| Methods |
Randomised
Controlled
Trial
Open‐label
Parallel‐group
Multicentre
ITT analysis |
| Participants |
Country:
Italy
Mean age: NR
% Female:73
Mean disease
duration: NR
Duration:60 days
Number randomised: 90
(HA 45, MPA 45)
Inclusion:
confirmed radiological signs of knee OA (Kellgren) and presence of pain
Exclusion:
knee joint disease other than OA
severe concomitant diseases or diseases inter‐
fering with evaluation of knee joint OA
pregnancy
allergy
skin infections
other IA treatments in past 3 mth
Baseline values:
% pt pain under load strong
HA:40, MPA: 64
% pt rest pain strong
HA: 20, MPA: 22
% pt pain on touch strong
HA: 18, MPA: 22
% pt night pain strong
HA: 16, MPA: 11 |
| Interventions |
Hyalgan (20mg/2ml)
5 weekly injections
at 7 day intervals
6‐methylprednis‐
olone acetate
(40mg/1 ml) 3 weekly injections (Depo‐Medrol)
Concurrent therapy:
Analgesic & NSAID consumption assessed |
| Outcomes |
daytime spon‐
taneous pain on
100 mm VAS
morning stiffness (min)
range of motion (goniometer)
pt and MD efficacy
assessment (0=
unsatisfactory,1=poor,2=fair,3=
good,4=excellent)‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
night pain, rest pain, pain under load, touch pain (0=absent,1= slight, 2=moder‐
ate,3=strong,4= very strong)
NSAID,analgesic
consumption,0‐3:0=none,1=occa‐
sional,2=continu‐
ous low doses,
3=continuous high doses)
effusion volume
(ml) |
| Notes |
Jadad's:2/5
R‐1,B‐0,W‐1
Drugs supplied by Fidia S.p.A.
P. Pierfederici and A. Perbellini, Fidia S.p.A. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
