Facts about the VAX-D G2 & the spinal decompression treatment invented by Dr. Dyer and is brought to you by the Back Pain Institute of Dallas. Dr. Taylor was trained by Dr. Dyer personally & is the only doctor in Texas with the latest VAX-D G2 Dynamic Spinal Decompression.
2. Consider These Facts On Back Pain & Back Surgery… FACTS: • More money is spent on the treatment of chronic pain than is spent on heart disease, AIDS and cancer combined. • Back pain is the number one cause of work absence after colds/flu. • 5.4 million Americans are disabled annually due to back pain. • 70% of patients who had lumbar back surgeries still complained of back pain. 23% complained of constant pain, and 35% were still under treatment. • The average cost for back surgery is about $40,000.00 • Only 37% of patients undergoing their first back surgery returned to work. Only 27% of patients with more than one back surgery return to work.
3. The Birth of A Phenomenon: The Discovery of Spinal Decompression In March of 1994 Dr. Allan Dyer along with neurosurgeon Dr. Gustavo Ramos and radiologist Dr. William Martin at the Departments of Neurosurgery and Radiology, Rio Grande Regional Hospital, McAllen, and Division of Neurosurgery, Health Sciences Center, University of Texas, undertook to measure the pressures inside the intervertebral disc as patients received VAX-D treatment. With a fluoroscopically guided cannula/catheter and pressure monitoring equipment, they watched and measured the patients’ disc pressures drop to negative levels. Thus the birth of spinal decompression with VAX-D. This discovery led to a landmark clinical study that showed for the first time it was possible to lower a intradiscal pressure in Vivo with a non-surgical treatment. 100 75 0 -100 -150 VAX-D actually lowers disc pressure to negative levels 0 10 20 30 40 50 60 70 80 90 VAX-D TENSION (LBS) D I S C P R E S S U R E
4. Effects of Vertebral Axial Decompression On Intradiscal Pressure HCA HOSPITAL STUDY McAllen Texas Gustavo Ramos MD, William Martin MD Departments of Neurosurgery and Radiology Journal of Neurosurgery 81: 350-353, 1994
5. INTRADISCAL PRESSURE MONITORING CATHETER INSERTED VIA A CANNULA INTO THE NUCLEUS PULPOSUS
7. Dr. RAMOS MONITORING PROCEDURE DUAL RECORDING VAX-D TENSION AND INTRADISCAL PRESSURE
8. 0 -150 +100 25 50 75 I NTRADISCAL PRESSURE - mm Hg.- VAX-D - TENSION Intradiscal Pressure Reduced to Negative Levels During VAX-D Treatment
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11. [11] Patent Number …... 6,039,737 [45] Date of Patent ..Mar. 21, 2000 Primary Examiner - Michael Buiz Assistant Examiner - Jonathan D. Goldberg Attorney, Agent - Blackwell Sanders Peper Martin [57] ABSTRACT A vertebral axial decompression table is operated by applying a baseline tension to the two table parts, increasing tension to about 50% of the maximum above baseline, then logarithmically increasing tension to maximum tension. This cycle is repeated a programmed number of times to effect therapy 23 Claims, 8 Drawing Sheets United States Patent [19] Dyer [54] OPERATION OF A VERTEBRAL AXIAL DECOMPRESSION TABLE [76] Inventor: Allan E. Dyer [21] Filed: Oct. 29, 1998 [30] Foreign Application Priority date Aug. 12, 1998 [AU] Australia .. 79929/98 [51] Int. Cl 7 ……………………..A61b 17/56 [52[ U.S. Cl………………………606/58; 606/54 [58] Field of Search ……………..606/54; 53, 57 [56] References cited U.S. Patent Documents 4,995,378 2/1991 Dyer ……128/75 5,115,802 5/1992 Dyer ……602/23
12. Fechners Law of Biological Response VAX-D employs the inverse of this principle and applies the force (Tension) in a reverse Logarithmic curve. Applying the tension in this manner avoids stimulating the proprioceptors in the back and spine. TIME - (Linear Scale) LOGARITHM OF STIMULUS THE MAGNITUDE OF THE SENSATION IS PROPORTIONAL TO THE LOGARITHM OF THE STIMULUS
