Superior responsiveness of the pain and function sections of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as compared to the Lequesne-Algofunctional Index in patients with osteoarthritis of the lower extremities

OBJECTIVE: To compare the responsiveness of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and a questionnaire format of the Lequesne-Algofunctional Index in patients with OA of the lower extremities. METHODS: Longitudinal analysis of the instruments' responsiveness [standardized response mean (SRM), effect size (ES)] in ambulatory patients undergoing hip or knee arthroplasty. RESULTS: At six months 36, and at one year 40 out of 43 patients undergoing hip (N=30) or knee arthroplasty (N=13) could be examined. Both responsiveness statistics revealed the same order of responsiveness. For both indices and for both locations, the pain sections were more responsive than the function sections. However, the WOMAC scales and the WOMAC global index (hip at 12 months: SRM=2.4; knee at 12 months: SRM=2.0 ) were more responsive than the comparable Lequesne sections and Lequesne index (hip at 12 months: SRM=2.1; knee at 12 months: SRM=1.5). CONCLUSIONS: Although our results are based on a German version using a self-report format, the WOMAC scales appear to be more responsive than the Lequesne index in patients with OA of the lower extremities.     

Does the hip powder of Rosa canina (rosehip) reduce pain in osteoarthritis patients?--a meta-analysis of randomized controlled trials

OBJECTIVE: Meta-analysis of randomized controlled trials (RCTs) - of a hip powder of Rosa canina (rosehip) preparation for symptomatic treatment of osteoarthritis (OA), in order to estimate the empirical efficacy as a pain reducing compound. METHOD: RCTs from systematic searches were included if they explicitly stated that OA patients were randomized to either rosehip or placebo. The primary outcome was reduction in pain calculated as effect size (ES), defined as the standardized mean difference (SMD). As secondary analysis the number of responders to therapy was analyzed as Odds Ratios (OR), and expressed as the Number Needed to Treat (NNT). Restricted Maximum Likelihood (REML) methods were applied for the meta-analyses using mixed effects models. RESULTS: The three studies (287 patients and a median trial-duration of 3 months) - all supported by the manufacturer (Hyben-Vital International) - showed a reduction in pain scores by rosehip powder (145 patients) compared to placebo (142 patients): ES of 0.37 [95% confidence interval (CI): 0.13-0.60], P=0.002. Test for homogeneity seemed to support that the efficacy was consistent across trials (I(2)=0%). Thus it seems reasonable to assume that the three studies were measuring the same overall effect. It seemed twice as likely that a patient allocated to rosehip powder would respond to therapy, compared to placebo (OR=2.19; P=0.0009); corresponding to a NNT of six (95% CI: 4-13) patients. CONCLUSIONS: Although based on a sparse amount of data, the results of the present meta-analysis indicate that rosehip powder does reduce pain; accordingly it may be of interest as a nutraceutical, although its efficacy and safety need evaluation and independent replication in a future large-scale/long-term trial.     

A 5-year randomized controlled, double-blind study of glycosaminoglycan polysulphuric acid complex (Rumalon) as a structure modifying therapy in osteoarthritis of the hip and knee

OBJECTIVE: To determine the structure (disease) modifying effect of a glycosaminoglycan polypeptide association complex (GP-C; Rumalon) in patients with knee and hip osteoarthritis (OA). METHODS: Double-blind, randomized, placebo-controlled five-year study. Primary assessment criterion was change in radiographic joint space width between baseline and follow-up at 5 years. Secondary outcome criteria included Lequesne algofunctional index (LAI), pain on passive motion and consumption of non-steroidal antiinflammatory drugs (NSAIDs). The patients received 10 courses of injections of placebo or GP-C 2 ml intramuscularly in 5 years (two courses each year). Each course included 15 injections administered twice weekly. RESULTS: There were 277 patients with knee OA and 117 patients with hip OA. Control and GP-C treated groups were comparable as to sex, age, duration of disease, body weight, X-ray stage and value of LAI at the baseline. Knee joint space at 5 years decreased 0.37+/-0.08 (mean+/-standard deviation) mm for GP-C and 0.42+/-0.08 mm for placebo groups (P=0.68). Hip joint space at 5 years decreased 0.21+/-0.08 mm for GP-C and 0.22+/-0.08 mm for placebo groups (P=0.53). In a subset of patients with hip OA, Kellgren-Lawrence> or =2 and JSW> or =1 mm, there was a trend in favor of GPC for lower joint space narrowing in 5 years (P=0.11). In addition, there were no statistical differences between the treatment groups in LAI, pain on passive motion and consumption of NSAIDs. Side-effects after GP-C (14.5%) were rare, mild and not more frequent than in the placebo group (15%). CONCLUSION: We were not able to demonstrate a structure modifying effect of GP-C in OA of the hip or knee. Radiographic progression of OA in both knee and hip OA was lower than expected in both study groups.     

