This trial is active, not recruiting.

Conditions dermatologic complications, pain, viral infection
Treatments scrambler therapy, questionnaire administration, dermatologic complications management/prevention
Sponsor Mayo Clinic
Start date March 2011
End date September 2016
Trial size 10 participants
Trial identifier NCT01347736, 11-00531, MC10CE, NCI-2011-00338


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients undergo scrambler therapy for approximately 30 minutes. Treatment continues for 10 days in the absence of pain progression or unacceptable toxicity.
scrambler therapy
Undergo scrambler therapy
questionnaire administration
Ancillary studies
dermatologic complications management/prevention complications management/prevention, dermatologic
Undergo scrambler therapy

Primary Outcomes

Change in pain on a 0-10 numerical rating scale.
time frame: 10 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Scrambler Therapy for the Treatment of Chronic Zoster Pain
Principal investigator Charles Loprinzi
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.