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:
- Complex regional pain syndrome (CRPS or RSD)
- Phantom limb pain
- Post-surgical pain
- Diabetic peripheral neuropathy (DPN)
- Neuropathy from other causes, such as stroke or spinal cord injury
- Reynaud's syndrome
- Post-herpetic pain (shingles)
- Non-healing wounds
- Fibromyalgia
- Abnormally cold or hot hands, with or without pain
- Sympathetically mediated (or maintained) pain
- People who have benefited from a sympathetic nerve block or sympathectomy
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
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.
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.
Approved: 6 September 2011 Version 1.05
Updated: April 2, 2018
