The aim of this study was to validate a Spanish version of the Chronic Pain Acceptance Questionnaire (CPAQ). Pain acceptance is the process of giving up the struggle with pain and learning to live a worthwhile life despite it. The Chronic Pain Acceptance Questionnaire (CPAQ) is the questionnaire most often used to measure pain acceptance in chronic pain populations.A total of 205 Spanish patients diagnosed with fibromyalgia syndrome who attended our pain clinic were asked to complete a battery of psychometric instruments: the Pain Visual Analogue Scale (PVAS) for pain intensity, the Hospital Anxiety and Depression Scale (HADS), the Medical Outcome Study Short Form 36 (SF-36), the Pain Catastrophising Scale (PCS) and the Fibromyalgia Impact Questionnaire (FIQ).Analysis of results showed that the Spanish CPAQ had good test-retest reliability (intraclass correlation coefficient 0.83) and internal consistency reliability (Cronbach's α: 0.83). The Spanish CPAQ score significantly correlated with pain intensity, anxiety, depression, pain catastrophising, health status and physical and psychosocial disability. The Scree plot and a Principal Components Factor analysis confirmed the same two-factor construct as the original English CPAQ.The Spanish CPAQ is a reliable clinical assessment tool with valid construct validity for the acceptance measurement among a sample of Spanish fibromyalgia patients. This study will make it easier to assess pain acceptance in Spanish populations with fibromyalgia. Fibromyalgia is a chronic musculoskeletal pain disorder of unknown aetiology, characterised by widespread pain and muscle tenderness and often accompanied by fatigue, sleep disturbance and depressed mood ,2. The pIn the last decade, "acceptance" has emerged as a valuable construct for contextual or third wave psychotherapies. Although sometimes misinterpreted as surrender , the reaHayes described, for the first time, a general measure of acceptance and experiential avoidance, the Acceptance and Action Questionnaire ,7. The CFactor analysis of the main tool for measuring acceptance, the Chronic Pain Acceptance Questionnaire (CPAQ), initially reveals 34 items and four components, which are as follows: activity engagement; pain willingness; thought control and chronicity. Based on evaluation of the psychometric properties of these four subscales, however, McCracken et al.  reduced The Activity Engagement subscale consists of eleven items and gauges the extent to which a person follows their activities in a normal way regardless of their experience of pain. The Pain Willingness subscale has nine items and measures how much a patient believes that avoiding or controlling pain are strategies that work for him. A total score is reached by combining both subscales. Previous research studies ,9,12,13 These results imply the potential of an improved outcome for acceptance-based clinical methods for chronic pain management. The CPAQ has already been validated in German  and Chin1, which was diagnosed by a Spanish National Health Service rheumatologist. The only exclusion criterion was a medical or psychiatric disorder that impeded the patient's ability to correctly answer the questionnaire. The study questionnaires and protocol were approved by the Ethical Committee of the regional health authority, and patients signed a consent form attesting to their willingness to participate in the study.Sample size was calculated according to the recommended 10:1 ratio of the number of subjects to the number of test items . The finAfter consenting to the study, recruited patients were given a battery of questionnaires for completion. All patients completed these instruments on the day of the visit. These included a pain form for demographic and pain-related variables, including the translated Spanish version of the CPAQ to be validated, a Pain Visual Analogue Scale (PVAS) for pain intensity, and the validated Spanish versions of the Hospital Anxiety and Depression Scale (HADS), the Short Form 36 (SF 36), the Pain Catastrophising Score (PCS) and the Fibromyalgia Impact Questionnaire (FIQ).Two researchers, who were aware of the objectives of the CPAQ, did the first translation into Spanish. Each researcher translated the questionnaire separately. Subsequently, two native English teachers who had no knowledge regarding the instrument carried out back-translations. Finally the two English versions were judged equivalent by a third native English teacher, . Any difThe PVAS consists of a 10 cm long straight line whose tips represent the limits of pain intensity (none to unbearable). The patients estimated the pain intensity experienced on the same day between 0 and 10.The Chronic Pain Acceptance Questionnaire (CPAQ) is a 20-item inventory designed to measure acceptance of pain.  is a 36-item instrument designed to measure general health status and health-related quality of life . One iteThe PCS is a 13-item scale designed to assess the catastrophising cognitions of individuals by asking them to reflect on thoughts or feelings associated with present painful experiences . The PCSThe Fibromyalgia Impact Questionnaire (FIQ) is a 10-item self-report questionnaire developed to measure the health status of fibromyalgia patients . The firPatients diagnosed with fibromyalgia, fulfilling the criteria previously described, who attended our clinics during the year 2009 were invited to participate until the expected sample was completed. In a subsample of 64 patients, test-retest reliability for a 2-week interval was calculated. Face validity was assessed asking patients from the Spanish Association of Fibromyalgia whether they thought that the test could adequately measure their pain acceptance. Construct validity was determined by correlating the Spanish CPAQ scores to validated Spanish versions of various psychometric instruments and comparing the results with those obtained from the original English version. As the FIQ, HADS and PCS reflect health status, mood changes and emotional distress (catastrophising) in fibromyalgia patients, we anticipated that higher CPAQ scores would be associated with lower FIQ, HADS and PCS scores. For patients' general health wellbeing, including physical, emotional and social functions, the SF-36 is able to measure these domains under eight different subscales. We predicted that acceptance, as measured by the CPAQ, should positively correlate to SF-36 subscales. Exploratory factor analysis was carried out as part of the validity test.Demographic data was analysed using the descriptive statistics of mean, standard deviation (SD) and range. Age and duration of pain were used as continuous variables. The remaining variables were used as dichotomous ones. The dichotomised categories and their prevalence for each variable are as follows: gender was dichotomised into male and female; marital status was grouped into married and single/separated/widowed; work status was divided into employed and unemployed and educational level was dichotomised into elementary/primary and secondary/tertiary. The CPAQ correlations were established with female, married, employed and secondary educational level.The association between the Spanish CPAQ and demographic characteristics were evaluated using Pearson correlations. Cronbach's α coefficient was used to examine the internal consistency  of the questionnaire. Test-retest reliability was assessed using analysis of variance intraclass correlation coefficients (ICC) . ICC wilNone of the participants were ruled out because of the exclusion criteria. The study sample consisted of 205 patients (90.7% women and 9.3% men) between the ages of 26 and 77 years . Each of the subjects described themselves as being of European ethnic origin. On average, the patients had suffered from fibromyalgia for 12.1 years (range 1-55 years), and 25.2% had been granted a disability pension. Two-thirds (65.7%) of patients were unemployed, whereas 34.3% of patients were employed full- or part-time. The majority of the participants were married (73.6%), while the rest were single/separated/widowed (26.4%) individuals. Finally, most participants had an elementary-primary education (59%), while 41% had received a secondary-tertiary education.The mean CPAQ total score was 40.9 . This amounted to a mean item rating of 2.0, which most closely corresponds with the lower range of the 0-6 scale and the rating category "Seldom true" for the average acceptance item. The mean for the subscales of activity engagement and pain willingness were 23.0  and 18.1 , respectively. The scores for other instruments are summarised in Table There was no significant association between CPAQ total score and most demographic characteristics, including age, sex, marital status, duration of pain or education level. However, work status  was almost correlated to CPAQ, suggesting that there might be an association Table .For assessing face validity a sample of patients (N = 200) randomly recruited from the Spanish Association of Fibromyalgia were asked whether they thought that the test could adequately measure their pain acceptance. A total of 93.5% (187 out of 200) of them agreed.The overall ICC value was 0.83 with individual values Table  indicateThe Pearson correlation was used to assess the relationship between CPAQ and other psychometric instruments, and the results are summarised in Table The psychometric properties of the Spanish version of the CPAQ among patients with fibromyalgia patients are adequate. The Scree plot indicated a two-factor construct of the translated questionnaire similar to its original English version. Both factors had eigenvalues greater than one. Principal Components with Varimax Rotation revealed a satisfactory percentage of Total Variance explained (40.7%) by the two factors. Looking at the Component Matrix of the two-factor construct, individual items could be allocated to the same subscales as they were in the English version of the CPAQ. Therefore, construct validity of the translated CPAQ can be supported.We have selected a two-factor solution, although it was not the only possible solution. More than two factors had eigenvalues above 1, and the Scree plot was not absolutely clear in supporting this decision. We have selected this solution because it seems the more coherent from a clinical point of view. This is the same factor structure obtained by both the original authors  and the The Spanish version of the CPAQ showed good test-retest reliability  and internal consistency reliability (Cronbach's α 0.83). Items n° 13 and 20 showed lower test-retest reliability than the other items (ICC < 0.5). In the original McCraken study, these data are not available , ICC valAs tends to happen in fibromyalgia surveys, the SF-36 scores were below average. In this case, the average total score for CPAQ in this fibromyalgia group (mean 40.9 with SD of 18.5) was lower than other samples, where usually the mean is around 50 ,13,16,17Regarding demographic data, the variable duration of pain has received special attention, as it may indicate that acceptance of chronic pain is in some way a product of experience or something acquired over time. In fact, one recent work showed a positive correlation between the CPAQ and duration of pain . HoweverThese study results concurred with our prediction and supported the content validity of the Spanish version of the CPAQ. In the future, the Spanish CPAQ could help to illustrate treatment mechanisms. To reach this goal, the next step would be to assess the responsiveness of the CPAQ to intervention. Further research with longitudinal designs and multivariate models would be required to investigate treatment mechanisms.As McCracken has already pointed out , the resThese findings hold potentially significant implications for the treatment of patients with fibromyalgia and chronic pain at a time in psychology when the usefulness of traditional, control-based approaches is under question. The increasingly popular Contextual Therapies approach proposes that attempting to control negatively valenced internal events, such as pain sensations and negative emotional reactions, is problematic. For example, from the Acceptance and Commitment Therapy (ACT) perspective, attempts to control aversive experiences are, in the best case, an unproductive endeavour that can hinder the pursuit of valued experiences or, in the worst case, an additional source of distress . ExperimFinally, in order to prevent misunderstandings, it should be noted that acceptance of chronic pain is but one part of a contextual model of chronic pain and its treatment. Other relevant processes include, among others, present-focused awareness, values-based guidance of actions and cognitive defusion. It will be interesting to continue to explore the influence of these processes on patient functioning.In conclusion, the study confirms the adequate psychometric properties of the Spanish version of the CPAQ in fibromyalgia patients. Although acceptance is considered to be one of the key processes of recovery in pain syndromes, there have been hardly any studies in our country to enhance our knowledge of this concept. This study will make it easier to assess acceptance in Spanish populations.The authors declare that they have no competing interests.BR, JGC, BC and ASS conceived the study design. BC performed the clinical diagnosis of fibromyalgia. YLdH and BR collected the data. BR and JVL conducted the statistical analysis, and all authors interpreted the results, drafted the manuscript and read and approved the final manuscript.Spanish version of the CPAQ.Click here for file


Most patients with advanced or metastatic cancer experience pain and despite several guidelines, undertreatment is well documented. A multicenter, open-label, prospective, non-randomised study was launched in Italy in 2006 to evaluate the epidemiology, patterns and quality of pain care of cancer patients. To assess the adequacy of analgesic care, we used a standardised measure, the pain management index (PMI), that compares the most potent analgesic prescribed for a patient with the reported level of the worst pain of that patient together with a selected list of clinical indicators. A total of 110 centres recruited 1801 valid cases. 61% of cases were received a WHO-level III opioid; 25.3% were classified as potentially undertreated, with wide variation (9.8–55.3%) according to the variables describing patients, centres and pattern of care. After adjustment with a multivariable logistic regression model, type of recruiting centre, receiving adjuvant therapy or not and type of patient recruited  had a significant association with undertreatment. Non-compliance with the predefined set of clinical indicators was generally high, ranging from 41 to 76%. Despite intrinsic limitations of the PMI that may be considered as an indicator of the poor quality of cancer pain care, results suggest that the recourse to WHO third-level drugs still seems delayed in a substantial percentage of patients. This delay is probably related to several factors affecting practice in participating centres and suggests that the quality of cancer pain management in Italy deserves specific attention and interventions aimed at improving patients’ outcomes. Pain is a major problem for patients with cancer. Meta-analyses report that most patients with advanced or metastatic cancer experience pain , undertrIn Italy, opioid consumption rates are yet among the lowest in Europe . As receTo improve the quality of cancer pain management, the Mario Negri Institute implemented a project on 2004 in Italy , and an Background and methods are described elsewhere , 2008. BAfter enrolment/inclusion, the following screening assessments were carried out and recorded weekly for the first month, with a final visit at week 12 (at the end of the study): (a) medical history including cancer history, (b) physical examination, (c) record of medications and recent therapies, including analgesic consumption, (d) pain and symptom assessment, (f) patients’ and physicians’ satisfaction with pain treatment and (g) patient's self-reported quality of life.Patients’ and physicians’ reports were collected using standardised forms at scheduled visits. Self-administered questionnaires were completed when the patient attended regular visits at the centre or during admission or at home depending on the setting of care. Investigators recorded information about patients and disease, pain medications and type and number of rescue doses in a case report form.Pain characteristics  were the primary outcome measures. Other patient-reported outcomes were collected too, such as satisfaction with care, quality of life and symptoms. Pain was measured using five items from the Italian version of the Brief Pain Inventory , developed by To construct the index, we determined which of four levels of analgesic drug therapy was the most potent one used: 0, no analgesic drug; 1, a non-opioid ; 2, a weak opioid ; and 3, a strong opioid . We then determined the patient's level of pain from the Brief Pain Inventory . No pain was scored as 0; mild pain, 1; moderate pain, 2; and severe pain, 3. The PMI, computed by subtracting the pain level from the analgesic level, ranges from −3  to +3 . Negative scores are considered to indicate pain undertreatment, and scores of 0 or higher are considered a conservative indicator of acceptable treatment see .As the PMI provides only a rough estimate of how pain is treated in a sample taking into account only some attributes of the pain characteristics . Then, wGiven the large number of centres, we used a web-based system to optimise the handling of all aspects of the clinical study, including data entry, quality assurance and validation. A general data entry engine for clinical trials developed by the Mario Negri Institute was used, which was compliant with current laws concerning ethical and regulatory issues  could see and evaluate up to 2500 eligible cases. We also assumed that at least half would already be receiving a WHO level III treatment and most of the others would eventually need a WHO level III analgesic during the longitudinal evaluation period.There were no formal estimates of the proportion of cases who might be classified as undertreated at inclusion, although, on the basis of a systematic review of the literature pertaining to the PMI . After univariate analysis, a logistic model was fitted using maximum likelihood estimation to express the odds of each variable relative to the reference category, after adjustment for all other covariates. For example, the risk of being classified as undertreated for a patient with 70 years of age or more was compared to one younger than 51 years, given the same sex, type of cancer and analgesic adjuvant therapy. In addition, 95% confidence intervals of the ORs were computed.In the descriptive analysis, absolute frequency was used for categorical variables and central trend and dispersion measurements  for quantitative continuous variables. When comparing groups, P-values must be considered with cautions as merely suggestive of a trend.Given the observational nature of the study, the relatively large sample size and the number of statistical tests, The study complied with Italian requirements for observational studies. The protocol was approved by the local research ethics committees of participating centres. All patients gave written informed consent to participate in the study. The full study protocol was published in an open-access journal before the study started , there was a clear tendency: the proportion of undertreatment ranged from 44.7 to 20.2% with a consistent and statistically significant gradient (P<0.0001). Among the other potential predictors tested with univariate analyses, the absence of bone metastasis and ongoing chemotherapy, being recruited in pain and palliative centres, having a colorectal cancer, and not receiving adjuvant analgesic therapy, were significantly associated with a higher probability of being classified as undertreated (OR=>1.2 and P<0.05). After multivariable logistic regression, only type of recruiting centre (P<0.01), receiving adjuvant therapy or not (P<0.001), and type of patient recruited  showed a significant association with undertreatment. To describe the effect of these three variables better, we assembled a new composite variable comprising all the possible mutually exclusive combinations of the original predictors transposed to 12 possible levels where we estimated the prevalence of undertreatment. Estimates ranged from 9.8  to 55.3% . When patients were classified according to the time of the follow-up or treatment before inclusion  compares the earlier results ranging from as low as 7–9% in a survey in the United Kingdom  than patients already followed by the centre. This factor has been underestimated in the literature and it should, therefore, be stressed that the patient's pain history is a significant variable in evaluating epidemiological and therapy-related information. A selection bias can also have occurred in our study as physicians may have referred those patients who needed expert advice for treating their pain, although 20% of negative PMI persisted also in patients referred to the centre since a long time .In this study, the setting of care and receiving an adjuvant analgesic drug treatment were also predictors of the PMI status. Being admitted to a hospice and the use of an adjuvant drug were in fact independently associated with more adequate analgesic treatments. These observations might be interpreted as indicative of a delay of starting strong opioids influenced by attitudes of practice and setting of care. Time of patient referral to the centre, considered as very important, is not enough to explain pain and pain treatment history. Organisation and expertise in pain management and monitoring by different specialists and in different settings, such as an in-patient hospice or outpatient pain clinic, probably influence the recourse to more potent drugs.The use of adjuvants for neuropathic pain is an indicator of compliance with available guidelines , and perAlthough the usefulness of the PMI is proved by the large number of studies that have used this score since 1994, some drawbacks are well known (Cochrane Review document that the addition of bisphosphonates can be beneficial (When we used a selected list of indicators to describe the attitude of Italian physicians towards treating subgroups of patients with specific clinical conditions, we found that the general picture captured by PMI does reflect substantial undertreatment. These indicators also added important information about less than optimal practices. Only 59% of patients with severe worst pain actually received a strong opioid as ‘around the clock therapy’ at the time of study enrolment, 44% with neuropathic pain had an adjuvant drug prescribed and 24% with breakthrough pain had a ‘rescue’ analgesic. The interpretation of the fact that only 38% of patients with bone metastasis actually were receiving bisphosphonates is less straightforward as the role of these drugs to obtain immediate pain relief remains uncertain, despite results from a neficial . InteresIn summary, in this prospective observational study, the PMI method indicated a high prevalence of analgesic undertreatment in Italy, around 50% in some subgroups, which varies according to several factors related to the characteristics of the cases and to some structural and organisation variables. These findings confirm the results of a systematic review (It is likely that after the first impact of the WHO guidelines on cancer pain after their first publication in 1986, the present overall strategy for managing cancer pain in Italy would need more structured interventions to improve and standardise quality of care. Evidences about the most effective interventions in changing the outcome of current practice in cancer pain management are scarce. Although guidelines implementation proved to have an impact on patient-reported outcomes . Others Our results also support the idea that palliative care, like the prevention and relief of symptoms in cancer patients, needs to be a component of patient care also during anticancer treatment, and not merely at the end of life. A wider approach is therefore needed, with better education on palliative care and pain management to improve the use of opioids, to standardise the practice of managing cancer pain to minimum standards .


Chest pain raises concern for the possibility of coronary heart disease. Scoring methods have been developed to identify coronary heart disease in emergency settings, but not in primary care.Data were collected from a multicenter Swiss clinical cohort study including 672 consecutive patients with chest pain, who had visited one of 59 family practitioners' offices. Using delayed diagnosis we derived a prediction rule to rule out coronary heart disease by means of a logistic regression model. Known cardiovascular risk factors, pain characteristics, and physical signs associated with coronary heart disease were explored to develop a clinical score. Patients diagnosed with angina or acute myocardial infarction within the year following their initial visit comprised the coronary heart disease group.The coronary heart disease score was derived from eight variables: age, gender, duration of chest pain from 1 to 60 minutes, substernal chest pain location, pain increasing with exertion, absence of tenderness point at palpation, cardiovascular risks factors, and personal history of cardiovascular disease. Area under the receiver operating characteristics curve was of 0.95 with a 95% confidence interval of 0.92; 0.97. From this score, 413 patients were considered as low risk for values of percentile 5 of the coronary heart disease patients. Internal validity was confirmed by bootstrapping. External validation using data from a German cohort  revealed a receiver operating characteristics curve of 0.75  with a sensitivity of 85.6% and a specificity of 47.2%.This score, based only on history and physical examination, is a complementary tool for ruling out coronary heart disease in primary care patients complaining of chest pain. Chest pain is a common complaint that occurs in 1 to 2% of primary care patients . Family Predictive scores for CHD in emergency settings have been developed -9, and aWe used data from a multicenter clinical cohort of primary care patients with chest pain (TOPIC - Thoracic Pain in Community)  to develThe initial survey used a research network of family practitioners. Fifty-eight independent offices, urban and rural, and one primary care outpatient clinic from Western Switzerland recruited patients from March to June 2001. Family practitioners consecutively enrolled all patients over 16 years of age who reported any type of chest pain during their visits (n = 672). The presence of chest pain was ascertained according to the usual practice of each family practitioner. Chest pain due to obvious causes such as trauma or known body metastases were also included. Patients with anginal equivalents alone, such as jaw pain, dyspnea on exertion, arm pain, and so on, were therefore excluded. Chest pain was not necessarily the chief complaint on presentation. Participating physicians had an average term of experience in private practice of 12 years (range 1 to 24). They received detailed information on the study and were trained to fill in the forms during a special meeting. Each patient gave informed consent to participate in the study. The study protocol was approved by the official state local Ethical Committee (Prot. 41/2000).Physicians completed the first part of the Case Report Form (CRF) during the patient's index visit. Additional follow-up information was obtained after three and twelve months . All completed forms were sent to the study coordination center. A set of predefined criteria was used for data entry checks. The data entry clerk reported inconsistencies to the principle investigators, who contacted physicians when needed for case resolution. Missing data were completed by contacting physicians by telephone and obtaining answers from the patient's record. Double data entry was used to identify transcription errors. Data cleaning and validation was performed by a group of physicians experienced in research. When the diagnosis reported by the family practitioner was not consistent throughout the year of follow-up, the final diagnosis for chest pain was discussed and approved by a group of clinicians who were not aware of the aim of this study.We recorded general patients' information as well as type, characteristics and location of chest pain. Chest pain was either already known or a new symptom. An initial plausible etiology, or early diagnosis, was noted. The first part of the CRF included 70 questions on history and clinical signs of chest pain, of which 12 questions concerned factors that were known to be associated with CHD , and fouIn a primary care setting, it is very difficult to have all patients' cardiovascular status assessed using a gold standard. We therefore opted to use a delayed diagnosis over one year to detect patients with CHD. During the initial visit, the suspected diagnosis was noted and then confirmed or modified during follow-up. Detailed information on patients' history and physical examination, level of anxiety expressed by patients and physicians, cardiovascular and thrombo-embolic risk factors, laboratory results obtained in emergencies, co-morbidities, medications, and treatment decisions at the end of the