Improvement In WOMAC Pain Scores Research Articles

Exploring the Efficacy of Alpha-Lipoic Acid in Comorbid Osteoarthritis and Type 2 Diabetes Mellitus

Background/Objectives. The comorbidity of osteoarthritis and type 2 diabetes mellitus poses a complex clinical challenge, complicating patient management due to overlapping pathophysiological mechanisms. This research aims to analyze the exacerbation of clinical symptoms and biochemical markers in patients with OA and T2DM compared to those with OA alone. Methods. We employed various assessment methods to evaluate inflammation, oxidative stress, and glycemic control in both cohorts. This study includes the administration of alpha-lipoic acid (ALA) to patients with comorbid OA and T2DM, monitoring its effects on joint function, inflammatory markers, oxidative stress levels, and glycemic control. Results. The findings indicate that T2DM significantly worsens clinical symptoms and biochemical markers in OA patients. Those with both conditions exhibited elevated indicators of inflammation and oxidative stress compared to OA-only patients. Additionally, correlations among metabolic, psychological, and inflammatory factors were identified. Body mass index emerged as a potential predictor for the deterioration of evaluated parameters. The analysis revealed that ALA administration led to statistically significant improvements in WOMAC pain scores, the Lequesne Algofunctional Index, and the AIMS-P compared to the control group. Conclusions. Further research into ALA’s effects on OA progression in patients with comorbidities is essential for developing personalized treatment approaches.

Does preoperative bone marrow edema affect clinical outcomes after medial open-wedge high tibial osteotomy?

PurposeThe aim of this study is to evaluate the results of high tibial osteotomy (HTO) in patients with bone marrow edema (BME) and assess the effect of factors on the subsequent results.MethodsA total of 138 patients who underwent medial open-wedge HTO using locking plate were included in this study. BME was observed in 108 patients using preoperative magnetic resonance imaging. Clinical results were evaluated before HTO and postoperatively at 12 months. Moreover, we evaluated the factors affecting the clinical results.ResultsThe clinical scores were all significantly improved regardless of the presence of BME. There were no differences in improvement of clinical scores between patients with BME and without BME. Patients with BME showed higher postoperative Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness scores than patients without BME. Furthermore, patients with BME on both the femur and tibia showed lower Knee Society function scores than patients with BME on either the femur or the tibia. Patients with large BME lesions exhibited a lower Hospital for Special Surgery score and WOMAC pain scores, postoperatively. In patients with BME, patients with undercorrection showed significantly lower improvement in WOMAC pain scores compared with patients with acceptable correction.ConclusionsThe clinical improvement after HTO in patients with varus and medial osteoarthritis was not different regardless of the presence or absence of BME. However, accurate alignment should be considered essential for achieving better clinical outcomes in patients with preoperative BME.

Efficacy of traditional Chinese exercise for the treatment of pain and disability on knee osteoarthritis patients: a systematic review and meta-analysis of randomized controlled trials.

To evaluate the efficacy of Traditional Chinese Exercises (TCEs) in treating knee osteoarthritis (KOA). Four databases without language or publication status restrictions were searched until April 1, 2022. Based on the principle of Population, Intervention, Comparison, Outcomes and Study design, the researchers searched for randomized controlled trials of TCEs in treating KOA. The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain was defined as the primary outcome, whereas stiffness and physical function were the secondary outcomes. Subsequently, two researchers conducted the process independently, and the data were analyzed using the RevManV.5.3 software. Overall, 17 randomized trials involving 1174 participants met the inclusion criteria. The synthesized data of TCEs showed a significant improvement in WOMAC pain score [standardized mean difference (SMD) = -0.31; 95% confidence interval (CI): -0.52 to -0.10; p = 0.004], stiffness score (SMD = -0.63; 95% CI: -1.01 to -0.25; p = 0.001) and physical function score (SMD = -0.38; 95% CI: -0.61 to -0.15; p = 0.001) compared with the control group. Sensitivity analyses were performed to determine the combined results' stability, which was unstable after excluding articles with greater heterogeneity. A further subgroup analysis showed that it might be the reason for the heterogeneity of the different traditional exercise intervention methods. Additionally, it showed that the Taijiquan group improved pain (SMD = 0.74; 95% CI: -1.09 to 0.38; p < 0.0001; I2 = 50%), stiffness (SMD = -0.67; 95% CI -1.14 to 0.20; p = 0.005) and physical function score (SMD = -0.35; 95% CI: -0.54 to 0.16; p = 0.0003; I2 = 0%) better than the control group. The Baduanjin group improved stiffness (SMD = -1.30; 95% CI: -2.32 to 0.28; p = 0.01) and physical function (SMD = -0.52; 95% CI: -0.97 to 0.07; p = 0.02) better than the control group. However, the other interventions showed no difference compared with the control group. This systematic review provides partial evidence of the benefits of TCEs for knee pain and dysfunction. However, due to the heterogeneity of exercise, more high-quality clinical studies should be conducted to verify the efficacy. https://inplasy.com/inplasy-2022-4-0154/, identifier: International Platform of Registered Systematic Review and Meta-analysis Protocols (INPLASY) [INPLSY202240154].

