| Methods |
Randomised
Controlled
Trial
Open‐label
Parallel‐group
ITT analysis |
| Participants |
Country:
Italy
Mean age: 65
% Female:88
Mean disease duration: 99 mth
(range 12‐300)
Duration:60 days
Number randomised:40
(HA 20, MPA 20)
Inclusion:
painful idiopathic OA of the knee by ARA criteria and radiologically assessed by Kellgren
previous NSAID treatment with poor results suggesting the usefulness of IA treatment
Exclusion:
serious concomitant disorders
ongoing infections
pregnancy
allergy or hypersensitivity to drugs
treatment with any IA drug in last 3 mth
Baseline values:
% pts with strong
pain under load
HA:65, MPA:55
% pts with strong
rest pain
HA:60, MPA:70 |
| Interventions |
Hyalgan (20 mg/2ml) 3 weekly injections
6‐methylpredniso‐
lone acetate (6‐MPA) 40 mg/1 ml 3 weekly injections (Depo‐
Medrol)
Concurrent therapy:
Analagesic & NSAID
permitted |
| Outcomes |
spontaneous pain (100 mm VAS), am stiffness, flexion (degrees)‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
night pain, pain under load, touch pain (0‐4:
0=none,1=slight,
2=moderate, 3=
strong, 4 = very
strong)
analgesic or NSAID consumption (0‐3: 0=none, 1=
occasional low
doses, 2=regular
low doses, 3 =
regular high doses)
joint effusion volume (ml)
pt and MD global efficacy (0‐4: 0 =
unsatisfactory, 1 = poor, 2 = fair,
3 = good, 4 = excellent) |
| Notes |
Jadad's:2/5
R‐1,B‐0,W‐1
Arthrocentesis performed if
effusion present and measured.
Pts kept at rest for 2 days after injection.
A. Perbellini,
Fidia S.p.A. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
