WOMAC Physical Function Research Articles

Polyacrylamide gel versus hyaluronic acid for the treatment of knee osteoarthritis: a randomised controlled study.

To assess non-inferiority of intra-articular injectable polyacrylamide hydrogel (iPAAG) to hyaluronic acid (HA) on symptomatic benefit in individuals with knee osteoarthritis (OA). This randomised, controlled, multi-centre trial recruited adults with symptomatic and radiographic knee OA from 3 clinical rheumatology sites in Denmark; two private clinics and one public hospital department. Participants were randomised 1:1 to receive a single intra-articular 6 mL injection of either HA or iPAAG on an outpatient basis. Primary outcome was change from baseline in WOMAC pain subscale after 26 weeks. Secondary outcomes were changes from baseline in WOMAC stiffness and physical function subscales, patients' global assessment of disease impact, EuroQoL-5D-5L, and proportion of positive OMERACT-OARSI responders after 26 and 52 weeks. 239 adults were randomised: 120 to HA and 119 to iPAAG. For the primary outcome, the least squares mean changes in WOMAC pain were -14.8 (95% CI: -18.0 to -11.7) for HA and -18.5 (95% CI: -21.7 to -15.4) for iPAAG; group difference: 3.7 (95% CI: -0.7 to 8.1). The lower boundary of the 95% CI respected the pre-specified non-inferiority margin of 9 WOMAC pain points. No statistically significant differences were observed for the secondary outcomes. For HA, 9 participants (7.6%) reported 13 adverse device effects (ADEs). For iPAAG, 35 participants (28.9%) reported 41 ADEs. All ADEs were mild/moderate, with no serious ADEs reported. iPAAG was found to be as effective and safe as HA for treatment of knee OA symptoms for at least 1 year after a single injection.

Efficacy and Safety of Stempeucel in Osteoarthritis of the Knee: A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled Study

Background: Osteoarthritis is a chronic, progressive, and degenerative condition with limited therapy options. Recently, biologic therapies have been an evolving option for the management of osteoarthritis. Purpose: To assess whether allogenic mesenchymal stromal cells (MSCs) have the potential to improve functional parameters and induce cartilage regeneration in patients with osteoarthritis. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 146 patients with grade 2 and 3 osteoarthritis were randomized to either an MSC group or placebo group with a ratio of 1:1. There were 73 patients per group who received either a single intra-articular injection of bone marrow–derived MSCs (BMMSCs; 25 million cells) or placebo, followed by 20 mg per 2 mL of hyaluronic acid under ultrasound guidance. The primary endpoint was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score. The secondary endpoints were WOMAC subscores for pain, stiffness, and physical function; the visual analog scale score for pain; and magnetic resonance imaging findings using T2 mapping and cartilage volume. Results: Overall, 65 patients from the BMMSC group and 68 patients from the placebo group completed 12-month follow-up. The BMMSC group showed significant improvements in the WOMAC total score compared with the placebo group at 6 and 12 months (percentage change: −23.64% [95% CI, −32.88 to −14.40] at 6 months and −45.60% [95% CI, −55.97 to −35.23] at 12 months P < .001; percentage change, −44.3%). BMMSCs significantly improved WOMAC pain, stiffness, and physical function subscores as well as visual analog scale scores at 6 and 12 months (P < .001). T2 mapping showed that there was no worsening of deep cartilage in the medial femorotibial compartment of the knee in the BMMSC group at 12-month follow-up, whereas in the placebo group, there was significant and gradual worsening of cartilage (P < .001). Cartilage volume did not change significantly in the BMMSC group. There were 5 adverse events that were possibly/probably related to the study drug and consisted of injection-site swelling and pain, which improved within a few days. Conclusion: In this small randomized trial, BMMSCs proved to be safe and effective for the treatment of grade 2 and 3 osteoarthritis. The intervention was simple and easy to administer, provided sustained relief of pain and stiffness, improved physical function, and prevented worsening of cartilage quality for ≥12 months. Registration: CTRI/2018/09/015785 (National Institutes of Health and Clinical Trials Registry–India).

The impact of post-traumatic stress on the clinical outcome in a cohort of patients with knee osteoarthritis and knee arthroplasty: A prospective study