Disability and quality of life of patients with knee or hip osteoarthritis in the primary care setting and factors associated with general practitioners' indication for prosthetic replacement within 1 year

OBJECTIVE: To assess disability and health-related quality of life (HRQoL) of patients with knee or hip OA in primary care and to determine factors associated with GPs' opinion that their patients will need prosthetic replacement within 1 year after the consultation. METHODS: Design: A cross-sectional national survey. Setting: Primary care in France. Participants: 1471 GPs and 4183 patients with hip or knee OA. Measures: Pain on an 11-point numeric scale (0-10), disability on the Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC) (1-100) and Lequesne index (0-24), and quality of life on the Medical Outcomes Study 36-item Short Form (MOS SF-36; 0-100). RESULTS: We analyzed records of 4121 patients (2540 knee, 1581 hip OA). Patients with knee or hip OA exhibited high and similar levels of pain (5.2+/-2.1 and 5.3+/-2.3) and disability (Lequesne score: 12.0+/-4.2 and 11.8+/-4.3; WOMAC score: 45.7+/-19.3 and 45.2+/-17.3) The decrease in HRQoL was similar for patients with either location of the disease. GPs more often considered that their patients with hip OA would need prosthetic replacement within 1 year (28.1%) than those with knee OA (15.8%). Most factors associated with GPs' opinion were identified for both locations of disease and were related to disability and pain levels. CONCLUSIONS: In the primary care setting, patients with knee or hip OA have similar, high disability levels and substantially low HRQoL. Patients' disability seems to play a central role in GPs' opinion of the need for their patients with either type of OA to undergo prosthetic replacement within 1 year.     

Modification of articular cartilage and subchondral bone pathology in an ovine meniscectomy model of osteoarthritis by avocado and soya unsaponifiables (ASU)

OBJECTIVE: To examine the effect of an oral preparation of avocado and soya unsaponifiables (ASU) on the development of joint pathology in an ovine model of osteoarthritis (OA), using computer-assisted histomorphometric methods. DESIGN: OA was induced in ovine knee joints by bilateral lateral meniscectomy (N=32). ASU (900 mg/weekday) was given orally to half the group (MenX+ASU), the remainder receiving placebo (MenX). Sixteen animals were used as non-operated controls (NOC). At 3 and 6 months post-meniscectomy, histological sections from the medial and lateral femoral condyles (MFC, LFC), tibial plateaux (MTP, LTP) and trochlear groove (TG) were prepared from all joints. Sections were scored using traditional histopathological scales, and computerized image analysis, measuring total cartilage area, uncalcified cartilage (UCC) and subchondral bone plate (SCP) thickness, and intensity of articular cartilage toluidine blue staining (mean greyscale intensity, black=255) as an index of proteoglycan (PG) content. RESULTS: Computerized image analysis showed significant histological differences not detectable by traditional scoring methods. ASU-treated animals at 6 months showed reduced loss of toluidine blue stain in the MTP (P=0.015) and LTP (P=0.001), and significantly greater staining in the TG than either placebo or NOC groups (P=0.011). UCC thickness increased after meniscectomy, but tended to be highest in ASU-treated animals, significantly so in the middle zone of the LFC (MenX+ASU: 1.03+/-0.21mm vs MenX: 0.79+/-0.14 mm, P=0.018; NOC: 0.77+/-0.17 mm). Lateral compartment SCP thickness increased post-meniscectomy but was increased significantly less in the inner zone of the LTP in ASU-treated sheep (MenX+ASU: 1.37+/-0. 23 mm vs MenX: 1.68+/-0.28 mm, P=0.033; NOC=1.22+/-0.33 mm). CONCLUSIONS: In this model ASU treatment following meniscectomy appeared to confer a subtle but statistically significant protective effect on articular cartilage. Although the drug failed to prevent focal cartilage lesions, characteristic of this model, histomorphometric analysis demonstrated greater PG content and UCC thickness in adjacent joint regions of ASU-treated animals. In addition, a statistically significant reduction of subchondral bone sclerosis was noted in the LTP region of the drug-treated group. An anabolic effect on chondrocytes, resulting in the stimulation of matrix production in regions distant to the insult, was also suggested by the data. These findings support other studies which have proposed that ASU may exhibit disease-modifying anti-OA activity.     

An optimal duration of daily wear for an insole with subtalar strapping in patients with varus deformity osteoarthritis of the knee

OBJECTIVE: To assess the optimal duration of daily wear for a laterally wedged insole with subtalar strapping in subjects with medial compartment osteoarthritis of the knee (knee OA). DESIGN: The setting was an outpatient clinic. Eighty-one patients with knee OA were prospectively randomized according to birth date and to either 2 weeks of treatment with a lateral wedge with subtalar strapping for less than 5 h (the short group), 5-10 h (the medium group) or greater than 10 h (the long group) each day, or to treatment with a subtalar strapping band without lateral wedge (the placebo group). Standing radiographs were used to analyze the femorotibial angle for each subject, both with and without their respective orthotic device. The remission scores of Lequesne index were compared among the four groups at the conclusion. RESULTS: The short (n=21), medium (n=20) and long (n=18) groups demonstrated a significant greater valgus correction of the femorotibial angle than the placebo group (n=22) (P<0.0001). The remission score was significantly improved in the medium group compared to the placebo (P=0.001) and long (P=0.001) groups. CONCLUSIONS: An optimal duration of insole with subtalar strapping wear for patients with varus deformity knee OA may be between 5 and 10 h each day.     

Reliability and validity of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index in Italian patients with osteoarthritis of the knee

OBJECTIVE: The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis (OA) Index is a tested questionnaire to assess symptoms and physical functional disability in patients with OA of the knee and the hip. We adapted the WOMAC for the Italian language and tested its metric properties in 304 patients with symptomatic OA of the knee. METHODS: Three hundred and four consecutive patients, attending 29 rheumatologic outpatient clinic in northern, central, and southern Italy, were asked to answer two disease-specific questionnaires (WOMAC and Lequesne algofunctional index) and one generic instrument (Medical Outcomes Study SF-36 Health Survey-MOS SF-36). A sample of 258 patients was readministered the WOMAC 7-10 days after the first visit and the structured interview, which also assessed demographic and other characteristics. Internal consistency was assessed using Cronbach's alpha, reliability using intraclass correlation coefficients (ICCs), and construct and discriminant validity using Spearman's correlations, Wilcoxon rank sum test, and Kruskal-Wallis test. RESULTS: All WOMAC subscales (pain, stiffness, and physical function) were internally consistent with Cronbach's coefficient alpha of 0.91, 0.81, and 0.84, respectively. Test-retest reliability was satisfactory with ICCs of 0.86, 0.68, and 0.89, respectively. In comparison with the SF-36, the expected correlations were found when comparing items measuring similar constructs, supporting the concepts of convergent construct validity. Very high correlations were also obtained between WOMAC scores and Lequesne OA algofunctional index. WOMAC physical function, but not WOMAC stiffness and pain subscales, was weakly associated with radiological OA severity (P=0.03). Also, WOMAC pain score was inversely correlated (P=0.01) with years of formal education. Examination of discriminant validity showed that the scores on the WOMAC and SF-36 followed hypothesized patterns: the WOMAC discriminated better among subjects with varying severity of knee problems, whereas the SF-36 discriminated better among subjects with varying levels of self-reported health status and comorbidity. CONCLUSION: The Italian version of WOMAC is a reliable and valid instrument for evaluating the severity of OA of the knee, with metric properties in agreement with the original, widely used version.     

Aceclofenac vs paracetamol in the management of symptomatic osteoarthritis of the knee: a double-blind 6-week randomized controlled trial

OBJECTIVE: To evaluate the efficacy and tolerability of aceclofenac, 200 mg/day, and paracetamol, 3000 mg/day, in the treatment of osteoarthritis (OA) of the knee. METHODS: This was a double-blind, parallel-group, multicentre clinical trial involving patients with symptomatic OA of the knee, conducted in Spain. Patients were randomly allocated to aceclofenac 100 mg twice daily (n=82) or paracetamol 1000 mg three times daily (n=86). Patients were assessed at baseline and 6 weeks. Primary efficacy measures were severity of pain (visual analogue scale, VAS), Lequesne OA knee index, and patient's and physician's global assessment of disease activity. Severity of knee pain at rest or walking, stiffness, knee swelling and tenderness, and assessment of health-related quality of life (Health Assessment Questionnaire, Western Ontario and McMaster Universities Osteoarthritis Index, and Short Form 36) were included as secondary endpoints. RESULTS: Both treatment groups showed significant improvement compared with their baseline values in the four primary endpoints. Mean between-treatment differences favoured aceclofenac over paracetamol on pain (VAS, 7.64 mm [95% confidence interval (CI), 0.44-14.85 mm]), Lequesne OA index (1.41 [95% CI, 0.45-2.36]), and patient's (0.33 [95% CI, 0.06-0.61]) and physician's (0.23 [95% CI, 0.01-0.47]) global assessments. Adverse events were similar for both drugs (paracetamol, 29% patients vs aceclofenac, 32%; P=0.71). Four patients withdrew in each group due to adverse events. Patients tended to prefer aceclofenac to paracetamol (P=0.001), and more treated with paracetamol withdrew from the study due to lack of efficacy (n=8 vs n=1, P=0.035, for paracetamol and aceclofenac, respectively). CONCLUSION: At 6 weeks, patients with symptomatic OA of the knee showed a greater improvement in pain and functional capacity with aceclofenac than paracetamol with no difference in tolerability.     

Efficacy and safety of a single intra-articular injection of non-animal stabilized hyaluronic acid (NASHA) in patients with osteoarthritis of the knee

OBJECTIVE: Non-animal stabilized hyaluronic acid (NASHA) is a novel hyaluronan (HA) preparation with a 4-week intra-articular half-life. This study compared the efficacy of a single injection of NASHA with placebo in patients with osteoarthritis (OA) of the knee. DESIGN: This was a 26-week randomized, double-blind, multicenter study of a single intra-articular knee injection with either NASHA or placebo (saline). Assessments included the Western Ontario McMasters Universities osteoarthritis index (WOMAC, Likert Scale) and patients' overall global disease status. A positive response was defined as a reduction in WOMAC pain score for the study knee of 40% from baseline with a minimum improvement of > or =5 points. RESULTS: A total of 346 (NASHA 172; placebo 174) patients were treated. WOMAC scores and quality of life were improved in both the NASHA and placebo groups. For the overall population, there were no statistically significant between-group differences in response rates for any efficacy parameters. In patients with OA confined to the knee (N=216), a greater response to NASHA than placebo was observed at week 6 (P=0.025). There were few treatment-related events. CONCLUSIONS: NASHA was not superior to placebo for the primary efficacy analysis. However, these data may be confounded by the inclusion of patients with OA at other sites, as significant benefits over placebo were found among patients with OA confined to the knee. Future trials of OA that examine a local therapy might need to consider restricting the study population to those patients having OA of only the signal joint.     

Influence of concomitant heeled footwear when wearing a lateral wedged insole for medial compartment osteoarthritis of the knee

OBJECTIVE: To compare the influence of concomitant heeled footwear when wearing a lateral wedged insole for medial compartment of osteoarthritis (OA) of the knee, between everyday walking shoes for outdoor use and socks or flat footwear without a heel for indoor use. DESIGN: A total of 227 outpatients were prospectively randomized and treated with a neutral wedged insole inserted into shoes (placebo with shoes; n=45), a wedged insole inserted into shoes (inserted insole with shoes; n=45), a sock-type ankle supporter with a wedged insole when wearing socks or flat footwear (inserted insole without shoes; n=46), a subtalar strapped insole when wearing shoes (strapped insole with shoes; n=45), and the strapped insole with socks or flat footwear (strapped insole without shoes; n=46). The Lequesne index of knee OA at week 12 was compared with the baseline in each treatment group. RESULTS: Twenty patients withdrew from the study, and the 207 patients who completed the 12-week study were evaluated. At the final assessment, participants wearing the inserted insole without shoes (P=0.003), the strapped insole with shoes (P<0.0001), and the strapped insole without shoes (P<0.0001) demonstrated significantly improved Lequesne index scores in comparison with their baseline assessments. No significant differences were found in the placebo (P=0.16) or the inserted insole with shoes (P=0.2) groups. CONCLUSION: Concomitant heeled footwear may decrease the efficacy of an inserted lateral wedged insole. The optimal usage of a lateral wedged insole for knee OA would be the combination with socks or flat footwear without heels.     

Self-reported prevalence of psoriasis and evaluation of the impact on the natural history of hip osteoarthritis: Results of a 10 years follow-up study of 507 patients (ECHODIAH study)

ObjectiveThe objective of the present study was to assess the frequency of self-reported psoriasis in a hip osteoarthritis (OA) cohort, and a secondary objective was to assess the course of hip OA with psoriasis.MethodsECHODIAH was a 3-year, randomised double-blind controlled trial evaluating diacerein vs. placebo in hip OA. During the 36 months of the trial, the Lequesne algofunctional index and pain visual analog scale (VAS) and joint space width (JSW) were assessed every 3 months. From month 36 to 120, the requirement for total hip replacement (THR) was collected annually via a phone call. At the end of 10 years of follow-up, the prevalence of self-reported psoriasis, family psoriasis was assessed by letter, retrospectively – (retrolective design).ResultsOf the 507 ECHODIAH patients, 279 were followed-up 10 years; 192 (68.8%) answered the psoriasis questionnaire. Twenty-two (11.4%) of 192 patients had self-reported psoriasis. Eighteen patients (9.4%) had family history of psoriasis. Eleven (50%) of 22 patients were diagnosed by a dermatologist. Baseline characteristics were similar between responders and non-responders, and between psoriasis and no psoriasis patients. The disease course was not different according to the presence of psoriasis, though total hip replacement was more frequent with psoriasis (77.2% after 10 years) than without (58.8%), no statistical difference (p = 0.10).ConclusionThe prevalence of self-reported psoriasis was high in this cohort, almost twice the frequency reported in the general population. The disease course was not modified by the presence of psoriasis. These data should be further confirmed.     

Relationship of limb length inequality with radiographic knee and hip osteoarthritis

OBJECTIVE: This study examined the relationship of limb length inequality (LLI) with radiographic hip and knee osteoarthritis (OA) in a large, community-based sample. METHODS: The total study group comprised 926 participants with radiographic knee OA, 796 with radiographic hip OA, and 210 (6.6%) with LLI >or=2cm. The presence of radiographic OA was defined as Kellgren/Lawrence (K/L) grade >or=2. Multiple logistic regression models were used to examine the relationship of LLI with hip and knee OA, while controlling for age, gender, race, body mass index, and history of hip or knee problems (joint injury, fracture, surgery, or congenital anomalies). RESULTS: In unadjusted analyses, participants with LLI were more likely than those without LLI to have radiographic knee OA (45.1% vs 28.3%, P<0.001) and radiographic hip OA (35.2% vs 28.7%, P=0.063). In multiple logistic regression models, knee OA was significantly associated with presence of LLI (adjusted Odds Ratio [aOR]=1.80, 95% Confidence Interval [95% CI] 1.29-2.52), but there was no significant relationship between hip OA and LLI (aOR=1.20, 95% CI 0.86-1.67). Among participants with LLI, right hip OA was more common when the contralateral limb was longer than when the ipsilateral limb was longer (30.3% vs 17.5%, P=0.070). CONCLUSION: LLI was associated with radiographic knee OA, controlling for other important variables. Future research should examine the relationship of LLI with hip or knee OA incidence, progression, and symptom severity, as well as the efficacy for LLI corrective treatments in OA.     

Medial and lateral osteoarthritis of the knee is related to variations of hip and pelvic anatomy

