Prevention of pressure injuries using a non-motorised decompression air mattress: a non-interventional study.

OBJECTIVE: Prevention of pressure injuries (PI) is a public health issue. Among the preventive measures, the use of support surfaces adapted to the risk of PI occurrence is recommended. This study aimed to report the incidence of PIs in patients at medium-to-high risk of occurrence of PIs and using a new non-motorised automated decompression air mattress combined with other recommended PI prevention measures. METHOD: An observational, national, multicentre, prospective, non-comparative study, with a follow-up period of 35 days was conducted. Patients at medium-to-high risk of PIs and without PIs at baseline were included if they were lying on a specific non-powered automated decompression air mattress. The primary outcome was the percentage of patients who developed at least one category 2 or more severe PI of the sacrum, backbone or heel between day 0 and day 35. RESULTS: In total, 81 patients were included from four participating centres. There was one report of a patient with a PI that fitted within the definition of the primary outcome, meaning an incidence of 1.2% (95% confidence interval (CI) 0-6.7%). More than 80% of patients rated the overall comfort and the stability of the non-motorised automated decompression air mattress as satisfactory or very satisfactory. In more than 80% of cases, the healthcare teams found the use of the mattress to be easy or very easy. CONCLUSION: This study has shown that in combination with other preventive measures, the use of a specific non-motorised air mattress with automated decompression is associated with a low incidence of PIs in patients with medium-to-high risk of occurrence of PIs.

MRI Segmentation of Cervical Muscle Volumes in Survived Strangulation: Is There an Association between Side Differences in Muscle Volume and the Handedness of the Perpetrator? A Retrospective Study.

We evaluate the potential value of magnetic resonance imaging (MRI) in the examination of survivors of manual strangulation. Our hypothesis was that trauma-induced edema of the cervical muscles might lead to a side difference in the muscle volumes, associated with the handedness of the perpetrator. In 50 individuals who survived strangulation, we performed MRI-based segmentation of the cervical muscle volumes. As a control group, the neck MRIs of 10 clinical patients without prior trauma were used. The ratio of the right to left muscle volume was calculated for each muscle group of the control and strangulation groups. Cutoff values for the assumed physiological muscle volume ratios between the right and left sides were identified from our control group. There was no significant difference among the individuals in the pathological muscle volume ratio between right-handed versus both-handed strangulation for the sternocleidomastoid, pretracheal, anterior deep, or trapezoid muscle groups. Only the posterior deep muscle group showed a statistically significant difference in the pathological muscle volume ratio for both-handed strangulations (p = 0.011). Measurement of side differences in cervical muscle volume does not allow for a conclusion concerning the probable handedness of the perpetrator.

A prospective cohort of patients with common scabies treated with 10% benzyl benzoate emulsion as monotherapy: EPIGALE study.

BACKGROUND: In addition to general measures, pharmacological treatment is the basis of the management of scabies. No recent data in real-life are available on the efficacy and safety of 10% benzyl benzoate emulsion for skin application administered as monotherapy. METHOD: This prospective, multicenter, French observational study comprised a registry and a prospective cohort with a follow-up at 28 days and a telephone call at week 12. To participate in the registry, patients had to be over 1 month old, ambulatory, presenting common, nonhyperkeratotic, untreated scabies. To be included in the cohort, patients had to be included in the registry and treated with two applications of 10% benzyl benzoate emulsion 8 days apart. The primary endpoint was cure at day 28. RESULTS: Of the 186 patients included in the registry, 116 were included in the cohort. Fourteen patients were included in the cohort without being included in the registry, which led to a total of 130 patients in the cohort. At day 28, 119/130 (91.5%; 95% CI 85.4-95.6%) were clinically cured. The cure was confirmed by dermoscopy in 44/47 patients (93%). Among the 130 patients, the cure rate was 82% at week 12. Of the 119 patients cured at day 28, the rate of cure at week 12 was 89.9%. CONCLUSION: In real life, two applications of 10% benzyl benzoate emulsion 8 days apart provides high cure rates in patients with common scabies.

Use of multilayer silicone foam dressings as adjuvant therapy to prevent pressure injuries.

