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Treatment of Painful Diabetic Neuropathy With Photon Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00539175
Recruitment Status : Completed
First Posted : October 4, 2007
Last Update Posted : October 4, 2007
Information provided by:
East Bay Institute for Research and Education

Brief Summary:

1. Objectives:

  1. To assess the efficacy of Photon Stimulation compared with placebo, in treating the pain of diabetic neuropathy.
  2. 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.

3. Methodology:

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.

4. Finding:

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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy, Painful Diabetic Neuralgia Diabetic Polyneuropathy Diabetic Mononeuropathy Device: infrared light Device: infrared light; placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Painful Diabetic Neuropathy With Photon Stimulation
Study Start Date : October 2004
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. pain intensity [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Semmes-Weinstein sensation, proprioception, quality of life [ Time Frame: one week ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with diabetes mellitus with painful neuropathy, defined as foot pain >/ 3 on a 0-10 numeric rating scale, chronic foot pain of at least 6 months' duration, and pain characterized as burning, shooting, or stabbing in nature.
  • Patients needed to have capacity to provide informed consent and be able to make serial visits for scheduled treatments.

Exclusion Criteria:

  • A history of peripheral vascular disease
  • Vitamin B12 deficiency
  • Low back pain with radiculopathy; Or
  • Another painful condition that was difficult to distinguish from painful diabetic peripheral neuropathy.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00539175

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United States, California
VA Northern California Health Care System
Martinez, California, United States, 94553
Sponsors and Collaborators
East Bay Institute for Research and Education
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Principal Investigator: Arthur LM Swislocki, MD VA Northern California Health Care System; UC Davis School of Medicine

Layout table for additonal information Identifier: NCT00539175     History of Changes
Other Study ID Numbers: Swislocki-1
First Posted: October 4, 2007    Key Record Dates
Last Update Posted: October 4, 2007
Last Verified: October 2007
Keywords provided by East Bay Institute for Research and Education:
diabetes mellitus
diabetic neuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications