WOMAC Physical Function Scores Research Articles

A new prediction model for patient satisfaction after total knee arthroplasty and the roles of different scoring systems: a retrospective cohort study

BackgroundAlthough total knee arthroplasty (TKA) is an efficacious treatment for end-stage osteoarthritis, ~20% of patients are dissatisfied with the results. We determined which factors contribute to patient satisfaction and compared the various scoring systems before and after surgery.MethodsIn this retrospective cohort study, 545 patients were enrolled and evaluated preoperatively and 1 year postoperatively. Patient demographics, as well as scores for the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Short Form (SF)-12, and 1989 Knee Society Clinical Rating System (1989 KSS), were recorded preoperatively and postoperatively. The possible predictors were introduced into a prediction model. Scores for overall satisfaction and the 2011 Knee Society Score (2011 KSS) were also assessed after TKA to identify the accuracy and agreement of the systems.ResultsThere were 134 male patients and 411 female patients, with an overall prevalence of satisfaction of 83.7% 1 year after surgery. A history of surgery (p < 0.001) and the 1989 KSS and SF-12 were of the utmost importance in the prediction model, whereas the WOMAC score had a vital role postoperatively (change in WOMAC pain score, p < 0.001; change in WOMAC physical function score, p < 0.001; postoperative WOMAC pain score, p = 0.004). C-index of model was 0.898 > 0.70 (95% confidence interval (CI): 0.86-0.94). The Hosmer-Lemeshow test showed a p value of 0.586, and the AUC of external cohort was 0.953 (sensitivity=0.87, specificity=0.97). The agreement between the assessment of overall satisfaction and the 2011 KSS satisfaction assessment was general (Kappa=0.437 > 0.4, p < 0.001).ConclusionA history of surgery, the preoperative 1989 KSS, and the preoperative SF-12 influenced patient satisfaction after primary TKA. We recommend the WOMAC (particularly the pain subscale score) to reflect overall patient satisfaction postoperatively.

Effect of preoperative long-term opioid therapy on patient outcomes after total knee arthroplasty: an analysis of multicentre population-based administrative data

BackgroundUp to 40% of patients are receiving opioids at the time of total knee arthroplasty (TKA) in the United States despite evidence suggesting opioids are ineffective for pain associated with arthritis and have substantial risks. Our primary objective was to determine whether preoperative opioid users had worse knee pain and physical function outcomes 12 months after TKA than patients who were opioid-naive preoperatively; our secondary objective was to determine the prevalence of opioid use before and after TKA in Alberta, Canada.MethodsIn this retrospective analysis of population-based data, we identified adult patients who underwent TKA between 2013 and 2015 in Alberta. We used multivariable linear regression to examine the association between preoperative opioid use and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and physical function scores 12 months after TKA, adjusting for potentially confounding variables.ResultsOf the 1907 patients, 592 (31.0%) had at least 1 opioid dispensed before TKA, and 124 (6.5%) were classified as long-term opioid users. Long-term opioid users had worse adjusted WOMAC pain and physical function scores 12 months after TKA than patients who were opioid-naive preoperatively (pain score β = 7.7, 95% confidence interval [CI] 4.0 to 11.6; physical function score β = 7.8, 95% CI 4.0 to 11.6; p < 0.001 for both). The majority (89 ([71.8%]) of patients who were long-term opioid users preoperatively were dispensed opioids 180–360 days after TKA, compared to 158 (12.0%) patients who were opioid-naive preoperatively.ConclusionA substantial number of patients were dispensed opioids before and after TKA, and patients who received opioids preoperatively had worse adjusted pain and functional outcome scores 12 months after TKA than patients who were opioid-naive preoperatively. These results suggest that patients prescribed opioids preoperatively should be counselled judiciously regarding expected outcomes after TKA.

Physical Therapy Use, Costs, and Value for Latent Classes of Good vs Poor Outcome in Patients Who Catastrophize About Their Pain Prior to Knee Arthroplasty

ObjectiveTo examine use, costs, and value of physical therapy (PT) among subgroups. DesignWe conducted an observational study of data from a randomized trial of a pain coping skills intervention. Good and poor outcome subgroups were determined based on Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Pain and Physical Function scores. The use and costs of PT care as well as changes in WOMAC Pain and Physical Function scores over 4 time periods during a 1-year follow-up were reported. We compared the number of PT visits, total PT costs, and cost per 1-unit improvement in WOMAC scores for the 2 latent subgroups. SettingFive academic medical centers. ParticipantsPatients who catastrophized about their pain prior to knee arthroplasty (N=384). InterventionsPain coping skills training, arthritis education, and usual care. Main Outcome MeasuresThe WOMAC Pain Scale was the primary outcome. ResultsThe value of PT was lower and the cost of PT was higher for poor vs good outcome subgroups beginning 2 months after knee arthroplasty. For example, during the 2- to 6-month period, participants in the poor outcome subgroup incurred a PT cost of $5181.22 per 1-unit improvement in WOMAC Pain compared with $437.87 per 1-unit improvement in WOMAC Pain for the good outcome subgroup (P<.001). From the 6- to 12-month period, WOMAC scores worsened for the poor outcome subgroup, indicating no benefit from PT. ConclusionsPatients in 2 latent classes demonstrated clinically important differences in value of PT. Future research should identify rehabilitation-based interventions that reduce utilization and enhance effectiveness for patients at high risk for poor outcome.

The effect of oral low molecular weight liquid hyaluronic acid combination with glucosamine and chondroitin on knee osteoarthritis patients with mild knee pain: An 8-week randomized double-blind placebo-controlled trial.

Background:The popularity of dietary supplements for knee osteoarthritis (OA) management is on the rise; however, their effects are still debated.Methods:This study aimed to investigate the effect of an oral low molecular weight liquid hyaluronic acid supplement in the treatment of knee OA patients with mild knee pain (visual analogue scale [VAS] ≤ 3) in Taiwan population. This was a randomized, double-blind, placebo-controlled study. Forty-seven subjects were enrolled and randomly allocated to either the A+HA or the placebo groups. The subjects were required to drink a bottle contained 20 mL of A+HA or placebo daily throughout an 8-week study period. The efficacy was assessed by using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the 36-item Short Form Survey (SF-36).Results:At Week 8, significant reductions from baseline in the WOMAC pain (–2.6 ± 1.68, P < .0001), stiffness (–1.2 ± 1.50, P = .007), physical function (–5.8 ± 4.39, P < .0001), and total (–9.4 ± 5.82, P < .0001) scores were observed in the A+HA group but not in the placebo group. Significant differences in the mean change of WOMAC scores from baseline at Week 8 between groups were detected (P < .01). At Week 8, the A+HA group also showed significant improvements in SF-36 physical functioning (2.7 ± 3.10, P = .001) and bodily pain (0.7 ± 1.50, P < .05) domains. Although the A+HA group had a higher increase in the SF-36 total score than the placebo group but the difference was not statistically significant (2.1 ± 12.75 vs 0.3 ± 19.66, P = .12).Conclusions:Oral administration of low molecular weight liquid HA appeared to be effective for knee OA patients with mild knee pain (VAS ≤ 3) in the relief of knee OA symptoms, particularly in pain and physical function.Clinical Trial Registration: NCT04352322.

Bioavailable turmeric extract for knee osteoarthritis: a randomized, non-inferiority trial versus paracetamol

BackgroundTo compare the efficacy and safety of bioavailable turmeric extract versus paracetamol in patients with knee osteoarthritis (OA).MethodsIn this randomized, non-inferiority, controlled clinical study, patients of knee OA were randomized to receive bioavailable turmeric extract (BCM-95®) 500 mg capsule two times daily or paracetamol 650 mg tablet three times daily for 6 weeks. The primary outcome measure was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. The secondary outcome measures were WOMAC total, WOMAC stiffness, and WOMAC physical function scores. Responder analysis of individual patients at different levels (≥ 20%, ≥ 50%, and ≥ 70%) for WOMAC score was calculated. TNF alpha and CRP levels were evaluated and adverse events (AE) were also recorded.ResultsSeventy-one and seventy-three knee OA patients, respectively in bioavailable turmeric extract and paracetamol groups, completed the study. Non-inferiority (equivalence) test showed that WOMAC scores were equivalent in both the groups (p value < 0.05) in all the domains within the equivalence limit defined by effect size (Cohen’s d) of 0.5 whereas CRP and TNF-α were better reduced with turmeric extract than paracetamol. After 6 weeks of treatment, WOMAC total score, pain, stiffness, and function scores got a significant improvement of 23.59, 32.09, 28.5, and 20.25% respectively with turmeric extract. In the turmeric extract group, 18% of patients got more than 50% improvement and 3% of patients got more than 70% improvement in WOMAC pain and function/stiffness score and none of the patients in the paracetamol group met the criteria. CRP and TNF-α got significantly reduced (37.21 and 74.81% respectively) in the turmeric extract group. Adverse events reported were mild and comparatively less in the turmeric extract group (5.48%) than in the paracetamol group (12.68%).ConclusionThe results of the study suggest that bioavailable turmeric extract is as effective as paracetamol in reducing pain and other symptoms of knee osteoarthritis and found to be safe and more effective in reducing CRP and TNF-α.Trial registrationClinical Trials Registry – India CTRI/2017/02/007962. Registered on 27 February 2017

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.

