Background
Methods/design
Study design
Objectives
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H1: There is no difference in the patients’ response rate between the EA group and the SA group.
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H2: There is no difference in the patients’ response rate between the MA group and the SA group.
Outcomes
Primary outcome
Secondary outcomes
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Numerical rating scale [21]: an 11-point patient-reported outcome measure (PROM) with scores ranging from 0 (no pain) to 10 (worst pain)
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WOMAC [23] pain subscale: a 5-item PROM with total scores ranging from 0 to 20; higher scores indicate worse pain
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WOMAC [23] function subscale: a 17-item PROM with total scores ranging from 0 to 68; lower scores indicate better physical function
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WOMAC [23] stiffness subscale: a 2-item PROM with total scores ranging from 0 to 8; higher scores indicate more stiffness
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Patient global assessment [24]: a 5-point Likert scale
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12-item Short Form Health Survey (SF-12) [25] physical dimension: total scores range from 0 to 100; lower scores indicate a worse quality of life
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SF-12 [25] mental dimension: total scores range from 0 to 100; higher scores indicate a better quality of life
Safety outcome
Sample size
Statistical analysis
Statistical analysis population
General analysis principles
Descriptive analyses
Baseline characteristic | Type | Levels or scale |
---|---|---|
Gender | Categorical | Male or female |
Age | Continuous | Years |
Nationality | Categorical | Han or other |
Duration of disease | Continuous | Years |
Kellgren–Lawrence grade | Categorical | Grade II or III |
Body mass index | Continuous | kg/m2 |
Years of education | Categorical | <9, 9–12, or >12 |
Affected knee | Categorical | Unilateral or bilateral |
Previous treatments | Categorical | Injections, medication, physical therapy, acupuncture, exercise, etc. |
Concomitant diseases | Categorical | Hypertension, coronary heart disease, diabetes mellitus, hyperlipidemia, etc. |
Numerical rating scale | Continuous | Point |
WOMAC pain subscale | Continuous | Point |
WOMAC function subscale | Continuous | Point |
WOMAC stiffness subscale | Continuous | Point |
Physical health, SF-12 | Continuous | Point |
Mental health, SF-12 | Continuous | Point |
Analysis of the primary outcome
Analysis of secondary outcomes
Outcomes | EA (n) | MA (n) | SAb (n) | P value | Pairwise comparison | |||||
---|---|---|---|---|---|---|---|---|---|---|
EA vs. SA | MA vs. SA | EA vs. MA | ||||||||
Difference (95% CI) | P value | Difference (95% CI) | P value | Difference (95% CI) | P value | |||||
Success rate, no. (%) | ||||||||||
4 weeks | x (xx.x) | x (xx.x) | x (xx.x) | – | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | – | – |
8 weeks | x (xx.x) | x (xx.x) | x (xx.x) | – | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | – | – |
16 weeks | x (xx.x) | x (xx.x) | x (xx.x) | – | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | – | – |
26 weeks | x (xx.x) | x (xx.x) | x (xx.x) | – | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | – | – |
Numerical Rating Scale, mean (SD) | ||||||||||
Baseline | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x |
4 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
8 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
16 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
26 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
WOMAC pain subscale, mean (SD) | ||||||||||
Baseline | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x |
4 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
8 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
16 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
26 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
WOMAC function subscale, mean (SD) | ||||||||||
Baseline | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x |
4 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
8 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
16 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
26 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
WOMAC stiffness subscale, mean (SD) | ||||||||||
Baseline | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x |
4 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
8 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
16 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
26 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
Patient global assessment, mean (SD) | ||||||||||
Baseline | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x |
4 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
8 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
16 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
26 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
SF-12 physical health, mean (SD) | ||||||||||
Baseline | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x |
4 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
8 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
16 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
26 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
SF-12 mental health, mean (SD) | ||||||||||
Baseline | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x | xx.x (xx.x- xx.x) | xx.x |
4 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
8 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
16 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | ||||
26 weeks | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) | xx.x (xx.x- xx.x) |