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Near Infrared Light for the Treatment of Painful Peripheral Neuropathy

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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

Tracking Information
First Submitted Date  ICMJE July 27, 2005
First Posted Date  ICMJE July 29, 2005
Results First Submitted Date  ICMJE August 2, 2012
Results First Posted Date  ICMJE September 5, 2012
Last Update Posted Date September 5, 2012
Study Start Date  ICMJE July 2005
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2012)
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 [ Time Frame: baseline, 4 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2005)
The proportion 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2012)
  • 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 [ Time Frame: baseline, 4 weeks ]
    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.
  • Percentage of Subjects That Have an Improvement of Two Points or More on the SF-8 at the End of Four Weeks of Treatment [ Time Frame: baseline, 4 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2005)
  • The proportion of subjects that have a forty percent reduction of pain measured by the neuropathic pain scale at the end of four weeks of treatment.
  • The proportion of subjects that have an improvement of two points or more on the SF-8 at the end of four weeks of treatment.
  • The proportion of subjects that have a reduction of ten or more on the neuropathy impairment score at the end of four weeks of treatment.
  • The proportion of subjects with foot dorsum sweat volume increases of greater than ten percent over baseline in the QSART at the end of four weeks of treatment.
  • The proportion subjects with great toe vibration detection or heat/VAS value percentile decreases of greater than ten percent over baseline percentiles in CASE IV at the end of four weeks of treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Near Infrared Light for the Treatment of Painful Peripheral Neuropathy
Official Title  ICMJE A Phase III, Double Blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Adjunct Monochromatic Near-infrared Photoenergy (MIRE) in Patients With Painful Axonal Peripheral Neuropathy
Brief Summary The purpose of this study is to determine if near infrared light therapy is effective in decreasing pain in patients with painful peripheral neuropathy. The hypothesis of the study was that the percentage of subjects with at least 40% improvement in visual analog scale score for pain after 4 weeks of treatment is higher for Monochromatic Near-infrared Photoenergy (MIRE) treatment than for sham treatment.
Detailed Description

Pain is a very common symptom, between 65-80%, in patients with peripheral neuropathy. This study is designed to evaluate the effectiveness of monochromatic near infrared photoenergy therapy (MIRE) in the treatment of pain in axonal peripheral neuropathy. This will be compared with a placebo (sham) device.

The MIRE is a FDA approved, drug-free, non-invasive, medical therapeutic device that uses near-infrared light emitting diodes to deliver monochromatic near infrared photoenergy (MIRE) through contact with the skin. The effect of MIRE is believed to increase local blood circulation by dilating vessels and to reduce pain by decreasing local swelling and inflammation. MIRE is also thought to increase local levels of nitric oxide (NO) which may decrease pain levels.

Study subjects will receive treatment with the device or the placebo device 3 times per week for 4 weeks. Response will be measured during and after the treatment period.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Neuropathy
Intervention  ICMJE
  • Device: MIRE
    Monochromatic near infrared photo energy (MIRE). A 30-minute application of MIRE results in a radiant exposure of 43.2 joules per square centimeter (J/cm^2). The design of the flexible pads allows the infrared energy to be delivered perpendicular to and in contact with the involved site. MIRE applied to the skin facilitates the release of a small molecule of the free radical nitric oxide from hemoglobin and other proteins in surrounding tissue. Increased levels of nitric oxide improve the circulation of blood enhancing wound healing and reducing pain.
    Other Name: Anodyne Therapy System
  • Device: Sham Device
    The sham device is non-active but otherwise identical to the study device.
Study Arms  ICMJE
  • Active Comparator: MIRE
    Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
    Intervention: Device: MIRE
  • Sham Comparator: Sham
    Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
    Intervention: Device: Sham Device
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 2, 2012)
30
Original Enrollment  ICMJE
 (submitted: July 28, 2005)
60
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults ages 18-85; able to give informed consent
  • Documented painful, distal peripheral neuropathy of idiopathic cause, or related to impaired glucose tolerance or diabetes mellitus.
  • Neuropathy documented by one of the following studies: nerve conduction studies and needle electromyography (EMG); quantitative sensory testing of the foot with Computer Aided Sensory Evaluator (CASE IV); quantitative sudomotor axon reflex test (Quantitative Sweat MeasurementSystem [Q-Sweat]); neurology specialty examination; and neuropathy impairment score (NIS) of less than 25.
  • Stable pharmacotherapy for neuropathic pain for at least two weeks.
  • Optimal pharmacotherapy has been achieved.
  • Subjects cannot be on Cyclooxygenase-2 (COX 2) inhibitors
  • Pain Visual Analog Scale (VAS) of greater than or equal to 4/10
  • Subject has provided written informed consent
  • Not currently using transcutaneous electrical nerve stimulation (TENS)
  • Not currently receiving acupuncture

Exclusion Criteria:

  • Pregnant or likely to become pregnant
  • Current diagnosis of cancer
  • Neuropathy impairment score (NIS) of greater than 25.
  • Diagnosis of severe neuropathy of known etiology for which specific treatment is available (i.e., acute and chronic inflammatory polyradiculoneuropathies, vasculitis, B 12 deficiency).
  • Unstable diabetes mellitus defined as a hemoglobin A1c (HbA1c) greater than 9%, and/or 10% of fasting blood sugars greater than 300 mg/dl for the week prior to enrollment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00125268
Other Study ID Numbers  ICMJE 927-05 00
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthew Butters, M.D. Principal Investigator, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Anodyne Therapy, LLC
Investigators  ICMJE
Principal Investigator: Matthew A Butters, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP