Clinical Trial: Treatment of Painful Diabetic Neuropathy With Photon Stimulation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Painful Diabetic Neuropathy With Photon Stimulation

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 pr

Detailed Summary:

• PURPOSE, METHODS, AND PROCEDURES:

1. Purpose:

  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. Methods

This is a double blinded, randomized, placebo-controlled study of approximately 170 patients with painful diabetic neuropathy. The study sample size is 170 patients. Of these 120 will be given treatments utilizing Photon Therapy, using a defined treatment protocol. We plan to recruit 120 patients to allow for drop out, and to provide 100 completed patients, as requested by FDA. 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. The Historical Control Group of patients, fifty, wil
Sponsor: East Bay Institute for Research and Education

Current Primary Outcome: pain intensity [ Time Frame: 1 week ]

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: East Bay Institute for Research and Education

Dates:
Date Received: October 2, 2007
Date Started: October 2004
Date Completion:
Last Updated: October 3, 2007
Last Verified: October 2007