Evaluation of the relationship between physical activity level and functional capacity, depression and quality of life in patients with knee osteoarthritis

Aim: The aim of this study was to investigate the effects of physical activity level on functional capacity, depression and quality of life in patients with knee osteoarthritis (OA).Materials and Methods: Seventy nine patients who were diagnosed with knee OA according to ACR (American College of Rheumatology) criteria who applied to Inonu University, Turgut Ozal Medical Center, Department of Physical Medicine and Rehabilitation, were included in the study. Radiological stage of knee osteoarthritis was evaluated according to the Kellgren Lawrence score. The patients were divided into two groups as Inadequate Activity Group (IAG) and Physically Active Group (PAG) according to their answers to the International Physical Activity Questionnaire (IPAQ-SF). Patients were evaluated using the ShortForm 36 (SF-36) questionnaire, the Beck Depression Inventory (BDI), and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).Results: WOMAC physical function scores were lower on PAG. The average BDI score of PAG was significantly lower than IAG. The average SF-36 scores in PAG were found to be significantly higher when compared with the IAG (p 0.05).Conclusion: Increased physical activity in patients with knee osteoarthritis; It has positive effects on functional capacity, depression and quality of life.

Platelet-Rich Plasma Combined With Hyaluronic Acid Improves Pain and Function Compared With Hyaluronic Acid Alone in Knee Osteoarthritis: A Systematic Review and Meta-analysis

To evaluate the efficacy of platelet-rich plasma (PRP) combined with hyaluronic acid (HA) injections versus HA injections alone for the management of knee osteoarthritis (OA). This study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Eligible randomized-controlled trials and observational studies directly comparing combined PRP-HA injections with HA injections alone were identified through a search of PubMed, Scopus, and Cochrane Central databases from inception to May 2020. A random effects model meta-analysis was conducted and the I2 statistic was used to assess for heterogeneity. Four studies comprising 377 patients (PRP-HA: 193, HA: 184) with knee OA ranging from I-IV Kellgren-Lawrence grading scale were included. The final follow-up was 12 months in 3 studies and 6 months in 1 study. Patients who received PRP combined with HA had significantly greater improvements compared with those injected with HA alone in terms of visual analog scale scores at 3-month (standardized mean difference [SMD] 1.13; 95% confidence interval [CI] 0.56-1.70; I2= 56.7%; P < .001), 6-month (SMD 1.08; 95% CI 0.54-1.62; I2= 67.9%; P < .001), and 12-month (SMD 1.13; 95% CI 0.74-1.52; I2= 0.0%; P < .001) and 12-month Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical functioning (SMD 0.91; 95% CI 0.65-1.17; I2= 0.0%; P < .001) and 12-month WOMAC stiffness (SMD 1.09; 95% CI 0.80-1.38; I2= 0.0%; P < .001) scores. No difference was identified in terms of 12-month WOMAC pain score (SMD 0.36; 95% CI -0.19 to 0.91; I2= 74.1%; P= .195). Symptomatic patients with knee OA who were injected with a combination of PRP and HA demonstrated greater improvement in pain and function compared with patients who received HA injections only, as assessed by 3-, 6-, and 12-month visual analog scale scores and 12-month WOMAC physical function and stiffness scores. This study provides encouraging evidence for the use of the combined PRP-HA injections in the management of symptomatic patients with knee OA. III (meta-analysis of randomized and non-randomized comparative trials).

