NCT01347736

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2014

Completed
Last Updated

April 4, 2018

Status Verified

February 1, 2018

Enrollment Period

1.7 years

First QC Date

March 30, 2011

Last Update Submit

April 2, 2018

Conditions

Dermatologic ComplicationsPainViral Infection

Outcome Measures

Primary Outcomes (1)

  • Change in pain on a 0-10 numerical rating scale.

    10 weeks

Study Arms (1)

Treatment (pain therapy)

EXPERIMENTAL

Patients undergo scrambler therapy for approximately 30 minutes. Treatment continues for 10 days in the absence of pain progression or unacceptable toxicity.

Other: scrambler therapyOther: questionnaire administrationProcedure: dermatologic complications management/prevention

Interventions

scrambler therapyOTHER

Undergo scrambler therapy

Treatment (pain therapy)
questionnaire administrationOTHER

Ancillary studies

Treatment (pain therapy)
dermatologic complications management/preventionPROCEDURE

Undergo scrambler therapy

Also known as: complications management/prevention, dermatologic, management/prevention, dermatologic complications
Treatment (pain therapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

PainVirus Diseases

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsInfections

Study Officials

  • Charles Loprinzi

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2011

First Posted

May 4, 2011

Study Start

March 1, 2011

Primary Completion

November 7, 2012

Study Completion

November 7, 2014

Last Updated

April 4, 2018

Record last verified: 2018-02

Locations

US(1)