How much does the Dallas Pain Questionnaire score have to improve to indicate that patients with chronic low back pain feel better or well?

PURPOSE: The Dallas Pain Questionnaire (DPQ) assesses the impact of low back pain (LBP) on four components (0-100) of daily life. We estimated the minimal clinically important improvement (MCII) and the patient acceptable symptom state (PASS) values of DPQ in LBP patients. METHODS: 142 patients with LBP lasting for at least 4 weeks completed a battery of questionnaires at baseline and 6 months later. Questions for MCII addressed patient-reported response to treatment at 6 months on a five-point Likert scale, while a yes/no question concerning satisfaction with present state was used to determine PASS. MCII was computed as the difference in mean DPQ scores between patients reporting treatment as effective vs. patients reporting treatment as not effective, and PASS was computed as the third quartile of the DPQ score among patients who reported being satisfied with their present state. RESULTS: MCII values were 22, 23, 2 and 10 for daily activities, work and leisure, social interest, and anxiety/depression, respectively. PASS values were 29, 23, 20 and 21 for the four components, respectively. The PASS total score threshold of 24 correctly classified 84.1 % of the patients who reported being unsatisfied with their present state, and 74.7 % of patients reported being satisfied. CONCLUSIONS: These values give information of paramount importance for clinicians in interpreting change in DPQ values over time. Authors should be encouraged to report the percentage of patients who reach MCII and PASS values in randomized clinical trials and cohort studies to help clinicians to interpret clinical results.

Core Outcome Measure Index for low back patients: do we miss anxiety and depression?

PURPOSE: The Core Outcome Measure Index (COMI) is a multidimensional questionnaire that investigates five dimensions in low back pain (LBP) patients, but does not address the psychological dimension. As the biopsychosocial perspective is recognized as important to capture the entire clinical picture of these patients, this multicenter prospective cohort study was designed to investigate the psychometric properties of a modified version of the COMI (COMIAD) which included 2 additional items, exploring anxiety and depression, respectively. METHODS: 168 subacute or chronic LBP patients recruited in spine clinics completed a set of questionnaires before and after treatment (follow-up at 6 months). Construct validity was explored by comparing each item of the COMIAD to validated full-length questionnaires. Thus two additional questionnaires were included to assess the construct validity of the anxiety and depression measures. The psychometric properties of the COMI and COMIAD were then compared. RESULTS: The two new items showed good internal consistency, high correlations with the corresponding full-length questionnaires, no floor or ceiling effect and good reproducibility (test-retest agreement kappa 0.68 for anxiety, 0.62 for depression). The addition of the 2 items did not alter internal validity (Cronbach's alpha = 0.88 and 0.87, respectively). The smallest detectable difference, the Minimal Clinically Important Improvement and the Patient Acceptable Symptom State were only minimally affected by the changes. CONCLUSION: The questions exploring anxiety and depression have good intrinsic and psychometric capacities (i.e., no floor or ceiling effects and high correlations with full-length scales) and did not significantly modify the psychometrics of the original COMI questionnaire. The COMIAD offers the possibility to include the psychological dimension in the multidimensional evaluation without significantly affecting questionnaire length.

Adalimumab in patients with hand osteoarthritis refractory to analgesics and NSAIDs: a randomised, multicentre, double-blind, placebo-controlled trial.

AIM: To test the efficiency of tumour necrosis factor blockers (adalimumab) in patients with painful refractory (non-responders to analgesics and non-steroidal anti-inflammatory drugs (NSAIDs)) hand osteoarthritis (OA). METHODS: We performed a randomised, double-blind, placebo-controlled, parallel group, multicentre study. Patients were randomised to: 1/1 adalimumab 40 mg for two subcutaneous injections at a 15-day interval or placebo and monitored for 6 months. The primary outcome was the percentage of patients with an improvement of more than 50% in global pain (Visual Analogue Scale) between week 0 (W0) and week 6 (W6). Secondary outcomes included the number of painful joints, swollen joints, morning stiffness duration, patient and practitioner global assessments, functional indexes for hand OA, and consumption of analgesics. Analysis on the mean primary outcome measure was done on patients who received at least one injection. RESULTS: 99 patients were recruited and 85 patients were randomised. Among them, 37 patients in the placebo group and 41 in the adalimumab group received at least one injection and were evaluated at W6 (n=78) on the main efficacy outcome. Mean age was 62 years, 85% were women, and mean level of pain was 62 mm at W0. At W6, 35.1% in the adalimumab group versus 27.3% in the placebo group had a pain reduction ≥50% (RR 1.12 (95% CI 0.82 to 1.54; p=0.48). There were no statistical differences for all secondary end points. The rate of adverse events was similar in the two groups. CONCLUSIONS: Adalimumab was not superior to placebo to alleviate pain in patients with hand OA not responding to analgesics and NSAIDs. TRIALS REGISTRATION NUMBER: NCT00597623.

