WOMAC Physical Function Subscale Research Articles

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.

Efficacy, General Safety, and Joint Safety of Tanezumab in Japanese Patients with Osteoarthritis: Subgroup Analyses from Two Randomized, Phase 3 Studies.

IntroductionTanezumab is a monoclonal antibody against nerve growth factor that is under investigation for the treatment of osteoarthritis (OA) pain. We conducted subgroup analyses of two randomized phase 3 studies to summarize efficacy, general safety, and adjudicated joint safety of tanezumab in Japanese patients with moderate-to-severe OA.MethodsIn Study 1 (NCT02528188), patients received subcutaneous tanezumab 2.5 mg or 5 mg every 8 weeks or daily oral nonsteroidal anti-inflammatory drugs (NSAID) for 56 weeks. The co-primary efficacy endpoints were change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale score and WOMAC Physical Function subscale score at Week 16 (overall study and Japan-specific endpoints) as well as Patient Global Assessment (PGA)-OA score at Week 16 (overall study endpoint only). In Study 2 (NCT02709486), patients received subcutaneous tanezumab 2.5 mg, 5 mg, or placebo every 8 weeks for 24 weeks. Safety monitoring included adjudicated composite joint safety endpoint (CJSE) including rapidly progressive osteoarthritis type 1 (RPOA1), RPOA2, primary osteonecrosis, pathological fracture, or subchondral insufficiency fracture.ResultsFor Study 1, Japanese patients (n = 200) treated with tanezumab 2.5 mg and 5 mg showed numerically greater improvements in WOMAC Pain, WOMAC Physical Function, and PGA-OA scores versus NSAID at Week 16. Incidences of treatment-emergent adverse events were generally similar between tanezumab 2.5 mg, 5 mg, and NSAID groups. In the integrated safety analysis (Studies 1 + 2; n = 306), ten patients were adjudicated to have a component of CJSE: RPOA1 [tanezumab 2.5 mg (n = 2), tanezumab 5 mg (n = 5)], RPOA2 [tanezumab 2.5 mg (n = 1), tanezumab 5 mg (n = 1)], or primary osteonecrosis [tanezumab 2.5 mg (n = 1)]. Time-adjusted adjudicated rates of RPOA1 and RPOA2 were higher with tanezumab than NSAID or placebo and increased with dose of tanezumab.ConclusionObservations from the Japanese subgroup were generally consistent with the overall study populations.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40122-022-00384-y.

Effect of transcutaneous electrical nerve stimulation (TENS) on knee pain and physical function in patients with symptomatic knee osteoarthritis: the ETRELKA randomized clinical trial

To determine the effectiveness of TENS at relieving pain and improving physical function as compared to placebo TENS, and to determine its safety, in patients with knee osteoarthritis. Multi-centre, parallel, 1:1 randomized, double-blind, placebo-controlled clinical trial conducted in six outpatient clinics in Switzerland. We included 220 participants with knee osteoarthritis recruited between October 15, 2012, and October 15, 2014. Patients were randomized to 3 weeks of treatment with TENS (n=108) or placebo TENS (n=112). Our pre-specified primary endpoint was knee pain at the end of 3-weeks treatment assessed with the WOMAC pain subscale. Secondary outcome measures included WOMAC physical function subscale and safety outcomes. There was no difference between TENS and placebo TENS in WOMAC pain at the end of treatment (mean difference-0.06; 95%CI -0.41 to 0.29; P=0.74), nor throughout the trial duration (P=0.98). Subgroup analyses did not indicate an interaction between patient/treatment characteristics and treatment effect on WOMAC pain at the end of treatment (P-interaction ≥0.22). The occurrence of adverse events was similar across groups, with 10.4% and 10.6% of patients reporting events in the TENS and placebo TENS groups, respectively (P=0.95). No relevant differences were observed in secondary outcomes. TENS does not improve knee osteoarthritis pain when compared to placebo TENS. Therapists should consider other potentially more effective treatment modalities to decrease knee osteoarthritis pain and facilitate strengthening and aerobic exercise. Our findings are conclusive and further trials comparing TENS and placebo TENS in this patient population are not necessary.

Nutraceutical supplements in management of pain and disability in osteoarthritis: a systematic review and meta-analysis of randomized clinical trials

This study designed to evaluate the effect of nutraceutical supplementation on pain intensity and physical function in patients with knee/hip OA. The MEDLINE, Web of Science, Cochrane Library, Scopus, EMBASE, Google Scholar, Science direct, and ProQuest in addition to SID, Magiran, and Iranmedex were searched up to March 2020. Records (n = 465) were screened via the PICOS criteria: participants were patients with hip or knee OA; intervention was different nutritional supplements; comparator was any comparator; the outcome was pain intensity (Visual analogue scale [VAS]) and physical function (Western Ontario and McMaster Universities Arthritis [WOMAC] index); study type was randomized controlled trials. The random effects model was used to pool the calculated effect sizes. The standardized mean difference (SMD) of the outcome changes was considered as the effect size. The random effects model was used to combine the effect sizes. Heterogeneity between studies was assessed by Cochran's (Q) and I2 statistics. A total of 42 RCTs were involved in the meta-analysis. Nutritional supplementation were found to improve total WOMAC index (SMD = − 0.23, 95% CI − 0.37 to − 0.08), WOMAC pain (SMD = − 0.36, 95% CI − 0.62 to − 0.10) and WOMAC stiffness (SMD = − 0.47, 95% CI − 0.71 to − 0.23) subscales and VAS (SMD = − 0.79, 95% CI − 1.05 to − 0.05). Results of subgroup analysis according to the supplementation duration showed that the pooled effect size in studies with < 10 months, 10–20 months and > 20 months supplementation duration were 0.05, 0.27, and 0.36, respectively for WOMAC total score, 0.14, 0.55 and 0.05, respectively for WOAMC pain subscale, 0.59, 0.47 and 0.41, respectively for WOMAC stiffness subscale, 0.05, 0.57 and 0.53, respectively for WOMAC physical function subscale and 0.65, 0.99 and 0.12, respectively for VAS pain. The result suggested that nutraceutical supplementation of patients with knee/hip OA may lead to an improvement in pain intensity and physical function.

Measures of Adult Knee Function.

Measures of Adult Knee Function.

Lower serum levels of alpha tocopherol and lycopene are associated with higher pain and physical disability in subjects with primary knee osteoarthritis: A case-control study.

Background: We aimed to determine dietary intake and serum concentration of α-tocopherol and lycopene in subjects with knee osteoarthritis (KOA) in relation to pain intensity and functional status and comparing them with healthy controls. Methods: This case-control study was conducted among 35 patients with primary KOA and 35 matched healthy subjects selected using convenience sampling method. Dietary intakes of alpha-tocopherol and lycopene were estimated from 24-hour dietary records. Visual Analogue Scale (VAS) and Western Ontario and McMaster (WOMAC) index were used to assess the pain and functional status, respectively. Results: Serum concentrations of alpha-tocopherol (0.024±0.005 vs. 0.028±0.007μmol/ml, p-value= 0.021) and lycopene (0.616±0.191 vs. 0.727±0.159μmol/l, p-value=0.011) were significantly lower in OA patients in comparison with healthy controls. Dietary intake of alpha-tocopherol was negatively associated with total WOMAC score (r=-0.401, p-value=0.021) and pain (r=-0.356, p-value=0.042) and physical function (r=-0.355, p-value=0.043) subscales. Dietary intake of lycopene was negatively associated with total WOMAC score (r=-0.616, p-value<0.001) and pain (r=-0.348, p-value=0.047) and physical function (r=-0.606, p-value<0.001) subscales. Additionally, serum concentration of alpha-tocopherol was negatively associated with total WOMAC score (r=-0.574, p-value<0.001) and physical function subscale (r=-0.571, p-value<0.001). Serum concentration of lycopene was negatively associated with total WOMAC score (r=-0.360, p-value=0.040) and physical function subscale (r=-0.350, p-value=0.046) Conclusion: Serum concentrations of α-tocopherol and lycopene were significantly lower in patients with KOA than in healthy controls. Significant negative association was detected between serum concentration and dietary intake of α-tocopherol and lycopene with functional disability in patients with KOA.

Effects of Resistance Exercise on Glycated Hemoglobin and Functional Performance in Older Patients with Comorbid Diabetes Mellitus and Knee Osteoarthritis: A Randomized Trial.

