search
Back to results

Scrambler Therapy in Treating Pain and Peripheral Neuropathy in Patients Previously Treated With Chemotherapy

Primary Purpose

Pain, Peripheral Neuropathy

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
scrambler therapy
questionnaire administration
management of therapy complications
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Pain

Eligibility Criteria

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

Inclusion Criteria:

  • Pain or symptoms of neuropathy or pain of >= 1 month (30 days) duration for which the patient wants intervention
  • Participants have to relate that tingling or pain was 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 and expected to have tingling or pain of at least 4/10 at the time of the first treatment
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0, 1, or 2
  • Life expectancy >= 3 months (90 days)
  • Case review by the study chair, or designate, as a case where treatment should be tried.
  • Ability to complete questionnaire(s) by themselves or with assistance - Ability to provide informed written consent

Exclusion Criteria:

  • 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, concurrently using ketamine, symptomatic brain metastases; Note: anti-convulsant use is allowed for neuropathy and heart failure (HF) if on a stable dose
  • 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
  • Currently on gabapentin or pregabalin Note: (because of data that support that patients don't do as well when on gabapentin or pregabalin, all patients on these medications will be weaned off of them prior to study initiation. The study team will provide instructions on how to do this).

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Arm Label

Supportive care (pain therapy)

Arm Description

Patients undergo scrambler therapy for 30 minutes daily for up to 10 consecutive days. Treatment continues in the absence of unacceptable toxicity.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in neurologic function will be done by Neurometer Current Perception Threshold (CPT) testing and with a Rydel-Seiffer graduated tuning fork.
Patients will also undergo neurologic function testing. This will be done in an exploratory measure to try to correlate changes in the patient reported outcome instrument data with changes in the different measures of neurologic function. The two measures will be Neurometer Current Perception Threshold (CPT) Testing and testing with a Rydel-Seiffer graduated tuning fork.

Full Information

First Posted
March 30, 2011
Last Updated
May 12, 2020
Sponsor
Mayo Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT01347723
Brief Title
Scrambler Therapy in Treating Pain and Peripheral Neuropathy in Patients Previously Treated With Chemotherapy
Official Title
Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Open Access Trial
Study Type
Observational

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (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 scrambler therapy in treating pain and peripheral neuropathy in patients previously treated with chemotherapy. Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy
Detailed Description
OBJECTIVES: I. To record the types of patients that we treat, along with the reported efficacy and potential toxicity associated with scrambler therapy. II. To get experience with patient reported outcome measurement tools that we use in this trial, including a report of analgesic use. OUTLINE: Patients undergo scrambler therapy for 30 minutes daily for up to 10 consecutive days. Treatment continues in the absence of unacceptable toxicity. After completion of study treatment, patients are followed up for 10 weeks. III. To explore neurologic testing changes in patients receiving scrambler therapy.

6. Conditions and Keywords

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

7. Study Design

Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (pain therapy)
Arm Description
Patients undergo scrambler therapy for 30 minutes daily for up to 10 consecutive days. Treatment continues in the absence of 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)
management of therapy complications
Other Intervention Name(s)
complications of therapy, management of
Intervention Description
Undergo scrambler therapy
Primary Outcome Measure Information:
Title
Change in pain on a 0-10 numerical rating scale.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Changes in neurologic function will be done by Neurometer Current Perception Threshold (CPT) testing and with a Rydel-Seiffer graduated tuning fork.
Description
Patients will also undergo neurologic function testing. This will be done in an exploratory measure to try to correlate changes in the patient reported outcome instrument data with changes in the different measures of neurologic function. The two measures will be Neurometer Current Perception Threshold (CPT) Testing and testing with a Rydel-Seiffer graduated tuning fork.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pain or symptoms of neuropathy or pain of >= 1 month (30 days) duration for which the patient wants intervention Participants have to relate that tingling or pain was 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 and expected to have tingling or pain of at least 4/10 at the time of the first treatment Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0, 1, or 2 Life expectancy >= 3 months (90 days) Case review by the study chair, or designate, as a case where treatment should be tried. Ability to complete questionnaire(s) by themselves or with assistance - Ability to provide informed written consent Exclusion Criteria: 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, concurrently using ketamine, symptomatic brain metastases; Note: anti-convulsant use is allowed for neuropathy and heart failure (HF) if on a stable dose 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 Currently on gabapentin or pregabalin Note: (because of data that support that patients don't do as well when on gabapentin or pregabalin, all patients on these medications will be weaned off of them prior to study initiation. The study team will provide instructions on how to do this).
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 Pain and Peripheral Neuropathy in Patients Previously Treated With Chemotherapy

We'll reach out to this number within 24 hrs