A Home Exercise Programme Is No More Beneficial than Advice and Education for People with Neurogenic Claudication: Results from a Randomised Controlled Trial

Objective: To compare the effectiveness of a physiotherapy programme with a control treatment of advice and education in patients with neurogenic claudication symptoms. Design: Pragmatic randomised controlled clinical trial. Setting: Primary care-based musculoskeletal service. Patients: Adults aged 50 or over with neurogenic claudication symptoms causing limitation of walking. Interventions: Condition-specific home exercises combined with advice and education, or advice and education alone. Main outcome measures: The primary outcome was the difference in improvement of symptom severity scores on the Swiss Spinal Stenosis Scale at eight weeks. Secondary outcomes included measures of physical function, pain and general well-being at eight weeks and 12 months. Results: There was no significant difference between groups in the Swiss Spinal Stenosis symptom severity scale at eight weeks (t = 0.47, p = 0.643): mean change (SD) control group -0.18 (0.47), treatment group -0.10 (0.66), difference (95% CI) 0.08 (-0.19, 0.35); baseline-adjusted difference 0.06 (-0.19, 0.31)]. An unplanned subgroup analysis suggested that for patients with the top 25% of baseline symptom severity scores, the physiotherapy exercise programme resulted in an improvement in the primary outcome, and modest but consistently better secondary outcomes at both time-points compared to the control group. The effectiveness in different subgroups requires further direct evaluation. Conclusions: In the treatment of patients with neurogenic claudication symptoms, a physiotherapist-prescribed home exercise programme is no more effective than advice and education

Knee Pain Predicts Subsequent Shoulder Pain and the Association Is Mediated by Leg Weakness: Longitudinal Observational Data from the Osteoarthritis Initiative

Objective: To assess whether the ‘spread’ of joint pain is related to pain-associated muscle loss in one joint leading to increased loading and subsequent pain in other joints. Methods: Associations between persistent knee pain (pain in one or two knees over years 0-3 versus no persistent pain) and incident shoulder pain at year 4 were examined in participants from the longitudinal NIH Osteoarthritis Initiative (OAI). Associations were assessed using log multinomial modelling, adjusted for age, sex, BMI, depression score, other lower limb pain and baseline leg weakness (difficulty standing from a sitting position). Results: In older adults with clinically significant knee OA or at risk of knee OA (n=3486), the number of painful joints increased yearly, from 2.1 joints (95% CI 2.0, 2.2) at baseline increasing by 5.2% (95% CI 2.2%, 8.3%) at year 4. Shoulders were the next most commonly affected joint after knees (28.5%). Persistent pain in 1 or 2 knees increased risk of bilateral shoulder pain at year 4 (1 knee RR 1.59 (95% CI 0.97, 2.61); 2 knees RR 2.02 (1.17, 3.49)) after adjustment for confounders. Further adjustment for leg weakness attenuated effect sizes (1 knee RR 1.13 (95% CI 0.60, 2.11); 2 knees RR 1.44 (0.75, 2.77)), indicating mediation by functional leg weakness. Conclusions: Spread of joint pain is not random. Persistently painful knees predict new bilateral shoulder pain, which is likely mediated by leg weakness; suggesting that biomechanical factors influence the spread of pain

Ultrasound-detected pathologies cluster into groups with different clinical outcomes: data from 3000 community referrals for shoulder pain

Background Ultrasound is increasingly used to evaluate shoulder pain but the benefits of this are unclear. This study examined whether ultrasound-defined pathologies have implications for clinical outcomes. Methods We extracted reported pathologies from 3000 ultrasound scans of people with shoulder pain referred from primary care. Latent class analysis (LCA) identified whether individual pathologies clustered in groups. Optimal group number was determined by the minimum Bayesian information criterion. A questionnaire was sent to all patients scanned over a 12-month period (n=2322). Data collected included demographics, treatments received, current pain and function. The relationship between pathology-defined groups and clinical outcomes was examined. Results LCA revealed four groups: 1. bursitis with limited inflammation elsewhere (n=1280); 2. bursitis with extensive inflammation (n=595); 3. rotator cuff tears (n=558); 4. limited pathology (n=567). 777 (33%) completed questionnaires; median (IQR) duration post-ultrasound scan was 25 (22, 29) months. Subsequent injections were most common in groups 1 & 2 (groups 1-4: 76%; 67%; 48%; 61%); surgery was most common in group 3 (23%; 21%; 28%; 16%). Shoulder Pain and Disability Index scores were highest in group 3 (median 48 and 30 respectively) and lowest in group 4 (32 and 9). Patients in group 4 who had surgery reported poor outcomes. Conclusion In a community-based population, ultrasound identified clusters of pathologies. Our retrospective data suggests these groups have different treatment pathways and outcomes. This requires replication in a prospective study to determine the value of a pathology-based classification in people with shoulder pain

RE: The OHStat Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: Explanation and Elaboration

[no abstract

Ensayo clínico sobre la aplicación de protocolo de rehabilitación multimodal en pacientes con adenocarcinoma de endometrio sometidas a cirugía onco-ginecológica

Introducción A día de hoy, existe mucha evidencia científica sobre los beneficios que aporta la aplicación del protocolo de rehabilitación multimodal (enhanced recovery after surgery o ERAS). Sin embargo, la mayoría de los estudios están realizados en el campo de Cirugía Colorrectal, por lo cual hay necesidad de nuevas investigaciones, de buena calidad, en materia de Ginecología. Éste fue el motivo de realizar el presente ensayo clínico. Objetivos El objetivo principal nuestro estudio fue valorar si existe diferencia en la estancia media hospitalaria en las pacientes oncológicas intervenidas por el cáncer de endometrio por vía laparoscópica siguiendo el protocolo de rehabilitación multimodal (ERAS), comparando con el protocolo tradicional. Los objetivos secundarios fueron analizar si aquello conlleva también al descenso de morbimortalidad perioperatoria, mejoría en la calidad de vida y descenso de los costes por paciente. Metodología Hemos llevado a cabo un ensayo clínico controlado, aleatorizado, con dos grupos paralelos, en el que el grupo de intervención se manejó según el protocolo de rehabilitación multimodal, y el grupo de control recibió cuidados tradicionales que se habían realizado en nuestro hospital hasta aquel momento. Se reclutaron en el ensayo 34 pacientes en el grupo de intervención y 34 pacientes en el grupo de control. Las medidas del protocolo ERAS realizadas fueron: asesoramiento preoperatorio (consejos sobre el estilo de vida), prehabilitación (cribado nutricional, de anemia y diabetes), evitar la preparación mecánica intestinal, reducción de las horas de ayuno preoperatorio, tolerancia oral a líquidos hasta las 2 h antes de la intervención, sobrecarga oral con hidratos de carbono (Sugarmix), uso de benzodiacepinas de corta duración, doble profilaxis de náuseas y vómitos postoperatorios (NVPO), doble profilaxis tromboembólica, rasurado con maquinilla, profilaxis antibiótica, evitar el uso de sonda nasogástrica y de drenajes, fluidoterapia restrictiva, mantenimiento de la normotermia, analgesia multimodal (infiltración de los puertos laparoscópicos y analgesia en planta sin opioides), control estricto de la glucemia, inicio de tolerancia oral precoz, movilización precoz, fisioterapia respiratoria, retirada de la sonda urinaria en las primeras 24 h. Resultados El alta hospitalaria el primer día en el postoperatorio fue posible en 23 pacientes del grupo de intervención (67.6%) y en 7 pacientes del grupo control (20.6%), siendo esta diferencia estadísticamente significativa (p=0.000). Esto no ha conllevado a mayor tasa de complicaciones, según la clasificación de Claiven y Dindo (p=0.645), pero sí a las mejores puntuaciones de dolor según la escala analógica visual (EVA) en el día 3 (p=0.023) y el día 10 en el postoperatorio (p=0.041). No hubo diferencia estadísticamente significativa en las puntuaciones en el postoperatorio inmediato (p=0.693) y el día 30 en el postoperatorio (p=0.566). Las puntuaciones de la calidad de vida de las pacientes según la escala EORTC QLQ-C30 también fueron mejores en el grupo de intervención, con significación estadística en todas las etapas. Se hizo el análisis de costes teniendo en cuenta sólo el coste medio de la estancia hospitalaria diaria y éste resultó en un ahorro de 851.97 euros por paciente en el grupo ERAS. Conclusiones El manejo de las pacientes oncológicas intervenidas por el cáncer de endometrio por vía laparoscópica siguiendo el protocolo de rehabilitación multimodal (ERAS) disminuye la estancia media hospitalaria, no aumenta la morbimortalidad, mejora la calidad de vida de las pacientes y reduce los costes sanitarios, comparando con el protocolo tradicionalIntroduction To date, there is a significant body of scientific evidence supporting the benefits of applying the enhanced recovery after surgery (ERAS) protocol. However, most studies have been conducted in the field of colorectal surgery, highlighting the need for new high-quality research in gynecology. This was the motivation for conducting the present clinical trial. Objectives The primary objective of our study was to assess whether there is a difference in the average hospital stay for oncological patients undergoing laparoscopic surgery for endometrial cancer following the multimodal rehabilitation protocol (ERAS) compared to the traditional protocol. The secondary objectives were to analyze whether this also leads to a decrease in perioperative morbidity and mortality, improvement in quality of life, and reduction in costs per patient. Methodology We conducted a randomized controlled clinical trial with two parallel groups, in which the intervention group was managed according to the multimodal rehabilitation protocol, and the control group received the traditional care previously provided at our hospital. A total of 34 patients were recruited for the intervention group and 34 patients for the control group. The ERAS protocol measures implemented included: preoperative counseling (lifestyle advice), prehabilitation (nutritional, anemia, and diabetes screening), avoiding mechanical bowel preparation, reducing preoperative fasting hours, allowing oral intake of liquids up to 2 hours before surgery, oral carbohydrate loading (Sugarmix), use of short-acting benzodiazepines, dual prophylaxis for postoperative nausea and vomiting (PONV), dual thromboembolic prophylaxis, shaving with a razor, antibiotic prophylaxis, avoiding the use of nasogastric tubes and drains, restrictive fluid therapy, maintenance of normothermia, multimodal analgesia (laparoscopic port infiltration and opioid-free ward analgesia), strict glycemic control, early oral intake, early mobilization, respiratory physiotherapy, and removal of the urinary catheter within the first 24 hours. Results Discharge from the hospital on the first day postoperatively was possible for 23 patients in the intervention group (67.6%) and 7 patients in the control group (20.6%), with this difference being statistically significant (p=0.000). This did not lead to a higher rate of complications, according to the Claiven and Dindo classification (p=0.645), but it did result in better pain scores according to the visual analogue scale (VAS) on day 3 (p=0.023) and day 10 postoperatively (p=0.041). There was no statistically significant difference in scores in the immediate postoperative period (p=0.693) and on day 30 postoperatively (p=0.566). The quality of life scores for the patients according to the EORTC QLQ-C30 scale were also better in the intervention group, with statistical significance at all stages. A cost analysis was performed considering only the average daily hospital stay cost, resulting in a savings of 851.97 euros per patient in the ERAS group. Conclusions The management of oncological patients undergoing laparoscopic surgery for endometrial cancer following the multimodal rehabilitation protocol (ERAS) reduces the average hospital stay, does not increase morbidity and mortality, improves the quality of life of patients, and reduces healthcare costs compared to the traditional protocol

Knee contact forces are not altered in early knee osteoarthritis.

OBJECTIVE: This study calculated knee contact forces (KCF) and its relations with knee external knee adduction moments (KAM) and/or flexion moments (KFM) during the stance phase of gait in patients with early osteoarthritis (OA), classified based on early joint degeneration on Magnetic Resonance Imaging (MRI). We aimed at assessing if altered KCF are already present in early structural degeneration. DESIGN: Three-dimensional motion and ground reaction force data in 59 subjects with medial compartment knee OA (N=23 established OA, N=16 early OA, N=20 controls) were used as input for a musculoskeletal model. KAM and KFM, and KCF were estimated using OpenSim software. RESULTS: No significant differences were found between controls and subjects with early OA. In early OA patients, KAM significantly explained 69% of the variance associated with the first peaks KCF but only KFM contributed to the second peaks KCF. The multiple correlation, combining KAM and KFM, showed to be higher. However, only 20% of the variance of second peak KCF was explained by both moments in established OA. CONCLUSION: KCF are not increased in patients with early OA, suggesting that knee joint overload is more a consequence of further joint degeneration in more advanced stages of OA. Additionally, our results clearly show that KAM is not sufficient to predict joint loading at the end of the stance, where KFM contributes substantially to the loading, especially in early OA

Plantar plate pathology is associated with erosive disease in the painful forefoot of patients with rheumatoid arthritis

Background: Disease-related foot pathology is recognised to have a significant impact on mobility and functional capacity in the majority of patients with rheumatoid arthritis (RA). The forefoot is widely affected and the metatarsophalangeal (MTP) joints are the most common site of symptoms. The plantar plates are the fibrocartilaginous distal attachments of the plantar fascia inserting into the five proximal phalanges. Together with the transverse metatarsal ligament they prevent splaying of the forefoot and subluxation of the MTP joints. Damage to the plantar plates is a plausible mechanism therefore, through which the forefoot presentation, commonly described as ‘walking on pebbles’, may develop in patients with RA. The aims of this study were to investigate the relationship between plantar plate pathology and clinical, biomechanical and plain radiography findings in the painful forefoot of patients with RA. Secondly, to compare plantar plate pathology at the symptomatic lesser (2nd-5th) MTP joints in patients with RA, with a group of healthy age and gender matched control subjects without foot pain. Methods: In 41 patients with RA and ten control subjects the forefoot was imaged using 3T MRI. Intermediate weighted fat-suppressed sagittal and short axis sequences were acquired through the lesser MTP joints. Images were read prospectively by two radiologists and consensus reached. Plantar plate pathology in patients with RA was compared with control subjects. Multivariable multilevel modelling was used to assess the association between plantar plate pathology and the clinical, biomechanical and plain radiography findings. Results: There were significant differences between control subjects and patients with RA in the presence of plantar plate pathology at the lesser MTP joints. No substantive or statistically significant associations were found between plantar plate pathology and clinical and biomechanical findings. The presence of plantar plate pathology was independently associated with an increase in the odds of erosion (OR = 52.50 [8.38–326.97], p < 0.001). Conclusion: The distribution of plantar plate pathology at the lesser MTP joints in healthy control subjects differs to that seen in patients with RA who have the consequence of inflammatory disease in the forefoot. Longitudinal follow-up is required to determine the mechanism and presentation of plantar plate pathology in the painful forefoot of patients with RA

Do quantitative and qualitative shear wave elastography have a role in evaluating musculoskeletal soft tissue masses?

Objectives: To determine if quantitative and qualitative shear wave elastography have roles in evaluating musculoskeletal masses. Methods: 105 consecutive patients, prospectively referred for biopsy within a specialist sarcoma centre, underwent B-mode, quantitative (m/s) and qualitative (colour map) shear wave elastography. Reference was histology from subsequent biopsy or excision where possible. Statistical modelling was performed to test elastography data and/or B-mode imaging in predicting malignancy. Results: Of 105 masses, 39 were malignant and 6 had no histology but benign characteristics at 12 months. Radiologist agreement for B-mode and elastography was moderate to excellent Kw 0.52-0.64; PABAKw 0.85-0.90). B-Mode imaging had 78.8% specificity, 76.9% sensitivity for malignancy. Quantitatively, adjusting for age, B-mode and lesion volume there was no statistically significant association between longitudinal velocity and malignancy (OR [95% CI] 0.40[0.10, 1.60], p=0.193), but some evidence that higher transverse velocity was associated with decreased odds of malignancy (0.28[0.06, 1.28], p=0.101). Qualitatively malignant masses tended to be towards the blue spectrum (lower velocities); 39.5% (17/43) of predominantly blue masses were malignant, compared to 14.3% (1/7) of red lesions. Conclusions: Quantitatively and qualitatively there is no statistically significant association between shear wave velocity and malignancy. There is no clear additional role to B-mode imaging currently. Key Points: • Correlation between shear wave velocity and soft tissue malignancy was statistically insignificant• B-mode ultrasound is 76.9 % sensitive and 78.8 % specific• Statistical models show elastography does not significantly add to lesion assessmen

Profiling microRNAs in individuals at risk of progression to rheumatoid arthritis

Background: Individuals at risk of rheumatoid arthritis (RA) demonstrate systemic autoimmunity in the form of anti-citrullinated peptide antibodies (ACPA). MicroRNAs (miRNAs) are implicated in established RA. This study aimed to (1) compare miRNA expression between healthy individuals and those at risk of and those that develop RA, (2) evaluate the change in expression of miRNA from "at-risk" to early RA and (3) explore whether these miRNAs could inform a signature predictive of progression from "at-risk" to RA. Methods: We performed global profiling of 754 miRNAs per patient on a matched serum sample cohort of 12 anti-cyclic citrullinated peptide (CCP) + "at-risk" individuals that progressed to RA. Each individual had a serum sample from baseline and at time of detection of synovitis, forming the matched element. Healthy controls were also studied. miRNAs with a fold difference/fold change of four in expression level met our primary criterion for selection as candidate miRNAs. Validation of the miRNAs of interest was conducted using custom miRNA array cards on matched samples (baseline and follow up) in 24 CCP+ individuals; 12 RA progressors and 12 RA non-progressors. Results: We report on the first study to use matched serum samples and a comprehensive miRNA array approach to identify in particular, three miRNAs (miR-22, miR-486-3p, and miR-382) associated with progression from systemic autoimmunity to RA inflammation. MiR-22 demonstrated significant fold difference between progressors and non-progressors indicating a potential biomarker role for at-risk individuals. Conclusions: This first study using a cohort with matched serum samples provides important mechanistic insights in the transition from systemic autoimmunity to inflammatory disease for future investigation, and with further evaluation, might also serve as a predictive biomarker