Despite progress in the prevention of pressure injuries (PIs), they remain a challenging public health problem because of their frequency and morbidity. Protection of the skin by multilayer silicone foam dressings may be an adjuvant measure to prevent PIs in high-risk patients. Despite the available clinical data and published recommendations on this measure, caregivers face difficulties in identifying patients who would benefit from this adjuvant measure. The objective of this work was to define the profiles of high-risk patients who would benefit optimally from this measure in combination with basic preventive procedures. This consensual expert opinion was drawn up using two methods: the Nominal Group Technique with eight medical and paramedical experts, and the Delphi process with 16 experts. The bases for this expert consensual opinion were a formal search and analysis of the published literature regarding evidence on the prevention of PIs using multilayer silicone foam dressings. The consensual expert opinion reported here addresses five proposals mostly intended to define patients who would benefit from the use of a multilayer silicone foam dressing (≥4 layers) to prevent PIs (sacrum and heels).

Incidence of pressure ulcer in patients using an alternating pressure mattress overlay: the ACTIVE study.

OBJECTIVE: The primary objective was to determine the clinical benefit of using a specific alternating-pressure mattress overlay (APMO) in the prevention of pressure ulcer (PU) in patients at medium to high risk. METHOD: This prospective study was conducted in five rehabilitation centres and three nursing homes. Patients at medium to high risk of PU, but without PU at baseline, and lying between 15 and 20 hours per day on a specific APMO were included. The primary endpoint was the percentage of patients who developed a sacral, spine, heel or trochanteric PU (supine support areas) of at least category II, at day 35. All patients were included in the analysis. RESULTS: A total of 89 patients were included; of whom six patients (6.7%) dropped out of the study (average (±standard deviation) follow-up 32±5.4 days). No sacral, spine, heel or trochanteric PU of at least category II was reported (i.e., an incidence of 0% [95% Confidence Interval: 0-4.1%] according to the exact Clopper-Pearson method]. Patients were 'satisfied' or 'very satisfied' with the comfort and stability of the APMO. The caregivers assessed as 'very easy' or 'easy' the implementation, maintenance and use of the APMO (turning over, moving to a sitting position). CONCLUSION: In combination with the usual measures to prevent PU, the results of our study showed a low incidence of PU in high-risk patients lying for between 15 and 20 hours a day on an APMO, use of which is therefore recommended in these patients.

Psychometric validation of a patient-reported outcome questionnaire (Qualipsosex) assessing the impact of psoriasis and psoriatic arthritis on patient perception of sexuality.

ABSTRACT: Psoriasis (Pso) and psoriatic arthritis (PsA) frequently have a negative impact on patients' sexual health. We have developed a specific questionnaire assessing the impact of Pso and PsA on patient perception of sexuality: the QualipsoSex Questionnaire (QSQ). The aim of the present study was to further validate this questionnaire by checking its psychometric properties including validity, reliability, and responsiveness.A cross sectional observational study with a longitudinal component for responsiveness and test-retest reliability was performed in 12 centers in France including 7 dermatologists and 5 rheumatologists. Psychometric properties were examined according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) check-list.At baseline, 114 patients had Pso and 35 patients had PsA including 17 peripheral arthritis, 4 axial disease, 13 patients with both axial disease and peripheral arthritis and one patient with an undifferentiated phenotype. The mean Pso Area and Severity Index score was 12.5. Genital organs were involved in 44.7% of Pso cases. Internal consistency, construct validity, and reliability were good with Cronbach's α coefficient, measure of sampling adequacy and intraclass correlation coefficient respectively at 0.87, 0.84, and 0.93. The QSQ also demonstrated acceptable sensitivity to change.The QSQ has demonstrated good psychometric properties fulfilling the validation process relative to the recommendations of the COSMIN check list. The QSQ is simple to score and may hopefully be valuable in clinical practice and in clinical trials.

Usual care including home exercise with versus without spa therapy for chronic low back pain: protocol for the LOMBATHERM' study, a multicentric randomised controlled trial.

BACKGROUND: Low back pain is highly prevalent and a major source of disability worldwide. Spa therapy is frequently used to treat low back pain, but the associated level of evidence for efficacy is insufficient. To fill this knowledge gap, this protocol proposes an appropriately powered, prospective, evaluator-blinded, multi-centre, two-parallel-arm, randomised (1:1), controlled trial that will compare spa therapy in addition to usual care including home exercise (UCHE) versus UCHE alone for the treatment of chronic low back pain. METHODS: Eligible patients (anticipated sample size of 358) will have had low back pain for more than 3 months and scores for pain greater than 40 mm on a visual analogue scale (VAS). Following initial consent for UCHE and baseline evaluations, patients are randomised (1:1) to UCHE alone, or UCHE plus spa therapy (18 days of mud packs, underwater massages, showers and water exercises under medical supervision). Patients in the latter arm will be requested to sign an additional consent form as per Zelen randomisation. Follow-up visits will occur at approximately months 1, 6 and 12 and (along with baseline assessments) will cover changes over time in VAS pain scores, the impact of lower back pain on daily life (the Rolland and Morris Disability Questionnaire (RMDQ)), inappropriate fears and beliefs about lower back pain (the fear, avoidance, belief questionnaire (FABQ)), general quality of life (the Euroqol Group 5 dimension, 5 level questionnaire (EQ-5D-5 L)), Patient Acceptable Symptom State (PASS), consumption of analgesic drugs and nonsteroidal anti-inflammatory drugs (NSAIDs), and overall state of health. Health resource use and days of sick leave (and subsequently the associated costs) will also be recorded. The primary outcome is the presence/absence of a clinically relevant change (improvement of at least 30%) in the VAS score for pain at 6 months. DISCUSSION: Despite the fact that previous, rather dated recommendations encourage spa therapy for the treatment of low back pain, the current literary corpus is methodologically poor. This protocol has been designed to provide results spanning a thorough range of outcomes at the highest evidence level possible. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03910023. Registered on 10 April 2019.

Determinants of daily pain trajectories and relationship with pain acceptability in hip and knee osteoarthritis. A national prospective cohort study on 886 patients.

OBJECTIVES: To study daily pain trajectories (DPT) in patients with knee (KOA) and hip osteoarthritis (HOA) over a one-month period and identify relationships with patients characteristics and acceptability. METHODS: This prospective, multicenter cohort study was conducted in France by 602 GPs, on outpatients, with painful KOA or HOA. Patients were asked to fill-in a 28-days daily pain diary. DPT were determined by the difference between daily pain and mean pain over 28 days. Pain peaks were defined as an increase of more than 1 point above the mean for up to three consecutive days. The number of pain peaks over the 28 day period allowed classifying the patient's pain trajectory as either "stable" or "unstable". A logistic regression model was used to identify predicting factors associated with stable pain profile. RESULTS: Overall, 1645 patients were included and 886 were analyzed, (56% women, 67.8 years, BMI 27.6 kg/m2, pain 6.0, KOA 71.3%). At one month, stable DPT was found in 59.5% of the patients whatever OA location. In HOA, a shorter duration of disease and pain, a greater disability and in KOA, a more recent disease, morning stiffness ≥ 15 minutes and flare-up were independent factors associated with "stable" DPT. At one month, acceptable pain state was more frequent (65.4%) in patients with stable profiles. CONCLUSION: In lower limb OA, pain is mostly stable over a 28-days period. Pain is better accepted when stable, with different determining factors according location. DPT should be considered when establishing HOA and KOA management.

Preliminary development of a questionnaire assessing the impact of psoriasis and psoriatic arthritis on patient's perception of sexuality.

Psoriasis and psoriatic arthritis impact sexuality and intimate relationships in both men and women, and can be associated with sexual dysfunctions.The aim of this study was to develop and validate a specific questionnaire assessing the impact of psoriasis and psoriatic arthritis on patients' sexuality. Two focus groups of patients, concerned by sexuality, were conducted in February 2015. Based on the verbatim transcripts, a content analysis was performed by a psychologist trained in qualitative procedures.After analysis of the verbatim reports by the research group, a preliminary questionnaire comprising 22 questions was drawn up. The areas covered by the questions concerned: the quality of daily life, tolerance of the cutaneous state by the patient, tiredness, mobility and flexibility of the joints, outside activities involving movement of all or part of the body. In the following step the questions were then submitted to a panel of experts for selection using a Delphi method. The experts were questioned about item relevance and content. After expert consensus had been reached, the instructions to participants completing the questionnaire, the wording of items, and the possible answers were finalized.The final questionnaire (comprising 14 questions) is entitled "Questionnaire of sexual quality of life perceived by patients with cutaneous and/or articular psoriasis" (short denomination: Qualipsosex). The quantitative step has not yet been conducted. This step will aim to evaluate the metrologic qualities (reliability, validity, and responsiveness) of the questionnaire and will need to be validated according to the consensus-based standards for the selection of health measurement instrument checklist.

Pressure ulcer prevention using an alternating-pressure mattress overlay: the MATCARP project.

OBJECTIVE: The primary objective was to assess the incidence of pressure ulcer (PU) in patients at high risk of PU and lying between 15-20 hours per day on an alternating-pressure mattress overlay (APMO). Secondary objectives were the patient's satisfaction with the comfort of the APMO, patient acceptance of its sound level, and the care team's assessment of its use and the moisture level. METHOD: This prospective observational study was conducted in three rehabilitation centres and two nursing homes between June 2016 and March 2017. To be included, patients should not have PU at baseline and present a high risk of PU (Braden score between 10-15). The primary endpoint was the percentage of patients in whom a PU developed over a 35-day period. RESULTS: A total of 83 patients were included in the study. Neurological disease was responsible for the reduced mobility of 44 (53.7%) patients, 10 patients (12.0%) dropped out (one patient for a serious adverse event (femoral neck fracture) considered not to be related to the APMO, four patients for adverse events, two of which were considered to be related to APMO and five for other reasons, including, in one case, discomfort with the APMO. These patients were considered in the analysis. Over the study period, 1.2% (1/83) (95% confidence interval (CI): 0.03 to 6.53) of patients developed a PU. Patient satisfaction with the comfort of the APMO, patient acceptance of its sound level, and the care team's assessment of its use were considered satisfying for most patients. CONCLUSION: Based on the findings of this study of a low incidence of PU in participating patients, the use of an AMPO is recommended in high-risk patients lying for between 15-20 hours a day.

Effect of unloading brace treatment on pain and function in patients with symptomatic knee osteoarthritis: the ROTOR randomized clinical trial.

Evidence is still inconclusive for the benefits of bracing in patients with knee osteoarthritis. To assess the effect of REBEL RELIEVER unloading knee brace in conservative treatment of knee osteoarthritis, a randomized controlled trial was conducted in 67 patients with symptomatic medial knee osteoarthritis, who randomly received 6-week treatment with either REBEL RELIVER unloading knee brace + usual care (Brace group, N = 32) or usual care alone (Control group, N = 35). Primary outcome was the global last 24h-pain relief (100-mm visual analogic scale [VAS]) at 6 weeks. Secondary endpoints included pain on motion (100-mm VAS), function (Lequesne index), safety and observance. At 6 weeks, mean [SD] last 24h-pain decreased significantly more in Brace group versus Control group (-41.35 [3.37] vs -15.37 [3.23], difference -25.98, 95% CI -41.64 to -10.33, P < 0.0001). Higher mean [SD] pain on motion decrease (-51.91 [3.49] vs -19.91 [3.34], difference -32.01, 95% CI -48.21 to -15.80, P < 0.0001) and better improvement of Lequesne index score (-5.8 [0.5] vs -2.3 [0.5], difference -3.5, 95% CI -5.0 to -2.0, P < 0.0001) were observed in Brace group. Safety and observance to the brace were excellent. The additive clinical benefit of wearing REBEL RELIEVER unloading knee brace was demonstrated in knee osteoarthritis patients.

Clinical classification criteria for neurogenic claudication caused by lumbar spinal stenosis. The N-CLASS criteria.

BACKGROUND CONTEXT: Because imaging findings of lumbar spinal stenosis (LSS) may not be associated with symptoms, clinical classification criteria based on patient symptoms and physical examination findings are needed. PURPOSE: The objective of this study was to develop clinical classification criteria that identify patients with neurogenic claudication (NC) caused by LSS. STUDY DESIGN: This study is a two-stage process that includes Phase 1, the Delphi process, and Phase 2, the cross-sectional study. PATIENT SAMPLE: Outpatients were recruited from spine clinics in five countries. OUTCOME MEASURE: The outcome measure includes items from the patients' history and physical examination. METHODS: In Phase 1, a list of potential predictors of NC caused by LSS was based on the available literature and was evaluated through a Delphi process involving 17 spine specialists (surgeons and non-surgeons) from eight countries. In Phase 2, 19 different clinical spine specialists from five countries identified patients they classified as having (1) NC caused by LSS, (2) radicular pain caused by lumbar disc herniation (LDH), or (3) non-specific low back pain (NSLBP) with radiating leg pain. The patients completed survey items and the specialists documented the examination signs. Coefficients from general estimating equation models were used to select predictors, to generate a clinical classification score, and to obtain a receiver operating characteristic curve. Conduction of the Delphi process, data management, and statistical analysis were partially supported by an unrestricted grant of less than 15,000 US dollars from Merck Sharp & Dohme. No fees were allocated to participating spine specialists. RESULTS: Phase 1 generated a final list of 46 items related to LSS. In Phase 2, 209 patients with leg pain caused by LSS (n=63), LDH (n=89), or NSLBP (n=57) were included. Criteria that independently predicted NC (p<.05) were age over 60 years, positive 30-second extension test, negative straight leg test, pain in both legs, leg pain relieved by sitting, and leg pain decreased by leaning forward or flexing the spine. A classification score using a weighted set of these criteria was developed. The proposed N-CLASS score ranged from 0 to 19 and had an area under the curve of 0.92, and the cutoff (>10/19) to obtain a specificity of >90.0% resulted in a sensitivity of 82.0%. CONCLUSIONS: Clinical criteria independently associated with neurogenic claudication due to LSS were identified. The use of these symptom and physical variables as a classification score for clinical research could improve homogeneity among enrolled patients.

Reduction of the Serum Levels of a Specific Biomarker of Cartilage Degradation (Coll2-1) by Hyaluronic Acid (KARTILAGE® CROSS) Compared to Placebo in Painful Knee Osteoarthritis Patients: the EPIKART Study, a Pilot Prospective Comparative Randomized Double Blind Trial.

BACKGROUND: Viscosupplementation is a symptomatic treatment of the knee osteoarthritis based on the intra-articular injection of hyaluronic acid (IAHA). Although many studies have investigated its effect on symptoms, few clinical studies have focused on its effects on biologicals markers of cartilage metabolism. In this study, we assessed the effect of an intra-articular injection of a reticulated hyaluronic acid compound on the level of a specific biomarker of type II collagen degradation. METHODS: Eighty one patients with symptomatic knee osteoarthritis were included in this randomized placebo controlled trial testing a reticulated hyaluronic acid (HA) with mannitol (KARTILAGE® CROSS, 16 mg/ml, one single injection of 2.2 mL; IAHA) versus saline solution. Primary outcome was the percentage of patients with a reduction of at least 10 nmol/l of serum Coll2-1 between baseline and day 90 (D90, 3 months after injection). Secondary outcomes concerned clinical evaluation and tolerance to the study product. RESULTS: A significant effect of IAHA was revealed by the sensitivity analysis of the decrease in cartilage marker. In the intention-to-treat population, the percentage of patients showing a decrease in the levels of serum Coll2-1 between inclusion and D90 showed was higher in HA (56.8%) than in placebo group (28.6%; P = 0.01). The same significant difference was observed between groups in the per protocol population (57.1% vs 29.0%; P = 0.02) corresponding to all patients having received the intra-articular injection (IA), being evaluated for the primary outcome on D-10 and D90, and with no major defined deviation. No significant differences between groups were observed on the changes in function (Lequesne index) or pain and on the number of adverse events. CONCLUSIONS: This is the first randomized double-blind placebo controlled trial showing that IA injection of reticulated HA with mannitol in knee osteoarthritis patients can reduce the serum levels of Coll2-1, a marker specific of type II collagen degradation. This finding suggests that IAHA may have a beneficial effect on cartilage degradation and that Coll2-1 could be used for the assessment of a single intra-articular treatment in clinical trials. TRIAL REGISTRATION: NCT02951585 ; clinicaltrial.gov. Retrospectively registered on October 28, 2016.

Clinical classification criteria for radicular pain caused by lumbar disc herniation: the radicular pain caused by disc herniation (RAPIDH) criteria.

