WOMAC Physical Function Scores Research Articles

Validating a Nonacupoint Sham Control for Laser Treatment of Knee Osteoarthritis

The goals of the present study were to evaluate the effect and safety of combined 10.6 microm and 650 nm laser acupuncture-moxibustion on patients with knee osteoarthritis (OA) and to validate a nonacupoint sham control for assessing the effect of point specificity on the treatment. A randomized, sham-controlled clinical trial was conducted in an outpatient clinical setting on patients with knee OA (n = 40). Laser irradiation was performed on acupoint Dubi (ST35) and a sham point three times a week for 4 wk. Outcome measurements were performed at baseline and at wk 2 and 4 using Western Ontario and McMaster Universities' Osteoarthritis Index (WOMAC). At the 2-wk assessment, i.e., after 6 treatments, improvement in the WOMAC pain score of the acupoint group was significantly greater than that of the control group (49.21% vs. 11.99%, respectively; p = 0.021). However, there were no significant differences between the two groups in the WOMAC physical function score (p = 0.129) or joint stiffness score (p = 0.705). No side effects were found during the trial. Combined 10.6-mum-650-nm laser acupuncture-moxibustion on acupoint ST35 is safe to use and was effective after 2-wk treatment, but not at the 4-wk assessment, in relieving knee OA pain compared to a nonacupoint sham control. A larger clinical trial to verify our findings is warranted.

Additional effect of pulsed electromagnetic field therapy on knee osteoarthritis treatment: a randomized, placebo-controlled study

The aim of this study was to evaluate if pulsed electromagnetic field therapy (PEMF) has additional effect on the classical physical treatment of knee osteoarthritis (OA) composed of hot pack, therapeutic ultrasound, and terminal isometric exercises. Forty patients (29 women and 11 men), ages 44 to 78 (mean age was 61.3 +/- 7.8 years) were included in our study. Patients with knee osteoarthritis [Kellgren-Lawrence criteria grade 2 and above and an average pain intensity of 40 or more on a 100-mm visual analog scale (VAS)] recruited from outpatient physical medicine and rehabilitation clinic were randomly assigned to receive PEMF or sham PEMF treatment in addition to their physical therapy. Both the PEMF and sham PEMF treatments being evaluated were 55 min/session, five sessions per week for 2 weeks. Each session comprise 20-min hot pack, 5-min therapeutic ultrasound, and 30-min PEMF or sham PEMF treatment applied to the knee of the patients. Patients were evaluated by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index and VAS at the baseline and at the end of treatment. Both PEMF and sham PEMF treatment groups showed statistically significant improvement in WOMAC pain and functional scores at the end of treatment (p < 0.001 in both groups). There were no statistically significant differences between groups in WOMAC pain, stiffness, and physical function scores after treatment (p = 0.906, p = 0.855, p = 0.809, respectively). There was neither difference in concomitant used acetaminophen dose in both groups (p = 0.289). The results of this study show that PEMF does not have additional effect on the classical physical treatment in reducing symptoms of knee OA.

Do worsening knee radiographs mean greater chances of severe functional limitation?

Development of functional limitation is thought to be unrelated to changes in severity of radiographic osteoarthritis (OA) of the knee. We evaluated the relationship of change in radiographic OA to the incidence of severe functional limitation. Participants of the Multicenter Osteoarthritis Study, a cohort study of persons with or at high risk of knee OA, were evaluated at 0 and 30 months. Subjects were classified as having no, incident, stable, or worsening radiographic OA. Incidence of severe functional limitation was defined by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function scores (≥36.1/68) and walking speed (≤1.0 meter/second) at 30 months. The relationship of the change in radiographic OA to the incidence of severe functional limitation was evaluated by calculating risk ratios adjusted for potential confounders. Of the 2,210 subjects included (mean age 62 years, mean body mass index 30 kg/m², 60% women), 53% had no, 6% had incident, 14% had stable, and 27% had worsening radiographic OA. Persons with incident radiographic OA had 1.9 and 1.8 times the risk by WOMAC physical function score and walking speed, respectively, to have incident severe functional limitation compared with those with no radiographic OA over 30 months. Compared with those with stable radiographic OA, persons with worsening radiographic OA had 2.2 and 2.3 times the risk of incident severe functional limitation, respectively. Changes in structural disease are associated with the development of severe functional limitations in persons with or even at high risk of knee OA.

Responsiveness of the International Knee Documentation Committee Subjective Knee Form in Comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, Modified Cincinnati Knee Rating System, and Short Form 36 in Patients with Focal Articular Cartilage Defects

Background The International Knee Documentation Committee Subjective Knee Form (IKDC SKF) is a patient-reported knee-specific outcome measure that has been shown to be a reliable, valid, and responsive measure for patients with a variety of knee conditions. Further testing is required to compare the reliability and responsiveness of the IKDC SKF to other commonly used patient-reported outcome measures for patients with articular cartilage lesions. Hypothesis The IKDC SKF has equal or better levels of reliability and responsiveness than the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), modified Cincinnati Knee Rating System (CKRS), and the Short Form 36 in patients with articular cartilage lesions. Study Design Cohort study (diagnosis); Level of evidence, 2. Methods Reliability was assessed by administering the 4 patient-reported outcome measures to 17 individuals who had undergone articular cartilage surgery 5 years before participation in this study. Responsiveness was determined by administering the 4 patient-reported outcome measures to 51 individuals with diagnosed focal articular cartilage defects who were scheduled to undergo surgical treatment. In both groups, the outcome measures were administered at baseline and at 6 and 12 months’ follow-up. Participants also provided a global rating of change in comparison to baseline at the 6- and 12-month follow-ups. Results Test-retest reliability coefficients were 0.91 and 0.93 for the IKDC SKF at the 6- and 12-month follow-ups, respectively. The effect sizes and standardized response means were large (>0.80) at 6 months after surgery for the WOMAC pain, physical function, and total scores and 12 months after surgery for the IKDC SKF; WOMAC pain, physical function, and total; and CKRS scores. Six months after surgery, significant differences between those who were improved compared with those who were unchanged or worse were found only for the IKDC SKF. Twelve months after surgery, significant differences between the improved and unchanged groups were found for all of the knee-specific patient-reported outcome measures. Finally, the IKDC SKF, WOMAC, and CKRS scores were able to differentiate between individuals who perceived themselves to be improved versus not improved and the minimum clinically important difference for the IKDC SKF was 6.3 at 6 months and 16.7 at 12 months. Conclusion The reliability and responsiveness of the IKDC SKF is comparable with other commonly used patient-reported outcome measures for patients with articular cartilage lesions. The IKDC SKF is a suitable alternative to other commonly used knee-specific instruments for measuring symptoms, daily function, and level of symptom-free sports activity in patients undergoing articular cartilage surgery.

Topical Diclofenac Solution

Topical diclofenac solution (Pennsaid) is a liquid formulation containing the NSAID diclofenac sodium (1.5% w/w). The solution base contains 45% w/w dimethyl sulfoxide (DMSO) to enhance the absorption of diclofenac through the skin. Topical diclofenac solution is applied directly to the knee for treatment of symptoms associated with osteoarthritis of the knee. In well designed 4- to 12-week trials in patients with primary osteoarthritis of the knee, topical diclofenac solution (40 drops four times daily) was significantly more effective than placebo or vehicle control (carrier solution without diclofenac) for improving Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index pain and physical function, and improving patient global assessment (PGA) and/or patient overall health assessment scores from baseline to the final assessments. Topical diclofenac solution (50 drops three times daily) was as effective as oral diclofenac 150 mg/day for improving WOMAC pain and physical function and PGA scores in a 12-week double-blind study in patients with osteoarthritis of the knee. Topical diclofenac solution was generally well tolerated. The most common treatment-emergent adverse event experienced by topical diclofenac solution recipients was dry skin at the application site. Gastrointestinal adverse events and abnormal laboratory parameters were less common with topical diclofenac solution than with oral diclofenac.

Validating Self-Report Measures of Pain and Function in Patients Undergoing Hip or Knee Arthroplasty

To investigate the factorial and construct validity of a four-item pain intensity scale, the P4, in patients awaiting primary total hip or knee arthroplasty secondary to osteoarthritis. A construct validation design was applied to a sample of convenience of 117 patients (mean age 65.6 [SD = 11.2] years) at their preoperative visit. All patients completed the P4 and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Exploratory and confirmatory factor analyses were used to examine the factorial structure of the P4 and WOMAC. To evaluate construct validity, we examined the correlation between the P4 and WOMAC pain sub-scales and the ability of the P4 to differentiate between patients awaiting hip and knee replacement. Two distinct factors consistent with the themes of pain and function were identified with P4 and WOMAC physical function items, but not with the WOMAC pain and physical function items. The P4 correlates more with the WOMAC pain scores (r = 0.67) than with the WOMAC physical function scores (r = 0.60). The P4's validity was supported in this patient group. The use of the P4 with the WOMAC physical function sub-scale provides a more distinct assessment of pain and function than the WOMAC pain and physical function scales.

Women with Pain due to Osteoarthritis: The Efficacy and Safety of a Once-Daily Formulation of Tramadol

This analysis assesses the efficacy and safety of treatment with a once-daily oral formulation of tramadol for up to 12 weeks compared with placebo in women with moderate-to-severe pain due to osteoarthritis of the knee. Two parallel, placebo-controlled phase III clinical trials were analyzed; patients were randomized to a fixed dosage of Tramadol Contramid once a day (OAD) 100, 200, and 300 mg daily, or placebo. The primary efficacy end points were the percentage difference from baseline of the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) subscale scores for pain and physical function, and the patient global rating of pain relief after 12 weeks of maintenance therapy. The analysis included 405 women receiving tramadol and 280 receiving placebo. At week 12, 179 of 204 women (87.7%) receiving tramadol rated their overall pain relief as effective or very effective compared with 134 of 177 (75.7%) receiving placebo. A time-weighted analysis revealed statistically significant improvements over placebo for all the WOMAC subscale scores across all three dosages. The percentage improvements from baseline of the WOMAC pain scores were significantly better than placebo for the 100-mg (58.8 +/- 37.1%, P = 0.018) and 300-mg (58.9 +/- 38.8%, P = 0.023) treatment arms; however, the 200-mg dosage was not significant (53.0 +/- 38.5%, P = 0.175). The WOMAC physical function scores showed significant improvement for the 100 (56.9 +/- 36.4%, P = 0.009), 200 (54.0 +/- 33.8%, P = 0.034), and 300 mg (53.4 +/- 41.4%, P = 0.043) daily dosages. For moderate-to-severe pain due to osteoarthritis of the knee, women experience significant analgesia and improvement of physical function over time with treatment with Tramadol Contramid OAD.

Predicting Short-Term Outcome of Primary Total Hip Arthroplasty: A Prospective Multivariate Regression Analysis of 12 Independent Factors

The purpose of this study was to investigate factors affecting the short-term outcome of primary total hip arthroplasty (THA) and develop a multivariate regression equation to predict the short-term outcome of primary THA. Prospectively collected data for 101 primary THAs performed at a single institution were used in this study. Twelve independent variables were analyzed via correlation and multivariate regression analyses. Correlation analyses showed that three variables significantly influenced Western Ontario and McMaster Universities Osteoarthritis (WOMAC) physical function (PF) score at minimum follow-up of 1 year: preoperative WOMAC PF score ( P < .0001), sex (GN, P = .0159), and the presence of preoperative comorbidities (CMB, P = .0246). Multivariate regression analysis yielded the following equation: Outcome = PF⁎0.45 − GN⁎9 + CMB⁎8 + 62, which can be used to predict the general short-term outcome of primary THA.

The effects of impaired joint position sense on the development and progression of pain and structural damage in knee osteoarthritis

