Electrical Stimulation Pain Therapy in Treating Chronic Pain and Numbness Caused By Chemotherapy in Patients With Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01196442
First received: September 3, 2010
Last updated: August 21, 2013
Last verified: August 2013
Results First Received: October 11, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Cancer-related Problem/Condition
Neurotoxicity
Pain
Peripheral Neuropathy
Interventions: Other: electrical stimulation pain therapy
Other: questionnaire administration

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled from 08/30/2010 through 06/11/2012 at a medical clinical

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No pre-assignment criteria

Reporting Groups
  Description
MC5A Calmare Therapy

Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.

electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10

questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months


Participant Flow:   Overall Study
    MC5A Calmare Therapy  
STARTED     39  
COMPLETED     39  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MC5A Calmare Therapy

Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.

electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10

questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months


Baseline Measures
    MC5A Calmare Therapy  
Number of Participants  
[units: participants]
  39  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     29  
>=65 years     10  
Age  
[units: years]
Mean ± Standard Deviation
  59  ± 0.7  
Gender  
[units: participants]
 
Female     23  
Male     16  
Region of Enrollment  
[units: participants]
 
United States     39  



  Outcome Measures
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1.  Primary:   Change in Pain Score From Day 1 to Day 10   [ Time Frame: From day 1 to day 10 ]

2.  Secondary:   Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1   [ Time Frame: Day 1 ]

3.  Secondary:   Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics   [ Time Frame: From day 1 to day 30 ]

4.  Secondary:   Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10   [ Time Frame: Day 10 ]

5.  Secondary:   Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1   [ Time Frame: month 1 ]

6.  Secondary:   Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2   [ Time Frame: month 2 ]

7.  Secondary:   Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3   [ Time Frame: Month 3 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Craig W. Swainey
Organization: Virginia Commonwealth University
phone: 804-828-9723
e-mail: cswainey@mcvh-vcu.edu


No publications provided


Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01196442     History of Changes
Other Study ID Numbers: MCC-13098, NCI-2010-01945
Study First Received: September 3, 2010
Results First Received: October 11, 2012
Last Updated: August 21, 2013
Health Authority: United States: Institutional Review Board