Clinical trial NCT00858130: Pilot Study for VeinoPlus to Improve Symptoms of Postthrombotic Syndrome (PTS)
Official title: Optimal Intensity and Frequency of a Portable Electrical Muscle Stimulator (VeinoPlus) to Improve Symptoms of Postthrombotic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Thrombotic Syndrome
Deep Vein Thrombosis
Venous Stasis Syndrome
Venous Insufficiency
Postphlebitic Syndrome
Keywords: Veinoplus
post thrombotic syndrome
deep vein thrombosis
electrical muscle stimulator
Venous stasis syndrome
venous insufficiency syndrome
Postphlebitic syndrome
history of deep vein thrombosis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: VeinoPlus USA
First posted: 2009-03-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients were told to use different voltages and numbers of treatment periods, and experiment with pad placement, to find intensity, frequency of use, and pad position for optimal PTS symptom relief. Assessments (Villalta score, QOL questionnaire, calf circumference) were obtained at study entry and after 8 weeks of device use.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Age \>18
* 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

Primary outcomes:
measure: Median Optimal Electrical Stimulation Intensity Level for Largest Benefit in Relief of Symptoms
timeFrame: Visit 2 (Week 8)
Secondary outcomes:
measure: Number of Study Participants Classified as a "Clinical Success"
timeFrame: Visit 2 (Week 8)
measure: Number of Study Participants With Improvements in PTS Severity (Villalta Score)
timeFrame: Visit 2 (Week 8)
measure: Number of Study Participants With Improvements in QOL (VEINES-QOL Score)
timeFrame: Vist 2 (Week 8)
measure: Number of Study Participants With Improvements in Venous Symptoms (VEINES-Sym Score)
timeFrame: Vist 2 (Week 8)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill; University of North Carolina Hospitals
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill, Department of Medicine, Division of Hematology/Oncology
name: Stephan Moll, MD
role: PRINCIPAL_INVESTIGATOR
References: