Fibromyalgia (FM) is a pain condition with associated symptoms contributing to distress. The Fibromyalgia Survey Diagnostic Criteria and Severity Scale (FSDC) is a patient-administered questionnaire assessing diagnosis and symptom severity. Locations of body pain measured by the Widespread Pain Index (WPI), and the Symptom Severity scale (SS) measuring fatigue, unrefreshing sleep, cognitive and somatic complaints provide a score (0–31), measuring a composite of polysymptomatic distress. The reliability and validity of the translated French version of the FSDC was evaluated.The French FSDC was administered twice to 73 FM patients, and was correlated with measures of symptom status including: Fibromyalgia Impact Questionnaire (FIQ), Health Assessment Questionnaire (HAQ), McGill Pain Questionnaire (MPQ), and a visual analogue scale (VAS) for global severity and pain. Test-retest reliability, internal consistency, and construct validity were evaluated.Test-retest reliability was between .600 and .888 for the 25 single items of the FSDC, and .912 for the total FSDC, with all correlations significant (p < 0.0001). There was good internal consistency measured by Cronbach’s alpha . Construct validity showed significant correlations between the FSDC and FIQ 0.670, HAQ 0.413, MPQ 0.562, global VAS 0.591, and pain VAS 0.663 .The French FSDC is a valid instrument in French FM patients with reliability and construct validity. It is easily completed, simple to score, and has the potential to become the standard for measurement of polysymptomatic distress in FM. The cornerstone symptom of fibromyalgia (FM) is chronic widespread pain, with presence of associated symptoms of fatigue, unrefreshing sleep, cognitive dysfunction, and a variety of somatic symptoms that may be present to variable degree in an individual patient ,2. It isThe only questionnaire that is disease specific for FM and addresses a number of domains for this condition is the Fibromyalgia Impact Questionnaire (FIQ), although with criticism that it does not fully address all aspects of FM, may not be sufficiently sensitive to change, and is complex to score ,4. OtherThe Fibromyalgia Survey Diagnostic Criteria and Severity Scale (FSDC) is a patient administered questionnaire that captures the key symptoms of FM, assesses symptom severity, and has the potential to be a useful instrument that can be applied in clinical care ,11. HoweEighty francophone patients with FM were invited to participate in this study, 7 of whom did not fully complete the questionnaires. Therefore, the study sample comprised 73 patients with an existing diagnosis of FM, usually made by a family physician and confirmed as a clinical diagnosis by a rheumatologist. Fifty-nine consecutive patients are current participants in a prospective cohort study in a multidisciplinary pain centre. The remaining 14 participants, members of a patient support group, were assessed by the study rheumatologist but were unable to participate in the cohort study due to distance from the study centre, and did not differ from the cohort study participants. All patients provided informed consent and ethical approval was obtained from the institutional review board of the Montreal General Hospital.At the time of the first assessment the following information was obtained: demographic and disease related information, questionnaires assessing symptoms and function associated with FM, and the FSDC. All questionnaires were validated French language versions with the exception of the FSDC. The patients were asked to complete the FSDC on a second occasion, within 7 days, and the questionnaire was returned by mail. If not returned, the study participant was prompted with a telephone call, and if the questionnaire was not returned within 2 weeks, the participant was counted as a study withdrawal.Patients completed the FIQ, a validated disease specific instrument assessing the health status of patients with FM . The FIQPain was assessed by a number of parameters. Pain intensity was measured by a 10 cm VAS. Pain quality was measured by means of the MPQ, a validated questionnaire comprising 78 descriptor words arranged into 20 subgroups and measuring the sensory, affective, evaluative, and miscellaneous components of pain . PatientThe FSDC is a patient administered questionnaire comprising 3 sections . The firThe translation protocol used to translate the FSDC is based on methodology that has been previously published ,17 and aThe experimental version of the instrument was tested on a sample of 5 bilingual patients to ensure clarity and comprehension. They completed both the French and English versions of the instrument, in random order, and indicated if they found any instructions or items difficult or ambiguous. An investigator was present for cognitive debriefing. Any items for which difficulties were encountered in the French translation, but not in the original version, were re-worded by the investigators. We assessed the test-re-test reliability of the French Canadian version by administering the instrument to a group of French-speaking patients twice within a 1 week period.Test-retest reliability of the FSDC was assessed with Pearson’s correlation coefficients. To assess internal reliability, an analysis of internal consistency using Cronbach’s coefficient α was performed with measurement of .9 < α ≥ .8 considered as representing good internal consistency. To test construct validity we hypothesized a strong to moderate relationship between the FSDC and other measures of symptom severity in FM including the FIQ and HAQ, and symptoms of fatigue, pain, and global status. Strength of correlation was graded according to the recommendation of Cohen as follows: 1. Moderate correlation coefficient (.30 to .49) 2. Strong correlation coefficient (.50 to 1.0) .The study sample consisted of 73 francophone patients, mean age 52 ± 9 years, 67(92%) female, and mean disease duration 12 ± 12 years. The 7 withdrawn patients did not differ demographically from the study sample. Demographic and disease related characteristics of the study sample are shown in Table Test-retest reliability was between .600 and .888 for the 25 single items of the FSDC, and .912 for the total FSDC, with all correlations significant (p < 0.0001) . The individual subcomponents of the FSDC including measurements for pain, fatigue, cognitive problems, awakening unrefreshed from sleep, and symptoms of abdominal pain, depression and headache were correlated with measurements of pain , and fatigue, restfulness, and depression as measured by the FIQ , still requires further validation in other settings for patients with FM, as well as testing in other groups of patients with pain. Furthermore, the FSDC requires correlation with other meaningful and objective measures of function and disability in FM patients, such as sick-leave. If shown to be sensitive to change, this severity scale could be a useful tool for assessing outcome in both the clinical as well as the study setting. This questionnaire is unique in its simplicity, with completion by patients within a few minutes, and time to score measured as less than one minute. This tool has the potential to become the standard for measurement of symptom severity in FM and other chronic pain conditions.Dr. Fitzcharles has received consulting fees, speaking fees, and/or honoraria  from Lilly, Pfizer, Purdue, and Valeant, and has given expert testimony for both the plaintiffs and defendants in medicolegal adjudication concerning pain in rheumatic conditions. Mr. Ste-Marie has no competing interests. Dr. Panopalis has received consulting fees, speaking fees, and/or honoraria  from Abbott, Bristol-Myers Squibb, and Pfizer. Dr. Menard has no competing interests. Dr. Shir has received consulting fees, speaking fees, and/or honoraria  from Astra-Zeneca, Janssen, Paladin, Pfitzer, and Purdue. Dr. Wolfe has no competing interests.MAF designed the study. FW provided background on the validated measure. HM participated in the translation of the validated measure. PP lead the statistical analysis. PSM collected data. MAF, PSM, and YS wrote the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/13/179/prepubAppendix. Questionnaire sur l’échelle de diagnostic et de sévérité de la fibromyalgie.Click here for file


Propofol has the disadvantage of causing pain or discomfort on injection. The aim of the study was to assess the efficacy of pretreatment with various drugs to alleviate the propofol injection pain.One hundred American Society of Anesthesiology (ASA) I and II adults, scheduled for various elective surgical procedures under general anesthesia (GA), were included in the study. They were randomly divided into four groups having 25 patients in each group. Group A received pretreatment with intravenous (i.v.) magnesium sulfate, group B received i.v. granisetron, group C received i.v. nitroglycerine and group D was the control group. One-fourth of the total calculated induction dose of propofol was administered over a period of 5 seconds. The patients were asked about the pain on injection. The intensity of pain was assessed using verbal response. A score of 0–3 which corresponds to no, mild, moderate and severe pain was recorded.All the three drugs reduced the incidence and intensity of pain on propofol injection but the order of efficacy in attenuation of pain on the propofol injection was granisetron > nitroglycerine > magnesium sulfate > control.Granisetron was the most effective followed by nitroglycerine and magnesium sulfate in attenuating pain on propofol intravenous injection. Ever since its introduction in the clinical scenario in 1977, propofol has attained unmatched popularity as an agent for intravenous (i.v.) induction. It is also used for short duration surgery, day care surgery, sedation and ambulatory surgery. But very often, it has the disadvantage of causing pain or discomfort on injection, especially when given in small veins on the dorsum of hand. This pain may be distressing to the patients and can reduce the acceptability of an otherwise useful agent. Among 33 clinical problems, propofol-induced pain ranked seventh when both clinical importance and frequency were considered.1Incidence of pain with i.v. propofol varies between 28% and 90% in adults and 28% and 85% in children. The younA number of both pharmacological  and non-pharmacological methods have been used–14 with None of the above-mentioned methods has been proved absolutely perfect for attenuation of pain due to propofol injection.3 antagonists like ondansetron have been found to decrease pain on propofol injection. Thus, the study was conducted with granisetron, another potent 5HT3 antagonist, to see its efficacy in decreasing pain on propofol injection.[5HTnjection.15Ketamine, an N-methyl D-aspartate (NMDA) antagonist, in the subanesthetic doses, reduces the propofol injection pain by virtue of its local anesthetic property. Magnesium, another NMDA antagonist, has antinociceptive effect in humans. The effect is primarily based on regulation of calcium ion influx into the cell, the natural physiological analgesic mechanism. This is why magnesium sulfate has been taken for study to attenuate the pain by propofol injection.Nitroglycerine also has an analgesic effect on propofol injection due to its vasodilating effect when applied topically on i.v. cannulation site. The study was conducted to see the analgesic effect of i.v. nitroglycerine to alleviate pain following propofol injection.18These proposed mechanisms prompted us to investigate the effect of pre-treatment with granisetron, magnesium sulfate and nitroglycerine on propofol injection pain.After obtaining approval from hospital ethics committee and informed consent from the patients, 100 patients belonging to American Society of Anesthesiology (ASA) physical status I and II, of either sex, aged between 21 and 50 years, undergoing elective surgery under general anesthesia, were studied. Patients less than 21 years and more than 50 years, patients belonging to ASA grade III and IV, patients with history of any systemic illness, history of drug allergy to granisetron, magnesium sulfate, nitroglycerine and propofol, patients who were taking any analgesic before surgery, morbidly obese patients and patients scheduled for emergency surgery were excluded from the study.They were randomly divided  into four groups of 25 patients each. The drug solution was prepared by a co-supervisor and given to observer who dispensed 5 ml of the study drug. Group A patients received pre-treatment with i.v. magnesium sulfate . Group B patients received pre-treatment with i.v. granisetron . Group C patients received pre-treatment with i.v. nitroglycerine . Group D patients received i.v. normal saline as a placebo .Patients of less than 21 years and more than 50 years, with ASA grade III and IV, neurological deficit, history of drug allergy to study drugs and propofol, history of taking any analgesic before surgery, history of diabetes/hypertension, history of cardiovascular/respiratory disease, morbid obesity and emergency surgery were excluded from the study. Prior to surgery, all the patients underwent thorough pre-anesthetic check-up and routine investigations like hemoglobin (Hb), total leukocyte count (TLC), differential leukocyte count (DLC), bleeding time (BT), clotting time (CT), routine urine and microscopic examination, serum creatinine, chest X-ray and electrocardiogram. If investigations were found to be within normal limits, then only the patients were selected for the study. Patients for the surgery were kept fasting for 6–8 hours and were premedicated with tab diazepam 10mg at night and 5mg 2hours prior to surgery with a sip of water.2, end-tidal carbon dioxide and ECG were monitored. The procedure was explained to patients. No analgesic drug was given to the patient before injecting propofol. Venous occlusion was done by compressing the forearm with a tourniquet to increase the local concentration of the drug. The study drug was injected over 10 seconds and thereafter the occlusion was removed and then first 25% of the calculated dose (2.5 mg/kg) of propofol (1% w/v in lipid base) was injected over 20 seconds. Then, patients were asked to tell the observer about the severity of pain. The intensity of pain was graded using a verbal rating scale and was assessed at 0, 5, 10, 15 and 20 seconds as after 20 seconds the patient may have been under the influence of propofol.[The i.v. access was established with an 18-G cannula in a suitable vein on dorsum of non-dominant hand without any local infiltration and i.v. fluid  was infused at 100 ml/hour. After 5 minutes, lactated Ringer’s infusion was stopped and the arm with the i.v. line was elevated for 15 seconds for gravity drainage of venous blood. Heart rate, noninvasive blood pressure, SPOpropofol.0 – None (negative response to question)1 – Mild pain 2 – Moderate pain 3 – Severe pain The observer was blinded to the drug being given to the patient. Thereafter, induction of anesthesia was continued with the rest of the calculated propofol dose, and for analgesia, fentanyl 2 μg/kg was given to all patients. The patient was intubated with appropriate size endotracheal tube after giving vecuronium. Anesthesia was maintained with isoflurane and nitrous oxide–oxygen (66–33%).2) test.Data collected were subjected to standard statistical analysis. Descriptive statistics such as range, mean, standard deviation (SD) were used to summarize the baseline clinical and demographic profile of the patients. Categorical data were analyzed using chi-square  among all the three groups – groups A, B and C was highly significant [The number of patients with grade 0 pain at 5 seconds was 11, 19, 13 and 5 in groups A, B, C and D, respectively. In our study, pain at 5 seconds showed statistically significant difference in pain relief in group A, group B and group C, when compared with group D. Statistical analysis (nificant .P < 0.05) [The number of patients with grade 0 pain at 10 seconds was 8, 19, 13 and 4 in groups A, B, C and D, respectively. At 10 seconds, there was no statistical significant difference when groups A and C were compared. Statistical analysis among all the three groups – groups A, B and C was significant ( < 0.05) .P > 0.05), there was no significant statistical difference. Statistical analysis (P < 0.05) among all the three groups – groups A, B and C was highly significant [The number of patients with grade 0 pain at 15 seconds was 5, 15, 9 and 3 in groups A, B, C and D, respectively. There were no significant statistical differences when groups A, B and C were compared among themselves . The numnificant . The ordnificant .In group A, 12% patients experienced nausea and shivering each. In group B, there were no significant postoperative complications, except for shivering in 4% patients. In group C, 8% patients experienced nausea, 4% had vomiting and hypothermia and 16% had shivering. These were much less in comparison to group D (control group). In group D, 8% patients experienced nausea, 12% patients had vomiting and 24% patients had hypothermia and shivering.The incidence of pain caused by propofol injection was reported to range from 28 to 90% in adults. Propofol belongs to the group of phenols that can irritate the skin, mucous membrane, and venous intima.–21 The pet al. speculated that the injection pain is caused by activation of the Kallikrein-Kinin system either by propofol or by the lipid solvent, thereby generating kinins, probably bradykinin.[Scott adykinin. Bradykinadykinin.A 4-point verbal categorical scoring system was chosen in this study rather than visual analogue score (VAS) as it was very simple to be used by the patient and also as appropriate hand eye coordination required for a VAS might not be present in all patients during the rapidly changing state of consciousness during induction.et al. reported that the incidence of pain was decreased to 25% in the ondansetron group in comparison to 55% in the saline group.[et al. suggested that this was due to dual mechanism of action of ondansetron as a sodium-channel blocker and 5HT3 receptor antagonist . The exact mechanism of alleviation of propofol injection pain by granisetron is not known. This may have been the result of a peripheral local anesthetic action, which attenuated the afferent pain pathway rather than a central analgesic effect, similar to the mechanism of ondansetron .[Granisetron reduced the incidence of propofol injection pain to 24% at 5 seconds, 24% at 10 seconds, 40% at 15 seconds and 40% at 20 seconds in comparison to the control group, whereas placebo had an incidence of 80% at 5 seconds, 84% at 10 seconds, 88% at 15 seconds and 88% at 20 seconds and showed statistical significance. Ambesh ne group. Ye et aleceptor).et al. concluded that pre-treatment with magnesium sulfate reduces the incidence to 36% in comparison to control saline group which has incidence of 86% on pain on propofol i.v. injection.[3)-gated calcium channel and of IP3 binding. Therefore, it may be considered as an intracellular calcium antagonist. It also has a role as a calcium antagonist at the ryanodine subgroup of calcium release channel receptors in the sarcoplasmic reticulum.[+ and Ca + in a voltage-dependent manner.[In our study, magnesium sulfate significantly reduced the incidence of pain up to 56% at 5 seconds, 68% at 10 seconds and 80% at 15 and 20 seconds, whereas the control group had an incidence of 80% at 5 seconds, 84% at 10 seconds, 88% at 15 seconds and 88% at 20 seconds and showed statistical significance. Dilek njection. Calcium eticulum. The secot manner. Magnesiut manner. This mecet al. reported that 18 patients (67%) pretreated with nitroglycerine experienced no pain compared with 10 (33%) in the placebo group in a study conducted in 60 patients.[et al. demonstrated dilation of the vein by more than 50% in over half the subjects treated with nitroglycerin within 15 minutes of application.[In this study, pre-treatment with i.v. nitroglycerine reduced the incidence up to 48% at 5 seconds, 48% in 10 seconds, 64% in 15 seconds and 64% in 20 seconds in comparison to control group which had incidence of 80% at 5 seconds, 84% in 10 seconds, 88% in 15 seconds and 88% in 20 seconds and showed statistical significance. Wilkinson patients. The veinatients 6% pretreapatients. while inpatients. Thereforatients 6% pretrealication.The present study postulates that pain on propofol i.v. injection can be attenuated by use of different drugs. Among them, granisetron was found to be the most effective than nitroglycerine followed by magnesium sulphate, without any significant postoperative complications. Maximum number of patients who had no pain belonged to group B, i.e., granisetron group and severe pain score was recorded in maximum numbers of patients in group D, i.e., placebo group, followed by group A, i.e., magnesium sulfate group.


To the Editor,We read the article ‘‘Does the patient with chest pain have a coronary heart disease? Diagnostic value of single symptoms and signs – a meta-analysis” by Haasenritter et al with interest . The autCardiovascular diseases are a major health and economic problem and have accounted for more than 50% of all-cause mortality in the last two decades . Chest pThe authors found that the accuracy of several index tests varied across subgroups determined by case definition of CHD. In respect to the case definition, most useful diagnostic parameters were history of CHD, known myocardial infarction (MI), typical angina, history of diabetes mellitus, exertional pain, history of angina pectoris, and male sex for stable CHD; and radiating pain to right arm/shoulder and palpitation for MI. However, the history of CHD and known MI were the most useful parameters for diagnosis of acute coronary syndrome.Some patients present with less-typical symptoms, such as nausea/vomiting, shortness of breath, fatigue, palpitations, or syncope. These patients tend to present later, are more likely to be women, diabetic or elderly patients, and less frequently receive reperfusion therapy and other evidence-based therapies than patients with a typical chest pain presentation. Registries show that up to 30% of patients with ST-elevation myocardial infarction present with atypical symptoms .Finally, we think that typical chest pain may describe acute coronary syndrome, but the physicians should evaluate patients together with other diagnostic criteria such as symptoms, laboratory parameters, and diagnostic methods.


