Parameter Evaluated . | Description . | Time Point . | Mean Estimate (95% CI) for Following Group: . | P for Overall Interaction (Group × Time) . | P for Comparison of Changes Between Groups . | ||||
---|---|---|---|---|---|---|---|---|---|
. | . | . | Fluoroscopy-Guided MLD . | Traditional MLD . | Placebo MLD . | . | . | . | . |
. | . | . | . | . | . | . | Fluoroscopy-Guided MLD vs Traditional MLD . | Fluoroscopy-Guided MLD vs Placebo MLD . | Traditional MLD vs Placebo MLD . |
Accumulation of fluid in suprafascial tissue | Local tissue water | B0 | 1.418 (1.365–1.473) | 1.354 (1.303–1.406) | 1.406 (1.354–1.459) | .665 | |||
P | 1.372g (1.326–1.419) | 1.292g (1.247–1.336) | 1.344g (1.300–1.391) | ||||||
P1 | 1.383 (1.328–1.438) | 1.315 (1.264–1.368) | 1.394 (1.340–1.449) | ||||||
P3 | 1.363 (1.309–1.420) | 1.288g (1.236–1.342) | 1.358 (1.303–1.415) | ||||||
P6 | 1.343g (1.290–1.399) | 1.298g (1.246–1.351) | 1.350g (1.297–1.405) | ||||||
P12 | 1.343g (1.305–1.383) | 1.332 (1.294–1.373) | 1.335g (1.297–1.374) | ||||||
Thickness of cutis | B0 | 1.29 (1.22–1.36) | 1.27 (1.20–1.34) | 1.32 (1.24–1.35) | .422 | ||||
P | 1.30 (1.23–1.37) | 1.29 (1.23–1.36) | 1.37 (1.31–1.44) | ||||||
P6 | 1.27 (1.20–1.34) | 1.30 (1.23–1.38) | 1.27 (1.21–1.35) | ||||||
P12 | 1.23 (1.16–1.30) | 1.28 (1.20–1.35) | 1.33 (1.25–1.41) | ||||||
Thickness of subcutis | B0 | 1.62 (1.49–1.76) | 1.52 (1.40–1.65) | 1.52 (1.40–1.65) | .118 | ||||
P | 1.38h (1.28–1.49) | 1.40g (1.30–1.51) | 1.36g (1.26–1.46) | ||||||
P6 | 1.38h (1.28–1.49) | 1.46 (1.36–1.58) | 1.30h (1.21–1.40) | ||||||
P12 | 1.34h (1.23–1.47) | 1.46 (1.34–1.60) | 1.25g (1.25–1.49) | ||||||
Thickness of cutis + subcutis | B0 | 1.52 (1.42–1.63) | 1.44 (1.34–1.55) | 1.45 (1.35–1.56) | .180 | ||||
P | 1.36g (1.27–1.27) | 1.38 (1.30–1.47) | 1.36 (1.28–1.45) | ||||||
P6 | 1.35h (1.27–1.44) | 1.40 (1.31–1.49) | 1.29h (1.21–1.37) | ||||||
P12 | 1.31h (1.22–1.41) | 1.40 (1.30–1.51) | 1.34g (1.24–1.44) | ||||||
Thickness of skin and subcutis through palpation | B0 | 4.43 (4.01–4.85) | 4.03 (3.61–4.45) | 4.65 (4.23–5.07) | .889 | ||||
P | 4.62 (4.23–5.00) | 4.23 (3.84–4.63) | 4.57 (4.18–4.96) | ||||||
P1 | 4.37 (3.96–4.78) | 4.25 (3.84–4.66) | 4.22 (3.81–4.62) | ||||||
P3 | 4.25 (3.82–4.68) | 4.19 (3.76–4.62) | 4.22 (3.79–4.64) | ||||||
P6 | 4.22 (3.77–4.67) | 4.03 (3.58–4.49) | 4.05g (3.60–4.50) | ||||||
P12 | 4.09 (3.61–4.57) | 3.92 (3.44–4.40) | 4.17 (3.69–4.65) | ||||||
Skin elasticity | Skin elasticity | B0 | 1.28 (1.19–1.37) | 1.26 (1.17–1.35) | 1.41 (1.31–1.51) | .741 | |||
P | 1.11h (1.04–1.18) | 1.06h (1.0–1.13) | 1.14h (1.07–1.21) | ||||||
P1 | 1.15g (1.08–1.23) | 1.07h (1.01–1.14) | 1.18h (1.11–1.26) | ||||||
P3 | 1.16g (1.10–1.23) | 1.07h (1.01–1.14) | 1.15h (1.08–1.22) | ||||||
P6 | 1.13g (1.07–1.20) | 1.10g (1.04–1.17) | 1.14h (1.08–1.22) | ||||||
P12 | 1.19 (1.11–1.27) | 1.07h (1.01–1.14) | 1.15h (1.08–1.23) | ||||||
Skin elasticity (through palpation) | B0 | 0.49 (0.32–0.67) | 0.26 (0.12–0.41) | 0.24 (0.10–0.40) | .023g | ||||
P | 0.40 (0.22–0.59) | 0.44 (0.26–0.64) | 0.56g (0.37–0.78) | .128 | .024g | .465 | |||
P1 | 0.37 (0.21–0.55) | 0.52g (0.35–0.72) | 0.42 (0.26–0.61) | .026g | .073 | .657 | |||
P3 | 0.17g (0.03–0.32) | 0.45 (0.29–0.64) | 0.50g (0.33–0.69) | .002g | <.001g | .724 | |||
P6 | 0.15g (0.05–0.25) | 0.23 (0.13–0.35) | 0.28 (0.17–0.40) | .026g | .007g | .621 | |||
P12 | 0.22g (0.11–0.34) | 0.20 (0.09–0.32) | 0.24 (0.13–0.37) | .160 | .067 | .669 |
Parameter Evaluated . | Description . | Time Point . | Mean Estimate (95% CI) for Following Group: . | P for Overall Interaction (Group × Time) . | P for Comparison of Changes Between Groups . | ||||
---|---|---|---|---|---|---|---|---|---|
. | . | . | Fluoroscopy-Guided MLD . | Traditional MLD . | Placebo MLD . | . | . | . | . |
. | . | . | . | . | . | . | Fluoroscopy-Guided MLD vs Traditional MLD . | Fluoroscopy-Guided MLD vs Placebo MLD . | Traditional MLD vs Placebo MLD . |
Accumulation of fluid in suprafascial tissue | Local tissue water | B0 | 1.418 (1.365–1.473) | 1.354 (1.303–1.406) | 1.406 (1.354–1.459) | .665 | |||
P | 1.372g (1.326–1.419) | 1.292g (1.247–1.336) | 1.344g (1.300–1.391) | ||||||
P1 | 1.383 (1.328–1.438) | 1.315 (1.264–1.368) | 1.394 (1.340–1.449) | ||||||
P3 | 1.363 (1.309–1.420) | 1.288g (1.236–1.342) | 1.358 (1.303–1.415) | ||||||
P6 | 1.343g (1.290–1.399) | 1.298g (1.246–1.351) | 1.350g (1.297–1.405) | ||||||
P12 | 1.343g (1.305–1.383) | 1.332 (1.294–1.373) | 1.335g (1.297–1.374) | ||||||
Thickness of cutis | B0 | 1.29 (1.22–1.36) | 1.27 (1.20–1.34) | 1.32 (1.24–1.35) | .422 | ||||
P | 1.30 (1.23–1.37) | 1.29 (1.23–1.36) | 1.37 (1.31–1.44) | ||||||
P6 | 1.27 (1.20–1.34) | 1.30 (1.23–1.38) | 1.27 (1.21–1.35) | ||||||
P12 | 1.23 (1.16–1.30) | 1.28 (1.20–1.35) | 1.33 (1.25–1.41) | ||||||
Thickness of subcutis | B0 | 1.62 (1.49–1.76) | 1.52 (1.40–1.65) | 1.52 (1.40–1.65) | .118 | ||||
P | 1.38h (1.28–1.49) | 1.40g (1.30–1.51) | 1.36g (1.26–1.46) | ||||||
P6 | 1.38h (1.28–1.49) | 1.46 (1.36–1.58) | 1.30h (1.21–1.40) | ||||||
P12 | 1.34h (1.23–1.47) | 1.46 (1.34–1.60) | 1.25g (1.25–1.49) | ||||||
Thickness of cutis + subcutis | B0 | 1.52 (1.42–1.63) | 1.44 (1.34–1.55) | 1.45 (1.35–1.56) | .180 | ||||
P | 1.36g (1.27–1.27) | 1.38 (1.30–1.47) | 1.36 (1.28–1.45) | ||||||
P6 | 1.35h (1.27–1.44) | 1.40 (1.31–1.49) | 1.29h (1.21–1.37) | ||||||