BackgroundKnee osteoarthritis (KOA) is one of the most common musculoskeletal disorders and commonly occurs in older adults, predominantly female populations. Both populations have intimate links with trauma-related stress. Therefore, we intended to evaluate the prevalence of post-traumatic stress disorder (PTSD), which arises from KOA and determine its effects on the postoperative results in patients undergoing total knee arthroplasty (TKA). MethodsThe patients who fulfilled the diagnosis of KOA from February 2018 to October 2020 were interviewed. Patients were interviewed by a senior psychiatrist about evaluating their overall experience during their most difficult or stressful situations. KOA patients who underwent TKA were further analyzed to investigate whether PTSD influences the postoperative results. The PTSD Checklist–Civilian Version (PCL-C) and Western Ontario McMaster Universities (WOMAC) Osteoarthritis Index were used to assess PTS symptoms and clinical outcomes after TKA, respectively. Results212 KOA patients completed this study with a mean follow-up of 16.7 months (7–36 months). The mean age was 62.5 ± 12.3 years, and 53.3% (113/212) were women. 64.6% of the sample (137/212) underwent TKA to relieve the symptoms of KOA. Patients with either PTS or PTSD tended to be younger (P < 0.05), female (P < 0.05) and undergo TKA (P < 0.05) than their counterparts. WOMAC-pain (P < 0.05), WOMAC-stiffness (P < 0.05), and WOMAC-physical function (P < 0.05) both before TKA and 6 months after TKA in the PTSD group is significantly higher compared to their counterparts. Logistic regression analysis showed that a history of OA-inducing trauma (adjusted OR = 2.0, 95% CI = 1.7–2.3, P = 0.003), posttraumatic KOA (adjusted OR = 1.7, 95% CI = 1.4–2.0, P < 0.001), and invasive treatment (adjusted OR = 2.0, 95% CI = 1.7–2.3, P = 0.032), were significantly associated with PTSD in KOA patients. ConclusionsPatients with KOA, especially those undergoing TKA, are associated with PTS symptoms and PTSD, indicating the need to evaluate it and offer care for them.

A Short Course of Celecoxib Prevents Heterotopic Ossification Following Cementless Total Hip Arthroplasty.

Heterotopic ossification (HO) is a common complication after total hip arthroplasty (THA) and can result in pain and loss of motion of the hip. This is the first study in the literature to determine if a short course of Celecoxib is effective in the prevention of HO in patients undergoing cementless THA. In this retrospective study of prospectively collected data, consecutive patients undergoing a primary cementless THA were reviewed at a 2-year follow-up. The Control group consisted of 104 hips that did not receive Celecoxib (Control group), while the 208 hips in the Celecoxib group received 100 mg twice daily for 10 days. Radiographs, patient-recorded outcome measures and range of motion (ROM) were evaluated. Overall, there was a significantly decreased incidence of HO in the Celecoxib group (18.7%) than in the Control group (31.7%) (p = 0.01). The odds that a patient developed HO using Celecoxib were 0.4965 times the odds that a patient developed HO without treatment. Clinically, the Celecoxib group demonstrated significantly greater improvement in their mean WOMAC stiffness (0.35 vs. 0.17, p = 0.02) and physical function scores (3.26 vs. 1.83, p = 0.03) compared to those in the Control group, but there was no difference in the ROM between the two groups. This study is the first to demonstrate that the lowest dose of Celecoxib for a short course of only 10 days is a simple and effective prophylactic treatment option that can significantly reduce the incidence of HO following cementless THA.

Examining the Relationships Among Treatment, Pain, and Physical Function in Patients with Osteoarthritis: A Mediation-Modeling Approach.

To better understand the relationships among treatment, pain, and physical function (PF). Data were collected from 2 published randomized trials of osteoarthritis patients received tanezumab or placebo. PF was measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) PF domain. Pain (WOMAC Pain domain) was a mediator of the effect of treatment on PF. A set of mediation models were investigated. Variables were treatment (tanezumab vs. placebo), WOMAC pain domain, and WOMAC PF domain. Cross-sectional mediation models were assessed separately at different weeks. Longitudinal mediation models used data from all weeks simultaneously. Results could identify a steady-state period. The cross-sectional and longitudinal mediation models showed stable indirect effect of treatment through pain on PF across time, indicating that a pseudo steady-state model was appropriate. Therefore, the longitudinal steady-state mediation models were used with all available data assuming relationships among variables in the model being the same at all time points; results showed that the indirect effect of the treatment on PF was 77.8% in Study 1 (NCT02697773) and 74.1% in Study 2 (NCT02709486), both P<0.0001, while the direct effect was 22.2% for Study 1 (P=0.0003) and 25.9% for Study 2 (P=0.0019). At least 75% of the treatment effect of tanezumab on physical functioning can be explained by the improvements in pain. However, tanezumab had an additional effect on physical functioning (~25%), which was independent of improvements in pain. Such independent effects are of considerable interest and require further research to determine their mechanisms.

Effect of Online Simulation-Based Education on Nurses' Knowledge and Skills Toward Electrocardiogram Interpretation

Background: Osteoarthritis (OA); a whole joint disorder is a most common and progressive disease that worsens with age. Synovitis and synovial effusion can play important role in early OA diagnosis and progression. Limited pharmacological interventions affecting synovial effusion are studied clinically in Indian population. Aim: This was a pilot, observational, single arm, open label study in real world set-up designed to evaluate the efficacy and safety of Mobileye® capsules containing sodium hyaluronate along with collagen and polysaccharides derived from rooster comb extract in subjects suffering from synovial effusion and knee pain of osteoarthritis. Materials and Method: The study was conducted on total 30 subjects at Outpatient Department (OPD) at three different sites under the supervision of medical doctor. All subjects consumed Mobileye® capsule orally twice daily for 3 months. Synovial effusion, VAS score, WOMAC score and safety parameters were assessed as scheduled. Results: Treatment with Mobileye® capsule showed significant and progressive improvement in all study related parameters. Baseline score vs. day 90 score (mean + SD) for synovial effusion, WOMAC pain score, WOMAC stiffness score, WOMAC physical function score, WOMAC total score and VAS score were 8.52+2.960 mm vs. 2.58+0.903 mm (p&lt;0.0001), 15.13+3.10 vs. 4.13+2.4 (p&lt;0.0001), 6.63+1.098 vs. 1.60+1.192 (p&lt;0.0001), 54.33+8.39 vs. 14.23+8.67 (p&lt;0.0001), 76.13+ 11 vs. 20.33+ 10.86 and 8.13 + 1.28 vs. 1.93+1.17 (p&lt;0.0001) respectively. No significant adverse events were reported. Conclusion: Oral intake of Mobileye® capsule is safe and effective intervention in reducing synovial effusion, pain, stiffness and in improving joint mobility. Keywords: Electrocardiogram interpretation, nurses' knowledge and skills, online simulation education.

Mobility and Hip Function Among Geriatric Patients With Displaced Neck of Femur Fractures Treated With Arthroplasty.

Neck of femur fractures result in impaired function for older people. Despite surgery, many patients experience a decrease in functional level and poorer health status after the injury. The objectives of this study were (1) to determine the short-term mobility and hip function of geriatric patients who underwent hip replacement surgery for a displaced neck of femur fracture in our local population and (2) to identify factors which affect the functional outcome of these patients. Patients aged 60years and above, who were admitted for neck of femur fracture from January 2017 to December 2020, and treated surgically with arthroplasty, were included. Information on patient demography, comorbidities, perioperative data, mobility, hip function and complications were retrospectively collected. Outcome measures used were independent ambulation and recovery of pre-fracture mobility at 1year after surgery while hip function was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total, pain, stiffness, and physical function scores. Factors associated with these outcomes were analyzed. 168 patients with a mean age of 75.2 (SD 8.4) years met the inclusion criteria. 32.1% of patients regained their pre-fracture mobility and 59.6% remained independent 1year after surgery. Logistic regression analysis identified age, gender, surgical procedure, and time to surgery as significant contributors to recovery of pre-fracture mobility. Older age and increasing requirement for postoperative ambulatory aid resulted in worse WOMAC total and physical function scores. No significant differences were observed in patient-reported hip function between those who had a total hip arthroplasty and those who had a hemiarthroplasty. Most geriatric patients with displaced neck of femur fractures did not regain pre-fracture mobility despite surgical treatment with arthroplasty.

Hyaluronic acid alone versus hyaluronic acid associated with adelmidrol for Intra-articular treatment of knee osteoarthritis: A long-term follow-up

Background: Hyaluronic acid (HA) has been used for many years for intra-articular treatment of knee osteoarthritis with satisfactory results. HA associated with Adelmidrol – an anti-neuroinflammatory compound – have been only recently introduced in orthopedic clinical practice with good preliminary results. Objective: To investigate whether HA associated with Adelmidrol provides better results than HA alone. Methods: Two cohorts of patients with moderate knee osteoarthritis were treated. Cohort 1 received 5 weekly intra-articular injections of HA during 2017 while Cohort 2, 4 weekly intra-articular injections of HA associated with Adelmidrol during 2018. The patients of the two Cohorts were assessed by WOMAC scale, SF-12 questionnaire and PGIC scale at 1 week (T0), 6 months (T1), 1 year (T2), and 2 years (T3) after the end of treatment. All the data were statistically analyzed. A p-value of &lt;0.05 was considered statistically significant. Results: According to the WOMAC Scale Cohort 1 had higher mean scores than Cohort 2 at each follow-up time, with a statistically significant difference between the two cohorts at T3 (p&lt;0.03) for all the WOMAC components, except for Stiffness. WOMAC Total mean score worsened statistically significantly only in Cohort 1, from T1 to T3 (T2 vs T1: p=0.0033; T3 vs T2: p=0.0007). The same happened for WOMAC Physical Function (T2 vs T1: p=0.0146; T3 vs T2: p=0.0046) and WOMAC Pain (T2 vs T1: p=0.0004; T3 vs T2: p=0.0002). WOMAC Stiffness worsened statistically significantly in Cohort 1 from T2 to T3 (T3 vs T2: p=0.0041), while in Cohort 2 no change on WOMAC scale was statistically significant at any time-point, for any components. The mean scores of the SF-12 questionnaire were better in Cohort 2 than in Cohort 1 at each follow-up time for both the Physical and the Mental components, with a statistically significant difference between the two groups for the latter, at T0 (p=0.0001). In both cohorts the mean score of the Physical component decreased from T0 to T3, but the difference was not statistically significant between the two groups (p=0.25). The mean score of the Mental component slightly increased in Cohort 1 and decreased in Cohort 2, without statistically significant differences between the two groups at any time-point. PGIC showed that Cohort 2 scored significantly better than Cohort 1 at T3 (p=0.0336). Conclusions: Overall, HA associated with Adelmidrol gave better long-term results than HA alone. KEY WORDS: Hyaluronic acid, Adelmidrol, Palmitoylethanolamide, Knee, Osteoarthritis, Synovitis, Mastocytes, Intra-articular injections, Visco-induction.

Outcome of Intra-articular Injection of Total Stromal Cells and Platelet-Rich Plasma in Primary Knee Osteoarthritis: A Randomized Clinical Trial.

Mesenchymal stem cell (MSC) therapy appeared promising in knee osteoarthritis (OA). We examined if a single intra-articular (IA) autologous total stromal cells (TSC) and platelet-rich plasma (PRP) injection improved knee pain, physical function, and articular cartilage thickness in knee OA. The study was performed in the physical medicine and rehabilitation department of Bangabandhu Shaikh Mujib Medical University, Dhaka, Bangladesh. Knee OAwasdiagnosed according to the American College of Rheumatology criteria and randomly assigned to treatment (received TSC and PRP) and control groups. Kallgreen-Lawrance (KL) scoring system was used to grade primary knee OA. The Visual Analogue Scale (VAS, 0-10 cm) for pain, WOMAC (Western Ontario and McMaster Universities Arthritis Index) for physical function, and medial femoral condylar cartilage (MFC) thickness (millimeters) under ultrasonogram (US) were documented and compared between groups before and after treatment. Statistical Package analyzed data for Social Scientists (SPSS 22.0; IBM Corp, Armonk, NY) was used for data analysis. Pre- and post-intervention outcomes were measured using the Wilcoxon-sign test, whereasMann-Whitney U-test calculated the difference between groups; a p-value <0.05 was considered statistically significant. Result:In the treatment group, 15 received IA-TSC and PRP preparation, and in the control group, 15 patientsreceived no injection, but quadricep muscle-strengtheningexercise. There was no significant difference betweengroups regarding VAS for pain, WOMAC physical function, and cartilage thickness before starting the treatment andtwo weeks after intervention. VAS for pain and WOMAC physical function scores improved profoundly in the treatment group after 12 and 24 weeks of intervention; the pain and physical function scores difference between groups was also significant. However, significant mean femoral cartilage thickness was not changed until the end of 24 weeks(U=175.00, p=0.009 two-tailed and U= 130.00, p=0.016 two-tailed, respectively, for right and left knee). Single TSC and PRP injection reduces knee pain and improves physical function and cartilage thickness in knee OA. While pain and physical function improvement happen earlier, cartilage thickness changetakes more time.

Association between ankle torque and performance-based tests, self-reported pain, and physical function in patients with knee osteoarthritis.

This study aimed to investigate the association between ankle torque and performance-based tests, self-reported pain, and physical function in patients with knee osteoarthritis (OA). The cross-sectional study was conducted with 39 individuals (24 females, 15 males; mean age: 57.3±6.2 years; range, 40 to 65 years) with knee OA between January 2014 and July 2015. Ankle torque was determined using an isokinetic dynamometer. The 40-m fast-paced walk test and a stair climb test were used to assess functional performance. Self-reported pain and physical function were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Pearson's correlation coefficients were calculated to test correlations between the dependent variables (40-m fast-paced walk test, stair climb test, WOMAC pain and physical function domains, sex, age, body mass index, and radiologic evidence of OA) and the independent variables (mean plantar flexor torque and dorsiflexor peak torque). A multiple linear regression analysis was applied to quantify the association between the dependent and independent variables. Dorsiflexor and plantar flexor peak torques in the concentric and eccentric modes were negatively correlated with the 40-m fast-paced walk and stair climb tests (r=-0.33 to -0.51, p≤0.05). A negative correlation was found between concentric plantar flexor torque and the WOMAC physical function score (r=-0.35, p=0.03). No correlation was found between ankle torques and the WOMAC pain score (p>0.05). The multiple linear regression analysis showed that the eccentric plantar flexor and dorsiflexor torques were significantly associated with the stair climb test (β=-0.001, 95% confidence interval [CI]: -0.001 to 0.000, p=0.03, and β=-0.002, 95% CI: -0.004 to 0.000, p=0.05, respectively). No significant associations were found between concentric plantar flexor and dorsiflexor torques and the stair climb test (p>0.05). No significant associations were found between the ankle torques and the 40-m fast-paced walk test and WOMAC physical function (p>0.05). Ankle torque plays an important role in functional performance. Thus, ankle torque deficit, especially eccentric plantar flexor and dorsiflexor torques, may exert a negative influence on stair climbing performance in patients with knee osteoarthritis.

