Failed back surgery syndrome is defined as persistent chronic low-back pain and/or leg pain lasting more than 1 year, despite of one or more surgical procedures. Instrumented spinal fusion has been offered by surgeons as a potential treatment to recover from pain and functional disability. Factors contributing to good outcome of instrumented spinal fusion have not been investigated extensively. This study evaluated the global perceived recovery and functional status of patients after instrumented fusion for the treatment of failed back surgery syndrome.Between January 2004 and September 2007, 100 patients underwent instrumented spinal fusion because of persistent back and/or leg pain lasting more than 1 year despite of one or more previous spine surgeries. The global perceived recovery of the patients was documented on a seven-point Likert scale, in which good outcome was defined as “complete recovery” and “almost complete recovery”. Pain was evaluated by the 100-mm visual analogue scale (VAS) of back pain and leg pain, and functional disability measured by the Roland Disability Questionnaire for Sciatica (RDQ) and Oswestry Disability Index (ODI). The Hospital Anxiety and Depression Scale (HADS) evaluated psychological co-morbidity. All patients were sent questionnaires by mail. Pearson’s correlation coefficient was calculated between outcome measures and preoperative patient characteristics.Eighty-two patients (82% response rate) returned questionnaires that were useful for analysis. After a mean follow-up period of 15 months, 35% of the patients reported good outcome, whereas 65% had unsatisfactory outcome. The mean (± SD) score of VAS low-back pain and leg pain was 45.7 ± 29 and 37.9 ± 31.9, respectively. The mean (± SD) RDQ and ODI score was 11.8 ± 5.4 and 30.6 ± 20.3, respectively. HADS score indicated a possible anxiety disorder in 28% of the patients and in 30% a possible underlying depression. Of the patients’ baseline characteristics, there was only a significantly negative correlation between level of education and outcome.The present study showed disappointing outcome of instrumented fusion for the treatment of failed back surgery syndrome in terms of perceived recovery, functional disability and pain. Conservative management is probably more beneficial and, therefore, more selective and careful assessment should be done in order to prevent unnecessary surgery. Failed back surgery syndrome (FBSS), also known as post-laminectomy syndrome, is defined as persistent low-back pain and/or leg pain lasting more than 1 year despite one or more surgical procedures. Nearly 20% of the patients undergoing spine surgery will require secondary surgery for persistent pain or surgery related complications during the subsequent years . SuccessThe “gold standard” in the treatment of FBSS is conservative management by pain control and cognitive behavioural therapy, although some FBSS patients may benefit from instrumented spinal fusion ,5,7,15. Previous studies regarding clinical outcome of instrumented spinal fusion in patients with FBSS, have not focused on possible associations between outcome and predefined influencing factors . In the The study was performed as a retrospective case series. All patients who had undergone instrumented spinal fusion between January 2004 and September 2007 were selected from the hospital electronic patient system (487 patients). Inclusion criteria were instrumented lumbosacral spinal fusion, one or more previous lumbosacral spine surgeries, and chronic low-back pain with or without leg pain, lasting more than 1 year after the index surgery  and bad recovery (“little recovery” to “worse than ever”). Secondary outcome measures were the postoperative scores of the visual analogue scale (VAS) of low-back pain (0-100 mm) and VAS leg pain (0-100 mm). Functional assessment was documented by the illness-specific Roland Disability Questionnaire for Sciatica (RDQ)  and Oswestry Disability Index (ODI) (0–100 with higher index indicating worse disability). Assessment of anxiety or depression was documented by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of a seven-item depression scale and a seven-item anxiety scale. The score ranges from 0–21 with a high score being indicative for depression/anxiety. The outcomes were assessed by a written questionnaire sent by mail.p = 0.05.All statistical analyses were performed by SPSS version 17.0 for Windows. Per included patient, the RDQ, ODI, HADS-anxiety and HADS-depression scores were calculated. Pearson’s correlation coefficients were calculated to analyse the association between the different outcome measures and preoperative patient characteristics . All statistical analyses had a statistical threshold of R = −0.228; p < 0.05). Other correlations between perceived recovery and preoperative characteristics could not be foundOf the 100 questionnaires sent by mail, two respondents had only filled in remarks on the questionnaire and 16 patients were lost to follow-up despite several attempts of telephone and mail contact. These 18 patients were excluded from analysis. The mean follow-up was 14.7 months . Of the responding 82 patients, 35% documented good recovery and 65% perceived no difference or worsening. The mean (± SD) score of VAS back pain and leg pain was 45.7 ± 29.6 and 37.9 ± 31.9, respectively. Functional disability measured by RDQ and ODI was 11.8 ± 5.4 and 30.6 ± 20.3, respectively. Assessment of the HADS documented that 28% had symptoms befitting an underlying anxiety disorder, and 30% showed symptoms related to an underlying depression (HADS scores ≥ 8)  need to be evaluated. Preferably, these approaches should be discussed by an interdisciplinary management team .Evidence-based guidelines on various treatment regimes of patients with FBSS are lacking since high-quality randomised controlled trials on this topic are scarce. Brox et al.  comparedRegarding demographic data and outcome in patients with FBSS, it is shown that female gender, higher age, obesity, number of spine surgeries, multiple fused spinal levels, smoking status and high usage of analgesics negatively influence experienced recovery ,12,14–16The present results have several limitations. Firstly, the study is conducted as a single-centre retrospective cohort with limited follow-up moments. Secondly, there is no available data on co-morbidity like osteoporosis, arthritis or polyneuropathy that may have influenced the outcome. Moreover, there is no routine radiographic examination focusing on fusion status, although the relationship between fusion and outcome is debatable . FinallyThe present study shows disappointing results in patients with FBSS treated with instrumented spinal fusion. Surgical candidates should be assessed and selected more carefully in order to prevent unnecessary surgery. Therefore, conservative pain management, behavioural therapy, and SCS is probably more beneficial in the majority of patients with FBSS.


Pain is strongly related to poor quality of life. We performed a cross-sectional study in a universitary hospital to investigate quality of life in women suffering from chronic pelvic pain (CPP) due to endometriosis and others conditions.Fifty-seven patients aged between 25 and 48 years-old submitted to laparoscopy because of CPP were evaluated for quality of life and depressive symptoms. Quality of life was accessed by a quality of life instrument [World Health Organization Quality of Life Assessment-Bref (WHOQOL-bref)]. Causes of pelvic pain were determined and severity of CPP was measured with a visual analogue scale. According to the intensity of pelvic pain score, patients were classified in two groups . Four dimensions on quality of life were measured . We stratified the analysis of quality of life according CPP causes (presence or not of endometriosis in laparoscopy).Patients with higher pain scores presented lower quality of life status in psychological and environmental dimensions. We found a negative correlation between pain scores and psychological dimension of quality of life . Quality of life scores were similar between groups with and without endometriosis Higher pain scores are correlated to lower quality of life; however the fact of having endometriosis in addition to CPP does not have an additional impact upon the quality of life. Chronic pelvic pain (CPP) can be defined as a nonmalignant pain perceived in structures related to the pelvis; constant or recurring over a period of 6 months. In some cases it might be associated with negative cognitive, behavioral and social consequences . The preEndometriosis is a benign disease that mainly affects females during reproductive years and it is strongly associated with pelvic pain, being the most common gynaecological cause of CPP . The strper se adds a negative effect in patients' quality of life.Patients with CPP suffer from different pain intensities, and an important point is if patients with more intense pain have greater alteration in quality of life ,13. OtheWe performed a cross-sectional study between April 2006 and December 2008.We included 66 consecutive patients complaining of pelvic pain aged between 25 and 48 years-old in the study. We defined pelvic pain as dysmenorrhoea and/or intermenstrual pelvic pain and/or dyspareunia of moderate to severe intensity lasting for more than 6 months . We exclOne month before laparoscopy, we collected baseline information , and patients answered an inventory about pelvic pain intensity. We interviewed all patients in order to evaluate: cognitive impairment, quality of life, anxiety symptoms, and depressive symptoms. After this initial evaluation, all patients were submitted to laparoscopy for pelvic pain investigation by the same investigator (JSLC). None of the patients had used oral contraceptives, progestagens, antinflamatory, antidepressives or psychotropic formulations in the three months that preceded the laparoscopy or Gonadotropin Releasing Hormone (GnRH) analogues in the last six months. Non-gynecologic causes of pelvic pain were excluded in all patients using history, physical examination and laboratory exams when appropriate.cognitive impairment was done using the Mini Mental State Examination (MMSE) [The Hamilton Anxiety Rating Scale (HARS)[The Visual Analogue Scale (VAS) was used to measure the mean pain intensity over the last three days (average for rest and activity). The 10-cm scale was marked with ''0'' (no pain) and ''10'' (worst possible pain), and the patients were instructed on how to use the scale . Since Cn (MMSE) ,17. Qualn (MMSE) . It is an (MMSE) . Anxietyle (HARS). The Brale (HARS). Finallyle (HARS). The samth VAS percentile) and Low CPP (< 25th VAS percentile). We compared epidemiological, anxiety symptoms, depressive symptoms and quality of life  between the groups. We also calculated the correlation between pelvic pain intensity and quality of life in the four dimensions. After this initial analysis, we classified patients according to the cause of pelvic pain. Patients were designated in two groups: endometriosis group and others' causes of pelvic pain group. The diagnosis of endometriosis was done using precise and standardized macroscopic criteria to make the visual diagnosis [According to pain score (VAS) we classified patients in two groups: High CPP  the sample size (n = 57), (ii) prevalence of endometriosis of 30% [All statistics data were collected in a computerized database. Statistical analysis was performed using Statistical Package for the Social Sciences (SPSS) 13.0. The parametric data were presented as mean and mean standard deviation. Student's t test was carried out when appropriate. Pearson correlation was determined between pain scores and quality of life. s of 30% , (iii) es of 30% , (iv) tyAt the time of inclusion women were aged 35.8 ± 8.6 years and they showed average pain scores of 5.9 ± 2.9 on a 10 point scale.th percentile) and 12 patients, with the Low CPP group (under the 25th percentile). Age, duration of formal education, parity, number of vaginal deliveries and cesarean section remained similar irrespective of CPP groups (High and Low CPP). Unexpectedly, patients with High CPP demonstrated a lower number of abortions Forty five patients presented pain scores consistent with the High CPP group  and environmental  domains. Scores in the psychological dimension and VAS were negatively correlated . However, we failed to demonstrate any correlation of other quality life domains and VAS . The others variables measured-MMSE and BDI scores-were similar between the two groups.We observed a statiscally significant reduction in quality life scores in patients classified in the High CPP group in the psychological , 32 patients; and others' causes of pelvic pain group (control group), 25 patients. All endometriosis were classified as minimal and mild endometriosis. These two groups were similar according epidemiological characteristics . Further, the MMSE, the BDI and the HARS scores were not affected by the cause of CPP. Moreover, scores from the VAS were similar between patients with endometriosis (6.7 ± 1.6) and those with others causes of CPP (7.5 ± 1.6) . Physical, psychological, social and environmental parameters of quality of life scale (WHOQOL-BREF) were similar between the groups.In this study, we demonstrated that the intensity of pelvic pain is inversely correlated with alteration in the quality of life of patients with CPP . Furthermore, we showed that the presence of endometriosis as a cause of CPP is not an independent factor for modifying quality of life in patients with CPP.Our study has some limitations: (i) all patients presented minimal/mild endometriosis according to ASRM criteria. Probably it was a selection bias because our service is a referral centre of infertility treatment and patients with more severe CPP or pelvic masses might have been directed to other services. Although endometriosis is an enigmatic disease and endometriosis classifications have poor correlation with clinical symptoms ,26, patiAuthors showed that patients with chronic pelvic pain present some degree of hyperalgesia and some impairment of quality of life parameters  measured by SF-36 instrument . Furtherper se. Infertility is another important characteristic of endometriotic patients. Although the number of pregnancies between the groups (endometriosis and without endometriosis) seems to be similar between the groups with, we can consider the possibility that infertility associated to endometriosis can also modify patients' quality of life. Authors have already demonstrated the diagnosis delay in endometriosis patients that suffer only from pain is almost twice the period of diagnosis for patients with infertility [As a distinctiveness of our paper, we investigated the effect of endometriosis itself in quality of life of patients that presented with CPP. Pain is one of the major concerns of patients with endometriosis and its effect upon quality of life has been already shown  and we dertility .In accordance to our findings, a plethora of publications have shown that patients with chronic pelvic pain have a decreased quality of life and, consequently, reduced social adjustment with an increase in psychiatric morbidity ,28, and In conclusion, we showed that the cause of pelvic pain does not influence the quality of life status or anxiety-depression symptoms. Further, we demonstrated that pain intensity is correlated to a decrease in quality of life in psychological domain; and that patients with higher pelvic pain scores have lower quality of life in psychological and environmental dimensions. With this study we can speculate that management of pelvic pain of CPP patients, independent of the causal factor, is the best approach to improve quality of life of these patients.(ASRM): American Society for Reproductive Medicine; (BDI): Beck Depression Inventory; (CPP): Chronic Pelvic Pain; (DIE): Deep Infiltrating Endometriosis; (GnRH): Gonadotropin Releasing Hormone; (IRB): Institutional Review Board; (MMSE): Mini Mental State Examination; (SPSS): Statistical Package for the Social Sciences; (HARS): The Hamilton Anxiety Rating Scale; (VAS): Visual Analogue Score; (WHOQOL-bref): World Health Organization Quality of Life Assessment-Bref.The authors declare that they have no competing interests.CAS, LMO, JSL conceived and designed the study. CAS and MC analysed and interpreted the data. JSL supervised and reviewed all the statistical analysis. VR, VG, CS, MC contributed to data collection and performed surgical procedures. All the authors contributed to write the manuscript. All the authors approved the final version of the manuscript.


A quality-improvement project was conducted to reduce severe pain and stress-related events while moving ICU-patients.The Plan-Do-Check-Adjust cycle was studied during four one-month phases, separated by five-month interphases. All consecutive patients staying more than 24 hours were evaluated every morning while being moved for nursing care . Phase 1 was considered as the baseline. Implemented and adjusted quality-interventions were assessed at phases 2 and 3, respectively. An independent post-intervention control-audit was performed at Phase 4. Primary-endpoints were the incidence of severe pain defined by a behavioral pain scale > 5 or a 0 to 10 visual numeric rating scale > 6, and the incidence of serious adverse events (SAE): cardiac arrest, arrhythmias, tachycardia, bradycardia, hypertension, hypotension, desaturation, bradypnea or ventilatory distress. Pain, SAE, patients' characteristics and analgesia were compared among the phases by a multivariate mixed-effects model for repeated-measurements, adjusted on severity index, age, admission type , intubation and sedation status.P = 0.04) and 2% in Phase 4 , P = 0.02). Incidence of SAE decreased significantly from 37% (baseline) to 17% in Phase 3 and 21% in Phase 4. In multivariate analysis, SAE were independently associated with Phase 3 , P < 0.01), Phase 4 , P = 0.03), intubation status , P < 0.01) and severe pain , P < 0.001).During the four studied phases, 630 care procedures were analyzed in 53, 47, 43 and 50 patients, respectively. Incidence of severe pain decreased significantly from 16% (baseline) to 6% in Phase 3 (odds ratio (OR) = 0.33 , Severe pain and serious adverse events are common and strongly associated while moving ICU patients for nursing procedures. Quality improvement of pain management is associated with a decrease of serious adverse events. Careful documentation of pain management during mobilization for nursing procedures could be implemented as a health quality indicator in the ICU. Pain is a frequent event in intensive care unit (ICU) patients, with an incidence of moderate to severe pain during the ICU stay of up to 50% in medical as well as surgical patients -3. Pain One of the most common painful procedures in ICU patients is moving and turning for nursing care procedures  ,13. PainThe present study was conducted to test the hypothesis that the implementation of a quality improvement process for pain management while moving ICU patients would be associated with a decreased incidence of both severe pain and SAE, and that those SAE would often be associated with pain events.The study took place in the 16-bed medical-surgical ICU of St Eloi Hospital, a 660-bed teaching and referral facility of the University of Montpellier in France, staffed by 35 registered nurses (RNs), 25 nurse assistants, 3 certified registered nurse anesthetists, 7 attending physicians and 4 residents. Nurse to patient ratio was 1:2.5 as required in France . The ICUAll consecutive patients ≥ 18 yrs old and staying in the ICU for more than 24 hrs were eligible. Exclusion criteria were decision to withdraw life-support within 48 hrs after admission and lacking data. Because of the observational, non-invasive design of this quality-improvement study based on the Plan-Do-Check-Adjust method which aimed to apply recommended practice guidelines , the neeA multidisciplinary work-group was created, composed of three registered nurses, three assistant nurses, and three physicians (two attending physicians and one resident). All members received institutional education provided by the Hospital Pain Committee. Five meetings were necessary to elaborate the quality study design. The first nursing care procedure in the morning was chosen to be studied because it accounts in our ICU for the care which requires the longest duration of turning, including the largest number of moves and nursing care procedures in the day . Also, the work group had the impression that there was a strong contrast between the end and beginning of the day regarding pain, agitation and the number of alarms ringing from monitoring systems early in the morning. Contrary to pain at rest, pain during procedures was rarely reported in medical charts. We made the hypothesis that managing procedural pain during the first turning of the day would be the most challenging in our ICU. Figure Every first turning of the day, between 6 and 8 AM was evaluated .During this phase, a de-identified questionnaire was given to every RN and nurse assistant in order to assess their knowledge of written guidelines regarding sedation-analgesia in the ICU and their difficulties in managing sedation-analgesia routinely.Based on Phase 1 and questionnaire results, educational interventions were planned and educational posters were constructed and posted. Educational intervention was provided for all the nursing and medical staff by members of the work group during scheduled courses intended for 5 to 10 staff members at a time. Educational objectives included the ability: 1) to assess and control pain at rest before any moving procedure, 2) to determine the duration of peak analgesia for analgesic drugs used in the ICU in order to anticipate administration of drugs before moving a patient, 3) to escalate analgesic drugs according to the World Health Organization's analgesic steps in case of ineffectiveness after having referred to previous pain assessment, 4) to administer music therapy as well as other non-pharmacological analgesia therapies. Analgesics were selected by physicians according to the clinical situation and administered by RNs. Non-pharmacological therapies were selected and administered by the RN only. In order to develop the use of non-pharmacological therapies, headphones and dedicated pieces of music therapy were implemented in every patient's room. Music scores were composed by music therapists. The main characteristics of music  progressively decreased, then stabilized to a low pattern , and finally increased slowly before removing