Wireless TENS for Peripheral Edema (Lower Limb Swelling)

Peripheral Edema Clinical Trial

Official title: Transcutaneous Electrical Nerve Stimulation for Peripheral Edema: A Single Arm Clinical Trial

Status Active, not recruiting

Clinical Trial Summary

This study is single center, subject will receive a wireless TENS device. All subjects will be allowed to keep the commercially-available device for use after the study. The primary goal is to test the feasibility of the study design and secondary is to test the preliminary efficacy of the TENS.

Clinical Trial Description

This study is single center, subject will receive a wireless TENS device. The coordinator will introduce the study device, be available to answer questions about the device, and assess adverse events. Subjects will be told that we are testing whether TENS, which has shown promise in some patients but needs to be tested formally, has an effects on lower limb swelling . The treatment period will be 3 weeks in duration. After the treatment period, all subjects will be asked to complete the Treatment-period Endpoint-Qualitative interview. All subjects will be allowed to keep the commercially-available device for use after the study. ;

Related Conditions & MeSH terms

• Edema
• Peripheral Edema

• NCT number: NCT04680533
• Study type: Interventional
• Source: University of Rochester
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: June 28, 2021
• Completion date: September 1, 2025