Optimal Intensity and Frequency of a Portable Electrical Muscle Stimulator (VeinoPlus) to Improve Symptoms of Postthrombotic Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Median Optimal Electrical Stimulation Intensity Level for Largest Benefit in Relief of Symptoms
Study Overview
Brief Summary
The investigators plan to perform an exploratory study to investigate the effects of electro-stimulation of the legs on the symptoms and clinical findings of post thrombotic syndrome (PTS), as well as quality of life of patients with PTS. The investigators theorize that electro-stimulation will provide both a mechanical benefit via muscular contraction and increased venous outflow from the affected extremity, as well as an anesthetic effect, which the investigators anticipate will translate into improved symptomatic outcomes, quality of life (QOL) benefits.
Detailed Description
The purpose of this study is to determine the optimal electrical stimulation intensity level at which subjects using the portable electrical muscle stimulator (VeinoPlus) have the largest benefit for relief of post thrombotic symptoms. To determine if the subjects reported benefit from the device and willingness to continue using the device.
Subjects will be pre-screened on the phone for eligibility, and an initial appointment will be set. The subject will be given a device and complete a quality of life survey. The subject will also be assessed on the Villalta scale. After two months, the subjects will return for the final visit where the Villalta scale and quality of life survey will be reassessed, and the device taken back.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Presence of previously objectively documented unilateral, lower extremity deep venous thrombosis
- •Presence of PTS (typical pain and swelling - worse after standing and vertical activity and relieved by rest and the horizontal position), severe enough that the patient is interested to explore a treatment option that might improve these symptoms. Symptoms had to have been stable for ≥ 3 months. Unstable symptoms are defined as: worsening, improving or variable symptoms over preceding months.
- •Subjects must be willing and able to give written informed consent.
Exclusion Criteria
- •Inability or refusal to provide informed consent
- •Pregnancy
- •Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
- •Geographic inaccessibility to prevent scheduled return evaluations
- •Incapable of responding to questionnaires
- •Expected lifespan <6 months
- •Presence of cardiac pacemaker
- •History of cardiac arrhythmia
- •Presence of infected, or inflamed areas or skin eruptions; phlebitis, thrombophlebitis, active venous ulceration
- •History of seizures
Arms & Interventions
Veinoplus
Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.
Intervention: VeinOPlus (Device)
Outcomes
Primary Outcomes
Median Optimal Electrical Stimulation Intensity Level for Largest Benefit in Relief of Symptoms
Time Frame: Visit 2 (Week 8)
The VeinoPlus® electrically stimulates leg muscles via motor nerves, causing muscle contractions. Two electrode pads are placed on the skin of the leg. Pad positions can be chosen by the patient, such as (a) both pads on the calf muscle of one leg, (b) one pad on the calf muscle and one on the plantar aspect of the foot of one leg, and (c) a pad posteriorly on each calf. Length of treatment is programmed into the device and is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations during the treatment cycle if desired. The intensity ranges from zero to fifty, with zero being no electrical stimulation, and fifty the highest intensity, which carries low quantities of electrical energy (\<5 micro coulombs). In this study subjects used the device at any setting, as many times a day as they liked, and varying the placement of the electrodes.
Secondary Outcomes
- Number of Study Participants Classified as a "Clinical Success"(Visit 2 (Week 8))
- Number of Study Participants With Improvements in QOL (VEINES-QOL Score)(Vist 2 (Week 8))
- Number of Study Participants With Improvements in Venous Symptoms (VEINES-Sym Score)(Vist 2 (Week 8))
- Number of Study Participants With Improvements in PTS Severity (Villalta Score)(Visit 2 (Week 8))