Autoimmune disorders and quadrivalent human papillomavirus vaccination of young female subjects.

OBJECTIVES: The aim of this study was to investigate whether the quadrivalent human papillomavirus (HPV) vaccine Gardasil is associated with a change in the risk of autoimmune disorders (ADs) in young female subjects. DESIGN: Systematic case-control study of incident ADs associated with quadrivalent HPV vaccination in young women across France. PARTICIPANTS AND SETTING: A total of 113 specialised centres recruited (from December 2007 to April 2011) females aged 14-26 years with incident cases of six types of ADs: idiopathic thrombocytopenic purpura (ITP), central demyelination/multiple sclerosis (MS), Guillain-Barré syndrome, connective tissue disorders (systemic lupus erythematosus, rheumatoid arthritis/juvenile arthritis), type 1 diabetes mellitus and autoimmune thyroiditis. Control subjects matched to cases were recruited from general practice. ANALYSIS: Multivariate conditional logistic regression analysis; factors included age, geographical origin, smoking, alcohol consumption, use of oral contraceptive(s) or vaccine(s) other than Gardasil received within 24 months before the index date and personal/family history of ADs. RESULTS: Overall, 211 definite cases of ADs were matched to 875 controls. The adjusted odds ratio (OR) for any quadrivalent HPV vaccine use was 0.9 [95% confidence interval (CI) 0.5-1.5]. The individual ORs were 1.0 (95% CI 0.4-2.6) for ITP, 0.3 (95% CI 0.1-0.9) for MS, 0.8 (95% CI 0.3-2.4) for connective disorders and 1.2 (95% CI 0.4-3.6) for type 1 diabetes. No exposure to HPV vaccine was observed in cases with either Guillain-Barré syndrome or thyroiditis. CONCLUSIONS: No evidence of an increase in the risk of the studied ADs was observable following vaccination with Gardasil within the time periods studied. There was insufficient statistical power to allow conclusions to be drawn regarding individual ADs.

Inflammatory pain pattern and pain with lumbar extension associated with Modic 1 changes on MRI: a prospective case-control study of 120 patients.

PURPOSE: To compare, in a case-control study, clinical characteristics of patients with low back pain (LBP) with and without Modic 1 signal changes on MRI. METHODS: Patients with chronic non-specific LBP and a recent (<6 months) MRI were prospectively screened and included in Modic 1 group or control group. Patients in control group were age- and gender-matched with patients with Modic 1 group. Pain characteristics, including night pain and worse pain on waking and morning stiffness, were recorded. The presence of at least one of these three characteristics indicated an inflammatory pain pattern. Patients were evaluated by questionnaires and physical examination (including lumbar range of motion). Data were analyzed by univariate and multivariate analyses. RESULTS: 120 patients were included (60 in each group). The groups did not differ in sedentary work (p = 0.25), morning stiffness for >60 min (p = 0.19), waking at night (p = 0.08), worse pain on waking (p = 0.09), back stiffness (p = 0.12), or pain with flexion (p = 0.87). Modic 1 patients more frequently exhibited an inflammatory pain pattern (p = 0.006), worse pain with lumbar extension (p < 0.005) and responded better to oral steroids (p = 0.004) than did controls. On multivariate analysis, Modic 1 changes were associated with sedentary work [odds ratio 0.22 (95% confidence interval 0.05-0.93)], pain with lumbar extension [11.2 (3.1-40.4)] and an inflammatory pain pattern [4.5 (1.2-16.9)]. CONCLUSIONS: Characteristics of patients with LBP and Modic 1 changes on MRI consist of an inflammatory pain pattern and pain with lumbar extension. Level of evidence 3b.

Bone marrow oedema predicts structural progression in a 1-year follow-up of 85 patients with RA in remission or with low disease activity with low-field MRI.

