Dermatologic ComplicationsNCT01347736
Scrambler Therapy in Treating Chronic Pain in Patients With Rash From Varicella Zoster Virus Infection
A study testing scrambler therapy, questionnaire administration and dermatologic complications management/prevention in people with Dermatologic Complications and Pain, run by Mayo Clinic at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatologic Complications, Pain, Viral Infection
- What is being tested?
- scrambler therapy, questionnaire administration and dermatologic complications management/prevention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to 7 Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scrambler Therapy for the Treatment of Chronic Zoster Pain
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
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Dermatologic Complications, Pain, Viral Infection
- Being tested
- scrambler therapy, questionnaire administration, dermatologic complications management/prevention
- Medical subject headings
- Pain, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scrambler therapyOther
Undergo scrambler therapy
questionnaire administrationOther
Ancillary studies
dermatologic complications management/preventionProcedure or surgery
Also called complications management/prevention, dermatologic, management/prevention, dermatologic complications
Undergo scrambler therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: scrambler therapy; Other: questionnaire administration; Procedure: dermatologic complications management/prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain on a 0-10 numerical rating scale.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startMar 2011
- Primary completion7 Nov 2012
- Study completion7 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatologic ComplicationsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Loprinzi, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347736
- Sponsor's protocol ID
- MC10CE
- Other IDs
- NCI-2011-00338, MC10CE, 11-00531, NCI-2011-00338
- Status last verified
- Feb 2018
- First submitted
- 30 Mar 2011
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scrambler Therapy for the Treatment of Chronic Zoster Pain
- ClinicalTrials.gov ID
- NCT01347736
- Acronym / sponsor ID
- MC10CE
- Conditions
- Dermatologic Complications, Pain, Viral Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- 7 Nov 2012 (actual)
- Study completion
- 7 Nov 2014 (actual)
- First posted
- 4 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (pain therapy) | Experimental | Other: scrambler therapy, Other: questionnaire administration, Procedure: dermatologic complications management/preventionPatients undergo scrambler therapy for approximately 30 minutes. Treatment continues for 10 days in the absence of pain progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| scrambler therapyUndergo scrambler therapy | Other | Treatment (pain therapy) |
| questionnaire administrationAncillary studies | Other | Treatment (pain therapy) |
| dermatologic complications management/preventionAlso: complications management/prevention, dermatologic, management/prevention, dermatologic complicationsUndergo scrambler therapy | Procedure or surgery | Treatment (pain therapy) |
Primary outcome
Change in pain on a 0-10 numerical rating scale.
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Loprinzi principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scrambler therapy, questionnaire administration and dermatologic complications management/prevention in people with Dermatologic Complications and Pain, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain on a 0-10 numerical rating scale. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.