare respectively continuous or ordinal variables between patients with and without a neuropatic pain componentMultivariate analysis: Sensitivity and specificity percentage of well classified observations and Youden index (i.e. sensitivity + specificity-1) will be calculated for different values of the score of the questionnaire by logistical regression analysis. Positive and negative predictive value for both instruments will also be calculated. The corresponding ROC (receiver operating characteristics) curves will be plotted and AUC calculated using the trapezoid method. Discriminant analysis will be used to analyze complementarily of PDQ and DN4 to each other.-Dlv and DN4-Dlv in patients with LBP, NSP or PND regarding of diagnosing a NePC. A validation of these questionnaires is necessary for its use in everyday clinical practice and also in (inter-)national research to make the outcome comparable in different countries. The key question of this study is whether a NePC as assessed by the physician is reflected in the outcome of the PDQ-Dlv and DN4-Dlv. In already published articles both questionnaires have proven to be useful in daily clinical practice and for research purposes with good clinimetric qualities [The rationale for this study is to provide detailed information on the clinimetric quality, including test-retest reliability, of the PDQualities ,14.R in a baby-bottle warmer at 45 degrees Celsius. To our knowledge we are the first to use this method. Because a bottle warmer has a reasonably good thermostat, the temperature of the water inside, and thus the TipThermR, will be kept at the set temperature. In this study we did not use the DFNS sensory testing protocol [This study chose an innovative and wide ranging approach to diagnose a NePC in patients in based on a more reliable identification and qualification of a NePC. In the absence of an internationally accepted ‘gold standard’  the chalprotocol ,20 but oprotocol .This study will aim to try to define patient groups at risk and to understand and assess the variability and burden of a NePC in individual patients. The PDQ  outcome -Dlv and DN4-Dlv in a general, unselected choronic pain population. To date, almost all screening questionnaires are validated in a defined, restricted, population, recruited in specialized pain clinics and pre-selected by precise medical diagnosis . Our choice of a non-selcted population might lead to a lower sensitivity and specificity of the PDQ-Dlv and DN4-Dlv in this study than published in the original validation studies [By the choice for a non-selective consecutive patient recruitment in specialized pain clinics, neurology clinics as well as general practices this study aims to validate the PDQ studies ,14. Howe-Dlv and DN4-Dlv in patients with chronic pain due to LBP, NSP or PND.In conclusion, this study seeks to identify the association between patient’ symptoms, the signs as found in the bedside examination and outcome of the QST measurements, the general and mental health status, functioning, pain attribution and quality of life with regard to the outcome of the PDQThis study is ongoing. The expected end date of patient recruitment in this study is July 1, 2013.-Dlv: Douleur neuropathique 4 questions dutch language version; DNIC: Diffuse noxious inhibitory control; DRI: Disability rating index; HADS: Hospital anxiety depression scale; LBP: Low back pain; NASQ paradigm: Nijmegen aalborg screening QST paradigm; NeP: Neuropathic pain; NePC: Neuropathic pain component; NRS: Numeric rating scale; NSP: Neck shoulder pain; PAS: Pain attribution scale; PDQ: Pain detect questionnaire; PDQ-Dlv: Pain detect questionnaire dutch language version; PGIC: Patients global impression of change; RAND-36: RAND 36-item health survey; Radboudumc: Radboud University medical center; QST: Quantitative sensory testing; VAS: Visual analogue scale.CPM: Conditioned pain modulation; DN4: Douleur neuropathique 4 questions; DN4The authors declare that they have no competing interests.HT, AW, OWS, CvW and KV designed the trial protocol. AW and KV secured funding for the validation study. HT, OWS and KV drafted the manuscript. AW and CvW contributed to the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2377/14/94/prepub


Low back pain is a highly prevalent condition with a significant global burden. Management of lifestyle factors such as overweight and obesity may improve low back pain patient outcomes. Currently there are no randomised controlled trials that have been conducted to assess the effectiveness of lifestyle behavioural interventions in managing low back pain. The aim of this trial is to determine if a telephone-based lifestyle behavioural intervention is effective in reducing pain intensity in overweight or obese patients with low back pain, compared to usual care.A randomised controlled trial will be conducted with patients waiting for an outpatient consultation with an orthopaedic surgeon at a public tertiary referral hospital within New South Wales, Australia for chronic low back pain. Patients will be randomly allocated in a 1:1 ratio to receive a lifestyle behavioural intervention (intervention group) or continue with usual care (control group). After baseline data collection, patients in the intervention group will receive a clinical consultation followed by a 6-month telephone-based lifestyle behavioural intervention  and patients in the control group will continue with usual care. Participants will be followed for 26 weeks and asked to undertake three self-reported questionnaires at baseline (pre-randomisation), week 6 and 26 post randomisation to collect primary and secondary outcome data. The study requires a sample of 80 participants per group to detect a 1.5 point difference in pain intensity (primary outcome) 26 weeks post randomisation. The primary outcome, pain intensity, will be measured using a 0–10 numerical rating scale.The study will provide robust evidence regarding the effectiveness of a lifestyle behavioural intervention in reducing pain intensity in overweight or obese patients with low back pain and inform management