Assessment of Residual Pain and Dissatisfaction in Total Knee Arthroplasty: Methods Matter.

Residual pain after total knee arthroplasty (TKA) refers to knee pain after 3 to 6 months postoperatively. The estimates of the proportion of patients who experience residual pain after TKA vary widely. We hypothesized that the variation may stem from the range of methods used to assess residual pain. We analyzed data from 2 prospective studies to assess the proportion of subjects with residual pain as defined by several commonly used metrics and to examine the association of residual pain defined by each metric with participant dissatisfaction. We combined participant data from 2 prospective studies of TKA outcomes from subjects recruited between 2011 and 2014. Residual pain was defined using a range of metrics based on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score (0 to 100, in which 100 indicates worst), including the minimal clinically important difference (MCID) and patient acceptable symptom state (PASS). We also examined combinations of MCID and PASS cutoffs. Subjects self-reported dissatisfaction following TKA, and we defined dissatisfied as somewhat or very dissatisfied at 12 months. We calculated the proportion of participants with residual pain, as defined by each metric, who reported dissatisfaction. We examined the association of each metric with dissatisfaction by calculating the sensitivity, specificity, positive predictive value, and Youden index. We analyzed data from 417 subjects with a mean age (and standard deviation) of 66.3 ± 8.3 years. Twenty-six participants (6.2%) were dissatisfied. The proportion of participants defined as having residual pain according to the various metrics ranged from 5.5% to >50%. The composite metric Improvement in WOMAC pain score ≥20 points or final WOMAC pain score ≤25 had the highest positive predictive value for identifying dissatisfied subjects (0.54 [95% confidence interval, 0.35 to 0.71]). No metric had a Youden index of ≥50%. Different metrics provided a wide range of estimates of residual pain following TKA. No estimate was both sensitive and specific for dissatisfaction in patients who underwent TKA, underscoring that measures of residual pain should be defined explicitly in reports of TKA outcomes. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Biclustering reveals potential knee OA phenotypes in exploratory analyses: Data from the Osteoarthritis Initiative

To apply biclustering, a methodology originally developed for analysis of gene expression data, to simultaneously cluster observations and clinical features to explore candidate phenotypes of knee osteoarthritis (KOA) for the first time. Data from the baseline Osteoarthritis Initiative (OAI) visit were cleaned, transformed, and standardized as indicated (leaving 6461 knees with 86 features). Biclustering produced submatrices of the overall data matrix, representing similar observations across a subset of variables. Statistical validation was determined using the novel SigClust procedure. After identifying biclusters, relationships with key outcome measures were assessed, including progression of radiographic KOA, total knee arthroplasty, loss of joint space width, and worsening Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, over 96 months of follow-up. The final analytic set included 6461 knees from 3330 individuals (mean age 61 years, mean body mass index 28 kg/m2, 57% women and 86% White). We identified 6 mutually exclusive biclusters characterized by different feature profiles at baseline, particularly related to symptoms and function. Biclusters represented overall better (#1), similar (#2, 3, 6), and poorer (#4, 5) prognosis compared to the overall cohort of knees, respectively. In general, knees in biclusters #4 and 5 had more structural progression (based on Kellgren-Lawrence grade, total knee arthroplasty, and loss of joint space width) but tended to have an improvement in WOMAC pain scores over time. In contrast, knees in bicluster #1 had less incident and progressive KOA, fewer total knee arthroplasties, less loss of joint space width, and stable pain scores compared with the overall cohort. We identified six biclusters within the baseline OAI dataset which have varying relationships with key outcomes in KOA. Such biclusters represent potential phenotypes within the larger cohort and may suggest subgroups at greater or lesser risk of progression over time.

