Algofunctional Index Research Articles

An Analysis of Early Outcomes of Knee Osteoarthritis Surgical Treatment

Introduction. Accounting for 33.3 % of all the cases of large joints osteoarthritis, the knee osteoarthritis is one of the most common diseases of the musculoskeletal system. It is a frequent cause of temporary and long-term disability. In this regard, the main goal of this study was to analyze early postoperative outcomes in such patients, as well as to establish a relationship between the predisposing factors and the development of the disease. Materials and methods . This paper presents a retrospective analysis of outcomes in 48 cases of arthroscopic treatment of the knee joint conducted at the Kuvatov Clinical Hospital. Patient population was predominantly female (36 cases), with the age averaging at 57. All the patients underwent arthroscopic surgery on the knee joint. The procedures included the resection of the damaged part of the meniscus, grinding and shaving off the damaged lateral or medial condyle hyaline cartilage, and debridement of the joint cavity. All the patients were assessed for pain using 10-point visual-analog scale of pain (pain VAS) prior to and two weeks after the surgery; the treatment efficacy was evaluated by the change in the number of points scored. The Leken algofunctional index was used for the assessment of the severity of gonarthrosis. The clinical symptoms of the disease were assessed prior to and two weeks after the arthroscopy. Results and discussion . We established that positive changes were clearly present two weeks following the surgery. Patients reported feeling better in general, lesser pain when walking, reduced swelling. In addition, the pain severity scores halved in comparison to the initial values. Conclusion. Our findings indicate that arthroscopic surgery is a clinically effective surgical treatment method. After the surgery, the patients demonstrated a drop in the pain intensity score, their knee joints felt less stiff, the motor functions of the knee joint were partially restored.

The value of postoperative prosthesis alignment and patellar height measurements on standard X-rays after Total Knee Arthroplasty: Does it relate to knee function after 5 years?

BackgroundThe purpose of this retrospective cohort study was to investigate the influence of parameters of malalignment on knee function 5 years post TKA and, additionally, to explore alterations in patellar height after TKA. MethodsAll 661 patients undergoing TKA between 2010 and 2011 were considered for inclusion. Preoperative and 1-year postoperative short-leg radiographs were assessed for malalignment parameters: coronal tibial angle (cTA), sagittal tibial angle (sTA), femoral flexion angle (FFA) and mediolateral tibial mismatch. Patellar height was measured using the modified Insall-Salvati ratio. We determined improvements in knee function utilizing the Knee Society Score (Function score, KSS-F), Oxford Knee Score (OKS) and Algofunctional index (AI). Influences of malalignment parameters were analyzed univariate and selected (p < 0.10) for multivariate linear regression analysis. Inter-observer reproducibility was assessed by test–retest analysis of 30 randomly selected radiographs and calculation of an intra-class correlation coefficient (ICC) for all radiographic parameters. ResultsThree-hundred and four patients were included. Multivariate regression showed degrees of cTA malalignment to be significantly associated with only the KSS-F (β = −3.52). Correction of coronal deformity was stronger associated with knee function (KSS-F β = 2.81; AI β = −0.36). Patellar height was significantly reduced after TKA (1.51 vs 1.44). Decrease of patellar height was weakly associated with the OKS (β = 10.69). ICC scores were: cTA 0.81, sTA 0.57, IS 0.72, FFA 0.75. ConclusionPostoperative coronal tibial plate alignment and correction of preoperative coronal deformity are associated with improved knee function 5 years post TKA. Decrease in patellar height was weakly associated with knee function. Short-leg radiography can be a sufficient screening tool for prosthesis alignment.

Comparison of Efficacy and Tolerability of Immediate Release Glucosamine HCL And Glucosamine HCL Sustained Release Formulation in the Treatment of Knee Osteoarthritis; A Randomised Clinical Trial

Background: Osteoarthritis (OA) is the most common form of and a leading cause of chronic disability between fourth and fifth decade of life, with a prevalence ranging between 17-60.6% in India. Objective: To compare the efficacy and safety profile of glucosamine HCl- sustained release (GLU-SR) with that of Glucosamine HCl- immediate release (GLU-IR) in patients with knee osteoarthritis (OA). Methods: This was an open labelled, randomised, controlled trial conducted in a tertiary care hospital at Kanpur. The study involved 60 patients with knee OA, randomised to receive single oral dose of 1,500 mg GLU-SR and GLU-IR for 60 days with 30 patients in each group. The primary efficacy being reduction in pain and improvement in function was assessed using visual analogue scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores. Intention-to-treat principle, repeated measure of ANOVA and mixed model analysis were used for statistical analysis. The history of adverse reactions experienced was collected throughout the study period. Results: There was a significant reduction in algo functional indices as primary outcome measure in both the groups (P < 0.001). A significant difference (P < 0.05) in the number of patients reporting ADR in the GLU-SR arm (38% lesser) was noted as compared to GLU-IR arm, with no difference in the use of rescue medications in both arms. Conclusions: From the observations made in this study it is concluded that GLU-SR is as effective as GLU-IR in the management of knee OA; with an advantage of having a better safety profile.

Lower serum clusterin levels in patients with erosive hand osteoarthritis are associated with more pain

BackgroundThe aims of this study were to analyse the serum concentrations of clusterin (CLU) in patients with hand osteoarthritis (OA) and in healthy controls, to compare CLU levels between patients with erosive and non-erosive disease, and to examine the association of CLU levels with clinical and laboratory parameters.MethodsA total of 135 patients with hand OA (81 with erosive and 54 with non-erosive disease) and 53 healthy individuals were included in this study. All patients underwent clinical and hand joint ultrasound examination. The Australian/Canadian (AUSCAN) hand osteoarthritis index, algofunctional index and a visual analogue scale (VAS) for the measurement of pain were assessed. Serum levels of CLU were measured by an enzyme-linked immunosorbent assay (ELISA).ResultsSerum levels of CLU were significantly lower in patients with hand OA than in control subjects (p < 0.0001). In addition, patients with erosive hand OA had significantly lower CLU levels than those with non-erosive disease (p = 0.044). Negative correlations between CLU levels and pain as assessed by the AUSCAN score and the VAS were found in patients with erosive hand OA (r = − 0.275; p = 0.013 and r = − 0.220; p = 0.049, respectively).ConclusionThe present study demonstrates that lower concentrations of CLU are found in hand OA patients than in healthy individuals, especially in those with erosive disease, and that CLU concentrations have a negative association with hand pain.

Cupping Therapy for Knee Osteoarthritis: A Synthesis of Evidence

Background: This systematic review was aimed to evaluate the efficacy and safety of cupping therapy for treating patients with knee osteoarthritis (KOA). Methods: The following databases were searched from their inception until June 2017: the Cochrane Central Register of Controlled Trials, PubMed, EMBASE, and 4 Chinese databases (Wan Fang Data, Chinese Biomedical Literature Database (CBM), VeiPu, and China National Knowledge Infrastructure (CNKI)). Randomized controlled trials (RCTs) assessing the effects of cupping therapy on KOA were included in this systematic review. A quantitative synthesis of the RCTs was conducted using RevMan 5.3 software. Study selection and data extraction and validation were performed independently by 2 reviewers. Cochrane criteria for risk of bias were used to assess the methodological quality of the trials. Results: A total of 5 studies met our inclusion criteria. We analyzed the data from these 5 RCTs involving 535 participants. All included studies were judged to be at high risk for bias. Dry cupping therapy plus Western medicine therapy was more effective than Western therapy alone in reducing the pain scores (mean difference (MD) = -1.79, 95% confidence interval (CI) -2.40 to -1.18; p < 0.01). In addition, the study participants in the dry cupping therapy plus Western medicine therapy group showed significantly greater improvements in the pain (MD = -0.73, 95% CI -1.61 to -0.41; p < 0.01), stiffness (MD = -0.94, 95% CI -1.30 to -0.58; p < 0.01), and physical function (MD = -10.07, 95% CI -13.45 to -6.69; p < 0.01) domains of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) compared to participants in the Western medicine therapy group. Moreover, when compared with Western medicine therapy alone, a meta-analysis of 4 RCTs suggested statistically significant favorable effects of wet cupping therapy plus Western medicine on the Lequesne Algofunctional Index (LAI) (MD = -3.44, 95% CI -4.21 to -2.68; p < 0.01). Conclusion: There is weak evidence to support the hypothesis that cupping therapy has beneficial effects on reducing the pain intensity and improving the physical function in patients with KOA.

Intra-articular steroids versus hyaluronic acid knee arthritis

The main objective of the study is to assess the efficacy of intra-articular (IA) injections of hyaluronic acid (HA), compared to corticoids in patients with osteoarthritis of knee in both the long-term follow-up, and whether there is a difference. Randomized study, from Mars 2015 until June 2016, compared two groups of patients with knee osteoarthritis; 1st group: injected by corticoids (only 1 injection/knee/month, n = 14), controlled by group (3 injections/knee of HA, n = 18). Evaluated by: pain intensity; Visual Analog Scale (VAS), Lequesne Algofunctional Index, and quality of life. The follow-up time was 12 months. After 12 months of follow-up, both treatment groups showed improvement in knee function, the corticoids group showing a greater improvement compared to HA group; in pain relief, in overall Lequesne Algofunctional Index, and quality of life. The IA injection of corticoids was better to improve the symptomatology in the long-term, corticods provided pain relief and quality of life in patients with knee OA, compared with IA of hyaluronic acid. However, IA hyaluronic acid is a good alternative the delay the surgery.

Effects of balneotherapy and spa therapy on quality of life of patients with knee osteoarthritis: a systematic review and meta-analysis.

Knee osteoarthritis (OA) is a degenerative disease which is expected to become one of the leading causes of disability by the next years. This work aims to assess if balneotherapy and spa therapy can significantly improve Quality of Life (QoL) of patients with knee OA. Medline via PubMed, Scopus, Web of Science, Cochrane Library, and PEDro were systematically searched for articles about trials involving patients with knee OA and measuring the effects of balneotherapy and spa therapy on study participants' QoL with validated scales. A qualitative and quantitative syntheses were performed. Seventeen studies were considered eligible and included in the systematic review. Fourteen trials reported significant improvements in at least one QoL item after treatment. Ten studies were included in quantitative synthesis. When comparing balneological interventions with standard treatment, results favored the former in terms of long-term overall QoL [ES = - 1.03 (95% CI - 1.66 to - 0.40)]. When comparing balneological interventions with sham interventions, results favored the former in terms of long-term pain improvement [ES = - 0.38 (95% CI - 0.74 to - 0.02)], while no significant difference was found when considering social function [ES = - 0.16 (95% CI - 0.52 to 0.19)]. In conclusion, even though limitations must be considered, evidence shows that BT and spa therapy can significantly improve QoL of patients with knee OA. Moreover, reduction of drug consumption and improvement of algofunctional indexes may be other beneficial effects. Further investigation is needed because of limited available data.

Basic calcium phosphate and pyrophosphate crystals in early and late osteoarthritis: relationship with clinical indices and inflammation.

