An Evaluation of the Effect of Low Level Laser Therapy on Diabetic Peripheral Neuropathy Pain
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|ClinicalTrials.gov Identifier: NCT04006392|
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Peripheral Neuropathy||Device: Erchonia FX-635 Device: Placebo Laser||Not Applicable|
Peripheral neuropathy is one of the most common chronic diseases and a leading cause of adult disability in the U.S. Diabetic neuropathy represents over a third of all neuropathies, making diabetes the leading cause of peripheral neuropathy, affecting about 15-18 million Americans.
Living with neuropathy can cause tremendous frustration and social isolation. The daily chronic pain impacts day-to-day functionality resulting in physical and psychological problems including impaired concentration, anxiety, depression, a decline in cognitive abilities, and sleep difficulties which in turn can lead to irritability and increased pain sensitivity. Additionally, the economic burden from medical costs and workplace productivity losses are high and on the rise as the incidence of peripheral neuropathy increases.
Peripheral neuropathy describes damage to the peripheral nervous system that interferes with vital nerve connections, distorting and sometimes interrupting messages between the brain and the rest of the body. Diabetic peripheral neuropathy is a chronic acquired form of nerve damage that can occur in individuals with diabetes wherein the primary cause is damage to nerve fibers and blood vessels from prolonged exposure to high blood sugar (glucose). While the precise mechanism for this damage remains unclear, a combination of factors likely plays a role, including the complex interaction between nerves and blood vessels. High blood glucose interferes with the ability of the nerves to transmit signals and weakens the walls of the small blood vessels (capillaries) that supply the nerves with oxygen and nutrients.
The primary and most debilitating symptom of diabetic peripheral neuropathy is a sensation of tingling, prickling, buzzing, pinching, burning, and/or sharp jabbing stabbing pain in the feet. Nerve pain from diabetic peripheral neuropathy can be severe, constant, and difficult to treat. Current therapies include an array of over-the-counter and prescription medications or alternative treatment options such as injections or patches of local anesthetics; surgical destruction of nerves; implantation of a device to relieve pain; transcutaneous electrotherapy (TENS); hand or foot braces and orthopedic shoes.
Low Level Laser Therapy (LLLT) communicates information to the receptors on the membrane of the cell and mitochondrion (the enzymatic engine of the cell). This energetic information reaches the cell's DNA, which directly controls cell function. When the cells receive better information, they work better, as do the tissues they comprise, like bones, cartilage, tendons, ligaments, etc. In this way, LLLT promotes the healing and regeneration of damaged tissues, having both local effects on tissue function and also systemic effects carried throughout the body by the blood and acupuncture meridians.
The key basic physiological effects of low level laser light include increased cell membrane polarization and permeability; Adenosine-5-triphosphate (ATP) production and respiratory chain activity; enzyme activity; collagen and epithelial production; capillary formation; macrophage (immune) activity; analgesic effects due to elevated endorphin production, electrolytic nerve blockage, and improved blood and lymph flow; anti-inflammatory effect due to improved circulation and accelerated tissue regeneration; and increased production of antioxidants. Of additional benefit is that light energy from low level lasers will only be absorbed by cells and tissues that are not functioning normally and has no effect on healthy cells.
Therefore, low level laser therapy has the potential benefit of providing an effective means of reducing low back pain that is simple, quick, non-invasive and side-effect free.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Placebo-controlled Randomized Evaluation of the Effect of the Erchonia® FX-635™ on Diabetic Peripheral Neuropathy Pain|
|Actual Study Start Date :||February 15, 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Erchonia FX-635
The Erchonia FX-635 is administered to the foot 12 times over 6 weeks (2 times each week) for 15 minutes per foot.
Device: Erchonia FX-635
The Erchonia FX-635 has three independent 17 milliWatts (mW) 635 nanometer (nm) red laser diodes mounted in scanner devices.
Sham Comparator: Placebo Laser
Noise and appearance of output is the same but no active therapy applied. Treatment administration procedure is the same as with the experimental arm.
Device: Placebo Laser
- Percent Change in Pain Rating on the Visual Analog Scale (VAS) [ Time Frame: Baseline and 6 weeks ]The Visual Analog Scale (VAS) assesses level or degree of pain. It is a horizontal line anchored on the left by the label '0: no pain at all' and on the right by the label '100: worst pain imaginable'. The subject marks a location on the 0-100 line that appears to represent any level of pain he or she is experiencing at that time. This marking is measured with a 0 to 100 mm ruler and the number recorded. For the primary study outcome, the percent change in the VAS pain score recorded at baseline and endpoint is calculated for each subject. Individual subject success is a 30% or greater change in VAS pain scores. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A positive (+) percent change indicates an increase in pain level and is negative for individual subject success. Overall study success is defined as a 35% or greater difference between the proportion of individual successes in each treatment group.
- Difference in Rescue Pain Medication Use [ Time Frame: Baseline and 6 weeks ]Evaluation of the differences in the frequency of use of standardized study pain relief medication for foot pain during the study duration, measured as the total number of doses of rescue pain medication taken across the 6-week evaluation period.
- Change in Total Score on the Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Baseline and 6 weeks ]The Neuropathic Pain Symptom Inventory (NPSI) is a 12-item self-administered patient-reported outcome (PRO) assessment tool to evaluate symptoms of neuropathic pain in adults over the past 24 hours. There are 10 descriptors representing 5 dimensions: burning pain, deep pain, paroxysmal pain, evoked pain, paresthesia/dysesthesia, and 2 temporal items. Each item is rated on a 0 to 10 scale where '0' means the item is not present at all and '10' means it is the worst possible presentation of the item. Responses to the individual items are added to get a total score. The higher the total score, the worst the subject's symptoms of neuropathic pain. The lower the total score, the lesser the symptoms. Therefore, an increase in the total score indicates a worsening of symptoms and a decrease in the total score indicates an improvement in symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04006392
|Contact: Sandra L Franco, DPMfirstname.lastname@example.org|
|United States, Arizona|
|Arizona Institute of Footcare Physicians||Completed|
|Mesa, Arizona, United States, 85204|
|United States, California|
|Jeffrey Kleis, DPM||Recruiting|
|Costa Mesa, California, United States, 92626|
|Contact: Jeffrey Kleis, DPM 714-760-4944|
|United States, Florida|
|Hialeah Hospital Medical Plaza||Recruiting|
|Hialeah, Florida, United States, 33139|
|Contact: Sandra L Franco, DPM 954-436-7400 email@example.com|
|Pensacola, Florida, United States, 32514|
|United States, New Jersey|
|Jordan Steinberg, DPM||Recruiting|
|Florham Park, New Jersey, United States, 07932|
|Contact: Jordan Steinberg, DPM 973-922-0484|
|Principal Investigator:||Sandra L Franco, DPM|