Extracorporeal Shockwave Therapy With a Modified Technique on Tendon and Ligament for Knee Osteoarthritis: A Randomized Controlled Trial.

There have been no definitive guidelines on the treatment method and specific points in the body. The aim of the study was to investigate the effects of extracorporeal shockwave therapy on treating the main tendons and ligaments of knee osteoarthritis. A total of 36 patients with knee osteoarthritis were enrolled in trial and organized into two groups: 3-wk extracorporeal shockwave therapy for the intervention group and 3-wk sham extracorporeal shockwave therapy for control group. Both groups received the same physical therapies: (1) transcutaneous electrical nerve stimulation, (2) magnetic field treatment, and (3) quadricep muscle strength training. Evaluation was performed before the start of treatment, at third week after the start of treatment, and 1 wk after the end of treatment. The study used randomized controlled trials (level of evidence, 1). Eextracorporeal shockwave therapy group had significant improvement in WOMAC pain score, physical function, and total score (mean difference = -2.8, P < 0.001; -5.1, P = 0.02; -8.3, P = 0.004, respectively), Visual Analog Scale score (mean difference = -2.3, P < 0.001), and the distance of 6-min walk test (mean difference = 28.7, P = 0.01) in the 1 wk after the end of treatment. Statistical significance in WOMAC pain, physical function, and total scores (mean difference = -3.0, P = 0.001; -5.6, P = 0.02; -9.3, P = 0.004, respectively) and Visual Analog Scale score (mean difference = -1.2, P = 0.027) was observed between the extracorporeal shockwave therapy group and control group. Extracorporeal shockwave therapy for the tendons and ligaments has clinical benefits for pain and physical function improvement in knee osteoarthritis. In addition, improvement in physical performance was observed in the short-term follow-up.

An Autologous Anti-Inflammatory Protein Solution Yielded a Favorable Safety Profile and Significant Pain Relief in an Open-Label Pilot Study of Patients with Osteoarthritis.

Osteoarthritis (OA) is a progressive and degenerative disease, which may result in significant pain and decreased quality of life. Recent updates in our understanding of OA have demonstrated that it is a whole joint disease that has many similarities to an unhealed wound containing inflammatory cytokines. The nSTRIDE Autologous Protein Solution (APS) Kit is a medical device under development for the treatment of OA. The APS Kit processes a patient's own blood at the point of care to contain high concentrations of anti-inflammatory cytokines and anabolic growth factors. This study assessed the safety and treatment effects of a single intra-articular injection of APS. Eleven patients were enrolled in this study. Sufficient blood could not be drawn from one patient who was subsequently withdrawn, leaving 10 patients treated. Minor adverse events (AEs) were experienced by seven subjects (63.6%). There was one serious AE (diverticulitis) unrelated to the device or procedure. One subject experienced AEs that were judged “likely” to be procedure related (arthralgia/musculoskeletal discomfort) and all resolved within 6 days of injection. All other AEs were unrelated to the device or procedure. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores improved significantly over time (ANOVA, p < 0.0001, 12.0 ± 1.2 preinjection, 3.3 ± 2.9 one year postinjection, and 72.5% WOMAC pain improvement). There was significant positive correlation between white blood cell concentration in APS and improvement in WOMAC pain scores.