P12 | 1.31h (1.22–1.41) | 1.40 (1.30–1.51) | 1.34g (1.24–1.44) | ||||||
Thickness of skin and subcutis through palpation | B0 | 4.43 (4.01–4.85) | 4.03 (3.61–4.45) | 4.65 (4.23–5.07) | .889 | ||||
P | 4.62 (4.23–5.00) | 4.23 (3.84–4.63) | 4.57 (4.18–4.96) | ||||||
P1 | 4.37 (3.96–4.78) | 4.25 (3.84–4.66) | 4.22 (3.81–4.62) | ||||||
P3 | 4.25 (3.82–4.68) | 4.19 (3.76–4.62) | 4.22 (3.79–4.64) | ||||||
P6 | 4.22 (3.77–4.67) | 4.03 (3.58–4.49) | 4.05g (3.60–4.50) | ||||||
P12 | 4.09 (3.61–4.57) | 3.92 (3.44–4.40) | 4.17 (3.69–4.65) | ||||||
Skin elasticity | Skin elasticity | B0 | 1.28 (1.19–1.37) | 1.26 (1.17–1.35) | 1.41 (1.31–1.51) | .741 | |||
P | 1.11h (1.04–1.18) | 1.06h (1.0–1.13) | 1.14h (1.07–1.21) | ||||||
P1 | 1.15g (1.08–1.23) | 1.07h (1.01–1.14) | 1.18h (1.11–1.26) | ||||||
P3 | 1.16g (1.10–1.23) | 1.07h (1.01–1.14) | 1.15h (1.08–1.22) | ||||||
P6 | 1.13g (1.07–1.20) | 1.10g (1.04–1.17) | 1.14h (1.08–1.22) | ||||||
P12 | 1.19 (1.11–1.27) | 1.07h (1.01–1.14) | 1.15h (1.08–1.23) | ||||||
Skin elasticity (through palpation) | B0 | 0.49 (0.32–0.67) | 0.26 (0.12–0.41) | 0.24 (0.10–0.40) | .023g | ||||
P | 0.40 (0.22–0.59) | 0.44 (0.26–0.64) | 0.56g (0.37–0.78) | .128 | .024g | .465 | |||
P1 | 0.37 (0.21–0.55) | 0.52g (0.35–0.72) | 0.42 (0.26–0.61) | .026g | .073 | .657 | |||
P3 | 0.17g (0.03–0.32) | 0.45 (0.29–0.64) | 0.50g (0.33–0.69) | .002g | <.001g | .724 | |||
P6 | 0.15g (0.05–0.25) | 0.23 (0.13–0.35) | 0.28 (0.17–0.40) | .026g | .007g | .621 | |||
P12 | 0.22g (0.11–0.34) | 0.20 (0.09–0.32) | 0.24 (0.13–0.37) | .160 | .067 | .669 |
Represented by percentage of water content interlimb ratios. B0 = baseline; MLD = manual lymph drainage; P = after intensive treatment; P1, P3, P6, and P12 = after 1, 3, 6, and 12 mo of maintenance treatment, respectively.
Cutis, subcutis, and cutis + subcutis, represented by interlimb ratios.
Through palpation, represented by pinch test scores.
Represented by induration force interlimb ratios.
Represented by palpation test scores.
At different time points. Significance of relative changes versus baseline in each treatment group separately. P values for overall interaction effect and comparisons of changes between treatment groups in case of presence of significant interaction effect.
With regard to within-group differences, P < .05 for changes in the estimated mean versus baseline that were statistically significant.
With regard to within-group differences, P < .0001 for changes in the estimated mean versus baseline that were statistically significant. B0 = baseline; MLD = manual lymph drainage; P = after intensive treatment; P1, P3, P6, and P12 = after 1, 3, 6, and 12 months of maintenance treatment, respectively.
