Photobiomodulation therapy (PBMT) is a low-level laser therapies that deliver specific wavelengths and intensities of light chosen for the patient's medical needs to enhance immune function, reduce inflammation, improve microcirculation and oxygenation, increase ATP production and support for cellular energy production or other effects. Because the treatment improves many basic physiologic capacities, and the spectrum of wavelengths allow a range of benefits, this therapy has numerous applications for treatment of systemic disease including as diabetes, cardiac, liver and kidney diseases, neurodegenerative diseases, psychiatric diseases, metabolic disorders, autoimmune disease, chronic fatigue and mitochondrial syndromes; inflammation and pain, osteoarthritis, and other degenerative conditions including joint, herniated disk and other spinal conditions; local use for dermatologic conditions and many others. It has been used to treat certain cancers by complementing traditional care, directly inducing tumor death through production of reactive oxygen species within the cancer cell as well as supporting immune response. It is often used to treat acute, chronic and post Lyme/tick-borne disease or other infections.
            There are a number of mechanisms by which PBMT may provide patient improvement including direct antibacterial and cleansing effects, stimulation of natural immune responses such as white cell activation, mitochondrial activation, stimulation of nitric oxide and resulting vasodilation, and venous oxygen increase. It is thought that the light stimulus induces cellular signals that affect chemical behavior, metabolism, gene expression and enzyme and protein activity.
            How Intravenous or Interstitial Therapy is Done
            Intravenous: During PBMT a slender fiber optic catheter is inserted in the arm intravenously via a thin, sterile butterfly needle. While blood irradiation therapy has most commonly been done by withdrawing blood, exposing it to ultraviolet radiation and reinjecting it, the endolaser instead uses a short fiberoptic catheter which can channel various intensities and wavelengths which may include ultraviolet, infrared or colors from the visible spectrum. The endolaser allows for safer and continuous treatment of a greater blood volume. The optical catheter will "irradiate" the circulating blood with the frequencies of light chosen for your condition. "Irradiation" refers only to the ultraviolet or other colored light energy; no radioactive substance is used. This procedure takes approximately one hour. The process is generally quite comfortable.
            Interstitial/Needle Insertion: In order to treat joints, spinal difficulties or a specific target, such as a tumor, the laser may be inserted directly into the targeted site. A local anesthetic will be used to numb the area followed by the insertion of one or several thin cannulas depending what is being treated. This may or may not be guided by ultrasound depending on the location and nature of the treatment. A fiberoptic cable delivering the low-level laser is guided into the cannula. In some cases, a drug will be administered to enhance treatment effects.
            Light Wavelengths and Their Purpose 
            Different wavelengths have different healing effects; you may receive more than one color of light over the course of a treatment. The wavelengths that will be used in your treatment are checked below:
            
              - Red: Energizing effects resulting from increased ATP production; enhances immune system, increase cell activity, regenerates damaged tissue structures and improves circulation.
 
              - Green: Increases oxygen uptake, reduces pain caused by inflammation and swelling.
 
              - Blue: Improves microcirculation by Nitric Oxide release, strong anti-inflammatory and anti-bacterial effects, accelerates wound healing, supports pain relief, activates telomerase and biogenesis of mitochondria with maximum anti-aging effects.
 
              - Yellow: Improvement in mood and antidepressant effects by enhancement of Vitamin D and serotonin production, positive influence on endocrine system and metabolism, stimulates the mitochondrial respiratory chain, used for chronic viral infections and it strong anti bacterial effects.
 
              - Ultraviolet: Directly kills bacteria and viruses and has a stimulating effect on the immune system. It has been used for a wide variety of diseases including Lyme and other infectious diseases, cardiovascular diseases, diabetes mellitus and other metabolic disorders, chronic liver and kidney diseases, macular degeneration, chronic pain syndromes, fibromyalgia and rheumatism, allergies and eczema, multiple sclerosis, depression and chronic fatigue syndrome. It has also been used in the treatment of various cancers.
 
              - Infrared: Can be used to selectively heat cancer cells, reduce pain and inflammation.
 
            
            Concurrent Use of Medications:
            In addition to the laser, you will receive:
            
              - No drugs or fluids will be injected.
 