Persistent post-surgical pain (PPSP) is a major clinical problem with significant individual, social and health care costs. The aim of this study was to examine the joint role of demographic, clinical and psychological risk factors in the development of moderate and severe PPSP after Total Knee and Hip Arthroplasty . This was a prospective study wherein a consecutive sample of 92 patients were assessed 24 hours before (T1), 48 hours after (T2) and 4–6 months (T3) after surgery. Hierarchical logistic regression analyses were performed to identify predictors of moderate and severe levels of PPSP. Four to six months after TKA and THA, 54 patients (58.7%) reported none or mild pain , whereas 38 (41.3%) reported moderate to severe pain (NRS >3). In the final multivariate hierarchical logistic regression analyses, illness representations concerning the condition leading to surgery (osteoarthritis), such as a chronic timeline perception of the disease, emerged as a significant predictor of PPSP. Additionally, post-surgical anxiety also showed a predictive role in the development of PPSP. Pre-surgical pain was the most significant clinical predictive factor and, as expected, undergoing TKA was associated with greater odds of PPSP development than THA. The findings on PPSP predictors after major joint arthroplasties can guide clinical practice in terms of considering cognitive and emotional factors, together with clinical factors, in planning acute pain management before and after surgery. With the aging population, a significant rise in the prevalence of knee and hip osteoarthritis is expected and, consequently, an increase in the number of surgical interventions such as total knee arthroplasty (TKA) and total hip arthroplasty (THA). Being amongst the most commonly performed surgeries worldwide Other potentially important but overlooked factors are patients’ illness representations as defined by the Common-Sense Self-Regulation Model (CS-SRM) .To our knowledge, studies aiming to understand the added contribution of psychological variables on PPSP have often missed the potential simultaneous influence of a multifactorial set of variables. Therefore, the aim of the present study is to explore, the combined contribution of demographic, clinical, and psychological factors as predictors of PPSP after knee and hip arthroplasties. Predictive models can potentially assist health care practitioners and patients in estimating the likelihood of success of major joint arthroplasties, providing clinicians with information that may be used to determine whether or not a patient is likely to develop moderate to severe levels of PPSPThis was a prospective study, conducted in a central hospital in northern Portugal, wherein a consecutive sample of 130 patients with osteoarthritis was enrolled. Ethical approval was granted by the Alto Ave Hospital Centre Ethical Committee and all patients provided their written informed consent to participate in this study. Inclusion criteria were 40 to 80 years old, being able to understand written information (informed consent), without any psychiatric or neurologic pathology , being classified with an ASA score  between grade I and III, and undergoing THA and TKA for diagnosis of coxarthrosis and gonarthrosis only (osteoarthrosis). Arthroplasties performed because of fractures were excluded, as well as hemiarthroplasties, revision and emergency arthroplasties.n = 3), repeated surgery/reoperation (n = 2), and ASA status IV along with the occurrence of post-surgical delirium (n = 1). Of the remaining 124 patients assessed pre and post-surgery, 32 did not complete the 4–6 months follow-up assessment, leaving a sample of 92 patients for analyses including all time points. Those patients lost to follow up had post-surgical complications (e.g. infections) or accidents (prosthesis displacement) that required the performance of a revision arthroplasty in the operated joint (n = 8), underwent an arthroplasty in another joint (n = 7) or did not attend the follow-up orthopedic consultation (n = 17). The final sample consisted of 92 patients (61 women), with a mean age of 64.0±7.86 years.Patients were initially assessed 24 hours before (T1) and 48 hours after (T2) surgery, at the hospital setting (face to face). Follow-up assessment, also face to face, was performed in the consultations 4–6 months later, following a specific schedule for each outpatient consultation. Prior to the study, all instruments and study procedures were piloted in a similar sample of 12 patients for evaluation of their acceptability, feasibility and comprehensibility. Six THA and six TKA patients were submitted to surgery at the same hospital in which the present study was conducted, and presented similar socio-demographic and clinical characteristics to the study sample. Data from these 12 patients was used to refine the assessment protocol procedures as well as the assessment tools. The following questionnaires were administered in a face to face interview by a trained psychologist see Table 1:Socio-Demographic Questionnaire. It included questions on age, education, residence, marital status, professional status, household and parity.Clinical Questionnaire. Consisted of questions about previous pre-surgical pain, its onset, duration and frequency, pain due to other causes, pain in other joints beyond the operated joint , back pain, disease onset, previous surgeries, height, weight, comorbidities, as well as the use of psychotropic drugs.Co-morbidities. Patients were directly questioned about the existence of pre-surgical co-morbid conditions that could affect TKA and THA surgical outcomes or this information was extracted from their medical chart. For this purpose, the Deyo–Charlson index Brief Pain Inventory – short form (BPI-SF) ‘Frequency scale’ of the McGill Pain Questionnaire Hospital Anxiety and Depression Scale (HADS) Revised Illness Perception Questionnaire (IPQ-R) Coping Strategies Questionnaire – Revised Form (CSQ-R) ‘Pain Catastrophizing scale’ of the Clinical data related to surgery, to anesthesia and to analgesia was gathered from medical records.From the sample of 92 patients, 44 (47.8%) were submitted to Total Knee Arthroplasty (14 on the left and 30 on the right side) and 48 (52.2%) to Total Hip Arthroplasty (25 on the left and 23 on the right side). Surgeries were performed by the team of Orthopedic Surgeons of the Orthopedics Unit of the above mentioned hospital.A) Total Knee Arthroplasty (TKA)For the knee, a cruciate-sacrifice prosthesis with a cobalt chromium bearing surface on an ultrahigh-molecular-weight polyethylene insert surface was placed in all cases. The surgical technique in all patients was an anterior midline approach with a medial parapatellar arthrotomy. These patients all had cruciate-sacrifice TKAs with all three components  cemented with a meticulous cement preparation technique. Resurfacing of the patellae was at the discretion of the surgeon. The most common technique for bone resection uses a 5° to 7° (depending on body habitus) valgus femoral cut and neutral tibial cut. Additionally, a correct ligament balancing was performed and tested to achieve equal and symmetric fixation and extension gaps. Intramedullary alignment guides were used for femoral and tibial cuts. The posterior cruciate ligament was resected. Bicondylar femoral and tibial components were implanted and cemented. A polyethylene liner was inserted between the metallic femoral and tibial prostheses. When at the infirmary, a continued passive range of motion was applied to these patients, who were also instructed to weight bear as tolerated.B) Total Hip Arthroplasty (THA)i.e., body habitus, severity of disease, etc). In all cases, a cementless technique was performed with a tapered stem design . Moreover, proximal porous coating was used to impart stability and allow for bone ingrowth. The implant was always collarless, allowing the prosthesis to be wedged into the bony metaphysis, providing for optimal fit and bone ingrowth. In addition, the tapered design allows subsidence into a tight fit and optimizes proximal load sharing of the implant, thereby optimizing bone ingrowth and minimizing stress shielding.For hip patients, a press-fit technique was used for both components: femoral and acetabular. Supplemental screws were used to fix the cup, when necessary. Cobalt chromium on ultrahigh-molecular-weight polyethylene was the bearing surface in all cases. The surgical technique was quite similar in every case. All procedures were done through a direct antero-lateral approach (Watson-Jones) For both types of surgeries, anterior–posterior (AP) hip and lateral knee radiographs were taken and reviewed after surgery and before the patient was transferred to the infirmary for continued care. At the follow-up consultation (T3), radiographs were taken again. The radiographs were reviewed to ensure that the prosthesis was inserted properly and that alignment was correct, which was verified and confirmed for all the patients included in this sample.After surgery, standardized postoperative nursing and physical therapy protocols were used for all patients. Patients were mobilized out of bed on the second postoperative day, and all patients had a postoperative anticoagulation protocol using LMWH (low-molecular-weight heparin). After surgery, patients were given systemic prophylactic antibiotics and prophylactic anticoagulant to decrease deep venous thrombosis risk.Moreover, no research-related change was introduced in the standard clinical protocol.In all patients, the mode of anaesthesia was determined by the health care team according to the usual standard anaesthetic protocols at the hospital, with no research-related change being introduced.n = 61/66.3%), which could be BSA  or epidural, or as: 2) loco-regional  plus peripheral nerve blocks (n = 31/33.7%). ASA score  was recorded, including cases of ASA grade I (7/7.6%), II (67/72.8%) and III (18/19.6%).The type of anesthesia in use was classified as: 1) loco-regional alone  of tramadol (600 mg), metamizol (6 g) and metoclopramide (60 mg). The standardized epidural protocol was a continuous epidural infusion (DIB) with ropivacaine (0.1%) and fentanyl (3 ug/ml). Finally, the standardized peri-neural protocol included a continuous peri-neural infusion (DIB) with ropivacaine (0.1%). For the three types of protocols, Paracetamol (1 g 6/6 h) and Non-steroidal anti-inflammatory drugs (NSAIDS - ketorolac 30 mg 12/12 h or parecoxib 40 mg 12/12 h) were always included as coadjuvant analgesics. All analgesic regimens included prokinetic treatment that was standardized to metoclopramide (10 mg i.v. 8/8 h). All protocols had indications for the prescription of rescue analgesics beyond the standardized analgesic protocol given moderate to severe acute post-surgical pain levels (NRS>3) The outcome measure was reporting moderate to severe pain 4–6 months after surgery (PPSP). Patients reporting significant “worst pain” levels in the surgical area (NRS >3) were considered as being PPSP positive, similarly to previous studies Data were analyzed using the Statistical Package for the Social Sciences (SPSS version 19.0). Internal consistency of responses to the questionnaires was assessed using Cronbach’s alpha The primary outcome variable was the report of moderate to severe pain at the 4 to 6 months follow-up. Patients were classified into two groups: none or mild pain (NRS ≤3 for “worst pain level”) and moderate to severe pain (NRS>3 for “worst pain level”) group.