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. 2015 Mar 16;2015(3):CD004020. doi: 10.1002/14651858.CD004020.pub3

Summary of findings 3. Lateral wedge insole compared with neutral insole for varus medial osteoarthritis of the knee.

Lateral wedge insole compared with neutral insole for varus medial osteoarthritis of the knee
Patient or population: patients with varus medial osteoarthritis of the knee
 Settings: general hospital
 Intervention: lateral wedge insole
 Comparison: neutral insole
Outcomes Illustrative comparative risks* (95% CI) Number of participants
 (studies) Quality of the evidence
 (GRADE) Comments
Assumed risk Corresponding risk
Neutral insole Lateral wedge insole
Pain 
 NRS: scale from 0 to 10
 Follow‐up: mean 12 months
(Higher score is worse)
Mean pain on walking score in control groups was 2.6 Mean pain on walking in intervention groups was
0.1 higher (0.45 higher to 0.65 lower)
224
 (2 studies) ⊕⊕⊕⊝
 Moderatea MD = 0.10
(95% CI ‐0.45 to 0.65)
Absolute percent change = 1.0%
(95% CI 4.5 to ‐6.5)
Relative percent change = 3.8%
(95% CI 1.7 to ‐25.0)
NNTB = not statistically significant
Stiffness 
 WOMAC: scale from 0 to 100
 Follow‐up: mean 12 months
(Higher score is better)
Mean stiffness score in control groups was
41.6
Mean stiffness in intervention groups was
0.07 higher (4.96 lower to 5.1 higher)
358
(3 studies)
⊕⊕⊕⊝
 Moderatea MD = 0.07
(95% CI ‐4.96 to 5.10)
Absolute percent change = 0.1%
(95% CI ‐5.0 to 5.1)
Relative percent change = 0.2%
(95% CI ‐11.9 to 12.3)
NNTB = not statistically significant
Function
WOMAC: scale from 0 to 100
 Follow‐up: mean 12 months
(Higher score is better)
Mean function score in control groups was
36.6
Mean function in intervention groups was
0.94 higher (2.98 lower to 4.87 higher)
358
(3 studies)
⊕⊕⊕⊝
 Moderatea MD = 0.94
(95% CI ‐2.98 to 4.87)
Absolute percent change = 0.9%
(95% CI ‐3.0 to 4.9)
Relative percent change = 2.6%
(95% CI ‐8.1 to 13.3)
NNTB = not statistically significant
Health‐related quality of life
HRQoL: scale from 0 to 1.0
Follow‐up: 12 months
(Higher score is better)
Mean health‐related quality of life score in control groups was
0.7
Mean health‐related quality of life score in intervention groups was
0.01 lower (0.05 lower to 0.03 higher)
179
(1 study)
⊕⊕⊕⊝
 Moderateb MD = 0.00
(95% CI ‐0.06 to 0.06)
Absolute percent change = 1.0%
(95% CI ‐5.0 to 3.0)
Relative percent change = 1.4%
(95% CI ‐7.1 to 4.3)
NNTB = not statistically significant
Treatment failure See comment See comment Not estimablec See comment Outcome not reported in included studies
Serious adverse events See comment See comment Not estimablec See comment Outcome not reported in included studies
Total number of adverse events See comment See comment Not estimablec See comment Outcome not reported in included studies
*The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
 CI: Confidence interval; NNTB: Number needed to treat for an additional beneficial outcome.
GRADE Working Group grades of evidence.
 High quality: Further research is very unlikely to change our confidence in the estimate of effect.
 Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
 Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
 Very low quality: We are very uncertain about the estimate.

aDowngraded for limitations in design and implementation of available studies suggesting high likelihood of bias.

bDowngraded for imprecision: Results were based on only one study with 179 participants.

cNo useful data were available.