              - Anesthetics
 
            
            Notice of FDA Status of Endolaser Treatment
            While the Weberneedle@ Endolaser is FDA approved for external use, its use internally is not recognized in the United States. Photodynamic laser therapy is provided by some physicians who practice integrative, functional, complementary or alternative medicine. Its use is controversial
            Informed Consent Form Photodynamic Intravenous or Interstitial Therapy Via Endolaser Page
            and not currently approved for this route by the US Food and Drug Administration ("FDA") or accepted by medical institutions in the United States. While internal use of the device is approved in Europe (CE Approval) and by Health Canada, the professional literature in support of the safety or effectiveness of the therapy has not been reviewed by FDA and may be considered as yet insufficient for general acceptance by the US medical community.
            Potential Adverse Reactions and Contraindications
            Intravenous Photodynamic Therapy
            Intravenous photodynamic therapy has been widely used globally for over 30 years with few ill effects. As with any intravenous therapy, there is some risk of side effects or adverse reactions. Patients can experience discomfort, swelling and bruising at the injection/insertion site. There could be an internal reaction to the heat of the laser in very sensitive individuals. There can be a clotting of the blood in the needle, and thrombophlebitis, an inflammation of the vein may also occur and in rare cases require some treatment such as hot packs and bed rest. While sterile technique is used, any invasive medical procedure presents the rare risk of infection that can be serious or life-threatening. Any intravenous procedure carries very rare risk of a cardiovascular event, such as a coronary or pulmonary emergency that includes arterial or ventricular arrhythmias, stroke, or embolism.
            As a result of the healing effects of the treatment, patients may experience a healing or "Herxheimer" reaction in which one feels "flu-like" symptoms such as aches, pains, and possibly low-grade fever as the body detoxifies from a rapid die-off of bacteria, toxins and pathogens. Patients may also experience transient hypoglycemic (low blood sugar) headache/or light- headedness, and a brief resetting of the menstrual cycle.
            Interstitial/NeedIe Insertions Therapy
            Risks and/or complications may include, but not limited to: bleeding, infection, increased pain, increased serum glucose, nerve injury, allergic reaction, menstrual irregularity or bleeding, leg edema, facial flushing, paralysis and death.
            The potential risks include increased pain and allergic reaction from local anesthetics, materials 
containing latex, IV anesthetics and/or other medications; infection on skin or in tissue, bones, joints, discs, nerves, ligaments, possibly blood stream (Sepsis), brain and spinal cord which in extremely rare cases might require hospitalization; bleeding into the interstitial space; nerve damage, nerve injury, tissue injury, tissue damage, temporary and permanent numbness and/or weakness, paralysis, spinal cord injury, urinary and/or fecal incontinence; headache; joint injection: In addition to the above complications, injection and fluid collection in the joint(s) may require antibiotic treatment, fluid aspiration and surgical interventions.
            Informed Consent Form Photodynamic Intravenous or Interstitial Therapy Via Endolaser Page
            Possible Contraindications
            The Weberneedle@ Endolaser should NOT be used:
            
              - where analgesia may mask progressive pathology, and where the practitioner would normally avoid the use of any other analgesia in order to retain the beneficial aspects of pain.
 
              - for direct aim into the eyes of humans or animals.
 
              - over areas injected with steroids in the past 2-3 weeks.
 
              - over areas that are suspicious or contain potentially cancerous tissue.
 
              - over areas of active hemorrhage.
 
              - on patients suspected of carrying serious infectious disease and or disease where it is advisable, for general medical purposes, to suppress heat or fevers.
 
              - over or near bone growth centers until bone growth is complete.
 
              - over or applied to the eye.
 
              - on ischemic tissues in individuals with vascular disease where the blood supply would be unable to follow the increase in metabolic demand and tissue necrosis might result.
 
            
            Additional Precautions
            Additional precaution should be used when the laser light is used on patients with the following conditions:
            
              - Over anesthetized areas.
 
              - On patients with hemorrhagic diathesis.
 
              - On patients on blood thinners such as Plavix, Aspirin, Coumadin, Lovenox or Heparin and 
patients with prosthetic heart valves. 
            
            Additional Notices
            Full Disclosure of Treatments: Patients must fully inform their treatment team of all diagnoses and all treatments that are currently, or have recently, undergone to ensure that potential drug interactions, contraindications and other concerns can be considered before beginning treatment. Patients with an implanted neurostimulation device must inform their physician before initiating therapy.
            Notice to Pregnant / Breastfeeding Women: All female patients must alert their physician if they know or suspect that they are pregnant or are breastfeeding.
            Informed Consent Form Photodynamic Intravenous or Interstitial Therapy Via Endolaser Page
            No Guarantees: No practice of medicine is an exact science, there are significant individual differences between patients, and there can be no guarantees as to the outcome of treatment. No guarantees are made that I will gain any benefit or not suffer any adverse consequences.
            Insurance Notice/FinanciaI Responsibility: This treatment is not covered by insurance, Medicare or other third-party. Patients are financially responsible for payment at the time of service, even if an invoice is submitted and the payor determines that it is not a medically necessary service or is experimental. I may also be responsible for the costs of laboratory tests associated with this treatment.
            Informed Consent
            I authorize the treatment outlined above, acknowledge that I have read and understood this form and that my physician has discussed with me the basis for my being an appropriate patient for treatment by photodynamic laser therapy. I have discussed alternative treatment options and the risks involved, which include rare complications that may not have been specifically mentioned above. I agree that I assume the risks of this therapy and to hold [NAME PHYSICIAN AND CENTER] its physicians, principals, and staff [and researchers] associated with this study harmless for the risks of treatment [participating in this study.]
            I have not been offered any guarantee as to outcome. I understand that I am responsible for payment. I represent that I am seeking treatment in order to further my own health and for no other reason. I do not represent a third party. I acknowledge receipt of a copy of this consent should I request it.