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.

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.

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).

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.

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.

Randomised, controlled trial of avocado-soybean unsaponifiable (Piascledine) effect on structure modification in hip osteoarthritis: the ERADIAS study.

OBJECTIVE: To assess the ability of avocado-soybean unsaponifiable-Expanscience (ASU-E) to slow radiographic progression in symptomatic hip osteoarthritis (OA). METHODS: Prospective, randomised, double blind, parallel group, placebo controlled 3 year trial. Patients with symptomatic (painful ≥1 year, Lequesne Index between 3 and 10) hip OA (American College of Rheumatology criteria) and a minimum joint space width (JSW) of the target hip between 1 and 4 mm on a pelvic radiograph were randomly assigned to 300 mg/day ASU-E or placebo. Standing pelvis, target hip anteroposterior (AP) and oblique views were taken annually. The primary outcome was JSW change at year 3, measured at the narrowest point on pelvic or target hip AP view (manual measure using a 0.1 mm graduated magnifying glass). The full analysis dataset (FAS) included all patients having at least two successive radiographs. An analysis of covariance Mixed Model for Repeated Measurements with Missing at Random (for missing data) was performed to compare adjusted 3 year JSW changes (primary outcome) and the percentages of 'progressors' (JSW loss≥0.5 mm) between groups. RESULTS: 399 patients were randomised (345 kept in the FAS), aged 62 (35-84) years, 54% women, mean body mass index 27 (SD 4) kg/m(2), mean symptom duration 4 (SD 5) years, 0-100 normalised Lequesne Index 30 (SD 9) and global pain visual analogue scale 37 (SD 23) mm. Mean baseline JSW was 2.8 (0.9) mm. There was no significant difference on mean JSW loss (-0.638 mm vs -0.672 mm, p=0.72, in the ASU-E and placebo groups, respectively) but there were 20% less progressors in the ASU-E than in the placebo group (40% vs 50%, respectively, p=0.040). No difference was observed on clinical outcomes. Safety was excellent. CONCLUSIONS: 3 year treatment with ASU-E reduces the percentage of JSW progressors, indicating a potential structure modifying effect in hip OA to be confirmed, and the clinical relevance requires further assessment.

A concomitant treatment by CO2-releasing suppositories improves the results of anorectal biofeedback training in patients with dyschezia: results of a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Dyschezia is a defecatory disorder that places a heavy burden on a patient's quality of life. Biofeedback is the recommended treatment in most cases. OBJECTIVE: The objective of our study was to test whether a CO2-releasing suppository for patients with dyschezia could be effective in improving biofeedback training results. DESIGN: A randomized, double-blind, multicenter, placebo-controlled study was conducted in patients (18-75 years of age) with dyschezia defined according to the modified Rome III criteria. Patients were randomly assigned to either a CO2-releasing suppository or placebo suppository once per day for 21 days. SETTINGS: This was a multicenter trial. PATIENTS: A total of 122 patients were randomly assigned (62 intervention group and 60 placebo group). MAIN OUTCOME MEASURES: The primary end point was the change from day 0 to day 21 in intensity of symptoms on the basis of a self-assessed dyschezia using a visual analog scale (range, 0-100). Analyses were performed using intention-to-treat principles. RESULTS: A greater reduction from baseline to day 21 in symptom visual analog scale score was observed in the intervention group (-41.3 mm) than in the control group (-22.3 mm). Some secondary efficacy parameters improved more in the intervention group, including the percentage of patients who improved ≥50%, symptom intensity over 21 days, stool stains on underwear or pads, and need to practice manual maneuvers to facilitate defecation at day 21. At day 21, rectal sensitivity in the intervention group (31.4 mL) was lower than in the control group (39.1 mL). LIMITATIONS: There was a lower number of patients recruited than planned by the protocol. The sponsor stopped the trial before the inclusion of 306 participants, with no intermediate analysis. In addition, the main analysis conducted on the full analysis set population could have led to a statistical bias. CONCLUSIONS: The results of this multicenter trial demonstrate the added benefits of a CO2-releasing suppository in patients with dyschezia who were treated by anorectal biofeedback training.

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.

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.

Reliability and validity of the cross-culturally adapted French version of the Core Outcome Measures Index (COMI) in patients with low back pain.

PURPOSE: To conduct a cross-cultural adaptation of the Core Outcome Measures Index (COMI) into French according to established guidelines. METHODS: Seventy outpatients with chronic low back pain were recruited from six spine centres in Switzerland and France. They completed the newly translated COMI, and the Roland Morris disability (RMQ), Dallas Pain (DPQ), adjectival pain rating scale, WHO Quality of Life, and EuroQoL-5D questionnaires. After ~14 days RMQ and COMI were completed again to assess reproducibility; a transition question (7-point Likert scale; "very much worse" through "no change" to "very much better") indicated any change in status since the first questionnaire. RESULTS: COMI whole scores displayed no floor effects and just 1.5% ceiling effects. The scores for the individual COMI items correlated with their corresponding full-length reference questionnaire with varying strengths of correlation (0.33-0.84, P < 0.05). COMI whole scores showed a very good correlation with the "multidimensional" DPQ global score (Rho = 0.71). 55 patients (79%) returned a second questionnaire with no/minimal change in their back status. The reproducibility of individual COMI 5-point items was good, with test-retest differences within one grade ranging from 89% for 'social/work disability' to 98% for 'symptom-specific well-being'. The intraclass correlation coefficient for the COMI whole score was 0.85 (95% CI 0.76-0.91). CONCLUSIONS: In conclusion, the French version of this short, multidimensional questionnaire showed good psychometric properties, comparable to those reported for German and Spanish versions. The French COMI represents a valuable tool for future multicentre clinical studies and surgical registries (e.g. SSE Spine Tango) in French-speaking countries.

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.

Ecological or recalled assessments in chronic musculoskeletal pain? A comparative study of prospective and recalled pain assessments in low back pain and lower limb painful osteoarthritis.

OBJECTIVES: The objective of this study was to compare ecological and recalled pain intensity assessments over 29 days in hip and knee osteoarthritis (O) and chronic low back pain (L). PATIENTS AND METHODS: Rheumatologists were asked to enroll patients with O and L, with pain intensity above 40 mm, in a prospective study for 29 days. Pain intensity was assessed with physicians on Days 1 and 29, and ecologically, over the intervening 28-day period, by random phone calls. RESULTS: We carried out correlation analyses for 353 (159 O, 194 L) patients: Overall recalled daily pain was strongly correlated with calculated 3-day mean pain assessments (r=0.96 [O]; 0.93 [L]) and evening pain (r=0.96 [O], 0.90 [L]). Correlations between ecological and recalled measures were stronger for recall over the last 7 days than for recall over the last 28 days in osteoarthritis patients (r=0.78, r=0.63), but were similar for both recall periods in low back pain patients (r=0.70, r=0.72). Correlations between assessments for the last 7 and 28 days were stronger for ecological (r=0.88 [O], 0.91 [L]) than for clinical (r=0.77 [O]; 0.86 [L]) assessments. After adjustment for current pain intensity, correlations remained significant for ecological assessments, but not for clinical assessments. Recalled pain assessments were more accurate when made after 24 hours (r=0.71 [O]; 0.70 [L]) than when made after 48 hours (r=0.63 [O]; 0.61 [L]). CONCLUSIONS: For both low back pain and osteoarthritis, overall daily pain recall is a reliable measurement correlated with daily ecological measurements, whereas a rapid decrease in recall occurs after 48 hours. The most reliable period for pain recall was 7 days, but the results obtained were influenced by current pain.

Study of the information delivery by general practitioners and rheumatologists to patients with acute low back pain.

Providing information to patients regarding appropriate management of LBP is a crucial component of primary care and treatment of low back pain (LBP). Limited knowledge is available, however, about the information delivered by physicians to patients with low back pain. Hence, this study aimed at evaluating (1) the self-reported practices of French physicians concerning information about patients with acute LBP (2) the consistency of these practices with the COST B13 guidelines, and (3) the effects of the delivery of a leaflet summarizing the COST B13 recommendations on the management of patient information, using the following study design: 528 French physicians [319 general practitioners (GP) and 209 rheumatologists (RH)] were asked to provide demographic information, responses to a Fear Avoidance Beliefs questionnaire adapted for physicians and responses to a questionnaire investigating the consistency of their practice with the COST B13 guidelines. Half of the participants (163 GP and 105 RH) were randomized to receive a summary of the COST B13 guidelines concerning information delivery to patient with low back pain and half (156 GP and 104 RH) were not given this information. The mean age of physicians was 52.1±7.6 years, 25.2% were females, 75% work in private practice, 63.1% reported to treat 10-50 patients with LBP per month and 18.2%<10 per month. The majority of the physicians (71.0%) reported personal LBP episode (7.1% with a duration superior to 3 months). Among the 18.4% (97) of the physicians that knew the COST B13 guidelines, 85.6% (83/97) reported that they totally or partially applied these recommendations in their practice. The average work (0-24) and physical activity (0-24) FABQ scores were 21.2±8.4 and 10.1±6.0, respectively. The consistency scores (11 questions scored 0 to 6, total score was standardized from 0 to 100) were significantly higher in the RH group (75.6±11.6) than in GP group (67.2±12.6; p<0.001). The delivery of a summary of the COST B13 guidelines significantly improved the consistency score (p=0.018). However, a multivariate analysis indicated that only GP consistency was improved by recommendations' delivery.The results indicated that GP were less consistent with the European COST B13 guidelines on the information of patients with acute LBP than RH. Interestingly, delivery of a summary of these guidelines to GP improved their consistency score, but not that of the RH. This suggests that GP information campaign can modify the message that they deliver to LBP, and subsequently could change patient's beliefs on LBP.

Comparison of general practitioners and rheumatologists' prescription patterns for patients with knee osteoarthritis.

BACKGROUND: To compare the prescription modalities of general practitioners (GPs) and rheumatologists (RHs) for symptomatic knee osteoarthritis (OA) and to determine correlates with prescription of low-dose NSAIDs. METHODS: This observational, prospective, national survey was carried out among a national representative sample of GPs (n = 808) and RHs (n = 134). Each physician completed a medical questionnaire for the 2 most recent patients fulfilling the ACR criteria for knee OA. RESULTS: GPs and RHs included 1,570 and 251 patients, respectively. Mean pain level of the knee (on a VAS, 0-100 mm) was greater for GP patients than for RH patients (49.8 ± 16.3 vs. 46.2 ± 17.1 mm, respectively; p < 0.01). As compared with patients of RHs, those of GPs more frequently had another joint affected by OA: 71.2% vs. 63.7% (p < 0.0001) and more often had hypertension and diabetes mellitus (p < 0.05). As compared with RHs, GPs more frequently prescribed low-dose NSAIDs (p < 0.0001), oral NSAIDs (p < 0.05), and topical NSAIDs (p < 0.0001) but less frequently symptomatic slow-acting drugs for OA (p < 0.01). Moreover, GPs more frequently recommended rehabilitation (p < 0.01) and loss of weight (p < 0.0001). Logistic regression analysis revealed an association of low-dose NSAIDs prescription and prescription by GPs, prescription of topical NSAIDs, no prescription of oral NSAIDs or coxibs and no intra-articular injection of steroids. CONCLUSIONS: This study identified speciality-related variability in some aspects of the management of knee OA. The clinical profile of patients with knee OA differed between GPs and RHs.

Development and validation of a questionnaire assessing volitional competencies to enhance the performance of physical activities in chronic low back pain patients.

BACKGROUND: Motivation has long been emphasized as the most important determinant of action. However, there is a substantial gap between people's goals and their attainment. Patients may be motivated and yet unable to take action if their volitional competencies are insufficient. One of the important tasks of volition is goal-maintenance. Research has stressed the importance of a volitional tool, the implementation intentions. Implementation intentions indicate where, when, and how the action leading to the goal will be performed. Forming implementation intentions favours the execution of goal-directed efforts, and reinforces the relationship between intentions and behaviours. Results from various studies clearly suggest that volitional competencies and implementation intentions could play a role in low back pain (LBP) patients. However, there is at present no questionnaire allowing assessing the capacity of implementation intentions of physical activities in LBP patients. METHODS/DESIGN: This study will develop such a questionnaire, using a 3-step approach. A first qualitative step to build categories and generate items; 30 patients suffering chronic LBP will be invited to participate in semi-structured interviews; verbatim and derived items will then be submitted to a panel of experts, using a Delphi method; a second quantitative step to examine the properties of items, and determine the factorial structure of the questionnaire; 100 patients suffering chronic LBP will be recruited to respond to this phase; and third, preliminary psychometric analyses (item-scale correlations, construct validity, reliability); 180 chronic LBP patients will be recruited for this phase of the study. The relationships between implementation intentions and variables affecting physical activity on chronic LBP patients, i.e. pain, physical capacities, fear-avoidance beliefs, kinesiophobia, work status, and level of physical activity will be considered. DISCUSSION: Developing a questionnaire to assess implementation intentions would allow investigating the role of these intentions in the transition from acute to chronic LBP. The results of this study should contribute to the understanding of the psychological processes at stake in the development of chronic LBP, and in particular to the identification of factors eventually favouring patients' participation in and adherence to active physical treatments.

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.