Electrical Foot Stimulation: A Potential New Method of Deep Venous Thrombosis Prophylaxis

James J. Czyrny; Robert E. Kaplan; Gregory E. Wilding; Christopher H. Purdy; Jack Hirsh

Disclosures

Vascular. 2010;18(1):20-27. 

In This Article

Results

By design, the sample was equally distributed in terms of gender (20 males, 20 females) and BMI (20 nonobese, BMI < 30; 20 obese, BMI > 30). The mean age of the sample was 62.6 years (SD 8.4 years). The mean BMI of the sample population was 30.6 (SD 5.6) (Table 1.) Two subjects dropped out of the study and were replaced. One subject developed a medical problem not related to the study, and the other subject did not return for the second session and could not be contacted by telephone.

For both the femoral and popliteal veins, at both time points (120 and 240 minutes), the electrical foot stimulation group exhibited a greater blood flow velocity measurement than the IPC group (Figure 2, Figure 3, Figure 4, and Figure 5).

Figure 2.

Femoral venous blood flow intermittent pneumatic compression (IPC) versus electrical stimulation. Time = 120 minutes (noninferiority: t value 5 2.70 and p value = .005) (N = 40).

Figure 3.

Femoral venous blood flow intermittent pneumatic compression (IPC) versus electrical stimulation. Time = 240 minutes (noninferiority: t value = 1.63 and p value = .055) (N = 40).

Figure 4.

Popliteal venous blood flow intermittent pneumatic compression (IPC) versus electrical stimulation. Time = 120 minutes (noninferiority: t value = 2.75 and p value = .004) (N = 40).

Figure 5.

Popliteal venous blood flow intermittent pneumatic compression (IPC) versus electrical stimulation. Time = 240 minutes (noninferiority: t value = 2.27 and p value = .014) (N = 40).

The primary analysis indicates that the experimental treatment (electrical foot stimulation) is noninferior relative to standard treatment (IPC). Noninferiority was achieved at time = 120 minutes for the femoral vein (t = 2.70; p = .005), and time 5 120 minutes (t = 2.75; p = .004) and time = 240 minutes (t = 2.27; p = .014) for the popliteal vein. Noninferiority was almost achieved at time = 240 minutes for the femoral vein (t = 1.63; p = .055).

After adjusting for baseline values using a mixed model, with baseline as a covariate, differences between therapy groups (electrical foot stimulation versus IPC) persisted. For the femoral vein, for time = 120 minutes, noninferiority was achieved (F = 2.80, p = .008). For the popliteal vein, for time = 120 and 240 minutes, noninferiority was achieved (F = 2.47, p = .018; F = 2.09, p = .043). There were no statistical differences between blood flow velocity measurements in the control leg for electrical foot stimulation compared with the control leg for IPC. Both modalities, electrical foot stimulation and IPC, were equally effective regardless of BMI.

No subjects requested that the study be stopped once it was initiated at either session. No unacceptable discomfort or injury occurred to any subjects during or following this study.

In response to the questionnaire, a majority of subjects indicated that both treatments were uncomfortable, 92.5% (37 of 40) for IPC and 82.5% (33 of 40) for electrical foot stimulation. A majority of subjects, 62.5% (25 of 40), found the IPC treatment more comfortable than the electrical foot stimulation treatment. When told that the electrical foot stimulation treatment would allow them to walk while on therapy, a majority of subjects, 75.0% (30 of 40), indicated that this would increase their likelihood of using electrical foot stimulation therapy.

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