Do Platelet-Rich Plasma Injections for Knee Osteoarthritis Work?

Recent evidence suggests a benefit in platelet-rich plasma injections (PRP) for the knee in the management of mild to moderate osteoarthritis (OA). There is a reported reduction in pain, stiffness, and improved function. However, there is very little level-one literature available that supports this practice and conclusively proves a benefitgained throughout the course. Three main randomized control trials (RCTs) conducted in North America are often referenced and cited to prove their efficacy. This study aimed to look at the outcomes of patients having undergone this treatment to determine if there was any benefit. This study aimed to determine if PRP injections administered in patients with knee OA over a six to eight-week time period demonstrated any benefit. The Western Ontario and McMaster Universities arthritis index (WOMAC) tool was used before each of the three PRP injections over the six to eight-week period, and six weeks after the final injection in 31 patients. Each injection was given spaced two to three weeks apart. The outcomes observed were pain, stiffness, and physical function, and the total WOMAC score was calculated. The third injection showed a reduction in total WOMAC score, pain, stiffness, and physical function by 16.36%, 16.37%, 5.12%, and 18.03%, respectively. However, all scores returned close to baseline at the sixth-weekfollow-up post treatment. Results showed a trend of reduction in the WOMAC score. However, they are overall indicative of a placebo effect from the injections. Further studies are neededto explore whether the grade of OA and patients' weight have a significant impact on the results.

Predicting Treatment Responses in Patients With Osteoarthritis: Results From Two Phase III Tanezumab Randomized Clinical Trials.

Prediction of treatment responses is essential to move forward translational science. Our question was to identify patient-based variables that predicted responses to treatments. We conducted secondary analyses on pooled data from two randomized phase III clinical trials (NCT02697773 and NCT02709486) conducted in participants with moderate to severe osteoarthritis randomized to subcutaneous placebo (n=514) or tanezumab 2.5 mg (n=514). We used gradient boosted regression trees to identify variables that predicted Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale scores at Week 16 and marginal plots to determine the directional relationship between each variable category and responses to placebo or tanezumab within the models. We also used Virtual Twins models to identify potential subgroups of response to the active treatment vs. placebo. We found that responses to placebo were predicted by baseline WOMAC Physical Function, baseline WOMAC Pain, the radiographic classification of the index joint, and the standard deviation of diary pain scores at baseline. In contrast, baseline WOMAC Pain along with failure of prior medications, duration of disease, and standard deviation of diary pain scores at baseline were predictive of tanezumab responses as expressed by the WOMAC Pain scores at Week 16. Those who responded to tanezumab vs. placebo were identified based on the radiographic classification of the index joint and either age or smoking status. These secondary-data analyses identified distinct and common patient-based variables to predict response to placebo or tanezumab. These findings will inform the design of future clinical trials, helping to move forward clinical pharmacology and translational science.

Efficacy and Safety of Naproxen Gel in Musculoskeletal Pain Management: A Prospective Cohort Study

Introduction: Naproxen is effective for various musculoskeletal conditions and has a longer half-life, making it a favourable choice for sustained relief. Additionally, there is a potential unmet need for guidelines on the usage of topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) in the Asia-Pacific region. A study on naproxen 10% gel aims to address this need and increase awareness of its therapeutic potential in the region. Aim: To assess the efficacy and safety of naproxen 10% gel in relieving pain associated with lower back, knee, cervical, synovitis, bursitis, muscle sprain, and tendinitis. Materials and Methods: This prospective, cohort, observational, open-label, single-arm, multicentric study was conducted at 458 centres in India, including Ahmedabad, Bengaluru, Chandigarh, Chennai, Delhi, Guwahati, Hyderabad, Indore, Jaipur, Kolkata, Lucknow, Meerut, Mumbai, Patna, and Pune, between February 2023 and May 2023. The data was collected from outpatient settings/clinics of orthopaedicians and clinicians who have been prescribing topical naproxen 10% gel to their patients. The study included patients aged 18 to 60 years of either sex who were suffering from back pain, muscle pain, sprains, frozen shoulder, arthritis, acute low back ache (non-specific), or pain. The data was captured during the scheduled follow-up visits planned by the treating clinician, with data recorded at 3, 5, 10, and 15 days. At the baseline visit, demographic details (age, sex, weight, height, body mass index, and symptoms), Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale score, pain intensity on movement score, Visual Analogue Scale (VAS), and overall pain score were obtained. Results: Out of 10,587 patients, 10,265 completed the present study. The majority of patients had lower back pain (n=3386, 32.99%) and knee pain (n=3184, 31.02%). The average pain intensity on movement score of patients with bursitis significantly decreased from the baseline to 15 days {mean change {95% Confidence Interval (CI)}: 6.04 (5.89, 6.20); p&lt;0.001}. Post-naproxen treatment, the average pain intensity, WOMAC pain score, VAS, and overall pain score significantly decreased from baseline to day 15 in patients with knee pain and lower back pain. A significant improvement in WOMAC, WOMAC pain (5.42 vs 17.98), WOMAC stiffness (1.49 vs 5.75), and WOMAC physical function score (18.93 vs 56.21) at day 15 was observed in patients with a muscle sprain. Adverse Events (AE) were reported in 173 (1.69%) patients overall, with dryness (n=125) being the most common, followed by erythema (n=20) and pruritus (n=17). Conclusion: Naproxen 10% gel is an effective topical treatment for lower back pain, knee pain, cervical pain, synovitis, bursitis, muscle sprain, and tendinitis. It could prove helpful in patients where the side-effects of oral NSAIDs are to be avoided.

Artificial intelligence-based volumetric analysis of muscle atrophy and fatty degeneration in patients with hip osteoarthritis and its correlation with health-related quality of life

PurposeArtificial intelligence (AI) technologies have enabled precise three-dimensional analysis of individual muscles on computed tomography (CT) or magnetic resonance images via automatic segmentation. This study aimed to perform three-dimensional assessments of pelvic and thigh muscle atrophy and fatty degeneration in patients with unilateral hip osteoarthritis using CT and to evaluate the correlation with health-related quality of life (HRQoL).MethodsThe study included one man and 43 women. Six muscle groups were segmented, and the muscle atrophy ratio was calculated volumetrically. The degree of fatty degeneration was defined as the difference between the mean CT values (Hounsfield units [HU]) of the healthy and affected sides. HRQoL was evaluated using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index and the Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ).ResultsThe mean muscle atrophy rate was 16.3%, and the mean degree of muscle fatty degeneration was 7.9 HU. Multivariate correlation analysis revealed that the WOMAC stiffness subscale was significantly related to fatty degeneration of the hamstrings, the WOMAC physical function subscale was significantly related to fatty degeneration of the iliopsoas muscle, and the JHEQ movement subscale was significantly related to fatty degeneration of the hip adductors.ConclusionWe found that fatty degeneration of the hamstrings, iliopsoas, and hip adductor muscles was significantly related to HRQoL in patients with hip osteoarthritis. These findings suggest that these muscles should be targeted during conservative rehabilitation for HOA and perioperative rehabilitation for THA.

The Effectiveness and Safety of Mesenchymal Stem Cells in the Treatment of Osteoarthritis: A Systematic Review and Meta-analysis of 28 Randomized Controlled Trials.

Objective To evaluate the effectiveness and safety of mesenchymal stem cells (MSCs) in the treatment of osteoarthritis (OA). Methods Chinese databases (such as CNKI and SinoMed) and English databases (such as PubMed and Embase) were searched to collect randomized controlled trials (RCTs) of MSCs in the treatment of OA. The retrieval time is from inception to October 10, 2021. The literature was strictly selected according to the inclusion and exclusion criteria, data was extracted, and the quality was evaluated. RevMan 5.3 software was used for meta-analysis. STATA was used to evaluate publication bias. The registration number of this systematic review and meta-analysis is CRD42021277145. Results A total of 28 RCTs involving 1494 participants were included. The primary outcomes showed that MSCs may reduce WOMAC pain and VAS at the 3rd-month follow-up [WOMAC pain: -3.81 (-6.95, -0.68), P = 0.02. VAS: -1.11 (-1.53, -0.68), P < 0.00001], and the effect lasts for at least 12 months [WOMAC pain: -4.29 (-7.12, -1.47), P = 0.003. VAS: -1.77 (-2.43, -1.12), P < 0.00001]. MSCs may also reduce WOMAC stiffness and physical function at the 6th-month follow-up [WOMAC stiffness: -1.12 (-2.09, -0.14), P = 0.03. WOMAC physical function: -4.40 (-6.84, -1.96), P = 0.0004], and the effect lasts for at least 12 months [WOMAC stiffness: -0.99 (-1.95, -0.03), P = 0.04. WOMAC physical function: -3.26 (-5.91, -0.61), P = 0.02]. The improvement of WOMAC pain, VAS, WOMAC stiffness, and WOMAC physical function may be clinically significant. Meanwhile, after the MSC injection, Lequesne had been reduced compared with the control group [-4.49 (-8.21, -0.77), P = 0.002]. For adverse events, there is no significant difference in the safety of MSC injection and the control group [1.20 (0.97, 1.48), P = 0.09]. The quality of WOMAC physical function and adverse events were moderate. Conclusion Based on current evidence, MSCs may be a safety therapy that have a good curative effect in the treatment of OA, the onset time is no later than 3 months, and the time to maintain the curative effect is no less than 12 months. However, these results should be generalized with caution due to the generally low quality of evidence and RCTs.

