Back to resultsWireless TENS for Peripheral Edema (Lower Limb Swelling)
Primary Purpose
Peripheral Edema
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Electrical Nerve Stimulation (TENS)
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Edema
Eligibility Criteria
Inclusion criteria (subjects must…)
- 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.
- Be willing and able to regularly check the email provided throughout the study.
- Be able to read English (i.e., is literate, can speak English, and is not blind) because patient-reported outcomes and consent form are only available in English.
- Be at least 18 years of age.
- Be able to provide informed consent.
Exclusion criteria (subjects must not…)
- Be currently using a TENS device for any reason.
- Have an acute and symptomatic lower extremity DVT (i.e., the diagnosis of DVT is less than 3 months prior to study enrollment).
- Have started anticoagulants within the past 3 months.
- Have lower extremity wounds or ulcers.
- Have a cardiac pace maker or defibrillator.
- Have epilepsy.
- Have a leg that is too small or too large for the TENS device to fit securely.
- Have cellulitis or fibrosis.
- Have any skin condition at the site where the electrode pads adhere such that the PI/Co-I think the device will not be safe for the subject.
- Have congestive heart failure.
- Have chronic kidney disease of stage 3 or greater.
- Have cirrhosis of the liver.
- Have previous surgery that removed lymphatic lower leg tissue.
- Have a diagnosis of lower limb lymphedema.
- Be pregnant or planning to become pregnant.
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TENS device
Arm Description
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.
Outcomes
Primary Outcome Measures
Water volume displacement
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.
Edema Symptom Diary score
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.
Screening failure
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.
Patient Refusal
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.
Outcome Measure completion
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.
Secondary Outcome Measures
Mean Treatment Adherence On skin time
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 Sessions
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.
Mean Treatment Adherence stimulations time
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.
Mean Treatment Adherence Frequency type
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.
Coordinator tape measurements of the lower limb
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
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.
Impression of Change in Edema Symptoms
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
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.
Full Information
NCT ID
NCT04680533
First Posted
December 10, 2020
Last Updated
August 8, 2023
Sponsor
University of Rochester
Collaborators
NeuroMetrix, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04680533
Brief Title
Wireless TENS for Peripheral Edema (Lower Limb Swelling)
Official Title
Transcutaneous Electrical Nerve Stimulation for Peripheral Edema: A Single Arm Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
May 28, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
NeuroMetrix, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single Arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TENS device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation (TENS)
Intervention Description
Quell TENS device. 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 Measure Information:
Title
Water volume displacement
Description
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.
Time Frame
day 28
Title
Edema Symptom Diary score
Description
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.
Time Frame
day 0 to day 28
Title
Screening failure
Description
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.
Time Frame
Entire recruitment period, up to 6 months
Title
Patient Refusal
Description
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.
Time Frame
Entire recruitment period, up to 2 years
Title
Outcome Measure completion
Description
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.
Time Frame
day -7 to day 28
Secondary Outcome Measure Information:
Title
Mean Treatment Adherence On skin time
Description
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.
Time Frame
day 0 to day 28
Title
Mean Treatment Adherence Sessions
Description
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.
Time Frame
day 0 to day 28
Title
Mean Treatment Adherence stimulations time
Description
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.
Time Frame
day 0 to day 28
Title
Mean Treatment Adherence Frequency type
Description
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.
Time Frame
day 0 to day 28
Title
Coordinator tape measurements of the lower limb
Description
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.
Time Frame
day 28
Title
Mean Change in monofilament threshold
Description
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.
Time Frame
day 0 to day 28
Title
Impression of Change in Edema Symptoms
Description
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.
Time Frame
day 28
Title
Lymphoedema Quality of Life
Description
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.
Time Frame
day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria (subjects must…)
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.
Be willing and able to regularly check the email provided throughout the study.
Be able to read English (i.e., is literate, can speak English, and is not blind) because patient-reported outcomes and consent form are only available in English.
Be at least 18 years of age.
Be able to provide informed consent.
Exclusion criteria (subjects must not…)
Be currently using a TENS device for any reason.
Have an acute and symptomatic lower extremity DVT (i.e., the diagnosis of DVT is less than 3 months prior to study enrollment).
Have started anticoagulants within the past 3 months.
Have lower extremity wounds or ulcers.
Have a cardiac pace maker or defibrillator.
Have epilepsy.
Have a leg that is too small or too large for the TENS device to fit securely.
Have cellulitis or fibrosis.
Have any skin condition at the site where the electrode pads adhere such that the PI/Co-I think the device will not be safe for the subject.
Have congestive heart failure.
Have chronic kidney disease of stage 3 or greater.
Have cirrhosis of the liver.
Have previous surgery that removed lymphatic lower leg tissue.
Have a diagnosis of lower limb lymphedema.
Be pregnant or planning to become pregnant.
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Wireless TENS for Peripheral Edema (Lower Limb Swelling)
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