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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01347736
First Posted: May 4, 2011
Last Update Posted: December 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mayo Clinic
March 30, 2011
May 4, 2011
December 21, 2016
March 2011
September 2017   (Final data collection date for primary outcome measure)
Change in pain on a 0-10 numerical rating scale. [ Time Frame: 10 weeks ]
Same as current
Complete list of historical versions of study NCT01347736 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Dermatologic Complications
  • Pain
  • Viral Infection
  • 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
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.
Interventions:
  • Other: scrambler therapy
  • Other: questionnaire administration
  • Procedure: dermatologic complications management/prevention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
Not Provided
September 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01347736
MC10CE
NCI-2011-00338 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC10CE ( Other Identifier: Mayo Clinic Cancer Center )
11-00531 ( Other Identifier: Mayo Clinic IRB )
NCI-2011-00338 ( Registry Identifier: NCI CTRP )
Yes
Not Provided
Not Provided
Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Charles Loprinzi Mayo Clinic
Mayo Clinic
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP