M2_LaserTherapy

2. Module 2: Realief™ Therapy Index Lesson 1: Therapeutic Lasers Learning Objectives Physiologic Effects Laser Principles Electromagnetic Energy Properties of Laser Light Goals of Therapy Tissue Penetration Treatment Dose Delivery Modes Progress Check Lesson 2: Laser Safety Learning Objectives FDA Classifications Self-Protection Measures Contraindications / Precautions FDA Health Performance Requirements Progress Check Lesson 3: Realief™ Therapy Learning Objectives The Realief Approach System Components Progress Check Lesson 4: Realief™ Treatment Protocol Learning Objectives Roles and Responsibilities Consultation Visit Treatment Visits Neural Response Patient Self-Care Progress Check Lesson 5: Realief™ Patient Outcomes Learning Objectives Realief™ Resources Progress Check Module 2 • Index © 2014 Realief™ Neuropathy Centers

3. Realief™ Therapy Instructions This module covers basic laser principles, laser safety, and Realief™ Therapy for peripheral neuropathy. • Comprehensive training Study the illustration, read the content, review the KeyConcept, and complete the Checkpoint before moving to the next screen. • Quick Review Study the illustration, review the Key Concept, and complete the Checkpoint. • Progress check Complete the Progress check at the end of each lesson. The answers are provided, so you can assess your mastery of objectives and decide whether to review content or move on to the next lesson. Key Concept The key concept allows you to review what you’ve learned or take a fast path through content. Checkpoint The checkpoint allows you to quickly check your understanding. Answers are provided. Module 2 • Instructions © 2014 Realief™ Neuropathy Centers

4. Therapeutic Lasers Learning Objectives After completing this lesson, you should be able to • Discuss the physiologic effects of laser therapy. • Describe how a therapeutic laser works. • Describe the properties of laser light. • Discuss the goals of laser therapy in terms of tissue penetration, treatment dose, and delivery modes. Module 2 • Lesson 1 • Screen 1 of 10 © 2014 Realief™ Neuropathy Centers

5. Therapeutic Lasers Physiologic Effects Therapeutic lasers deliver energy to the body in the form of photons (particles of light). Laser light induces photochemical reactions that provide extra energy for tissue healing. • When laser light penetrates body tissue, it is absorbed into the mitochondria (energy cells) by chromophores (light receptors). This stimulates the production of ATP (adensosine triphosphate) and increases the energy available for metabolism. • Laser therapy works with the body’s own resources through two mechanisms: 1) interactions between photons and tissue cells and 2) chemical changes induced by those interactions. Thus, healing begins when the laser light is applied and continues when the laser is turned off. • Studies show that laser light may increase the production of the chemicals that block pain sensations, improve tissue perfusion (blood flow), and reduce the intensity of the inflammatory process. Tuner 2010 Key Concept Therapeutic lasers induce photochemical reactions that provide extra energy for tissue healing. Checkpoint Therapeutic lasers use _______________ energy. light heat Unlike therapeutic lasers which use light energy, surgical lasers use heat energy to excise (cut out) diseased issue. Module 2 • Lesson 1 • Screen 2 of 10 © 2014 Realief™ Neuropathy Centers

6. Therapeutic Lasers Laser Principles Laser is an acronym for light amplification by the stimulated emission of radiation, whichdescribes how lasers work. • Atoms, the basic unit of matter, have a nucleus and orbiting electrons. Each orbit represents a different energy level. Electrons normally occupy the ground state, their lowest, most stable energy level. • Lasers have anenergy source, such as a battery, and a lasing medium, which may be a gas, liquid (dye), or solid.The lasing medium is placed in an elongated cavity between two reflection mirrors. When energy is applied to the lasing medium, electrons are stimulated to move from their ground state to an excited state, a higher energy level. As the excited electrons fall back (relax) to the ground state, they emit energyin the form of photons. • The photons reflect off the mirrors, travel back and forth within the lasing medium, and excite other electrons. The presence of many excited electrons sets the stage for stimulated emission of multiple photons and significant light amplification. The mirror at one end of the lasing medium is a partial reflector: it reflects some light and lets some light through. The light that makes it through is the light beam used for laser therapy. Key Concept Lasers stimulate the emission of multiple photons by applying energy to a lasing medium. Checkpoint Stimulated electrons emit light energy when they return to the _____________ state. ground excited Module 2 • Lesson 1 • Screen 3 of 10 © 2014 Realief™ Neuropathy Centers

7. Therapeutic Lasers Electromagnetic Energy Figure A: Electromagnetic spectrum Figure B: Wavelength Photons form waves of light that carry electro-magnetic energy from one place to another. • The spectrum of electromagnetic energy (radiation) ranges from gamma rays to radio waves. Visible light, which ranges from red to violet, is a small slice of the spectrum. Both ultraviolet and infrared light are outside the visible portion of the spectrum. Note that 1) shorter waves carry more energy than longer waves and 2) there are no distinct boundaries between the types of waves (Figure A). • Wavelength is the length of one cycle of a wave or, as shown in Figure B, the distance between identical points on successive waveforms. It is measured in nanometers (nm). Visible light waves range from 400 to 800 nm. Infrared light waves range from 700 nm to 100,000 nm. Therapeutic lasers cleared by the U.S. Food and Drug Administration (FDA) use wavelengths between 630 and 980 nm. Key Concept Light waves carry electromagnetic energy from one place to another. Checkpoint Infrared waves are shorter than visible light waves and therefore carry ______ energy. less more The FDA grants clearance for medical devices that are exactly like those already on the market. Clearance permits manufacturers to sell their equipment, but not to make medical claims. Module 2 • Lesson 1 • Screen 4 of 10 © 2014 Realief™ Neuropathy Centers

8. Therapeutic Lasers Properties of Laser Light Stimulated emission produces monochromatic light waves that travel in synchrony in one direction. • Laser light is monochromatic because emitted photons produce many light waves that are similar in phase (shape) and length (energy). Some lasers have one characteristic wavelength. Some have two or more wavelengths within a certain range. • Laser light is confined by design to a narrow beam. Unlike ordinary light, which scatters in many directions, laser light moves in one direction and remains strong and concentrated. • Laserlight waves launch in unison and maintain a constant phase over long distances. This property, called coherence, allows laser light to penetrate deep into tissue. The more nearly monochromatic the light wave, the higher the degree of light coherence. Key Concept Laser light is monochromatic, directional, and coherent. Checkpoint Monochromatic light has _________ wavelengths. one many The wavelength is equivalent to the energy difference between the excited and ground states of an electron. Module 2 • Lesson 1 • Screen 5 of 10 © 2014 Realief™ Neuropathy Centers

9. Therapeutic Lasers Goals of Therapy To be therapeutic, laser light must: • Penetrate deep enough to reach the injured tissue. Treatment wavelengths that are too short or too long may not be suitable for the patient’s condition. • Carryjust enough energy to induce a photochemical reaction in the injured tissue. Treatment doses that are too low or too high may not produce the desired physiologic response. • Delivered often enough to relieve symptoms. Treatment intervals too widely spaced may not relieve acute symptoms; intervals too closely spaced may not relieve chronic symptoms. Key Concept Laser light must penetrate deep enough, carry enough energy, and be delivered often enough to be clinically effective. Checkpoint Laser therapy parameters are based on specific knowledge of the ____________________ . patient’s problem The optimal laser therapy parameters – wavelength, treatment dose, and treatment intervals – depend on patient parameters - general health, location of the injured tissue, skin pigmentation, and the physiologic response to treatment. type of laser Module 2 • Lesson 1 • Screen 6 of 10 © 2014 Realief™ Neuropathy Centers

10. Therapeutic Lasers Tissue Penetration The depth of tissue penetration is primarily determined by wavelength. • Photons are absorbed by water, melanin (in skin), and hemoglobin (in blood). The absorption rate varies with wavelength. • The diagram shows that an 800 nm wavelength penetrates deeper than 630 nm or 980 nm: – At visible red wavelengths of 630 nm to 750 nm, absorption by melanin and hemoglobin is high. – At infrared wavelengths of 750 nm to 980 nm, absorption is low. – At wavelengths greater than 980, absorption by water is high. • Red wavelengths are best suited for treating superficial conditions such as surface wounds. Infrared wavelengths are best suited for treating deeper tissue such as damaged nerves. Key Concept The depth of tissue penetration is primarily determined by the wavelength. Checkpoint Deep tissue penetration is best achieved with a wavelength of _________ nm. 850 980 Module 2 • Lesson 1 • Screen 7 of 10 © 2014 Realief™ Neuropathy Centers