Although cross-sectional studies have reported impaired proprioceptive acuity in people with osteoarthritis (OA), there have been no longitudinal studies to evaluate whether those with such impairments increase the risk of OA or its worsening. We studied subjects from the Multicenter Osteoarthritis Study study, a longitudinal study of people with or at high risk of knee OA. At baseline, we quantified acuity as the amount of a subject's error when attempting to reproduce a test knee flexion angle (a measure of joint position sense). We tested proprioception 10 times in the right leg and used a person's worst score as their proprioceptive acuity. At baseline and the 30-month followup, we assessed the presence of frequent pain, obtained Western Ontario and McMasters Universities OA Index (WOMAC) scores, and acquired posteroanterior and lateral weight-bearing knee radiographs read for Kellgren/Lawrence grade and individual radiographic features. We examined the relation of baseline proprioceptive acuity in quartiles with baseline knee pain (frequent pain yes/no), WOMAC pain score, self-reported physical function, and radiographic OA, and with changes from baseline in pain, physical function, and radiographic OA adjusted for age, sex, body mass index, and quadriceps strength. At baseline, proprioceptive acuity was associated with the presence and severity of knee pain but not with the presence of radiographic OA. However, among the 2,243 subjects with baseline acuity assessments and 30-month followup, there were no strong associations between proprioceptive acuity and development of adverse OA outcomes. Acuity was not significantly associated with the new onset of frequent knee pain. Those with the worst acuity at baseline had slightly greater worsening of WOMAC pain scores (0.47 on a 20-point scale) and physical function scores (by 1.5 points on a 0-68-point scale) compared with those with the best proprioceptive acuity, whose pain and physical function score deteriorated less (for pain P = 0.05; for physical function P = 0.02). Radiographic worsening was not significantly associated with proprioceptive acuity. Proprioceptive acuity as assessed by the accuracy of reproduction of the angle of knee flexion had modest effects on the trajectory of pain and physical functional limitation in knee OA.

Efficacy and safety of diacerein in early knee osteoarthritis: a randomized placebo-controlled trial

The objective of this study was to evaluate the efficacy and safety of diacerein in early, symptomatic knee osteoarthritis in Indian population. Sixty-four patients of knee osteoarthritis fulfilling American College of Rheumatology Criteria were randomized to receive either diacerein or placebo for 8 weeks, followed by 4 weeks "treatment-free" follow-up in this single-blind, parallel group, post-marketing trial. Primary efficacy variable was visual analogue scale (VAS) assessment of pain on movement; secondary efficacy variables included Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC) subscores for stiffness and physical function, rescue medication use and physician's clinical global impression (CGI). Compared to placebo, diacerein showed highly significant (p < 0.01) reductions in VAS pain scores, significant (p < 0.05) reductions in WOMAC physical function scores, significantly lower requirement for rescue medication, and significantly better CGI grades. Incidence of adverse events were significantly (p < 0.01) higher in diacerein arm with urine discoloration and soft stool being the most common ones. However, most events were of mild to moderate intensity. In Indian patients with knee osteoarthritis, diacerein effectively reduces pain and improves physical function, and despite frequent adverse events, overall tolerability seemed to be good.

Tai Chi Is Beneficial for Knee Osteoarthritis

Sherry Boschert is with the San Francisco bureau of Elsevier Global Medical News. SAN FRANCISCO — The gentle martial art tai chi significantly improved pain and physical function in a randomized, controlled trial in 40 obese patients around age 65 with knee osteoarthritis. Participants were randomly selected to attend hour-long classes twice a week for 12 weeks to learn and practice 10 modified forms of classical Yang style tai chi or to receive wellness education and engage in stretching in a control group. Patient characteristics were similar between groups, with baseline pain scores of 209 in the tai chi group and 220 in the control group on the Western Ontario and McMaster Osteoarthritis (WOMAC) Index, which was the main outcome measure. After 12 weeks, WOMAC pain scores decreased by 157 points in the tai chi group and 39 points in the control group, a significant difference (P = .004), Chenchen Wang, MD, reported at the annual meeting of the American College of Rheumatology. She and her associates repeated the pain assessment at 24 and 48 weeks to gauge the durability of the effects. Those who continued their tai chi practice continued to show significant improvements in pain and secondary measures of function, compared with the control group, said Dr. Wang of Tufts University, Boston. The tai chi group showed significant improvements, compared with the control group, in the WOMAC physical function score; the patient and physician global assessment scores (on visual analog scales); a timed chair-stand test; an assessment of knee proprioception; and in depression scores on the Center for Epidemiology Studies Depression (CES-D) Index. “This is a very promising study,” Dr. Wang said. “However, these results should be confirmed by future large studies.” Findings from a previous review by Dr. Wang and her associates of 47 studies of tai chi for various chronic medical problems suggested benefits in physical and mental health and function (Arch. Intern. Med. 2004;164:493-501), but a dearth of high-quality studies left these conclusions in doubt and led to the current study, she said. Sessions in the current trial included a warm-up, review of technique, and practice of the meditative movements, some of which were modified for the osteoarthritic cohort by incorporating chairs or other accommodations. Patients were obese, with a baseline body mass index of 30 kg/m2 in both groups. The mean age was 63 years in the tai chi group and 68 years in the control group. Both groups were predominantly white and female. Patients had had knee osteoarthritis for a mean of 10 years. Some patients used nonsteroidal anti-inflammatory drugs or other analgesics for their arthritis pain during the study, but medication use did not differ significantly between groups. One limitation of the study was that it was not double blind. Also, results could vary depending on the style of tai chi practiced, or by the effectiveness of the teacher or tai chi master, Dr. Wang said.