consultation were also collected. CRFs included information on further examinations and laboratory assays, referrals to specialists, admissions to emergency wards, hospitalizations, and health events during the follow-up period. The diagnoses retained after 12 months of follow-up were grouped in six categories: chest wall, CHD, psychogenic, respiratory, digestive, and miscellaneous. CHD included angina pectoris, unstable angina, and myocardial infarction (MI). When the diagnosis of chest pain was inconsistent or uncertain through the follow-up, a group of investigators discussed the case. When the group of investigators was unable to confirm the diagnosis, or if the diagnosis at 12 months was missing, the patient was contacted for further information through his family practitioner. If the patient could not be contacted, the diagnosis at three months was retained. Ten percent of all CRFs were revised by the group of investigators in evaluating the consistency of the final diagnosis.External validity was done using data from a German (Marburg) study. Briefly, 1,199 patients aged 35 and over with chest pain observed in one of 74 family practitioners' offices in Germany were successively included in this study. Chest pain was previously unknown and present for a maximum of one month. Patients were followed-up during six months. Cases were defined as patients having been diagnosed with CHD during the following six months by experts who were blinded to patients' clinical conditions. Variables used from this study were age, sex, cardiovascular risk, history of CVD, presence of retrosternal chest pain, pain triggered by exertion, and pain at palpation. Having a cardiovascular risk was defined as having at least one of the following characteristics: family history of CVD, diabetes, hypertension or treated hypertension, hyperlipidemia or treated hyperlipidemia, smoking or obesity (Body Mass Index ≥30).P < 0.1) were eligible for inclusion in a multivariable logistic model. A variable was retained in the model if it significantly contributed to the model (P < 0.05). Goodness of fit was assessed by means of the Hosmer and Lemshow test. A score was then defined on the basis of the coefficients of the logistic regression, and rounded to the nearest unit. Area under the receiver operating characteristic (ROC) curve was an indicator of the discriminatory power of the score. The coefficient of the logistic model with CHD as the dependent variable and the score as the unique independent variable was estimated as a second performance index [low-risk category, and percentile 95 of the non-CHD group for the high-risk category. Patients with a score between these two cut-off values were considered at intermediate-risk. The sensitivity and specificity of the prediction rule for discriminating low- from intermediate- or high-risk cases indicated the classification performance of the score. The prevalence of CHD at given score levels and risk categories was determined, and the mean of the estimated individual probabilities was given. Sensibility analysis was performed to assess the effect of not considering patients with unknown cardiovascular risk status to be at risk. Data were reanalyzed, considering patients with unknown cardiovascular risk status as patients having a risk.From previous studies we expected a prevalence of CHD of 10%. The study was powered to detect factors for which the risk of CHD was increased by two (20% vs. 10%) with β set at 0.2 and α at 0.05. The smallest expected exposure group was the one including patients with previous history of CVD (20%). This required including 127 patients with history of CVD and 510 without, or a total of 637 patients with chest pain. Expecting 10% lost to follow-up or missing data, we rounded this to 700 patients. Bivariate analyses were performed to identify factors associated with CHD in patients with chest pain. Fishers' exact test was used. Variables associated with CHD  or were younger than 16 (n = 5). In the remaining group of 661 patients, an average of 11.2  patients were recruited in each of the 59 centers. The total practice-year we followed was of 4.8 years including Thursdays, Saturdays and Sundays when practices are closed. This corresponds to an average of 0.7 patients with chest pain for every GP for every working day. The recruitment period was nevertheless not the same between physicians. Eleven physicians stopped recruiting before they were meant to. If we overview the intervals from which patients were recruited for each physicians, inclusion was constant over time. Physicians apparently either stopped recruiting or continued recruiting per protocol. The mean age of patients included in analysis was 55.4 years (SD ±19), and 314 patients (47.5%) were male. Most patients  were already known to their family practitioners, and 314 (47.5%) had never experienced the same type of pain before. One hundred and twenty patients (18.2%) had previous evidence of CHD or CVD  and 433 patients (65.5%) were known to have one or more cardiovascular risk factors, 196 were known to have none. The presence of cardio-vascular risk was unknown to the physician for 32 of the 661 patients. Eighty-five patients (12.9%) were diagnosed with CHD, including 75 cases of angina pectoris (11.1%), six cases of unstable angina (0.9%) and four cases of myocardial infarction (0.6%). None of the 196 patients for which it was known that they had no risk factor, and two of the 32 patients with unknown laboratory status were diagnosed with CHD.P = 0.1 . Including all 661 patients in the regression model, the following variables were not significant at a P = 0.05 level: previously having a similar complaint , not position dependent , sudden excruciating pain , oppressive pain , and not increased by a deep breath . These variables were excluded, and the coefficient of regression was computed for the seven remaining predictors (Table P = 0.250). The absence of any clustering effect for physicians was confirmed using random-effects logistic regression . Adjusting for clustering had no effect on CHD score values. Only two cases were not identified at three months and were reported as such during the follow-up period. Results of the logistic regression excluding these two cases remain the same.Age and gender were combined in a single ordinal variable; men <55 and women <65 made the reference group. Men from 55 years to 64 years and women from 65 years to 74 years were coded 1, and men 65 years or over and women 75 years or over were coded 2. Previously having a similar complaint was confounded by other factors  are given in Table 2 = 0.538). The cut-off point for low-risk (defined as the fifth percentile of the CHD patients) was 5. Thus, the 413 (62.5%) patients with scores <5 were defined as low-risk. In the low-risk group, one patient was diagnosed with stable angina and another with myocardial infarction during the following 12 months. The sensitivity of this rule is 97.6% (83/85), the specificity 71.3% (411/576), the negative likelihood ratio of 0.033, and the negative predictive value of 99.5% (411/413).The area under the curve (AUC) of the receiver operating characteristics (ROC) Figure  was 0.94high-risk (defined as the 95th percentile of the non-CHD group) was 7. According to this rule, 87 patients (13.2%) with scores >7 were defined as being at high-risk. Finally, 161 patients (24.4%) were classified as intermediate-risk. The prevalence of CHD in the low-risk category was 0.5% (2/413), 12.4% (20/161) in the moderate category and 72.4% (63/87) in the high-risk category . Mean sensitivity and specificity for the rule-out threshold values were 0.956 (SD 0.027) and 0.710 (SD 0.077), respectively.The results of the 300 iterations of score development (bootstrapping) gave consistent results with the initial analysis, except for 40 samples. The mean area under the curve for the 300 different prediction rules applied to the original sample was 0.942 (SD 0.004), and the mean calibration index was 0.87 (SD 0.13). When the predictive rules where applied to the bootstrap samples, we had a mean area under the curve of 0.950 (SD 0.011), and a mean calibration index of 0.97 (SD 0.07). The difference between both calibration indexes revealed the Nevertheless, the classification appears to be relatively stable because the 392 patients in the low-risk category were classified on average 283.35 times (range 149 to 300) in the low-risk category by the bootstrap rules. The mean prevalence of CHD in the low-risk category was 0.005 (SD 0.005). The distribution of the prevalence of CHD by risk category is given in Table P = 0.254) between patients included in analysis (14.7%) and those who were excluded for missing data (12.3%). The area under the curve was of 0.752 . Prevalence of CHD in the low risk category (score <5) was of 5.2% , which are all known to be associated with CHD , and easOur data show both similarities and differences from the published determinants used to rule out CHD. The American College of Physicians  developeThe major strength of our study is the development of a clinical tool for family practitioners, using data collected by a research network in primary care . The useOur study has some limitations. We would first like to remind physicians that scores derived from logistic regression cannot identify unusual presentations. Consider the example of a young patient who abuses cocaine, and presenting an acute myocardial infarction. This patient would be classified in the low-risk group . ClinicaIn summary, we developed a clinical prediction score to rule out CHD in primary care patients with chest pain. This clinical tool may limit clinical investigation in patients with chest pain in primary care where the presentation and the management are completely different from the emergency departments. However, further analyses of the proposed score should be conducted in various primary care contexts to evaluate its true benefit better and evaluate its implementation.AUC: area under the curve; BMI: body mass index; CHD: coronary heart disease; CI: confidence interval; CRF: case report form; CVD: cardiovascular disease; ECG: electrocardiogram; OR: odds ratio; TOPIC: thoracic pain in community; ROC: rater operating characteristic; SD: standard deviationThe authors declare that they have no competing interests.LH, FV, BB, and TB conceived the design, acquired the data and critically revised the manuscript. BG, PV, CR and BF planned, analysed and interpreted the data, and drafted the manuscript. SB and NDB planned, analysed and interpreted data from the validation cohort, and revised the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1741-7015/8/9/prepub


