WOMAC Pain Subscale Score Research Articles

Exploring the relationship between disease-related pain and cortisol levels in women with osteoarthritis

To determine if (1) Osteoarthritis (OA)-related pain is associated with the diurnal cortisol pattern and cortisol levels; (2) the diurnal pattern of cortisol varies with severity of OA pain and (3) the association between OA pain and cortisol is mediated by daily experience variables (DEV). In a community-based study of changes in regional and widespread pain among women with OA, participants (n=31) completed daily diaries and collected three saliva samples daily for 7 days. Severity of OA-related pain was assessed by the validated Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. Multilevel regression analyses estimated associations between OA pain and diurnal cortisol levels and slopes, controlling for body mass index (BMI), medication use, time and day. Mediation analyses examined DEV as potential mediators of the association between OA pain and cortisol. The mean age was 57 years and average BMI 31kg/m2. Mean WOMAC pain subscale score was 8.8. Women with higher WOMAC pain scores had higher cortisol throughout the day. The estimated association of WOMAC with cortisol [β 0.083(0.02, 0.15) P=0.009] represents a ∼9% increase in cortisol for every unit increase in WOMAC pain score. Women with WOMAC pain scores ≥9 had higher cortisol levels than those with scores <9. Examination of DEV revealed no significant mediated associations between these relationships at the daily level. In women with OA, disease-related pain is positively associated with cortisol production, particularly with greater pain severity. Future studies should explore biologic mediating variables between OA pain and cortisol.

Survivorship of the Bernese Periacetabular Osteotomy: What Factors are Associated with Long-term Failure?

The Bernese periacetabular osteotomy (PAO) continues to be a commonly performed nonarthroplasty option to treat symptomatic developmental hip dysplasia, but there are few long-term followup studies evaluating results after PAO. (1) What is the long-term survivorship of the hip after PAO? (2) What were the validated outcomes scores among patients who had PAO more than 14 years ago? (3) What factors are associated with long-term failure? One hundred fifty-eight dysplastic hips (133 patients) underwent PAO between May 1991 and September 1998 by a single surgeon. Of those, 37 hips (34 patients [26%]) were lost to followup; an additional seven patients (5% [eight hips]) had not been seen in the last 5 years. The 121 hips (in 99 patients) were retrospectively evaluated at a mean of 18 years (range, 14-22 years). Survivorship was assessed using Kaplan-Meier analysis with total hip arthroplasty (THA) as the endpoint. Hips were evaluated for activity, pain, and general health using the UCLA Activity Score, modified Harris hip score, WOMAC, and Hip disability and Osteoarthritis Outcome Score (HOOS). Failure was defined as a WOMAC pain subscale score ≥ 10 or having undergone THA. Hips were divided into three groups: asymptomatic (did not meet any failure criteria at any point in time), symptomatic (met WOMAC pain failure criteria at previous or most recent followup), and replaced (having undergone THA). A multinomial logistic regression model using a general estimating equations approach was used to assess factors associated with failure. Kaplan-Meier analysis with THA as the endpoint revealed a survival rate (95% confidence interval [CI]) of 74% (66%-83%) at 18 years. Twenty-six hips (21%) underwent THA at an average of 9 ± 5 years from the surgery. Sixty-four hips (53%) remained asymptomatic and did not meet any failure criteria at most recent followup. Thirty-one hips (26%) were symptomatic and considered failed based on a WOMAC pain score of ≥ 10 with a mean ± SD of 11 ± 4 out of 20 at most recent followup. Although some failed initially by pain, their most recent WOMAC score may have been < 10. Of the 16 symptomatic hips that failed early by pain (reported a WOMAC pain subscale score ≥ 10 in the prior study), two were lost to followup, two underwent THA at 16 and 17 years, four still failed because of pain at most recent followup, and the remaining eight had WOMAC pain scores < 10 at most recent followup. Asymptomatic hips reported better UCLA Activity Scores (asymptomatic: mean ± SD, 7 ± 2; symptomatic: 6 ± 2, p = 0.001), modified Harris hip scores (pain, function, and activity sections; asymptomatic: 80 ± 11; symptomatic: 50 ± 15, p < 0.001), WOMAC (asymptomatic: 2 ± 2, symptomatic: 11 ± 4, p < 0.001), and HOOS (asymptomatic: 87 ± 11, symptomatic: 52 ± 20, p < 0.001) compared with symptomatic hips at long-term followup. Age older than 25 years at the time of PAO (symptomatic: odds ratio [OR], 3.6; 95% CI, 1.3-9.8; p = 0.01; replaced: OR, 8.9; 95% CI, 2.6-30.9; p < 0.001) and a preoperative joint space width ≤ 2 mm (replaced: OR, 0.3; 95% CI, 0.12-0.71; p = 0.007) or ≥ 5 mm (replaced: OR, 0.121; 95% CI, 0.03-0.56; p = 0.007) were associated with long-term failure while controlling for poor or fair preoperative joint congruency. This study demonstrates the durability of the Bernese PAO at long-term followup. In a subset of patients, there was progression to failure over time. Factors of progression to THA or more severe symptoms include age older than 25 years, poor or fair preoperative hip congruency, and a preoperative joint space width that is less than 2 mm or more than 5 mm. Future studies should focus on evaluating the two failure groups that we have identified in our study: those that failed early and went on to THA and those that are symptomatic at long-term followup. Level III, therapeutic study.

Hypertonic dextrose injections (prolotherapy) in the treatment of symptomatic knee osteoarthritis: A systematic review and meta-analysis.

Hypertonic dextrose injections (prolotherapy) is an emerging treatment for symptomatic knee osteoarthritis (OA) but its efficacy is uncertain. We conducted a systematic review with meta-analysis to synthesize clinical evidence on the effect of prolotherapy for knee OA. Fifteen electronic databases were searched from their inception to September 2015. The primary outcome of interest was score change on the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Three randomized controlled trials (RCTs) of moderate risk of bias and one quasi–randomized trial were included, with data from a total of 258 patients. In the meta-analysis of two eligible studies, prolotherapy is superior to exercise alone by a standardized mean difference (SMD) of 0.81 (95% CI: 0.18 to 1.45, p = 0.012), 0.78 (95% CI: 0.25 to 1.30, p = 0.001) and 0.62 (95% CI: 0.04 to 1.20, p = 0.035) on the WOMAC composite scale; and WOMAC function and pain subscale scores respectively. Moderate heterogeneity exists in all cases. Overall, prolotherapy conferred a positive and significant beneficial effect in the treatment of knee OA. Adequately powered, longer-term trials with uniform end points are needed to better elucidate the efficacy of prolotherapy.

Traditional Chinese Medications for Knee Osteoarthritis Pain: A Meta-Analysis of Randomized Controlled Trials.

Traditional Chinese medication (TCM) has analgesic and anti-inflammatory effects in patients with knee osteoarthritis (OA). We conducted the first systematic review of the best quantitative and qualitative evidence currently available in order to evaluate the effectiveness of TCM in relieving pain in knee OA. A comprehensive literature search was conducted using three English and four Chinese biomedical databases from their inception through March 1, 2015. We included randomized controlled trials of TCM for knee OA with intervention durations of at least two weeks. The effects of TCM on pain and other clinical symptoms were measured with the visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The total effectiveness rate, which was used to assess overall pain, physical performance and wellness, was also measured. Two researchers independently extracted data on study design, population characteristics, duration, intervention, outcomes, risk of bias, and primary results. We performed a random-effects meta-analysis when appropriate. We also explored factors that could explain the heterogeneity by conducting subgroup and meta-regression analyses. Twenty-three studies, totaling 2362 subjects, met the eligibility criteria. Treatments were formulated with an average of 8 Chinese herbs and were prescribed based on the traditional Chinese diagnostic method of syndrome differentiation. The mean treatment duration was seven weeks, with oral administration occurring one to three times a day. Compared with non-steroidal anti-inflammatory drugs and intra-articular hyaluronate injections, 18 of the studies showed significantly improved VAS pain scores (Mean Difference [MD] [Formula: see text] 0.56; 95% confidence interval [CI], 0.18 to 0.94; [Formula: see text]), six of the studies showed significantly improved WOMAC pain subscale scores (MD [Formula: see text] 2.23; 95% CI, 0.56 to 3.91; [Formula: see text]), and 16 of the trials showed significantly improved total effectiveness rates (risk ratio [Formula: see text] 1.12; 95% CI, 1.05 to 1.19; [Formula: see text] 0.0003). In addition, TCM showed a lower risk of adverse events than standard western treatments. This evidence suggests that TCM is safe and effective for improving pain, function, and wellness in treatments of knee OA. However, there is inherent clinical heterogeneity (diverse TCM formulations, controls, and treatment regimens) among the included trials. Despite these limitations, the potential analgesic effects of TCM warrant further methodologically rigorous research to determine the clinical implications of TCM on pain management in knee OA.

A Combined Patient and Provider Intervention for Management of Osteoarthritis in Veterans: A Randomized Clinical Trial.

Management of osteoarthritis requires both medical and behavioral strategies, but some recommended therapies are underused. To examine the effectiveness of a combined patient and provider intervention for improving osteoarthritis outcomes. Cluster randomized clinical trial with assignment to osteoarthritis intervention and usual care groups. (ClinicalTrials.gov: NCT01130740). Department of Veterans Affairs Medical Center in Durham, North Carolina. 30 providers (clusters) and 300 outpatients with symptomatic hip or knee osteoarthritis. The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved delivery of patient-specific osteoarthritis treatment recommendations to primary care providers through the electronic medical record. The primary outcome was total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months. Secondary outcomes were WOMAC function and pain subscale scores, physical performance (Short Physical Performance Battery), and depressive symptoms (Patient Health Questionnaire-8). Linear mixed models that were adjusted for clustering of providers assessed between-group differences in improvement in outcomes. At 12 months, WOMAC scores were 4.1 points lower (indicating improvement) in the osteoarthritis intervention group versus usual care (95% CI, -7.2 to -1.1 points; P = 0.009). WOMAC function subscale scores were 3.3 points lower in the intervention group (CI, -5.7 to -1.0 points; P = 0.005). WOMAC pain subscale scores (P = 0.126), physical performance, and depressive symptoms did not differ between groups. Although more patients in the osteoarthritis intervention group received provider referral for recommended osteoarthritis treatments, the numbers who received them did not differ. The study was conducted in a single Veterans Affairs medical center. The combined patient and provider intervention resulted in modest improvement in self-reported physical function in patients with hip and knee osteoarthritis. Department of Veterans Affairs, Health Services Research and Development Service.

Efficacy and safety of low-dose SoluMatrix meloxicam in the treatment of osteoarthritis pain: a 12-week, phase 3 study

Objective:Nonsteroidal anti-inflammatory drugs (NSAIDs) such as meloxicam are commonly used to treat osteoarthritis (OA) but are associated with potentially serious dose-related adverse events (AEs). SoluMatrix meloxicam has been developed with the goal of enabling effective treatment at low doses. This phase 3 study evaluated the efficacy and safety of low-dose SoluMatrix meloxicam capsules 5 mg and 10 mg administered once daily for 12 weeks in patients with OA-related pain.Research design and methods:This randomized, double-blind study enrolled patients ≥40 years of age with confirmed hip or knee OA (Kellgren–Lawrence grade II–III) who were chronic users of NSAIDs and/or acetaminophen for OA pain and had Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale mean scores ≥40 mm. Eligible patients experienced an OA pain flare (defined as a ≥15 mm increase in the WOMAC pain subscale score) following discontinuation of NSAIDs/acetaminophen. Patients were randomized to receive once-daily SoluMatrix meloxicam 5 mg or 10 mg, or placebo for 12 weeks.ClinicalTrials.gov identifier: NCT01787188.Main outcome measures:The primary outcome measure was the mean change from baseline in WOMAC pain subscale score at week 12.Results:Low-dose SoluMatrix meloxicam 5 mg (−36.52 [2.49]; P = 0.0005) and 10 mg (−34.41 [2.68]; P = 0.0059) once-daily treatment significantly reduced the mean (standard error) WOMAC pain subscale score from baseline at week 12 compared with placebo (−25.68 [2.64]). Patients treated with SoluMatrix meloxicam 5 mg or 10 mg reported significantly greater improvements in total WOMAC score and in WOMAC stiffness and function subscale scores at 12 weeks compared with placebo. The most common AEs in the combined low-dose SoluMatrix meloxicam group were headache, diarrhea, nausea, osteoarthritis, and urinary tract infection.Conclusions:Low-dose SoluMatrix meloxicam may have a potential role as a new therapeutic option for the management of OA-related pain.

Efficacy of Hip Strengthening Exercises Compared With Leg Strengthening Exercises on Knee Pain, Function, and Quality of Life in Patients With Knee Osteoarthritis.

The purpose of this study was to compare the efficacy of hip and leg strengthening exercise programs on knee pain, function, and quality of life (QOL) of patients with knee osteoarthritis (KOA). Single-Blinded Randomized Clinical Trial. Patients with KOA. Male and female subjects were recruited from patients referred to the University of Calgary Sport Medicine Center and from newspaper advertisements. Thirty-seven and 35 patients with KOA were randomly assigned to either a 12-week hip or leg strengthening exercise program, respectively. Both exercise programs consisted of strengthening and flexibility exercises, which were completed 3 to 5 days a week. The first 3 weeks of exercise were supervised and the remaining 9 weeks consisted of at-home exercise. Knee Injury and Osteoarthritis Score (KOOS) and Western Ontario McMaster Arthritis Index (WOMAC) questionnaires, 6-minute walk test, hip and knee range of motion (ROM), and hip and leg muscle strength. Statistically and clinically significant improvements in the KOOS and WOMAC pain subscale scores were observed in both the hip and leg strengthening programs. There was no statistical difference in the change in scores observed between the 2 groups. Equal improvements in the KOOS and WOMAC function and QOL subscales were observed for both programs. There was no change in hip and knee ROM or hip and leg strength in either group. Isolated hip and leg strengthening exercise programs seem to similarly improve knee pain, function, and QOL in patients with KOA. The results of this study show that both hip and leg strengthening exercises improve pain and QOL in patients with KOA and should be incorporated into the exercise prescription of patients with KOA.

Surgical fixation methods for tibial plateau fractures.

Surgical fixation methods for tibial plateau fractures.

A randomized, double-blind, placebo-controlled 12 week trial of acetaminophen extended release for the treatment of signs and symptoms of osteoarthritis

Objective:Determine efficacy and safety of acetaminophen extended release (ER) 1300 mg given three times daily compared to placebo for relieving signs and symptoms of hip or knee osteoarthritis.Research design and methods:Sixty investigators at 58 private, ambulatory, primary care sites in the US enrolled 542 outpatient adults ≥40 years old with moderate to severe idiopathic osteoarthritis pain into a randomized, placebo-controlled, double-blind 12 week clinical trial. Patients were randomly assigned to treatment given three times daily of acetaminophen 1300 mg (n = 267) or placebo (n = 275).Results:The three primary endpoints measured through week 12 favored acetaminophen ER as follows: least squares (LS) mean change from baseline for WOMAC physical function subscale score was significantly greater for acetaminophen ER than for placebo (P = 0.011); LS mean patient’s global assessment of response to therapy was significantly greater for acetaminophen ER than for placebo (P = 0.010); and LS mean change from baseline for WOMAC pain subscale score was marginally greater for acetaminophen ER than for placebo (P = 0.054). LS mean change from baseline for secondary endpoints through week 12 also favored acetaminophen ER compared with placebo: significantly for WOMAC stiffness subscale score (P = 0.004), significantly for WOMAC total index score (P = 0.013), and marginally for Nottingham Health Profile energy subscale score (P = 0.057). The percentage of patients with any adverse event was similar for both treatment groups. Hepatic transaminases exceeded 3 × ULN in seven acetaminophen ER patients and one placebo patient. Elevations were attributed to health conditions in three of seven acetaminophen ER patients; elevations in the remaining four patients returned to or toward normal.Conclusions:Acetaminophen ER 1300 mg, a nonprescription drug, given three times daily, can provide effective relief of signs and symptoms of osteoarthritis of the hip or knee and was well tolerated.ClinicalTrials.gov registration number:ClinicalTrials.gov identifier: NCT00240799.

Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study

Objective:NSAIDs, such as diclofenac, are the most commonly used medications to treat osteoarthritis (OA), but they are associated with dose-related adverse events (AEs). Low-dose submicron diclofenac was developed using a new, proprietary dry milling process that creates submicron drug particles (SoluMatrix Fine Particle Technology), enabling effective treatment at lower doses than other commercially available diclofenac drug products. This phase 3 study evaluated the efficacy and safety of low-dose submicron diclofenac 35 mg three times daily (tid) and twice daily (bid) in patients with OA pain.Research design and methods:This double-blind study enrolled patients ≥40 years of age with clinically and radiographically confirmed (Kellgren–Lawrence grade II–III) hip or knee OA. Eligible patients were chronic NSAID and/or acetaminophen (APAP) users with baseline Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) pain subscale scores ≥40 mm by visual analog scale and an OA flare (≥15 mm increase in WOMAC pain subscale score following discontinuation of NSAIDs/APAP at screening). Patients were randomized to submicron diclofenac 35 mg tid, submicron diclofenac 35 mg bid, or placebo for 12 weeks.ClinicalTrials.gov identifier:ClinicalTrials.gov identifier: NCT01461369.Main outcome measures:Efficacy parameters included mean change from baseline in WOMAC pain subscale score at week 12 (primary efficacy parameter) and in average total WOMAC score over 12 weeks.Results:Submicron diclofenac 35 mg tid significantly improved WOMAC pain subscale scores from baseline at 12 weeks (−44.1; p = 0.0024) compared with placebo (−32.5). Submicron diclofenac 35 mg bid provided numerical improvement in pain at week 12 that did not reach statistical significance (−39.0; p = 0.0795) compared with placebo. Submicron diclofenac 35 mg tid (−35.9; p = 0.0002) and 35 mg bid (−30.3; p = 0.0363) improved the average total WOMAC score in treated patients over 12 weeks compared with placebo (−23.2). The most frequent AEs in the submicron diclofenac-treated groups were diarrhea, headache, nausea, and constipation. The inclusion of patients with a documented requirement for analgesic therapy (OA ‘flare’) at baseline and the high rates of rescue medication usage in the placebo group may have impacted the study outcome for the submicron diclofenac treatment groups.Conclusions:Low-dose submicron diclofenac is an effective therapeutic option for the treatment of OA pain.

THU0200 Lower-Dose Solumatrix® Meloxicam: Efficacy and Safety in A Phase 3 Study in Adults with Osteoarthritis Pain

BackgroundNon-steroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed for the management of osteoarthritis (OA) pain. As a class, NSAIDs are associated with dose-related, serious gastrointestinal, cardiovascular, and renal adverse events (AEs),...

SAT0446 A Novel Green-Lipped Mussel Lipid Extract (BIOLEX) for the Treatment of Pain in Osteoarthritis of the Hip and Knee: A Randomized Double-Blind, Placebo Controlled Trial

BackgroundPain is the primary symptom of concern for patients with osteoarthritis (OA). Numerous studies have shown that pain control is frequently inadequate for people with symptomatic OA. Furthermore, the use...

Lower-dose diclofenac capsules developed using solumatrix fine particle technology result in clinically meaningful improvements in pain in a phase 3 study of patients with osteoarthritis

Lower-dose diclofenac capsules developed using solumatrix fine particle technology result in clinically meaningful improvements in pain in a phase 3 study of patients with osteoarthritis

Longitudinal assessment of pain in patients with knee osteoarthritis (OA): using data from the Study of Real World Therapies (SORT)

Longitudinal assessment of pain in patients with knee osteoarthritis (OA): using data from the Study of Real World Therapies (SORT)

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.

The influence of femoral offset on health-related quality of life after total hip replacement

Several factors have been implicated in unsatisfactory results after total hip replacement (THR). We examined whether femoral offset, as measured on digitised post-operative radiographs, was associated with pain after THR. The routine post-operative radiographs of 362 patients (230 women and 132 men, mean age 70.0 years (35.2 to 90.5)) who received primary unilateral THRs of varying designs were measured after calibration. The femoral offset was calculated using the known dimensions of the implants to control for femoral rotation. Femoral offset was categorised into three groups: normal offset (within 5 mm of the height-adjusted femoral offset), low offset and high offset. We determined the associations to the absolute final score and the improvement in the mean Western Ontario and McMaster Universities osteoarthritis index (WOMAC) pain subscale scores at three, six, 12 and 24 months, adjusting for confounding variables. The amount of femoral offset was associated with the mean WOMAC pain subscale score at all points of follow-up, with the low-offset group reporting less WOMAC pain than the normal or high-offset groups (six months: 7.01 (sd 11.69) vs 12.26 (sd 15.10) vs 13.10 (sd 16.20), p = 0.006; 12 months: 6.55 (sd 11.09) vs 9.73 (sd 13.76) vs 13.46 (sd 18.39), p = 0.010; 24 months: 5.84 (sd 10.23) vs 9.60 (sd 14.43) vs 13.12 (sd 17.43), p = 0.004). When adjusting for confounding variables, including age and gender, the greatest improvement was seen in the low-offset group, with the normal-offset group demonstrating more improvement than the high-offset group.

The association of parity with osteoarthritis and knee replacement in the Multicenter Osteoarthritis Study

We evaluated the association of parity to both risk of knee replacement (KR) and knee osteoarthritis (OA). The NIH-funded Multicenter Osteoarthritis Study (MOST) is a longitudinal observational study of persons age 50-79 years with either symptomatic knee OA or at elevated risk of disease. Baseline and 30-month knee radiographic OA (ROA) was defined as Kellgren/Lawrence (K/L) grade ≥2 or KR. Women were grouped based by number of births: 0; 1 (reference group); 2; 3; 4; and 5 or more. We examined the relation of parity to the incidence over 30 months of ROA and KR using a Poisson regression model. Generalized estimating equations (GEE) were used to control for correlation between two knees within a subject. We adjusted for age, BMI, race, education, occupation, baseline estrogen use, clinical site, injury, and for KR analyses WOMAC pain and use of pain medication. Among 1618 women who reported parity information, mean age was 62.6 years, mean BMI 30.7 kg/m(2), mean WOMAC pain subscale score 3.7 at baseline. There were 115 KRs and 134 cases of incident knee ROA over 30 months. The relative risk of incident KR was 2.7 times as high (95% CI: 1.0, 7.3) and relative risk of incident knee ROA was 2.6 times as high (95% CI: 1.2, 5.3) among women with five to 12 children compared with those with one birth. Parity in women at risk for OA is associated with both incident ROA and KR, particularly for those with more than four children.

FRI0300 A large randomised, controlled trial comparing the efficacy and safety of topical ketoprofen in transfersome gel with oral celecoxib for osteoarthritis knee pain

BackgroundIDEA 033 is a topically applied osteoarthritis (OA) treatment that uses novel Transfersome (TM IDEA AG) – an aqueous dispersion of ultra-deformable carriers – to deliver ketoprofen to soft tissue.ObjectivesTo...

AB0990 A double-blind, randomised, placebo-controlled trial to evaluate the safety and efficacy of epicutaneously applied ketoprofen in transfersome gel for the treatment of pain associated with osteoarthritis (OA) of the knee

BackgroundIDEA 033 is an epicutaneously applied formulation of ketoprofen in Transfersome – aqueous dispersion of ultra-deformable carriers – for the treatment of pain in OA, which potentially minimises systemic adverse...

SAT0329 A double-blind, placebo-controlled trial comparing the safety and efficacy of epicutaneously applied ketoprofen in transfersome gel with naproxen for the treatment of pain associated with osteoarthritis (OA) of the knee

BackgroundIDEA 033 is a formulation of ketoprofen in Transfersome – ultra-deformable carriers – that is applied epicutaneously for the treatment of pain associated with OA, thus minimising the potential for...