| Methods |
Randomised
Controlled
Trial
Parallel‐group
Open‐label
ITT analysis |
| Participants |
Country:
Turkey
Mean age: 58
% Female: 100
Mean disease duration: 54 wk
Duration:15 wk
Number randomised: 40
(HA 20, BA 20)
Inclusion:
presence of pain
Kellgren scale
(result:Gr. 2 or 3)
Exclusion:
knee jt disease other than OA
history of allergy, skin infections
other i‐a treatments in the 3 mths prior to study
Baseline values:
WOMAC function
HA:45.5, BA:45.6
maximum flexion
HA:110.5,
BA:116.0 |
| Interventions |
Sodium hyaluronate 20 mg (Orthovisc)
3 injections: 1 every 7 days
Betamethasone 3 mg/ml (Celestone choronodose)
3 injections: 1 every 7 days
Concurrent therapy:
Paracetamol per‐
mitted |
| Outcomes |
Kellgren and Lawrence rating
intensity of spontaneous pain and clinical severity in terms of pain felt during normal living activities(1=slight
,2=moderate,3=
severe)
WOMAC function subscale for ADL
(1=none,2=mild,
3=moderate,
4=severe,
5=extreme)
joint flexion in o
NSAID use
(0=none,
1=occasional,
2=continuous low doses,
3=continuous high doses)
pt and investigator
judgement of efficacy (0=un‐
satisfactory,1=
poor,2=fair,3=
good,4=excellent)
morning stiffness
effusion (presence/absence)
Blood pressure and heart rate,
blood and urine study start and end |
| Notes |
Jadad's: 2/5
R‐1,B‐0,W‐1
When present effusion extracted by arthrosynthesis to dryness
Pt kept in rest for one day after inj
Trial population consisted of all female. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
