Wireless TENS for Peripheral Edema (Lower Limb Swelling)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral Edema
• Intervention / Treatment: Device: Transcutaneous Electrical Nerve Stimulation (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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Rachel De Guzman; Phone Number: (585) 275-9361; Email: TENS.edema.study@urmc.rochester.edu
• Study Contact Backup: Name: Jennifer Gewandter; Phone Number: 585-276-5661; Email: TENS.edema.study@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria (subjects must…)

1. Have had lower extremity edema for at least 3 months.
2. 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.
3. 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.
4. Not currently using diuretics to control their edema.
5. 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.
6. 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.
7. 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.
8. Have an active and accessible email.
9. Be willing and able to regularly check the email provided throughout the study.
10. 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.
11. Be at least 18 years of age.
12. Be able to provide informed consent.

Exclusion criteria (subjects must not…)

1. Be currently using a TENS device for any reason.
2. Have an acute and symptomatic lower extremity DVT (i.e., the diagnosis of DVT is less than 3 months prior to study enrollment).
3. Have started anticoagulants within the past 3 months.
4. Have lower extremity wounds or ulcers.
5. Have a cardiac pace maker or defibrillator.
6. Have epilepsy.
7. Have a leg that is too small or too large for the TENS device to fit securely.
8. Have cellulitis or fibrosis.
9. 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.
10. Have congestive heart failure.
11. Have chronic kidney disease of stage 3 or greater.
12. Have cirrhosis of the liver.
13. Have previous surgery that removed lymphatic lower leg tissue.
14. Have a diagnosis of lower limb lymphedema.
15. Be pregnant or planning to become pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Transcutaneous Electrical Nerve Stimulation (TENS); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 28
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.	day 0 to day 28
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.	Entire recruitment period, up to 6 months
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.	Entire recruitment period, up to 2 years
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.	day -7 to day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 0 to day 28
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.	day 0 to day 28
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.	day 0 to day 28
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.	day 0 to day 28
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.	day 28
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.	day 0 to day 28
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.	day 28
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.	day 28

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: NeuroMetrix, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Estimated): May 28, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: STUDY00005655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes