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

Primary Purpose

Dermatologic Complications, Pain, Viral Infection

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

scrambler therapy

questionnaire administration

dermatologic complications management/prevention

About this trial

This is an interventional treatment trial for Dermatologic Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (pain therapy)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01347736

First Posted

March 30, 2011

Last Updated

April 2, 2018

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01347736

Brief Title

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

Official Title

Scrambler Therapy for the Treatment of Chronic Zoster Pain

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

March 2011 (Actual)

Primary Completion Date

November 7, 2012 (Actual)

Study Completion Date

November 7, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatologic Complications, Pain, Viral Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (pain therapy)

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

scrambler therapy

Intervention Description

Undergo scrambler therapy

Intervention Type

Other

Intervention Name(s)

questionnaire administration

Intervention Description

Ancillary studies

Intervention Type

Procedure

Intervention Name(s)

dermatologic complications management/prevention

Other Intervention Name(s)

complications management/prevention, dermatologic, management/prevention, dermatologic complications

Intervention Description

Undergo scrambler therapy

Primary Outcome Measure Information:

Title

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

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles Loprinzi

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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