| Methods |
Randomised
Controlled
Trial
Double‐blind
Blinded metrologist
Parallel‐group
Placebo‐ controlled
Single centre,
2 wk washout
Per protocol analysis: n=84 |
| Participants |
Country:
England
Mean age: 65
% Female: 69
Mean disease
duration:NR
Duration:5 mth
Number randomised:91
(HA 45, PL 46)
Inclusion:
clinical history of knee OA
radiological evidence of knee OA (Kellgren and
Lawrence 1‐4)
pain in at least one knee >= 30 mm on a VAS for at least 1/5 activities in prior 2 wk
Exclusion:
pts with inflammatory bowel disease, anserine bursitis or pain referred from other structures (e.g. ipsilateral hip or lumbar spine)
Baseline values:
pain on active
movement
HA: mild 43.7
moderate 48.5
PL: mild 53.0
moderate 49.3
pain at rest
HA: mild 20.8
moderate 25.2
PL: mild 30.3
moderate 38.9 |
| Interventions |
Hyalgan (20mg/2ml) 5 weekly injections
Placebo:saline 2 ml 5 weekly injections
Concurrent therapy:
paracetamol permitted |
| Outcomes |
daily VAS pain in the am, pm, getting up from chair, climbing stairs, painful activity, at rest for 20 min, active and passive movement, patellofemoral tenderness, flexion by goniometer, morning stiffness (min), interference with activity of daily living, escape analgesia count,
pt and metrologist global assessment |
| Notes |
Jadad's:5/5
R‐2,B‐2,W‐1
Most affected knee studied.
90 pts had bilateral disease
Effusions aspirated to dryness
Stratification by
xray severity |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