the headphones from the patient. In other words, music characteristics followed a U-shape. Total duration of a music therapy session was 40 ± 5 minutes. Nurses and physicians were specifically educated by a music therapist during this interphase.Finally, the clinical information system software was modified to include specificities of pain management for nursing care procedures. Posters referring to pain management and the sedation-analgesia algorithm were created to highlight educational objectives previously described. Posters were posted in every patient's room. These posters are shown in electronic supplement in their original French version as well as an English version . This phase was aimed to measure the impact of the educational interventions.During six months (October 2010 to March 2011) a data and problems analysis was performed and multidisciplinary medical and nursing strategy was adjusted. As from this moment, medical staff was asked to systematically order one or more analgesics to be administered early in the morning before the nursing care procedures. Nurses had the possibility of using one or more of these analgesic drugs according to their discretion based on pain assessments. Moreover, pain management for the nursing procedure was standardized and systematically checked along with other nursing issues during daily medical rounds. Compliance with the quality improvement project was corrected by reminders and analysis of specific situations by the nurse manager and the ICU medical director during their weekly nursing medical round.Every first turning of the day, between 6 and 8 AM was evaluated . This phase was aimed to measure the impact of adjustments made during the second interphase.A consolidation step was added to the PDCA-cycle to measure sustained quality-improvement as the new standard ,23. Ther1) Pain was measured by the bedside RN while the patient was at rest before and during any moving procedures routinely throughout the study process, using validated ICU pain tools. Communicating patients rated their discomfort intensity on the visually enlarged numeric rating scale (NRS) from 0 (no pain) to 10 (maximum imaginable discomfort) . For non2) SAE related to acute stress-response were assessed by physiological parameters , measured continuously by the ICU monitor and recorded before and while the moving procedure by the bedside RN on a sheet dedicated to the study. SAE were defined as cardiac arrest, a new arrhythmia event and clinically relevant changes before and during the procedure defined as follows:- Tachycardia: heart rate ≥ 110 beats/minute (b/min) if < 100 b/min before the procedure- Bradycardia: heart rate ≤ 60 b/min if > 70 b/min before- Hypertension: mean arterial pressure ≥ 110 mmHg if < 100 mmHg before- Hypotension: mean arterial pressure ≤ 65 mmHg if > 70 mmHg before- Desaturation: oxygen saturation ≤ 90% if > 92% before- Bradypnea: respiratory rate ≤ 10 c/min if > 10 c/min before- Ventilatory distress: severe ventilator asynchrony (nonstop coughing or impossible ventilation) in mechanically ventilated patients and/or tachypnea (respiratory rate ≥ 35 c/min if it was < 35 c/min)3) Pharmacological therapies given within four hours prior to the moving procedure were reported by the bedside nurse on the patient flow sheet. Non-pharmacological therapies  performed to decrease pain while being moved were reported by the bedside nurse on a sheet dedicated to the study.4) Demographic and medical data were prospectively recorded. Age, gender, type of admission  and Simplified Acute Physiological Score (SAPS) II  were colPain was measured by bedside nurses at rest before and during any moving procedures, similarly to the other phases but reported routinely on the patient's flow sheet instead of a dedicated study sheet. Physiological parameters were recorded every 30 minutes by the patient's Clinical Information System . Maximal or minimal values, which had been recorded an hour before and after the moving procedure, were analyzed. Pharmacological therapies were evaluated as for the other phases. Non-pharmacological therapies were not assessed because of the absence of systematic notification in the medical chart.The primary endpoints were the incidence of severe pain defined by the proportion of patients who developed a severe pain event (BPS > 5 and/or NRS > 6) and the incidence of SAE defined by the proportion of patients who developed at least one SAE while being moved. Secondary endpoints were incidence of moderate pain, the existence of a relationship between pain and SAE, and a change in analgesic ordering practice patterns.n = 100 procedures needed to be analyzed for every phase, with alpha 0.05 and beta 0.10. Missing data were expected because bedside RNs would sometimes forget or not have enough time to fill in the sheets dedicated for the study due to an eventual high workload in the ICU. Taking into account missing data and the rate of empty rooms in the ICU at a given time, this meant enrolling consecutive patients hospitalized in the ICU within one month for every phase. Also, repeated one-month phases could allow for implementing the study effect (Hawthorne effect) into a routine process which was part of the quality-improvement project [Based on previous data , an inci project . Referenth to 75th percentiles according to data distribution. Student t-test or Wilcoxon test (quantitative data) and chi-square test  were used to compare patients included in the four phases. Because moving for nursing care procedures was evaluated every day of the ICU stay, one patient could be evaluated several times (repeated measures).Quantitative data were shown as mean and standard deviation or median and 25P-value was less than 0.20 in the univariate analysis and a stepwise procedure was used to select the final model. Furthermore, a sensitivity analysis was performed, removing tachycardia and hypertension, which are common events associated with pain, from the definition of SAE. This was done to measure the impact of the quality project on the incidence of other SAE. A P-value of ≤ .05 was considered statistically significant. Data were analyzed by a senior statistician from the Department of Statistics of the University of Montpellier Hospital using the R.2.13.0 software.Thus, pain events, serious adverse events and analgesic ordering were compared in univariate analysis using a generalized linear mixed-effects model for repeated measures, taking into account repeated measures as random variables. Multivariate analysis of pain events and SAE was secondly performed using a generalized linear mixed-effects model for repeated measures. Variables were selected if Among the nursing staff, 21 (60%) RNs and 17 (68%) nurse assistants answered the questionnaire during Phase 1. Pain assessment tools were thought to be adapted to ICU patients by all 21 (100%) RNs. Before the study, 17 (71%) RNs had already experienced a disagreement with doctors regarding pain management and 5 (29%) nurse assistants had experienced a disagreement with RNs. Disagreements occurred because some patients could have been in pain but physicians or nurses did not allow for increasing analgesics because of the risk of developing side-effects. Fourteen (58%) RNs did not refer to patients' previous pain assessments and analgesia documentation to better adjust analgesia for nursing care procedures for a given patient. Among the 21 RNs, 9 (43%) desired more autonomy in pain management. A greater autonomy was achieved in the quality improvement project by allowing nurses to administer selected analgesics. Because almost half of the nurses did not want greater autonomy, analgesic choice remained the physicians' role and pain management was developed more collaboratively between nurses and physicians. Educational interventions aimed at decreasing the incidence of severe pain and SAE and improving analgesics ordering were evaluated during the four studied phases.Overall 630 procedures were analyzed in 193 patients during the four studied phases, in 53, 47, 43 and 50 patients, respectively. The flow chart of the study is shown in Figure Incidence of severe pain, as well as at least one SAE , decreased over the quality improvement study, while the proportion of analgesia given for nursing care procedures increased Figure . The difP = 0.04) and Phase 4 , P = 0.02). Incidence of moderate pain did not significantly decrease during the study  and Phase 4 , P = 0.03) whereas a higher incidence of SAE was associated with intubated status , P < 0.01) and severe-pain , P < 0.001) .A lower incidence of SAE was independently associated with Phase 3 , There was a change in analgesic ordering practice patterns across the quality improvement project Table . Use of The main findings of this quality improvement project are that moving an ICU patient for nursing care procedures is associated with severe adverse events (SAE) in one out of three procedures. The incidence of at least one SAE  is strongly associated with severe pain in multivariate analysis. A healthcare quality improvement project of pain management, while moving ICU patients, is associated with a decrease in both severe pain and SAE.Being moved for nursing care procedures is one of the most painful procedures experienced by the patient during the ICU stay, whatever the type of admission  ,13,16,33One of the reasons not to treat pain is that ICU physicians may be uncomfortable ordering analgesic drugs  because Tramadol was the only drug that's use significantly increased through the study. Except in the case of severe renal impairment, tramadol is an opioid associated with a minimal risk of ventilatory depression . This coIn order to reduce the risk of such drug adverse events, non-pharmacological therapies were developed throughout the study. Despite the implementation of music therapy as a new technology available for every patient and despite specific educational interventions, there was an increased use of non-pharmacological therapy but this increase was not sustained during the third phase of the study. Music therapy was poorly implemented throughout the project. Some nurses reported that the time which was required for a music therapy session (40 minutes) did not allow for easily preventing or treating procedural pain contrary to analgesic drugs. Also, nurses should have been more comfortable with analgesic drug use as the quality-improvement project was developed and might have discarded non-pharmacological therapies at the same time for different reasons including trust in their efficacy, timing and so on. If positive effects of music therapy and standard music listening have been shown in small-sized physiological studies in critically ill patients ,45, the Decreased pain-associated stress response could partly explain the decrease of SAE observed during the last two studied phases (adjusted intervention and consolidation P-D-C-A-steps). Pain induces reflex responses that may alter respiratory mechanics and increase cardiac demand via tachycardia and increased myocardial oxygen consumption, leading to desaturation and blood pressure changes. Stress response may also induce hypercoagulability, immunosuppression and persistent catabolism ,5. In thThis study constitutes an improvement in quality and safety in healthcare. Such processes are fundamental to improving our healthcare, by changing our systems, avoiding overuse of ineffective care and underuse of effective care . QualityOur study has several limitations. First, there were less missing data in the third phase (adjusted intervention P-D-C-A phase) than in the two first phases. This could be explained by a high workload during February and September 2010, much higher than in April 2011. Indeed, one-third of the unit had to be closed unexpectedly in April after Phase 3 had begun. To deal with missing data and to avoid a possible bias due to more frequently evaluating patients in pain in the two first phases, patients were randomly enrolled in Phase 4. This phase (consolidation of P-D-C-A-steps) was aimed to reinforce the results observed in the previous phase ,23. SecoA focused quality improvement project on pain management in the ICU was associated with improved pain management during patient turning for nursing procedures as determined by 1) a decreased incidence of severe pain; 2) an increased use of analgesic drugs; 3) a decreased incidence of serious adverse events. Careful documentation of pain management while moving ICU-patients for nursing procedures could be implemented as a health quality indicator in the ICU-setting.