BACKGROUND CONTEXT: Classification criteria are recommended for diseases that lack specific biomarkers to improve homogeneity in clinical research studies. Because imaging evidence of lumbar disc herniations (LDHs) may not be associated with symptoms, clinical classification criteria based on patient symptoms and physical examination findings are required. PURPOSE: This study aimed to produce clinical classification criteria to identify patients with radicular pain caused by LDH. STUDY DESIGN: The study design was a two-stage process. Phase 1 included a Delphi process and Phase 2 included a cohort study. PATIENT SAMPLE: The patient sample included outpatients recruited from spine clinics in five countries. OUTCOME MEASURES: The outcome measures were items from history and physical examination. MATERIALS AND METHODS: In Phase 1, 17 spine experts participated in a Delphi process to select symptoms and signs suggesting radicular pain caused by LDH. In Phase 2, 19 different clinical experts identified patients they confidently classified as presenting with (1) radicular pain caused by LDH, (2) neurogenic claudication (NC) caused by lumbar spinal stenosis, or (3) non-specific low back pain (NSLBP) with referred leg pain. Patients completed survey items and specialists documented examination signs. A score to predict radicular pain caused by LDH was developed based on the coefficients of the multivariate model. An unrestricted grant of less than US$15,000 was received from MSD: It was used to support the conception of the Delphi, data management, and statistical analysis. No fees were allocated to participating spine specialists. RESULTS: Phase 1 generated a final list of 74 potential symptoms and signs. In Phase 2, 209 patients with pain caused by LDH (89), NC (63), or NSLBP (57) were included. Items predicting radicular pain caused by LDH (p<.05) were monoradicular leg pain distribution, patient-reported unilateral leg pain, positive straight leg raise test <60° (or femoral stretch test), unilateral motor weakness, and asymmetric ankle reflex. The score had an AUC of 0.91. An easy-to-use weighted set of criteria with similar psychometric characteristics is proposed (specificity 90.4%, sensitivity 70.6%). CONCLUSIONS: Classification criteria for identifying patients with radicular pain caused by LDH are proposed. Their use could improve the homogeneity of patients enrolled in clinical research studies.

Hyaluronan for knee osteoarthritis: an updated meta-analysis of trials with low risk of bias.

BACKGROUND: The effectiveness of intra-articular hyaluronic acid (IAHA) injection for knee osteoarthritis (KOA) is debated. OBJECTIVES: To evaluate the effect of IAHA for patients with KOA by analysing data from trials of IAHA versus placebo with low risk of bias, to provide the highest level of evidence. METHODS: A systematic review and meta-analysis was conducted. Randomised controlled trials (RCTs) with a low risk of bias (adequate randomisation and concealment and double-blind design) that investigated IAHA versus placebo (saline solution) injection were eligible. The primary efficacy measure was pain intensity and secondary outcome function at 3 months. The treatment effect was summarised with the standardised mean difference (SMD) calculated from differences in means of pain and function measures between treatment and control groups at 3 months. Trials were pooled by a random-effects model with DerSimonian and Laird weights. Statistical heterogeneity was explored by a visual exploration of forest plots and the I(2) statistic. RESULTS: A total of eight RCTs (2 199 randomised patients) met our inclusion criteria. IAHA significantly reduced the pain intensity (SMD=-0.21, 95% CI (95% CI) -0.32 to -0.10) and improved function (SMD=-0.12, 95% CI -0.22 to -0.02). Trials showed no heterogeneity. CONCLUSIONS: This meta-analysis of high-quality trials of IAHA versus placebo shows that IAHA provides a moderate but real benefit for patients with KOA.

Validity of the French version of the Core Outcome Measures Index for low back pain patients: a prospective cohort study.

PURPOSE: Among the many questionnaires available to evaluate low back pain (LBP) patients, the Core Outcome Measures Index (COMI) has the unique advantage to investigate five dimensions using seven short questions. The aim of this study was to explore additional properties of the questionnaire in a French-speaking non-surgical population. METHODS: This study was conducted on 168 patients suffering from subacute or chronic LBP and followed up for 6 months in three French-speaking countries. In addition to basic psychometric properties (e.g., construct validity, floor and ceiling effect, reproducibility), internal validity was analyzed by a factor analysis using Cronbach's alpha. Responsiveness and sensitivity to change were assessed through minimal detectable change (MDC), effect size, and Minimal Clinically Important Improvement (MCII). We used an anchor-based method with receiver operating characteristic (ROC) curve analysis to assess MCII and the Patient Acceptable Symptom State. RESULTS: Construct validity, reliability (Cronbach's alpha = 0.87), reproducibility and the absence of floor and ceiling effects were confirmed. Factor analysis indicated a one-dimensional construct that validates the use of a sum score. The MDC (2.1) was inferior to the MCII (2.3). The limit below which the patient claims to be in a fair condition (Patient Acceptable Symptom State) was set at 3. CONCLUSIONS: The COMI is a self-report questionnaire with the capacity to easily and quickly explore several dimensions in patients with LBP that can be then summarized in a meaningful sum score. Additional knowledge provided by our study should encourage the widespread use of the COMI among the spine community.

Efficacy of a CO2-releasing suppository in dyschezia: a double-blind, randomized, placebo-controlled clinical trial.

BACKGROUND: Constipation has a significant impact on quality of life. Aim of this study was to evaluate the safety and the efficacy for relieving dyschezia symptoms of a CO2-releasing suppository in a randomized, placebo-controlled, clinical trial. METHODS: Fifty-three office-based primary care physicians and 24 gastroenterologists conducted the study in France, between November 2010 and January 2012. Patients (aged 18-75 years) with dyschezia were eligible. Patients were randomly allocated a once-a-day suppository (CO2-releasing suppository or placebo) for 21 days. Primary endpoint was the change, from Day 0 to Day 21, in the intensity of discomfort related to dyschezia based on a self-assessed 0-100 visual analogue scale. RESULTS: A total of 323 patients were randomized, i.e. 166 into the intervention group and 157 into the placebo group. Co-variance analysis showed a greater reduction in discomfort visual analogue scale score in the intervention group (-34.5mm; standard error of the mean: 1.8mm) than in the placebo group (-26.2mm; standard error of the mean: 1.9 mm; p<0.001). The greater efficacy of the CO2-releasing suppository was confirmed for all secondary efficacy parameters. No significant side effects for either treatment were observed. CONCLUSION: A CO2-releasing suppository is more effective than a placebo for the relief of symptoms of dyschezia. This efficacy is associated with a good safety profile.

Decrease of a specific biomarker of collagen degradation in osteoarthritis, Coll2-1, by treatment with highly bioavailable curcumin during an exploratory clinical trial.

BACKGROUND: The management of osteoarthritis (OA) remains a challenge. There is a need not only for safe and efficient treatments but also for accurate and reliable biomarkers that would help diagnosis and monitoring both disease activity and treatment efficacy. Curcumin is basically a spice that is known for its anti-inflammatory properties. In vitro studies suggest that curcumin could be beneficial for cartilage in OA. The aim of this exploratory, non-controlled clinical trial was to evaluate the effects of bio-optimized curcumin in knee OA patients on the serum levels of specific biomarkers of OA and on the evaluation of pain. METHODS: Twenty two patients with knee OA were asked to take 2x3 caps/day of bio-optimized curcumin (Flexofytol®) for 3 months. They were monitored after 7, 14, 28 and 84 days of treatment. Pain over the last 24 hours and global assessment of disease activity by the patient were evaluated using a visual analog scale (100 mm). The serum levels of Coll-2-1, Coll-2-1NO2, Fib3-1, Fib3-2, CRP, CTX-II and MPO were determined before and after 14 and 84 days of treatment. RESULTS: The treatment with curcumin was globally well tolerated. It significantly reduced the serum level of Coll2-1 (p<0.002) and tended to decrease CRP. No other significant difference was observed with the other biomarkers. In addition, curcumin significantly reduced the global assessment of disease activity by the patient. CONCLUSION: This study highlighted the potential effect of curcumin in knee OA patient. This effect was reflected by the variation of a cartilage specific biomarker, Coll2-1 that was rapidly affected by the treatment. These results are encouraging for the qualification of Coll2-1 as a biomarker for the evaluation of curcumin in OA treatment. TRIAL REGISTRATION: NCT01909037 at clinicaltrials.gov.