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

Pain Clinical Trial

Official title:

Scrambler Therapy for the Treatment of Chronic Zoster Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347736
• Other study ID #: MC10CE
• Secondary ID: NCI-2011-00338MC
• Status: Completed
• Phase: N/A
• First received: March 30, 2011
• Last updated: April 2, 2018
• Start date: March 2011
• Est. completion date: November 7, 2014

Study information

• Verified date: February 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 7, 2014
• Est. primary completion date: November 7, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatologic Complications
• Infection
• Pain
• Viral Infection
• Virus Diseases

Intervention

Other:
• scrambler therapy
Undergo scrambler therapy
• questionnaire administration
Ancillary studies

Procedure:
• dermatologic complications management/prevention
Undergo scrambler therapy

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain on a 0-10 numerical rating scale.		10 weeks