Wireless TENS for Peripheral Edema (Lower Limb Swelling)
- Conditions
- Peripheral Edema
- Interventions
- Device: Transcutaneous Electrical Nerve Stimulation (TENS)
- Registration Number
- NCT04680533
- Lead Sponsor
- University of Rochester
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 52
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TENS device Transcutaneous Electrical Nerve Stimulation (TENS) The device is worn on the upper calf right below the knee and secured by an elastic band. The device is controlled by an App and alternates between treatment periods and rest periods. Participants will be asked to wear the device 7-8 hours per day alternating legs.
- Primary Outcome Measures
Name Time Method Patient Refusal Entire recruitment period, up to 2 years The rate at which participants who are approached and screened for the study but choose to not participate in the study will be assessed using study records. The rate recorded will be the total percentage of patient refusals during the total recruitment period of the study.
Screening failure Entire recruitment period, up to 6 months The rate at which participants who are approached and screened for the study but are ineligible will be assessed using study records. The rate recorded will be the total percentage of screening failures during the total recruitment period of the study.
Edema Symptom Diary score day 0 to day 28 Swelling and symptoms associated with edema will be recorded in the Edema Symptom Diary using a verbal rating scale of swelling in the lower limbs and feet using the anchors "none", "a little bit", "quite a bit" "a lot", or "very much", which converts to a 1 to 5 measurable scale, with \[1 = none, 5 = very much\]. The scores per each symptom per day will be summed and averaged over 7 days. The higher the score the worse the health outcome. The range of scores the participant can achieve per day is between 6 - 30.
Outcome Measure completion day -7 to day 28 The rate of outcome measure completion by participants over course of enrollment in the study will be assessed using the study dispositions records in REDCap. The rate recorded will be the total percentage of completed outcome measures during the period of enrollment in the study.
Water volume displacement day 28 The volume of water displaced by the combination of the foot and ankle, and the entire lower limb below the knee of the most affected limb at baseline will be measured using a Volumeter, which is a water displacement measurement device. The volumes will be recorded in Volumeter Measurements form.
- Secondary Outcome Measures
Name Time Method Mean Treatment Adherence On skin time day 0 to day 28 Treatment adherence will be evaluated using data from the TENS device's App to review the time that the device was in contact with the skin per day. The Quell Health account for each subject will be set up at the baseline visit using a de-identified, unique dummy email address created for the study to protect subjects' privacy.
Mean Treatment Adherence Frequency type day 0 to day 28 Treatment adherence will be evaluated using data from the TENS device's App to review the type of frequency stimulation the participant receives per day. The Quell Health account for each subject will be set up at the baseline visit using a de-identified, unique dummy email address created for the study to protect subjects' privacy.
Mean Treatment Adherence Sessions day 0 to day 28 Treatment adherence will be evaluated using data from the TENS device's App to review the number of treatment sessions/day. The Quell Health account for each subject will be set up at the baseline visit using a de-identified, unique dummy email address created for the study to protect subjects' privacy.
Coordinator tape measurements of the lower limb day 28 The blinded coordinator will use a tape measure at the arch of the foot, 1/2 and the distance between the middle of the kneecap and the ankle, and at the knee crease of both limbs regardless of which is more affected. Measurements will be recorded in the Coordinator Lower Limb Swelling form.
Mean Change in monofilament threshold day 0 to day 28 Measuring the lightest touch that the participant can feel on their big toe using a monofilament. Recording the threshold once the participant guesses the touches in the trial pair correctly 7 or 8 times.
Mean Treatment Adherence stimulations time day 0 to day 28 Treatment adherence will be evaluated using data from the TENS device's App to review the amount of time the participant received stimulation per day. The Quell Health account for each subject will be set up at the baseline visit using a de-identified, unique dummy email address created for the study to protect subjects' privacy.
Impression of Change in Edema Symptoms day 28 Impression of change in edema symptoms is measured from baseline to first endpoint and first endpoint to second endpoint. The form uses a 1 - 7 scale, with anchors "very much improved", "much improved", "minimally improved", "not changed", "minimally worse", "much worse", or "very much worse", with \[1 = very much improved, 7 = very much worse\]. The range of scores the participant can achieve 0 - 105.
Lymphoedema Quality of Life day 28 Quality of life is measure over the course of the study using a 1 - 4 scale, with anchors "not at all", "a little bit", "quite a bit", or "very much", with \[0 = not at all, 4 = very much\]. If the question is not applicable the scale value is 0. Overall quality of life (Q22) is measure using a 0 - 10 NRS scores \[0 = poor, 10 = excellent\]. Each answer's score is summed by domain, Function 1-3; Appearance 4-9; Symptoms 10-15; and Mood 16-21. Each domain score is by the total number of questions answered in the domain. If fewer than 50% of the items were answered, the whole domain is scored as 0. The higher the LYMQOL (Lymphoedema Quality of Life) domain scores the more severe the edema. The 5th domain, Overall quality of life 22, is measure using a 0 - 10 numerical rating scale (NRS) scores, with \[0 = poor, 10 = excellent\]. The range of scores the participant can achieve per domain is: Function 0 - 32; Appearance 0 - 24; Symptoms 0 - 24; Mood 0 - 24; and Overall quality of life 0 - 10.
Trial Locations
- Locations (1)
University of Rochester Medical Center
🇺🇸Rochester, New York, United States