of these patients.ACTRN12615000478516, Registered 14/05/2015.Australian New Zealand Clinical Trials Registry,  Low back pain is a common condition and poses significant burden to individuals and society. Globally, the median point prevalence of low back pain has been reported to be 15 % . The latn = 6828; OR 1.21, 95 % CI: 1.07, 1.37), increased risk of chronic low back pain , and higher rates of health care seeking for low back pain  [While the aetiology of low back pain remains unclear, it is now widely accepted that effective treatment for low back pain requires consideration of the psychological and behavioural factors. Several lifestyle behavioural factors are reported to be associated with an increased prevalence and persistence of low back pain including weight, sleep disturbance, psychological distress, and beliefs. Among the most compelling evidence is the association between overweight and obesity and low back pain , 7. One p = 0.009) [Given these widely reported associations between lifestyle behavioural factors and low back pain, it is suggested that targeting these as part of low back pain management could improve patient outcomes , 10, 11.= 0.009) . While pGiven the large numbers of patients who suffer from low back pain and are overweight or obese , 7, an iThe primary objective of the study is to determine if a telephone-based lifestyle behavioural intervention is effective in reducing pain intensity in overweight or obese patients with low back pain, compared to usual care. Secondary objectives are to investigate if the intervention improves key secondary outcomes: disability and function, anthropometry , quality of life, diet, physical activity and health care utilisation, compared to usual care.The study will employ a parallel group randomised controlled design Fig. , as partOne hundred and sixty patients waiting for an outpatient orthopaedic consultation at a public tertiary referral hospital within NSW for non-specific low back pain will be recruited. All patients over 18 years of age waiting for an outpatient consultation for low back pain will be sent an information letter to invite participation in a telephone survey as part of the ongoing cohort study. Patients will be asked to contact the researchers if they do not wish to participate or can refuse upon receipt of the telephone call. Patients consenting to the telephone survey will then be screened for eligibility for the RCT by a trained interviewer, invited to participate if eligible for the study and asked to complete the baseline survey at the time of the call.Chronic low back pain defined as: pain in the lower back (i.e. between the 12th rib and buttock crease) with/without leg pain and a duration of longer than 3 months since the onset of pain ;Aged 18 years or older;2 and <40 kg/m2 – based on self-reported weight and height;Classified as overweight or obese with a BMI of ≥27 kg/mHave access to and can use a telephone;Low back pain severe enough to cause at least average low back pain intensity ≥3 of 10 on a 0–10 numerical rating scale (NRS) in the last week or moderate level of interference in activities of daily living (adaptation of item 8 on SF36).To be eligible participants must meet the following criteria:Known or suspected serious pathology as the underlying cause of back pain ;A previous history of obesity surgery;Currently participating in any prescribed, medically supervised or commercial weight loss program;Back surgery in the last 6 months or booked in for surgery in the next 6 months;Unable to comply with the study protocol that requires them to, adapt meals or exercise, due to non-independent living arrangements;Any medical or physical impairment, apart from back pain, precluding safe participation in exercise such as uncontrolled hypertension, or morbid obesity (BMI ≥40);Cannot speak and read English sufficiently to complete the study procedures.Patients will be excluded if they meet the following criteria:A randomisation schedule will be created a priori by an independent investigator using SAS 9.3 through the SURVEYSELECT procedure. Consenting patients who are eligible for the trial will be allocated, in a 1:1 allocation ratio, to either receive the lifestyle behavioural intervention at that time (intervention group) or remain as part of the cohort and be told they will be offered clinical services in 6 months (control group). To randomise patients, a trained interviewer will open a sealed opaque envelope containing group allocation. A staff member not involved in the study will prepare the envelopes. Patient progress through the study is outlined in Fig. All outcome assessors will be blind to group allocation.Patients randomised to the intervention group will be provided brief advice and education about the benefits of weight loss and physical activity for their conditions by trained telephone interviewers. Participants will then be invited to attend a one hour consultation with the study physiotherapist at Hunter New England Population Health, NSW, Australia and referred to the NSW Get Healthy Information and Coaching Service (GHS) , 20.The consultation will involve a low back pain clinical assessment and detailed low back pain education based on principles recommended by clinical practice guidelines. The consultation will also apply behaviour change techniques to support a healthy lifestyle and weight management for low back pain. This intervention content was informed by Self Determination Theory (SDT) , 22. AccFollowing the consultation, patients randomised to the intervention group will be referred to the established GHS . The refn = 6) made within the first three months of the program [The GHS service involves 10 individually tailored coaching calls delivered over a 6 month period by a qualified health professional including dieticians, exercise physiologists and psychologists . The sup program . This sc program .All health coaches, regardless of multidisciplinary background, receive training to ensure they meet the requirements of the service and to promote consistency across the program. The service conducts audits of coaching quality as part of its quality improvement practices. To ensure the GHS health coaching is relevant for low back pain participants, health coaches will be provided additional training by a study investigator (CW) in evidence-based management for low back pain (2 h interactive training session) and provided with information resources to guide specific advice to be provided to study participants. The training session includes the topics of diagnosis, prognosis and evidence-based management strategies including the role of a healthy lifestyle and weight loss. The information provided is contained within international clinical practice guidelines for low back pain. Resources also detail guideline recommended advice about the nature of the condition, the diagnosis, prognosis and evidence-based treatments, as well as common misconceptions about back pain and its management.Participants randomised to the control group will continue on the usual care pathway and take part in data collection during the 6 month intervention period. Currently no active management of low back pain patients waiting for an outpatient orthopaedic consultation occurs. Control group patients will be informed that a face-to-face appointment to determine the need for further care will be available in 6 months.Participants will be followed for 6 months (26 weeks) and be asked to complete three self-reported questionnaires at baseline (pre-randomisation), week 6 and 26 weeks post randomisation to collect primary and secondary outcome data. All participants will be mailed a questionnaire one week prior to the 6 and 26 week time point and then asked to provide responses in one of two ways: via telephone or returned postal questionnaire. The baseline questionnaire will be completed via telephone only. Participants will also be asked to record the primary outcome ‘pain intensity’ at week 2, 10, 14, 18 and 22. Participants will be asked to provide these data via telephone or reply to text message, whichever their preference. During the 26 week telephone survey participants will be asked to attend a follow up clinic appointment (intervention group) or initial clinical appointment (control group) with a health professional.The following demographic items will be collected at baseline: age, Aboriginal and/or Torres Strait Islander status, employment status, country of origin, highest level of education, health insurance status and medical conditions. Length of time waiting for consultation (days) and triage classification will be obtained from hospital records.Pain intensity will be measured using a 0–10 NRS, as the average pain over the last week where zero indicates ‘no pain’ and ten indicates the ‘worst possible pain’ . Pain in2); waist circumference measured at 26 weeks post randomisation taken at the level of the narrowest point between the inferior rib border and the iliac crest by trained assessors using a flexible tape measure to the nearest 0.1 cm [The secondary outcomes include: low back pain disability, using the Roland Morris Disability Questionnaire (RMDQ) ; self-ret 0.1 cm ; qualityt 0.1 cm ; global t 0.1 cm ; psycholt 0.1 cm ; sleep qt 0.1 cm ; health t 0.1 cm , dietaryt 0.1 cm , alcoholt 0.1 cm  and selft 0.1 cm ; health t 0.1 cm ; and attt 0.1 cm  and the t 0.1 cm . See TabThe delivery of the intervention will be assessed using attendance records for the physiotherapy consultation and data regarding delivery of the GHS intervention including, commencement and number, length, timing of coaching calls and achievement of identified goals which will be provided by the GHS. Patient reported receipt of care  will be collected at all secondary collection time points. Participants will be monitored for adverse events throughout the intervention period. All adverse events will be recorded and serious adverse events will be assessed and managed on a case-by-case basis according to Good Clinical Practice (GCP) guidelines . Trial dSample size was calculated using Stata sample size calculator. Using a standard deviation of 2.3, a two-sided alpha of 0.025 (to account for multiple outcomes of interest – pain and weight)  and alloBetween group differences in pain intensity will be assessed using linear mixed models, with random intercepts for individuals to account for correlation of repeated measures. We will obtain estimates of the effect of the intervention and 95 % confidence intervals by constructing linear contrasts to compare the adjusted mean change in outcome from baseline to each time point between the treatment and control groups. Dummy coded variables representing group allocation will be used to ensure blinding of the analyses. Missing data will be assessed for randomness if this is more than 10 %.Linear mixed models will be used to assess treatment effects on secondary outcomes as per the primary outcome. We will compare the adjusted mean change (continuous variables) or difference in proportions (dichotomous variables) in outcome from baseline to each time point between the treatment and control groups.An economic evaluation will also be undertaken. We will develop costing models from the perspective of the health service and broader societal perspective. These models will utilize data regarding patient quality of life (SF12v2), health care and community services use, work absenteeism. We will calculate costs based on published normative data and estimated out of pocket costs reported by participants. We will also investigate the mechanisms underlying the intervention using causal mediation analysis and include the following measures at baseline, 6 weeks and 6 months: pain attitudes (SOPA), fear avoidance beliefs (FABQ) and symptoms of psychological distress (DASS 21), weight loss (kg), health behaviours , diet, alcohol, smoking, sleep quality).This is the first RCT designed to evaluate the effectiveness of a lifestyle behavioural intervention for low back pain patients who are overweight or obese. The results will inform care pathways by providing robust evidence about the effectiveness of such management for overweight patients with low back pain.


Postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy (LC) has multifactorial etiology. Pain and use of opioids are among the important factors.The present study aimed to evaluate the efficacy of intrapritoneal (IP) injection of bupivacaine on PONV.This was a double-blind randomized clinical trial, conducted on 66 patients aged 20-60, ASA I or II, candidates for LC. Patients were randomly assigned to two groups. Bupivacaine group received 20 mL bupivacaine 0.25% in the gallbladder bed, before and after cholecystectomy and the control group did not. The incidence of nausea and postoperative pain intensity was measured with Visual analogue scale (VAS) at 1, 2, 3 and 4 hours after operation, at rest and when coughing and changing positions. Nausea and vomiting occurrence were assessed at the same times.There were no demographic data differences between groups. No differences were found between the two groups, in terms of incidence of nausea and vomiting. Furthermore, both groups were similar with respect to opioid consumption, during four hours post-operation.Intraperitoneal bupivacaine administration at the beginning and end of laparoscopic cholecystectomy reduced only visceral and shoulder pains at the 4th postoperative hour, but had no effect on reducing neither PONV, nor opioid demand, during the first four postoperative hours. Laparoscopic cholecystectomy (LC) is an established, universally accepted procedure for cholelithiasis treatment, to decrease patient discomfort. This procedure is well tolerated by patients, however, an increased incidence of postoperative nausea and vomiting (PONV) predisposes patients to psychological distress increase and delayed recovery and discharge times , 2. AlthPain following LC can be divided into three major groups:Parietal pain caused by surgical incision;Visceral pain originating from gallbladder bed and caused by visceral manipulation during the operation and finallyShoulder pain secondary to distension of diaphragm by neuropraxia of phrenic nerve , 5.Due to the different pathophysiological mechanisms of these pain components, different local anesthetic interventions have been developed to reduce postoperative pain, like peritoneal infiltration, instillation into the peritoneal cavity or subdiaphragmatic area, intraperitoneal spraying above the gallbladder and combined peritoneal-peritrocal ropivacaine -12. HoweThe present study aims to evaluate the efficacy of intraperitoneal local anesthetic bupivacaine on PONV, after managing the visceral and shoulder pains. To avoid any confusion in different components of pain, we decided to eliminate parietal pain by injection bupivacaine into the abdominal wall, in both groups. So that we could fully concentrate on visceral and shoulder pain and to see if IP bupivacaine injection could affect the opioid demand by influencing visceral and shoulder pain.Intra-abdominal dull pain that cannot exactly be located is considered as visceral pain, while the sharp pain felt in the abdominal wall is deemed as the parietal pain.2), history of opioids abuse, antiemetic and steroids administrations within 24 hours prior to the surgery, history of motion sickness or PONV and patients with migraine whose surgery changed to open cholecystectomy. Patients were randomly assigned to two groups using a computer based randomization method. All patients received the same anesthetic agent and protocol. General anesthesia was induced by 0.2 µg/kg sufentanil, followed by 3-5 mg/kg thiopental and 0.6 mg/kg atracurium to facilitate tracheal intubation. Anesthesia was maintained with propofol infusion (200 µg/kg/minute) and injection of 0.1 µg/kg sufentanil, every 15 minutes.This was a double-blind, randomized clinical trial conducted on 66 patients of both sexes (aged 20 to 60 years), September 2010 to April 2011. All patients were registered for LC operation, according to the American Society of Anesthesiologists physical status I and II. All studies were performed in accordance with the ethical guidelines, set by the ethical committee of Faculty of Medical Sciences, Kermanshah University of Medical Sciences (Iran). The study was registered in Iranian Registry of Clinical Trials (IRCT13880112946N1). All patients were well informed of the study and all signed a written consent. The exclusion criteria were obesity  did not get such injections.Patients in bupivacaine group received 20 mL of bupivacaine in the gallbladder bed, after abdominal CO2 was carefully evacuated at the end of the operation by manual compression of the abdomen with open trocars. For elimination of the parietal pain and concentration on the visceral and shoulder pains, both groups received local administration of 5 mL bupivacaine 0.25% at incision of each trocar and different layers of abdomen. For reversal of muscle relaxation, 40 µg/kg neostigmine and 20 µg/kg atropine were administered and patients were transferred to the post anesthesia care unit (PACU) after tracheal extubation.During operation, patients were placed in the reverse Trendelenburg position. Pneumoperitoneum was created with a closed Veress needle technique and LC was performed using four trocars, placed in the standard position. The gallbladder was retracted via a supraumbilical trocar port. During laparoscopy, intra-abdominal pressure was maintained at 12 mmHg. COThe incidence and severity of nausea and postoperative pain intensity at rest, when coughing and changing positions from supine to sitting were measured, using the visual analog scale (VAS) at one, two, three and four hours after the operation. The incidence of vomiting was evaluated by a “yes” or “no” question at the same time. At the first, second, third and fourth hours after surgery, when examining the intensity of pain and nausea, the patients were asked if they had vomiting. If the answer was positive, the frequency was recorded. All assessments were recorded by trained nurses who were blinded to the study and group assignments.Patients could request for rescue analgesia and antiemetic at any time after operation. Fifty milligram tramadol and 10 mg metoclopramide was intravenously administered as a rescue analgesic and antiemetic, respectively (rescue antiemetic treatment in VAS > 3).The statistical analysis was performed using SPSS package . For statistical analysis of the demographic data and for comparison of the two groups, Chi square, Mann-Whitney U-test and the student t-test analyses were performed.A total of 73 patients were assessed for eligibility, of which 66 patients were enrolled into the study. There were no differences among the groups with respect to patients' characteristics and operative data. Bupivacaine and control groups did not differ significantly in mean age  and intraoperative opioid usage . Female patients comprised 97.1% of the bupivacaine group and 85.5% of the control group, indicating no significant difference in this regard (P = 0.166).The means values for the pain VAS during resting, coughing and changing positions for four hours following operation are presented in The highest pain levels were experienced during the first postoperative hour and these levels were gradually diminished with time. No significant difference was found between the two groups in terms of incidence of nausea  and vomiThere was no significant difference in parietal pain between the two groups. Visceral and shoulder pains showed significant differences between the control and bupivacaine groups only in 4th post-operative hours. Although the viseral and shoulder pain intensity at the other time was lower in Bupivacaine group. That was not statistically significant .Variables related to analgesic consumption in the bupivacaine and control group is shown in This randomized, double-blind, placebo-controlled trial aimed to investigate the effects of IP administration of bupivacaine on visceral and shoulder pain, as well as its effects on PONV after LC.2 insufflation and also after resection of gallbladder did not reduce the patient’s demand for extra opioids and had no effect on PONV.Our results showed that IP administration of 20 mL bupivacaine 0.25% in the gallbladder bed after abdominal CO2, resulting in stretching of the peritoneum, residual pneumoperitoneum after CO2 insufflation, peritoneum distension, diaphragm irritation and visceral organ irritation and manipulation have been reported to influence the severity of pain and PONV (The origin of pain and PONV, following LC is not entirely cleared, but it is probably multifactorial. Insufflation of COand PONV , 13.Although, in several studies using local anesthetics in peritoneal cavity reduced postoperative pain and PONV, the use of different pain control techniques, including the application of intraperitoneal and/or peritrocar local anesthetics has still remained controversial , 12, 14.Visceral and shoulder pain were significantly different at the 4th post-operative hour between the two groups. Some studies have shown that parietal pain can be blocked by infiltration of local anesthetic agents at incisions and visceral and shoulder pains by IP administration of local anesthetics -9. A metFindings of this study demonstrated that 20 mL intraperitoneal bupivacaine 0.25% administration at the beginning and also at the end of the laparoscopic cholecystectomy process, reduced only visceral and shoulder pains at the 4th postoperative hour, but had no effect on reducing neither PONV, nor opioid requirement, during the first four postoperative hours. However, further studies are needed on larger populations with different doses and concentrations of bupivacaine and also combination of bupivacaine and other analgesic drugs, to gain the maximum benefits of intraperitoneal analgesic in postoperative pain treatment.


Background. The differential diagnoses of acute appendicitis obstetrics, and gynecological conditions (OB-GYNc) or nonspecific abdominal pain in young adult females with lower abdominal pain are clinically challenging. The present study aimed to validate the recently developed clinical score for the diagnosis of acute lower abdominal pain in female of reproductive age. Method. Medical records of reproductive age women (15–50 years) who were admitted for acute lower abdominal pain were collected. Validation data were obtained from patients admitted during a different period from the development data. Result. There were 302 patients in the validation cohort. For appendicitis, the score had a sensitivity of 91.9%, a specificity of 79.0%, and a positive likelihood ratio of 4.39. The sensitivity, specificity, and positive likelihood ratio in diagnosis of OB-GYNc were 73.0%, 91.6%, and 8.73, respectively. The areas under the receiver operating curves (ROC), the positive likelihood ratios, for appendicitis and OB-GYNc in the validation data were not significantly different from the development data, implying similar performances. Conclusion. The clinical score developed for the diagnosis of acute lower abdominal pain in female of reproductive age may be applied to guide differential diagnoses in these patients. Abdominal pain is one of the most common chief complaints of emergency department patients. It was the main symptom of 12.1% to 20.4% of noninjury visits to emergency departments of USA, and 16.8% to 17.8% of them were in severe conditions .CT scan improved accuracy in diagnosing appendicitis and can detect other causes of abdominal pain in female patients . The useAlthough ultrasound is not as accurate as CT scan, it also showed benefit in diagnosing acute lower abdominal pain , 8, espeClinical prediction rules, through which clinical findings were systematically applied to predict difficult clinical conditions , may be μL), predominate neutrophil ≥75% in complete blood count, and a constant. The assigned scores and algorithm for diagnostic prediction were shown , tenderness at right lower quadrant of abdomen, tenderness at left lower quadrant of abdomen, leukocytosis  acute appendicitis (ICD10 code K-35); (2) obstetrics and gynecological conditions (OB-GYNc), including ectopic pregnancy (ICD10 code O-00), pelvic inflammatory disease (ICD10 code N70), and complicated ovarian cyst (ICD10 code N83); and (3) nonspecific abdominal pain (NSAP) . Study variables were age, marital status, duration of pain, presence of shifting of pain, nausea and vomiting, pregnancy, abnormal vaginal bleeding, presence of fever, systolic blood pressure, site of abdominal pain, presence of guarding or rebound tenderness from abdominal examination, result of complete blood count, and urine pregnancy test. Item scores were calculated and diagnostic prediction was performed for each patient. Final professional diagnoses in the medical records were considered as the reference standard for testing of the score accuracy.Patients' characteristics of the development data and the validation data were summarized. Score predicted diagnosis of each patient was compared with final professional diagnosis. Diagnostic indices were calculated in the validation data. The abilities to discriminate appendicitis and OB-GYNc, in terms of areas under the receiver operating curves of the two data sets, were compared with the test for equality of two ROC curves. The positive likelihood ratios for the diagnosis of appendicitis and OB-GYNc of the development data and the validation data were tested with chi-squared for homogeneity test. The probability curves of appendicitis score and OB-GYN score were estimated from logistic regression postestimation function on actual rates of appendicitis and OB-GYNc in the development data and validation data.The study was approved by the Ethical Committee of Nakornping Hospital and the Ethical Committee of the Faculty of Medicine, Chiang Mai University.The patients' characteristics of the derivation data and the validation data were similar . AppendiWhen comparing the score-predicted diagnoses and the final professional diagnoses in patients from the validation data, the score correctly diagnosed 24 of 33 NSAP patients (72.7%), 181 of 203 appendicitis patients (89.2%), and 46 of 66 OB-GYNc patients (69.7%). The overall accuracy of the score was 83.1% (251/302) . The scoP = 0.068). The positive likelihood ratios for diagnosis of appendicitis in the validation data and the development data were 4.39 and 2.97, respectively (P = 0.100). The areas under ROC curves for the discrimination of OB-GYNc and “non-OB-GYNc” were not different in the validation data and the development data . The ROC areas of the development data reported in this study were different from those reported in our previous study because in previous study we reported the ROC areas of individual scores (appendicitis score for appendicitis and OB-GYN score for OB-GYNc), not as the whole algorithm like in this study. Similarly, the positive likelihood ratios for diagnosis of OB-GYNc were not significantly different in the validation data and the development data  (When using the criteria in = 0.244) . The est= 0.244) .The present study was the