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Electrical Stimulation
Wireless TENS for Pain Relief in Lower Limb Swelling
Phase 1 & 2
Waitlist Available
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Not currently using diuretics to control their edema.
Have an active and accessible email
Timeline
Screening 3 weeks
Treatment Varies
Follow Up entire recruitment period, up to 2 years
Awards & highlights
Study Summary
This trial is testing a TENS device to see if it is effective for pain relief. The subjects will be able to keep the device after the study.
Who is the study for?
This trial is for adults who've had lower limb swelling for at least 3 months, with a pitting scale score of 2+ or higher. Participants should not be using diuretics, compression wraps, physical therapy, or lymphatic massage and must avoid starting any new medications that affect edema during the study. They need to have access to a smartphone and email.Check my eligibility
What is being tested?
The trial is testing the use of a wireless Transcutaneous Electrical Nerve Stimulation (TENS) device on individuals with peripheral edema. It aims to determine if this commercially-available TENS device is feasible for use in studies and preliminarily effective in reducing lower limb swelling.See study design
What are the potential side effects?
Potential side effects may include skin irritation where the TENS electrode pads adhere, discomfort from electrical stimulation, muscle twitching during treatment sessions, and possible increase in swelling if improperly used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not using water pills for swelling.
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I have an active email that I check regularly.
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I have had swelling in my legs for at least 3 months.
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I am not using and will not start any physical or occupational therapy or lymphatic massage two weeks before and during the study.
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I have had swelling in my legs for at least 3 months.
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I am not using and will not start occupational or physical therapy, or lymphatic massage.
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I am not using water pills for swelling.
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I am 18 years old or older.
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I have noticeable swelling that leaves a dent when pressed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ entire recruitment period, up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~entire recruitment period, up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Edema Symptom Diary score
Outcome Measure completion
Patient Refusal
+2 moreSecondary outcome measures
Coordinator tape measurements of the lower limb
Impression of Change in Edema Symptoms
Lymphoedema Quality of Life
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: TENS deviceExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous Electrical Nerve Stimulation (TENS)
2023
N/A
~680
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
841 Previous Clinical Trials
533,665 Total Patients Enrolled
NeuroMetrix, Inc.Industry Sponsor
6 Previous Clinical Trials
388 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not currently using compression stockings or any kind of wraps or bandages.I am not using water pills for swelling.I have an active email that I check regularly.I have had swelling in my legs for at least 3 months.My kidney function is moderately to severely reduced.I am not using and will not start any physical or occupational therapy or lymphatic massage two weeks before and during the study.I have had swelling in my legs for at least 3 months.I started taking blood thinners within the last 3 months.I have a skin condition where the electrode pads would be placed.I have epilepsy.I have cellulitis or fibrosis.I am not using and will not start occupational or physical therapy, or lymphatic massage.I am not using water pills for swelling.You are willing and able to regularly check the email provided throughout the study.I have cirrhosis of the liver.I agree not to start or change any edema-related medications for 2 weeks before and during the study.I have been diagnosed with congestive heart failure.I am 18 years old or older.I have wounds or ulcers on my legs.Your leg is either too small or too large for the TENS device to fit properly and stay in place.I have a painful blood clot in my leg.I had surgery to remove lymph tissue from my lower leg.I have noticeable swelling that leaves a dent when pressed.I haven't used compression stockings or wraps for 2 weeks, or my doctor agrees they're not helping much.I have swelling in my leg due to lymphedema.You are currently using a TENS device for any reason.
Research Study Groups:
This trial has the following groups:- Group 1: TENS device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for participants in this research endeavor?
"Affirmative. According to clinicaltrials.gov, this medical research is actively enlisting participants with the initial post date being June 28th 2021 and most recent update occurring on September 6th 2022. The study requires 52 individuals from a single site for enrollment."
Answered by AI
What is the maximum quantity of participants allowed in this experiment?
"Affirmative. According to the clinicaltrials.gov website, this medical trial is actively enrolling patients; the experiment was first uploaded on June 28th 2021 and recently updated on September 6th 2022. The study requires 52 participants from a single site."
Answered by AI
What end result is this clinical trial seeking to ascertain?
"This clinical analysis, which will be monitored over a two-year period, seeks to measure water volume displacement. Auxiliary results include the mean change in monofilament threshold (using a lightest touch test of the big toe), appraisal of alteration in edema symptoms (utilizing a 0 - 105 scoring range with anchors "very much improved" to "very much worse"), and estimated treatment adherence stimulations time measured by TENS device's App."
Answered by AI
Who else is applying?
What site did they apply to?
University of Rochester Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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