LOW LEVEL LASER Treatment for Osteo- arthritis of the Hand FDA Study ANMA Las Vegas July, 2008

1. LOW LEVEL LASER Treatment for Osteo- arthritis of the Hand FDA StudyANMA Las Vegas July, 2008 Dr. Larry Lytle BS, DDS, PhD Low Level Laser Consultant Rapid City, SD

2. Osteoarthritis • Defined • 60 million people - 80% over 75 Yrs. are affected • Diagnosis –x-rays-clinical osteophyte formation –bony sclerosis

3. TREATMENT • DRUGS COX-2 anti-inflammatory NSAID -nonsteroidal anti-inflammatory Aspirin - Acetaminophen -Tylenol • Surgery – Joint Replacement • Alternatives - Supplements

4. Objective of Study • Determine the effectiveness of the Q Laser System in controlling symptoms of Osteoarthritis of the Hand • Over the Counter • Placebo controlled

5. SUBJECTS • 45 Test Group • 46 Placebo • Four Investigators • 3 Years

6. SUBJECT SCREENING • American College of Rheumatology (ACR) Classification Criteria for Osteoarthritis of the Hand • Radiographic analysis. • Clinical Examination and Symptoms • Range of Motion • Exclusions

7. INSTRUMENTS • Q Laser System **Q1000 -8 LEDs and 12 5 mW laser diodes arranged to form 6 direct soliton waves and 32 indirect soliton waves **Ultra Probe - single diode 50 mW continuous beam enhancer probe

8. Instruments

9. PROCEDURE • The Q1000 Laser or the placebo were applied to proprioceptive points as shown in following slides for one minute each on days 1,3,5,7,and 9. • Applied the Ultra Enhancer Probe for 30 seconds to acupoints for the five treatment days • Applied the Ultra Probe to each of the ten knuckles for 30 seconds on each of the five treatment days

10. PROPRIOCEPTIVE POINTS

11. ACUPOINTS

12. KNUCKLES

13. RESULTS Results from baseline to day 10

14. RESULTS VAS Results from baseline – day 10 and day 42

15. Range of Motion

16. Results Michigan Hand Outcomes Questionnaire (MHQ) (1) overall hand function (2) activities of daily living (ADLs): treated hand and both hands combined (3) pain (4) work performance (5) aesthetics (6) patient satisfaction with hand function

17. Results • SATISFACTION ASSESSMENT Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied

18. Results • Ease of Use • 89.02% of subjects responded ‘very easy. • Instructions • 95.12% of subjects responded ‘very easy.’.’

19. Results Overall success using the Q Laser System for treating Osteoarthritis ranged from 69% to 85%. It is doubtful that any other treatment can achieve this high of success and at a nominal daily cost

20. WORKSHOP Capri Room 10:00 Sunday

21. LIGHT IS THE UNIVERSAL HEALER

22. BIG BANG

23. LIGHT

24. WAVEOR PARTICLE

25. E=mc²

26. Electromagnetic Spectrum

28. Proton-Neutron-Electron Newtonian Description

29. Atom

30. Proton • Number of protons produces different magnetic fields • 20 protons = calcium atom • 79 protons = gold atom • 1 proton = hydrogen atom • An atom cannot gain or lose a proton

31. ION • Hydrogen ion is a hydrogen atom (single proton) that loses its electron and is positively charged • Atom that gains or loses an electron and becomes either positively or negatively charged is an ion

32. pH • Stands for “potential hydrogen” • pH is determined by the amount of hydrogen ions present • More hydrogen ions = acid • Fewer hydrogen ions = alkaline

33. Redox Potential Describes the quality of a system measured in millivolts either as Electron rich referred to as reduced Electron poor referred to oxidized Which in turn regulates the system

34. PHOTONS • Are small packets of light energy in the form of a wave element with a defined wavelength & a frequency related to that wavelength

35. Laser Energy Coherent Monochromatic

36. Wavelength = Color Wavelength Blue Light Wavelength Red Light

37. Cosmic Rays • Gamma Rays • X-Rays • Ultraviolet • Visible Light • Infrared • Microwaves • Radio waves • .0000000001 • .000000001 • .000001 • .00001 • .0005 • .01 • 10 • 10,000 Wavelength In Millimeters Lasers are measured in Nanometers

38. FREQUENCY • Pulse Frequency or Number of pulses per second Altered by movement

39. CONSTRUCTIVE INTERFERENCE When the combined amplitude of waves is greater than individual amplitude, the signal gets stronger.

40. Harmonic Resonance Is the same thing as constructive interference

41. CONSTRUCTIVE INTERFERENCE

42. DESTRUCTIVE INTERFERENCE When one wave is peaking & the other is troughing, they cancel each other out

43. Out of Resonance When the waves are not converging and cancel each other

44. DESTRUCTIVE INTERFERENCE

45. Canceling Waves

46. Laser Output Power • Measured in milliwatts (mW) • Higher power output over similar area = higher power density • Variation of Output Power affects results

47. Power Density • Light concentration-Energy Density – W/cm2 • More power is not better • Body sets up impedance, or polarizes against, too much power and becomes less effective

48. Joules • Measurement of energy delivered by a laser-Dose • Formula: Output x Time ÷ Area

49. Dose • Measured in J/CM2 is the Energy Density of the photons emitted

50. Penetration • The ability to get laser energy deep into the tissue is a key to success