| Methods |
Randomised
Controlled
Trial
Double‐blind
Parallel‐group
Both per protocol and ITT analyses |
| Participants |
Country:
England
Mean age:71
% Female:62
Mean disease duration: NR
Duration:6 mth
Number randomised:63
(HA 32, TH 31)
Inclusion:
bilateral effusions
bilateral sympto‐
matic knee OA
(ARA criteria)
self‐selected knee pain average of >30 mm during 2 wk run‐in
Exclusion:
Coexistent rheumatological or serious medical disease
Baseline values:
pain on nomina‐
ted activity
HA:77.2, TH:75.8
pain at rest
HA:53.2, TH:55.3
pain at night
HA:57.8, TH:62.2 |
| Interventions |
Hyalgan (20mg)
5 weekly injections
Triamcinolone hexacetonide 20 mg followed by 4 placebo (1 ml of 0.9% saline) injections
Concurrent therapy:
Paracetamol per‐
mitted |
| Outcomes |
pain on self‐selected activity (10 cm VAS)‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
pain at rest, night
duration of stiffness
range of motion
joint effusion
local heat
synovial thickening
joint line and periarticular tenderness
xray score
synovial fluid volume |
| Notes |
Jadad's:4/5
R‐1,B‐2,W‐1
Active treatment was always given to worse knee with contra‐
lateral knee re‐
ceiving 5 placebo
injections
Joint aspirated to dryness before
injection.
Study sponsored by Fidia SPA. Drs. B. Guillou and J.M. Grouin of Fidia S.p.A. provided statistical analysis. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