• Moving an ICU patient for nursing care procedures is associated with serious adverse events in one out of three procedures.• Serious adverse events are strongly associated with severe pain during these procedures.• Health quality improvement of pain management is associated with a decrease of both severe pain and serious adverse events.• Careful documentation of pain management while moving ICU patients could be implemented as a health quality indicator in the ICU setting.BPS: Behavioral pain scale; BPS-NI: non-intubated BPS; COGAR: Comité d'Organisation et de Gestion de l'Anesthésie Réanimation du Centre Hospitalier Universitaire de Montpellier; ICU: Intensive care unit; NRS: Numeric rating scale; RASS: Richmond Agitation Sedation Scale; RN: Registered nurse; SAE: Serious adverse event; SAPS: Simplified Acute Physiological Score; WHO: World Health OrganizationThe authors declare that they have no competing interests.GC, SJ, SDL, CG and MPS conceived the study and participated in its design and coordination. ADJ and NM performed the statistical analysis. ADJ, GC and SJ drafted the manuscript. MC and BJ helped to correct the manuscript. JC was in charge of English editing. All authors read and approved the final manuscript.Analgesia protocol for procedures - English language. Poster referring to procedural pain management, created by the work group to highlight educational objectives and posted in every patient's room. English translation.Click here for fileAlgorithm for continuous sedation-analgesia - English language. Poster referring to continuous sedation-analgesia algorithm, adapted from [ted from  by the wClick here for fileAnalgesia protocol for procedures - French language. Poster referring to procedural pain management, created by the work group to highlight educational objectives and posted in every patient's room. Original French version.Click here for fileAlgorithm for continuous sedation-analgesia - French language. Poster referring to continuous sedation-analgesia algorithm, adapted from [ted from  by the wClick here for fileAdditional tables. Table S1: Incidence of pain calculated on overall procedures for each of the four studied phases. Table S2: Sensitivity analysis of factors associated with serious adverse events determined by multivariate mixed-effects model analysis after removing tachycardia and/or hypertension from serious adverse events.Click here for file


The aim of this study was to compare the efficacy and safety of sublingual buprenorphine with intravenous morphine sulfate for acute renal colic in the emergency department.In this double-dummy, randomized controlled trial, we enrolled patients aged 18 to 55 years who had a clinical diagnosis of acute renal colic. Patients received either 2 mg sublingual buprenorphine with an IV placebo, or 0.1 mg/kg IV morphine sulfate with a sublingual placebo. Subjects graded their pain with a standard 11-point numeric rating scale (NRS) before medication administration and 20 and 40 minutes after that. The need for rescue analgesia and occurrence of side effects were also recorded in the two groups.P <0.0001). The two regimens did not differ significantly for pain reduction (P?=?0.260). Dizziness was more frequently reported by the buprenorphine group  but other adverse effects observed within 40 minutes were similar in the two groups.Of 69 patients analyzed, 37 had received buprenorphine, and 32 had taken morphine. Baseline characteristics were similar in both groups. NRS pain scores were reduced across time by administration of both buprenorphine (from 9.8 to 5.22 and then 2.30) and morphine (from 9.78 to 4.25 and then 1.8), significantly  is as effective as morphine sulfate (0.1 mg/kg) in acute renal colic pain management. Renal colic is a severely painful condition frequently encountered in emergency departments (EDs) . As reliBuprenorphine is an analgesic with mixed agonist-antagonist properties which has been shown to have a role in acute pain management in postoperative pain and orthopedic injuries ,6. HowevWe compared the effectiveness of sublingual buprenorphine with that of IV morphine sulfate for pain management in ED patients with renal colic.http://www.clinicaltrials.gov (NCT01546701).This is a double-dummy, placebo controlled randomized clinical trial in patients with acute renal colic in the ED. Using block randomization (with a computer generated sequence) and a sealed envelope mechanism for allocation concealment, patients were divided into two groups, one receiving sublingual buprenorphine with IV placebo and the other receiving IV morphine with sublingual placebo. The study was performed in the emergency department of Imam Hospital, a tertiary referral center with approximately 50,000 visits per year. The ethics committee approved the study protocol and the study was registered in Eligible patients for our study were those with acute colicky pain aged between 18 and 55 years old and who had a clinical diagnosis of acute renal colic based on medical history and a positive urinalysis for hematuria. The numerical rating scale (NRS), validated by Bijur et al., was used to measure severity of pain [Eligible patients were randomly allocated into two groups to receive either sublingual buprenorphine as 2 mg tablets plus IV injection of 0.1 mL/kg sterile water or a sublingual placebo plus 0.1 mg/kg IV morphine sulfate (1 mg/mL). All the researchers and participants remained blind to the treatment and results throughout the study.The primary outcome was the efficacy of the drug with regards to reducing the NRS 20 and 40 minutes after administration and the need for rescue analgesia, which was an IV injection of fentanyl (0.75 μg/kg). The secondary outcome was the occurrence of adverse effects.Patients were asked to rate their pain in a verbally administered NRS with 0 representing no pain and 10 the worst imaginable pain. The severity of pain was reevaluated at 20 and 40 minutes after analgesic administration. The patients were monitored for any change in their vital signs including blood pressure, pulse rate, respiratory rate and oxygen saturation during the study. Hypotension was defined as a drop of more than 20 mmHg in systolic blood pressure, and respiratory depression as a respiratory rate below 12 . The patients were also asked about their feelings of nausea, vomiting, dizziness, pruritus, or drowsiness.t-tests or exact tests. Repeated measure ANOVA was used to assess the effect of intervention on pain scores across time and between the study groups at each time point. Side effects were compared using χ2 tests and P <0.05 was considered statistically significant. The sample size was calculated as 25 for each group according to the study conducted by Finlay et al. [Baseline demographic and clinical variables were compared using independent Student’s y et al.  with α aBetween March 2011 and April 2012, 118 patients with acute renal colic were assessed for eligibility, 38 were excluded from randomization because they did not meet the inclusion criteria and 80 were enrolled and randomized into the two treatment groups. During the study period, 11 patients were lost to follow-up. Of 69 patients whose data were finally analyzed, 37 and 32 received buprenorphine and morphine, respectively  when analyzed using the repeated measure ANOVA in both groups (Table P?=?0.260) . No significant difference between the two groups was noted in terms of respiratory depression and hypotension. There was no significant difference between the two groups regarding the occurrence of nausea, vomiting or pruritus, except that the patients in buprenorphine group reported dizziness more frequently (P <0.05)  (5) Table . There wThe results of this study demonstrated that administration of 2 mg sublingual buprenorphine effectively reduced pain in patients with acute renal colic. Although the number of patients was not enough to perform equivalency tests, the results showed that the analgesic effect of buprenorphine was comparable to 0.1 mg/kg IV morphine.To the best of our knowledge, there are no other studies on sublingual buprenorphine in the treatment of renal colic in the ED. However, our results are compatible with the results of a previous study in this center on the effectiveness of sublingual buprenorphine in acute bone fractures . In thatOur study faced several limitations. First, many patients had to be excluded due to previous use of opioids or addiction. Secondly, some of the patients might have been drug seekers and IV drug users imitating renal colic to get morphine. It is possible that they were not recognized and were included in study. Thirdly, NRS may be an inappropriate measurement upon arrival of the patients as they tend to choose the highest NRS , assuming that this will accelerate their treatment process. It may justify the number of patients whose NRS was 10 at the beginning; however, this situation is expected to be similar in both groups and does not seem to influence the change in NRS during the observation time. Another limitation of our study was the use of 2 mg buprenorphine tablets which may be the cause of slightly higher rate of side effects in this group; using smaller doses and then titrating it to effect may reduce the occurrence of side effects. Finally, this study did not find a significant difference between the two groups probably because of the small sample size.In conclusion, sublingual buprenorphine can be used as an effective analgesic with minor side effects for acute pain relief in patients with renal colic, and its effectiveness is comparable to that of IV morphine.ED: Emergency department; IV: Intravenous; NRS: Numeric rating scale.All authors declare that they have no competing interests.PP and MJ developed the study questions, designed the methods for data acquisition, and supervised the collection of data. BMD performed statistical analysis. PP, MJ, and BMD jointly participated in drafting the manuscript. AD helped in the interpretation of data and also revised the manuscript critically. All authors read and approved the final version of the manuscript.