Platelet-Rich Plasma Versus Hyaluronic Acid in the Treatment of Knee Osteoarthritis: A Meta-analysis of 26 Randomized Controlled Trials

To compare the effectiveness and safety of platelet-rich plasma (PRP) and hyaluronic acid (HA) in patients with adult knee osteoarthritis (KOA) and to explore the most effective and safe protocol by using a meta-analysis method. This study was based on Cochrane methodology for conducting a meta-analysis. Only randomized controlled trials with an experimental group that used PRP and a control group that received HA were eligible for this study. The participants were adults who had KOA. The outcome measures were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the visual analog scale (VAS), the EuroQol VAS, the International Knee Documentation Committee, the Tegner score, the Lequesne Scale, the Knee injury Osteoarthritis Outcome Score, satisfaction rate, and adverse events. Subgroup analyses was performed for patients with different doses, types, and times of PRP interventions and grades of OA. The Review Manager Database was used to analyze the included studies. Twenty-six randomized controlled trials involving 2430 patients were included. The WOMAC total scores, WOMAC physical function scores, and VAS scores of the PRP group were better than the those of the HA group at 3, 6, and 12 months. The PRP group had better WOMAC pain, WOMAC stiffness, EuroQol VAS, and International Knee Documentation Committee scores than the HA group at 6 and 12 months. There was no significant difference in adverse events between the 2 groups (relative risk 1.21, 95% confidence interval 0.95-1.54; P= .13). For the nonsurgical treatment of KOA, compared with HA, intra-articular injection of PRP could significantly reduce patients' early pain and improve function. There was no significant difference in adverse events between the 2 groups. PRP was more effective than HA in the treatment of KOA, and the safety of these 2 treatment options was comparable. Level I, meta-analysis of Level I RCTs.

The effects of platelet-rich plasma injection in knee and hip osteoarthritis: a meta-analysis of randomized controlled trials.

We conducted this updated meta-analysis to evaluate the effects of PRP in patients with knee or hip OA. PubMed, Embase, and Web of Science were searched to identify randomized controlled trials (RCTs) that compared the efficacy of PRP with other intra-articular injections. The outcomes of interest included Western Ontario and McMaster (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS), Visual Analog Scale (VAS), Harris Hip Score (HHS), and International Knee Documentation Committee (IKDC). Twenty-four RCTs with 21 at knee OA and three at hip OA were included in this meta-analysis. The PRP injections significantly improved the WOMAC score, VAS score, IKDC score, and HHS score as compared with comparators. The WOMAC pain, stiffness, and physical function scores were also significantly better in the PRP group than in the control group. Most of the evaluated parameters that favored PRP were observed in knee OA but not in hip OA, at short-term (at 1, 2, 3, 6, 12months) but not long-term follow-up (at 18months), in RCTs with low risk of bias. Intra-articular PRP injection provided better effects than other injections for OA patients, especially in knee OA patients, in terms of pain reduction and function improvement at short-term follow-up. Key Points • This updated meta-analysis, based on great sample size and high-quality studies, evaluates the effects of PRP in patients with knee or hip OA. • Intra-articular PRP injection provided better effects than other injections for OA patients. • Most of the evaluated parameters that favored PRP were observed in knee OA at short term (at 1, 2, 3, 6, 12months).

Effectiveness of a novel hydrolyzed collagen formulation in treating patients with symptomatic knee osteoarthritis: a multicentric retrospective clinical study.

Knee osteoarthritis (OA) is a musculoskeletal disorder that may have a heavy impact on the patients' quality of life. Intra-articular collagen injection may be a safe adjuvant. Recently, CHondroGrid (CG), a hydrolyzed (< 3 kDa) bovine collagen injectable formulation, has been placed on the market. The aim of this study was to investigate the safety and performance profile of CG. Patients affected by Kellgren Lawrence grade 1 to 4 knee OA and BMI < 30 were treated by administering three CG injections of 2 ml (4 mg) each (at 15 days and 45 days from the first one, respectively) and were followed up for six months after the last administration. Clinical records were retrospectively assessed to compare VAS, Lequesne and WOMAC total, pain, stiffness, and physical function scores collected at baseline and 15, 45, and 225 days after the first injection. At the last follow-up, 70 patients (37 men and 33 women, aged 57.1 ± 14.5 years) treated with CG showed a 50% reduction in their median Lequesne score, a 50% reduction in their VAS score at rest and moving, and a ≥ 50% reduction for all other scores under consideration. CG may be a safe and effective adjuvant in the treatment of symptomatic knee OA.

Clinical efficacy and safety of stem cell therapy for knee osteoarthritis: A meta-analysis.

Background:We performed a meta-analysis of the efficacy and safety of stem cell therapy as a clinical treatment of knee osteoarthritis. This meta-analysis is expected to provide evidence of the efficacy of stem cell therapy, which is currently controversial, as a conservative treatment for knee osteoarthritis.Methods:An online search for relevant articles was conducted in the PubMed, EMBASE, and Cochrane Library databases. The search terms were “stem cells” and “osteoarthritis.” We conducted a quality assessment of the included articles and extracted the following indicators: Visual Analogue Scale (VAS) score, Subjective International Knee Documentation Committee (IKDC) score, Western Ontario and McMaster Universities (WOMAC) subscales, and adverse events. The RevMan5.3 software was used for determining effect sizes.Results:Nine randomized controlled trials involving 339 patients were included. VAS score and IKDC score from baseline to 24 months were improved in the stem cell therapy group compared to those in the control group. However, no significant difference was observed between the 2 groups in IKDC score changes from baseline to 6 and 12 months, as well as in WOMAC-Pain, WOMAC-Stiffness, and WOMAC-Physical Function score changes at each visit point.Conclusion:Stem cell therapy is certainly superior to traditional treatments in the conservative treatment of KOA; it considerably reduces pain with no obvious additional side effects.

The relationship between urinary C-Telopeptide fragments of type II collagen, knee joint load, pain, and physical function in individuals with medial knee osteoarthritis

ObjectiveConsidering the osteoarthritis (OA) model that integrates the biological, mechanical, and structural components of the disease, the present study aimed to investigate the association between urinary C-Telopeptide fragments of type II collagen (uCTX-II), knee joint moments, pain, and physical function in individuals with medial knee OA. MethodsTwenty-five subjects radiographically diagnosed with knee OA were recruited. Participants were evaluated through three-dimensional gait analysis, uCTX-II level, the WOMAC pain and physical function scores, and the 40m walk test. The association between these variables was investigated using Pearson's product-moment correlation, followed by a hierarchical linear regression, controlled by OA severity and body mass index (BMI). ResultsNo relationship was found between uCTX-II level and knee moments. A significant correlation between uCTX-II level and pain, physical function, and the 40m walk test was found. The hierarchical linear regression controlling for OA severity and BMI showed that uCTX-II level explained 9% of the WOMAC pain score, 27% of the WOMAC physical function score, and 7% of the 40m walk test. ConclusionGreater uCTX-II level is associated with higher pain and reduced physical function and 40m walk test performance in individuals with medial knee OA.

Efficacy and Safety of Tongning Gel for Knee Osteoarthritis: A Multicentre, Randomized, Double-Blinded, Parallel, Placebo-Controlled, Clinical Trial.

Objective To evaluate the efficacy and safety of Tongning Gel (TNG) compared to placebo-controlled (PC) for knee osteoarthritis (KOA). Methods A multicentre, randomized, double-blinded, parallel, placebo-controlled, clinical trial was performed in 576 patients (432 patients in the TNG group, 144 patients in the PC group), and 1 in the experimental group withdrew due to nonuse of drug. Patients were randomized to receive TNG or PC applied to knee skin at 3g per time, 2 times per day, which lasted for 3 weeks. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score was used to evaluate the primary efficacy of TNG and WOMAC stiffness and physical function and total scores were used to evaluate the secondary efficacy of TNG. All participants who received at least one dose of study drug were included in the safety analysis. This trial has been registered in Chinese Clinical Trial Registry (no. CTR20131276). Results Primary efficiency outcome: there were significant differences in the decreased value of WOMAC pain score between two groups (P < 0.05), and the decreased value of WOMAC pain score in the TNG group were better than those in the PC group (P < 0.05). Secondary efficiency outcome: the WOMAC total score, WOMAC stiffness score, WOMAC physical function score, and the decrease of the above indexes of the two groups of patients after treatment were statistically significant (P < 0.05), and the improvement of the above indexes in the TNG group was better than that of the PC group (P < 0.05). Safety Evaluation. A total of 42 adverse events were reported by 29 patients: 25 adverse events reported by 16 patients (3.71%) in the experimental group and 17 adverse events were reported by 13 patients (9.03%) in the control group. And 8 adverse reactions were reported by 6 patients including 2 adverse reactions by 2 patients (0.46%) in the experimental group and 6 adverse reactions by 4 patients (2.78%) in the control group. Two cases of significant adverse events occurred in the experimental group. Both groups had one serious adverse event, respectively, which were not relevant to the intervention. Conclusion These results of the trial demonstrate that TNG is superior to placebo in the treatment of patients with KOA, and TNG can improve other symptoms of KOA, such as stiffness and physical function. TNG is safe for the treatment of knee osteoarthritis as a whole.

Efficacy and tolerability of duloxetine in patients with knee osteoarthritis: a meta-analysis of randomised controlled trials.

