Scrambler Therapy in Treating Pain and Peripheral Neuropathy in Patients Previously Treated With Chemotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01347723|
Recruitment Status : Completed
First Posted : May 4, 2011
Last Update Posted : January 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pain Peripheral Neuropathy||Other: scrambler therapy Other: questionnaire administration Procedure: management of therapy complications||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||194 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Open Access Trial|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Supportive care (pain therapy)
Patients undergo scrambler therapy for 30 minutes daily for up to 10 consecutive days. Treatment continues in the absence of unacceptable toxicity.
Other: scrambler therapy
Undergo scrambler therapyOther: questionnaire administration
Ancillary studiesProcedure: management of therapy complications
Undergo scrambler therapy
Other Name: complications of therapy, management of
- Change in pain on a 0-10 numerical rating scale. [ Time Frame: 3 years ]
- Changes in neurologic function will be done by Neurometer Current Perception Threshold (CPT) testing and with a Rydel-Seiffer graduated tuning fork. [ Time Frame: 3 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347723
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Charles Loprinzi||Mayo Clinic|