The purpose of this clinical study is to determine the effectiveness of the Erchonia® EVRL™, manufactured by Erchonia Corporation (the Company), in providing prescription home use application for temporary relief of idiopathic neuropathy foot pain in individuals diagnosed with idiopathic neuropathy by a suitably qualified and licensed health professional.
This clinical study is a single-arm, active treatment group only, non-inferiority prospective design to evaluate the efficacy of the Erchonia® EVRL™ for prescription home use application in providing temporary relief of foot pain due to idiopathic peripheral neuropathy. There will be a single active treatment only subject group in this study. All enrolled subjects will self-administer the treatments with the active (true) Erchonia® EVRL™ laser in his or her own home.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
The Erchonia® EVRL™ is made up of (1) 635 nanometers red laser diode and (1) 405 nanometers violet laser diode mounted in a portable handheld device. The diodes are positioned approximately 3 to 6 inches from the top of the foot. The treatments will be self-administered by the subject at his or her's place of residence, two times per day for 21 days. Each procedure administration lasts 5 minutes per foot, for a total of 10 minutes.
Franco & Co
Miramar, Florida, United States
RECRUITINGNumber of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale
The Visual Analog Scale (VAS) will be used to assess pain from baseline to the 6-week endpoint for each subject. Subjects will be instructed to indicate the overall level of pain experienced in their feet by placing a cross (X) on a 10-centimeter horizontal line. The left end of the line will be labeled "0," representing "no pain," and the right end will be labeled "100," representing "the worst pain imaginable." Individual subject success is defined as a 30% or greater change in VAS pain scores across the evaluation period. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A lower VAS pain score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome.
Time frame: Baseline and 3 weeks
Neuropathic Pain Symptom Inventory
The Neuropathic Pain Symptom Inventory (NPSI) is a 12-item self-administered patient-reported outcome assessment tool with a recall/ observation period of over the past 24 hours. It contains 10 descriptors representing 5 distinct dimensions on the basis of factor analysis: burning pain, deep pain, paroxysmal pain, evoked pain, paresthesia/dysesthesia, and 2 temporal items designed to assess pain duration and the number of pain paroxysms. The NPSI has a maximum total score of 100, a lower score from baseline to study endpoint represents a better outcome.
Time frame: Baseline and 3 weeks
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