Intra-articular botulinum toxin A for osteoarticular pain

Intra-articular botulinum toxin A injection (IA BoNT/A) is a promising new approach to arthritis joint pain (Mahowald et al., 2006. J. Neurotoxicity Res. 9, 179). 42 patients with refractory arthritis knee pain were randomized to receive 100 U IA-BoNT/A (B) (Allergan, Inc.) or IA-saline (P). 2 P patients dropped out before 1 mo evaluation, 21/40 patients requested 2nd injection at 1 mo and entered open-label phase. At 1–3 mo fu, 4 P and 3 B patients were re-injected. There was a significant decrease in the Short Form McGill Multidimensional Pain Questionnaire (SF-MPQ) pain score 3 mo after IA-BoNT/A (20.1 to 15.9, p=.022) and a non-significant decrease in the IA-P grp. 10x TST improved significantly in IA-BoNT/A grp (37.3 to 33-s, p=.04) at 3 mo and a non-significant decrease in the IA-P grp. In subgroup analysis based on baseline pain severity we found a greater analgesic effect of IA-BoNT/A in those with severe baseline pain (⩾7 on NRS)—SF-MPQ total pain decreased from 23.8 (8.8) to 15.8 (9.1) at 3 mo (p=.002). 3 mo 10X TST decreased from 37 (10.5) to 31.5 (12.6) s, p=.05. WOMAC Physical Function score improved from 39.8 (8.8) to 32.7 (10.1), p=.013, WOMAC Total score improved from 56.8 (11.4) to 47.6 (13.3), p=.029. There were no significant adverse effects. Results of open-label phase will be discussed. Conclusion: IA-BoNT/A produced clinically and statistically significant decreases in severe OA and RA knee pain, and improvements in function.

Pain, physical functioning and quality of life of individuals awaiting total joint replacement: a longitudinal study

To investigate if pain, physical function and the quality of life changed among adults with osteoarthritis while on the waiting list for hip or knee joint replacement. A longitudinal study of patients listed for primary hip or knee joint replacement. Participants were interviewed at baseline (n = 105) and followed up at 3 (n = 84), 6 (n = 47) and 9 months (n = 24), or until their joint replacement. Measurement tools used were a visual analogue scale (VAS), Western Ontario and McMaster's Universities (WOMAC) Osteoarthritis Index and the Medical Outcomes Study Short Form Health Survey (SF-36). Baseline data indicated high levels of pain as measured by VAS [mean 7.0 (SD 2.2)] and WOMAC pain [mean 11.2 (SD 3.5)]. At baseline, the mean physical function measured by WOMAC was 40.3 (SD 12.1). At the 3-month follow-up, there was significant deterioration in VAS pain scores (0.6; 95% CI mean difference 0.3, 1.0); WOMAC pain scores (1.2; 95% CI mean difference 0.7, 1.8) and WOMAC physical function scores (4.8; 95% CI mean difference 2.8, 6.7) compared with baseline. The often long wait for joint replacement surgery and deterioration in pain and physical function has highlighted the need for active management by health professionals while patients are on the waiting list.

Poster 34: Extended-Release Morphine Sulfate With Sequestered Naltrexone is Effective in Treating the Pain of Osteoarthritis