Safety and efficacy of adipose-derived mesenchymal stem cells for knee osteoarthritis: A systematic review and m-analysis.

This research aimed to study the safety and efficacy of adipose-derived mesenchymal stem cells (ADMSCs) for knee osteoarthritis (OA). We used six databases to search for records and then screened them for eligibility. In both randomized and non-randomized studies, the risk of bias was assessed. The data were then retrieved and used in single-arm and double-arm analyses using Comprehensive Meta-Analysis (CMA) Version 3.0 and RevMan Version 5.3, respectively. Based on the study's inclusion criteria, we included 15 studies with a total of 463 patients. According to our single-arm analyses, there was a significant improvement in quality of life (QOL) among the three dose subgroups (high, medium, and low doses), as measured by SF-36 scores after a year of follow-up [low dose: mean (M)=-23.99; 95% confidence interval (CI) [-31.49 to -16.49]; P&lt;0.001; medium dose: M=-15.96; 95% CI [-23.5 to-8.42]; P&lt;0.001; high dose: M=-19.31; 95% CI [-28.02 to -10.59], P&lt;0.001] and the knee injury and osteoarthritis outcome score (KOOS) QOL sub-score after six months following ADMSCs injection in the low-dose group (M=24.9; 95% CI [4.3 to 45.6]; P&lt;0.05). Moreover, after three months of follow-up, we detected significant pain reduction as measured by the numeric pain rating scale (NPRS), with no significant difference between the low and medium doses (low dose: M=-3.12; 95% CI [-5.09 to -1.14]; P&lt;0.01; medium dose; M=-2.17; 95% CI [-3.13 to -1.21]; P&lt;0.001). However, after a year, the results were no longer significant. Despite finding no significant difference between them after 6 and 12 months post-treatment in the Visual Analogue scale (VAS) scale and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score, double-arm analyses revealed significant pain reduction in the ADMSCs group over the control after 12 months as estimated by the WOMAC pain sub-score (mean difference (MD)=-1.85, 95% CI [-3.55, -0.15], P&lt;0.05). After six months, the low dosage group's knee functions and activity levels improved significantly, as determined by the WOMAC physical function and stiffness subscales (M=-23.79; 95% CI [-38.43 to -9.16]; P=0.001; M=-10.25; 95% CI [-17.31 to -2.59]; P&lt;0.01, respectively), as well as the KOOS scores after a year (P&lt;0.01 for all KOOS subscales). In the ADMSCs injections group, there were no serious adverse effects [event rate (ER)=0.11; 95% CI [0.03-0.3]; P=0.001]. In the present single-arm meta-analysis, ADMSCs were associated with significant reduction in pain and improvement in QOL and knee functions in patients with knee OA. However, double arm analyses did not confirm these positive findings, which may be returned to the small sample size of included patients. Therefore, to introduce ADMSCs into clinical practice and establish guidelines for their use, more randomized controlled clinical trials with large sample sizes and long-term follow-ups are needed.

Efficacy of Oxygen-Ozone Therapy and Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Meta-analysis and Systematic Review.

This systematic review and meta-analysis evaluated the effect of the intra-articular injection of platelet-rich plasma (PRP) and oxygen-ozone therapy and provided an evidence-based methodology to treat KOA. Databases, including Cochrane Library, PubMed, and EMBASE, were searched. The retrieval period was before 2021. Two reviewers performed the process of screening and data extraction. Mean differences were calculated [95% confidence interval (CI)] with an inverse-variance method and fixed effect model. Meta-analysis was performed using the latest version of STATA version 16. A total of 12 studies out of 769 articles were evaluated. The mean difference of visual analog scale score between ozone and control groups in the first month after injection was -0.02 (MD, -0.02; 95% CI: -0.32, 0.28; P < 0.05). Mean differences of WOMAC pain, stiffness, and physical function score between baseline and after PRP were -3.53 (MD: -3.53; 95% CI: -4.04, -3.02; P = 0.00), -0.60 (MD: -0.60; 95% CI: -4.0 - 0.864, -0.34; P = 0.00), and -5.96 (MD: -5.96; 95% CI: -7.83, -4.09; P = 0.00). Our results showed that to treat knee osteoarthritis, using PRP for a longer period of 6 - 12 months after the intervention shows better clinical results, while oxygen-ozone therapy has short-term results.

