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

NCT ID: NCT01347736

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-11-07

Brief Summary

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

Detailed 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.

Conditions

Dermatologic Complications; Pain; Viral Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (pain therapy)

Patients undergo scrambler therapy for approximately 30 minutes. Treatment continues for 10 days in the absence of pain progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

scrambler therapy

Intervention Type: OTHER

Undergo scrambler therapy

questionnaire administration

Intervention Type: OTHER

Ancillary studies

dermatologic complications management/prevention

Intervention Type: PROCEDURE

Undergo scrambler therapy

Interventions

scrambler therapy

Undergo scrambler therapy

Intervention Type: OTHER

questionnaire administration

Ancillary studies

Intervention Type: OTHER

dermatologic complications management/prevention

Undergo scrambler therapy

Intervention Type: PROCEDURE

Other Intervention Names

complications management/prevention, dermatologic; management/prevention, dermatologic complications

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Loprinzi

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

NCI-2011-00338

Identifier Type: REGISTRY

Identifier Source: secondary_id

MC10CE

Identifier Type: OTHER

Identifier Source: secondary_id

11-00531

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-00338

Identifier Type: REGISTRY

Identifier Source: secondary_id

MC10CE

Identifier Type: -

Identifier Source: org_study_id