11. Therapeutic Lasers Treatment Dose Parameters that affect Treatment Dose Parameter Description Unit of Measurement Output power Rate of energy delivery Watts (W) Watts per square centimeter (W/cm2 Power density Power per unit area Power per unit of time per unit area Joules per square centimeter (J/cm2) Energy density Wavelength Penetration of energy nanometers (nm) The treatment dose is the total amount of energy delivered to the injured tissue. It is determined by factors such as wavelength, power density, and treatment technique. • Output power is the rate at which energy is delivered by the laser system. It is measured in Watts or Joules per second. Therapeutic lasers have output powers that range from 5 mW to 12 W. A higher outputpower achieves the desired treatment dose more quickly. •Power density is power per unit area. It is determined by the laser beam diameter and measured in Watts per square centimeter (W/cm2). Therapeutic lasers operate at power densities of 2 W/cm2 or less. The closer the light beam is to the surface tissue, the greater the power density (light concentration). • Energy density is power per unit of time per unit area.It is measured in Joules per square centimeter (J/ cm2). Energy densities of up to 10.0 J/cm2 have been recommended for deep pain conditions. Energy density describes the duration of exposure to the laser beam (dosage). Key Concept The treatment dose is the total amount of energy delivered to injured tissue. Checkpoint The trend in laser therapy has been to _____________ power density and dose. increase decrease “The trend in laser therapy for the past 10 years has been to increase power density and dose, since this has been shown to improve therapeutic outcomes considerably.” Source: Tuner 2010 Module 2 • Lesson 1 • Screen 8 of 10 © 2014 Realief™ Neuropathy Centers

12. Therapeutic Lasers Delivery Modes Laser light can be delivered in continuous, pulsed, or superpulsed waves. • In continuous wave emission, the laser delivers light energy at a constant intensity during the therapy session. This mode delivers the greatest amount of energy in the shortest amount of time. • In pulsed wave emission, the laser delivers energy in modulated doses, either by switching the power on and off or using a shutter to interrupt the light beam. The on / off cycle, called the duty cycle, determines how much energy is delivered. A 10 Watt laser emitting a pulsed light wave on a 50% duty cycle delivers 5 Watts of energy. Thus, pulsing reduces the amount of energy delivered in a certain period of time. • In superpulsed emission, the laser delivers energy in short intense doses. The peak power is high, often 1,000 times higher than the average power output; and the duty cycle short, usually 0.1% or less. Superpulses penetrate deeper than continuous or pulsed waves. Key Concept Superpulsed laser light has high energy and a short duration. Checkpoint Superpulsed waves deliver small, high energy treatment doses that reach ___________ tissue. superficial deep Module 2 • Lesson 1 • Screen 9 of 10 © 2014 Realief™ Neuropathy Centers

13. Therapeutic Lasers Progress Check 1 1. Match the property of laser light to its therapeuticbenefit. Property of laser light a. Monochromatic b. Coherent c. Directional Therapeutic benefit c. Remains strong and concentrated a. Delivers a specific amount of energy b. Penetrates deep into tissue 2. Select each statement that correctly describes therapeutic lasers. √ Laser therapy works with the body’s resources through photochemical reactions. Therapeutic lasers use heat energy to induce interactions between photons and tissue cells. √ Infrared wavelengths of 750 nm to 970 nm are best suited for treating damaged nerves. √ Superpulsed light waves penetrate deeper than continuous light waves. Module 2 • Lesson 1 • Screen 10 of 10 © 2014 Realief™ Neuropathy Centers

14. Laser Safety Learning Objectives After completing this lesson, you should be able to • Discuss the relative risks of radiation exposure for each FDA-defined laser classification. • Describe measures to protect the eyes and skin from laser damage. • List contraindications and precautions for the use of a therapeutic laser. Module 2 • Lesson 2 • Screen 1 of 6 © 2014 Realief™ Neuropathy Centers

15. Laser Safety FDA Classifications The FDA classifies lasers according to the potential risk of damage to the eyes or skin. Classifications are based primarily on output power. Class I lasers do not emit radiation at known hazard levels. Examples: CD players, laser printers Class II lasers produce less than 1 mW power. They have a bright light that does not damage eyes unless someone stares at the light without blinking or turning away. Examples: bar code scanners, some laser pointers. Class IIIa lasersproduce1-5 mW of power and have a power density less than 2.5 mW/cm2. They can cause eye injury, but the risk following a short accidental exposure is small. Examples: low light lasers Class IIIb lasers produce 5-500 mW of power. Eye injury can occur both with the direct beam or beam reflections. The extent of injury depends on the power that enters the eyes and the duration of exposure. Examples: Lasers used in physical medicine and rehabilitation Self-protective measures are required. Class IV produce more than 5 Watts of power and have no upper limit. Eye injury can occur with any amount of beam exposure or reflection. Therapeutic lasers fall into the lowest Class IV power range of 5 Watts to 12 Watts. Self-protective measures are required. Module 2 • Lesson 2 • Screen 2 of 6 © 2014 Realief™ Neuropathy Centers

16. Laser Safety Self-Protection Measures The American National Standards Institute (ANSI) provides guidance for the safe use of lasers in health care facilities. Key Concept The nominal hazard zone for Class IV lasers is 21 feet in any direction from the laser beam. The maximum permissable exposure (MPE) is the level of laser radiation to which a person can be exposed without adverse biological changes in the eye. The nominal hazard zone (NHZ) is the space in which the level of direct, reflected, or scattered radiation exceeds the MPE. • Checkpoint • The NHZ for Class IV lasers is 21 feet in any direction from the laser beam. Anyone within the NHZ is required to wear safety goggles. Sunglasses are not sufficiently protective. Even with safety goggles, it is important to: – Avoid pointing the laser beam toward the eyes. – Remove reflective jewelry before entering the treatment room. – Cover reflective surfaces in the treatment room. – Remove reflective items such as mirrors or medical instruments from the treatment room. Self protection measures include ________________ . safety goggles • sunglasses ANSI Z136.3 (2005) is the definitive document on laser safety in all health care environments. Module 2 • Lesson 2 • Screen 3 of 6 © 2014 Realief™ Neuropathy Centers

17. Laser Safety Contraindications / Precautions Contraindications are clinical conditions that preclude the use of a high-power laser under any circumstances. The laser is contraindicated for use: Over the uterus, abdomen, and lower back in pregnant women. It may be used to treat ankle and wrist pain, but practitioners are cautious about using laser therapy during pregnancy. Over primary or secondary lesions in cancer patients. Some practitioners use a laser to relieve pain in the terminal stages of illness, provided they have the full consent of both patient and physician. Over the thyroid gland as the laser light may release hormones that accelerate the heart rate, increase blood pressure, or raise body temperature. Key Concept Laser therapy is contraindicated for use over a pregnant uterus, cancer lesion, and thyroid gland. Precautions are necessary over tattoos and in epilepsy. • • Checkpoint A contraindication is a condition in which a therapy can __________________ be used. • Precautions are required in the some circumstances. Practitioners may start therapy from a distance and elicit patient feedback before setting laser parameters. Tattoos have pigments that absorb even low energy laser light. The patient may feel heat or pain when the laser is applied. Pulsed visible light can cause seizures in epileptic patients. The effect of invisible light is unclear (Tuner 2010). sometimes never • • Module 2 • Lesson 2 • Screen 4 of 6 © 2014 Realief™ Neuropathy Centers

18. Laser Safety FDA Health Performance Requirements Under the FDA/CDRH Federal Laser Product Performance Standard (FLPPS), manufacturers are required to classify their laser and certify by means of a product label and a written report that all health performance requirements have been met. FLPSS is applicable to lasers or laser systems sold by a company within or imported into the U.S. The required features include: Protective housing Protective housing warning labels and logotype labels Product identification label and certification statement Safety interlocks Emission indicator Remote interlock connector Key control Beam attenuator Specification of control locations Viewing optic limitations Scanning beam safeguards Manual reset of beam cutoff • • • • • • • • • • • • Source: United States Department of Labor. OSHA Technical Manual U.S. Federal Laser Product Performance Standard: 21 CFR Part 1000 (parts 1040.10 and 1040.11). Available at: http:// www.osha.gov/dts/osta/otm/otm_iii/otm_iii_6.html Accessed June 23, 2011. Module 2 • Lesson 2 • Screen 5 of 6 © 2014 Realief™ Neuropathy Centers

