Pilot Trial of Neuromuscular Stimulation in Human Subjects with Chronic Venous Disease

Figures & data

Table 1 Demographic Data of Recruited Subjects

	Healthy Subjects	Superficial Venous Insufficiency	Deep Venous Insufficiency	Deep Venous Obstruction	ANOVA
Number	10	10	10	10
Age (years)	30.7±10	55.0±15	58.6±18	53.2±16	<0.001
Sex	50% M	40% M	80% M	70% M	0.04
BMI (kg/m^2)	23.6±4	26.4±6	30.1±3	34.8±6	<0.001
CEAP clinical severity score	0.8±1	3.1±1	4.4±1	4.0±1	<0.001
Unilateral leg volume (mL)	1451.1±574	1730.2±390	2025.8±1029	2501.7±814	<0.001

Note: Mean ± standard deviation.

Table 2 Anatomical Segments Affected by Venous Disease in Trial Patients (Disease may affect more than one segment in any one subject, therefore total not equal to participant number in each group)

Vein Segment Affected	Superficial Venous Insufficiency	Deep Venous Insufficiency	Deep Venous Obstruction
Venae cava	0	0	1
Iliac	0	0	4
Femoral	7	9	6
Popliteal	6	8	1
Below knee (including perforators)	9	8	3

Figure 1 CONSORT diagram of VeINS trial (DNA – did not attend follow-up, VV – varicose vein).

Table 3 Haemodynamic changes in the femoral vein, with use of NMES, “Device off” compared to “Device on”

Percentage Change from Baseline	Group
	Healthy Subjects		Superficial Venous Insufficiency		Deep Venous Insufficiency		Deep Venous Obstruction
	Median	IQR	Median	IQR	Median	IQR	Median	IQR
Peak velocity	34.8**	−4–81	62.8**	25–138	9.0	−10 – 84	14.8	−8–51
TAMV	−14.2	−30 – 55	28.1**	−2 – 111	28.2	−30 – 66	−5.1	−28–35
Volume Flow	−22.5	−40–40	37.5*	−10–172	17.4*	1–49	5.9	−11–21

Notes: *p<0.05, **p<0.01, Wilcoxon signed-rank.

Abbreviation: IQR, interquartile range.

Figure 2 Haemodynamic changes in the femoral vein with neuromuscular electrical stimulation, taken at weeks 0 and 6 (*p<0.05, Wilcoxon matched pairs signed-rank).

Table 4 Laser Doppler Fluximetry changes in the hand and foot with use of NMES, “Device off” compared to “Device on”

Percentage Change from Baseline	Healthy Subjects	Superficial Venous Insufficiency	Deep Venous Insufficiency	Deep Venous Obstruction
Leg flux	274.8 ± 279**	264.9 ±283*	69.3 ± 126	46.9 ± 50*
Arm flux	84.0 ± 126**	71.3 ± 76*	23.7 ± 57	106.5 ± 115*

Notes: Mean ± standard deviation; *p<0.05, **p<0.01, Wilcoxon signed-rank.

Table 5 Changes in unilateral leg volume over 6 weeks regular NMES use

	Healthy	Venous Disease
Week 0 (mL)	1451.1 ± 574	2085.9 ± 840
Week 6 (mL)	1552.2 ± 580	1797.2 ± 491
Significance (Wilcoxon signed-rank)	0.61	0.03

Note: Median ± interquartile range.

Table 6 Mean Quality of Life Scores and Changes Over Time

	CEAP C0-3			CEAP C4-6
	Week 0 N=17	Week 6 N=16	Week 8 N=11	Week 0 N=18	Week 6 N=14	Week 8 N=13
VCSS	2.9	2.9	3.4	9.6	6.5	7.4
VDS	0.69	0.71	0.78	1.9	1.1**	1.3
AVVQ	9.6	8.0	9.2	26.6	22.4	23.6
EQ5D	0.81	0.86	0.90	0.7	0.7	0.7
SF-12	99	102	94	85	95	87
CES-D	8.9	7.3	10.6	12.4	11.1	12.5

Notes: **p<0.01, Mann–Whitney U, week 0 to week 6.

Abbreviations: VCSS, venous clinical severity score; VDS, venous disability score; AVVQ, Aberdeen varicose vein questionnaire; SF-12, short form 12.