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Near Infrared Light for the Treatment of Painful Peripheral Neuropathy

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: NCT00125268
Recruitment Status : Terminated (Unable to enroll enough patients)
First Posted : July 29, 2005
Results First Posted : September 5, 2012
Last Update Posted : September 5, 2012
Sponsor:
Collaborator:
Anodyne Therapy, LLC
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Peripheral Neuropathy
Interventions Device: MIRE
Device: Sham Device
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MIRE Sham
Hide Arm/Group Description Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE). Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
Period Title: Overall Study
Started 16 14
Completed 15 13
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title MIRE Sham Total
Hide Arm/Group Description Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE). Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device. Total of all reporting groups
Overall Number of Baseline Participants 16 14 30
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 14 participants 30 participants
68  (17) 74  (11) 71  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Female
8
  50.0%
4
  28.6%
12
  40.0%
Male
8
  50.0%
10
  71.4%
18
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 14 participants 30 participants
16 14 30
1.Primary Outcome
Title Percentage of Subjects That Have a Greater Than or Equal to Forty Percent Decrease on the Visual Analog Pain Scale at the End of Four Weeks of Treatment
Hide Description Pain was measured by a 10 cm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. On this scale 0 means no pain and 10 cm means extreme pain. The investigator measures the mark made by the subject in cm and records this for the value of pain.
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MIRE Sham
Hide Arm/Group Description:
Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Percentage of Subjects That Have a Forty Percent Reduction of Pain Measured by the Neuropathic Pain Scale at the End of Four Weeks of Treatment
Hide Description The neuropathic pain scale consists of 10 questions with individual answers rated from 1 to 10, with 0 = no pain to 10 = the most intense pain imaginable. The overall score could range from 0 to 100, with 0 = no pain to 100 = the most intense pain imaginable.
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MIRE Sham
Hide Arm/Group Description:
Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percentage of Subjects That Have an Improvement of Two Points or More on the SF-8 at the End of Four Weeks of Treatment
Hide Description The SF-8 Health Survey has 8 questions, each question measuring each of the eight domains of health. Scores are calibrated so that 50 is the average score or norm. A lower score indicates poorer health, and a higher score indicates excellent health.
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MIRE Sham
Hide Arm/Group Description:
Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected over the 4 weeks of the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MIRE Sham
Hide Arm/Group Description Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE). Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
All-Cause Mortality
MIRE Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
MIRE Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      1/14 (7.14%)    
General disorders     
Carcinoma *  0/16 (0.00%)  0 1/14 (7.14%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MIRE Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      1/14 (7.14%)    
General disorders     
Hypocalcemia *  0/16 (0.00%)  0 1/14 (7.14%)  1
*
Indicates events were collected by non-systematic assessment
This study was terminated early because the study was unable to enroll enough patients.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Matthew A. Butters
Organization: Mayo Clinic
Phone: 480-301-7745
EMail: butters.matthew@mayo.edu
Publications:
Layout table for additonal information
Responsible Party: Matthew Butters, M.D. Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00125268    
Other Study ID Numbers: 927-05 00
First Submitted: July 27, 2005
First Posted: July 29, 2005
Results First Submitted: August 2, 2012
Results First Posted: September 5, 2012
Last Update Posted: September 5, 2012