Multiple myeloma is the second most common haematological malignancy. Novel therapies have led to improvement in survival. Current myeloma management is matching the progress made in improved survival through disease control while optimising quality of life with effective supportive care. Supportive treatment is an essential part of the therapeutic management of myeloma patients because it is directed towards improving the patient’s quality of life and also can improve survival. The aim of this review is to highlight the relationship among life of quality, supportive care, and improvement in survival. Conflict of interest:None declared. Introduction Multiple myeloma (MM) is the second most common haematological malignancy, comprising an estimated 1% of all cancers with an incidence of about 4.5 cases per 100,000 per year ,3,4. NovIt is difficult to define clearly the meaning of the term “quality of life” and it carries different senses for everyone. It involves broad concepts that affect overall life contentment, including good health, adequate housing, employment, personal and family safety, interrelationships, education, and leisure pursuits. Therefore, the life satisfaction most affected by health or illness is defined by the term “health-related quality of life” (HRQoL) ,7. RelatQuality of Life QuestionnairesKarnofsky and Burchenal developed a clinical scale to quantify the functional performance of cancer patients in 1949 ,9 Table. SystemaIn 2005, the Eastern Cooperative Oncology Group (ECOG) launched a clinical trial (E1A05) to evaluate a new treatment regimen for MM. HRQoL was determined to be a secondary goal for this trial, with the purpose of quantifying treatment-induced reduction of disease-specific symptoms as well as treatment-related symptoms and toxicities. Based on a comprehensive literature search, the authors concluded that no HRQoL instrument existed to adequately capture key MM symptoms and concerns from the patient’s perspective. This led to collaboration among the ECOG Myeloma, Patient Outcomes and Survivorship, and Patient Representative committees to develop a patient-reported outcome (PRO) measure to assess MM symptoms and concerns [4]. The task force identified several types of measures that fall under the PRO umbrella, including HRQoL, functional status, symptom status, overall well-being, satisfaction with care, and treatment adherence. What Affects the Quality of Life? Previous studies have demonstrated that the most common physical symptoms indicated by MM patients at presentation are especially skeletal pain and fatigue. Despite significant improvements in the treatment of MM, it remains a chronic incurable disease that is associated with reduced HRQoL due to spontaneous fractures, spinal cord compression, osteolytic lesions, recurrent infections, renal failure, anaemia, mood disorders accompanied by reduced physical functioning, and side effects of different types of treatment used to control this disease ,19,20,21Treatments and Quality of Life Some studies have been conducted about the relationship between myeloma treatments and quality of life. Alegre et al. specified that patients with relapsed or refractory MM treated with long-term lenalidomide reported clinically relevant improvements in certain quality-of-life and symptoms scores regardless of treatment response . TransplSupportiveCare The role of the physician in combining life quality and supportive care in MM patients is important because effective supportive treatment results in improved quality of life. Although much of the supportive care can be provided by haematologists, in some patients symptomatic management is achieved through the collaboration of colleagues in the fields of palliative medicine, pain management, clinical oncology, and orthopaedics . A studyIn addition to chemotherapy, prophylaxis and supportive treatment of bone destruction, pain, anaemia, renal failure, fatigue, infections, hypercalcaemia, and emotional distress are essential parts of the therapeutic management of myeloma patients. The concerted action of supportive therapies can significantly help to maximise the benefits of treatment and to improve the wellbeing of myeloma patients in phases of disease progression as well as during phases of remission. Management of symptoms in patients with myeloma at all stages should follow the principles of evidence-based palliative medicine . Thus, sSupportive Care for Bone DiseaseBone pain, particularly in the spine and chest, is the major symptom in MM, which presents at diagnosis in more than two-thirds of patients. Osteolytic lesions, fractures of long bones, vertebral collapse, and plasmacytomas, which directly affect neural tissues, are the most common causes of bone pain. Later in the course of the disease, pain often arises as a side effect of therapies, e.g., thalidomide or bortezomib neuropathy . Long boSupportive Care for Anaemia Anaemia affects more than two-thirds of MM patients . AnaemiaSupportive Care for InfectionsInfections, especially bacterial infections, are frequent complications of MM. Augustson et al. reported that up to 10% of myeloma patients die within 60 days after the diagnosis because of infective causes . IncreasSupportive Care for Peripheral NeuropathyMany patients with myeloma have subclinical or even clinical peripheral neuropathy at diagnosis, often due to comorbidities like diabetes mellitus, vitamin B12 deficiency, or carpal tunnel syndrome . This wiThe symptoms of BiPN improve or completely resolve in the majority of patients after a median of 3 months following discontinuation of the drug, while in some patients maximum improvement may take 2 years . TreatmeSupportive Care for Renal FailureRoughly 15%-25% of myeloma patients have a creatinine value of >2 mg/dL at diagnosis. Patients with reversed renal failure have better overall survival than those without improvement . DehydraSupportive Care for PainPain is frequently the predominant symptom of myeloma at diagnosis. It is also a common indicator of relapse or progressive disease. Many myeloma patients suffer from pain, particularly in the skeleton . FracturEffective analgesia can be achieved by regular administration of oral medication in myeloma patients. The WHO Pain Treatment Ladder shown in  has beenNSAIDs must be given carefully because of renal toxicity and gastrointestinal effects. COX-2 inhibitors have less gastrointestinal and renal toxicity. Opioids’ long-term effect and tolerance are better, but they are more expensive. The adverse effects of opioids are dryness of mouth, nausea, and emesis. The combination of opioids and NSAIDs is more effective, but also more toxic. Adjuvant medications such as corticosteroids, anti-emetics, neuroleptics, antidepressants, and benzodiazepines should be given as required . Supportive Care for Thromboembolism Myeloma and other plasma cell disorders have an association with venous thromboembolism (VTE) . The incSupportive treatment is an essential part of the therapeutic management of myeloma patients because while directed towards improving the patient’s quality of life, they also have significant effects against the disease and can improve survival . CarefulRecommendations • A therapeutic trial of ESA should be considered in a patient with persistent symptomatic anaemia  in whom haematinic deficiency has been excluded. • One of darbepoetin, epoetin alfa, or epoetin beta can be chosen. Dose-doubling after 4 weeks in patients with a haemoglobin increase of <10 g/dL can be considered. ESA treatment should be stopped after 6-8 weeks if there has been no haemoglobin response. The haemoglobin concentration should not rise above 12 g/dL. • All patients who are due to start thalidomide- or lenalidomide-containing therapy should undergo a risk assessment for VTE. • In patients receiving thalidomide or lenalidomide, aspirin (75-325 mg) may be considered as VTE prophylaxis in low-risk patients, but in the case of ≥2 risk factors, LMWH or warfarin (target INR: 2.5) is recommended, unless contraindicated. • The duration of thromboprophylaxis remains unclear but is guided by risk factors such as active disease and is deescalated or discontinued unless there are ongoing significant risk factors. • Prophylactic immunoglobulin is not routinely recommended but may be useful in patients with severe, recurrent bacterial infections and hypogammaglobulinaemia. • Prophylactic acyclovir is recommended for patients receiving VAD, high-dose dexamethasone, or a bortezomib-based regimen who are at high risk of reactivation or new acquisition of herpetic infections and following autologous stem cell transplantation. • Pain should be assessed regularly in myeloma patients at all stages of the disease and measured using a 0-10 or a verbal none-mild-moderate-severe scale. • Patients who repeatedly score pain as ≥5/10 should be referred to a palliative care or pain team. • Effective analgesia can be achieved by regular administration of oral medication. The WHO Pain Treatment Ladder  has been• Local radiotherapy is helpful for pain control; a single-fraction dose of 8 Gy is recommended. The use of vertebroplasty or kyphoplasty may be considered in patients with persistent pain. • Clinical evidence of a significant  or progressive peripheral neuropathy at diagnosis should be appropriately investigated to identify treatable causes, and referral to a neurologist should be made so that appropriate neurological investigations can be performed. • Patients who develop a significant  or progressive chemotherapy-induced peripheral neuropathy should be managed with graded dose reduction or drug withdrawal. • All patients with chronic peripheral neuropathic pain should be considered for multimodal analgesic treatment including an opioid, ion channel blocker, and SNRI. • Dehydration, infections, analgesics, hypercalcaemia, and hyperuricaemia increase tubular cast formation. Fluid intake of at least 3 L per day, limitation of analgesic usage, prevention of infections, and oral or intravenous bicarbonate replacement can improve renal functions. The authors of this paper have no conflicts of interest, including specific financial interests, relationships, and/ or affiliations relevant to the subject matter or materials included.


INTRODUCTION: The aim of this study was to compare the efficacy of two irrigants on decreasing the pain and swelling at different times after treatment of necrotic pulp.MATERIALS AND METHODS: Fifty patients with single canal tooth and necrotic pulp were selected and divided into two groups, twenty-five in each. Rotary files were used for preparing the canals and 0.2% chlorhexidine gluconate and 2.5% sodium hypochlorite were used for irrigation of canals. Then canals were filled by lateral condensation technique. A questionnaire was given to patients asking for the level of their pain and swelling. The patients were followed for 48h. Visual Analogue Scale (VAS) was used for determination of pain degree. The scale with 4 levels was used for measurement of the intensity of swelling. The data were statistically analyzed using Mann-Witney and Kruskal-Wallis tests.RESULTS: The research showed no significant difference between irrigant solutions in decreasing the amount of pain and swelling after endodontic treatments. No significant relationship was detected between the incidence of pain with swelling, age, and sex. Flare-up in maxilla was more than mandible.CONCLUSION: According to results of this in vivo study it was concluded that efficacies of 0.2% chlorhexidine gluconate and 2.5% NaOCl are the same. DiffereMicrobial, chemical or mechanical injuries to pulp or periradicular tissue and specially microrganisms and their by products are the most important reasons of pulpal or periapical inflammation -12. RemoMany bacterias, as observed in an infectious canal, were removed from canal during root canal treatment, but despite of adequate cleaning, many remain in anatomical complexities of root canals .et al. in a clinical study on toxic properties of 5.25% SH, observed no significant difference in postoperative pain in cases which were irrigated with either SH or normal salin. They declared that toxicity of 5.25% SH is not more than normal saline  is considered because of antibacterial effect, durablility and it's non toxic property as irrigant . White ehe canal .et al. compared antibacterial effect of 2.5% SH and 0.2% CG with six another irrigants. They found that CG was more effective on E. Faecalis . 2.5% SH and 0.2% CG were used for appropriate groups. All teeth were isolated after removing of carries and access cavity preparation. Using K-file, working length was established by periapical radiography at 0.5-1mm of apical foramen. Rotary files (Easy-Race) were used for canal preparation. Root canals were prepared by crown-down technique. After each file removal, 1.5-2 ml irrigant was used for each group. Canals were dried with praper points. Root canals were filled with gutta-percha and AH26 sealer by lateral condensation technique. The tooth were then temporary filled with cavit.Two VAS forms were given to the patients for measuring of the pain and swelling. The VAS pain form was scaled from 0-9 and patients marked the appropriate level of the pain in specified times. Data were collected and classified in 4 groups: no pain, mild, moderate, and severe. The swelling was classified in 4 scales: no swelling, mild, moderate, and severe. The patients were followed-up for 48h. Data were analyzed by Mann-Whitney an Kruskal-Wallis tests.In this study, no significant difference was found for the incidence of pain in two groups for each period of time. According to the Mann-Witney test, the incidence of pain in two groups were analougous . The camAccording to Acute pain and swelling after treatment was considered as flare up . AlthougHowever, Sim reported higher incidence of flare-up in necrotic teeth . BecauseThere are many studies about antibacterial properties of irrigant solutions ,26,27. Set al. showed that this technique affected the prevention of problems following treatment and inadequate irrigation (Crown-down technique with rotary files were used, in this study, for better cleaning of canal. Marshal rigation .Researchers found no significant difference between antibacterial effect of CG and 2.5% SH . Others In our study in SH group, the severe pain was recorded in all intervals, while in CG group the strain wasn't observed after treatment except one case in the first 12h after treatment. The amount of strain pain in SH group was more than the CG group, but it is not statistically significant.et al. found no relashionship between value of flare-up with age and sex (The amount of severe swelling was observed in SH group in two time intervals, but in CH group no severe pain was recorded. No relashonship was obsereved between the incidence of pain with age and sex. Yeh  and sex . Zoulo a and sex .The incidence of the pain has been studied in maxilla and mandible, but in spite of the results of Torabinejad study , the sevIn this research, SH and CG had equal effect on severety of pain and swelling after treatment. So, 0.2% CG can be recommended as an acceptable irrigant for endodontic treatments.


Neck pain is a common complaint in patients presenting for chiropractic treatment. The few studies on predictors for improvement in patients while undergoing treatment identify duration of symptoms, neck stiffness and number of previous episodes as the strong predictor variables. The purpose of this study is to continue the research for predictors of a positive outcome in neck pain patients undergoing chiropractic treatment.Acute (< 4 weeks) (n = 274) and chronic (> 3 months) (n = 255) neck pain patients with no chiropractic or manual therapy in the prior 3 months were included. Patients completed the numerical pain rating scale (NRS) and Bournemouth questionnaire (BQ) at baseline prior to treatment. At 1 week, 1 month and 3 months after start of treatment the NRS and BQ were completed along with the Patient Global Impression of Change (PGIC) scale. Demographic information was provided by the clinician. Improvement at each of the follow up points was categorized using the PGIC. Multivariate regression analyses were done to determine significant independent predictors of improvement.Baseline mean neck pain and total disability scores were significantly (p < 0.001and p < 0.008 respectively) higher in acute patients. Both groups reported significant improvement at all data collection time points, but was significantly larger for acute patients. The PGIC score at 1 week  and the baseline to 1 month BQ total change score  were identified as independent predictors of improvement at 3 months for acute patients. Chronic patients who reported improvement on the PGIC at 1 month were more likely to be improved at 3 months . The presence of cervical radiculopathy or dizziness was not predictive of a negative outcome in these patients.The most consistent predictor of clinically relevant improvement at both 1 and 3 months after the start of chiropractic treatment for both acute and chronic patients is if they report improvement early in the course of treatment. The co-existence of either radiculopathy or dizziness however do not imply poorer prognosis in these patients. Patients suffering from neck pain are second only to low back pain patients in terms of the frequency of presentation for chiropractic treatment -4. For mManipulative therapy to the cervical spine has traditionally been considered somewhat controversial by certain health care practitioners. Recent high quality research evidence supports the relative safety of chiropractic SMT to the cervical spine with no increased risk of vertebral artery injury compared to patients seeking care from other primary medical physicians who do not manipulate the neck -13. A feThis is a prospective cohort study with three month follow-up. Ethics approval was obtained from the Canton of Zürich Switzerland ethics committee (EK-19/2009) and written informed consent was obtained from all patients.Consecutive new patients over the age of 18 with neck pain of any duration who had not undergone chiropractic or manual therapy in the prior 3 months were recruited from multiple chiropractic practices in Switzerland. Patients with specific pathologies of the cervical spine that are contraindications to chiropractic manipulative therapy, such as tumours, infections, inflammatory arthropathies, acute fractures, Paget’s disease, anti-coagulation therapy, cervical spondylotic myelopathy, known unstable congenital anomalies and severe osteoporosis, were excluded. Although the data was collected for subacute patients (symptoms between 4 and 12 weeks), for this study these patients were not used due to the small sample size .All active members of the Association of Swiss Chiropractors (ASC)  were asked to contribute patients to this study. Notification and instructions about this study as well as the study protocol were sent to all chiropractors by email as well as discussed verbally during the annual mandatory post-graduate continuing education (CE) convention held immediately prior to the start of data collection. Workshops were also conducted during the CE convention by one of the authors on the use of outcome measures in clinical practice. It was emphasized via email and verbally that there should be no changes in the treatment methods used by the contributing chiropractors as the purpose of this study was to evaluate outcomes as would be found in routine chiropractic practice. Therefore, standardization of treatment method or treatment number was not desired. It is known however, from the data collected for the ‘Swiss Job Analysis’ study done in 2009 that the ‘diversified’ technique is applied to between 76 and 100% of chiropractic patients in Switzerland. The other commonly used treatments used include advice on the activities of daily living, trigger point therapy, therapeutic exercises and mobilization techniques .The numerical rating scale (NRS) for neck pain and a separate NRS for arm pain as well as the Bournemouth Questionnaire for neck (BQN) disability, which has been translated and validated in German , were adOne week after the first treatment, data from the NRS (neck), NRS (arm), Patient Global Impression of Change (PGIC) scale , and theAdditional information provided by the treating chiropractor at the initial consultation included: patient age, gender, marital status, paid employment, whether or not the onset of pain was due to trauma, whether or not the patient smokes, whether or not the patient was currently taking pain medication, duration of current complaint, number of previous episodes, whether or not the patient also had signs and symptoms of cervical radiculopathy, whether or not the patient also complained of dizziness and the patient’s general health status. This information was completed on a baseline information form.All variables were identified in advance and were taken from information completed by the