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

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

Study Overview

• Status: Completed
• Conditions: Pain; Viral Infection; Dermatologic Complications
• Intervention / Treatment: Other: questionnaire administration; Other: scrambler therapy; Procedure: dermatologic complications management/prevention

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: questionnaire administration; Ancillary studies; Other: scrambler therapy; Undergo scrambler therapy; Procedure: dermatologic complications management/prevention; Undergo scrambler therapy; Other Names: complications management/prevention, dermatologic; management/prevention, dermatologic complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in pain on a 0-10 numerical rating scale.	10 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2011
• Primary Completion (Actual): November 7, 2012
• Study Completion (Actual): November 7, 2014

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: May 3, 2011
• First Posted (Estimate): May 4, 2011

Study Record Updates

• Last Update Posted (Actual): April 4, 2018
• Last Update Submitted That Met QC Criteria: April 2, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Virus Diseases
• Other Study ID Numbers: MC10CE (Other Identifier: Mayo Clinic Cancer Center); NCI-2011-00338 (Registry Identifier: NCI CTRP); 11-00531 (Other Identifier: Mayo Clinic IRB)