χ2) were performed to compare socio-demographic, clinical and psychological measures between these two pain groups (NRS≤3 vs NRS>3) and also between the two surgical groups (TKA and THA). Descriptive statistics for continuous variables are presented as mean and standard deviations, whereas categorical data are presented as numbers and percentages.Normality for continuous variables was assessed with the Kolmogorov-Smirnov Test evidencing that distribution of data differed significantly from normality assumptions. Thus, non-parametric Mann-Whitney or Chi-square tests . Those were conceptualized into three categories: demographic, clinical and psychological. In addition, Spearman correlations were calculated for the psychological variables that distinguished between NRS≤3 and NRS>3 groups in order to further investigate the association between psychological constructs. In all comparisons, two-sided tests were performed with p<0.05 used to indicate statistical significance.The potential predictors selected for inclusion were those found to better distinguish between the two pain groups  and the second one addressed the immediate post-surgical period (T2). For both models, “Pre-surgical pain intensity” and “Number of pain problems elsewhere” were entered in block 1. Another clinical variable, pre-surgical pain interference, was considered for inclusion in block 1. Nevertheless, it showed considerable overlap to the other two baseline pain predictors  and was excluded from both models due to multicollinearity (VIF >2). Type of arthroplasty was entered in block 2 as it distinguished the two pain groups in univariate analyses as found in previous studies In all regression models, the variance inflation factor value (VIF) for every independent variable was calculated to control for the influence of multicollinearity, with each variable only being included if its VIF was less than 2.χ2 = 8.372, p = 0.004). The groups did not differ significantly in any of the socio-demographic measures. Moreover, they did not differ in any other clinical measure with the exception of worst level of pre-surgical pain intensity , pre-surgical pain interference  and number of pain problems elsewhere , with patients presenting moderate to severe PPSP reporting worst results. Furthermore, moderate to severe PPSP patients showed a worst pre-surgical psychological profile , perception of more chronicity of the medical condition (osteoarthritis) that led to surgery , along with a more negative emotional representation of the surgical condition .Fifty-four patients reported none or mild pain (NRS ≤3) 4–6 months after arthroplasty, whereas 38 reported moderate to severe pain (NRS >3).  profile Table 2,z = −3.062, p = 0.002) and a heightened acute post-surgical pain intensity, both in terms of average  and worst  pain, at T2 (48 hours after surgery). No other distinction on clinical parameters was found between groups at T2 .Patients reporting moderate to severe levels of PPSP at T3 also reported high anxiety , and were also comprised by more women than men . Both groups were similar concerning clinical measures, such as BMI (Body Mass Index) and previous surgical procedures. However, TKA patients had suffered longer from their surgical disease  and presented more medical comorbidities . Although the groups did not differ in terms of pre-surgical pain intensity and in total pre-surgical pain interference levels on daily activities, TKA patients reported pre-surgical pain of longer duration . Furthermore, this latter group presented more pain problems elsewhere , as well as pain in other joints   see Table 3.z = −2.090, p = 0.037)  Table 3;z = −2.453, p<0.001) and worst  pain. No other distinction on clinical parameters was found between groups 48 hours after surgery .Immediately after surgery, TKA patients exhibited heightened acute post-surgical pain intensity, both in terms of average  of PPSP over and above the same demographic and clinical variables used for Model 1 see  and 5. The The present study aimed to examine the joint role of demographic, clinical and psychological risk factors for persistent pain experience 4 to 6 months after total knee (TKA) and hip arthroplasty (THA). Amongst the clinical factors, pre-surgical pain intensity and type of arthroplasty were the key predictors of PPSP development. Regarding psychological variables, pre-surgical illness perceptions concerning the duration (acute versus chronic) of the condition leading to surgery, namely osteoarthritis, arose as a significant predictive factor. Post-surgical anxiety was the second psychological variable found to be a risk factor for the development of moderate to severe PPSP. The results of this study improve knowledge on PPSP after major joint arthroplasties, and point to potential preventive targets for healthcare professionals.In line with previous evidence, either in arthroplasties This study did not corroborate previous findings wherein acute post-surgical pain arose as a PPSP predictor As expected Concerning the influence of psychological factors on PPSP, one interesting finding of this study is that in face of the prospect of undergoing an arthroplasty, patients who perceive the surgical disease (osteoarthritis) as more chronic are also more likely to develop moderate to severe PPSP.Timeline beliefs concern the patient’s expectations about the duration of the disease and its characteristic course Additionally, the emotional illness representations did retain marginal significance, needing to be revisited in further studies. Other studies have demonstrated that patients’ beliefs about whether their illness has an emotional impact, such as feeling depressed, angry or upset, relate with health outcomes Although all these studies demonstrated the significant role of illness representations in the prediction of health and disease-related outcomes, none have tried to relate the former with pain outcomes, with the exception of previous studies performed by our team, one concerning PPSP after hysterectomy Present findings suggest that pre-surgical arthroplasty patients could benefit from pre-surgical preventive interventions, aimed at restructuring illness cognitions, in order to reduce the likelihood of PPSP development. This can be achieved using brief cognitive-behavior techniques, involving the identification of maladaptive illness representations and the promotion of adaptive cognitions concerning the surgical disease (such as regarding illness duration). This often involves the reframing of illness perceptions and the induction of a more positive view of the expectations concerning the surgical disease A major focus of our work was to identify the predictors of persistent pain after TKA and THA surgery. Both emotional and cognitive factors emerged as important predictors of PPSP. Previous research corroborated the role of pre-surgical anxiety as a potential risk factor for PPSP Even though present findings revealed a stronger predictive value of post-surgical anxiety in comparison to pre-surgical anxiety, the latter has been found to be a strong predictor of the former, in orthopaedic samples and in across other surgeries The aim of the current study was to approach TKA and THA jointly, as both are categorized as major joint surgeries. However, we are aware that different results have been reported for PPSP after TKA and THA, regarding both the influence of psychological factors affecting PPSP Another potential limitation concerning internal validity is the loss to follow-up of 32 patients from T2 to T3. Additional analyses were performed to investigate potential differences between the patients that remained in the study and those who were not assessed at follow ups but no significant differences were found for baseline characteristics (T1) or in respect to acute post-surgical issues (T2). Therefore, the 92 remaining patients seem to be representative of this cohort.Regarding external validity, the generalizability of the results is limited by this being a single site and single country study, confined to TKA and THA patients. Future studies should thus be implemented to test if these results can be replicated.


Distal upper limb pain  can be non-specific, or can arise from specific musculoskeletal disorders. It is clinically important and costly, the best approach to clinical management is unclear. Physiotherapy is the standard treatment and, while awaiting treatment, advice is often given to rest and avoid strenuous activities, but there is no evidence base to support these strategies. This paper describes the protocol of a randomised controlled trial to determine, among patients awaiting physiotherapy for distal arm pain, (a) whether advice to remain active and maintain usual activities results in a long-term reduction in arm pain and disability, compared with advice to rest; and (b) whether immediate physiotherapy results in a long-term reduction in arm pain and disability, compared with physiotherapy delivered after a seven week waiting list period.Between January 2012 and January 2014, new referrals to 14 out-patient physiotherapy departments were screened for potential eligibility. Eligible and consenting patients were randomly allocated to one of the following three groups in equal numbers: 1) advice to remain active, 2) advice to rest, 3) immediate physiotherapy. Patients were and followed up at 6, 13, and 26 weeks post-randomisation by self-complete postal questionnaire and, at six weeks, patients who had not received physiotherapy were offered it at this time. The primary outcome is the proportion of patients free of disability at 26 weeks, as determined by the modified DASH  questionnaire.We hypothesise (a) that advice to maintain usual activities while awaiting physiotherapy will be superior than advice to rest the arm; and (b) that fast-track physiotherapy will be superior to normal (waiting list) physiotherapy. These hypotheses will be examined using an intention-to-treat analysis.Results from this trial will contribute to the evidence base underpinning the clinical management of patients with distal upper limb pain, and in particular, will provide guidance on whether they should be advised to rest the arm or remain active within the limits imposed by their symptoms.http://www.controlled-trials.com (reference number: ISRCTN79085082).Registered on  Upper limb pain is common and responsible for considerable disability, demand for health care and lost productivity. Among working-aged respondents to a recent population survey in England, 15% had consulted a GP within the past year with upper limb pain . FurtherDistal upper limb pain is defined as pain in the elbow, forearm, wrist or hand, may be non-specific in origin, or may arise from a number of specific disorders . In a study of patients presenting to primary care and physiotherapy services with upper limb pain, 42% of patients had pain in the distal arm and at twelve months 48% were still in pain, and 19% reported unremitting pain (never pain-free for as long as seven consecutive days) . AlthougPatients with upper limb pain are commonly referred to physiotherapy and, while awaiting treatment, are often advised to rest the arm and avoid purported harmful activities as a precautionary measure. Indeed, online health advice offered by the UK National Health Service (NHS) states that ‘it is likely that your GP will probably advise you to temporarily stop doing the task or activity that is causing your symptoms’ . SimilarThe Back Book) has been shown to be effective in promoting positive beliefs and contributing to improved clinical outcomes [The Whiplash Book), where a booklet focusing on reducing anxiety about the injury, and stressing the benefits of remaining active, has been well received by patients and caused a positive shift in beliefs [The Arm Book which also provides evidence based advice on how to deal with upper limb pain or injury. However, its effectiveness is currently unproven [Written information providing evidence-based advice to patients with back pain  arise in the absence of well-defined local pathology, and the natural history and predictors of arm pain share much in common with these other musculoskeletal disorders – fear-avoidance, health anxiety, pessimistic attitudes, psychological distress and adverse psychosocial factors ,5,13. WeThe primary aim of this study is to investigate whether, among patients awaiting physiotherapy for distal upper limb pain , advice to remain active and maintain usual activities results in a long-term reduction in upper limb pain and disability, compared with advice to rest.Potential participants will be identified from patients with distal upper limb pain referred to physiotherapy. However, whether physiotherapy itself is efficacious in the management of distal upper limb pain is not well established. Therefore, in the context of the proposed trial, a pragmatic opportunity exists to determine the value of early physiotherapy in comparison with treatment that is delayed until the usual waiting list time. Therefore, a secondary aim is to determine, among the same patient population, whether immediate (‘fast-track’) physiotherapy results in a long-term reduction in upper limb pain and disability, compared with physiotherapy delivered at the usual waiting list time – typically, after a period of approximately seven weeks.This paper presents the protocol for a multi-centre, randomised, controlled trial. Potentially eligible patients with distal upper limb pain are identified from waiting lists in out-patient physiotherapy departments. Recruited patients undergo telephone screening in the first instance, followed by a pre-trial assessment by a research nurse, to confirm eligibility and collect baseline information. Eligible patients are randomised to one of three groups:• Group 1 – advice to remain active while awaiting physiotherapy treatment;• Group 2 – advice to rest the arm while awaiting physiotherapy treatment; or• Group 3 – immediate physiotherapy.All participants are followed up by postal questionnaire 6, 13 and 26 weeks post-randomisation to determine arm pain and function. In addition, at six weeks, participants from Groups 1 and 2 who indicate that they still require physiotherapy are offered immediate treatment. Thus, this treatment will be delivered at around seven weeks equating, approximately, to that on a ‘usual care’ waiting list.Ethical approval has been obtained from the South Central – Hampshire A Research Ethics Committee (11/SC/0107). All participants are required to provide written informed consent at initial assessment. Patients are required to consent to complete the study questionnaire, undergo the brief examination and, if eligible, to be randomised into one of the treatment groups. Participants are not being made aware that there are two different types of advice to prevent compromise of the advice being given.From January 2012 to January 2014, male and female patients aged 18 years or older were identified from out-patient physiotherapy services in fourteen UK trial sites ; employment circumstances ; symptom history  and all prior treatments to date. In addition, data were collected on general health, physical and mental well-being, fatigue, other symptoms , somatic distress, health beliefs  and smoking status.Patients also underwent a standardised upper limb examination: the Southampton Examination Schedule for Upper Limb Disorders which includes inspection and palpation of the upper limbs, and clinical provocation tests . The Schedule is based on a national Delphi consensus, has been validated in hospital out-patient and community settings, and has been applied in previous large-scale epidemiological studies ,15.Both questionnaire and examination assessed factors were considered as important prognostic markers, potential modifiers of treatment response, baseline measure of outcomes, or were important for randomisation and minimisation.Randomisation was conducted by the Robertson Centre for Biostatistics, a registered clinical trials unit at the University of Glasgow.Patients were allocated to one of the three treatment groups using a mixed randomisation and minimisation algorithm to maintain treatment balance with respect to treatment centre, laterality , a broad categorisation of diagnosis , and baseline arm function, as assessed using a modified DASH score . For each new patient, the minimisation variables were entered into a web-based data collection system, created by the trials unit; the system then allocated the patient to one of the three groups. One third of patients were allocated completely at random, whilst two-thirds were allocated according to the minimisation algorithm. Randomisation to the three groups, or entry to the minimisation procedure, was determined according to a pre-specified allocation schedule generated using the method of randomised permuted blocks of nine participants. This schedule was known only to a restricted group of staff at the trials unit. Within the minimisation algorithm, in the event of a tie between treatment groups , treatment was allocated at random between the tied treatment groups.Because of the nature of the interventions, it was not possible to blind study participants. However, to prevent ‘contamination’ it is important that participants were unaware of the differing advice given to others. Therefore, patients were informed that if they participated, they would be randomised to immediate physiotherapy or advice, without giving explicit details about the nature of the advice (or even the fact that there were two advice groups).• Group 1 – advice to remain active;Participants randomised to receive advice to remain active were given a seven-page leaflet focusing on positively shifting beliefs about activity and arm pain, along with practical advice on staying active. The messages were reinforced verbally by a research nurse using a brief standardised script. The experimental leaflet was developed from the findings of a recent Health and Safety Executive Research Report of a comprehensive review of arm pain : this reThe Back Book, The Whiplash Book, and The Arm Book[These messages are very similar to those that apply to back and upper limb pain and are amenable to presentation written form - similar to  Arm Book,10,12. C• Group 2 – advice to rest the arm; orParticipants randomised to receive advice to rest the arm received a leaflet similar in length, design and appearance to the booklet for Group 1. This leaflet was based on material available via NHS Direct: it covers a range of diagnoses, can be taken to reflect current clinical practice, and contrasts with the approach adopted for the experimental leaflet (Group 1). The style is solidly biomedical and the advice is about rest and avoidance (as well as treatment), rather than maintaining activity.• Group 3 – immediate physiotherapy.Participants randomised to receive immediate physiotherapy were fast-tracked to treatment which they received at the earliest opportunity. Additional physiotherapy staff were provided in all participating trial centres so initial physiotherapy assessment  and first treatment would occur in a matter of days, rather than weeks. Whilst this trial is intended to be pragmatic in so far as it is reflective of usual physiotherapy practice, we undertook additional work to ensure the treatment programmes were compliant with both the Medical Research Council’s and the CONSORT organisation’s guidance on developing and reporting complex interventions. In the early phases of the study we documented and developed the intervention to ensure it represents best usual care. This involved a review of appropriate treatment guidelines and the literature to ascertain current best practice. It also included discussions with physiotherapists involved in the trial in order to establish current practice and, if any differences were encountered, to reconcile the findings of the literature with actual clinical practice. A broad set of guidelines was developed in accordance with best practice which gave therapists the flexibility to treat patients on an individual basis without being overly prescriptive.Further, it is important that the interventions be documented so they can be reported and replicated, and the physiotherapists who deliver the intervention be involved in this process (to facilitate compliance with the treatment protocol). Treatments were recorded using a standardised pro forma and record, for example, treatment modality, number and timing of appointments attended, and time to discharge.Follow-up is still ongoing. Participants are followed up at 6, 13, and 26 weeks post-randomisation by self-complete postal questionnaires, and non-responders receive a reminder questionnaire after two weeks. After a further two weeks, non-responders are followed up by telephone, and are asked brief questions on the primary outcome only, using a standardised pro forma. In addition, at six weeks patients randomised to receive advice (Groups 1 or 2) receive a letter offering them a physiotherapy appointment which, if accepted, is received at the earliest opportunity. This approach, requiring an active opt-in to treatment, is consistent with current practice for patients not involved in the trial. Also, the delay between randomisation and the offer of appointment is equivalent to what would be usual care physiotherapy in most UK centres. Participants electing to receive physiotherapy are offered immediate treatment and receive that therapy, as per usual protocol (and as per Group 3), at the discretion of the treating physiotherapist. Although the precise treatment modalities given may differ between fast-track and delayed physiotherapy groups, this reflects usual care, where treatment choice may be dependent on time elapsed since initial referral and activities undertaken in the interim.The DASH  questionnaire is an instrument designed to measure physical function and symptoms in patients with single or multiple musculoskeletal disorders of the upper limb. It has been shown to have good test-retest reliability and validity. Further, it has high internal consistency, correlates well with other measures of arm function, and discriminates between persons who are/are not able to undertake activities of daily living, or work without restriction . HoweverAccordingly, we developed a modified instrument to determine arm function. Based in part and in format on the original DASH questionnaire, and called here the 'modified DASH', this instrument asks participants to rate difficulty in performing eleven pre-specified activities over the previous seven days because of pain in their distal upper limb Figure . This moThus, for the current trial, the primary outcome is the proportion of patients free of disability at 26 weeks post-randomisation, as determined by the modified DASH. As a secondary outcome for participants randomised to Group 1/Group 2, we aim to determine the proportion who still seek physiotherapy at six weeks. In addition, we collect information on the type of treatments given, and time to discharge. Other secondary outcomes, in all participants, include: upper limb pain and function, coping, fear of movement, ability to function at work, aspects of general health and quality of life.In addition, health care costs will be collected from participants using structured questionnaires. These will record distal upper limb related hospital admissions, out-patient attendances, and visits to/from relevant health professionals. Published UK sources of data on unit cost will be applied to value use of resources. For EQ-5D and SF-12 outcomes, published UK tariffs will be used to convert these data to quality of life weights.The study is powered to determine a difference in the proportion of patients fully recovered at 26 weeks post-randomisation, as assessed using the modified DASH. The principal analysis will consist of a comparison between participants in Group 1 and Group 2 . We have previously shown that, among persons with distal arm pain undergoing usual care, 51% were free of disability at six months, with little further improvement (up to 60%) at 12 months . Thus, wAnalysis will determine whether, at 26 weeks post-randomisation, patients in Group 1  experience an improvement in upper limb pain and function, compared with those in Group 2 (advice to rest the painful arm). In addition, we will examine whether, at 26 weeks post-randomisation, patients who received immediate physiotherapy (Group 3) experience an improvement in upper limb pain and function compared with those who received delayed treatment (from Groups 1 and 2 combined).Estimation of the treatment effects will be based on intention-to-treat and will be conducted at the end of the follow-up period . To address the primary research question a logistic regression model will be fitted to estimate the odds ratio for full recovery at 26 weeks post-randomisation between Group 1 and Group 2. The model will include treatment group , age , and as categorical variables: sex, study centre, pain location , laterality  and baseline modified DASH score . If small numbers in any of these sub-groups causes problems for model convergence, alternative specifications will be considered.For the primary analysis of the impact of advice to remain active compared to advice to rest, the method of recycled predictions (using 1000 bootstrap samples) will be used to estimate the absolute difference in the probability of being fully recovered between the two groups, with a 95% confidence interval.Likewise, for the secondary research question, the impact of early compared to delayed physiotherapy, the method of recycled predictions (using 1000 bootstrap samples) will be used to estimate the absolute difference in the probability of being fully recovered between the early physiotherapy group and the two delayed physiotherapy groups combined, with a 95% confidence interval.Although the main analysis will classify the modified DASH score dichotomously – i.e. fully recovered (zero disabilities) or not – as a secondary analysis the modified DASH score will be considered as a continuous variable. A linear regression model will be fitted, including the treatment group, age, sex, study centre, pain location, laterality and baseline modified DASH score (as a continuous variable). Again, if small numbers in any of these sub-groups causes problems for model convergence, alternative specifications will be considered. To assess the impact of advice to remain active compared with advice to rest, and to compare early with usual care physiotherapy, appropriate contrasts will be applied to the coefficients of the above model to estimate the adjusted mean differences in modified DASH scores between Groups 1 and 2, and between Group 3 and the mean of Groups 1 and 2 combined, with 95% confidence intervals.The above analysis will be repeated using the same outcome measures collected at different assessment time points (6 and 13 weeks post-randomisation). In addition, evidence of treatment effect heterogeneity will be assessed by including terms for interactions between treatment and each of the other variables in the regression models.Finally, a cost-utility analysis will be performed to assess the health care and patient costs, and quality of life effects, associated with provision of each of the three treatments. A series of incremental cost per Quality Adjusted Life Year (QALY) ratios will be calculated. Sensitivity analysis will be employed to quantify the uncertainty surrounding the calculated ratios. In addition, non-parametric methods will be used for calculating the confidence intervals around cost per QALY ratios, using bootstrapped estimates of the mean cost and QALY differences. To summarise cost-effectiveness, cost effectiveness acceptability curves will be employed to show the probability that different interventions are cost effective for different values of willingness to pay per additional QALY.We have outlined the rationale and design of a randomised controlled trial to investigate whether, amongst patients awaiting physiotherapy treatment for distal upper limb pain, advice to remain active results in a long-term reduction in arm pain and disability, compared with advice to rest. Further, the trial gives rise to a pragmatic opportunity to examine whether, among the same patient population, immediate (‘fast-track’) physiotherapy results in a long-term reduction in arm pain and disability, compared with physiotherapy delivered at the usual time – typically, after a waiting list period of 6–8 weeks.Patients awaiting physiotherapy for distal arm pain are commonly advised to rest the affected limb and avoid strenuous activities to ‘prevent further injury’. However, there is currently no sound evidence to support this strategy. The current trial is novel, in that it tries to address this, although similar strategies have been applied in other areas and have led to enormous clinical benefit. In low back pain, for >20 yrs the benefits of remaining active – as opposed to bed-rest, widely advocated at the time – have been well known. The evidence supporting maintenance of activity among persons with low back pain is now well established. Indeed recent studies from Australia have demonstrated that widespread publicity campaigns, promoting this message, result in a reduction in the number of claims for back pain compensation, and medical payments for back pain in the general population . HoweverThe results of this trial will have an immediate influence on the management of patients with distal arm pain. Also, depending on the results, it may inform future research studies to refine management. For example, we may find that there is a worthwhile benefit from remaining active and maintaining usual activities while awaiting physiotherapy treatment. If this is the case, this would provide strong evidence that the advice currently given to patients with distal arm pain should be changed. Alternatively, if there is no additional benefit from advice to remain active, this would support the current treatment strategies and current advice that is given. It would also provide the stimulus for examining in more detail the differences between low back pain and distal arm pain – i.e. why, when the risk factors for long-term pain and disability are similar, do similar treatment approaches fail to work?In addition, we may find that ‘fast-track’ physiotherapy has beneficial outcomes, compared to physiotherapy delivered at the usual time. This would provide good evidence in support of a rapid-access policy which, in turn, would translate into clear and immediate patient benefit. It would be unethical to conduct a study where some patients received physiotherapy and others did not. However, if the current trial demonstrates that there is no additional benefit from early physiotherapy, this would provide the rationale  for randomised trials of specific physiotherapeutic modalities. This might lead to more refined physiotherapy treatments and more efficient use of healthcare resources.South Central – Hampshire A Research Ethics Committee (reference number: 11/SC/0107).DASH: Disabilities of the Arm, Shoulder and Hand; NHS: National Health Service; QALY: Quality Adjusted Life Year.The Arm Book, to which the experimental leaflet in this trial is related: he may receive future royalties on the booklet.Kim Burton was involved in the development of GTJ is chief investigator of the trial, and is ultimately responsible for all aspects of trial conduct. GJM, KTP, DC, KWB, KB, PM, AM were co-applicants on the original funding application, contributed to the overall design of the trial and are jointly responsible for oversight of trial conduct. CM was a collaborator on the original funding application; PH was responsible for production of physiotherapy treatment guidelines; both also contribute to trial oversight. KB was responsible for production of the advice material – for both the active and passive advice groups. AM is the trial statistician and drafted the trial analysis plan, to which all other authors had the opportunity for critical input. KM is the trial manager responsible for day-to-day management of the trial. GTJ was responsible for drafting the manuscript. All authors read, had critical input, and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/15/71/prepub


To explore the diagnostic procedure of acute fatal chest pain in emergency department (ED) in order to decrease the misdiagnosis rate and shorten the definite time to diagnosis. The ultimate aim is to rescue the patients timely and effectively.Three hundreds and two patients  complained with acute chest pain and chest distress presenting to our ED were recruited. They were divided into two groups according to visiting time . The misdiagnosis rate, definite time for diagnosis and medical expense were analyzed. Patients of Group I were diagnosed by initial doctors who made their diagnosis according to personal experience in outpatient service or rescue room in ED. While patients of Group II were all admitted to rescue room and were diagnosed and rescued according to the acute chest pain screening flow-process diagram. Differences inter-group was compared.The misdiagnosis rate of fatal chest pain in Group I and Group II was 6.8% and 0% respectively, and there was statistic difference (P=0.000). The definite time to diagnosis was 65.3 min and 40.1 min in control and Group II respectively, the difference had statistic significance (P=0.000). And the mean cost for treatment was 787.5/124.5 ¥/$ and 905.5/143.2 ¥/$ respectively, and there was statistic difference too (P=0.012).Treating emergency patients with acute chest pain according to the acute chest pain screening flow-process diagram in rescue room will decrease misdiagnosis apparently, and it can also shorten the definite time to correct diagnosis. It has a remarkable positive role in rescuing patients with acute chest pain timely and effectively. Chest pain is a common urgent condition in emergency department (ED). And fatal chest pain is a more serious condition threatening the lives of patients and security of medical treatment. The definite time to correct diagnosis of fatal chest pain is an important factor for treatment and prognosis . HoweverThree hundreds and two patients complained of acute chest pain and chest distress aged from 19 to 84 years  were recruited to our study. The patients were divided into two groups according to the visiting time to ED. The patients visiting from October 2010 to March 2011 were enrolled in Group I, and Group II included patients visiting from October 2011 to March 2012. The misdiagnosis rate, definite time for diagnosis and medical expense were analyzed.The patients of Group I were triaged by the responsible nurse to outpatient service or rescue room of ED. And they were diagnosed by initial doctors according to personal judgment and experience. While patients of Group II were all enrolled in rescue room and were diagnosed and rescued according to the acute chest pain screening flow-process diagram Figure . The disSPSS 13.0 software was used for data management and analysis. Measurement data was described as In 147 patients with acute chest pain in Group I, 137 were definitely diagnosed as fatal acute chest pain. And 10 were misdiagnosed. The misdiagnosis rate was 8.53%. The mean definite time to diagnosis was 65.3±35.0min. All 155 patients with acute chest pain in Group II, were definitely diagnosed as fatal acute chest pain. 0 was misdiagnosed. Misdiagnosis rate was 0%. The mean definite time to diagnosis was 40.1±12.7min (Table Acute chest pain is a very serious emergency that threatened patient’s lives. Make a definite diagnosis as soon as possible and start certainty therapy is very critical. The main factors that delayed diagnosis and treatment of this kind of patients include insufficient cognition by oneself, time delays before visiting and diagnosis and management delayed in the hospital . And theIn the past, the hospital pattern of diagnosis and treatment presented as assessment or previewing patients with acute chest pain by physicians depending on their personal medical expertise. This kind of pattern had multiple disadvantages. Firstly, medical resources could not be distributed effectively and reasonably. The amount of emergency patients in hospitals of class three grades A increased rapidly with the social development and the concept transition. Sometimes, there were too many patients lining up in apex time. Emergency doctors had no time to care for some patients who really needed diagnosis and cure in precedence. And acute chest pain is one of the preferential diseases. If these patients were passive and then too much time was lost in examination for first things first, that would cause the delay of diagnosis and cure . SecondlTo aim directly at the above issues, we adopted two major measures to solve them. First, all the patients complained with chest pain and chest distress were admitted to rescue room for diagnosis and cure. The consummate monitor and emergency equipments ensured the compact diagnose and examination time, which should be controlled better. And the misdiagnosis rate of fatal chest pain was thus decreased . Second,To sum up, we think it is important to start the rescue procedure of acute chest pain when patients complain of high-risk symptoms. And the acute chest pain screening flow-process diagram should be followed in diagnosing and rescuing patients in rescue room.


Acute postthoracotomy pain is a well-known potential problem, with pulmonary complications, ineffective respiratory rehabilitation, and delayed mobilization in the initial postoperative period, and it is followed by chronic pain. The type of thoracotomy, intercostal nerve damage, muscle retraction, costal fractures, pleural irritation, and incision scar are the most responsible mechanisms.Our aim was to assess whether preoperative ultrasound suprascapular nerve block with thoracic epidural analgesia was effective for postthoracotomy shoulder pain relief.Thirty-six American Society of Anesthesiologist classification physical status I–III patients (2011–2012), with a diagnosis of lung cancer and scheduled for elective open-lung surgery, were prospectively included in the study. Eighteen of the patients received an ultrasound-guided suprascapular nerve block with 10-mL 0.5% levobupivacaine, using a 22-gauge spinal needle, 1 hour before operation (group S); 18 other patients had thoracic epidural analgesia only, and no nerve block was performed. Standard general anesthesia was administered. Degree of shoulder pain was assessed by a blinded observer when discharging patients from the recovery room, and thereafter at 1, 3, 6, 12, 24, 36, 48, and 72 hours on infusion at rest and 12, 24, 36, 48, and 72 hours on coughing. The same blinded observer also recorded the total amount of epidural levobupivacaine and fentanyl used by the 2 groups.P = 0.0001) and fentanyl (P = 0.005) used postoperatively was statistically lower than in the epidural group. Visual analogue scale measurements in the suprascapular group were statistically significantly lower at 0, 1, 3, 6, 12, 24, 36, and 48 hours than those in the epidural group, both at rest and coughing.In the suprascapular block group, the total amount of levobupivacaine (Postthoracotomy shoulder pain reduces patient function and postsurgical rehabilitation potential after thoracotomy, and various studies on explaining the etiology and management of postthoracotomy shoulder pain have been conducted. Theories of the etiology involved either musculoskeletal origin or referred pain. In this study, we concluded that preoperative ultrasound-guided suprascapular nerve block with thoracic epidural analgesia could achieve effective shoulder pain relief for 72 hours postoperatively, both at rest and coughing. Acute postthoracotomy pain is a well-known potential problem, with pulmonary complications, ineffective respiratory rehabilitation, and delayed mobilization in the initial postoperative period, and it is followed by chronic pain. The type of thoracotomy, intercostal nerve damage, muscle retraction, costal fractures, pleural irritation, and incision scar are the most responsible mechanisms.Long-term postthoracotomy pain is a sequela problem after thoracotomies. Katz et al.Ipsilateral shoulder pain also coincides with the postoperative period and has been reported in >75% of various studies. A possible stimulus that might explain this referred pain is that the pleural sides of the mediastinum and diaphragm are conducted via the phrenic nerve. Other reported etiologies are transection of the major bronchus, patient position during surgery, straining of muscles and joints around the shoulder, and thoracotomy tube.The suprascapular nerve originates from the brachial plexus and has many sensorial afferents from most of the shoulder joint. In a detailed survey of the international literature, we were unable to find any studies on the effectiveness of preoperative ultrasound-guided suprascapular nerve block with thoracic epidural analgesia for severe postthoracotomy ipsilateral shoulder pain. Therefore, we conducted this prospective, randomized study to assess the hypothesis of whether blockade of the suprascapular nerve, by directly visualizing this nerve preoperatively with ultrasound, could reduce the severity of ipsilateral shoulder pain.Ethical approval for this study was provided by the Institutional Review Board of Istanbul Education and Research Hospital in January 2011. Written informed consent was obtained from each patient before inclusion in the study. Thirty-six American Society of Anesthesiologist classification physical status I–III patients, with a diagnosis of lung cancer and scheduled for elective open-lung surgery between 2011 and 2012 were prospectively included in the study. The same surgeons performed a lobectomy through a posterolateral thoracotomy incision in the sixth intercostal space. Patients with severe cardiopulmonary or renal disease, allergies to local anesthetics, known psychiatric or neurologic diseases, alcohol or narcotics abuse, contraindications to thoracic epidural or suprascapular block, preexisting shoulder problems, or previous thoracotomy history were excluded.5) for heart rate and ST-segment changes, with noninvasive pulse oximetry (SpO2), and an arterial catheter for invasive blood pressure monitoring and blood gas analysis. Airway pressures, ventilation parameters, inspired oxygen concentration, expired end-tidal carbon dioxide concentration (EtCO2), and end-tidal sevoflurane concentration were also monitored.After the patients arrived in the operating theater, a 16-gauge IV cannula was inserted into the forearm opposite to the surgical side, and then standard premedication was given with 2-mg midazolam IV A 20-gauge epidural catheter was placed in the T6–T7 interspace using the midline approach and a saline loss of resistance technique under a C-arm scope, through an 18-gauge Tuohy epidural needle. The catheter was advanced 3 to 5 cm inside the epidural space, and a test dose of 3-mL lidocaine 2% with epinephrine 1:200,000 was given to exclude misplacement of the catheter. Eighteen of the patients received an ultrasound-guided suprascapular nerve block with 10-mL 0.5% levobupivacaine using a 22-gauge spinal needle 1 hour before the operation (group S), and the other 18 patients received thoracic epidural analgesia only, and no nerve block was performed. An epidural block was induced with 10-mL 0.5% levobupivacaine + 2.5 μg/mL fentanyl at anesthesia induction, and then maintained with 5 mL/h infusion and 10-mL bolus per 45 minutes during surgery. All patients were monitored with 2-lead electrocardiography , fentanyl (1 μg/kg), and vecuronium (0.1 mg/kg). A double-lumen endobronchial tube was then placed, and the lungs ventilated using a 50% oxygen in air mixture with a Drager–Julian pressure-cycled ventilator . Patients were then placed in the lateral decubitus position, and neuromuscular block was maintained with IV boluses of 0.01 mg/kg vecuronium per hour.2 concentration; pressure-controlled mandatory ventilation mode was used. Intraoperative arterial pressure and heart rate were maintained within 20% of baseline values by altering the concentration of sevoflurane, or by administering IV fluids and ephedrine boluses. At the end of the operation, at the start of skin closure, sevoflurane inhalation was discontinued, and the residual neuromuscular block was antagonized (neostigmine 2 mg and atropine 1 mg IV). When the patient was judged to be awake, extubation was performed with adequate oxygenation (SpO2 90% at room air). All patients had only 1 chest drain tube. The patient was then transferred to the intensive care unit. Postoperative analgesia consisted of a patient-controlled epidural analgesia infusion of 0.5% levobupivacaine + 2.5 μg/mL fentanyl . Postoperatively, patients were assessed and their data recorded by a blinded observer. The degrees of pain at rest  and on coughing (VAS C) were assessed using a 10-cm VAS, with zero signifying no pain and 10 signifying the worst pain. Degree of shoulder pain was assessed by an observer when discharging patients from the recovery room and then at 1, 3, 6, 12, 24, 36, 48, and 72 hours on infusion at rest and 12, 24, 36, 48, and 72 hours on coughing. The same observer also recorded the total amount of epidural levobupivacaine and fentanyl consumption by the groups.General anesthesia was maintained with 2% end-tidal concentration sevoflurane and 40 to 45 EtCOt-test or the Mann–Whitney U test for continuous variables and χ2 test or Fisher’s exact test for categorical variables. A P value < 0.05 was considered statistically significant.In this prospective, double-blind study, all statistical analysis was performed with the Number Cruncher Statistical System  statistical software program. Data are expressed as mean (SD). Statistical comparisons were made by Student’s P = 0.0001) and fentanyl (P = 0.005) were statistically lower than in the epidural group  at 72 hours. VAS coughing measurements in the suprascapular group were statistically significantly lower at 12, 24, 36, 48, and 72 hours than those in the epidural group (VAS measurements at rest in the suprascapular group were statistically significantly lower at 0, 1, 3, 6, 12, 24, 36, and 48 hours than those in the epidural group . There wal group .Postthoracotomy shoulder pain reduces patient function and postsurgical rehabilitation potential after thoracotomy. The incidence of postthoracotomy shoulder pain in various studies ranges from 21% to 97%, and thoracic epidural analgesia is ineffective for eliminating this pain after surgery. General approaches to postthoracotomy shoulder pain consist of regular administration of NSAIDs and acetaminophen, intraoperative injection of local anesthetic into the pericardiac fat pad, interscalene brachial plexus block, stellate ganglion blockade, and direct blockade of the phrenic nerve.Various studies were conducted to explain the etiology and management of postthoracotomy shoulder pain. Theories on the etiology involved either musculoskeletal origin or referred pain.In a 2008 review about shoulder pain, GernerWe designed a prospective, randomized study in which suprascapular nerve block with ultrasound guidance was effective for postthoracotomy shoulder pain. However, many etiologies and theories were considered for explaining ipsilateral postthoracotomy shoulder pain; the theory most emphasized in the literature was that irritation of the pericardium or mediastinal and diaphragmatic pleural surfaces resulted in pain transferred to the ipsilateral shoulder via the phrenic nerve.In contrast, Mark and BrodskyThe suprascapular nerve has both motor and sensory components originating from the ventral rami of C4, C5, and C6 spinal nerves and goes through the upper trunk of the brachial plexus. The nerve runs inferiorly, laterally, and posteriorly to enter the supraspinatus fossa via the suprascapular notch and innervates the supraspinatus and infraspinatus muscles. The suprascapular nerve innervates 70% of the shoulder joint and supplies the posterior glenohumeral joint capsule, acromioclavicular joint, subacromial bursa, and coracoclavicular ligament.Chan et alWe would like to point out a possible limitation of this study, in that we did not perform a physical examination of whether the shoulder joint experienced tenderness before we administered the nerve block.Tan et alPeng et alAs a result of this study, we concluded that preoperative ultrasound-guided suprascapular nerve block with thoracic epidural analgesia could be part of a multimodal analgesic treatment for postthoracotomy shoulder pain management.The authors have indicated that they have no conflicts of interest regarding the content of this article.


Lumbar Disc Herniation (LDH) and Lumbar Spinal Stenosis (LSS) are the most common diagnoses of low back and leg pain symptoms. The Japanese Orthopedic Association Back Pain Evaluation Questionnaire (JOABPEQ) is a measure of health related quality of life in these patients. This study aimed to cross-culturally translate and validate the JOABPEQ in Iran.This was a prospective clinical validation trial. The translation and cross-cultural adaptation of the original questionnaire were performed in accordance with the published guidelines. A total of 103 patients with LDH or LSS were asked to respond to the questionnaire at two time points: pre- and post-operation (pre- and post-operative assessments) and were followed up for 6 months. To evaluate the reliability the internal consistency was assessed using the Cronbach's alpha coefficient and validity was assessed using the convergent validity. Responsiveness to the clinical change also was assessed comparing patients’ pre- and postoperative scores.The Cronbach’s alpha coefficients for the JOABPEQ at preoperative and postoperative assessments ranged from 0.71 to 0.81 indicating a good internal consistency for the questionnaire. Furthermore, the correlation of each item with its hypothesized subscale of the JOABPEQ showed satisfactory results suggesting that the items had a substantial association with the subscale representing the concept. Further analysis also indicated that the questionnaire was responsive to change (P less than 0.0001).In conclusion, the Iranian version of JOABPEQ performed well and the findings suggest that it is a reliable and valid measure of back pain evaluation among LDH and LCS patients.Japanese Orthopedic Association Back Pain Evaluation Questionnaire, Low back pain, Postoperative


Leg pain associated with low back pain (LBP) is recognized as a risk factor for a poor prognosis, and is included as a component in most LBP classification systems. The location of leg pain relative to the knee and the presence of a positive straight leg raise test have been suggested to have clinical implications. To understand differences between such leg pain subgroups, and whether differences include potentially modifiable characteristics, the purpose of this paper was to describe characteristics of patients classified into the Quebec Task Force (QTF) subgroups of: 1) LBP only, 2) LBP and pain above the knee, 3) LBP and pain below the knee, and 4) LBP and signs of nerve root involvement.Analysis of routine clinical data from an outpatient department. Based on patient reported data and clinical findings, patients were allocated to the QTF subgroups and described according to the domains of pain, activity limitation, work participation, psychology, general health and clinical examination findings.A total of 2,673 patients aged 18–95 years (median 47) who were referred for assessment of LBP were included. Increasing severity was consistently observed across the subgroups from LBP only to LBP with signs of nerve root involvement although subgroup differences were small. LBP patients with leg pain differed from those with LBP only on a wide variety of parameters, and patients with signs of nerve root involvement had a more severe profile on almost all measures compared with other patients with back-related leg pain.LBP patients with pain referral to the legs were more severely affected than those with local LBP, and patients with signs of nerve root involvement were the ones most severily affected. These findings underpin the concurrent validity of the Quebec Task Force Classification. However, the small size of many between-subgroup differences amid the large variability in this sample of cross-sectional data also underlines that the heterogeneity of patients with LBP is more complex than that which can be explained by leg pain patterns alone. The implications of the observed differences also require investigation in longitudinal studies. Low back pain (LBP) is commonly triaged or classified into LBP due to serious pathology, LBP with nerve root compression, and non-specific LBP (NSLBP). Most paThe belief that NSLBP consists of a number of subgroups, with different prognoses and different treatment responses, has increased over the last decade, and this has been mirrored in a proliferation of studies reporting research into NSLBP subgroups aimed at identifying homogeneous groups of patients with similar trajectories or who would benefit from a certain intervention-10. It iThe report of the 1987 Quebec Task Force suggested distinguishing between pain referral above and below the knee. This haPut simply, knowing the distinctions between patient groups with LBP only, those also with leg pain above the knee, those with leg pain below the knee and those with nerve root involvement, would clarify which subgroup classifications are useful. This information could assist in clinical decision making for individual patients, in quality assurance and in the design of research projects.The objective of this study was to describe physical, psychological and social factors in LBP patients when they first had contact with a secondary care outpatient clinic. The cohort was described using the Quebec classification subgroups of (a) LBP only, (b) LBP and leg pain above the knee, (c) LBP and leg pain below knee, and (d) LBP and signs of nerve root involvement.This study was based on data collected as part of the daily clinical routine in the conservative care department of The Spine Centre of Southern Denmark. This outpatient, secondary care department is a non-surgical unit in a public hospital with a geographic catchment area with approximately 1.2 million inhabitants. The depData were collected in the Spine Centre’s electronic clinical registry named the SpineData database . Patients answered a comprehensive self-reported baseline questionnaire on a touch screen in the waiting area prior to their first consultation. The clinicians entered results of a core set of clinical tests either when examining the patient or after the first consultation. Clinicians in the department were physical therapists, chiropractors, rheumatologists, orthopaedic surgeons and general medical practitioners.th 2008 and November 4th 2011 with LBP as their main complaint were selected for the analyses. The main complaint was defined by the patient’s response when asked to indicate on the touch screen body chart the area for which the patient was seeking care. To be included in the study, patients had to have completed the Centre’s electronic patient questionnaire with no missing data on pain intensity or in the pain drawing. An additional inclusion criterion was that data from a clinician’s neurological examination needed be present. For patients who were referred to the centre for more than one episode of LBP during the study period (< 2% of the cohort) only data for the latest episode was included.Patients aged 18 years or older who were seen in The Spine Centre between December 15The cohort was described on six health domains . Except for the clinical examination findings, all items were self-reported by patients.Pain items were: duration of the present episode (months), previous LBP episodes (yes/no), intensity of low back pain  for each of ‘LBP now’ , ‘worst in the last 14 days’ , ‘typical in the last 14 days’ , which were collectively averaged to form a single 0-10 scale), intensiActivity limitation was measured with the 23-item Roland Morris Disability Questionnaire (RMDQ) and calcWork participation was assessed by questions on: Regular employment , sick listing (proportion of persons in regular employment who reported any sick listing within the previous three months), and sick days (days off work during the preceding three months among the regular employed).Psychological characteristics were depressive symptoms and fear of movement. Depressive symptoms were measured by the two PRIME-MD 1000 screening questions using a General health was assessed using the Euroqol health thermometer (Euroqol VAS) that measures self-reported health state today .Directional preference was recorded from the clinical examination and defined as being present if either centralisation or peripheralisation of pain occurred with tests of end-range movements or postures as described in the Mechanical Diagnosis and Therapy system by McKenzie. Centrallocal LBP only if their pain drawing only included local LBP and their worst leg pain intensity in the preceding 14 days was zero . LBP with leg pain above the knee (LBP + pain above knee) was defined as persons who indicated on the pain drawing that they had pain in the anterior or posterior thigh but no pain in the calf or feet, and rated their worst leg pain intensity as being one or more . LBP with leg pain below the knee (LBP + pain below knee) was defined as a person with a pain drawing indicating pain in the calf and/or foot and their worst leg pain intensity being at least one. LBP with signs of nerve root involvement (LBP + NRI) was arbitrarily defined as any person with any leg pain present on their pain drawing, their worst leg pain intensity was one or more, and at least one of the following findings was present on the painful side during the clinical examination: muscle weakness, impaired tendon reflexes, altered sensation to touch or pinprick, a straight leg raise test that provoked their familiar leg pain , or a positive prone knee bend test combined with pain to the anterior thigh (Reverse Laségue Test). The term ‘signs of nerve root involvement’ should be considered a label given to patients fulfilling these criteria rather than a definition of a diagnostic entity. There is always imprecision for the classification of radiculopathy when only clinical signs are available[LBP + NRI subgroup single signs of NRI occurred as a positive SLR in 117 patients, altered sensation in 149, muscle weakness in 3 patients, and impaired tendon reflexes in 4, while the rest of the group had two or more signs.Patients were classified as having vailable and our Patients, whose pain drawing and pain scales were ambiguous, for example where their leg pain intensity was reported as zero but they indicated leg pain on the pain drawing, were excluded from the analysis. People excluded for this reason did not necessarily give contradictory or inaccurate answers. For example, a person could have reported having leg pain within the previous two weeks but did not have leg pain on the exact day when the pain drawing was made. However, allocation of such a person into a classification group would have been ambiguous and we opted to exclude such patients in order to obtain the most definitive data.t-test or Wilcoxon Ranksum Test for ordinal and continuous variables. Group differences were considered statistically significant at p<.05. As the high number of variables tested increases the risk of mass significance, between-subgroup comparisons should be interpreted as only hypothesis-generating. Analyses were performed using STATA IC 11.2 .Results are reported either as proportions with 95% confidence intervals (95% CI) or medians with inter-quartile ranges (IQR) . Differences between the subgroups were tested using Kruskal-Wallis one-way Analysis of Variance. When group differences were significant at the 5% level, pairwise comparisons were performed using Chi Square Tests for proportions and, A total of 9,377 people above 18 years were registered in the database as new LBP patients during the study period. Due to a staged implementation of the electronic questionnaires across the four geographic sites of The Spine Centre during this period, there were both patient and clinician questionnaires available in electronic format for only 4,294 of them. People completing the electronic questionnaire had the same gender distribution as the entire patient population and were on average one year younger. We excluded 964 people from the analyses because of ambiguous data. After excluding such patients and those with missing data, 2,673 people fulfilled the criteria for allocation to subgroups. The study flowchart is shown in Figure local LBP only and those with LBP + NRI were less often females than patients with LPB + pain above knee and LBP + pain below knee, whereas the median age of patients in the LBP + pain below knee subgroup was higher than in the other groups . Patients with s Table . Of the local LBP only had the longest duration of pain at the time of first consultation, and those with LBP + NRI the shortest duration. About three-quarters of the cohort reported previous LBP episodes, which were less frequent in the local LBP only group as compared with patients with leg pain  by reducing the ‘noise’ (ambiguous data).A limitation of this study was the definition of nerve root involvement. Classification into the group with signs of nerve root involvement required the presence of just one positive finding in the neurological examination, and the reliability of these findings in this setting is unknown. The unquantified reliability of our examination procedures is an inherent limitation of data from large clinical databases that were not collected for a specific research project. However, the data were also inherently more representative of routine care and our results demonstrate that even this ‘loose’ definition of signs of nerve root involvement defines a distinctive subgroup. It is possible that our definition of ‘nerve root involvement’ led to underestimation of subgroup differences, but the findings indicated that even very simple clinical examination data can add valuable information.Another potential weakness of this study is that the inclusion criteria and the gradual implementation of the electronic database over the study period meant that only about 25% of the patients seen during this time period were described in this study. All known selection biases have been reported. There were no clinically important differences on gender or age between those who filled in the electronic questionnaires and those who did not. People who could be unambiguously allocated to the defined subgroups had slightly more severe symptoms and more disability than those who could not be allocated. This bias towards those with a more severe profile means that the proportions allocated to each group may not truly reflect the whole patient population.A further weakness is that some constructs, notably the psychosocial constructs, were measured using screening questions only, though such an approach has been used in other contexts including in the Bournemouth Questionnaire. The scrLastly, it should be recognised that some differences between subgroups may have been a result of referral patterns. For example, patients in the cohort with local LBP only had longer pain duration when seen at the department which was probably because leg pain prompts referral at an earlier stage than local LBP.In summary, the findings in this study confirm that leg pain in addition to LBP is an important indicator of a more severe condition than LBP only, almost regardless of health domain. Moreover, we found that clinical signs of nerve root involvement defined a subgroup of people more severely affected than other leg pain patients on activity limitation, work participation and psychological factors. Although between-subgroup differences were small, collectively these findings underpin the concurrent validity of the Quebec Task Force Classification. However, the results also show that variability in these cross-sectional data between individual patients with LBP is more complex than can be simply explained by the presence of leg pain patterns. There is also a need to investigate the clinical importance of the observed subgroups differences in longitudinal outcome studies.The authors have no financial or non-financial competing interests to declare.AK and PK formed the study idea. All authors were involved in the design of the study, interpretation of data, revision of the manuscript, and gave final approval of the manuscript. AK performed the data analysis and wrote the initial draft of the manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/13/236/prepub