L. Nairn

Glucosamine and chondroitin for knee osteoarthritis: a double-blind randomised placebo-controlled clinical trial evaluating single and combination regimens

Objective To determine if the dietary supplements, glucosamine and/or chondroitin, result in reduced joint space narrowing (JSN) and pain among people with symptomatic knee osteoarthritis. Methods A double-blind randomised placebo-controlled clinical trial with 2-year follow-up. 605 participants, aged 45–75 years, reporting chronic knee pain and with evidence of medial tibio-femoral compartment narrowing (but retaining >2 mm medial joint space width) were randomised to once daily: glucosamine sulfate 1500 mg (n=152), chondroitin sulfate 800 mg (n=151), both dietary supplements (n=151) or matching placebo capsules (n=151). JSN (mm) over 2 years was measured from digitised knee radiographs. Maximum knee pain (0–10) was self-reported in a participant diary for 7 days every 2 months over 1 year. Results After adjusting for factors associated with structural disease progression (gender, body mass index (BMI), baseline structural disease severity and Heberdens nodes), allocation to the dietary supplement combination (glucosamine–chondroitin) resulted in a statistically significant (p=0.046) reduction of 2-year JSN compared to placebo: mean difference 0.10 mm (95% CI 0.002 mm to 0.20 mm); no significant structural effect for the single treatment allocations was detected. All four allocation groups demonstrated reduced knee pain over the first year, but no significant between-group differences (p=0.93) were detected. 34 (6%) participants reported possibly-related adverse medical events over the 2-year follow-up period. Conclusions Allocation to the glucosamine–chondroitin combination resulted in a statistically significant reduction in JSN at 2 years. While all allocation groups demonstrated reduced knee pain over the study period, none of the treatment allocation groups demonstrated significant symptomatic benefit above placebo. Trial Registration ClinicalTrials.gov identifier: NCT00513422; http://www.clinicaltrials.gov

Early Rehabilitation After Total Knee Replacement Surgery: A Multicenter, Noninferiority, Randomized Clinical Trial Comparing a Home Exercise Program With Usual Outpatient Care

To determine, at 6 weeks postsurgery, if a monitored home exercise program (HEP) is not inferior to usual care rehabilitation for patients undergoing primary unilateral total knee replacement (TKR) surgery for osteoarthritis.

Self‐reported knee instability before and after total knee replacement surgery

To determine the prevalence and burden of pain and activity limitations associated with retaining presurgery self‐reported knee instability 6 months after total knee replacement (TKR) surgery and to identify early potentially modifiable risk factors for retaining knee instability in the operated knee after TKR surgery.

Post-Acute Rehabilitation After Total Knee Replacement: A Multicenter Randomized Clinical Trial Comparing Long-Term Outcomes

To evaluate the long‐term benefit of providing a post‐acute, outpatient group exercise program for patients following primary total knee replacement (TKR) surgery for osteoarthritis.

Prevalence and determinants of physical activity and sedentary behaviour before and up to 12 months after total knee replacement: a longitudinal cohort study:

Objective: This study aims to evaluate the prevalence and determinants of inadequate physical activity and excessive sedentary behaviour before and after total knee replacement. Design, setting and subjects: Secondary analysis was performed on data from a cohort of 422 adults (45–74 years), drawn from 12 public or private hospitals, undergoing primary unilateral or bilateral total knee replacement surgery. Main measures: Questionnaires were used to determine the presence of inadequate physical activity and excessive sedentary behaviour before and 6  and 12 months after total knee replacement surgery. Knee pain, activity limitations, comorbidities, muscle strength, psychological well-being, fatigue, sleep and body mass index were measured/assessed as possible determinants of physical activity or sedentary behaviour. Results: Before surgery, 77% (n = 326) of the cohort participated in inadequate physical activity according to World Health Organization guidelines, and 60% (n = 253) engaged in excessive sedentary behaviour. Twelve months after surgery, 53% (n = 185) of the cohort engaged in inadequate physical activity and 45% (n = 157) in excessive sedentary behaviour. Inadequate physical activity before surgery (P = 0.02), obesity (P = 0.07) and comorbidity score >6 (P = 0.04) predicted inadequate physical activity 12 months after surgery. Excessive sedentary behaviour and activity limitations before surgery predicted excessive sedentary behaviour 12 months after surgery. Conclusion: Although there were improvements after total knee replacement, 12 months after surgery about half the cohort did not meet World Health Organization recommendations for activity. Pre-surgery assessment of physical activity, activity limitations, sedentary behaviour and body mass index is essential to identify patients at risk for long-term inactivity.

Prevalence and Determinants of Fatigue Following Total Knee Replacement: A Longitudinal Cohort Study.

To evaluate the prevalence and determinants of clinically important fatigue before and up to 12 months after total knee replacement (TKR) surgery.

352 WORK DISABILITY AMONG PEOPLE WITH MILD TO MODERATE KNEE OSTEOARTHRITIS

open-ended free text question, which were coded into thematic groups. Ordered logistic regression modelling was used to look at the association between patients pre-operative expectations and baseline characteristics (age, sex, education, ASA status, K&L grade, obesity, medication use, WOMAC score, EQ5D score). The OMERACT-OARSI responder criteria were used to classify patients as improved/not improved 12-months after THR. Logistic regression modelling was used to explore whether pre-operative expectations predict response to THR, adjusting for baseline characteristics. Results: A greater number of recorded pre-operative expectations were associated with younger age, women, more education, lower ASA grade, obesity, greater medication use, and worse pre-operative pain and function (WOMAC score). Analyses identifying predictors of outcome, suggested that the more pre-operative expectations a patient had, the more likely they were to improve after surgery. Each individual expectation a patient had, was associated with a 26% increase in the probability of improvement (95%CI 1%-56%). Sensitivity analyses, using different methods to classify patients as responders to surgery, support this finding. Analyses within WOMAC subgroups suggest the association is strongest for stiffness and function. Other predictor variables were associated with improved patient outcomes. Educated people had greater improvement following surgery, as were those with worse baseline pain and function. Patients with less severe radiographic change had a better outcome. Patients with higher ASA grades were less likely to respond, as were obese patients. Age, sex and pre-operative medication use were not associated with outcome. Conclusions: This study demonstrates variability in patients’ pre-operative expectations of THR surgery. Patients with a larger number of pre-operative expectations are more likely to have a good clinically important outcome 12-months post-THR. This appears to be driven more by stiffness and function, rather than pain. The majority of patients described expectations regarding function which is likely an artefact of how the expectation question was worded, asking patients what they would be “able to do”. These findings have implications for informed patient-clinician decision-making. As unfulfilled expectations are related to patients reporting poor outcomes of surgery and lower levels of satisfaction, some have suggested surgeons should attempt to moderate patients hopes of surgery when discussing the likely outcomes of surgery given their individual characteristics. An alternative point of view is that the patients greater expectations contributed to outcome by acting as a psychological contextual factor, which ultimately influences pain and function post-op (unconditioned “placebo”). Further research should address these two different causes of action.

338 SCREENING, RECRUITMENT AND BASELINE CHARACTERISTICS OF THE LONG-TERM EVALUATION OF GLUCOSAMINE SULPHATE (LEGS) STUDY PARTICIPANTS

Clinical trials evaluating potential ’disease-modifying’ agents for osteoarthritis are required to demonstrate both symptomatic and structural benefit. Ideally, to reduce ceiling or floor effects, study participants are required to have at least moderate pain, yet retain sufficient tibiofemoral joint space to allow the measurement of narrowing over time. To describe study recruitment procedures and baseline demographics of people with symptomatic knee osteoarthritis participating in the Long-term Evaluation of Glucosamine Sulphate (LEGS) study (NCT00513422).

P295 THE PHYSICAL ACTIVITY FOR OSTEOARTHRITIS MANAGEMENT (PAFORM)STUDY. A RANDOMISED CONTROLLED CLINICAL TRIAL EVALUATING HYDROTHERAPY AND TAI CHI CLASSES

Purpose: To determine whether Tai Chi or hydrotherapy classes for people with chronic symptomatic hip or knee osteoarthritis (OA) can result in measurable clinical benefits. Methods: A randomised controlled trial was conducted among 152 people, aged 59 years and over, with chronic symptomatic hip or knee OA. Participants were randomly allocated for 12 weeks to hydrotherapy classes (n=55), Tai Chi classes (n=56) or waiting list control (n=41). Outcomes were assessed at 12 weeks (post treatment) and 24 weeks (sustainability) after randomisation and included pain and physical function (WOMAC), general health status (SF-12v2), psychological well being and physical performance (‘up and go’, 50 ft walk time, timed stair climb). Results: At the 12 week post treatment assessment, 49% (n=27), 34% (n=19) and 15% (n=6) of participants allocated to hydrotherapy, Tai Chi and control group, respectively, were treatment responders according to OMERACT-OARSI responder criteria D. The difference in treatment responder rate between the three allocation groups was significant (chi-squared=12.4, df = 2, p=0.002). Compared with control, participants allocated to hydrotherapy classes demonstrated mean improvements (95% confidence interval) of 6.5 (0.4 to 12.7) and 10.5 (3.6 to 14.5) for pain and physical function scores (range 0-100), respectively, while participants allocated to Tai Chi classes demonstrated improvements of 5.2 (-0.8 to 11.1) and 9.7 (2.8 to 16.7). The 95% CI for treatment effect sizes for physical function for hydrotherapy or Tai Chi classes ranged from moderate to large (.50 to .76). Both class allocations achieved significant improvements in the SF-12 physical component summary score, but only allocation to hydrotherapy classes achieved significant improvements in the measures of physical performance. All significant improvements were sustained at 24 weeks after randomisation. In this almost exclusively Caucasian sample, class attendance was higher for hydrotherapy with 81% attending at least half of the available 24 classes, compared with 61% for Tai Chi. Conclusions: Access to either hydrotherapy or Tai Chi classes can provide sustained improvements in pain and physical function for many older, sedentary people with chronic symptomatic hip or knee OA. The improvements achieved in physical function were greater than those demonstrated for traditional land-based exercise programs.