Pilot Study for VeinoPlus to Improve Symptoms of Postthrombotic Syndrome (PTS)
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Cardiology, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/1/2017 |
| Start Date: | March 2009 |
| End Date: | November 2009 |
Optimal Intensity and Frequency of a Portable Electrical Muscle Stimulator (VeinoPlus) to Improve Symptoms of Postthrombotic Syndrome
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.
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.
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.
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.
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
We found this trial at
1
site
Chapel Hill, North Carolina 27599
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