Wireless TENS for Peripheral Edema (Lower Limb Swelling)
Stopped: Terminated early due to lack of time.
United States3 participantsStarted 2021-06-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Have had lower extremity edema for at least 3 months.
✓. Currently have edema of at least 2+ (i.e., 3-4mm depression rebounds within a few seconds, but not immediately) on the pitting scale. 21 Pitting will have been assessed by a Clinician, the clinician Co-I within 6 weeks of the screening visit or at the screening visit by the research staff.
✓. Willing to not start or change the dosages of any medications that could affect edema for 2 weeks prior to enrollment, and throughout the duration of the study.
✓. Not currently using diuretics to control their edema.
✓. Not currently using and willing to not start using occupational therapy, physical therapy, or lymphatic massage (at home or by PT) 2 weeks prior to and throughout the duration of the study.
✓. Not currently using compression stockings or Velcro or bandage wraps at least 2 weeks prior to enrollment in the study or based on shared decision making of the potential subjects' clinician or the clinician co-investigator are receiving sufficiently little benefit from these therapies to warrant stopping their use for the duration of the study.
✓. Have access to a smart phone or device with an Apple or Android operating system with iOS 10 or later, or Android 6 or later. iOS and Android devices must have Bluetooth Low Energy (LE, also called Bluetooth Smart) compatibility. The smart phone or device must have the ability to access the TENS device's Quell App, Zoom App or software and, the ability to connect to the cellular data or Wi-Fi on a daily basis during the trial.
✓. Have an active and accessible email.
Exclusion criteria
What they're measuring
1
Mean Change in Edema Symptom Diary Score
Timeframe: From baseline visit (Day 0) to final endpoint visit (Day 21)