Reversed shoulder arthroplasty may be used for severe arthropathy where conventional prostheses cannot restore the function sufficiently. We analyzed the medium–term results and potential complications of the reversed prostheses, and also the influence of etiology on the result.52 women and 7 men, average age 70 (60–82) years, were followed for mean 4 (2–7) years. The indications were cuff tear arthropathy (CTA) (23), fracture sequelae (20), and revision of a failed conventional arthroplasty (16).The average Constant score improved from 18 (2–55) points to 59 (17–96) points. It rose from 26 to 74 points in patients with CTA, from 12 to 48 in those with fracture sequelae, and from 10 to 54 points in revision arthroplasty. We also found an overall improvement in active forward flexion from 47° to 105°, and in active abduction from 46° to 93°. Scapular notching was seen in 51 shoulders. Radiolucent lines below the base–plate were present in 2 cases. There were no instances of loosening. Revisions were necessary in 15 patients: 5 with infections , 5 with hematoma, 3 with dislocations, and 2 with disconnections of the shaft components.Reversed prosthetic replacement is a suitable method for restoring function and attaining pain relief in severe arthropathies. The results in revision arthroplasty are less predictable, with complications and revision rates higher than those in CTA patients. The reversed prosthesis should therefore only be used when conventional methods have failed. A painful malfunctioning shoulder due to joint incongruence in combination with a loss of the centering action of the rotator muscles may be caused by severe rotator cuff arthritis, malunited/pseudarthrotic fractures, or loss of the tubercles in prosthesis revision. Contraction of the deltoid muscle when raising the arm induces a cranial migration of the head. An anatomically unconstrained prosthesis does not restore a stable center of rotation and is likely to fail .A reversed prosthesis is a way out of this dilemma, since it allows reconstruction of a stable center of rotation besides replacement of the articular surfaces . DespiteWe compared the results and the complication rates after implantation of a reversed prosthesis in the 3 diagnosis groups. Preoperatively, the groups showed substantial differences in terms of loss of function and degree of destruction.We treated 68 consecutive shoulders with a reversed Delta III prosthesis (DePuy) during the period 2002 – 2007. 59 patients (52 women) with an average age of 70 (60–82) years participated in this study and they were followed prospectively for mean 4 (2–7) years. The indications were cuff tear arthropathy (CTA) in 23 patients, fracture sequelae in 20 patients, and revision of a conventional prosthesis in 16 patients.9 patients did not show up for follow–up because of living too far away (3) or because they were satisfied with the result and did not see any reason for a repeat examination (2). 1 patient was dissatisfied and had undergone further surgery, and 3 could not be reached.The clinical outcome was evaluated using the Constant score, by investigators not involved in the surgery. Strength was measured with a tensiometer at the wrist joint in maximal abduction in the scapular plane. Preoperative and postoperative mobility and pain relief were registered.CTA was classified according to 20 patients had fracture sequelae , which wProsthesis revision was done in 16 patients . This waThe extent of scapular notching was classified according to Rotator cuff condition and rupture size were recorded during surgery .Constant score values are given as mean and median values, as well as 25% and 75% percentiles.Abduction, flexion, and strength parameters were tested non–parametrically with regard to the diagnoses using the Wilcoxon test. The p–values of each comparison were adjusted using the Bonferroni method.Multiple regression models were calculated to compare the diagnostic significance of the Constant score with respect to diagnosis . Separate models for the follow–up examinations (pooled for months 3–36 and more) were estimated. The pooled models also included the months as covariant. The distribution of the residues was checked for normal distribution using Q–Q plots or scatter plots.The average Constant score improved from 18 to 59 points in the overall patient population after 36 months , but droAt average follow–up, the Constant score rose from 15 (2–55) to 55 (17–96) in the overall patient population (a difference of 40), from 26 (2–55) to 74 (44–96) in CTA (a difference of 48), from 12 (2–38) to 48 (17–90) in fracture sequelae (a difference of 36), and from 10 (2–26) to 54 (21–75) points in the revision operations (a difference of 44). The global postoperative gain and the gain per diagnosis group were statistically significant (p < 0.001).The improvement comprised all components of the Constant score, but in particular pain relief and improvement in strength . The mosThese results are also reflected in the improvement in active forward flexion in the overall patient population from 47° (0–100) to 105° (30–180)  and in aWe observed scapular notching in 51 of 59 shoulders: Sirveaux grade 0 in 8 cases, grade 1 in 27 cases, grade 2 in 21 cases, grade 3 in 2 cases, and grade 4 in 1 case. There were no statistically significant differences between the groups. No effect on the Constant score could be seen.Radiographically detectable limited lysis was observed once in zone 1 (upper base–plate of the glenoid component) and once in zone 2 (lower base–plate). Manifest loosening was not observed. No resorption zones were detected around the peg and the screws in the glenoid and in the humerus shaft. Heterotopic ossifications occurred in the region of the lower joint capsule in 14 cases. However, a bony spur was present on the medial margin of the scapular notch in 38 patients . Consequently, the notching appeared deeper than it actually was.We noted 3 cases of dislocation , 1 case of acromion fracture, 1 case of fracture of the coracoid process, and 2 disconnections of the shaft components associated with massive scapular notching. Hematomas led to revisions in 5 cases. Infections were observed in 5 joints. All infections occurred after prior surgery, i.e. 3 after osteosynthesis and 2 after prosthesis revision because of deep infection. This means that 2 of the 6 patients who were admitted to the hospital with a pre–existing prosthesis infection had a reinfection. Overall revisions were necessary in 15 patients. Transient neurological deficits were observed in 2 patients.Implantation of a reversed prosthesis restores a stable center of rotation and thus provides the prerequisites for restoration of function. Considering the often catastrophic initial situation, the outcome was surprisingly good. It is not so much the plain postoperative functional score that is important but rather the gain in function, as a measure for comparison of the preoperative and postoperative state (the “Delta constant”). In the individual patient, a low postoperative value in absolute terms may nevertheless signify a major improvement compared to the preoperative situation.The Constant score obtained in our study was lower than or similar to that in the literature . HoweverFunctional improvement is particularly attributable to the increase in flexion and abduction, but not to external rotation, which did not usually improve—or not significantly. Thus, various authors now evaluate the degree of active external rotation  preoperatively using MRI and, if appropriate, carry out a latissimus dorsi transfer in the same session . RestoraLooking at the individual components of the Constant score, pain relief and increase in strength appear to be the most important parameters affecting the general improvement of function . This isIn our opinion, the most interesting result of our investigation was the continuous fall in score values starting after 3 years postoperatively . SeveralSeveral factors contributed to the low dislocation rate (3/59) in our series compared to up to 25% in the literature. Important factors are meticulous positioning of the implant components, pre–tensioning of the deltoid and coracobrachial muscles, extensive mobilization, and resection of scarred and contracted parts of the capsule and bone fragments, as well as the best possible reconstruction of the external and internal rotators of the rotator cuff .In a survey of the literature, we found relatively high levels of scapular notching . The lowThe revision rate (15/59) is similar to that reported in the literature (17–50%) . All revWe found a complication rate of one–third when scapular notching was not taken into account. This is similar to that reported by In agreement with numerous reports in the literature, our findings indicate that the reversed shoulder prosthesis must be regarded as a salvage procedure despite the astonishingly good results. The gain of function is impressive and depends strongly on etiology, but there are high rates of complications and revisions.


The intuitive early diagnostic guess could play an important role in reaching a final diagnosis. However, no study to date has attempted to quantify the importance of general practitioners' (GPs) ability to correctly appraise the origin of chest pain within the first minutes of an encounter.The validation study was nested in a multicentre cohort study with a one year follow-up and included 626 successive patients who presented with chest pain and were attended by 58 GPs in Western Switzerland. The early diagnostic guess was assessed prior to a patient's history being taken by a GP and was then compared to a diagnosis of chest pain observed over the next year.Using summary measures clustered at the GP's level, the early diagnostic guess was confirmed by further investigation in 51.0%  of patients presenting with chest pain. The early diagnostic guess was more accurate in patients with a life threatening illness  and in patients who did not feel anxious . The predictive abilities of an early diagnostic guess were consistent among GPs.The GPs early diagnostic guess was correct in one out of two patients presenting with chest pain. The probability of a correct guess was higher in patients with a life-threatening illness and in patients not feeling anxious about their pain. The decision making process for a General Practitioner (GP) is intuitive and does not merely rely on specific signs. The early intuitive diagnostic guess arises during the initial few minutes of a patient encounter and could also play a role in treatment decisions ,2, althoThis validation study was nested in a large multicentre observational study exploring the management of thoracic pain in primary care ,10 in whIn patients with chest pain, we measured the prevalence of cases for which physicians had an early diagnostic guess, which was confirmed by further investigations and a one year follow-up. Furthermore, we examined if this predictive ability was influenced by previous encounters with the patient, previous manifestation of similar chest pain, the severity of the illness and by the patients' anxiety, age, and gender.Fifty-eight general practitioners (GP)working in private practice and six working as residents in an academic primary care outpatient department in Western Switzerland volunteered to participate to this study Table . For praPatients sixteen years of age and over reporting any type of chest pain during the first minutes of their visit were consecutively enrolled. The presence of chest pain was ascertained according to the usual practice of each GP. Chest pain due to obvious causes such as trauma or known body metastases was also included and was not necessarily the chief complaint on presentation.Physicians gave their early diagnostic guess after the first minutes of the encounter with the patient. They were asked to complete the initial part of the case report form (CRF) before investigating the patient's history or performing any medical examination. Physicians based their early diagnostic guess on their previous knowledge of the patient, initial contact, and spontaneous presentation of complaint. GPs were free to report the early diagnostic guess in any terms and made no guess if the most probable cause of pain was unclear. Reported diagnoses were then divided into six categories Table .GPs also recorded if a diagnosis for a similar complaint was already known and whether the patient was feeling anxious about the pain. The diagnostic guess was recorded at four time points during the initial patient encounter: prior to history taking and physical exam, post history taking, post physical exam, and at the end of the encounter.We used the diagnosis eventually retained after one year of follow-up as the definite diagnosis to be contrasted with the early diagnostic guess. An independent panel of physicians confirmed the follow-up diagnosis. Any new investigation, additional tests, reports from hospitals, or specialist referral that occurred after the initial diagnosis made at the end of the initial encounter was considered to reach the definite diagnosis. Adjudicators remained blinded to the early diagnostic guess. For the patients that were lost at follow-up, the information collected during the study and the patient's up to date medical records were used by the adjudicators. This method is not believed to be perfect but is the best acceptable solution for studies in family practice settings . QualityPrevalence of cases for which the early diagnostic guess was to be confirmed was calculated at a cluster level for each GP. Summary measure for all GPs was given using a frequency weighed mean value with a 95% CI. Influence of age (<50 yrs vs. >50 yrs), sex , known vs. unknown patient, new vs. known manifestation of chest pain, severe vs. non severe illness and patient anxiety over the predictive ability of early diagnostic guess were estimated. Predictive ability was calculated stratifying the results for each of these variables. Odds of correctly diagnosing the illness early were calculated using random effect logistic regression, adjusting for cluster effects verified by quadrature check. Homogeneity of these effects across GPs was verified by calculating the intraclass correlation coefficient (ρ). No correction for multiple testing was planned; significance level was set at p < 0.05. The study protocol was approved by the official Ethical Commission of Internal Medicine (Prot. 41/2000).Among 24,620 consecutive primary care encounters within 59 different general practices, 672 patients presenting with thoracic pain (main or ancillary symptom) were included in the study during five weeks in 2001. Follow-up was 100% at 3 months and 96% at one year. Predictive ability of early diagnostic guess was similar between patients with full data and those with missing data. Patients with missing data were excluded, and one GP with incomplete CRFs was not included in the analysis, leaving 626 (93.2%) patients and 58 GPs. During quality control, only one final diagnosis was contested and resolved after discussion between the GP and the adjudicators. A mean of 12 (SD = 7) patients with chest pain were seen by each GP who participated to the analysis. Their median number of years of practice was 14 yrs (ranging from 1 to 24 yrs) (Table A very slight majority of women were seen with chest pain 51.4%); 51.9% of patients were over 50 yrs. Physicians suspected an illness and reported a specific early diagnostic guess for 441 patients (70.4%); they did not make a guess for 185 patients. GPs' early diagnostic guess was confirmed for 319 patients  presenting with chest pain. After history taking, this prediction had an absolute improvement of 11.7%, after physical examination of 22.9%, and at the end of the first encounter of 30.9%  of the early diagnostic guesses made after the first minutes of the encounter were concordant with the definite diagnosis retained after 12 months. Apparently, the patient's complaint and non-verbal communication play an important role in the decision making process. Predictive ability of the early diagnostic guess was higher in patients with severe illness (65.4%) and for those who did not express anxiety (62.9%). It is important to note that even if the majority of diagnoses are correctly predicted by what has been referred to as "gut feelings" 1% of the.To our knowledge, this is the first quantitative study to examine the performance of the first diagnostic impression for patients presenting with chest pain. Our observations should be consistent with what general practitioners experience in their daily work as study data was collected from multiple private practices with a variety of physicians and a large patient sample size. Following patients over one year made it possible to improve the validity of the final diagnosis compared to the diagnosis reached at the end of the first encounter.A study design limitation is the absence of randomization to select a representative sample of GPs. However, we observed that the 58 general practitioners from our study showed similar traits to those sampled in Western Switzerland in 2004 . Also, tEarly diagnostic guess may be obtained by means of non-explicit pathways, based on intuition, associations with stored information and pattern recognition . The firThe GPs' early diagnostic guess was correct in one out of two patients presenting with chest pain. The probability of a correct guess was higher for life threatening illness and in patients without anxiety concerning their pain.CI 95%: confidence Interval of 95%; COPD: chronic obstructive pulmonary disease; CRF: case report form; GP: general practitioner; ICC: intraclass correlation coefficient.BF has taken part in advisory board meetings and received honoraria to speak at meetings of drug companies producing drugs to treat iron deficiency. The other authors have no competing interest. We are indebted to the Swiss Academy of Medical Sciences for a grant (RMMA 6/2000).FV, BF, LH, MJ, BB, TB, AP participated in the conception of the study. FV, BF, MJ, LH and PV planned the statistical analysis. FV, BF, LH, PV, and MJ interpreted the results. FV, BF, LH, and PV drafted and revised the manuscript. All authors have read and approved the manuscript. They had full access to all of the data  in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2296/11/14/prepub


In the treatment of chronic back pain, cognitive methods are attracting increased attention due to evidence of effectiveness similar to that of traditional therapies. The purpose of this study was to compare the effectiveness of performing a cognitive intervention based on a non-injury model with that of a symptom-based physical training method on the outcomes of low back pain (LBP), activity limitation, LBP attitudes (fear-avoidance beliefs and back beliefs), physical activity levels, sick leave, and quality of life, in chronic LBP patients.Educational programme : the emphasis was on creating confidence that the back is strong, that loads normally do not cause any damage despite occasional temporary pain, that reducing the focus on the pain might facilitate more natural and less painful movements, and that it is beneficial to stay physically active. 2. Individual symptom-based physical training programme : directional-preference exercises for those centralising their pain with repetitive movements; 'stabilising exercises' for those deemed 'unstable' based on specific tests; or intensive dynamic exercises for the remaining patients. Follow-up questionnaires (examiner-blinded) were completed at 2, 6 and 12 months. The main statistical test was an ANCOVA adjusted for baseline values.The study was a pragmatic, single-blind, randomised, parallel-group trial. Patients with chronic/recurrent LBP were randomised to one of the following treatments: 1. A total of 207 patients participated with the median age of 39 years (IQR 33-47); 52% were female, 105 were randomised to the educational programme and 102 to the physical training programme. The two groups were comparable at baseline. For the primary outcome measures, there was a non-significant trend towards activity limitation being reduced mostly in the educational programme group, although of doubtful clinical relevance. Regarding secondary outcomes, improvement in fear-avoidance beliefs was also better in the educational programme group. All other variables were about equally influenced by the two treatments. The median number of treatment sessions was 3 for the educational programme group and 6 for the physical training programme group.An educational approach to treatment for chronic LBP resulted in at least as good outcomes as a symptom-based physical training method, despite fewer treatment sessions.Clinicaltrials.gov: # NCT00410319 Increased attention is being directed towards cognitive behavioural issues in the management of chronic low back pain (cLBP). One reason is that cognitive interventions have generally demonstrated effectiveness in self-reported disability-5 and siA cognitive approach in this context is not a well-defined term. It covers a spectrum from an educational approach to cognitive behavioural treatments delivered by psychologists. For LBP, our impression is that most reported cognitive interventions can be classified as educational approaches designed to produce altered behaviour through insight and understanding, and not psychological treatments as such. A crucial part of such interventions will be what kind of insight emerges, how effectively it is delivered, and the person's internalisation of the message received.Cognitive theories include elements of central pain perception as well as optimisation of peripheral muscular control-23.Among several cognitive/educational models, the one by Indahl has been shown to be particularly effective regarding return-to-work,8,9. ThiIn contrast, the 'injury model,' where pain is taken as a sign of injury from increased loading, seems not to have been useful as a basis for clinical management,33. In cIt is well known that certain jobs and working positions are associated with increased back pain,35. HoweRegarding exercises and other physical therapies in cLBP, randomised controlled trials (RCT) generally show small effect sizes on a group basis. However, subgroup analyses suggest greater effectiveness for such treatments in people with particular clinical profiles. Individualised, symptom-based physical training programmes had, at the preparation of our study, shown success in an RCT with acute patients and withThe specific aims of this study were to compare the effects of prescribing for cLBP patients either:- an educational approach designed to improve confidence in the robustness of the spine, or- symptom-based physical training treatmenton the primary outcomes of back pain and activity limitation, and secondary outcomes of LBP attitudes (fear-avoidance/back beliefs), physical activity levels, work ability, quality of life, sick leave, and a number of other health-care treatments.The study was a pragmatic, single-blinded, randomised, parallel-group trial with follow-up periods of 2, 6 and 12 months. It was conducted in accordance with The Declaration of Helsinki 2000 and approved by the local Research Ethics Committee (ref. no. VF 20040016).CLBP patients were recruited from the clinic at a multidisciplinary non-surgical Back Center. The patients were referred to the clinic from general practitioners and chiropractors from across the Funen county in Denmark. Most had already had various treatments, with less than satisfactory outcomes.The following inclusion criteria were chosen: 18 to 60 years of age, LBP for at least 4 out of the previous 12 months and a mean LBP score over the last 14 days of ≥ 4 . The back pain had to be greater than any associated leg pain. Exclusion criteria included the presence of cancer, traditional inflammatory diseases , sequelae after earlier back surgery, conditions of competing joint or muscle disease, psychiatric illnesses, or any general disease that would hinder intensive physical training. Due to the use of MRI scanning in this study, current pregnancy or the presence of magnetic metal in the body were additional exclusion criteria.The original power analysis was designed to identify a difference between return-to-work proportions from 80% to 60%, and showed that n = 100 in each arm would give a power of 84%. However due to a subsequent recognition that pain and pain-related activity might be earlier and more sensitive indicators of changed behaviour resulting in earlier return-to-work, these were raised to the status of primary variables.Recruitment and initial physical examinations were conducted in the period from June 2004 to October 2005. Consecutively referred patients, classified as suitable on the basis of screening criteria, were informed about the study. People were informed that the purpose of the study was to compare two different treatments for chronic/recurrent LBP: one with a primary concentration on fear-reducing information, and the other on symptom-based physical training. They were also informed that the current waiting period for assessment and treatment at the clinic was more than 3 months, whereas participation in the study would result in an MRI scan, with earlier diagnosis and treatment.All the people who then expressed an interest in participating in the study underwent a comprehensive examination by the same clinician (PHS) lasting up to 1½ hours, during which further assessment against the inclusion and exclusion criteria was performed. A diagnosis was not given to the patient at this point, and the objective findings were explained to them in a neutral way. Patients not included received the usual treatment offered at The Back Center.The patients who were considered eligible for inclusion were then asked to provide written informed consent and subsequently to visit a secretary who managed the randomisation, using unmarked sealed envelopes, containing a note on which was randomly written either:• Educational programme (EDUC), or• Physical training programme (TRAIN).During this and following procedures, the principal investigator was not present.After randomisation, the patients completed self-report questionnaires.They received a schedule, including a date for an MRI scan in the following week, and an appointment for the first consultation with either a medical professor (TB) for EDUC, or with a specially trained physiotherapist for TRAIN.The same investigator (PHS) managed the baseline examination and controlled the follow-up forms, blinded to the treatment group. In the data, treatment groups were named X and Y until the end of analyses.To avoid a possible variation across the participants in level of confidence resulting from some having had an MRI and others not, all had a standard lumbar MRI . Two experienced claustrophobia and failed to undergo the scan. One patient had a pelvic MRI only, because her symptoms were located around the sacro-iliac joints. The imaging protocol consisted of one localiser and four imaging sequences. Most patients demonstrated degenerative changes. More detailed imaging results will be published separately.During the first visit, both groups received an additional specific physical examination. In the EDUC group this was short, and mostly directed towards possible tense and tender muscles and a fear-avoidance movement pattern. In the TRAIN group, possible directional preference and neuromuscular stability were tested (see below). In both groups, explanations of the MRI scan, of the objective findings from the baseline examination, and if possible, a clarification of the pathology causing the patient's symptoms, were given. Especially in the EDUC group disc degeneration was explained thoroughly, but in both groups it was emphasised that the relationship between disc degeneration and pain is weak.The educational approach was adapted from Indahl and is dInitially, the patient's perception of his/her back problem was mapped, for example, its course, the way he/she handled it, the precautions he/she was taking, and the prognosis. The goal was to give the patient a new insight, if needed, aimed at changing his/her perception towards one that was less focussed on the current LBP condition and instilled more confidence in managing the condition into the future.Information on pathoanatomy and physiology included the view of their own lumbar MRI scan, emphasising the positive aspects rather than focusing on possible abnormalities, unless they had particular significance. They were informed that pain episodes from high-load movements are temporary and do not cause permanent damage.It was emphasised that pain has a physical cause, whether it could be found or not. Tension could increase pain by stressing tender joints and/or by primary muscular pain. Awkward movements could also occur if they were carried out with overly conscious control, in contrast to natural movements, especially when accompanied by fear of pain. Several simple metaphors were used to help reinforce this message. Such information may assist in the performance of more natural spinal movements and accordingly result in less pain. This mental attitude requires an understanding of the above mechanisms.One specific back-muscle stretching (seated flexion + rotation) exercise was practised with the patients.At the first consultation, the physiotherapist began with a complete Mechanical Diagnostic Therapy (MDT) examination to find a possible directional preference. In the case of centralisation (where radiating pain shortened its radiating distance) or just pain relief with this procedure, patients were treated with the relevant directional-preference exercises, along with advice on optimal postures. The emphasis was on gradual progression with an attempt to eventually regain full function.If such MDT testing was negative Fig. , the patThis included assessing the patient's usually painful movements when also performing so-called stabilisation procedures. If he/she could not activate the trunk muscles appropriately, or had pain relief by pretension of the trunk muscles during exercise, they were deemed 'unstable.' Accordingly, an individual programme was initiated with an emphasis on regaining stability. The exercise regime went from muscular stabilisation in basic neutral positions towards stabilisation in everyday functions.If patients were not classified as having a directional preference or as being unstable, they were assigned to an intensive dynamic exercise programme. This programme emphasised adequate balance, endurance and strength exercises of the trunk muscles, fitness training and 'therapy-ball' exercises. This programme was conducted in a group setting but was concluded with an assessment of each individual's final muscle control.In addition, participants in the TRAIN group were treated in a 'best practice' manner that augmented their physical training with other therapies. This meant that several health professionals could be involved as deemed relevant by the physical therapist: a nurse (medication or pain management), a chiropractor (manipulative therapy), a doctor (steroid injection) or conferences (multi-disciplinary approaches to pain management) in continued treatment plans. Each patient also received individual recommendations for further training at home, outside or in a club/training centre.The physical training programmes were managed by two physiotherapists, one who was a credentialled MDT therapist, and the other who had attended all MDT courses but was not yet a graduate. They had completed training courses in kinetics control and had several years' experience with cLBP patients.The patients completed questionnaires at baseline and at 2, 6 and 12 months after the end of the treatment. Because treatment duration differed, we deemed the treatment period to end 2 months after the first examination. In other words, the 2-month follow-up period covered 2-4 months after baseline.Baseline and/or outcomes data were collected on the following clinical characteristics:Demographic data : gender, age, marital status, education, occupation, sick leave, level of physical activity .Numerical