19. Laser Safety Progress Check 1. Select each statement that describes the safe use of a Class IV laser. √ Anyone within the Nominal Hazard Zone of 21 feet is required to wear safety goggles. The laser beam can be pointed toward the eyes if the patient is wearing safety goggles. √ It is necessary to remove reflective jewelry before entering the treatment room. √ A Class IV laser is contraindicated for use during pregnancy. It is safe to hold the laser beam over cancer lesions. √ Precautions are required when using a laser over a tattooed area of skin. Module 2 • Lesson 2 • Screen 6 of 6 © 2014 Realief™ Neuropathy Centers

20. Realief™ Patient Outcomes Learning Objectives After completing this lesson, you should be able to: • Discuss the Realief™ Therapy approach to caring for patients with peripheral neuropathy. • Identify and describe the components of the Realief™ Therapy system. Module 2 • Lesson 3 • Screen 1 of 4 © 2014 Realief™ Neuropathy Centers

21. Realief™ Therapy The Realief Approach Therapy delivery Realief™ Therapy restores more normal nerve function and reduces the intensity and surface area of peripheral neuropathy symptoms. Key Concept Realief™ Therapy restores more normal nerve function and reduces peripheral neuropathy symptoms. • Realief™ Therapy is delivered with a Class IV gallium aluminum arsenide (GaAlAs) diode laser with up to 12 W of output power. The red aiming beam is used to guide therapy delivery. The therapeutic wavelength is selectable. Laser therapy can be delivered in continuous, pulsed, and superpulsed waves. Checkpoint • The Realief™ Treatment Protocol is a software-guided sequence of clinical evaluations that results in a system- recommended treatment plan. The treatment plan includes the number, frequency, and duration of laser treatments and supports the therapeutic process. • The Realief Treatment Protocol includes an initial consultation, initial treatments to reduce peripheral neuropathy symptoms, and maintenance treatments to prevent the recurrence of symptoms. All treatments, are customized to the patient’s condition on the day of treatment. The Realief Treatment Plan includes the number, frequency, and ________ of treatments. intensity duration • Realief™ Neuropathy Centers support their patients throughout the recovery process. Realief support may include instructions to manage recovery sensations, exercises to restore muscle strength and coordination, and stretching to relieve tissue tightness and improve range of motion. Module 2 • Lesson 3 • Screen 2 of 4 © 2014 Realief™ Neuropathy Centers

22. Realief™ Patient Outcomes Learning Objectives After completing this lesson, you should be able to • Provide clinical evidence to support the efficacy of Realief™ Therapy. Module 2 • Lesson 5 • Screen 1 of 4 © 2014 Realief™ Neuropathy Centers

23. Realief™ Patient Outcomes Realief™ Resources Realief™ Neuropathy Centers is dedicated to providing symptom relief and functional improvements to people suffering from peripheral neuropathy and advancing the medical understanding of the disease. As a provider of Realief Therapy you’ll have access to the following resources that demonstrate individual and cumulative patient symptom relief. Realief™ Patient Report: This is available for all patients and is as up-to-date as their last therapy. The report summarizes all data collect as part of the patients care including: • Symptom, exam and functional changes noted at each visit • Changes in PN medications • Pre and post initial care, balance, quality of life and modified total neuropathy scores On-Line Symptom/Exam Comparisons: For all patients in care, you are able to show pre and post care results for each treatment visit. Side-by-side Graphical over time Module 2 • Lesson 5 • Screen 2 of 4 © 2014 Realief™ Neuropathy Centers

24. Realief™ Patient Outcomes Realief™ Resources Cumulative Patient Results: On an on-going basis we are reviewing, analyzing and tabulating cumulative patient outcomes. This data will be available in a few different formats. Patient Outcomes Report Medical Providers Patient Report Annual Statistical Analysis of Realief System Data All these assets and more are available on the Realief Resource Center. Module 2 • Lesson 5 • Screen 3 of 4 © 2014 Realief™ Neuropathy Centers

25. Realief™ Patient Outcomes Progress Check 1. Check each statement that correctly describes the resources you have available to provide clinical evidence to support the efficiency of Realief™ Therapy. √ Realief™ Patient Report summarizing all symptom, exam and functional improvements. Peer review published data. √ On-line side-by-side and graphical summary of symptom and exam results over time. Module 2 • Lesson 5 • Screen 4 of 4 © 2014 Realief™ Neuropathy Centers