Customized Individually-Made and Conventional Total Knee Implants are associated with Similar Improvements in Patient-Reported Outcomes

Background Customized individually-made (CIM) implants aim to reproduce knee kinematics by restoring patient-specific anatomy. There is sparse data comparing outcomes of CIM implants with conventional implants. The purpose of this study was to compare short-term outcomes of total knee arthroplasty (TKA) performed with CIM versus off-the-shelf (OTS) implants. Methods We retrospectively compared clinical outcomes of 123 CIM TKAs with 282 concurrent, matched OTS TKAs performed at a single academic medical center by two high-volume arthroplasty surgeons. All CIM TKA were included. Perioperative outcomes evaluated included hospital length-of-stay (LOS), discharge disposition, and patient-reported outcome measures (PROMs) at baseline, 3 months, and 1 year. Student’s t-tests were used for continuous variables, and chi-squared tests were used for categorical variables. Results Baseline demographics were statistically similar between groups. CIM Baseline WOMAC Pain and Physical Function scores were statistically, but not clinically, better. There were no differences in LOS (CIM 2.19d vs. OTS 2.35d; p=0.30) or proportion discharged home (78.7% vs. 83.5%, p=0.26). There were no differences in WOMAC subscores or the KSS Functional Score at 3-month and 1-year follow-up. The CIM cohort had a statistically significant, but not clinically significant, higher KSS-Function score at 1-year (79.4 vs. 72.6, p=0.02), but the change from preoperative baseline was not significant between groups. Conclusions Compared to traditional TKA implants, CIM implants offered similar improvements and patient-reported outcome scores through the first postoperative year. Longer-term outcomes as well as cost-effectiveness of CIM implants should be studied.

Efficacy and safety of tanezumab, NSAIDs, and placebo in patients with moderate to severe hip or knee osteoarthritis and a history of depression, anxiety, or insomnia: post-hoc analysis of phase 3 trials

Objective: Treatment outcomes for chronic pain can be poor in patients with depression, anxiety, or insomnia. This analysis evaluated the efficacy and safety of subcutaneous tanezumab, nonsteroidal anti-inflammatory drugs (NSAIDs), and placebo in patients with osteoarthritis (OA) and a history of these conditions using data from three phase 3 studies. Methods: A post-hoc analysis of data from two pooled placebo-controlled studies and one NSAID-controlled study of subcutaneous tanezumab. All patients had moderate to severe knee or hip OA that was inadequately controlled with standard-of-care analgesics. Efficacy outcomes were least-squares mean change from baseline to Week 16 in Western Ontario McMaster Universities OA Index (WOMAC) Pain, WOMAC Physical Function, Patient’s global assessment of OA, and EQ-5D-5L scores. Results were summarized for patients with and without a history of depression, anxiety, or insomnia at baseline. Results: 1545 patients were treated in the pooled placebo-controlled studies (history of depression, 12%; anxiety, 8%; insomnia, 10%; any, 23%) and 2996 in the NSAID-controlled study (16%, 11%, 13%, 28%, respectively). In groups with positive histories, 38–80% took antidepressant or anxiolytic medications at baseline. Within treatments, largely similar improvements in efficacy outcomes were observed in patients with and without a history of depression, anxiety, or insomnia; the types of treatment-emergent adverse events were similar. Conclusions: Patients with OA and a history of depression, anxiety, or insomnia did not appear to experience reduced efficacy outcomes or an altered safety profile in response to tanezumab or NSAID treatment as compared with those without. NCT02697773; NCT02709486; NCT02528188

Intra-Articular Leukocyte-Rich Platelet-Rich Plasma versus Intra-Articular Hyaluronic Acid in the Treatment of Knee Osteoarthritis: A Meta-Analysis of 14 Randomized Controlled Trials.

(1) Background: To evaluate the clinical effects of leukocyte-rich platelet-rich plasma (LR-PRP) and hyaluronic acid (HA) injections in treating patients suffering from knee osteoarthritis (OA); (2) Methods: Randomized controlled trials (RCTs) were searched from PubMed, Web of Science, and Cochrane Library. Keywords were: platelet-rich plasma, LR-PRP, leukocyte-rich, hyaluronic acid, and knee osteoarthritis. The included RCTs were published between the 1st of November 2011 and the 3rd of February 2021. Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores, visual analog scale (VAS) scores, International Knee Documentation Committee (IKDC) scores, and adverse events were used as outcomes for evaluation; (3) Results: A total of 14 RCTs were enrolled. At 6 months, revealed that the LR-PRP group was better than the HA group in WOMAC total, pain, and physical function scores. At 12 months, the LR-PRP group was better than the HA group in WOMAC stiffness and physical function scores. There was no significant difference in adverse events; (4) Conclusion: LR-PRP injection showed no significant pain relief effect as compared with HA injection. However, LR-PRP demonstrated better overall outcomes as compared to HA in knee OA patients at the follow-up periods of 3, 6, and 12 months. LR-PRP injection may be recommended as a feasible option in treating patients with knee OA.