Objective: To assess the efficacy, tolerability, and pharmacokinetics of an extended-release morphine sulfate plus sequestered naltrexone compound (SNC) (naltrexone released if product tampering occurs) compared with polymer-coated extended-release morphine sulfate (P-ERMS; Kadian). Design: Prospective, randomized, double-blind crossover. Setting: Outpatient research sites. Participants: Adults (N=113) unable to control osteoarthritis (hip, knee) pain with nonopioid analgesics or received ≤40mg/d of oral morphine equivalents. Patients (median age, 57.0y) were mostly women (68.5%) and white (88.3%). Interventions: Washout from previous medication, P-ERMS dose titration to effective analgesia, two 14-day treatment periods (P-ERMS or SNC), 7 days P-ERMS after each treatment period. Main Outcome Measures: Average pain intensity (0−10 scale); daily Brief Pain Inventory (BPI) (worst, least, average, current; 0−10 scales); Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; Patient Global Assessment of Medication (1 [poor] to 5 [excellent]); morphine, naltrexone, and 6-β naltrexol pharmacokinetics. Results: Mean pain intensity after washout was 7.1; after P-ERMS titration, 2.1. For treatment days 7 and 14, intensities were: P-ERMS, 2.3 and 2.4; SNC, 2.4 and 2.3 (P=NS), respectively. For the BPI scales, P-ERMS and SNC were similar over the 14-day periods. WOMAC pain, physical function, and composite scores were similar between treatments. Most patients rated medications as good to excellent (P-ERMS, 78.9%; SNC, 91.5%). Steady-state morphine exposure area under the curve was similar between treatments. Most naltrexone levels were below limits of quantification; 6-β naltrexol levels were low or below limit of quantification. Adverse events were mostly mild to moderate; most common were: constipation (double-blind P-ERMS, 12.7%; SNC, 15.5%), nausea (8.5%; 9.9%), and somnolence (8.5%; 9.9%). Conclusions: SNC provided similar pain relief to P-ERMS; most patients rated P-ERMS and SNC as good to excellent. Naltrexone was adequately sequestered; low levels, when present, did not negatively impact patients’ pain scores or produce symptoms associated with opioid withdrawal.

Steroid injection for osteoarthritis of the hip: A randomized, double‐blind, placebo‐controlled trial

To determine the efficacy of fluoroscopically guided corticosteroid injection for hip osteoarthritis (OA) in a randomized, double-blind, placebo-controlled trial. Fifty-two patients with symptomatic hip OA were randomly allocated to receive placebo (10 mg bipuvicaine, 2 ml saline) (n = 21) or corticosteroid treatment (10 mg bipuvicaine, 40 mg triamcinolone hexacetonide) (n = 31). Patients were followed up for 1, 2, 3, and 6 months. The primary outcome measure was the pain improvement response, defined as a 20% decrease in the Western Ontario and McMaster Universities OA Index (WOMAC) pain score (on 5 100-mm visual analog scales [VAS]) (WOMAC20) from baseline to 2 months postinjection. Secondary outcomes were a 50% decrease in the WOMAC pain score (WOMAC50), changes in other WOMAC subscale scores, patient's global assessment of health (on a 100-mm VAS), and Short Form 36 (SF-36) quality of life indices. Analyses were based on the intent-to-treat principle. The mean WOMAC pain score fell 49.2% (decreasing from 310.1 mm to 157.4 mm) at 2 months postinjection in patients receiving corticosteroid, compared with a decrease of 2.5% (from 314.3 mm to 306.5 mm) in the placebo group (P < 0.0001). The proportion of WOMAC20 responders at 2 months' followup was significantly higher in the corticosteroid group (67.7%) compared with the placebo group (23.8%) (P = 0.004); similar proportions of WOMAC50 responders were observed between groups (61.3% in the corticosteroid group versus 14.3% in the placebo group; P = 0.001). Response differences were maintained at 3 months' followup (58.1% responders in the corticosteroid group versus 9.5% responders in the placebo group; P = 0.004). Significant differences in the WOMAC stiffness and physical function scores (P < 0.0001), patient's global health scores (P = 0.005), and SF-36 physical component scores (P = 0.04) were observed, with patients in the corticosteroid group showing greater improvements. There were no differences in the frequency of adverse events between groups. This placebo-controlled trial confirms that corticosteroid injection can be an effective treatment of pain in hip OA, with benefits lasting up to 3 months in many cases. Future studies should address questions related to the benefits of repeated steroid injection and the effects of this treatment on disease modification.

Effects of quadriceps electrical stimulation program on clinical parameters in the patients with knee osteoarthritis

The aim of this study was to evaluate the effects of electrical stimulation program on pain, disability, and quadriceps strength in the patients with knee osteoarthritis. Fifty women diagnosed as knee osteoarthritis were randomized into two groups as electrical stimulation and biofeedback-assisted isometric exercises. Both of the programs were performed 5 days a week, for a duration of 4 weeks. Outcome measures for pain were visual analogue scale pain score and Western Ontario McMaster osteoarthritis index (WOMAC) pain score. Disability and stiffness were assessed with WOMAC physical function and stiffness score. One repetition maximum (RM) and 10 RM were used for measuring quadriceps strength. In addition, 50 m walking time and 10 steps stairs climbing up-down time were evaluated. Both groups showed significant improvements in pain, physical function, and stiffness scores after the therapy. There were statistically significant improvements in 50 m walking time and 10 steps stairs climbing up-down time and 1 RM and 10 RM values indicating the improvement in muscle strength. In addition, there were no significant differences between the groups after the therapy. We conclude that electrical stimulation treatment was as effective as exercise in knee osteoarthritis and electrical stimulation treatment can be suggested especially for the patients who have difficulty in or contraindications to perform an exercise program.

(818): Health-related quality-of-life (HRQoL) outcomes for patients with chronic osteoarthritis (OA) pain of the hip or knee treated with once-daily OROS hydromorphone versus ER oxycodone

Health-related quality-of-life (HRQoL) measures provide important information about the outcomes of treatment from the patient’s perspective. In this study, HRQoL outcomes of opioid therapy for the treatment of chronic osteoarthritis (OA) pain were evaluated. A 6-week, open-label, randomized, comparative, repeated-dose, parallel-group study assessed the efficacy, safety, and quality-of-life impact of once-daily OROS® hydromorphone and twice-daily ER oxycodone in 126 patients with chronic OA pain of the knee or hip who had received chronic NSAIDs or another non-steroidal, non-opioid analgesic. Patients completed the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire at baseline and after 6 weeks of treatment. HRQoL outcomes were defined as changes in WOMAC scale scores from baseline to 6 weeks and were evaluated within and between treatment groups using analysis of variance. Large effect size (>0.8 SD unit) improvements in WOMAC scale scores were observed in both treatment groups. Among OROS® hydromorphone patients, mean (SE) scores improved by 12.6 (±1.6, P< .001) points on the WOMAC physical function scale, 4.3 (±0.5, P< .001) points on the WOMAC pain scale, and 1.7 (±0.2, P< .001) points on the WOMAC stiffness scale. For patients receiving ER oxycodone, scores improved by 11.8 (±1.8, P< .001) points on the WOMAC physical function scale, 4.0 (±0.5, P< .001) points on the WOMAC pain scale, and 1.8 (±0.3, P< .001) points on the WOMAC stiffness scale. Differences in outcomes between treatment groups were not statistically significant. OROS® hydromorphone provides an effective once-daily treatment option for patients with chronic OA pain as evidenced by the significant HRQoL improvement (relative to baseline) in WOMAC physical function, pain, and stiffness scale scores.

Comparison of the therapeutic efficacy of TENS versus intra-articular hyaluronic acid injection in patients with knee osteoarthritis: A prospective randomized study

Knee osteoarthritis (OA) is perceived as a major public health problem, and today, various treatment modalities are used to manage this condition. The purpose of this study was to assess and compare the efficacy of transcutaneous electrical nerve stimulation (TENS) and intra-articular hylan G-F 20 (Synvisc; Genzyme Corporation, Ridgefield, NJ) in patients with symptomatic knee OA. A total of 60 patients with primary knee OA were randomized into 2 treatment groups. TENS was applied for 3 weeks in the first group, and in the second group, hylan G-F 20 was injected intra-articularly once a week for 3 weeks. Patients were then followed for 6 months. Disease severity was measured with the Lequesne Index. Efficacy in terms of pain, functional status, and quality of life was assessed through analysis of changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and short Form 36 Health Survey (SF-36) scores. Adverse events were monitored throughout the study. WOMAC pain scores were improved at the first control visit in the TENS group and in the viscosupplementation group; this improvement was statistically significant. WOMAC stiffness scores showed a statistically significant decrease in the TENS group at the first control visit. Stiffness did not decrease during the first month in the second group; however, these patients exhibited improvement during the sixth month after injection. Physical function scores and SF-36 total scores did not change in either group after treatment. Pain relief was observed at the first month and continued throughout the 6-month follow-up period in both groups. Stiffness decreased by the sixth month in both groups. Improvement in WOMAC physical function scores was greater in the intra-articular hylan group than in the TENS group at the end of follow-up; however, quality of life was not improved in either group. These therapies used in combination may alleviate symptoms in patients with OA.

