Introduction
Patients and methods
Patients
Treatment
Outcome measurement
Statistical analysis
Results
Patient characteristics
Characteristics | Laser moxibustion (n = 84) | Traditional moxibustion (n = 55) | P value |
---|---|---|---|
Age (mean (SD), yrs) | 61.25 ± 5.55 | 64.73 ± 6.92 | 0.086 |
No. (%) of woman | 66 (78.6%) | 39 (70.9%) | 0.304 |
Affected knees (%) | |||
Single knee | 10 (11.9%) | 10 (18.2%) | 0.302 |
Both knees | 74 (88.1%) | 45 (81.8%) | |
Length of knee OA (median (IQR), yrs) | 6.5 (0.17, 7.75) | 5 (0.25, 8) | 0.120 |
BMI (mean (SD), kg/m2) | 25.34 ± 4.44 | 24.22 ± 2.60 | 0.231 |
Comparison of the WOMAC score between 10.6-μm laser and traditional moxibustion groups
WOMAC index* | Time point | Laser moxibustion (n = 84) | Traditional moxibustion (n = 55) | P value† |
---|---|---|---|---|
Pain | Baseline | 230.71 ± 93.18 | 336.62 ± 117.38 | <0.001 |
Mid-term | 143.33 ± 84.89 | 239.93 ± 123.51 | ||
End of treatment | 90 (48.5, 143.75) | 130 (70, 218) | ||
Follow-up | 63.5 (29.5, 119.75) | 110 (48, 200) | ||
Stiffness | Baseline | 97.24 ± 49.57 | 45.14 ± 25.24 | <0.001 |
Mid-term | 53 (24.5, 92) | 26 (15.5, 45.5) | ||
End of treatment | 44.40 ± 33.60 | 18 (11, 32) | ||
Follow-up | 32 (10, 54.75) | 15 (6, 30) | ||
Function | Baseline | 725.53 ± 345.98 | 568.96 ± 261.29 | 0.005 |
Mid-term | 477.20 ± 288.18 | 375.73 ± 243.71 | ||
End of treatment | 299 (176.75, 531.50) | 216 (117, 395) | ||
Follow-up | 226 (112.5, 425.75) | 191 (106, 329) |
WOMAC index (percentage of change from baseline, %)* | Time point | Laser moxibustion (n = 84) (%) | Traditional moxibustion (n = 55) (%) | Naïve estimate of treatment effect† (%) | Doubly robust causal treatment effect‡ (%) | P value§ |
---|---|---|---|---|---|---|
Pain | Mid-term | − 32.62 ± 41.15 | − 24.65 ± 43.42 | − 8.0 | − 7.5 | 0.222 |
End of treatment | − 47.66 ± 46.37 | − 52.87 ± 31.57 | 5.2 | 2.9 | 0.383 | |
Follow-up | − 57.57 ± 46.59 | − 57.90 ± 31.77 | 0.3 | 10.1 | 0.298 | |
Stiffness | Mid-term | − 28.55 ± 49.32 | − 13.32 ± 69.19 | − 15.2 | − 15.2 | 0.087 |
End of treatment | − 42.28 ± 56.45 | − 38.28 ± 52.71 | − 4.0 | − 3.1 | 0.396 | |
Follow-up | − 53.99 ± 45.17 | − 45.44 ± 46.92 | − 8.6 | − 8.0 | 0.217 | |
Function | Mid-term | − 28.88 ± 47.46 | − 21.71 ± 79.25 | − 7.2 | − 7.1 | 0.279 |
End of treatment | − 41.43 ± 49.30 | −39.03 ± 71.26 | − 2.4 | − 2.9 | 0.403 | |
Follow-up | − 55.95 ± 37.91 | − 50.84 ± 43.67 | − 5.1 | − 23.1 | 0.006 |
Comparison of the SF-36 scores between 10.6-μm laser and traditional moxibustion groups
SF-36 dimensions | Time point | Laser moxibustion (n = 84) | Traditional moxibustion (n = 55) | P value* |
---|---|---|---|---|
PF (physical functioning) | Baseline | 60 (40, 70) | 60 (45, 70) | 0.713 |
Mid-term | 65 (50, 80) | 62.5 (50, 70) | ||
End of treatment | 67.5 (55, 80) | 65 (53.75, 75) | ||
Follow-up | 70 (56.25, 80) | 60 (53.75, 71.25) | ||
RP (role-physical) | Baseline | 0 (0, 50) | 25 (0, 56.25) | 0.140 |
Mid-term | 25 (0, 75) | 37.5 (0, 100) | ||
End of treatment | 25 (0, 50) | 25 (0, 75) | ||
Follow-up | 25 (0, 75) | 25 (0, 75) | ||
RE (role-emotional) | Baseline | 33.33 (0, 100) | 33.33 (0, 100) | 0.152 |
Mid-term | 33.33 (0, 100) | 66.67 (0, 100) | ||
End of treatment | 33.33 (0, 100) | 66.67 (0, 100) | ||