OBJECTIVE: We evaluated if increased risk of combined hip and lateral knee osteoarthritis (OA) could be attributed to anatomical reasons in the hip region resulting in increased abductor moment over the knee. METHODS: We measured pelvic width, femoral offset, femoral neck length and angle in 29 women with lateral knee OA (13 unilateral, 16 bilateral) and 27 women with bilateral medial OA. Twenty-one of these patients with normal hips (lateral/medial OA of the knee=12/9) and 35 with associated hip OA (lateral/medial OA of the knee=17/18) were evaluated separately. Radiographic examinations in 14 women planned for hip prosthesis because of failures after hip fracture acted as controls. RESULTS: Patients with lateral OA of the knee had wider pelvis than controls (13.7 mm increased distance between the medial borders of the acetabulum, P=0.001). Patients with medial OA had 11.4mm longer distance from the centre of the femoral head to the centre of the proximal part of the femoral shaft (P=0.005), corresponding to a higher offset. The pelvic and hip anatomy also differed between patients with medial and lateral OA of the knee. In the groups without hip OA, presence of lateral knee OA was associated with a wider pelvis (P=0.009), shorter femoral neck (P=0.02) and Head-Shaft distance (P=0.04). In the groups with OA of the hip associated lateral OA of the knee also implied increased Neck Shaft angle (coxa valga, P=0.008), but there was no difference in pelvic width (P=0.15). We found a shorter lever arm over the hip in lateral knee OA compared to medial knee OA (P=0.02), but not when compared to controls. CONCLUSION: Our findings suggest that occurrence of medial or lateral OA has a biomechanical background originating from pelvis and hip anatomy.     

A 3-month, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a highly optimized, capacitively coupled, pulsed electrical stimulator in patients with osteoarthritis of the knee

OBJECTIVE: To investigate the efficacy and safety of a capacitively coupled, pulsed electrical stimulation device in treating knee osteoarthritis (OA). DESIGN: Fifty-eight outpatients with moderate to severe OA of the knee entered a 3-month, double-blind, placebo-controlled trial, using either an active or placebo device at home for 6 to 14 h/day. Outcome measures included a patient global evaluation, a patient report of knee pain severity, and the Western Ontario and McMaster Universities (WOMAC) questionnaire. RESULTS: Active treatment provided superior outcomes between baseline and 3-month follow-up measurements: 50.6% greater improvement than placebo in patient global (P=0.03), 31.2% in patient pain (P=0.04), 25.1% in WOMAC stiffness (P=0.03), 29.5% in WOMAC function (P=0.01), 19.9% in WOMAC pain (P=0.11), and 27% in total WOMAC (P=0.01). The percent of patients who improved by more than 50% was 38.5 active vs 5.3 placebo in patient global (P=0.01), 43.6 vs 15.8 in patient pain (P=0.04), 38.5 vs 10.5 in WOMAC pain (P=0.03), 28.2 vs 5.3 in WOMAC stiffness (P=0.08), 23.1 vs 5.3 in WOMAC function (P=0.14), and 23.1 vs 5.3 in total WOMAC (P=0.14). Twenty-one percent of placebo and 18% of actively treated patients developed a transient rash at the electrode sites. No other adverse device effects were reported. CONCLUSION: A highly optimized, capacitively coupled, pulsed electrical stimulus device significantly improved symptoms and function in knee OA without causing any serious side effects.     

Cross-cultural adaptation and validation of Singapore English and Chinese versions of the Lequesne Algofunctional Index of knee in Asians with knee osteoarthritis in Singapore

OBJECTIVE: To cross-culturally adapt and validate Singapore English and Chinese versions of the Lequesne Algofunctional Index of knee in patients with knee osteoarthritis (OA) in Singapore. METHODS: Singapore English and Chinese versions were cross-culturally adapted from the source English version following standard guideline (including cognitive debriefing). Patients were asked to complete an identical, pretested questionnaire containing the Lequesne index, Short Form 36 Health Survey (SF-36), and EQ-5D twice within 6 days. Reliability was assessed using Cronbach's alpha and intraclass correlation coefficients (ICC). Dimensionality was assessed by principal component factor analysis. Construct validity was tested by item-to-scale correlations and 12 and six a priori hypotheses for convergent and divergent construct validities, respectively. RESULTS: Singapore English and Chinese Lequesne indices were well accepted by patients in pilot testing and were therefore administered to a consecutive sample of 127 English- and 131 Chinese-speaking Singaporeans with knee OA. Acceptable internal consistency was observed for activities of daily living and the global index (alpha=0.72-0.82), and the good test-retest reliability for all scales in both versions (ICC=0.66-0.94). Expected item-to-scale correlations were presented only in activities of daily living in both versions. Factor analysis yielded two factors for both versions. Convergent and divergent construct validities were supported by the presence of hypothesized correlations between the Lequesne index and SF-36 and EQ-5D scales. CONCLUSION: Both versions of the Lequesne index demonstrated acceptable reliability and validity among multiethnic Asian patients with knee OA, which suggests that it could be used as a global index in the health-related quality of life (HRQoL) measurements in Singapore and possibly other Asian countries.     

A 2-year follow-up of a study to compare the efficacy of lateral wedged insoles with subtalar strapping and in-shoe lateral wedged insoles in patients with varus deformity osteoarthritis of the knee

OBJECTIVE: This study was conducted in order to assess the effect of wearing a lateral wedged insole with a subtalar strap for 2 years in patients with osteoarthritis varus deformity of the knee (knee OA). DESIGN: The setting was an outpatient clinic. The efficacies of the strapped insole and a traditional shoe insert wedged insole (the inserted insole), as a positive control, were compared at the baseline and after 2 years of treatment. Randomization was performed according to birth date. The 61 female outpatients with knee OA who completed a prior 6-month study were asked to wear their respective insoles continuously as treatment during the course of the 2-year study. The femorotibial angle (FTA) was assessed by standing radiographs obtained while the subjects were barefoot and the Lequesne index of the knee OA at 2 years was compared with those at baseline in each insole group. RESULTS: There were 61 patients in the original study, but 13 patients (21.3%) did not want to wear the insole continuously and five (8.2%) withdrew for other reasons. The 42 patients who completed the 2-year study were evaluated. At the 2-year assessment, participants wearing the subtalar strapped insole (n=21) demonstrated significantly decreased FTA (P=0.015), and significantly improved Lequesne index (P=0.031) in comparison with their baseline assessments. These significant differences were not found in the group with the traditional shoe inserted wedged insole (n=21). CONCLUSION: Only those participants using the subtalar strapped insole demonstrated significant change in the FTA in comparison with the baseline assessments. If the insole with a subtalar strap maintains FTA for more than 2 years, it may restrict the progression of degenerative articular cartilage lesions of knee OA.     

Hyaluronate improves pain, physical function and balance in the geriatric osteoarthritic knee: a 6-month follow-up study using clinical tests

OBJECTIVE: To investigate the effects of intraarticular hyaluronic acid (HA) (Artzal, Seikagaku Corp., Japan) in geriatric participants with unilateral knee osteoarthritis (OA). METHOD: This was a prospective, observer-blind study with 6 months follow-up done in the setting of an outpatient rehabilitation department in a university-affiliated tertiary care medical center. Sixty-eight patients, aged 65 years or above, with symptoms and radiographic evidence of unilateral knee OA for at least 6 months were recruited. Patients received five weekly intraarticular injections of Artzal into symptomatic knees. Fifty-six participants completed the study. Fifty age-, body mass- and gender-matched healthy individuals were selected as control. Visual analog scale (VAS), Lequesne index and four balance tests including single-leg stance test (SLS), function reach test (FRT), timed "Up-and-Go" test (TUG) and Berg balance scale (BBS) were assessed before injection and at each follow-up visit in the OA group. Four balance tests were obtained on healthy participants for data comparison. RESULTS: Before Artzal injections, the OA group showed significantly worse VAS, Lequesne index and four balance tests scores than did the control group (P < 0.001). Significant improvement in all outcome measures were noted at 1 week, 1, 3 and 6 months post the fifth injection compared with baseline before injection. Local adverse events were reported in four patients (7.1%). CONCLUSION: Significant improvement in pain, physical function and balance tests was demonstrated after five weekly Artzal injections in geriatric patients with knee OA. The effect had rapid onset at 1 week and may last for 6 months.     

Efficacy of a combination of FCHG49 glucosamine hydrochloride, TRH122 low molecular weight sodium chondroitin sulfate and manganese ascorbate in the management of knee osteoarthritis

OBJECTIVES: The objective of this study was to evaluate the oral combination of glucosamine HCl, sodium chondroitin sulfate and manganese ascorbate for the treatment of osteoarthritis (OA) of the knee. DESIGN: A randomized placebo-controlled study design was implemented. We recruited 93 patients with OA of the knee from a single center. The intervention group received 1000 mg FCHG49 glucosamine HCl, 800 mg TRH122 low molecular weight sodium chondroitin sulfate and 152 mg manganese ascorbate twice daily (Cosamin DS). Patients were evaluated initially and then every 2 months for 6 months. The primary outcome was the Lesquene Index of severity of osteoarthritis of the knee (ISK). RESULTS: Patients with radiographically mild or moderate OA (N=72) in the intervention group showed significant improvement in the ISK at 4 and 6 months (P=0.003 and P=0.04, respectively). The response rate to the medication was 52% vs a 28% response rate to placebo. Patients with radiographically severe osteoarthritis (N=21) did not show significant improvements in the ISK. There was a 17% incidence of adverse events in the intervention group and 19% in the placebo group. CONCLUSIONS: The studied combination of glucosamine HCl, sodium chondroitin sulfate and manganese ascorbate was found to be effective for the treatment of radiographically mild to moderate OA of the knee as measured by the ISK. This is the first U.S. study of these agents.     

Correlation between radiographic severity of knee osteoarthritis and future disease progression. Results from a 3-year prospective,placebo-controlled study evaluating the effect of glucosamine sulfate

OBJECTIVE: To investigate the relationship between baseline radiographic severity of knee osteoarthritis (OA) and the importance of long-term joint space narrowing. DESIGN: Sub-analysis from a three-year randomized, placebo-controlled, prospective study, of 212 patients with knee OA, recruited in an osteoarthritic outpatient clinic and having been part of a study evaluating the effect of glucosamine sulfate on symptom and structure modification in knee OA. MATERIAL AND METHODS: Measurements of mean joint space width (JSW), assessed by a computer-assisted method, were performed at baseline and after 3 years, on weightbearing anteroposterior knee radiographs. RESULTS: In the placebo group, baseline JSW was significantly and negatively correlated with the joint space narrowing observed after 3 years (r=-0.34, P=0.003). In the lowest quartile of baseline mean JSW (<4.5mm), the JSW increased after 3 years by (mean (S.D.)) 3.8% (23.8) in the placebo group and 6.2% (17.5) in the glucosamine sulfate group. The difference between the two groups in these patients with the most severe OA at baseline was not statistically significant (P=0.70). In the highest quartile of baseline mean JSW (>6.2mm), a joint space narrowing of 14.9% (17.9) occurred in the placebo group after 3 years while patients from the glucosamine sulfate group only experienced a narrowing of 6.0% (15.1). Patients with the most severe OA at baseline had a RR of 0.42 (0.17-1.01) to experience a 0.5mm joint space narrowing over 3 years, compared to those with the less affected joint. In patients with mild OA, i.e. in the highest quartile of baseline mean JSW, glucosamine sulfate use was associated with a trend (P=0.10) towards a significant reduction in joint space narrowing. CONCLUSION: These results suggest that patients with the less severe radiographic knee OA will experience, over 3 years, the most dramatic disease progression in terms of joint space narrowing. Such patients may be particularly responsive to structure-modifying drugs.     

The association between joint stress from physical activity and self-reported osteoarthritis: an analysis of the Cooper Clinic data

OBJECTIVE: The purpose was to evaluate the association between estimated joint stress from physical activity (PA) and hip/knee osteoarthritis (OA). DESIGN: A nested case-control study was performed using data from the Aerobics Center Longitudinal Study. Participants without self-reported OA at baseline who attended the clinic between 1974 and 1993 and returned a follow-up questionnaire in 1990 or 1995 were eligible. Cases were those who reported a physician diagnosis of OA of the knee and/or hip at follow-up (N = 415). A random sample of persons in the remaining cohort were classified as controls (N = 1995). PA was measured at baseline by self-report and subjects were classified as 'moderate/high' or 'low' joint stress by PA type. Those reporting no PA were classified as sedentary with 'no' joint stress (the reference group). Men and women were analyzed separately. Stratified analysis and multiple logistic regression were used to assess the relationship between hip/knee OA and joint stress as predicted by PA. RESULTS: After adjustment for age, body mass index, years of follow-up, and history of hip/knee joint injury, among men, there was no association between hip/knee OA and low joint stress while moderate/high joint stress was associated with reduced risk of hip/knee OA (adjusted odds ratio (OR) = 0.62, 95% confidence interval (CI) = 0.43-0.89). Among women, both levels of joint stress were associated with reduced risk of hip/knee OA (OR = 0.58, 95% CI = 0.34-0.99 for low and OR=0.24, 95% CI = 0.11-0.52 for moderate/high). CONCLUSIONS: PA may reduce the risk of hip/knee OA, especially among women. Further research should assess the combined effects of frequency, intensity, duration and joint stress level of PA on incidence of hip/knee OA.