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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01347736
First received: March 30, 2011
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Dermatologic Complications
Pain
Viral Infection
Other: scrambler therapy
Other: questionnaire administration
Procedure: dermatologic complications management/prevention

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Scrambler Therapy for the Treatment of Chronic Zoster Pain

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in pain on a 0-10 numerical rating scale. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2011
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: scrambler therapy
Undergo scrambler therapy
Other: questionnaire administration
Ancillary studies
Procedure: dermatologic complications management/prevention
Undergo scrambler therapy
Other Names:
  • complications management/prevention, dermatologic
  • management/prevention, dermatologic complications

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347736

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Charles Loprinzi Mayo Clinic
  More Information

No publications provided

Responsible Party: Loprinzi, Charles, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01347736     History of Changes
Other Study ID Numbers: MC10CE, NCI-2011-00338, MC10CE, 11-00531, NCI-2011-00338
Study First Received: March 30, 2011
Last Updated: March 24, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Infection
Communicable Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 19, 2014