WOMAC Pain Subscale Score Research Articles

A Phase 3 study of lower-dose diclofenac submicron particle capsules demonstrates effective pain relief in patients with osteoarthritis

A Phase 3 study of lower-dose diclofenac submicron particle capsules demonstrates effective pain relief in patients with osteoarthritis

Women Recover Faster Than Men after Standard Knee Arthroplasty

Specific anatomic differences are believed to account for gender-specific function and health-related quality of life after TKA. However, there are conflicting data in the literature regarding these gender-specific outcomes, especially as woman appear to have surgery later in the course of the disease compared with men. We asked whether (1) women had worse knee function and health-related quality of life after TKA compared with men, (2) lower improvements in scores, and (3) slower recovery after surgery. Using a cohort study design, we retrospectively analyzed prospectively collected data from three multicenter randomized controlled trials evaluating rehabilitation measures after standard unisex knee arthroplasty in 494 patients (141 men and 353 women). The primary outcome was self-reported physical function as measured by the WOMAC at 3, 6, 12, and 24 months after surgery. Secondary outcomes included the pain and stiffness scales of the WOMAC and the physical and mental component summaries of the SF-36. At the time of surgery, the women were on average older (70.8 versus 67.8 years), had lower mean physical function (55 versus 47), higher mean pain scores (54 versus 48), and greater stiffness (54 versus 46) as measured by the WOMAC. At the 3-, 6-, 12-, and 24-month followups, men and women had similar WOMAC scores. Improvements were greater for women compared with men for WOMAC function and pain subscale scores at the 3-month (function, 28 versus 23; pain, 32 versus 25) and 6-month followups (function, 32 versus 27; pain, 36 versus 31). At the 12- and 24-month followups we noted no differences in improvement between men and women. Although women had greater functional limitations at the time of surgery than men, they recover faster early after standard TKA although function is similar at 12 and 24 months. Women also had greater improvement of WOMAC scores after standard TKA than men. Level II, prognostic study. See the guidelines for authors for a complete description of levels of evidence.

Inflammatory Characteristics on Ultrasound Predict Poorer Longterm Response to Intraarticular Corticosteroid Injections in Knee Osteoarthritis

To assess whether inflammation on ultrasound is predictive of clinical response to intraarticular (IA) corticosteroid injections in patients with knee osteoarthritis (OA). Patients with symptomatic knee OA were randomized to receive either an IA injection of 40 mg triamcinolone acetonide in the treatment group or 1 cc 0.9% saline in the placebo group. Clinical response was assessed by changes in baseline Western Ontario and McMaster Universities (WOMAC) index scores and physician global assessment at 4 and 12 weeks. Ultrasounds were performed at each visit. Patients and assessors were blinded to treatment status. Seventy-nine patients were enrolled into the study. Four-week data were available for 67 patients in the primary analysis comparing change in WOMAC pain score from baseline to 4 weeks. There was almost no change in the WOMAC pain subscale score from baseline to 4 weeks in the control group, but there was a significant improvement in WOMAC pain subscale score from 10.8 (SD +/- 3.2) at baseline to 8.75 (SD +/- 4.0) at 4 weeks in the treatment group (adjusted p = 0.001). Of the 34 patients in the treatment group; 16 (47%) had inflammatory disease and 18 (53%) had noninflammatory disease as determined by ultrasound. There was no difference in the change in WOMAC pain score between the inflammatory and noninflammatory patients in the treatment group at 4 weeks. There was a statistically significant greater improvement in pain subscale scores among noninflammatory patients than among inflammatory patients at 12 weeks. Intraarticular corticosteroid injections are an effective short-term treatment for symptomatic knee OA compared to placebo. Patients with noninflammatory characteristics on ultrasound had a more prolonged benefit from IA corticosteroids compared to inflammatory patients.

Nettle sting for chronic knee pain: A randomised controlled pilot study

Non-pharmacological interventions for chronic knee pain are increasingly requested by patients and are recommended in current treatment guidelines. An intervention that has been used for many years for pain relief is nettle sting. To explore the feasibility of a definitive RCT of nettle sting for chronic knee pain, in particular the acceptability of the research to GPs and patients, and the optimal methods for recruitment and outcome measurement. Patient blinded pilot RCT, set in two inner city primary care practices in Plymouth, UK. Potential participants were identified from practice computerised databases using three different approaches: age and analgesic use, age and appropriate Read code, or age alone. Patients had to be aged between 55 and 80 years with knee pain and a presumptive clinical diagnosis of OA knee, with a baseline WOMAC pain subscale score of more than 4. They were randomised to receive either treatment with Urtica dioica, or placebo intervention with Urtica galeopsifolia daily for 1 week. The main outcome measure for the treatment effect was the WOMAC pain subscale; other outcomes included quantitative and qualitative data to inform the design of a future study. Out of 45 patients who were eligible, 42 were recruited. Invitations targeted at patients who were both currently receiving repeat prescriptions for non-steroidal or analgesic drugs and had relevant Read codes proved most efficient for recruitment. Mean baseline WOMAC pain subscale scores were 9.2 (S.D. 3.4) and 7.9 (2.3) in the two groups. The mean reduction in pain score at the end of treatment in the nettles group was 1.7 (95% confidence interval 0.6, 2.9) and in the controls 1.6 (CI 0.5, 2.7). All GP practices, and all patients approached, were willing to be involved in the research. Patients liked the treatment mostly because it was 'natural'. The sting was acceptable and viewed as a minor irritation. Research into nettle sting is acceptable to patients and GPs, and patients do not find the treatment more than a minor irritation. Larger rigorous studies are justified to determine the effectiveness of this ancient therapy.

Acupuncture treatment for chronic knee pain: a systematic review

To evaluate the effects of acupuncture on pain and function in patients with chronic knee pain. Systematic review and meta-analysis of randomized controlled trials of adequate acupuncture. Computerized databases and reference lists of articles were searched in June 2006. Studies were selected in which adults with chronic knee pain or osteoarthritis of the knee were randomized to receive either acupuncture treatment or a control consisting of sham (placebo) acupuncture, other sham treatments, no additional intervention (usual care), or an active intervention. The main outcome measures were short-term pain and function, and study validity was assessed using a modification of a previously published instrument. Thirteen RCTs were included, of which eight used adequate acupuncture and provided WOMAC outcomes, so were combined in meta-analyses. Six of these had validity scores of more than 50%. Combining five studies in 1334 patients, acupuncture was superior to sham acupuncture for both pain (weighted mean difference in WOMAC pain subscale score = 2.0, 95% CI 0.57-3.40) and for WOMAC function subscale (4.32, 0.60-8.05). The differences were still significant at long-term follow-up. Acupuncture was also significantly superior to no additional intervention. There were insufficient studies to compare acupuncture with other sham or active interventions. Acupuncture that meets criteria for adequate treatment is significantly superior to sham acupuncture and to no additional intervention in improving pain and function in patients with chronic knee pain. Due to the heterogeneity in the results, however, further research is required to confirm these findings and provide more information on long-term effects.

Musculoskeletal findings in obese subjects before and after weight loss following bariatric surgery

To determine the point prevalence of painful musculoskeletal (MSK) conditions in obese subjects before and after weight loss following bariatric surgery. Longitudinal, interventional, unblended. Forty-eight obese subjects (47 women, one man, mean age 44+/-9 years; mean body mass index (BMI) 51+/-8 kg/m(2)) recruited from an academic medical center bariatric surgery program. Comorbid medical conditions; MSK findings; BMI; Western Ontario McMaster Osteoarthritis Index (WOMAC) for pain, stiffness and function; and SF-36 for quality of life. Consecutive subjects were recruited from the University Hospitals of Cleveland Bariatric Surgery Program. Musculoskeletal signs and symptoms and non-MSK comorbid conditions were documented at baseline and at follow-up. SUBJECTS completed the SF-36 and the WOMAC questionnaires. Analyses were carried out for each MSK site, fibromyalgia syndrome (FMS) and for the cumulative effect on the spine, upper and lower extremities. The impact of change in comorbid medical conditions, BMI, physical and mental health domains of the SF-36 on the WOMAC pain subscale score was evaluated. SF-36 outcomes were compared to normal published controls. Forty-eight subjects were available for baseline and a follow-up assessment 6-12 months after gastric bypass surgery. They lost an average of 41+/-15 kg and the mean BMI decreased from 51+/-8 to 36+/-7 kg/m(2). Baseline comorbid medical conditions were present in 96% before surgery and 23% after weight loss. There was an increased prevalence of painful MSK conditions at baseline compared to general population frequencies. Musculoskeletal complaints had been present in 100% of obese subjects before, and 23% after weight loss. The greatest improvements occurred in the cervical and lumbar spine, the foot and in FMS (decreased by 90, 83, 83 and 92%, respectively). Seventy-nine percent had upper extremity MSK conditions before and 40% after weight loss. Before surgery, 100% had lower extremity MSK conditions and only 37% did after weight loss. The WOMAC subscale and composite scores all improved significantly, as did the SF-36((R)). Change in BMI was the main factor impacting the WOMAC pain score. There was a higher frequency of multiple MSK complaints, including non-weight-bearing sites compared to historical controls, before surgery, which decreased significantly at most sites following weight loss and physical activity. These benefits may improve further, as weight loss may continue for up to 24 months. The benefits seen with weight loss indicate that prevention and treatment of obesity can improve MSK health and function.

Multicenter, randomized, double-blind, active-controlled, parallel-group trial of the long-term (6–12 months) safety of acetaminophen in adult patients with osteoarthritis

Objective: This study evaluated the safety of acetaminophen 4 g/d administered for up to 12 months to adult patients with osteoarthritis pain, using naproxen 750 mg/d as an active comparator. Methods: This multicenter, multidose, single-dummy, randomized, double-blind, active-controlled, parallel-group study enrolled patients with mild to moderate osteoarthritis pain of the hip or knee. Patients received acetaminophen 4 g/d or naproxen 750 mg/d for 12 months (group 1) or 6 months (group 2). Patients in both groups had follow-up visits at months 1, 3, and 6 of treatment (or at the time of study withdrawal). Patients in group 1 also had follow-up visits at months 9 and 12 (or at the time of study withdrawal). Tolerability evaluations consisted of determinations of hepatic (aminotransferase activities) and renal (serum creatinine) function, adverse events, and physical examinations. Adverse events reported by the patient or observed by the investigator during clinical evaluation were recorded. In addition, patients were questioned at each visit regarding the occurrence of adverse events using a nonspecific question. Investigators rated the intensity of adverse events and their subjective assessment of the relationship to study medication while blinded to the treatment group. At all visits, patients completed the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in visual analog scale format, to assess pain, stiffness, and physical function over the previous 2 weeks. The primary efficacy end point was the mean change from baseline in the WOMAC pain subscale score at 6 months. Data from the 6- and 12-month groups were combined for analysis. Results: Of 581 randomized patients, the safety population included 571 patients who received ≥1 dose of study medication. The 571 patients had a mean (SD) age of 59.3 (8.6) years, 395 (69.2%) were female, and 480 (84.1%) were white. Of 290 patients randomized to receive acetaminophen, 134 completed 3 months of treatment, 96 completed 6 months, 60 completed 9 months, and 55 completed a full 12 months. The median dose adherence ranged from 95.5% to 98.6% during the trial. The completion and adherence patterns were similar for patients receiving naproxen. Of 291 patients randomized to receive naproxen, 151 completed 3 months, 124 completed 6 months, 85 completed 9 months, and 80 completed 12 months. The median dose adherence ranged from 96.4% to 98.4% during the trial. No patient in either treatment group experienced hepatic failure, hepatic dysfunction, aminotransferase levels ≥2x the upper limit of the reference range, renal failure, or serum creatinine levels ≥1.5x the upper limit of the reference range. No statistically significant differences were observed between the 2 treatment groups in the proportion of patients who reported ≥1 adverse event (206 [71.8%] acetaminophen, 209 [73.6%] naproxen) or in the proportion of patients who discontinued treatment because of adverse events (71 [24.7%] acetaminophen, 63 [22.2%] naproxen). Among adverse events considered to be drug related and reported by ≥1% of patients, constipation and peripheral edema were reported more frequently in the naproxen group than in the acetaminophen group (9.9% vs 3.1% [ P<0.002] and 3.9% vs 1.0% [ P<0.033], respectively). No adverse event reported in the acetaminophen group was considered both serious and related to study medication. One subject in the naproxen group had an event that was considered serious and related to study drug: gastrointestinal bleeding. No statistically significant differences were observed between the 2 treatment groups for the primary efficacy end point. Conclusion: With physician supervision, acetaminophen was found to be generally well tolerated in these patients for the treatment of osteoarthritis pain of the hip or knee for periods of up to 12 months.