| Methods |
Randomised
Controlled
Trial
Placebo controlled
Single centre |
| Participants |
Country:
Turkey
Mean age: 55.1
% Female: 80
Mean disease duration: 2.25 y
Duration: 8 wk
Number randomised: 30
(HA 20 (30 knees), PL 10 (10 knees))
Inclusion:
fulfill ACR criteria for knee OA with radiological evidence and symptoms
knee pain persisting for more than one year and pain >40/100 (VAS) for more than 15 days in the last month
Exclusion:
any other serious systemic diseases, depression, avian allergy, other arthropathies, neoplasms, recent trauma, knee instability, effusion in the knee, a varus or valgus deformity of >15 degrees, flexion contracture of >20 degrees,
had received intraarticular corticosteroids within the 6 mth prior to start of study
Baseline values:
Walking pain
HA: 71.0,
PL: 67.0
Night pain
HA: 45.0
PL: 54.0
Rest pain
HA: 46.7
PL: 51.0
Need for paracetamol
HA: 1.0
PL: 0.9
WOMAC pain
HA: 15.7
PL: 17.6
WOMAC stiffness
HA: 6.3
PL: 6.1
WOMAC function
HA: 49.6
PL: 47.8
15 m walk time
HA: 20.6
PL: 17.9 |
| Interventions |
Hylan G‐F 20
(2 ml 10 mg/ml) (Synvisc) 3 weekly injections,
Saline 2 ml
3 weekly injections
Both medial approach, after injection, knees wrapped with bandage and patients instructed to rest for 24h.
Concurrent therapy: Paracetamol permitted for analgesia. No additional physiotherapy or anti‐inflammatory drugs. |
| Outcomes |
Pain at rest, at night and on walking (0‐100 mm VAS), WOMAC pain (5‐25), WOMAC stiffness (2‐10), WOMAC physical function (17‐85), walking time for 15 m, need for paracetamol, evaluation of treatment by patient (1=treatment is not effective, 2=less effective, 3=effective, and 4=very effective) |
| Notes |
Jadad's: 2/5
R‐1, B‐0, W‐1
If bilateral, both knees injected. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