Knee osteoarthritis (OA) is one of the most common joint diseases, and pharmacotherapy is necessary to control its symptoms. To evaluate efficacy and tolerability of duloxetine in patients with knee OA. PubMed, Web of Science, Embase, Cochrane Library and ClinicalTrials.gov were searched to identify randomised controlled trials comparing duloxetine with placebo for knee OA. Data including pain, stiffness, physical function, and adverse events were extracted for meta-analysis. The protocol was prospectively registered in PROSPERO (CRD42018097110). Data from six randomised controlled trials including 2059 participants were pooled. Duloxetine achieved significant reductions in primary outcomes including Brief Pain Inventory 24-h average pain score (weighted mean difference (WMD) = -0.74, 95% confidence interval (CI) = -0.92 to -0.57), weekly mean of the 24-h average pain score (WMD = -0.76, 95% CI = -0.96 to -0.56), WOMAC stiffness score (WMD = -0.47, 95% CI = -0.60 to -0.34) and WOMAC physical function score (WMD = -4.44, 95% CI = -5.24 to -3.64). Furthermore, duloxetine demonstrated a higher number of treatment-emergent adverse events (risk ratio (RR) = 1.31, 95% CI = 1.20-1.44) and discontinuations (RR = 2.26, 95% CI = 1.63-3.12); however, no difference in serious adverse events (RR = 0.92, 95% CI = 0.40-2.11) was observed. Duloxetine is effective in the management of chronic pain and loss of physical function in knee OA with acceptable adverse events despite having no advantage in treating joint stiffness. Future trials should focus on determining the optimal treatment regimen.

Effect of Tanezumab on Joint Pain, Physical Function, and Patient Global Assessment of Osteoarthritis Among Patients With Osteoarthritis of the Hip or Knee

Patients with osteoarthritis (OA) may remain symptomatic with traditional OA treatments. To assess 2 subcutaneous tanezumab dosing regimens for OA. A randomized, double-blind, multicenter trial from January 2016 to May 14, 2018 (last patient visit). Patients enrolled were 18 years or older with hip or knee OA, inadequate response to OA analgesics, and no radiographic evidence of prespecified joint safety conditions. Patients received by subcutaneous administration either tanezumab, 2.5 mg, at day 1 and week 8 (n = 231); tanezumab, 2.5 mg at day 1 and 5 mg at week 8 (ie, tanezumab, 2.5/5 mg; n = 233); or placebo at day 1 and week 8 (n = 232). Co-primary end points were change from baseline to week 16 in Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Pain (0-10, no to extreme pain), WOMAC Physical Function (0-10, no to extreme difficulty), and patient global assessment of osteoarthritis (PGA-OA) (1-5, very good to very poor) scores. Among 698 patients randomized, 696 received 1 or more treatment doses (mean [SD] age, 60.8 [9.6] years; 65.1% women), and 582 (83.6%) completed the trial. From baseline to 16 weeks, mean WOMAC Pain scores decreased from 7.1 to 3.6 in the tanezumab, 2.5 mg, group; 7.3 to 3.6 in the tanezumab, 2.5/5 mg, group; and 7.3 to 4.4 in the placebo group (least squares mean differences [95% CI] vs placebo were -0.60 [-1.07 to -0.13; P = .01] for tanezumab, 2.5 mg, and -0.73 [-1.20 to -0.26; P = .002] for tanezumab, 2.5/5 mg). Mean WOMAC Physical Function scores decreased from 7.2 to 3.7 in the 2.5-mg group, 7.4 to 3.6 in the 2.5/5-mg group, and 7.4 to 4.5 with placebo (differences vs placebo, -0.66 [-1.14 to -0.19; P = .007] for tanezumab, 2.5 mg, and -0.89 [-1.37 to -0.42; P < .001] for tanezumab, 2.5/5 mg). Mean PGA-OA scores decreased from 3.4 to 2.4 in the 2.5-mg group, 3.5 to 2.4 in the 2.5/5-mg group, and 3.5 to 2.7 with placebo (differences vs placebo, -0.22 [-0.39 to -0.05; P = .01] for tanezumab, 2.5 mg, and -0.25 [-0.41 to -0.08; P = .004] for tanezumab, 2.5/5 mg). Rapidly progressive OA occurred only in tanezumab-treated patients (2.5 mg: n = 5, 2.2%; 2.5/5 mg: n = 1, 0.4%). The incidence of total joint replacements was 8 (3.5%), 16 (6.9%), and 4 (1.7%) in the tanezumab, 2.5 mg; tanezumab, 2.5/5 mg; and placebo groups, respectively. Among patients with moderate to severe OA of the knee or hip and inadequate response to standard analgesics, tanezumab, compared with placebo, resulted in statistically significant improvements in scores assessing pain and physical function, and in PGA-OA, although the improvements were modest and tanezumab-treated patients had more joint safety events and total joint replacements. Further research is needed to determine the clinical importance of these efficacy and adverse event findings. ClinicalTrials.gov Identifier: NCT02697773.