second part of the previous study in clinical prediction rule for the diagnosis of acute lower abdominal pain in females of reproductive age . In geneClinical scoring for the diagnosis of abdominal pain has been extensively studied for appendicitis –22. TherThis study has several limitations. The obvious one is retrospective design of the study. Clinical signs and symptoms that were not documented either could be absent of such clinical findings or were not evaluated. The different observers may have different interpretations of physical examination, and clinical signs that change over time may not be well recorded.Using of final professional diagnoses as the reference standard is another limitation. The problem of different follow-up times and different clinical judgments amongst doctors also leads to misclassification. These limitations can be reduced if a prospective validation study of the diagnostic scoring system is performed, with interobserver agreement of measurements, including standardized criteria for diagnostic indicators, objective criteria for final diagnosis of each condition, and standardized follow-up time.The result of this study should be used with caution. Patients in our setting were mainly referred from smaller hospitals in Chiang Mai. Most of them needed to be admitted to either general surgery department or obstetrics and gynecology department. Different patients' characteristics and different patient flows in other settings would affect the accuracy of the scoring system. For example, myoma uteri complications such as necrosis or torsion were rare in our settings. In other hospitals where myoma uteri complications are major causes of acute lower abdominal pain, this diagnostic score may not be suitable for such settings. Applying this scoring system to different settings, different patterns of patients flow, could probably lead to misdiagnoses in some conditions. External validation in different settings should be performed prior to adoption into clinical practice in other settings. Further impact studies of the score to assess its impacts on multidimensions of clinical practice, such as time spent in emergency department, additional diagnostic value on top of unaided junior physicians' judgments, and time and cost of diagnosis, should be conducted in the future.The clinical diagnostic score can triage appendicitis, OB-GYNc, and NSAP in female patients with acute lower abdominal pain. The diagnostic score can guide emergency department physicians for proper admissions and selective managements.


Unknown etiology and pathophysiology of prostate pain syndrome (PPS) has led to a lack of proper and competent treatment in modern medicine. According to the guidelines of European Association of Urology (EAU), use of complementary treatments is recommended for PPS. In this preliminary study, analyzing the signs and symptoms of PPS from the viewpoint of Iranian traditional medicine (ITM) was helpful in selecting the appropriate alternative treatment.Two male patients diagnosed with PPS were evaluated and treated according to the ITM. Each patient took 15 mL oxymel 45 minutes after lunch and dinner. For each patient, four clinical visits were made with one week intervals and the validated Farsi version of international prostate symptom score (IPSS) and numeric pain rating score (NPRS) were completed for them.Considering the fact that other major pathological causes are ruled out, many of the symptoms and signs observed in these patients were similar to those associated with flatulency-related diseases in ITM. Selecting treatment with oxymel was based on this view and led to improvements in the digestive and urinary symptoms according to Farsi version of the IPSS and NPRS. According to the European Association of Urology (EAU) guidelines on chronic pelvic pain, prostate pain syndrome (PPS) is defined as “persistent or recurrent episodic prostate pain associated with symptoms suggestive of urinary tract and/or sexual dysfunction with no proven infection or other obvious pathology" . In spitTwo male patients inhabited Tehran, Iran, were referred by their urologist from the Urology Clinic of Sina Hospital, Tehran University of Medical Sciences, to Iranian Traditional Medicine Clinic for further evaluation based on Avicenna’s viewpoint. A summary of their characteristics is presented in The main complaint of patient 1 was periodic and sharp pain in the perineal and suprapubic regions. Symptoms were aggravated after drinking cold water and flatulent foodstuffs. He also complained of increased urinary frequency and dysuria following urination. He experienced hesitation at initiation of urination with slow stream and straining. In recent years, his level of physical activity decreased and became mostly sedentary after the patient changed his job to become a tailor, which had further aggravated his symptoms. A sonography of the scrotum had normal findings. Prescribed medications for chronic prostatitis included long-term cycles of antibiotics, despite no evidence of bacterial infection in urine cultures or prostatic secretions, an alpha-blocker, and an analgesic. He experienced no relief with any of these oral medications. The patient reported cholecystectomy because of gallbladder stone