| Methods |
Randomised
Controlled
Trial
Double‐blind
Masked observer
Parallel‐group
Multicentre (n=15)
Double‐dummy
Stratified by pain severity
Placebo and
naproxen controlled
2 week washout
Both per protocol n=333 (HA 105, PL 115,
naproxen 113) and post‐hoc ITT analyses |
| Participants |
Country:
United States
Mean age:64
% Female:58
Mean disease duration:NR
Duration:26 wk
Number randomised:495
(HA 164, PL 168, naproxen 163)
Inclusion:
>= 40 y
knee OA (ACR criteria)
knee pain >= 1 y
knee pain >= 20/100 mm VAS on 50 foot walk
pain >= 20 mm on >= 1 WOMAC pain items
moderate or marked pain on 6 point categorical scale
xray >= 1 osteophyte and Kellgren and Lawrence Grade 2 to 3
no prior IA HA within 1 y
no other IA injection within 3 mth
Exclusion:
NR
Baseline values:
50 foot walk pain HA: 54
PL: 55
Naproxen: 54 |
| Interventions |
Hyalgan 2 ml (20 mg) 5 weekly injections in
saline vehicle
+lidocaine and SF aspiration
+oral placebo bid
Placebo=lidocaine + SF aspiration
+ 2 ml saline 5 weekly injections
+oral placebo bid
naproxen 500 mg bid + lidocaine ( 5 weekly sham injection) + SF aspirated only if effusion
Concurrent therapy:
acetaminophen 2000 mg daily per‐
mitted, aspirin <=
650 mg permitted |
| Outcomes |
Pain on 50 foot walk on 10 cm VAS immediately after walk‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Pt. and observer global assess‐
ments of knee pain six point categorical scale
(none,slight,mild,
moderate,
marked)
50 foot walk time
WOMAC VAS
heel to buttock distance (cm)
knee range of motion (degrees)
by goniometry
midpatellar knee circumference
synovial effusion (presence/absence)
acetaminophen tablet count
overall evaluation of treatment by pt. and observer |
| Notes |
Jadad's:4/5
R‐1,B‐2,W‐1
Worse knee selected for study if bilateral.
Sponsored by Fidia Pharma‐
ceutical Corporation.
R. Fiorentini (Fidia) provided guidance. F. Dosey & F.
Patarnello (Fidia) provided statistical support. D. Westcott (Fidia) provided secretarial
assistance.
Comparison of the decrease from baseline from the HA versus PL revealed a difference of only 1.5 mm, which was not statistically significant, therefore because statistical significance for this ITT analysis was not achieved, the data for all 2o effectiveness variables was analysed only for completers (333/495). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
