The following section contains the IRB-approved information for prospective volunteers in Sacramento, California. William Conard, MD., Principal Investigator.

The study is closed.

Please contact us to learn about how you can now receive PhotoMed's non-invasive therapy.


Patient Information for PhotoMed Technologies' Study

 

Do you have chronic pain or loss of function?

Do you have chronic pain or loss of function due to:

We also invite people who participated in our previous studies

 

Are you interested in trying PhotoMed's non-invasive investigational therapy?

Click here for a PDF of the study brochure

Chronic pain is often maintained by the nervous system, even after the original source of pain has healed.

In many cases, people with pain or loss of function also have abnormal thermal regulation of the affected body parts. Light treatment can help these abnormal temperatures to normalize. In this study, we want to see how well changes in abnormal temperature regulation predict future pain relief.

PhotoMed is the first light therapy company to correlate thermal changes with pain relief. Data gathered in this study will help us further refine our treatment protocols by showing us which wavelengths are most effective for each condition.

Patients with normal temperature regulation are also welcome.

What is light therapy?

Light therapy is used to prompt the body to repair damage associated with chronic pain, lost range-of-motion, wounds, and other symptoms.

Cells and nerves are sensitive to light in addition to chemical, electrical, and pressure stimulation. Studies of single nerves have demonstrated that certain colors tend to activate or inhibit nerves. Some colors can act as anti-inflammatory agents. See Figure 1b.

This study will be looking to see to what extent our light therapy can provide relief to people with different causes of pain.

Visible and infrared light are FDA approved to treat chronic pain by increasing blood flow. This study compares responses to different wavelengths that have not been studied extensively.

 

Light therapy and PhotoMed’s innovations

PhotoMed provides more wavelengths

Laser- and LED-based light therapy research has mostly been limited to the red and infrared wavelengths (colors). See Figure 1a. PhotoMed removes this research limitation by providing the entire visible spectrum. See Figure 1b.

In addition, the wavelength can be set to change during therapy to accommodate subtly different wavelength needs for different people and conditions.

Thermal imaging provides objective feedback to identify when patients respond to the light therapy. See Figure 2.

Thermal Images

 

 

Light was applied three times with different settings. The last application prompted the response.

 

Study Information

Non-invasive

No Drugs  

This is an experimental study to see if light from PhotoMed's investigational device will help with certain conditions. Certain colors will be applied to various locations on the body for about 8 minutes per visit. The power is very low and most people cannot feel the light.

In this study, we will compare the effectiveness of different colors and treatment locations at reducing pain and improving function. We believe that optimal colors vary for different people and conditions.

Many conditions, such as complex regional pain syndrome (CRPS or RSD) and diabetic peripheral neuropathy (DPN), affect how the body regulates temperature in the hands or feet. Patients diagnosed with sympathetically maintained pain are likely to have abnormal temperature regulation. We measure changes in skin temperature that may be used to guide the therapy. We want to determine if the changes predict relief. See Figure 2.

For the most part, the treatments were developed through observation of skin temperature changes. Each time the investigator follows a pre-defined treatment protocol or personalizes a therapy, information is added to the database that will be used to improve treatment protocols.

Investigators are encouraged to collaborate to speed the process of finding the most effective treatment settings and locations.

Who is Eligible?

People with chronic pain or loss of function are invited to participate in this study. Abnormal temperature control is not required. Some conditions, such as active cancer or HIV, or pregnancy may be disqualifying. Some medications, such as blood thinners, may be disqualifying.

Eligibility is not restricted due to symptom severity, duration, number of surgeries, or current medications.

This study is not a replacement for your current therapies. You should continue to see your primary care doctors and specialists and take the medications you have been prescribed.  

Potential Benefits and Risks

Your participation in this study may or may not benefit you. This experimental therapy has helped some people with severe pain that was not relieved by conventional therapies.

Typically, the therapy will be discontinued if you have not seen improvement by your 5th visit.

Previous light therapy studies have shown that the technology is safe and easy to use. However, as with any experimental device, there is the potential that unknown risks exist.

Some patients have reported unmasking of pain or sensation previously hidden by severe neuropathic pain, drugs, neurostimulators, or diabetic numbness. Restoring the ability to sense heat, cold, and pain helps diabetic neuropathy patients prevent injury.

Cost

There is no charge for participation in the study. You remain responsible for your other financial obligations as a patient.

To Participate as a Subject

If you are considering enrolling in the study, please contact us for more information. We will also put you in touch with your nearest investigator.  

A Final Thought

PhotoMed is devoted to developing and implementing non-invasive alternatives to conventional, ineffective therapies.  We would be pleased to discuss any of our programs with you. 

The PDS 400TM is for investigational use only

Approved: 6 September 2011 Version 1.05     

 

Updated: April 2, 2018

 


Mission

PhotoMed Technologies is a dedicated to finding non-invasive solutions to chronic pain and functional impairments.

Founded and funded as our family mission to help people with no path forward. We appreciate your donations and support.

Allan Gardiner

 

New Frontiers

PhotoMed's methods and equipment open new areas for pain, biophysics, physiology, neuroscience and other areas of research.

How can PhotoMed's team help you advance your mission?

 

Vision

PhotoMed Technologies envisions a future when collaborating clinics, including those rural and remote, can offer their patients the most current non-invasive solutions developed by passionate practitioners and researchers around the globe.

 

Get in Touch

Phone:
(510) 526 7373

Email:
research@photomedtech.com
Address:
65 Franciscan Way
Kensington, CA 94707 USA

 

 

 

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Copyright © 2011-2018 · PhotoMed Technologies™, Inc. · All rights reserved

PhotoMed's products are for investigational use only. Methods and equipment may be covered by issued or pending patents.