chiropractor on the baseline information form at the first consultation and from changes in variables between baseline and the data collection time points . Continuous variables consisted of patient age, NRS (neck), NRS (arm), BQN scores and change scores. All other variables, with the exception of ‘number of previous episodes’ and ‘general health’, were dichotomized for ease of interpretation (yes/no or present/absent as appropriate). The ‘number of previous episodes’ was divided into 3 categories: none, 1 to 3 episodes, and 4 or more episodes. ‘General health’ was categorized as ‘good’, ‘average’, or ‘poor’ as determined by the treating chiropractor.Patients whose symptoms were less than 4 weeks in duration were classified as ‘acute’ and those whose symptoms were longer than 12 weeks were classified as ‘chronic’. Sub-acute patients were not included in this study to make a clear distinction between acute and chronic patients. Acute vs. chronic patients were analyzed separately as previous research has shown that length of complaint is a strong predictor of outcome . MoreoveOutcomes were evaluated using the NRS (neck), NRS (arm) and the BQN total and sub-scale raw change  scores. For the prediction analysis the outcome ‘improvement’ was defined as scores of 1 (much better) or 2 (better) on the PGIC scale. Scores of 3 (slightly better), 4 (no change), 5 (slightly worse), 6 (worse) and 7 (much worse) were categorized as ‘not improved’.2 test for categorical variables and the unpaired t-test for continuous variables. Within patient differences for continuous variables were analysed using the paired t-test.Baseline factors were compared between acute (symptoms < 4 weeks) and chronic (symptoms > 12 weeks) patients using the chi2 was used as the index of the percentage of the variance in the outcome explained by the model. SPSS version 17 was used for all data analyses.Multivariate regression analyses were carried out to determine statistically significant independent predictors of improvement. ‘Improvement’ as the dependent variable in the regression analysis was categorized as scores of 1 (much better) or 2 (better) on the PGIC. First, all potential predictors were separately entered into a univariate model and those significantly associated with improvement (p < 0.1) were entered in a forward stepwise multivariate model, which entered only those variables independently associated with ‘improvement’ (p <0.05). Variables in the model were checked for redundancy by noting the correlation coefficients (>0.8) between variables in the presence of the other variables in the model. The properties of the final predictive model were ascertained by calculating the sensitivity, specificity, % correctly classified, and the area under the Receiver Operator Characteristic (ROC) curve. A value of at least 70% for the area under the ROC was considered acceptable for discriminative accuracy . The adjOf the 260 active members of the Association of Swiss Chiropractors, 81 (31%) recruited patients for this study. Six hundred fifty seven neck pain patients provided baseline data with 274 being acute (< 4 weeks), 124 being subacute (4 – 12 weeks) and 255 being chronic (> 12 weeks). The 124 subacute patients in the database were not included in this study and 4 other patients were deleted from the database because they could not be reached for the three consecutive follow-up telephone calls. This resulted in baseline data for 529 total acute and chronic patients  of the variance in improvement at 1 month.Table In the subsequent multivariate model for improvement at 3 months, only two variables remained as independent predictors in the acute patients and one variable in the chronic patients Table . The PGIThe predictors of improvement in acute and chronic neck pain patients undergoing chiropractic treatment appear to be very similar to those found for patients suffering from low back pain -25. The Although the various demographic details collected at baseline in this study were largely not predictive of improvement at 1 week, 1 month or 3 months, it is important to emphasize two clinical conditions that were not predictive of a worse outcome. Thus neck pain patients who also had cervical radiculopathy (34 acute and 29 chronic patients) or who reported associated dizziness (51 acute and 64 chronic patients) improved as much as neck pain patients without these additional signs or symptoms. Previous studies on low back pain patients undergoing chiropractic treatment reported that the presence of additional leg pain was a negative predictor of improvement -27. The Acute neck pain sufferers (symptoms < 4 weeks) presented with higher levels of pain and disability compared to chronic patients (symptoms > 12 weeks), but improved more quickly and in a higher proportion than chronic patients. Although the acute patients did better than the chronic patients , it is important to point out that many of the chronic patients also improved. Additionally, the percentage of chronic patients reporting improvement continued to rise at each data collection time point whereas this appeared to level off at 1 month for acute patients. This study intentionally analyzed acute and chronic patients separately rather than including duration of neck pain into the prediction model. Previous research has already shown that duration of neck pain is a strong predictor of outcome  and it wAlthough there was no significant age difference between the acute and chronic neck pain patients in this study, the chronic patients were significantly less likely to be in paid employment, reported significantly more prior episodes of neck pain and were less likely to be in good general health. The duration of symptoms and the number of previous episodes of neck pain have been found to be predictors of outcome in previous studies ,8,14. SuThere are several limitations to this study. Although a high proportion of both acute and chronic neck pain patients improved at all time points, without a control group this improvement cannot be attributed to treatment. It is also acknowledged that the improvement for many of the acute patients was most likely due to natural history. In this study we collected baseline variables using paper questionnaires but subsequent outcomes were collected through telephone interviews. It has been shown that telephone interview data may have a slightly positive effect on outcomes encouraging patients to report more favorably -31. An aData was also purposely not collected on specific treatments applied or frequency of chiropractic treatment. It would be interesting and important for the education of chiropractors to compare treatment and technique methods with patient outcomes in the future. Data was collected in this study on the date of the last treatment however, and this will be evaluated and reported when the 1 year outcomes data is assessed in the near future.Another limitation to the study may be the validity of the Bournemouth Questionnaire to adequately measure the psychosocial domains such as depression, anxiety, etc. as these variables were not predictive of improvement at 3 months. However, when compared to the NPAD and NDI the BQ was much more sensitive to change on all domains , includiA further limitation may be the fact that most of the variables that were not continuous variables were dichotomized into yes/no or present/absent with the exception of ‘number of previous episodes’ and ‘general health’. This was done to facilitate the clinical utility of this study and assist in interpretation of the results. In most cases there was a straightforward yes/no  answer. In those few variables where this was not the case, we used clinical experience to make the decision and it is fair to say that we may have made the wrong judgment on those two variables which were categorized with three options. This is the same model used in a similar research study done on low back pain patients however .Although this study found that neither the presence of radiculopathy nor dizziness were negative predictors of outcome, no power analysis was done to determine whether the 115 patients with dizziness or the 63 patients with radiculopathy were adequate sample sizes to definitively draw these conclusions. However, at least for the dizziness patients, 115 is approximately one fifth of the total sample of 529 patients.Previous research has identified ‘stiffness’ as a predictor of outcome (8) in neck pain patients treated with SMT. This was not included in the baseline evaluations done by the treating chiropractors and is therefore another limitation in this study.The final possible limitation to this study may be the fact that compared to baseline there were fewer patients at the 1 and 3 month analyses. This was primarily due to the fact that it was not yet time for the 1 month and 3 month telephone calls for several patients. However, both the acute and chronic groups at 3 months had nearly 200 patients each. The first author of this study is directly in charge of large medical databases in two departments at this hospital. Experience of periodically calculating and monitoring pain scores, PGIC scores, proportions of patients improving or worsening with various treatments in these databases has consistently demonstrated that once a threshold of approximately 100 patients in a cohort is reached, additional patients make minimal difference in the statistical results calculated. Therefore this missing data is unlikely to have changed the outcomes with sample sizes this large. If outcome data was available for any of the follow-up time periods, the patient and their baseline data remained in this study.For the most part, baseline variables were not predictive of outcome in neck pain patients and as a consequence prediction of outcome at 1 week was not possible using the potential predictors measured in this study. Instead, the most consistent predictor of improvement at both 1 and 3 months for both acute and chronic neck pain patients undergoing chiropractic treatment is significant self-reported improvement early on. Importantly, the co-existence of cervical radiculopathy or dizziness in addition to neck pain was not associated with a negative outcome for either acute or chronic patients.The authors declare that they have no competing interests.CP: Concept and design of the study, collection and entry of data, analysis and interpretation of data, drafting and revising the manuscript, final approval of the manuscript. JB: Concept and design of the study, data analysis and interpretation, revising the manuscript, final approval of the manuscript. BKH: Concept and design of the study, data analysis, revising the manuscript, final approval of the manuscript. All authors read and approved the final manuscript.


Fibromyalgia (FMS) is a valid clinical condition that affects 2%–4% of the population with a pivot symptom of widespread body pain. The cause and cure of FMS are as yet unknown. The concept of FMS has evolved over the past two decades to incorporate symptoms beyond pain as contributing to the global spectrum of suffering. FMS is now recognized to be grounded in the neurological domain with evidence of dysregulation of pain processing. Appreciation of the neurophysiologic mechanisms operative in FMS has contributed to rational treatment recommendations, although a “gold standard treatment” does not currently exist. Ideal treatments for FMS patients should be individualized with emphasis on active patient participation, good health practices, and multimodal intervention, incorporating nonpharmacologic and pharmacologic treatments. Predictors of outcome, which is favourable in over 50% of patients, are unknown, but those with better outcome do more physical activity and use fewer medications. Fibromyalgia (FMS) is a condition characterized by the pivot symptom of pain throughout the body, and with abnormality centered in the nervous system . Over thAn evolution of the clinical understanding of FMS over the last two decades has emphasised the importance of symptoms beyond pain which form an integral part of this condition and contribute to global suffering. In this context, it became necessary for the criteria for a diagnosis of FMS to be reevaluated. The coming of age of FMS was heralded by the publication of updated criteria for the diagnosis of FMS, taking into consideration additional symptoms that are present to a variable degree in individual patients . In addiNeurophysiological studies have contributed to the acceptance of FMS as a valid condition. Demonstration of objective changes in the research setting has given clinicians the confidence to acknowledge a condition that presents with only subjective complaint and no objective clinical findings . DysreguEven with objective scientific support of abnormality, some scepticism still exists regarding the validity of subjective complaints requiring complete reliance on the practice of the art of medicine . The conThis paper is based on a review of the literature achieved by a comprehensive literature search using MEDLINE, CINAHL, Cochrane, PUBMED, EMBASE, Cochrane Library, and PsycINFO. MEDLINE is widely used as a premier source for biographic coverage of the literature and the CINAHL for nursing literature. In addition to the formal search, a manual search from the references cited by original studies and reviews was also used where indicated.Clinicians are traditionally skeptical of any condition wherein there is disconnection between complaint and physical examination findings. This was first evident with the construct of phantom limb syndrome, now accepted as a real phenomenon and cause of pain in the absence of anatomical tissue in the periphery . BeginniBeginning with their landmark study in 1981, Yunus and coworkers have championed the recognition of this condition over the past three decades . In thisThere have been physicians who have disputed the validity of a condition presenting with subjective complaints and associated with considerable functional impairment, without objective clinical findings. Some have even suggested that FMS was mostly a manifestation of depression , 13. HowThe clinical challenge of this condition remains as there is still no objective clinical finding or test to confirm the diagnosis, or gauge severity of symptoms. Physicians are required to assess this syndrome on the basis of subjective report only. This has fostered a sense of clinical uncertainty leading physicians to often consider a diagnosis of FMS only when other possible diagnoses have been excluded . This inInitially, FMS was considered to be a condition of pain, and this concept was reinforced by the 1990 ACR criteria which only included features of pain and localized body tenderness . The undThe typical patient is female in her 40's or 50's with a few years of ill-defined musculoskeletal pain . Onset oPain is described as being diffuse, deep, and continuous often with periods of exacerbation. Pain symptoms may be modulated by various factors including psychological stress, excessive physical activity, fatigue, or changes in the weather . Some paMultiple symptoms contribute to the burden of suffering and are increasingly recognized as important from the patient perspective and require attention for achieving optimal patient care , 19, 26.FMS patients can experience important cognitive dysfunction, which associates with pain, but not current depression or anxiety, and includes poor working memory, spatial memory alterations, free recall, and verbal fluency –32. CognPatients with FMS are heterogeneous and attempts have been made to group patients into categories to help direct treatments and predict outcome , 34, 35.FMS may accompany other medical, neurological, or rheumatologic illnesses as a comorbid condition . ConditiCriteria for the classification of FMS were established almost two decades ago and take into account only the symptom of pain . AlthougThe original 1990 criteria for classification of FMS pose at least 2 important practical problems . FirstlyAccording to the 1990 criteria for a classification of FMS, in addition to widespread body pain, tender points were required to be present in at least 11/18 designated areas . Tender The correct examination method for tender points is also debatable. Methods that have been used include digital palpation, myalgic scoring, or dolorimetry . AlthougTaking into account the presence of symptoms other than pain and the questions posed by tender points, new criteria for a diagnosis of FMS have recently been published . These nAs early as 1989, Yunus has advocated that a diagnosis of FMS should not be made by exclusion, but rather by positive assessment of a constellation of symptoms . AdditioPrimary care physicians will be the first to evaluate and manage patients with a complaint of body pain due to FMS , 50, 51.The clinical presentation of FMS can however be quite diverse with some areas of the body more painful than others, fluctuations in intensity of pain and variable intensity of other associated symptoms. Patients also differ considerably in terms of severity of functional impairment , 53. ThiIt is also time to dispel the fallacy that FMS is a primary psychogenic condition. As mentioned earlier, depression and FMS are biologically different conditions and depression is present in any chronic diseases, including those with organic pathology, such as cancer and coronary artery diseases. There is no question that the psyche and the body are tightly linked. Illness, particularly prolonged and poorly recognized, fosters mood disturbance. Conversely, mood disorder is associated with reduced motivation to be physically active, resulting in muscle deconditioning and subsequent pain complaint. FMS patients have a greater prevalence of lifetime as well as current mood disorder compared to other populations, but this should not be viewed as causative in each and every patient. It is possible that a vulnerable psychological status may predispose an individual to onset of a pain process, particularly if triggered by some event –56.A clinical evaluation can be used to exclude most other conditions that could masquerade as FMS , 57. SomAlthough the exact cause of FMS is unknown, abnormalities of nervous system pain processing can plausibly explain the persistence of pain in the absence of tissue damage . The reaThe evidence for genetic predisposition stems from studies showing familial aggregation of FMS , 60. ThePsychologic and stress-related factors are the second area of consideration regarding pathogenesis of FMS. Up to 40% of patients' report the onset of symptoms preceded by some triggering event, which might be either psychological or physical . An abnoAlthough FMS patients have a greater lifetime frequency of depression , depressThe concept of a neurological versus a purely somatoform disorder to explain the pathogenesis of FMS continues to stimulate debate , 67. TheChronic pain, as occurs in FMS, may be perpetuated by numerous interacting mechanisms, including increased excitation or reduced inhibition , 69. NeuTreatments will be fully addressed in another article of this supplement. We will however provide a brief introduction by emphasizing new concepts that apply to management of FMS. Firstly, the concept of symptom-based treatments is logical and will allow a focussed starting point for a physician. Secondly, in the setting of no single “gold standard” treatment, a multimodal approach which includes both nonpharmacologic and pharmacologic treatments is rational –77. In tFinally, as patients with FMS commonly report sensitivity to medications, clinical experience suggests that low doses of medications can be used, with gradual increase in dose depending upon efficacy and tolerability. It is the authors' experience that doses of medications used in real life clinical practices are often much lower than those reported in industry-controlled studies. It is also notable that many of the adverse effects of medications present symptoms similar to those experienced by patients with FMS. Therefore, any patient being treated with a medication should be carefully evaluated for both efficacy as well as side effects, and medications should be discontinued unless there is evidence for definite benefit. In addition, combinations of medications are also more commonly used in practice, although there is limited evidence to support this practice from randomised clinical trials. A key principle to management of patients with FMS is to encourage a shift of locus of control towards the patient and to ensure that the patient is an active rather than a passive participant in management. Understanding and support should form the cornerstone of care for these patients, with treatment strategies directed towards psychological status and physical symptoms within the context of family and society. Most patients will eventually with time find some treatment modality which will at least somewhat modulate, but not cure symptoms, improve health status globally and improve function.Evidence-based treatment guidelines include those developed by the American Pain Society (APS) in 2005 and the European League Against Rheumatism (EULAR) in 2008 , 78. RecNonpharmacologic treatments are an important component of management and recommended in both sets of guidelines. These might include a tailored exercise program, water therapy, physiotherapy, relaxation, cognitive behavioural training, and psychological support .Factors that can help predict the outcome for patients with FMS are as yet not fully understood, but patients that do well are more likely to be engaged in physical activity and use less medication. Realistic outcome goals should be emphasized. Reduction of symptoms should be translated into improved functional status. When a patient reports improvement in symptoms without a parallel functional change, the physician should question first the true efficacy of the treatment, secondly the side effect profile which might be contributing to poor effect on function, and finally patient motivation to achieve an improved health status.A study of outcome done by postal questionnaire in the USA suggested continued pain and disability, with little change over time , 53. HowThere is accumulating and ample evidence in the scientific literature to support the existence of FM as an entity and as a diagnosable condition by its own characteristic features, even in the absence of an objective clinical test. There has been a substantial progress in an understanding of the pathophysiology of FMS in the past 20 years. Now it is known that it is a neurobiological disease. The mechanisms predominantly involve central sensitization, contributed by genetics, endocrine factors, poor sleep, psychosocial and physical stress, and physical trauma. The initial clinical challenge is to correctly diagnose FMS on the basis of patient report and in the absence of an objective clinical test to confirm diagnosis or gauge severity of symptoms. Therefore, the accurate recognition of FMS and assessment of response to treatments still require the time-honoured art of clinical medicine . There i