The current study aimed to investigate the association of calcium pyrophosphate (CPP) and basic calcium phosphate (BCP) crystals in synovial fluid (SF) of patients with osteoarthritis (OA) with disease severity, clinical symptoms, and synovial inflammation. One-hundred-and-ten patients with knee OA completed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) self-assessment questionnaire, the Lequesne algofunctional index survey, and the visual analogic scale forms; they also underwent power Doppler ultrasonography (PDUS) to assess synovial inflammation. Scanning electron microscopy (SEM) was used to detect SF crystals. SEM analyses uncovered CPP crystals in 26 patients (23.6%), BCP crystals in 24 patients (21.8%), and both types of crystals in 7 patients (6.3%). Categorizing patients according to SF crystal type, a strong association between BCP crystal presence, and higher WOMAC and Lequesne index scores has been uncovered. Classifying our patients according the severity Kellgre-Lawrence score, we found that the prevalence of CPP alone (27.8%) or in combination with BCP (11.1%) was higher in the late stage group with respect to the early one (CPP 21.6% and CPP + BCP 4.1%, respectively). The prevalence of BCP crystals alone was, instead, higher in the early (23%) with respect to the late group (19.4%). No association between the presence of crystals and the radiographic scores has been observed. Considering the growing evidence supporting a role of low-grade inflammation in OA pathogenesis, the results of this study suggest a role for calcium crystals in the development of the disease.

Low-level laser therapy and interferential current in patients with knee osteoarthritis: a randomized controlled trial protocol.

The aim of this study is to investigate the effects of low-level laser therapy and interferential current (IFC) on pain intensity, central sensitization, muscle strength and functional capacity in patients with knee osteoarthritis. Participants will be patients aged between 50 and 80years, with knee osteoarthritis, pain intensity ranging from 3 to 8 points (0-10 scale), Lequesne Algofunctional Index ranging from 5 to 15 points, and Kellgren & Lawrence grade≥2. A total of 168 patients will be randomly allocated into four groups as follows: active IFC+laser sham (G1), IFC sham+active laser (G2), active IFC+laser (G3) and IFC+laser sham (G4). Evaluators will be blinded to group allocation. Primary outcomes will be pain at rest and during movement measured with the visual analog pain scale. Clinical Trials Registry (NCT02898025. Registered on 20April 2016).

Galectin-3 serum profile in patients with knee osteoarthrosis: association with the disease course

Aim of the work was to study the level of galectin-3 in serum in patients with osteoarthrosis of knee joints and to evaluate its association with the course of the disease. Materials and methods. We examined 141 patients with osteoarthrosis (OA) of knee joints (76.6% of women), an average age of 58.4 ± 7.91 years, a disease duration of 10.5 ± 6.50 years, an II-III radiological stage. 33.3% of patients had a combination of OA knee and hip joints. Diagnosis of OA was established on the basis of criteria ACR 1991 and recommendations EULAR (2010). The Lequesne algo-functional index, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS) were determined. Functional disorders were evaluated by the Health Assessment Questionnaire (HAQ). The content of galectin-3 in the blood was determined by the enzyme-linked immuno sorbent assay. Results. It has been established that in 75% of patients with OA of knee joints aberrant levels of galectin-3 in the blood are detected, including 44% of subjects with a registered high level of the index (>15.8 ng/ml). The weak associative relationships between the level of galectin-3 and the age of patients and the duration of OA were established. Among patients with aberrant levels of galectin-3, persons with severe clinical manifestations of OA appeared more often. The increase in the level of galectin-3 was associated with a significant increase in the pain syndrome and the deterioration of physical function by the indexes of Lequesne, WOMAC, KOOS, HAQ. Conclusions. In patients with OA, the increase in the production of galectin-3 is a factor in the deterioration of the clinical course of the disease, the increase in pain syndrome and functional disorders. A close associative relationship was found between the level of galectin-3 and the clinical severity indexes of OA and the weak associative relationship between the level of galectin-3 and the age and duration of the disease

Mental Health-Ill Health Differences in Disease Severity and Its Sociodemographic Biobehavioral Predictors Among Patients With Knee Osteoarthritis.

Our aim in this cross-sectional study was to investigate mental health-ill health differences in disease severity and its sociodemographic biobehavioral predictors among patients with knee osteoarthritis (OA). Applying convenient sampling, 180 patients with knee OA in Tabriz, Iran, were recruited to participate in completing a three-section questionnaire (SF-12, Lequesne Algofunctional Index and Self-Management Behaviors Scale). Separate hierarchical multiple linear regressions were performed with OA severity as dependent variable: one for OA patients with positive mental health and other for OA patients with mental disorders symptoms. Among the patients with positive mental health, but not those with symptoms of mental disorder, pain management, duration of OA, physical activity management, living alone, and level of education were significant predictors of disease severity. Health care providers with a better understanding on the determinants of disease severity by mental health status may identify vulnerable patients and develop targeted interventions to foster disease management behaviors among OA patients.

Clinical significance of Matrilin-3 gene polymorphism in Egyptian patients with primary knee osteoarthritis.

Osteoarthritis (OA) is a multifactorial, degenerative, and inflammatory disorder of joints causing damage of the articular cartilage, formation of osteophytes, and eburination of the subchondral bone. Matrilin-3 (MATN-3) is a non-collagenous oligomeric extracellular matrix protein (ECM), which is the smallest member of the matrilin family. This study was conducted to identify the potential association and clinical significance of MATN-3 rs8176070 (SNP6) polymorphism in a series of Egyptian patients with primary knee OA. Polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) was used to determine genotypes of MATN-3 SNP6 for 50 primary knee OA patients in addition to 50 healthy subjects of the same sex and age range. Full history was obtained from OA patients, followed by clinical examination, together with clinical assessment of the severity of knee OA using Lequesne Algofunctional Index score and radiological grading using the Kellgren-Lawrence grade scale (KL). With regard to genotypes of MATN-3 gene SNP6 (rs8176070), a statistically significant difference between OA patients and healthy control subjects was found for the B\b genotype and b allele (p=0.046 and 0.042 respectively), with the prevalence being higher in OA patients with a high risk to develop OA (Odds Ratio [OR]=2.250, 95% CI=1.011-5.008). Patients with the B\b genotype had worse clinical and radiological findings than those with B\B and b\b genotypes. The investigated polymorphism in the MATN-3 gene may reflect the risk and severity of knee OA in Egyptian patients, particularly with the B\b genotype.

Influence of HLA Matching on the Efficacy of Allogeneic Mesenchymal Stromal Cell Therapies for Osteoarthritis and Degenerative Disc Disease

BackgroundThe necessity for more effective therapies for chronic osteoarticular diseases has led to the development of treatments based on mesenchymal stem cells (MSCs), the natural precursors of musculoskeletal tissue. Treatments with autologous MSCs yielded excellent results, with nearly 70% improvement of pain and disability in osteoarthritis and degenerative disc disease. Using allogeneic MSCs is logistically more convenient and would widen the pool of eligible patients, but potential immune rejection should be considered. In this context, MSCs are purportedly immune evasive and better tolerated than other cell types.MethodsWe used samples collected during the performance of 2 randomized clinical trials using allogeneic bone marrow MSCs for treatment of osteoarthritis (NCT01586312) and degenerative disc disease (NCT01860417). Serum samples were used to determine anti-HLA antibodies, whereas either blood or MSC samples were used for HLA typing of recipients and donors, respectively. Algofunctional indexes were used as indicators of clinical evolution, and the correlation between the number of donor-host HLA mismatches and the efficacy of treatment was determined.ResultsImmune response was weak and transient, with reactivity decaying during the first year. Consistently, better donor-recipient HLA matching did not enhance efficacy.ConclusionsThis lack of reactivity is presumably due to the cooperation of 2 factors, (1) downregulation of the host immune responses by the transplanted MSCs and (2) effective insulation of these cells inside the articular cavity or the intervertebral disc, respectively. Interestingly, better HLA matching did not enhance efficacy. These observations have medical relevance as they support the clinical use of allogeneic cells, at least as a single-dose administration. Multiple-dose applications will require further research to exclude possible sensitization.

Patient Acceptable Symptom State in Knee Osteoarthritis Patients Succeeds Across Different Patient-reported Outcome Measures Assessing Physical Function, But Fails Across Other Dimensions and Rheumatic Diseases

The aims of this study are (1) to establish the Patient Acceptable Symptom State (PASS) cutoff values of different patient-reported outcome measures (PROM) assessing physical function in patients with knee osteoarthritis (OA), and (2) to assess the influence of sex, age, duration of symptoms, and presence of depressive feelings on being in PASS. Patients fulfilling the clinical American College of Rheumatology knee OA criteria received standardized nonsurgical treatment and completed different questionnaires at baseline and 3 months assessing physical function: Knee Injury and Osteoarthritis Outcome Score, Lequesne Algofunctional Index, Lower Extremity Functional Scale, numerical rating scale, and the physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index. PASS values were defined as the 75th percentile of the score of questionnaires for those patients who consider their state acceptable. Of the 161 included patients, 62% were women with a mean age of 59 years (SD 9) and body mass index of 30 kg/m2 (SD 5). Standardized PASS values (95% CI) for different questionnaires for physical function varied between 48 (44-54) and 54 (50-56). Female patients and patients feeling depressed were found to have a lower probability to be in PASS for physical function, with OR (95% CI) varying from 0.45 (0.23-0.91) to 0.50 (0.26-0.97) and from 0.27 (0.14-0.55) to 0.38 (0.19-0.77), respectively. PASS cutoff values for physical function are robust across different PROM in patients with knee OA. Our results indicate that PASS values are not consistent across dimensions and rheumatic diseases, and that the use of a generic PASS value for patients with OA or even patients with other rheumatic diseases might not be justifiable.

Clinical efficacy and safety of mesenchymal stem cell transplantation for osteoarthritis treatment: A meta-analysis.

PurposeThe aim of this study was to evaluate the therapeutic efficacy and safety of mesenchymal stem cells (MSCs) for the treatment of patients with knee osteoarthritis (OA).MaterialsWe performed a meta-analysis of relevant published clinical studies. An electronic search was conducted for randomized controlled trials (RCTs) of MSC-based therapy in knee OA. The visual analogue scale (VAS), International Knee Documentation Committee (IKDC) form, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne algofunctional indices (Lequesne), Lysholm knee scale (Lysholm), Tegner activity scale (Tegner) and adverse events (AEs) were evaluated.ResultsEleven eligible trials with 582 knee OA patients were included in the present meta-analysis. We demonstrated that MSC treatment could significantly decrease VAS and increase IKDC scoresafter a 24-month follow-up compared with controls (P<0.05). MSC therapy also showed significant decreases in WOMAC and Lequesne scores after the 12-month follow-up (P<0.01). Analysis of Lysholm (24-month) and Tegner (12- and 24-month) scores also demonstrated favorable results for MSC treatment (P<0.05).ConclusionOverall, MSC transplantation treatment was shown to be safe and has great potential as an efficacious clinical therapy for patients with knee OA.

Efficacy and safety of rebel reliever ® brace in patients with knee osteoarthritis – A phase III randomized controlled trial

