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
Sponsored by
About this trial
This is an interventional treatment trial for Dermatologic Complications
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
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
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
No
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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