Clinical Outcomes of Knee Osteoarthritis Treated With an Autologous Protein Solution Injection: A 1-Year Pilot Double-Blinded Randomized Controlled Trial

Background: Osteoarthritis (OA) is a debilitating disease resulting in substantial pain and functional limitations. A novel blood derivative has been developed to concentrate both growth factors and antagonists of inflammatory cytokines, with promising preliminary findings in terms of safety profile and clinical improvement. Purpose: To investigate if one intra-articular injection of autologous protein solution (APS) can reduce pain and improve function in patients affected by knee OA in a multicenter, randomized, double-blind, saline-controlled study. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Forty-six patients with unilateral knee OA (Kellgren-Lawrence 2 or 3) were randomized into the APS group (n = 31), which received a single ultrasound-guided injection of APS, and the saline (control) group (n = 15), which received a single saline injection. Patient-reported outcomes and adverse events were collected at 2 weeks and at 1, 3, 6, and 12 months through visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee injury and Osteoarthritis Outcome Score (KOOS), Short Form–36 (SF-36), Clinical Global Impression of Severity/Change (CGI-S/C), Patient Global Impression of Severity/Change (PGI-S/C), and Outcome Measures in Rheumatology–Osteoarthritis Research Society International (OMERACT-OARSI) responder rate. Imaging evaluation was also performed with radiograph and magnetic resonance imaging (MRI) before and after treatment (12 months and 3 and 12 months, respectively). Results: The safety profile was positive, with no significant differences in frequency and severity of adverse events between groups. The improvement from baseline to 2 weeks and to 1, 3, and 6 months was similar between treatments. At 12 months, improvement in WOMAC pain score was 65% in the APS group and 41% in the saline group (P = .02). There were no significant differences in VAS pain improvement between groups. At 12 months, APS group showed improved SF-36 Bodily Pain subscale (P = .0085) and Role Emotional Health subscale (P = .0410), as well as CGI-C values (P = .01) compared with saline control. Significant differences between groups were detected in change from baseline to 12 months in bone marrow lesion size as assessed on MRI and osteophytes in the central zone of the lateral femoral condyle, both in favor of the APS group (P = .041 and P = .032, respectively). There were no significant differences between APS and control groups in other measured secondary endpoints. Conclusion: This study provides evidence to support the safety and clinical improvement at 1-year follow-up of a single intra-articular injection of APS in patients affected by knee OA. Treatment with APS or a saline injection provided significant pain relief over the course of the study with differences becoming apparent at between 6 and 12 months after treatment. Trial Registration: NCT02138890 (ClinicalTrials.gov identifier)

White blood cell concentration correlates with increased concentrations of IL-1ra and improvement in WOMAC pain scores in an open-label safety study of autologous protein solution.

BackgroundThere has been debate on which blood components should be included in autologous therapies. Autologous Protein Solution (APS) is a unique blood-derived therapy composed of concentrated white blood cells, platelets, and plasma to contain high concentrations of anti-inflammatory cytokines and anabolic growth factors to potentially address osteoarthritis. The primary aim of the exploratory secondary analysis was to identify characteristics of an Autologous Protein Solution (APS) that may correlate with improved Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores and OMERACT-OARSI responder status after treatment of subjects with an intra-articular injection of APS.MethodsEleven subjects were enrolled in a pilot study of a single intra-articular injection of APS in subjects with knee osteoarthritis. Two APS kits were processed per patient. The output of the first APS kit was injected intra-articularly. White blood cell (WBC) and cytokine concentrations were measured from the output of the second APS kit. WOMAC surveys were completed at baseline and at follow up visits. Linear regression analyses were performed on the blood components of APS with subject outcomes. Anderson-Darling analysis was used to determine whether the cytokine concentrations in whole blood and APS had a normal distribution. Either paired t-test analyses or Wilcoxon signed-rank analyses were performed for normal and non-parametrically distributed data, respectively.ResultsThe WBC concentration in APS was significantly (p < 0.05) and strongly (R2 > 0.7) correlated with IL-1ra in APS but not significantly correlated with IL-1β. The ratio of IL-1ra to IL-1β in APS was significantly correlated with improved WOMAC pain scores one week and six months post-injection. 85.7 % of subjects whose APS had a IL-1ra:IL-1β ratio greater than 1000 or a WBC count greater than 30 k/μl were OMERACT-OARSI responders six months post-injection.ConclusionsThe correlations between the IL-1ra:IL-1β ratio and WBC concentration in a subject’s APS and their WOMAC pain scores and classification as OMERACT-OARSI responders suggest the potential utility of these characteristics as diagnostic markers. Additional studies are ongoing to determine whether APS is safe and effective and to further evaluate the relationship between APS composition and clinical outcomes.Trial Registration(NCT01773226)Electronic supplementary materialThe online version of this article (doi:10.1186/s40634-016-0043-7) contains supplementary material, which is available to authorized users.