Purpose: According to OARSI guidelines, management of knee osteoarthritis consists of a combination of both non-pharmaceutical and pharmaceutical treatments, including knee braces. However, evidence is still inconclusive for the benefits of bracing in the treatment of knee osteoarthritis. The aim of this randomized open-label clinical trial was to compare the efficacy of the Rebel Reliever® knee brace in combination with usual care to that of usual care alone, after a 6-week treatment period. Methods: 67 patients with symptomatic medial knee osteoarthritis (Kellgren-Lawrence grade II-IV) were randomized into 2 groups: Brace group (brace + usual care) and Control group (usual care alone). Rebel Reliever® is a lightweight aluminum knee brace which applies corrective forces by a 3-point pressure system, gradually adjustable. Usual care consisted of analgesics and self exercises program. Primary endpoint was the global last-24 h knee pain (assessed via a 100-mm visual analogic scale [VAS]) after 6 weeks of treatment. Secondary endpoints included pain during motion (100-mm VAS), function (Lequesne index), clinical global improvement according to both patients and investigators, responder rate (OARSI-OMERACT criteria), as well as observance. Results: Study population consisted of 67 patients aged 65.7 ± 9.6 years, mainly women (65.7%). Of them, 32 were assigned to the Brace group and 35 to the Control group. At baseline, last 24h-pain was 63.8 ± 10.6 mm in the Brace group and 64.7 ± 13.5 mm in the Control group. Pain during motion was 73.4 ± 12.7 mm and 71.9 ± 13.8 mm in the Brace and Control groups, respectively. Function (Lequesne index) was 13.42 ± 3.74 in the Brace group and 12.63 ± 3.22 in the Control group. After 6 weeks, last 24h-pain decrease in the Brace group was statistically higher compared to the Control group (−41.35 ± 3.37 mm vs. −15.37 ± 3.23 mm; p < 0.0001). Similarly, decrease in pain in motion was significantly higher in the Brace group than in the Control group (−51.91 ± 3.49 mm vs. −19.91 ± 3.34 mm; p < 0.0001). Improvement of algofunctional Lequesne index score was also significantly higher in the Brace group (−5.8 vs. −2.3; p < 0.001). Clinical global improvement was more pronounced in the Brace group, with more patients feeling ‘better’ to ‘considerably improved’ in the Brace group compared to the Control group (86.2% vs. 3.1%) and with investigators reporting more patients ‘much’ to ‘very much’ improved in the Brace group than in the Control group (82.1% vs. 3.1%). Responder rate (OARSI-OMERACT criteria) was significantly higher in the Brace group (72.4% vs. 34.4%; p = 0,003). These observed differences were clinically relevant. Observance to the brace was excellent ( > 90% of the actual/theoretical wearing days). Conclusions: Superiority of Rebel Reliever® knee brace + usual care compared to usual care alone was demonstrated. Combining Rebel Reliever® knee brace with usual care is a powerful non pharmacological therapeutic strategy to handle medial knee osteoarthritis. NCT02021136.

КОМПЛЕКСНАЯ КУРОРТНАЯ ТЕРАПИЯ КОКСАРТРОЗА В СОЧЕТАНИИ С ОСТЕОПЕНИЕЙ У ЖЕНЩИН В СОСТОЯНИИ ПОСТМЕНОПАУЗЫ

Objective: To evaluate the clinical efficacy of the new technology of restorative treatment of coxarthrosis burdened with osteopenia in postmenopausal women in the dynamics of clinical and algofunctional indices. Methods: Observations were made of 120 postmenopausal women aged 50-60 years with coxarthrosis with the concomitant osteopenic syndrome. Researchers were conducted in three representative groups: control (outpatient) received only Natekal D3; the comparison group at the sanatorium received drinking mineral water and radonotherapy; in the main group, patients received additional magnetotherapy. Results: The dynamics of clinical and algofunctional indices testifies to the advantage of complex balneo-, magneto- and rational pharmacotherapy. Conclusion: The expediency of health-resort treatment of coxarthrosis in combination with osteopenia in postmenopausal women with the complex application of radon, magnetic and medicament therapy was proved. Keywords: Coxarthrosis, postmenopause, radonotherapy, magnetotherapy, algofunctional indices.

Efficacy, tolerability, and safety of an oral enzyme combination vs diclofenac in osteoarthritis of the knee: results of an individual patient-level pooled reanalysis of data from six randomized controlled trials.

