Treatment of Painful Diabetic Neuropathy With Photon Stimulation
- To assess the efficacy of Photon Stimulation compared with placebo, in treating the pain of diabetic neuropathy.
- To show that Photonic Stimulation for the treatment of painful diabetic neuropathy is cost effective compared to traditional medical interventions. The latter will be explored by an extensive search of the literature and from an equal number of patients being treated in traditional medical practices using traditional medical interventions. At the conclusion of the study the data will be analyzed for cost-benefits and the possibility of crafting a best-practices approach to treat these syndromes that cost billions of dollars a year in health care expenses and lost productivity.
2. Research Design
This is a double blinded, randomized, placebo-controlled study of 120 patients with painful diabetic neuropathy. These 120 will be randomly assigned treatments utilizing Photon Therapy, using a defined treatment protocol. We expect that some patients will drop out, and our goal is 100 treated patients, for statistical purposes. The Photon Therapy group will be split into two groups, one group that receives Active Photon Therapy and one group that will be treated with the same type of equipment that has been modified to emit no infrared photons (Non Active Photon Therapy Group ("Placebo")). The patients in the "Non Active Photon Therapy Group" will be offered an Active Photon Treatment Session after completion of the study. The patients in the Photon Therapy Groups will be randomized. There will also be an Historical Control Group of patients, fifty, will have received traditional medical interventions (e.g., narcotics, seizure medications) in traditional medical practices. Data from these individuals will be used to calculate potential cost savings.
Subjects who meet the inclusion and exclusion criteria and have signed a valid informed consent will be eligible to participate in the study. After screening, subjects in the Photon Therapy groups (both active and nonactive) will undergo four treatment sessions. The first treatment session will vary from the second, third and fourth. During all treatment session, each patient will be imaged with the TIP Infrared Camera before, and after treatment. Infrared imaging can visualize skin temperature changes in a noninvasive manner (2). The first treatment will utilize slightly different protocol than subsequent visits, reduced Photon dosage, 120 instead of 240 joules. Proprioception and protective sensation, characterized by the Semmes-Weinstein monofilament test, and visual and analog pain scoring will also be evaluated before and after each Photon Therapy treatment.
To date, we have just completed 120 patients, using a block randomization scheme not previously reported in this field. We have collected data on nerve function, pain, quality of life, and skin circulation. The data will remain stored until the study is complete to preserve the blinded nature of the project. Data analysis is still incomplete.
4. Clinical Significance
Diabetic neuropathy is a chronic and progressive condition that potentially leads to disabling pain, and worse, amputation, for many individuals in the United States each year. Present treatments utilize antiseizure medications, opiate analgesics, and antidepressants, and are inconsistently effective. Development of a new treatment strategy potentially could have significant benefit for a great many patients.
|Diabetic Neuropathy, Painful Diabetic Neuralgia Diabetic Polyneuropathy Diabetic Mononeuropathy||Device: infrared light Device: infrared light; placebo|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Treatment of Painful Diabetic Neuropathy With Photon Stimulation|
- pain intensity [ Time Frame: 1 week ]
- Semmes-Weinstein sensation, proprioception, quality of life [ Time Frame: one week ]
|Study Start Date:||October 2004|
|Study Completion Date:||October 2006|
Active Comparator: 2
active treatment with infrared light
Device: infrared light
pulsed infrared light will be applied to feet, ankles and popliteal fossae of patients with diabetic neuropathy
Placebo Comparator: 1
sham (placebo) treatment without infrared light
Device: infrared light; placebo
patients will be exposed to the same machine used to provide pulsed infrared light, but the light emitting diodes will not be activated. All other aspects of the treatment will be the same. The patient and investigator will be blind to treatment assignment.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00539175
|United States, California|
|VA Northern California Health Care System|
|Martinez, California, United States, 94553|
|Principal Investigator:||Arthur LM Swislocki, MD||VA Northern California Health Care System; UC Davis School of Medicine|