Comparison of efficacy of the intermittent pneumatic compression with a high- and low-pressure application in reducing the lower limbs phlebolymphedema

Figures & data

Figure 1 Characteristic changes (infiltration of lymph) within the second toe – a massive Stemmer’s sign.

Figure 2 Positive compression test – a specific indentation characteristic for protein-rich fluid under the skin.

Figure 3 Study flowchart and CONSORT diagram.

Abbreviation: IPC, intermittent pneumatic compression.

Table 1 General characteristics of the study population in groups A, B, and C

	Group A	Group B	Group C	P-value
Number of patients	24	23	26	>0.05
Sex	15F/9M	13F/10M	16F/10M	>0.05
Number of smokers	13	12	13	>0.05
Age (years)
Average	49.5	51.5	52.2	>0.05
Min–max	42.3–62.2	44.6–60.3	45.6–63.4
SD	4.2	6.1	7.1
BMI (kg/m^2)
Average	26.4	27.7	27.8	>0.05
Min–max	22.3–32.5	19.6–32.2	20.2–32.4
SD	3.7	4.2	4.6
Edema occurrence (years)
Average	5.6	5.6	5.8	>0.05
Min–max	0.8–10.4	0.6–12.6	0.6–14.2
SD	4.2	4.4	4.8
Initial volume of edema (cm^3)
Average				>0.05
R	14,423.34	14,562.02	14,078.22
L	13,902.11	14,103.23	13,944.21
SD
R	4,781.12	4,454.24	4,303.88
L	4,423.33	4,223.25	3,993.84

Notes: Group A underwent a monthly antiedematous therapy including a manual lymphatic drainage, multilayer bandaging, and IPC with the output pressure 120 mmHg. Group B underwent the same basic treatment as group A and IPC with the output pressure of 60 mmHg. Group C (control) underwent only a basic treatment without IPC.

Abbreviations: BMI, body mass index; F, female; L, left limb; max, maximum; M, male; min, minimum; R, right limb; SD, standard deviation; IPC, intermittent pneumatic compression.

Table 2 Characteristics of chronic venous insufficiency in given groups

CEAP scalea (number of patients)	Group A	Group B	Group C	P-value
C3 EP AS2,3 PR	10R/10L	9R/11L	10R/11L	>0.05
C4 EP AS2D13 PR	8R/7L	8R/7L	9R/8L	>0.05
C4 EP AS2,3 D13,14 P18 PR	6R/7L	6R/5L	7R/7L	>0.05

Notes:

a C₃ E_P A_S2,3 P_R, primary failure, edema, the presence of reflux above and below the knee in saphenous vein; C₄ E_P A_{S2 D13} P_R, primary failure, edema and trophic changes in the skin and subcutaneous tissue, the presence of reflux above and below the knee in saphenous vein and femoral vein; and C₄ E_P AS2,3 D13,14 P18 P_R, primary failure, edema and trophic changes in the skin and subcutaneous tissue, the presence of reflux above and below the knee in saphenous, femoral, and popliteal vein and shank perforators. Group A underwent a monthly antiedematous therapy including a manual lymphatic drainage, multilayer bandaging, and IPC with the output pressure of 120 mmHg. Group B underwent the same basic treatment as group A and IPC with the output pressure of 60 mmHg. Group C (control) underwent only a basic treatment – without IPC.

Abbreviations: R, right limb; L, left limb; IPC, intermittent pneumatic compression; CEAP, clinical etiology anatomy pathophysiology.

Table 3 Patients’ characteristics in terms of edema according to categories by Olszewski

Edema severity according to Olszewski’sa (number of patients)	Group A	Group B	Group C	P-value
IIa	5R/3L	4R/4L	4R/3L	>0.05
IVa	10R/9L	10R/8L	12R/10L	>0.05
IVc	2R/1L	2R/1P	3R/2L	>0.05

Notes:

a Type IIa, pitting edema in the foot and shank; type IVa, pitting edema in the entire limb; and type IVc, edema with hyperkeratosis, fibrosis, and leakage of lymph in the entire limb. Group A underwent a monthly antiedematous therapy including a manual lymphatic drainage, multilayer bandaging, and IPC with the output pressure of 120 mmHg. Group B underwent the same basic treatment as group A and IPC with the output pressure of 60 mmHg. Group C (control) underwent only a basic treatment – without IPC.

Abbreviations: R, right limb; L, left limb; IPC, intermittent pneumatic compression.

Table 4 Patients’ characteristics in terms of edema according to categories by Brunner

Edema severity according to Brunnera (number of patients)	Group A	Group B	Group C	P-value
II	2R/1L	2R/1L	3R/2L	>0.05
III	9R/7L	8R/7L	9R/6L	>0.05
IV	2R/1L	2R/1L	3R/2L	>0.05
V	1R/1L	1R/1L	1R/1L	>0.05

Notes:

a Grade II, all-day edema resolves spontaneously after the night, with positive Stemmer’s sign; grade III, constant edema does not pit and does not significantly reduce upon limb elevation; grade IV, permanent edema distorting a limb, complicated as associated with irreversible skin changes, ie, fibrosis and papillae, as a result of inflammation of the skin; grade V, elephantiasis, massive edema distorting a leg with skin thickening, and changes in muscles – dystrophy, disabling the function of a limb. Group A underwent a monthly antiedematous therapy including a manual lymphatic drainage, multilayer bandaging, and IPC with the output pressure of 120 mmHg. Group B underwent the same basic treatment as group A and IPC with the output pressure of 60 mmHg. Group C (control) underwent only a basic treatment – without IPC.

Abbreviations: R, right limb; L, left limb; IPC, intermittent pneumatic compression.

Figure 4 The IPC device.

Abbreviation: IPC, intermittent pneumatic compression.

Figure 5 The 12-chamber IPC application.

Abbreviation: IPC, intermittent pneumatic compression.

Figure 6 The Perometer 400T measurement.

Table 5 Between-group comparisons of changes in right limb volume (cm³)

	Before treatment	After treatment	P-value
Group A
Average	14,423.34	8,755.23	0.00001
SD	4,781.12	7,878.77
Group B
Average	14,562.02	12,511.47	0.00022
SD	4,454.24	8,954.43
Group C
Average	14,078.22	12,305.67	0.00031
SD	4,303.88	9,887.98

Notes: Group A underwent a monthly antiedematous therapy including a manual lymphatic drainage, multilayer bandaging, and IPC with the output pressure of 120 mmHg. Group B underwent the same basic treatment as group A and IPC with the output pressure of 60 mmHg. Group C (control) underwent only a basic treatment – without IPC.

Abbreviation: SD, standard deviation; IPC, intermittent pneumatic compression.

Figure 7 Comparison of percentage edema reduction in the right lower limb between groups A, B, and C.

Notes: Group A underwent a monthly antiedematous therapy including a manual lymphatic drainage, multilayer bandaging, and IPC with the output pressure of 120 mmHg. Group B underwent the same basic treatment as group A and IPC with the output pressure of 60 mmHg. Group C (control) underwent only a basic treatment – without IPC.
Abbreviation: IPC, intermittent pneumatic compression.

Figure 8 Comparison of percentage edema reduction in the left lower limb between groups A, B, and C.

Table 6 Between-group comparisons of changes in left lower limb volume (cm³)

	Before treatment	After treatment	P-value
Group A
Average	13,902.11	8,734.23	0.00001
SD	4,423.33	6,956.44
Group B
Average	14,103.23	12,567.78	0.00028
SD	4,223.25	9,123.84
Group C
Average	13,944.21	12,270.67	0.00023
SD	3,993.84	9,563.86

Notes: Group A underwent a monthly antiedematous therapy including a manual lymphatic drainage, multilayer bandaging, and IPC with the output pressure of 120 mmHg. Group B underwent the same basic treatment as group A and IPC with the output pressure of 60 mmHg. Group C (control) underwent only a basic treatment – without IPC.

Abbreviation: SD, standard deviation; IPC, intermittent pneumatic compression.