Follow-up | 33.33 (0, 100) | 33.33 (0, 100) | ||
VT (vitality) | Baseline | 45 (30, 55) | 55 (40, 65) | 0.006 |
Mid-term | 45 (65, 60) | 55 (45, 60) | ||
End of treatment | 50 (40, 60) | 60 (45, 70) | ||
Follow-up | 50 (35, 65) | 60 (45, 70) | ||
MH (mental health) | Baseline | 64 (48, 79) | 72 (64, 84) | 0.002 |
Mid-term | 64 (52, 76) | 72 (60, 80) | ||
End of treatment | 64 (56, 75) | 68 (60, 76) | ||
Follow-up | 68 (60, 80) | 64 (56, 80) | ||
SF (social functioning) | Baseline | 75 (62.5, 87.5) | 75 (62.5, 100) | 0.039 |
Mid-term | 75 (62.5, 87.5) | 75 (62.5, 87.5) | ||
End of treatment | 75 (62.5, 84.38) | 75 (62.5, 87.5) | ||
Follow-up | 75 (62.5, 87.5) | 75 (62.5, 87.5) | ||
BP (bodily pain) | Baseline | 55 (35, 59.38) | 67.5 (45, 67.5) | < 0.001 |
Mid-term | 57.5 (45, 67.5) | 67.5 (55, 67.5) | ||
End of treatment | 67.5 (55, 67.5) | 67.5 (57.5, 77.5) | ||
Follow-up | 67.5 (57.5, 75) | 67.5 (55, 77.5) | ||
GH (General Health) | Baseline | 35 (30, 50) | 50 (35, 60) | 0.001 |
Mid-term | 40 (30, 55) | 45 (35, 55) | ||
End of treatment | 40 (31.25, 55) | 55 (35, 65) | ||
Follow-up | 45 (35, 58.75) | 50 (45, 65) |
SF-36 dimensions (change from baseline)* | Time point | Laser moxibustion (n = 84) | Traditional moxibustion (n = 55) | Naïve estimate of treatment effect† | Doubly robust causal treatment effect‡ | P value§ |
---|---|---|---|---|---|---|
PF (physical functioning) | Mid-term | 6.49 ± 17.11 | 3.45 ± 13.01 | 3.034 | 1.255 | 0.370 |
End of treatment | 9.82 ± 18.34 | 6.27 ± 18.21 | 3.549 | 3.305 | 0.212 | |
Follow-up | 12.14 ± 16.52 | 4.27 ± 19.40 | 7.870 | 9.423 | 0.005 | |
RP (role-physical) | Mid-term | 14.58 ± 39.43 | 10.00 ± 49.91 | 4.583 | 6.051 | 0.236 |
End of treatment | 5.95 ± 37.35 | 5.45 ± 49.46 | 0.498 | 7.857 | 0.280 | |
Follow-up | 12.20 ± 42.07 | 5.00 ± 44.46 | 7.202 | 4.165 | 0.370 | |
RE (role-emotional) | Mid-term | 11.91 ± 45.89 | 6.67 ± 42.26 | 5.238 | 7.714 | 0.302 |
End of treatment | 7.14 ± 48.01 | 0.00 ± 56.29 | 7.143 | −2.870 | 0.409 | |
Follow-up | 10.32 ± 17.42 | − 0.61 ± 47.79 | 10.924 | 15.492 | 0.109 | |
VT (vitality) | Mid-term | 2.38 ± 15.55 | 2.09 ± 14.16 | 0.290 | − 2.794 | 0.205 |
End of treatment | 7.08 ± 15.05 | 4.82 ± 17.16 | 2.265 | 2.799 | 0.208 | |
Follow-up | 6.79 ± 17.78 | 5.09 ± 20.13 | 1.695 | 1.180 | 0.373 | |
MH (mental health) | Mid-term | 0 (−8, 12) | − 3.42 ± 14.49 | 5.037 | 5.059 | 0.076 |
End of treatment | 0 (− 8, 12) | − 4.15 ± 17.82 | 6.336 | 5.879 | 0.063 | |
Follow-up | 3.95 ± 16.15 | − 5.31 ± 20.81 | 9.261 | 8.746 | 0.034 | |
SF (social functioning) | Mid-term | 0.45 ± 19.25 | − 0.91 ± 20.25 | 1.356 | 0.613 | 0.445 |
End of treatment | 1.79 ± 22.05 | − 0.23 ± 19.62 | 2.013 | 2.273 | 0.288 | |
Follow-up | 2.53 ± 20.05 | − 3.18 ± 23.10 | 5.712 | − 2.429 | 0.423 | |
BP (bodily pain) | Mid-term | 7.68 ± 15.31 | 4.50 ± 14.44 | 3.179 | 0.375 | 0.461 |
End of treatment | 12.17 ± 19.47 | 8.14 ± 17.20 | 4.036 | 1.897 | 0.309 | |
Follow-up | 16.01 ± 18.79 | 4.32 ± 20.46 | 11.694 | 13.587 | 0.002 | |
GH (general health) | Mid-term | 3.81 ± 14.64 | − 1.91 ± 12.11 | 5.719 | 4.606 | 0.132 |
End of treatment | 4.58 ± 13.56 | 3.91 ± 16.24 | 0.674 | − 1.658 | 0.312 | |
Follow-up | 6.37 ± 14.21 | 1.73 ± 17.75 | 4.642 | 5.481 | 0.168 |