A prospective randomised controlled clinical trial comparing the efficacy of different molecular weight hyaluronan solutions in the treatment of knee osteoarthritis

Viscosupplementation consists of injecting exagenous hyaluronan (HA) into the synovial joints to restore the normal rheological environment which deteriorates severely in osteoarthritic (OA) joints. Efficacy might be related to the rheological properties and molecular weight (MW) of the hyaluronan preparations. This prospective, controlled, double-blind, randomised clinical trial was aimed at comparing the elastoviscous properties of a high molecular weight viscosupplement, hylan G-F 20, with that of a lower molecular weight hyaluronan product in order to determine the relationship of elastoviscosity to efficacy, alongside placebo, in the treatment of patients with knee OA. The results were analysed as a "completers" analysis with 59 patients. Primary outcome measures included the Western Ontario and Mc Master Universities' Osteoarthritis Index (WOMAC) for pain, stiffness and function scores, and patient and physician global assessments (0-100 scale). For patient (PGA) and physician global assessments (PhGA), the 0-100 scale was used, with 100 being the worst. Follow-up assessments were made at intervals of 1, 3 and 6 months after the first injection. Local adverse events, such as transient pain at the injection site or warm knee lasting for one night, were recorded in two patients (3%). In all groups, the WOMAC pain score exhibited a significant difference from the baseline value; neither treatment group was significantly different from the placebo group, but total pain score was significantly better than baseline for both of the HA groups at the end of 6 months (p < 0.05). Improvement in WOMAC physical function score favoured both sodium hyaluronate and hylan G-F 20 after the first month, and remained significant until the end of 6 months (p < 0.01). In the placebo group, the physical function scores became worse after the end of the 1st month; the scores at the end of 6 months were no different from those at the beginning. The WOMAC stiffness scores of both of the hyaluronic acid groups improved with the first injection, and remained significantly better than the placebo group until the end of the survey (p < 0.001). All groups expressed improvement with PGA scores after the first injection. At the end of 6 months all three groups were similar, but the treatment groups were significantly better than the placebo group (p < 0.05), and all were significantly better than at the beginning (p < 0.05). The PhGA scores were similar in all groups until after the third injection. The second group was slightly better in the controls at 1 and 3 months, but all the groups were similar at the end of 6 months. Although the placebo group seemed worse, it was not statistically significant. Compared with lower molecular weight HA, the higher molecular weight HA might be more efficacious in treating knee OA, but heterogeneity of previous studies limited definitive conclusions. Patients treated by injection of either of two hyaluronan preparations showed clinical improvement for pain, though no different from the placebo group; WOMAC stiffness scores were better than placebo in the HA groups, whereas PGA scores showed improvement in all groups but HA groups were better than placebo. PhGA scores were worse in the placebo group, but not to a statistically-significant extent. The HA groups did not differ in terms of clinical efficacy.

Effects of different hyaluronic acid products on synovial fluid NO levels in knee osteoarthritis

The aim of the present study was to evaluate the effects of different hyaluronic acid forms on synovial fluid nitric oxide (NO) levels and glutathione peroxidase (GSHPx) activities in the treatment of patients with knee osteoarthritis (OA). Forty patients were equally randomized into two groups and treated with native sodium hyaluronate (group I) or with cross-linked hylan G-F 20 (group II). Clinical evaluations and synovial fluid aspirations were performed before the first (baseline), the second (week 1), and third injections (week 2), and a week after the third injection (week 3). NO levels were reduced at the end of the study in both groups (p<0.01 in group I, p=0.001 in group II), while no significant change was found in GSHPx activity. Also, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores and WOMAC physical function scores were gradually improved at all follow-ups in the two groups. No significant differences between the two groups of NO levels, GSHPx activity, WOMAC pain scores, WOMAC stiffness scores, and WOMAC physical function scores were recorded during the study. Intra-articular hyaluronic acid therapy may reduce synovial fluid NO levels. These effects do not seem to be dependent on the molecular weight and various structural changes of hyaluronan products.