Are bisphosphonates effective in the treatment of osteoarthritis pain? A meta-analysis and systematic review.

ObjectiveOsteoarthritis (OA) is the most common form of arthritis worldwide. Pain and reduced function are the main symptoms in this prevalent disease. There are currently no treatments for OA that modify disease progression; therefore analgesic drugs and joint replacement for larger joints are the standard of care. In light of several recent studies reporting the use of bisphosphonates for OA treatment, our work aimed to evaluate published literature to assess the effectiveness of bisphosphonates in OA treatment.MethodsLiterature databases were searched from inception to the 30th June 2012 for clinical trials of bisphosphonates to treat OA pain. Data was appraised and levels of evidence determined qualitatively using best evidence synthesis from the Cochrane Collaboration. The two largest studies were conducted with risedronate in the treatment of knee OA, for which meta-analyses were performed for pain and functional outcomes.ResultsOur searches found 13/297 eligible studies, which included a total of 3832 participants. The trials recruited participants with OA of the hand (n = 1), knee (n = 8), knee and spine (n = 3), or hip (n = 1). Our meta-analysis of the two largest knee studies using risedronate 15 mg showed odds ratios favouring placebo interventions for the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain (1.73), WOMAC function (2.03), and WOMAC stiffness (1.82). However, 8 trials (61.5%) reported that bisphosphonates improve pain assessed by VAS scores and 2 (38.5%) reported significant improvement in WOMAC pain scores compared to control groups.ConclusionsThere is limited evidence that bisphosphonates are effective in the treatment of OA pain. Limitations of the studies we analysed included the differences in duration of bisphosphonate use, the dose and route of administration and the lack of long-term data on OA joint structure modification post-bisphosphonate therapy. Future more targeted studies are required to appreciate the value of bisphosphonates in treating osteoarthritis pain.Trial RegistrationPROSPERO Register CRD42012002541

Alendronate treatment for hip osteoarthritis: prospective randomized 2-year trial

We examined the clinical efficacy of alendronate treatment for hip osteoarthritis using multiple outcome measures. Fifty patients with symptomatic hip osteoarthritis were enrolled in this prospective trial. The patients were randomly assigned to an alendronate group (35 mg/week alendronate and 600 mg/day calcium lactate) or a control group (600 mg/day calcium lactate) for 2 years. The groups were compared with regard to the following five parameters. The primary outcome measures are the following: (1) the Western Ontario and McMaster Universities (WOMAC) osteoarthritis pain score and the visual analog score (VAS). The secondary outcome measures are the following: (2) joint space width (JSW) measured on radiographs using a semiautomatic computer software, (3) the biochemical markers urinary N-telopeptide of type I collagen (NTX-I) and C-terminal cross-linking telopeptide of type II collagen (CTX-II), (4) dual-energy X-ray absorptiometry of the hip and lumbar spine, and (5) bone marrow edema on magnetic resonance images. The alendronate group showed pain improvement trends in VAS and WOMAC scores, whereas the control group showed worsening of pain. The alendronate group showed significant improvement in WOMAC pain scores after 12 months (p = 0.031) but no significant prevention of structural osteoarthritis progression, defined as a decrease in JSW >0.30 mm or conversion to total hip arthroplasty. There was significantly larger decrease in the biochemical markers and significantly increased bone density in the alendronate group. Alendronate treatment by standard dose for osteoporosis showed clinical efficacy for decreasing pain but failed to show preventive effects for structural progression of hip osteoarthritis.

AB0992 Knee lavage versus intra articular hyaluronan in advanced knee osteoarthritis

BackgroundMany patients with advanced knee osteoarthritis (OA) who are indicted for total knee joint replacement (TKR) are unfit for operation or refuse it for different reasons. Palliative treatment for this...

The effect of intra-articular hyaluronic acid treatment on gait velocity in older knee osteoarthritis patients: A randomized, controlled study

Purpose: To determine the effect of intra-articular hyaluronic acid (HA) on gait velocity, pain, and function, in older knee osteoarthritis (OA) patients. Materials and methods: Thirty knee OA patients (Kellgren–Lawrence II–III) [72.44 (±6.11) years old] were randomized, using the ‘RANDBETWEEN’ function in Microsoft Excel, to receive three weekly injections of HA (2ml of 20mg/ml HA), or placebo (P) (1.2ml of 0.001mg/ml HA), with fifteen participants per group. Patients and assessors were blind to treatment. Self-selected and fast gait velocities were measured with the GAITRite® system. Knee pain, stiffness, and physical function were measured with the Western Ontario McMaster Osteoarthritis OA index (WOMAC OA index). Data from 1 week, 3 and 6 months post-treatment were analyzed using repeated measures ANOVA. Results: The HA group significantly improved self-selected and fast gait velocity, while the P group only significantly improved self-selected gait velocity. Mean improvements in self-selected gait velocity [Mean (SD); 95% CI] [1.25 (52.4)cm/s; −18.38; 20.88] and fast gait velocity [7.16 (71.75)cm/s; −19.72; 34.04] were not significantly different between groups. Improvements in WOMAC pain scores were significantly greater in the HA group than the P group [−2.47 (6.39); −4.86; −0.08], while improvements in stiffness [−0.87 (2.42); −1.77; 0.04] and physical function [−7.23 (19.77); −14.63; 0.16] scores were not. Conclusions: The overall effect of HA on gait velocity in older knee OA patients was not significant compared to placebo. The preliminary results of improved fast gait velocity following HA treatment should be investigated further, along with the incidence of falls, in a larger sample of older knee OA patients.ClinicalTrials.gov ID: NCT00778076.

Comparison of glucosamine sulfate and a polyherbal supplement for the relief of osteoarthritis of the knee: a randomized controlled trial [ISRCTN25438351

BackgroundThe efficacy and safety of a dietary supplement derived from South American botanicals was compared to glucosamine sulfate in osteoarthritis subjects in a Mumbai-based multi-center, randomized, double-blind study.MethodsSubjects (n = 95) were screened and randomized to receive glucosamine sulfate (n = 47, 1500 mg/day) or reparagen (n = 48, 1800 mg/day), a polyherbal consisting of 300 mg of vincaria (Uncaria guianensis) and 1500 mg of RNI 249 (Lepidium meyenii) administered orally, twice daily. Primary efficacy variable was response rate based on a 20% improvement in WOMAC pain scores. Additional outcomes were WOMAC scores for pain, stiffness and function, visual analog score (VAS) for pain, with assessments at 1, 2, 4, 6 and 8 weeks. Tolerability, investigator and subject global assessments and rescue medication consumption (paracetamol) were measured together with safety assessments including vital signs and laboratory based assays.ResultsSubject randomization was effective: age, gender and disease status distribution was similar in both groups. The response rates (20% reduction in WOMAC pain) were substantial for both glucosamine (89%) and reparagen (94%) and supported by investigator and subject assessments. Using related criteria response rates to reparagen were favorable when compared to glucosamine. Compared to baseline both treatments showed significant benefits in WOMAC and VAS outcomes within one week (P < 0.05), with a similar, progressive improvement over the course of the 8 week treatment protocol (45–62% reduction in WOMAC or VAS scores). Tolerability was excellent, no serious adverse events were noted and safety parameters were unchanged. Rescue medication use was significantly lower in the reparagen group (p < 0.01) at each assessment period. Serum IGF-1 levels were unaltered by treatments.ConclusionBoth reparagen and glucosamine sulfate produced substantial improvements in pain, stiffness and function in subjects with osteoarthritis. Response rates were high and the safety profile was excellent, with significantly less rescue medication use with reparagen. Reparagen represents a new natural productive alternative in the management of joint health.Trial registrationCurrent Controlled Trials ISRCTN25438351.