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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
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.
University of Rochester Medical Center
Rochester, New York, United States
Mean Change in 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.
Time frame: From baseline visit (Day 0) to final endpoint visit (Day 21)
Mean Change in Coordinator Tape Measurements of the Lower Limb
The blinded coordinator measures the arch of the foot, the midpoint between the kneecap and ankle, and the knee crease on both limbs, regardless of which is more affected. These measurements are recorded in the Coordinator Lower Limb Swelling form. For analysis, the individual measurements are summed for each visit, and the average of these sums across relevant records is calculated separately for baseline and final endpoint visits to assess changes over time.
Time frame: From baseline visit (Day 0) to final endpoint visit (Day 21)
Mean Change in Patient Global Impression of Change in Edema Symptoms Score
The Patient Global Impression of Change in Edema Symptoms (PGIC-Edema) form contains multiple items, each rated on a 1-7 scale, with 1 = "very much improved," 4 = "not changed," and 7 = "very much worse." The total score is the sum of all item scores, with a possible range of 0-105. Higher scores indicate worse edema symptoms. For each participant, the baseline total score and final endpoint total score (Day 21) were calculated, and mean change was defined as the value at the final endpoint visit minus the value at the baseline visit.
Time frame: Baseline visit (Day 0) and final endpoint visit (Day 21)
Mean Change in Lymphoedema Quality of Life Questionnaire (LYMQOL) Score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Lymphoedema Quality of Life Questionnaire (LYMQOL) contains 26 items, each scored on a 0-4 scale, where 0 = "not at all" and 4 = "very much." Higher scores indicate worse quality of life. The total score is the sum of all item scores, with a possible range of 0-104. For each participant, the baseline total score and final endpoint total score (Day 21) were calculated, and mean change was defined as the value at the final endpoint visit minus the value at the baseline visit.
Time frame: Baseline visit (Day 0) and final endpoint visit (Day 21)