Scrambler Therapy in Treating Chronic Pain in Patients With Rash From Varicella Zoster Virus Infection
This study is ongoing, but not recruiting participants.
Sponsor:
Mayo Clinic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01347736
First received: March 30, 2011
Last updated: November 27, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention |
|---|---|
|
Dermatologic Complications Pain Viral Infection |
Other: scrambler therapy Other: questionnaire administration Procedure: dermatologic complications management/prevention |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Scrambler Therapy for the Treatment of Chronic Zoster Pain |
Resource links provided by NLM:
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- Change in pain on a 0-10 numerical rating scale. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | March 2011 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Other: scrambler therapy
Undergo scrambler therapy
Other: questionnaire administration
Ancillary studies
Procedure: dermatologic complications management/prevention
Undergo scrambler therapy
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Loprinzi, Charles, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01347736 History of Changes |
| Other Study ID Numbers: | MC10CE, NCI-2011-00338, MC10CE, 11-00531, NCI-2011-00338 |
| Study First Received: | March 30, 2011 |
| Last Updated: | November 27, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Herpes Zoster Virus Diseases Herpesviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on May 16, 2013