ObjectiveTo compare efficacy, safety, and tolerability of an oral enzyme combination (OEC) containing proteolytic enzymes and bioflavonoid vs diclofenac (DIC), a nonselective nonsteroidal anti-inflammatory drug in the treatment of osteoarthritis of the knee.Materials and methodsThis was an individual patient-level pooled reanalysis of patient-reported data from prospective, randomized, double-blind, parallel-group studies in adult patients with moderate-to-severe osteoarthritis of the knee treated for at least 3 weeks with OEC or DIC. Appropriate trials were identified with a systemic literature and database search. Data were extracted from the original case-report forms and reanalyzed by a blinded evaluation committee. The primary end point was the improvement of the Lequesne algofunctional index (LAFI) score at study end vs baseline. Secondary end points addressed LAFI response rates, treatment-related pain-intensity changes, adverse events, and laboratory parameters.ResultsSix trials were identified that enrolled in total 774 patients, of whom 759 had post-baseline data for safety analysis, 697 (n=348/349 with OEC/DIC) for intent to treat, 524 for per protocol efficacy analysis, and 500 for laboratory evaluation. LAFI scores – the primary efficacy end point – decreased comparably with both treatments and improved with both treatments significantly vs baseline (OEC 12.6±2.4 to 9.1±3.9, DIC 12.7±2.4 to 9.1±4.2, effect size 0.9/0.88; P<0.001 for each). In parallel, movement-related 11-point numeric rating-scale pain intensity improved significantly (P<0.001) and comparably with both treatments from baseline (6.4±1.9/6.6±1.8) to study end (3.8±2.7/3.9±2.5). Overall, 55/81 OEC/DIC patients of the safety-analysis population (14.7%/21.1%, P=0.022) reported 90/133 treatment-emergent adverse events, followed by premature treatment discontinuations in 22/39 patients (5.9%/10.2%, P=0.030). Changes in laboratory parameters were significantly less with OEC vs DIC: on average 18.8% vs 86.3% of patients presented a decrease with respect to hemoglobin, hematocrit, or erythrocyte count (P<0.001), and 28.2% vs 72.6% showed an increase in AST, ALT, or GGT (P<0.001).ConclusionWhen compared with DIC, OEC showed comparable efficacy and a superior tolerability/safety profile associated with a significantly lower risk of treatment-emergent adverse events, related study discontinuations, and changes in laboratory parameters.

Use of the Lower Extremity Functional Scale (LEFS-Brazil) questionnaire compared to Lequesne Algofunctional Index for definition of knee and hip osteoarthritis severity

Use of the Lower Extremity Functional Scale (LEFS-Brazil) questionnaire compared to Lequesne Algofunctional Index for definition of knee and hip osteoarthritis severity

Responsiveness of four patient-reported outcome measures to assess physical function in patients with knee osteoarthritis

Objectives: The aim of this study was to evaluate the responsiveness of four patient-reported outcome measures (PROMs) to measure change in physical function simultaneously in patients with knee osteoarthritis (OA) following currently recommended COSMIN (COnsensus-based Standards for the selection of health status Measurement INstruments) standards.Method: Patients with knee OA receiving conservative treatment following a stepped care approach were invited to complete a set of questionnaires at baseline and 3 months. Questionnaires included four widely used measures of physical function: the Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), the Lequesne algofunctional index (LAI), the Lower Extremity Functional Scale (LEFS), and the Western Ontario and McMaster University Osteoarthritis Index Physical Function subscale (WOMAC-PF). Responsiveness of physical function was investigated according to the COSMIN standards by testing 15 a priori defined hypotheses. Responsiveness was considered positive if > 75% of the hypotheses could be confirmed.Results: A total of 161 patients participated [61% female, mean (sd) age 59 (9) years and body mass index 29.7 (5.0) kg/m2]. Baseline values of the four PROMs were, mean (sd): KOOS-PS 53.6 (16.8), LAI 11.0 (4.0), LEFS 40.6 (14.1), and WOMAC-PF 51.8 (19.4). We could confirm 12 out of 15 predefined hypotheses (80%) about expected correlations for the WOMAC-PF whereas for the KOOS-PS, LAI, and LEFS < 75% hypotheses could be confirmed (73, 67, and 73%. respectively).Conclusions: Our results suggest that the WOMAC-PF is able to detect changes over time in physical function and therefore should be the measure of first choice in clinical trials evaluating the effectiveness of an intervention on physical function in knee OA patients.