Rating Scale 0 (no pain) -10 (as bad as could be), averaged over the preceding two weeks.a 15-item questionnaire covering activity limitation averaged over 2 weeks, each item scoring 0, 1 or 2 (significant complaints); range 0-30. These two outcome measures have had widespread use over the past two decades, especially in RCTs from Denmark.a 23-item tool, where each question is scored 0 (no disability) or 1 (some disability). The RMQ was undertaken only at baseline enabling a comparison with other studies.Fear-Avoidance Beliefs Questionnaire (FABQ) [ (FABQ) : assesseBack Beliefs Questionnaire (BBQ)[ire (BBQ): comprisPhysical activity : They were asked how many minutes weekly they had spent on several listed physical activities from intensive sport, to biking/walking, to gardening etc.Work ability : an 11-item scale on the patient's work situation[situation. The ansQuality of life [of life : after tUse of medical services: the numbers and types of LBP-related treatments received in addition to those in the project, and during the whole study period . Use of pain medication was divided into 5 groups: Nothing/weak pain killers or morphine-containing medication, both 1-4 or 5-7 days weekly.Number of sessions during the study treatments: treatment costs were estimated by counting the numbers of treatments the patients in the two treatment arms received.Treatment preference: to assess whether patient treatment preferences had an influence on LBP outcomes, patients were asked, before randomisation, which intervention they would prefer being allocated to.Data from the questionnaires and MRI evaluation forms were entered into a database using Epidata 3.1  using double data entry. Errors were corrected by a secretary who was blinded to treatment allocation. Data were transferred to SPSS (SPSS Base 14.0) for statistical analysis.2 was performed. Treatment effect was estimated at each of the three follow-up stages for the primary and secondary outcomes. No interim analyses were planned nor performed in this study.Demographic variables are presented as summary statistics: medians and inter-quartile ranges (IQR) are used for continuous and ordinal variables. To facilitate inclusion in meta-analyses, outcomes are also reported as mean and SD despite their skewed distribution. Frequencies are reported for binary variables. The primary endpoints were reduction in pain and activity limitation. Treatment groups were compared using an ANCOVA analysis with adjustment for baseline values. As a sensitivity analysis of missing data for the primary and essential secondary outcomes, another ANCOVA analysis was performed, where missing values were imputed with the last observation carried forward. This could be viewed as an intention-to-treat analysis. For changes over time within each treatment group, Friedman's Test was used except for work ability, where χThe sponsors of this study had no role in the scientific process.The numbers and flow of patients are shown in Fig. The losses to follow-up were all due to non-attendance, even after a second written invitation. In Denmark, it is considered unethical to pressure participants beyond this.was significantly reduced over time and approximately equally in the two treatment groups Table .was significantly reduced during the course for EDUC (p <.001) but not for TRAIN (p = .17). A consistent trend  considering clinically relevant improvements (≥ 5)/"no-change" /worsening (≤ -5) favoured EDUC significantly at 2 months (p = .03), but not significantly at 6 and 12 months). However, a relevant question is whether there was an association between reporting less activity limitation and reduced fear-avoidance belief over time. We therefore made a post-hoc regression analysis on Δ'activity limitation' and ΔFABQ, finding significant associations at all three follow ups (p = .04/<.001/<.001), irrespective of type of treatment (p = .16/.17/.12).A post-hoc analysis  for EDUC only Table . BBQ wasreported physical activity and work ability  and 'misc phys. activity' revealed nothing that changed the above conclusions (data not shown).There was no statistically significant difference (p = .65-.87) between the two groups regarding the total number of health-care contacts outside the project Table . The sliEDUC: these patients had 1-6 sessions , each lasting between 30 and 60 minutes. TRAIN: these patients had more sessions , each lasting between 30 and 60 minutes. Most treatments were the described training sessions. Forty patients had 1-2 of their treatments as a part of the multidisciplinary model, visiting a nurse for medication counselling (n = 22), seeing a chiropractor (n = 18), and/or a doctor (n = 9). Moreover, on top of the mentioned number of treatments, 22 of the patients in TRAIN compared with 0 in EDUC were discussed in multi-disciplinary conferences and 36% of the patients in TRAIN had between 1 and 6 phone consultations compared with 2% with EDUC.initially, 28% had directional-preference exercises (MDT), 42% stabilising exercises, 25% dynamic exercises, and 5% were unknown. Further treatments: 10 patients: MDT→dynamic; 24 Stability→Dynamic; 1 stability→MDT; 8 MDT→stability.before randomisation, 4% stated that they would prefer EDUC, and 21% preferred TRAIN; 73% had no preference while 2% didn't respond. The groups were too small for meaningful statistical analyses  were comparable with those who consented with regard to age, gender, BMI, LBP and activity limitation, but non-participants had less sick leave during the previous 12 months.Sixteen patients (eight in each group) didn't respond to all three follow-up questionnaires.Comparisons of the baseline characteristics of non-responders and responders are shown in Table No side effects were recorded within any treatment group. Numbers needed to treat analysis was not performed due to similar effectiveness of both treatments on most variables.This is the first study comparing a cognitive educational method based on a non-injury model with that of contemporary symptom-based physical training. We have demonstrated that, among patients with cLBP, the educational/cognitive intervention with few consultations was at least as effective as an individualised, multidisciplinary physical-training approach. 'At least' refers to the observed overall trend of more improvement in activity-limitation with EDUC. There was a statistically significant difference at 2 months in favour of EDUC in the proportion of people improving by a Minimal Important Change (MIC) in activity-limitation . As postThe cognitive educational approach was based on a non-injury model and had the focus on giving the patients an understanding of the robustness of the spine and the unlikelihood that any normal or even strenuous activity should cause any harm. With this understanding, unconscious neuro-muscular control is believed to encourage natural movements, as opposed to consciously controlled, often tense and awkward movements. Other cognitive interventions for LBP seem more or less to be based on the traditional injury model. By adding even a little caution at the end of such a cognitive session, the patient's likelihood of acquiring better coping strategies may be reduced.Fear avoidance behaviour may be a natural consequence of the traditional medical model. On the other hand, we have all been reared in the traditional medical model and the chance of giving double messages is likely. In a non-injury model, one is devoid of such caution. Thus, cognitive intervention in a non-injury model poses challenges which are different from interventions based on a traditional model, and comparisons are therefore not useful.The more marked effect of the cognitive educational approach in the Norwegian studies,,8,9 may Would it be more effective if physical treatment were added to the cognitive intervention? In the authors' opinion, probably not. The basic idea with the present cognitive model is to reduce undue focus on the pain. For many people, a demand for physical training increases pain-focus, especially if they are unable to follow their plan, or if they don't like physical exercise. Given that physical training in cLBP patients generally results in effect sizes of marginal clinical importance,,49 it isThe physical training part of this study was chosen pragmatically on the background of what has become usual practice at a university clinic with physiotherapists who are well trained and well acquainted with evidence-based practice. The trial was not designed to prove efficiency in any subgroups, but to merely reflect current best practice at our clinic and probably also several similar clinics.Recent studies have further investigated the components used in our study within the symptom-regulated programme,56,57. TIt can be argued that physical training should be supervised for a longer time period than was used in this study, and with higher loads. In support of that argument, Hayden et al. found increased effects in studies with a total of > 20 hours training, although they also interpreted the effect sizes having marginal clinical impact,57.In the current study, 18 patients in TRAIN had manipulation. Should manipulation have been added systematically? According to Chou et al, it does However, it might be relevant in initial physical training settings to convince participants that the back can withstand quite heavy-loaded movements, and to identify possible movements that some patients fear, often unconsciously. Bio-feedback/EMG could be used to investigate this,71. In oThat participants got earlier treatment and that all had an MRI might have also caused a selection bias, but this effect would have been equally distributed in the two groups. MRI was taken to reassure patients that their examination was thorough and to exclude serious pathology.A cognitive, educational intervention for cLBP resulted in at least as good outcomes as a symptom-based physical training method despite fewer treatment sessions. The outcome of this study and several corresponding studies and reviews-76 indicANCOVA: Analysis of co-variances; BBQ: Back believe questionnaire; cLBP: chronic low back pain; EDUC: Educational programme; FABQ: Fear-avoidance beliefs questionnaire; GP: General practitioner; IQR: Interquartile range; LBP: Low back pain; MDT: Mechanical diagnostic therapy; MRI: Magnetic resonance imaging; RMQ: Rowland-Morris disability questionnaire; SD: Standard Deviation; TRAIN: symptom-based physical training programme;The authors declare that they have no competing interests.PHS wrote the protocol and the manuscript together with TB. Performed most practical aspects in running the study, except where blinding prevented her participation. Performed all patient investigations, organised questionnaires, and carried out the statistical analyses, as directed by LK and TB. TB gave ideas to the project. Took an active part in writing the protocol and the manuscript together with PHS and AI. Performed the cognitive treatment with all patients. CM organised the patient flow through the Center. Took part in scientific structuring of the project, and in drafting the manuscript. LK planned and instructed PHS in performing the statistical analyses. Wrote the statistical method section, and adjusted the results chapter to convey the data analyses. DL structured and supervised the symptom-based physical treatment. AI created the specific cognitive method, and trained TB and PHS in the practical aspects of running it with the patients. Took part in the writing process. All have read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/11/212/prepub