Scrambler Therapy in Treating Chronic Pain in Patients With Rash From Varicella Zoster Virus Infection



Status:Completed
Conditions:Chronic Pain, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:March 2011
End Date:November 7, 2014

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Scrambler Therapy for the Treatment of Chronic Zoster Pain

This pilot clinical trial studies how well scrambler therapy works treating chronic pain in
patients with rash from varicella zoster virus infection. Scrambler therapy may help relieve
pain from a rash caused by varicella zoster virus infection

PRIMARY OBJECTIVES:

I. To explore whether we can decrease post-herpetic neuralgia (PHN) pain with scrambler
therapy.

OUTLINE: Patients undergo scrambler therapy for approximately 30 minutes. Treatment continues
for 10 days in the absence of pain progression or unacceptable toxicity. After the completion
of study treatment, patients are followed up for 10 weeks.

Inclusion Criteria:

- Pain of >= 1 month (30 days) duration attributed to zoster, for which the patient
wants intervention

- Pain at least a four out of ten problem during the prior week, on a 0-10 scale where
zero was no problem and ten was the worst possible problem

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0, 1, or 2

- Life expectancy >= 3 months (90 days)

- Ability to complete questionnaire(s) by themselves or with assistance

- Provide informed written consent

Exclusion Criteria:

- Any of the following because this study involves an investigational agent whose
genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are
unknown

- Pregnant women

- Patients with implantable drug delivery systems, e.g. Medtronic Synchromed

- Patients with heart stents or metal implants such as pacemakers, automatic
defibrillators, aneurysm clips, vena cava clips and skull plates; (metal implants for
orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as
are central venous access devices)

- Patients with a history of myocardial infarction or ischemic heart disease within the
past six months

- Patients with history of epilepsy, brain damage, use of anti-convulsants for seizure
prevention, symptomatic brain metastases; Note: anti-convulsant use is allowed for
neuropathy and heart failure (HF) if on a stable dose

- Other identified causes of pain in the area that was affected by herpes zoster

- Skin conditions such as open sores that would prevent proper application of the
electrodes

- Other medical or other condition(s) that in the opinion of the investigators might
compromise the objectives of the study

- Prior treatment with Calmare MC-5A therapy

- Patient initiation of a new analgesic treatment within 7 days prior to initiation of
protocol treatment
We found this trial at
1
site
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
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