OBJECTIVES: To identify the predictive factors of MRI-determined structural progression in patients with rheumatoid arthritis (RA) in remission or with low disease activity (LDA). METHODS: In this 1-year longitudinal study, patients with RA in clinical remission (disease activity score (DAS) 44≤1.6) or with LDA (1.6

Tuberculosis after conversion from azathioprine to mycophenolate mofetil in a long-term renal transplant recipient.

We report the third case in the literature of a patient with a long-lasting renal allograft who experienced tuberculosis just after the switch from azathioprine to mycophenolate mofetil. The switch was likely responsible for the reactivation of dormant tuberculosis; prophylactic antituberculous treatment should be considered in cases of such a therapeutic change.

[Sprained ankle in children]. / L'entorse de cheville de l'enfant.

OBJECTIVE: To review the literature on sprained ankle in children. We can describe our clinical experience but not statistical analysis because of the few cases. MATERIALS AND METHODS: We searched MedLine with sprain, ankle, children, talo-fibular ligament, ligament injury as key words. RESULTS: We found few and no results from a prospective or randomized trial. We analyzed three surgical publications: Vahvanen (1983, 1984), and Chaumien (1986). Vahvanen's studies concerned 50 ankles treated nonoperatively and 40 treated operatively, and Chaumien described 19 patients. Vahvanen's results suggest that sprained ankle is surprisingly common in children and that primary repair of the ligament will resolve symptoms and lead to a stable ankle joint. Chaumien's description revealed severe lesions defined by radiographic criteria. Sixteen of the 18 patients who underwent surgery healed without any complications. The surgical repair of acute ankle sprain in children has generated much controversy. CONCLUSION: Ankle sprain is a common injury in children and probably underestimated. Clinical evaluation and pain on pressure at the anterior talo-fibular ligament are used in diagnosis. Radiographic studies are necessary to eliminate fractures or an avulsion fragment. Ultrasound can be helpful. Most practitioners and orthopedic surgeons prefer to treat ankle sprains in children nonoperatively.

Relapse of Wegener's granulomatosis. Concerning a case after 20 years of remission.

Immunosuppressive drugs have transformed the prognosis of systemic Wegener's granulomatosis. Nowadays, the main residual problem is illness relapses, for which management is largely undefined. We describe the case of a patient, aged 47 in 1977. The diagnosis of Wegener's granulomatosis was made when faced with polyarthralgias, cutaneous vasculitis, rhinitis, dyspnea, hemoptysis and global decline of her physical condition. The treatment associated high-dose corticotherapy and intramuscular cyclophosphamide for 1 year. This treatment led to a complete remission. Twenty years later, the patient was hospitalized for reoccurrence of rhinitis, dyspnea and right knee effusion associated with biological inflammatory syndrome, renal insufficiency and antibodies against polymorphonuclear neutrophil cytoplasm, type c-ANCA. Chest CT-scan disclosed parenchymal infiltrates. Wegener relapse was diagnosed and the combination of three methylprednisolone perfusions followed by oral prednisone (1 mg/kg/d) and a monthly bolus of cyclophosphamide led to a new remission. Nevertheless, 4 months after beginning the treatment the patient died from an infectious complication (Pneumocystis carinii and aspergillosis). Relapses of Wegener's granulomatosis are frequent and difficult to predict. Moreover, some cases occur very early. The remarkable efficiency of cyclophosphamide to induce remission is however shaded by the high rate of relapse. Other drugs are studied to identify more efficient therapy, able to both induce remission and prevent relapses, but reliable data are still missing to determine the best therapeutic regimen.

Value of the bell test and the hyperextension test for diagnosis in sciatica associated with disc herniation: comparison with Lasègue's sign and the crossed Lasègue's sign.

OBJECTIVES: To evaluate the reliability, sensitivity, specificity and positive (PPV) and negative (NPV) predictive values for the diagnosis of sciatica associated with disc herniation of the bell test (BT) and the hyperextension test (HT). METHODS: According to magnetic resonance imaging, computed tomography scanning or myelography findings, patients were classified as having sciatica associated with disc herniation (group A) or sciatica without disc herniation or sciatica of other mechanical origin (group B). Four clinical manoeuvres [bell test (BT), hyperextension test (HT), Lasègue's sign (LS) and the crossed Lasègue's sign (CL)] were tested by three investigators. Intra- and interobserver reliabilities were calculated using the kappa correlation coefficient or the intraclass correlation coefficient (ICC). The sensitivity, specificity, PPV and NPV of the four manoeuvres were calculated. Stepwise logistic regression analysis was performed to determine the best set of variables predicting sciatica caused by disc herniation. RESULTS: Seventy-eight patients (43 in group A, 35 in group B; 33 males) with a mean age of 50+/-16 yr were included. Interobserver reliabilities ranged from 0.58 to 0.64 for the BT, 0.35 to 0.50 for the HT, 0.27 to 0.47 for LS and 0.43 to 0.72 for CL. LS had the best sensitivity (0.77-0.83) and CL the best specificity (0.74-0.89), while PPV and NPV were equivalent for the four manoeuvres (0.55-0.75 for PPV and 0.45-0.59 for NPV). The best PPV was observed for the association of HT with CL (0.67-0.85). Stepwise logistic regression analysis did not allow us to propose a set of variables predicting sciatica caused by disc herniation. CONCLUSION: This study suggests that clinical values of the BT and HT are of interest, and are similar to those of LS and CL.

Monolayer anulus fibrosus cell cultures in a mechanically active environment: local culture condition adaptations and cell phenotype study.

Intervertebral disc cells can be cultured in vitro. Several culturing systems in a mechanically active environment have been developed to study the relationship between mechanical stimulations and biochemical events. The aim of this study was to assess the phenotype of rabbit intervertebral disc cells from the anulus fibrosus (AF) region cultured on flexible substrate before and after application of cyclic tensile stretch (CTS) and to control culture conditions during application of CTS. CTS was applied with a pressure-operated instrument, inducing the deformation of flexible-bottomed culture plates (Flexercell) at 20% and 5% stretch, at a frequency of 1 Hz, during 30 minutes to 24 hours. A significant decrease in culture medium volume and temperature was observed (52% and 2.1 degrees C at 20% stretch and 24 hours' application of CTS). These phenomena were inhibited by adding culture medium around culture wells and by a culture medium temperature control system. Like AF cells cultured in plastic wells, AF cells cultured on flexible substrate expressed collagen type II, but collagen type I mRNA was not detected. In both culture conditions, neosynthesized proteoglycans had the same aggregating properties. CTS at 20% stretch during 12 hours did not induce cell detachment from the substrate and did not modify aggregating properties of neosynthesized proteoglycans; AF cells continued to express collagen type II but not collagen type I mRNA. In conclusion, the Flexercell system appears to be appropriate for studying, at the cellular level, the metabolic responses to CTS.

Transmission of Salmonella montevideo in wheat by stored-product insects.

Sitophilus oryzae (L.), S. granarius (L.), Tribolium castaneum (Hbst.), Oryzaephilus surinamensis (L.), Rhyzopertha dominica (F.), Tenebroides mauritanicus (L.), and Cryptolestes pusillus (Schon.) transmitted Salmonella montevideo from wheat contaminated with 10(6) organisms/g to clean wheat. The insects were fed on the contaminated grain for 21 days and were then transferred to clean grain and allowed to feed for 21 days. They were subsequently transferred to two more samples of clean wheat. All species carried S. montevideo into the initial sample of clean wheat but not into a second or third sample. Progeny of the original insects that developed in the contaminated wheat exhibited less ability than the original adults to contaminate clean wheat. Data indicated that few S. montevideo could be carried by the stored-product insects in large masses of grain.

Survival of Salmonella montevideo on Wheat Stored at Constant Relative Humidity.

Eleven samples of Ottawa variety hard red winter wheat were inoculated with a standardized suspension of Salmonella montevideo. The contaminated wheat samples were placed in constant relative humidity (RH) chambers held at 25 C. Relative humidities were 7, 11, 22, 33, 43, 53, 62, 75, 84, 92, and 98%. Constant RH at 25 C was maintained with different saturated salt solutions in the sealed chambers. Periodic counts of viable S. montevideo cells per gram of wheat were made over a 28-week sampling period. Viable counts of S. montevideo on wheat held at 7, 11, and 22% RH decreased from an initial 10 cells/g of wheat to a final count of 10 cells/g in each sample. Samples stored at 33, 43, 53, and 62% RH decreased from 10 viable cells/g to 3.6 x 10, 10, 10, and 20 viable cells/g, respectively. No viable S. montevideo cells were detected in the samples held at 75, 84, 92, and 98% RH after 22, 16, 26, and 16 weeks, respectively.

Salmonella survey of plant foods used in and around the home.

Nine of 100 plant food samples investigated yielded salmonellae. A brilliant green tetrathionate-brilliant green agar combination gave the most salmonellae recoveries.