about four years ago. He complained of bloating and distention, heartburn pain, and discomfort in epigastrium and used omeprazole for his duodenal ulcers.Patient 2 was referred with chief complaints of postmicturition pain in the tip of the penis and testis with dysuria. He described a feeling of chest tightness and nausea as well as urinary retention. He had a history of an episode of urinary tract infection in the preceding years without any recurrence. He reported increased urinary frequency and a burning sensation in his urethra that had caused a hesitation to initiate. Sonography of the scrotum, kidney, and bladder revealed normal structures and a moderate postvoid residual volume. He was a driver and was in sitting position during most of his day at work. Similar to patient 1, this patient had repeated long-duration series of antibiotics, alpha-blocker, and analgesic despite no bacterial infection of prostate secretions or urine on the laboratory reports. He also reported heartburn, bloating and distention with feeling of fullness in throat, and gastroesophageal reflux. Other complaints included a feeling of incomplete bowel movements and pain in the anus and rectum.Physical examination of the abdomen, genitourinary tract, and a digital rectal examination (DRE) to assess rectal soft tissue were performed for both patients. There were no clinically significant findings except moderate suprapubic tenderness and some tender points in the groins, proximal thighs, and perinea. No tumoral lesion or glomerulation was observed in the cystoscopy of the patients. Bladder biopsy and hydrodistention were also performed. Bladder biopsy and urine cytology results were negative for malignancy. Moderate prostate enlargements in the sonography could not explain the observed clinical symptoms in patients.th day of treatment score (post-treatment score) in The validated Farsi version of the international prostate symptom score (IPSS)  and numeThe differential diagnosis of bladder pain and urinary symptoms have been discussed in details in Avicenna's Canon of Medicine Book III, Part 19, in two sections :In section 1, Bladder-related diseases, pain is acknowledged as the most common symptoms of bladder disease. Differential diagnosis of bladder pain have been discussed in details in this section. Bladder paresis, weakness, and hematoma are also discussed in this section. In section 2, Urination-related diseases, Avicenna classifies urinary symptoms and differentiates storage symptom from voiding symptom; in addition, he offers definitions and accounts of the causes and different diagnostic methods for dysuria, incontinence, difficult urination, polyuria, intermittency, oliguria, anuria, enuresis, diabetes, and hematuria.Common causes of lower urinary tract symptoms based on Avicenna's system of concepts are:bladder calculus;bladder/urethra ulcers and pustules;inflammation, inflation, tumor, and mass;obstructive and anatomic causes ;neurologic causes (sensory and motor dysfunction of bladder or sphincter);trauma ;causes related to involved organs  through digestive system;urine causes; andwind or gas ("Reeh" in Arabic).Nowadays almost all of the aforementioned causes of lower urinary tract symptom are detected through clinical and paraclinical procedures with high sensitivity and accuracy except for the last mentioned cause. Based on Avicenna's system, these symptoms are caused by flatulency in pelvic organs. In the context of traditional medicine, "Reeh" is a current flow with blasting force in the body that acts like the “wind” in the nature and plays a crucial role in the pelvic organs ducts to facilitate execratory functions such as urination, defecation, and erection-ejaculation in physiologic conditions. Therefore, we can consider it as an equivalent to the peristaltic waves in excretory organs such as bowel, ureter, and the bladder. Any disturbance in the production process of "Reeh", either in its quantity or quality, leads to not only failure of these physiologic functions but also flatulence and spasms that produce pains with specific characteristics. This pain is reported to be distending, stabbing, or onerous in quality. It is a nonlocalized shifting pain with a sudden and sever onset that can last short at certain times, especially in good digestive conditions. This specific clinical symptomatic diagnosis distinguishes traditional medicine diagnostic approach from modern approaches. Therefore, chronic pelvic pain and lower urinary tract symptoms that have unknown etiology and pathophysiology can be considered in this group. Due to the identical physiologic performance of "Reeh" in the excretory organs such as the gastrointestinal and urogenital tracts, it is reasonable to associate PPS with multiple organs in these patients in the absence of reliable pathologic evidences. Evaluation of the two patients with final diagnosis of PPS in the framework of traditional medicine reveal that poor gastrointestinal digestive function disturbs production of a potent" Reeh" and finally, results in the impairment of the excretory function of related organs and lead to flatulency. Avicenna emphasizes that pains in the bladder and kidney that are due to this cause can be reduced by fasting and proper digestion . Followi