Minimal clinically important decline in physical function over one year: EPOSA study

BackgroundThe Australian/Canadian hand Osteoarthritis Index (AUSCAN) and the Western Ontario and McMaster Universities knee and hip Osteoarthritis Index (WOMAC) are the most commonly used clinical tools to manage and monitor osteoarthritis (OA). Few studies have as yet reported longitudinal changes in the AUSCAN index regarding the hand. While there are published data regarding WOMAC assessments of the hip and the knee, the two sites have always evaluated separately. The current study therefore sought to determine the minimal clinically important difference (MCID) in decline in the AUSCAN hand and WOMAC hip/knee physical function scores over 1 year using anchor-based and distribution-based methods.MethodsThe study analysed data collected by the European Project on Osteoarthritis, a prospective observational study investigating six adult cohorts with and without OA by evaluating changes in the AUSCAN and WOMAC physical function scores at baseline and 12–18 months later. Pain and stiffness scores, the performance-based grip strength and walking speed and health-related quality of life measures were used as the study’s anchors. Receiver operating characteristic curves and distribution-based methods were used to estimate the MCID in the AUSCAN and WOMAC physical function scores; only the data of those participants who possessed paired (baseline and follow up-measures) AUSCAN and WOMAC scores were included in the analysis.ResultsOut of the 1866 participants who were evaluated, 1842 had paired AUSCAN scores and 1845 had paired WOMAC scores. The changes in the AUSCAN physical function score correlated significantly with those in the AUSCAN pain score (r = 0.31). Anchor- and distribution-based approaches converged identifying 4 as the MCID for decline in the AUSCAN hand physical function. Changes in the WOMAC hip/knee physical function score were significantly correlated with changes in both the WOMAC pain score (r = 0.47) and the WOMAC stiffness score (r = 0.35). The different approaches converged identifying two as the MCID for decline in the WOMAC hip/knee physical function.ConclusionsThe most reliable MCID estimates of decline over 1 year in the AUSCAN hand and WOMAC hip/knee physical function scores were 4 and 2 points, respectively.

Clinical characteristics and disability in patients with knee osteoarthritis: real world experience from Bulgaria.

ObjectivesAlthough knee osteoarthritis (KOA) is a leading cause of impaired functioning among older adults globally, little is still known about the complex mechanisms of disability accumulation in these patients. The aim of the study was to analyze the clinical parameters of patients with KOA in a Bulgarian population and to determine which of these clinical characteristics define disability to the greatest extent.Material and methodsPatients aged 40–80 years with symptomatic KOA were included. The assessment tools for pain, clinical disease severity, and disability were the pain visual analogue scale (VAS) and disease-specific questionnaires: Algofunctional Index of Lequesne, Western Ontario and McMaster Universities OA Index (WOMAC), and the Health Assessment Questionnaire-Disability Index (HAQ-DI), respectively. Radiographs of the knees were obtained and graded according to the Kellgren-Lawrence (KL) system.ResultsOne hundred and thirty-two patients (81% women) participated in the study. The median values of VAS (mm), WOMAC, Lequesne, and HAQ-DI scores were 52, 37.5, 11, 0.88, respectively. Men had milder disease, resulting in lower VAS, WOMAC, Lequesne, and HAQ-DI scores and less structural damage compared to women (p < 0.05). WOMAC index correlated positively with age of the patients but not with duration of the complaints. Patients with severe and very severe pain did not differ in their HAQ-DI, disease severity and KL grading. WOMAC physical function score and Lequesne index were independent predictors for the HAQ-DI in patients with KOA.ConclusionsBulgarian patients with KOA had moderate disability which showed a strong relationship with physical function of WOMAC and disease severity. Multiple layers of causality coexist to determine the knee pain in Bulgarian patients with KOA.

The role of hip abductor strength on the frontal plane of gait in subjects with medial knee osteoarthritis.

This study aimed to investigate the relationship of hip abductor strength with external hip and knee adduction moments, pain and physical function, and trunk, pelvis, and hip kinematics in the frontal plane during walking in subjects with medial knee osteoarthritis. Twenty-five subjects with medial knee osteoarthritis were evaluated through an isokinetic strength test for hip abductor, three-dimensional gait analysis (kinetics and kinematics), and pain and physical function scores. Regression models were used to control the influence of other parameters such as pain, age, gender, severity, walking speed, mass, and height. No relationship was found of hip abductor strength with peak of external knee adduction moment and knee adduction angular impulse. Hip abductor strength explained 17% of contralateral pelvic drop and 21% of hip adduction angle. In addition, hip abductor strength explained 4% and 1% of the variance in the WOMAC physical function score and 40-m fast paced walk test, respectively. Considering the relationship of hip abductor strength with contralateral pelvic drop and hip adduction angle, specific exercises might improve physical function and lower limb dynamic alignment during gait.

The EQ-5D-5L Is Superior to the -3L Version in Measuring Health-related Quality of Life in Patients Awaiting THA or TKA

As a generic measure of health-related quality of life among patients awaiting THA or TKA, the three-level version of the EQ-5D (EQ-5D-3L), which has three response levels of severity (no problems, some problems, and extreme problems/unable) to five questions, is widely used. Previous studies indicated that the ceiling effect of the EQ-5D-3L limits its application. The five-level version of the EQ-5D (EQ-5D-5L) was developed to enhance the measurement properties of the tool by adding two levels: slight problems and severe problems. However, only a few small studies have compared the EQ-5D-3L and EQ-5D-5L in patients awaiting THA and TKA. The purpose of this study was to examine the performance of the EQ-5D-3L and EQ-5D-5L among patients awaiting THA or TKA in terms of (1) response patterns, (2) convergent construct validity, (3) known-group validity, and (4) informativity and discriminatory power. This is a retrospective analysis of the Alberta Bone and Joint Health Data Repository, which recorded information on all patients receiving hip or knee arthroplasties between April 2010 and March 2017 in Alberta, Canada (n = 37,377). Patients receiving THA or TKA and who completed the EQ-5D and WOMAC at baseline (presurgery) were included in this study (n = 24,766). The EQ-5D-3L was administered to all patients in 2010, and was gradually replaced by the EQ-5D-5L between 2013 and 2016; the EQ-5D-5L reached full application in all clinics by 2017.A propensity score was used to match patients 1:1 who completed either the EQ-5D-3L or EQ-5D-5L before surgery. Response patterns have been explored using ceiling and floor effects and distribution across severity levels of each dimension. Convergent construct validity was examined using Spearman's correlation (rho) against the WOMAC. Known-group validity was examined by gender, preoperative risk factors, mental health, obesity, and WOMAC physical function score. Informativity and discriminatory power were examined using the Shannon (H') and Shannon evenness (J') indices. A total of 3446 pairs of patients awaiting THA (55% women; mean age, 66 years) and 5428 pairs of patients awaiting TKA (59% women; mean age 67 years) were included in this analysis; the study group included all patients who were kept in the propensity score matching. Ceiling and floor effects were comparable and small (less than 0.5%) for both versions; the responses across severity levels for each dimension were more evenly distributed for the EQ-5D-5L. Convergent construct validity was stronger for the EQ-5D-5L as it consistently had stronger correlations with the WOMAC overall and domain scores than the EQ-5D-3L (rho(3L-THA), -0.77 to -0.31; rho(3L-TKA), -0.71 to -0.24; rho(5L-THA), -0.71 to -0.17; rho(5L-TKA), -0.64 to -0.17; all p values < 0.001). The hypotheses of known-group analyses were confirmed for both versions. The EQ-5D-5L demonstrated stronger informativity and discriminatory power than the EQ-5D-3L, particularly for the mobility dimension (THA, H'(5L/3L)=1.66/0.37, J'(5L/3L)=0.72/0.23; TKA, H'(5L/3L)=1.66/0.41, J'(5L/3L)=0.71/0.26). This study demonstrates the superior construct validity, and informativity and discriminatory power of the EQ-5D-5L compared with the EQ-5D-3L among patients awaiting THA or TKA. Compared with the three-level version, the five-level version of the EQ-5D differentiates between patients awaiting THA and TKA much better based on their mobility, which is a key health aspect or outcome in these patients. Our findings suggest that the EQ-5D-5L is more appropriate for this population.