Introduction: Pneumatic compression therapy is proposed as a supplementary treatment tool for lymphedema. The conventional pneumatic compression devices apply sequential pressure on the limbs in distal-to-proximal direction without holding pressure below the compression site. However, for effective lymphatic drainage, it is necessary to apply the compressive force with maintaining a low level of pressure on the distal site. We have developed a novel pneumatic compression device that can apply sequential pressure from distal to proximal while maintaining low pressure on the distal from the compression site. In this study, we aimed to evaluate the efficacy of the novel device in managing lower limb edema compared to the conventional pneumatic compression device.
Methods: This is a prospective randomized double-blind clinical study. We recruited 20 patients with stage 1 lymphedema on unilateral lower extremity. Lymphedema was diagnosed by clinical history, physical examination and lymphoscintigraphy. The patients were randomized into 2 groups; conventional device group and novel device group. Both groups underwent totally 12 sessions of pneumatic compression treatment for 4 weeks. We evaluated the visual analogue scale (VAS) of lymphedema, the circumferences of lower limbs (foot, ankle, 10cm below the knee, knee, 10cm above the knee, 25cm above the knee) and the thickness of subcutaneous tissue using ultrasound. The evaluations were performed before and after the treatment sessions. We compared the evaluation data between the groups.
Result: In demographic data, there were no significant differences between the groups. Both groups showed significant decrement of VAS after treatment sessions. However, there were no significant differences in the VAS of pre- and post-treatment between the groups. The novel device group showed greater rate of change of the VAS than the conventional device group, but there was no statistical significance. In comparison of the leg circumferences, the novel device group showed significant decrease in all the measurement sites. In the conventional device group, the leg circumferences were significantly decreased only in the foot, ankle, 10cm above knee, and 25cm above knee. The novel device group revealed significantly greater rate of decrease of the leg circumferences in the knee and 25 cm above knee than the conventional group. In comparison of the subcutaneous thickness, the novel device group showed significant decrease of thickness in the thigh and ankle.
Conclusion: In this study, we have confirmed the effectiveness of the pneumatic compression in management of early stage lymphedema. The novel pneumatic compression device has showed significant reduction of lower limb edema. Compared to the conventional device, it has been observed that the novel device was significantly more effective in reducing edema in the proximal lower limb.
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