Parameter Evaluated . | Description . | Time Point . | Mean Estimate (95% CI) for Following Group: . | P for Overall Interaction (Group × Time) . | P for Comparison of Changes Between Groups . | ||||
---|---|---|---|---|---|---|---|---|---|
. | . | . | Fluoroscopy-Guided MLD . | Traditional MLD . | Placebo MLD . | . | . | . | . |
. | . | . | . | . | . | . | Fluoroscopy-Guided MLD vs Traditional MLD . | Fluoroscopy-Guided MLD vs Placebo MLD . | Traditional MLD vs Placebo MLD . |
Accumulation of fluid in suprafascial tissue | Local tissue water | B0 | 1.418 (1.365–1.473) | 1.354 (1.303–1.406) | 1.406 (1.354–1.459) | .665 | |||
P | 1.372g (1.326–1.419) | 1.292g (1.247–1.336) | 1.344g (1.300–1.391) | ||||||
P1 | 1.383 (1.328–1.438) | 1.315 (1.264–1.368) | 1.394 (1.340–1.449) | ||||||
P3 | 1.363 (1.309–1.420) | 1.288g (1.236–1.342) | 1.358 (1.303–1.415) | ||||||
P6 | 1.343g (1.290–1.399) | 1.298g (1.246–1.351) | 1.350g (1.297–1.405) | ||||||
P12 | 1.343g (1.305–1.383) | 1.332 (1.294–1.373) | 1.335g (1.297–1.374) | ||||||
Thickness of cutis | B0 | 1.29 (1.22–1.36) | 1.27 (1.20–1.34) | 1.32 (1.24–1.35) | .422 | ||||
P | 1.30 (1.23–1.37) | 1.29 (1.23–1.36) | 1.37 (1.31–1.44) | ||||||
P6 | 1.27 (1.20–1.34) | 1.30 (1.23–1.38) | 1.27 (1.21–1.35) | ||||||
P12 | 1.23 (1.16–1.30) | 1.28 (1.20–1.35) | 1.33 (1.25–1.41) | ||||||
Thickness of subcutis | B0 | 1.62 (1.49–1.76) | 1.52 (1.40–1.65) | 1.52 (1.40–1.65) | .118 | ||||
P | 1.38h (1.28–1.49) | 1.40g (1.30–1.51) | 1.36g (1.26–1.46) | ||||||
P6 | 1.38h (1.28–1.49) | 1.46 (1.36–1.58) | 1.30h (1.21–1.40) | ||||||
P12 | 1.34h (1.23–1.47) | 1.46 (1.34–1.60) | 1.25g (1.25–1.49) | ||||||
Thickness of cutis + subcutis | B0 | 1.52 (1.42–1.63) | 1.44 (1.34–1.55) | 1.45 (1.35–1.56) | .180 | ||||
P | 1.36g (1.27–1.27) | 1.38 (1.30–1.47) | 1.36 (1.28–1.45) | ||||||
P6 | 1.35h (1.27–1.44) | 1.40 (1.31–1.49) | 1.29h (1.21–1.37) | ||||||
P12 | 1.31h (1.22–1.41) | 1.40 (1.30–1.51) | 1.34g (1.24–1.44) | ||||||
Thickness of skin and subcutis through palpation | B0 | 4.43 (4.01–4.85) | 4.03 (3.61–4.45) | 4.65 (4.23–5.07) | .889 | ||||
P | 4.62 (4.23–5.00) | 4.23 (3.84–4.63) | 4.57 (4.18–4.96) | ||||||
P1 | 4.37 (3.96–4.78) | 4.25 (3.84–4.66) | 4.22 (3.81–4.62) | ||||||
P3 | 4.25 (3.82–4.68) | 4.19 (3.76–4.62) | 4.22 (3.79–4.64) | ||||||
P6 | 4.22 (3.77–4.67) | 4.03 (3.58–4.49) | 4.05g (3.60–4.50) | ||||||
P12 | 4.09 (3.61–4.57) | 3.92 (3.44–4.40) | 4.17 (3.69–4.65) | ||||||
Skin elasticity | Skin elasticity | B0 | 1.28 (1.19–1.37) | 1.26 (1.17–1.35) | 1.41 (1.31–1.51) | .741 | |||
P | 1.11h (1.04–1.18) | 1.06h (1.0–1.13) | 1.14h (1.07–1.21) | ||||||
P1 | 1.15g (1.08–1.23) | 1.07h (1.01–1.14) | 1.18h (1.11–1.26) | ||||||
P3 | 1.16g (1.10–1.23) | 1.07h (1.01–1.14) | 1.15h (1.08–1.22) | ||||||
P6 | 1.13g (1.07–1.20) | 1.10g (1.04–1.17) | 1.14h (1.08–1.22) | ||||||
P12 | 1.19 (1.11–1.27) | 1.07h (1.01–1.14) | 1.15h (1.08–1.23) | ||||||
Skin elasticity (through palpation) | B0 | 0.49 (0.32–0.67) | 0.26 (0.12–0.41) | 0.24 (0.10–0.40) | .023g | ||||
P | 0.40 (0.22–0.59) | 0.44 (0.26–0.64) | 0.56g (0.37–0.78) | .128 | .024g | .465 | |||
P1 | 0.37 (0.21–0.55) | 0.52g (0.35–0.72) | 0.42 (0.26–0.61) | .026g | .073 | .657 | |||
P3 | 0.17g (0.03–0.32) | 0.45 (0.29–0.64) | 0.50g (0.33–0.69) | .002g | <.001g | .724 | |||
P6 | 0.15g (0.05–0.25) | 0.23 (0.13–0.35) | 0.28 (0.17–0.40) | .026g | .007g | .621 | |||
P12 | 0.22g (0.11–0.34) | 0.20 (0.09–0.32) | 0.24 (0.13–0.37) | .160 | .067 | .669 |
Parameter Evaluated . | Description . | Time Point . | Mean Estimate (95% CI) for Following Group: . | P for Overall Interaction (Group × Time) . | P for Comparison of Changes Between Groups . | ||||
---|---|---|---|---|---|---|---|---|---|
. | . | . | Fluoroscopy-Guided MLD . | Traditional MLD . | Placebo MLD . | . | . | . | . |
. | . | . | . | . | . | . | Fluoroscopy-Guided MLD vs Traditional MLD . | Fluoroscopy-Guided MLD vs Placebo MLD . | Traditional MLD vs Placebo MLD . |
Accumulation of fluid in suprafascial tissue | Local tissue water | B0 | 1.418 (1.365–1.473) | 1.354 (1.303–1.406) | 1.406 (1.354–1.459) | .665 | |||
P | 1.372g (1.326–1.419) | 1.292g (1.247–1.336) | 1.344g (1.300–1.391) | ||||||
P1 | 1.383 (1.328–1.438) | 1.315 (1.264–1.368) | 1.394 (1.340–1.449) | ||||||
P3 | 1.363 (1.309–1.420) | 1.288g (1.236–1.342) | 1.358 (1.303–1.415) | ||||||
P6 | 1.343g (1.290–1.399) | 1.298g (1.246–1.351) | 1.350g (1.297–1.405) | ||||||
P12 | 1.343g (1.305–1.383) | 1.332 (1.294–1.373) | 1.335g (1.297–1.374) | ||||||
Thickness of cutis | B0 | 1.29 (1.22–1.36) | 1.27 (1.20–1.34) | 1.32 (1.24–1.35) | .422 | ||||
P | 1.30 (1.23–1.37) | 1.29 (1.23–1.36) | 1.37 (1.31–1.44) | ||||||
P6 | 1.27 (1.20–1.34) | 1.30 (1.23–1.38) | 1.27 (1.21–1.35) | ||||||
P12 | 1.23 (1.16–1.30) | 1.28 (1.20–1.35) | 1.33 (1.25–1.41) | ||||||
Thickness of subcutis | B0 | 1.62 (1.49–1.76) | 1.52 (1.40–1.65) | 1.52 (1.40–1.65) | .118 | ||||
P | 1.38h (1.28–1.49) | 1.40g (1.30–1.51) | 1.36g (1.26–1.46) | ||||||
P6 | 1.38h (1.28–1.49) | 1.46 (1.36–1.58) | 1.30h (1.21–1.40) | ||||||
P12 | 1.34h (1.23–1.47) | 1.46 (1.34–1.60) | 1.25g (1.25–1.49) | ||||||
Thickness of cutis + subcutis | B0 | 1.52 (1.42–1.63) | 1.44 (1.34–1.55) | 1.45 (1.35–1.56) | .180 | ||||
P | 1.36g (1.27–1.27) | 1.38 (1.30–1.47) | 1.36 (1.28–1.45) | ||||||
P6 | 1.35h (1.27–1.44) | 1.40 (1.31–1.49) | 1.29h (1.21–1.37) | ||||||
P12 | 1.31h (1.22–1.41) | 1.40 (1.30–1.51) | 1.34g (1.24–1.44) | ||||||
Thickness of skin and subcutis through palpation | B0 | 4.43 (4.01–4.85) | 4.03 (3.61–4.45) | 4.65 (4.23–5.07) | .889 | ||||
P | 4.62 (4.23–5.00) | 4.23 (3.84–4.63) | 4.57 (4.18–4.96) | ||||||
P1 | 4.37 (3.96–4.78) | 4.25 (3.84–4.66) | 4.22 (3.81–4.62) | ||||||
P3 | 4.25 (3.82–4.68) | 4.19 (3.76–4.62) | 4.22 (3.79–4.64) | ||||||
P6 | 4.22 (3.77–4.67) | 4.03 (3.58–4.49) | 4.05g (3.60–4.50) | ||||||
P12 | 4.09 (3.61–4.57) | 3.92 (3.44–4.40) | 4.17 (3.69–4.65) | ||||||
Skin elasticity | Skin elasticity | B0 | 1.28 (1.19–1.37) | 1.26 (1.17–1.35) | 1.41 (1.31–1.51) | .741 | |||
P | 1.11h (1.04–1.18) | 1.06h (1.0–1.13) | 1.14h (1.07–1.21) | ||||||
P1 | 1.15g (1.08–1.23) | 1.07h (1.01–1.14) | 1.18h (1.11–1.26) | ||||||
P3 | 1.16g (1.10–1.23) | 1.07h (1.01–1.14) | 1.15h (1.08–1.22) | ||||||
P6 | 1.13g (1.07–1.20) | 1.10g (1.04–1.17) | 1.14h (1.08–1.22) | ||||||
P12 | 1.19 (1.11–1.27) | 1.07h (1.01–1.14) | 1.15h (1.08–1.23) | ||||||
Skin elasticity (through palpation) | B0 | 0.49 (0.32–0.67) | 0.26 (0.12–0.41) | 0.24 (0.10–0.40) | .023g | ||||
P | 0.40 (0.22–0.59) | 0.44 (0.26–0.64) | 0.56g (0.37–0.78) | .128 | .024g | .465 | |||
P1 | 0.37 (0.21–0.55) | 0.52g (0.35–0.72) | 0.42 (0.26–0.61) | .026g | .073 | .657 | |||
P3 | 0.17g (0.03–0.32) | 0.45 (0.29–0.64) | 0.50g (0.33–0.69) | .002g | <.001g | .724 | |||
P6 | 0.15g (0.05–0.25) | 0.23 (0.13–0.35) | 0.28 (0.17–0.40) | .026g | .007g | .621 | |||
P12 | 0.22g (0.11–0.34) | 0.20 (0.09–0.32) | 0.24 (0.13–0.37) | .160 | .067 | .669 |
Represented by percentage of water content interlimb ratios. B0 = baseline; MLD = manual lymph drainage; P = after intensive treatment; P1, P3, P6, and P12 = after 1, 3, 6, and 12 mo of maintenance treatment, respectively.
Cutis, subcutis, and cutis + subcutis, represented by interlimb ratios.
Through palpation, represented by pinch test scores.
Represented by induration force interlimb ratios.
Represented by palpation test scores.
At different time points. Significance of relative changes versus baseline in each treatment group separately. P values for overall interaction effect and comparisons of changes between treatment groups in case of presence of significant interaction effect.
With regard to within-group differences, P < .05 for changes in the estimated mean versus baseline that were statistically significant.
With regard to within-group differences, P < .0001 for changes in the estimated mean versus baseline that were statistically significant. B0 = baseline; MLD = manual lymph drainage; P = after intensive treatment; P1, P3, P6, and P12 = after 1, 3, 6, and 12 months of maintenance treatment, respectively.
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