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

March 30, 2011
March 24, 2014
March 2011
September 2014   (final data collection date for primary outcome measure)
Change in pain on a 0-10 numerical rating scale. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 2014   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01347736
MC10CE, NCI-2011-00338, MC10CE, 11-00531, NCI-2011-00338
Yes
Loprinzi, Charles, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Charles Loprinzi Mayo Clinic
Mayo Clinic
March 2014

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