| Methods |
Randomised
Controlled
Trial
Open‐label
Parallel‐group
1 wk washout
ITT analysis |
| Participants |
Country:
Turkey
Mean age: 61
% Female: 78
Mean disease duration: NR
Duration: 56 days
Number randomised: 40
(HA 20, PT 20)
Inclusion:
idiopathic OA according ACR criteria
AP xray Kellgren and Lawrence 2 or 3 study knee and <4 other knee
>40 yr
walk 25 m without help
stop all NSAIDs and muscle relaxants 1 wk before study
Exclusion:
ia inj or important trauma episode within last 3 mths
oral or im steroid episode within last 2 mths
HA inj within last 12 mths
start of quadriceps exercise program in last 4 mths
presence of fixed flexion contracture at knee >10 degrees
valgus/varus >15 degrees on standing knee xrays
anticoagulant treatment
knee surgery episode
joint diseases: secondary OA or inflammatory jt disease, pseudo
‐gout attack in last 3 mths, FM, intrajoint tumor, excessive symptoms in same hip or other knee that may interfere with study, anserine bursitis
functional damages: hemi‐
paresis episode
others: multiple i‐a inj or aspiration,liver or kidney disease, pregnancy, lacta‐
tion, insufficient contraception, peripheral neuropathy or vascular inadequacy, osteonecrosis, immune suppresive disease, diabetes mellitus
Baseline values:
spontaneous pain
HA:2.61, PT:2.21
activity pain
HA:4.68, PT:3.71
night pain
HA:2.43, PT:2.17
25 m walk time
HA:22.4, PL:18.6 |
| Interventions |
Sodium hyaluronate 1.5% 15 mg/ml
2 ml Orthovisc
2 weekly injections
+ 5 days/wk for a total of 10 sessions in‐patient physical therapy program (paraffin, short wave, quadriceps exercises) directed towards knees
Physical therapy program only
Concurrent therapy:
Paracetamol per‐
mitted |
| Outcomes |
spontaneous pain, pain during daily activities and night pain (0‐4:
0=none,1=light, 2=medium, 3=
strong, 4=very
strong and 100 mm VAS)
paracetamol use
morning stiffness (min)
range of motion: flexion/extension goniometer
knee circumfer‐
ence
25 metre walk time
pt global (1‐4)
MD global (1‐4)
(1=ineffective,2=
slightly effective,
3=effective, 4=
very effective)
side effects |
| Notes |
Jadad's: 2/5
R‐1,B‐0,W‐1
If bilateral OA, more symptomatic knee in study |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
