Status:
TERMINATED
Near Infrared Light for the Treatment of Painful Peripheral Neuropathy
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Anodyne Therapy, LLC
Conditions:
Peripheral Neuropathy
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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 percen...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00125268
Start Date
July 1 2005
End Date
April 1 2010
Last Update
September 5 2012
Active Locations (1)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85254