Type 2 diabetes mellitus (T2DM) is significantly associated with osteoarthritis (OA). This study investigated the effects of two resistance exercise approaches on glycated hemoglobin (HbA1c) level and function performance. Enrolled were 70 older patients with both T2DM and knee OA. The dynamic group performed resistance exercises with an elastic resistance band. The isometric group underwent isometric contraction exercises. After the 12-week intervention, a significant within-group improvement (all p < 0.001) was observed for the chair stand test (CST; 10.8%, vs. 7.1%), timed up and go (TUG) test (12.6% vs. 7.6%), Western Ontario and McMaster Universities Osteoarthritis (WOMAC) physical function subscale (62.3% vs. 36.1%), and overall WOMAC (54.5% vs. 34.5%) in the dynamic and isometric group, respectively. In addition, in terms of between-group differences, the dynamic group had significant improvements in CST (p = 0.011), TUG (p < 0.001), WOMAC physical function subscale (p = 0.033), and overall WOMAC (p = 0.036) scores compared with the isometric group. However, no significant change in HbA1c was observed in either group. In conclusion, the dynamic resistance exercise significantly improved muscle strength, dynamic balance, and physical function in this comorbid population; however, there was no notable difference in change in HbA1c among different resistance exercises.

Depression negatively affects patient-reported knee functional outcome after intraarticular hyaluronic acid injection among geriatric patients with knee osteoarthritis

PurposeIntraarticular hyaluronic acid injection (IAHA) is a popular treatment for knee osteoarthritis (OA). This study investigates whether depression, anxiety, and pain affect self-reported knee function in geriatric OA people who have received IAHA.MethodsThrough convenience sampling, 102 geriatric patients (mean age = 70.91 ± 7.19; 28 males) with knee OA who had undergone IAHA participated in this study. All participants self-reported depression using the Geriatric Depression Scale (GDS), anxiety using the State-Trait Anxiety Inventory (STAI), knee function using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and the International Knee Documentation Committee subjective knee evaluation form (IKDC), and pain severity using the Visual Analogue Scale (VAS). They completed the aforementioned questionnaires at baseline before injection and then again at 2-, 4-, and 6-month follow-ups.ResultsDepression was significantly associated with IKDC, WOMAC physical function subscale, and total WOMAC scores. Anxiety was only significantly associated with the WOMAC pain subscale score. Pain severity was significantly associated with IKDC, WOMAC stiffness subscale, WOMAC physical function subscale, and total WOMAC scores.ConclusionGiven that depression negatively affected patient-reported knee function among geriatric OA patients who had undergone IAHA, further attention should be paid to the depressive status of this population.

Characteristics of young and lower functioning patients following total knee arthroplasty: a retrospective study

BackgroundRates of total knee arthroplasty (TKA) procedures in younger, more medically complex patients have dramatically increased over the last several decades. No study has examined categorization of lower and higher functioning subgroups within the TKA patient population. Our study aimed to determine preoperative characteristics of younger patients who are lower functioning following TKA.MethodsPatients were categorized into higher and lower functioning subgroups defined using a median split of 1) postoperative Timed Up and Go (TUG) test times and 2) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscale scores. A split in age (65 years) was used to further classify patients into four categories: younger lower functioning, younger higher functioning, older lower functioning and older higher functioning. Measures from preoperative domains of health, psychological, physical performance and pain severity were examined for between-group differences.ResultsComparing mean values, the younger lower functioning subgroup using the TUG had significantly weaker knee extensor, slower gait speed, higher body mass index and greater pain compared to other subgroups. The younger lower functioning subgroup using the WOMAC physical function subscale demonstrated higher pain levels and Coping Strategies Questionnaire-Catastrophizing Subscale scores compared to the older lower functioning subgroup.ConclusionsPoorer preoperative physical performance and pain severity appear to have the largest influence on early postoperative TKA recovery in younger lower functioning patients relative to both younger and older higher functioning patients.

Increasing comorbidity is associated with worsening physical function and pain after primary total knee arthroplasty

BackgroundPrevious studies suggested that pre-operative comorbidity was a risk factor for worse outcomes after TKA. To our knowledge, studies have not examined whether postoperative changes in comorbidity impact pain and function outcomes longitudinally. Our objective was to examine if increasing comorbidity postoperatively is associated with worsening physical function and pain after primary total knee arthroplasty (TKA).MethodsWe performed a retrospective chart review of veterans who had completed Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Short Form-36 (SF36) surveys at regular intervals after primary TKA. Comorbidity was assessed using a variety of scales: validated Charlson comorbidity index score, and a novel Arthroplasty Comorbidity Severity Index score (Including medical index, local musculoskeletal index [including lower extremity and spine] and TKA-related index subscales; higher scores are worse ), at multiple time-points post-TKA. We used mixed model linear regression to examine the association of worsening comorbidity post-TKA with change in WOMAC and SF-36 scores in the subsequent follow-up periods, controlling for age, length of follow-up, and repeated observations.ResultsThe study cohort consisted of 124 patients with a mean age of 71.7 years (range 58.6–89.2, standard deviation (SD) 6.9) followed for a mean of 4.9 years post-operatively (range 1.3–11.4; SD 2.8). We found that post-operative worsening of the Charlson Index score was significantly associated with worsening SF-36 Physical Function (PF) (beta coefficient (ß) = -0.07; p < 0.0001), SF-36 Bodily Pain (BP) (ß = -0.06; p = 0.002), and WOMAC PF subscale (ß = 0.08; p < 0.001; higher scores are worse) scores, in the subsequent periods. Worsening novel medical index subscale scores were significantly associated with worsening SF-36 PF scores (ß = -0.03; p = 0.002), SF-36 BP (ß = -0.04; p < 0.001) and showed a non-significant trend for worse WOMAC PF scores (ß = 0.02; p = 0.11) subsequently. Local musculoskeletal index subscale scores were significantly associated with worsening SF-36 PF (ß = -0.05; p = 0.001), SF-36 BP (ß = -0.04; p = 0.03) and WOMAC PF (ß = 0.06; p = 0.01) subsequently. None of the novel index subscale scores were significantly associated with WOMAC pain scores. TKA complications, as assessed by TKA-related index subscale, were not significantly associated with SF-36 or WOMAC domain scores.ConclusionsIncreasing Charlson index as well as novel medical and local musculoskeletal index subscale scores (from novel Arthroplasty Comorbidity Severity Index) post-TKA correlated with subsequent worsening of physical function and pain outcomes post-TKA. Further studies should examine which comorbidity management could have the greatest impact on these outcomes.Electronic supplementary materialThe online version of this article (doi:10.1186/s12891-016-1261-y) contains supplementary material, which is available to authorized users.

Sensitivity to Change of a Computer Adaptive Testing Instrument for Outcome Measurement After Hip and Knee Arthroplasty and Periacetabular Osteotomy.

Study Design Clinical measurement study. Background Computer adaptive testing (CAT) methods may allow detection of change across the continuum of osteoarthritis (OA) care. Objective To evaluate the sensitivity to change of a self-report OA CAT instrument (OA-CAT) following surgery. Methods Core measures consisted of the 5-item OA-CAT function, pain, and disability scales; the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); the University of California at Los Angeles activity rating scale; and the Medical Outcomes Study 12-Item Short-Form Health Survey (SF-12), which were administered in 3 samples. Fifty-three patients with hip dysplasia completed the core measures, the Hip disability and Osteoarthritis Outcome Score physical function short form (HOOS-PS), and the Modified Harris Hip Score (MHHS) before periacetabular osteotomy, and at 6 months, 1 year, and 2 years after periacetabular osteotomy. The hip (n = 62) and knee (n = 66) arthroplasty samples completed core measures and the MHHS or the Knee Society's Knee Scoring System at baseline and at 3-month follow-up. Mean change, floor and ceiling effects (percent), and effect size were calculated. Results For osteotomy, the 6-month physical function effect sizes for the OA-CAT, WOMAC, HOOS-PS, MHHS, and SF-12 physical component summary scores were 0.66 (95% confidence interval [CI]: 0.08, 1.61), 0.78 (95% CI: 0.56, 1.10), 0.91 (95% CI: 0.70, 1.21), 0.64 (95% CI: 0.22, 1.07), and 0.87 (95% CI: 0.53, 1.38), respectively. Effect-size trends were all increased at 1 year, and most were level at 2 years. For hip arthroplasty, the OA-CAT, WOMAC, MHHS, and SF-12 effect sizes were 1.27 (95% CI: 0.88, 1.84), 1.50 (95% CI: 1.20, 1.80), 0.68 (95% CI: 0.35, 1.04), and 0.56 (95% CI: 0.29, 0.88), respectively. For knee arthroplasty, the OA-CAT, WOMAC, Knee Society Knee Scoring System, and SF-12 effect sizes were 0.81 (95% CI: 0.56, 1.14), 0.85 (95% CI: 0.61, 1.10), 0.09 (95% CI: -0.22, 0.40), and -0.01 (95% CI: -0.39, 0.31), respectively. The OA-CAT and SF-12 demonstrated smaller ceiling effects than the HOOS-PS and other instruments, especially at 1 and 2 years. Administration time was less for the OA-CAT than for the WOMAC physical function subscale. Conclusion The OA-CAT shows potential for outcome measurement after hip and knee surgery. Larger studies are needed to better understand relative performance. J Orthop Sports Phys Ther 2016;46(9):756-767. Epub 5 Aug 2016. doi:10.2519/jospt.2016.6442.

Efficacy and Safety of Duloxetine on Osteoarthritis Knee Pain: A Meta-Analysis of Randomized Controlled Trials.

The aim of this meta-analysis was to evaluate the efficacy and safety of duloxetine for management of osteoarthritis knee (OAK) pain. A systematic literature search of articles for management of OAK using duloxetine were performed in PubMed, EBSCO, EMBASE, ScienceDirect, MEDLINE, ClinicalTrials.gov, Google Scholar, and Cochrane Central Register of Controlled Trials from the available date of inception until the latest issue (October 2013). Potentially relevant randomized controlled trials (RCTs) regarding to comparison of efficacy and safety of duloxetine with placebo for managing OAK pain were included. Also, studies with specific data regarding to pain reductions and response rate, Patient Global Impression of Improvement (PGI-I), functional improvement, Western Ontario and McMaster Osteoarthritis Index (WOMAC), adverse events (AEs), treatment-emergent AEs (TEAEs), mortality were included and analyzed, and those with confounding conditions were excluded. Studies were assessed for quality using the Jadad five-point score for RCTs. Finally, a meta-analysis of all RCTs eligible for inclusion criteria was performed using Review Manager 5.1 meta-analysis software. Three RCTs that enrolled 1,011 patients were included in our meta-analysis. There were statistically significant differences between patients taking duloxetine and those taking placebo with regard to the reductions in pain intensity (992 patients, mean difference [MD] = -0.88, 95% confidence interval [CI] -1.11--0.65, P < 0.0001), a moderate improvement in pain intensity (>= 30% response rate; 989 patients, risk ratio [RR] = 1.49, 95% CI 1.31-1.70, P < 0.0001), a substantial improvement in pain intensity (>=50% response rate; 989 patients, RR = 1.69, 95% CI 1.27-2.25, P = 0.0004). Statistically significant differences in PGI-I (976 patients, MD = -0.47, 95% CI -0.63 to -0.30, P < 0.0001) and WOMAC-physical function subscale (977 patients, MD = -4.25, 95% CI -5.82 to -2.68, P < 0.0001) were observed. Similarly, more AEs, TEAEs, and discontinuations for any reason were associated with the use of duloxetine than with placebo (1,011 patients, RR = 2.15, 95% CI 1.48-3.11, P < 0.0001; 1,011 patients, RR = 1.32, 95% CI 1.16-1.49, P < 0.0001; 1,011 patients, RR = 1.43, 95% CI 1.14-1.78, P = 0.002, respectively). However, differences in serious AEs were not significantly statistically different. Moreover, no deaths occurred during these three studies. This analysis suggests duloxetine (60/120 mg quaque die (QD)), compared with placebo control, resulted in a greater reduction in pain, improved function and patient-rated impression of improvement, and acceptable adverse effects for the treatment of OAK pain after approximately 10-13 weeks of treatment.

Identification of serological profiles associated with total joint replacement in osteoarthritis patients

Purpose: 1. To identify patients who will progress to requiring total joint replacement (TJR) amongst a population with moderate-to severe-osteoarthritis (OA) by measuring tissue specific biomarkers in serum thus establishing a panel of prognostic biomarkers that may provide molecular insight into the mechanism and pathology of the progression of OA. 2. Investigate the effect of NSAIDs on the predictive and diagnostic serum profile. Methods: OA patients were randomly selected from clinical trials investigating the anti-NGF therapeutic antibody tanezumab. Serum samples from 240 patients who underwent a TJR (cases) and from 440 control OA patients who did not undergo TJR were used. Control group consisted of ∼2 patients per case matched on: age (<65 or ≥ 65 years), Kellgren-Lawrence (K-L) grade, gender, BMI category (<30 or ≥30 kg/m2), OA severity (severe if both WOMAC Pain and Physical function subscale scores were ≥7 and the Patient Global Assessment score was ≥4 (i.e. Poor or Very Poor), otherwise baseline OA severity was classified as not severe). On the average, the OA population was 62 years old, 80% K-L grade ≥3, females (68%), BMI ∼31 kg/m2, WOMAC pain score of 7. Serum samples were analyzed for bone (Total Osteocalcin, CTX-I, DKK1, SOST), cartilage (C2M, COMP, PIIANP), connective tissue (PINP, ICTP, C1M), synovial tissue (C3M), protease burden (MMP-9) as well as inflammation markers (IL6, hsCRP, VEGF). Classification and Regression Tree analysis was used to identify biomarker phenotypes. Results: For NSAID and non-NSAID users separately, biomarker phenotypes were identified at baseline for patients predisposed for TJR. At baseline, a biomarker combination for patients who used NSAIDs before start of tanezumab clinical trials identified 96% of patients who underwent a TJR and 61% of the patients who did not undergo a TJR. Identification of these biomarker phenotypes lowers the odds of a TJR by 14-fold as compared to not having knowledge of the biomarkers. For patients who did not use NSAIDs, 83% of patients who had a TJR and 63% of the patients who did not undergo a TJR, were identified which lowers the odds of a TJR by 3.6-fold. For patients who used NSAIDs continuously, 84% of patients who had a TJR and 77% of the patients who did not have a TJR, were identified which lowers the odds of a TJR by 4.7-fold. Conclusions: Serological biomarker profiles for predicting TJR were identified irrespective of NSAID use and may assist in identifying those patients whom will need a TJR. The profiles also suggest that NSAID use increases the importance of the role of bone metabolism in TJR pathology. The results need validation on other cohorts, and may finally provide value to patients and payers in selecting the most optimal treatment strategy for moderate-to-severe OA patients.

Identification of cut-points in commonly used hip osteoarthritis-related outcome measures that define the patient acceptable symptom state (PASS)

To determine patient acceptable symptom state (PASS) estimates in outcome measures commonly used in hip osteoarthritis (OA). Identification of cut-points on commonly used outcome measures associated with patient satisfaction with their current state of health. As part of a randomized controlled trial, 70 patients with a clinical diagnosis of hip OA undergoing a 9-session physiotherapy treatment program completed four physical performance measures and three self-report measures at 9 weeks and 1 year. Upon completion of treatment, patients assessed their current health status according to the PASS question. Cut-points were estimated using receiver operating characteristic curves (anchor-based method), based on the patient's response to the PASS question. At 9 weeks and 1 year, identified cut-points were, respectively, ≤10 and ≤11 for the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale; ≤35 and ≤40 on the WOMAC physical function subscale; ≥+5 and ≥+6 on the global rating of change score; ≤6.05 and ≤5.30 s for the timed-up-and-go; ≤28.3 and ≤24.9 for the 40-m self-paced walk test; ≥11 and ≥12 repetitions for the 30-s chair stand test; and ≥46 repetitions for the 20-cm step test. Initial target cut-points signaling patient satisfaction with their current symptom state following physiotherapy in patients with hip osteoarthritis were determined for seven outcome measures over 1 year.

Reproducibility, validity, and responsiveness of the hip outcome score in patients with end‐stage hip osteoarthritis

To evaluate reproducibility, validity, and responsiveness of the Hip Outcome Score (HOS) in patients with end-stage hip osteoarthritis. In a cohort of 157 consecutive patients (mean age 66 years; 79 women) undergoing total hip replacement, the HOS was tested for the following measurement properties: feasibility (percentage of evaluable questionnaires), reproducibility (intraclass correlation coefficient [ICC] and standard error of measurement [SEM]), construct validity (correlation with the Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC], Oxford Hip Score [OHS], Short Form 12 health survey, and University of California, Los Angeles activity scale), internal consistency (Cronbach's alpha), factorial validity (factor analysis), floor and ceiling effects, and internal and external responsiveness at 6 months after surgery (standardized response mean and change score correlations). Missing items occurred frequently. Five percent to 6% of the HOS activities of daily living (ADL) subscales and 20-32% of the sport subscales could not be scored. ICCs were 0.92 for both subscales. SEMs were 1.8 points (ADL subscale) and 2.3 points (sport subscale). Highest correlations were found with the OHS (r = 0.81 for ADL subscale and r = 0.58 for sport subscale) and the WOMAC physical function subscale (r = 0.83 for ADL subscale and r = 0.56 for sport subscale). Cronbach's alpha was 0.93 and 0.88 for the ADL and sport subscales, respectively. Neither unidimensionality of the subscales nor the 2-factor structure was supported by factor analysis. Both subscales showed good internal and external responsiveness. The HOS is reproducible and responsive when assessing patients with end-stage hip osteoarthritis in whom the items are relevant. However, based on the large proportion of missing data and the findings of the factor analysis, we cannot recommend this questionnaire for routine use in this target group.

Comparing the Lower Limb Tasks Questionnaire to the Western Ontario and McMaster Universities Osteoarthritis Index: Agreement, Responsiveness, and Convergence With Physical Performance for Knee Osteoarthritis Patients

ObjectiveTo compare the Lower Limb Tasks Questionnaire (LLTQ) with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in terms of agreement, responsiveness, and convergence. DesignCross-sectional with an exploratory repeated-measures subsample analysis. SettingCommunity-based seniors’ centers and arthritis clinics. ParticipantsIndividuals with symptomatic knee osteoarthritis (N=76) participated, with a subsample of 18 participants contributing to the pre- and postarthroplasty subanalysis. InterventionNot applicable. Main Outcome MeasuresBland and Altman plots of agreement with 95% limits of agreement, statistical responsiveness, and standardized response mean (SRM) were calculated for LLTQ and WOMAC subscales. Both t tests and Wilcoxon rank-sum tests were used to examine changes in pre- and postarthroplasty self-reported function, 50-ft walk speed, stair ascent/descent speed, and isometric quadriceps strength. ResultsThe agreement (bias) of the LLTQ activities of daily living (ADL) subscale when compared with the WOMAC physical function (PF) subscale was 1%±10% (mean ± SD), and the 95% limits of agreement were –19% to +22%. The statistical responsiveness of the WOMAC-PF and LLTQ ADL was 1.17 and –.63, respectively. The SRMs for these scales were .90 and –.61, respectively. The WOMAC-PF scores showed a notable improvement over the first 6 weeks postarthroplasty, while LLTQ ADL scores were unchanged. The objective measures of function were all significantly worse at 6 weeks. ConclusionsThe LLTQ demonstrated adequate agreement with the WOMAC and acceptable responsiveness for use in place of the WOMAC in nonspecialized clinics. The LLTQ may more accurately represent functional status after total knee arthroplasty, but further study in larger samples is recommended.

Civamide Cream 0.075% in Patients with Osteoarthritis of the Knee: A 12-Week Randomized Controlled Clinical Trial with a Longterm Extension

To evaluate the safety and efficacy of civamide cream 0.075% for the treatment of osteoarthritis (OA) of the knee. We conducted a 12-week, multicenter, randomized, double-blind study with a 52-week open-label extension. Patients with OA of the knee received either civamide cream 0.075% or a lower dose of civamide cream, 0.01%, as the control. The 3 co-primary endpoints in the double-blind study were the time-weighted average (TWA) of change from baseline to Day 84 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, the WOMAC physical function subscale, and the Subject Global Evaluation (SGE). In the 52-week open-label extension study, the Osteoarthritis Pain Score and SGE were assessed. A total of 695 patients were randomized to receive civamide cream 0.075% (n = 351) or civamide cream 0.01% (control; n = 344) in the double-blind study. Significance in favor of civamide cream 0.075% was achieved for the TWA for all 3 co-primary efficacy variables: WOMAC pain (p = 0.009), WOMAC physical function (p < 0.001), and SGE (p = 0.008); and at Day 84 for these 3 variables (p = 0.013, p < 0.001, and p = 0.049, respectively). These analyses accounted for significant baseline-by-treatment interactions. In the 52-week open-label extension, efficacy was maintained. Civamide cream 0.075% was well tolerated throughout the studies. These studies demonstrate the efficacy of civamide cream for up to 1 year of continuous use. Civamide cream, with its lack of systemic absorption, does not have the potential for serious systemic toxicity, in contrast to several other OA treatments.

Impact of Pain Reported During Isometric Quadriceps Muscle Strength Testing in People With Knee Pain: Data From the Osteoarthritis Initiative

Muscle force testing is one of the more common categories of diagnostic tests used in clinical practice. Clinicians have little evidence to guide interpretations of muscle force tests when pain is elicited during testing. The purpose of this study was to examine the construct validity of isometric quadriceps muscle strength tests by determining whether the relationship between maximal isometric quadriceps muscle strength and functional status was influenced by pain during isometric testing. A cross-sectional design was used. Data from the Osteoarthritis Initiative were used to identify 1,344 people with unilateral knee pain and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores of 1 or higher on the involved side. Measurements of maximal isometric quadriceps strength and ratings of pain during isometric testing were collected. Outcome variables were WOMAC physical function subscale, 20-m walk test, 400-m walk test, and a repeated chair stand test. Multiple regression models were used to determine whether pain during testing modified or confounded the relationship between strength and functional status. Pearson r correlations among the isometric quadriceps strength measures and the 4 outcome measures ranged from -.36 (95% confidence interval=-.41, -.31) for repeated chair stands to .36 (95% confidence interval=.31, .41) for the 20-m walk test. In the final analyses, neither effect modification nor confounding was found for the repeated chair stand test, the 20-m walk test, the 400-m walk test, or the WOMAC physical function subscale. Moderate or severe pain during testing was weakly associated with reduced strength, but mild pain was not. The disease spectrum was skewed toward mild or moderate symptoms, and the pain measurement scale used during muscle force testing was not ideal. Given that the spectrum of the sample was skewed toward mild or moderate symptoms and disease, the data suggest that isometric quadriceps muscle strength tests maintain their relationship with self-report or performance-based disability measures even when pain is elicited during testing.

Tramadol Hydrochloride Extended-Release Once-Daily in the Treatment of Osteoarthritis of the Knee and/or Hip: A Double-Blind, Randomized, Dose-Ranging Trial

This 12-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial evaluated tramadol ER (extended-release tramadol) in the management of osteoarthritis pain. Adults with knee and/or hip osteoarthritis and baseline pain intensity of ≥40 on a 100-mm visual analog scale (0 = no pain, 100 = extreme pain) received once-daily tramadol ER 100 mg (n = 201), 200 mg (n = 199), or 300 mg (n = 199), celecoxib 200 mg (n = 202; to test model sensitivity), or placebo (n = 200). Coprimary efficacy variables were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, WOMAC physical function subscale, and patient global assessment of disease activity. Tramadol ER 300 mg significantly improved patient global assessment scores compared with placebo (P ≤ 0.05), but not the other 2 coprimary efficacy variables. Tramadol ER 200 and 100 mg were not significantly different from placebo for the coprimary efficacy variables. Daily diary arthritis pain intensity scores improved significantly for tramadol ER 300 and 200 mg compared with placebo. WOMAC joint stiffness subscale, physician's global assessment, arthritis pain intensity in index and nonindex joints, and overall sleep quality scores improved significantly for tramadol ER 300 mg compared with placebo. Significant differences in efficacy between celecoxib and placebo validated the model sensitivity. Adverse events occurred more frequently with tramadol ER than placebo in the gastrointestinal (nausea, constipation, diarrhea) and central nervous (dizziness, headache) systems. In this study, tramadol ER 300 mg was effective in the management of moderate to severe painful osteoarthritis of the hip or knee. A large, increasing placebo response during the study may have contributed to the lack of statistical separation between tramadol ER 200 or 100 mg and placebo.

Improving physical activity and function in overweight and obese older adults with osteoarthritis of the knee: a feasibility study.

Osteoarthritis of the knee, a prevalent condition in older adults, can impact physical function and ability to perform physical activity. This randomized controlled trial examined the effects of a 6-month self-efficacy-based, individually delivered, lower-extremity exercise and fitness walking intervention with 6-month follow-up on physical activity and function. The 26 subjects were mostly older (M = 63.2 years, SD = 9.8), White (83%), obese (BMI M = 33.3, SD = 6.0) women (96%). Physical activity was measured by diaries. Physical function was measured by the 6-minute walk, Short Physical Performance Battery (SPPB), and WOMAC Physical Function subscale. Exercise self-efficacy was assessed by a questionnaire. Results showed significant increases in self-reported performance of lower-extremity exercise and participation in fitness walking distance in the 6-minute walk, and SPPB scores from baseline to 6-month follow-up with a trend for improvement in self-efficacy. Results suggest that the intervention was feasible, acceptable, and improved physical activity and function.