13. Logarithmic Formula Exp [ C x Ln (Bti) ] = BTn + [ N x In ] N DECOMPRESSION LOGARITHMIC PHASE RETRACTION LOGARITHMIC PHASE VAX-D DOUBLE LOG THERAPY CURVE 30 60 100 80 60 40 20 PERCENT MAXIMUM TENSION 90 PRETENSION Seconds
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15. VAX-D PROPRIOCEPTOR THRESHOLD 150 100 50 0 -50 -100 -150 I N T R A D I S C A L P R E S S U R E -200 200 250 20 40 60 80 100 TENSION - lbs. VAX-D vs TRACTION TRACTION
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17. VAX-D Genesis G2 System In 2007 VAX-D released the Genesis G2 System with true ‘Biofeedback Motion Control’ for absolute accuracy in decompression of the lumbar and cervical spine. The equipment has a unique ability, in that the tensioning source can be programmed to move simultaneously in the horizontal plane and the vertical plane to follow the curves of the spine. This system also accurately tracks the horizontal and vertical movement curves and adjusts position and tension (instantly) at the same time. These advances are significant because variability in flexion or extension curves greatly increases patient comfort and muscle relaxation.
18. G2 Cervical: A System Like No Other • Patients receiving VAX-D cervical treatment are treated wearing a harness with an integrated supportive cervical collar. • The collar is designed to allow some mobility of the patient’s head and neck during decompression, while providing a circumferential lift system. • The collar provides the necessary immobilization and protection for patients in the post treatment period when the muscle guarding reflexes have been reduced. • Without the protection of the collar, head and neck movements will trigger muscle spasm, increased intradiscal pressure and neck pain. • Patients wear the collar during the treatment and for 1-2 hours after to provide stability and to help the proprioceptors accommodate to movements of the head and neck.
19. Genesis Dynamic Mode for Cervical Decompression The Genesis Dynamic Mode allows the operator to program the tensionometer to move synchronously in the horizontal and vertical plane in order to apply tension in a logarithmic time/force progression that can be designed to follow a curvature comfortable for the spine. The tensionometer head moves in an ‘arc’ from the starting point to the end point. It can be programmed to move in an upward (flexion) or downward (extension) arc. Communication with the patient will determine the most comfortable settings for the Dynamic Mode. Genesis ‘Dynamic’ Treatment for Cervical Herniated Disc A lower angle of tension tends to place more force on the mandible and TMJ. A higher angle of pull tends to transfer more of the tensile forces to the occiput, because of the circumferential (collar) harness system. Once the most comfortable treatment parameters have been established, they will be recorded and remembered by the system for future treatm ents.
20. VAX-D Therapeutic Indications - HERNIATED LUMBAR DISCS Extruded and/or Subligamentous One or more levels - DEGENERATED DISC DISEASE - LUMBAR AND SCIATIC NERVE COMPRESSION - FAILED BACK SURGERIES - POSTERIOR FACET SYNDROMES
21. MULTI-CENTER EFFICACY STUDY 778 CASES HERNIATED AND DEGENERATED LUMBAR DISCS NEUROLOGICAL RESEARCH JOURNAL VOLUME 20, 1998 Drs. E. Gose, R. K. Naguszewski, W. K. Naguszewski
22. EXTRUDED 53% MULTIPLE 72% SINGLE 73% FAILED BACK SURGERY 68% DEGEN. DISC 72% FACET SYNDROME 68% Vertebral axial decompression therapy for pain associated with herniated or degenerated discs or facet syndrome: An outcome study Pain Remission 778 cases 100 75 50 25 PERCENT OF CASES HERNIATED LUMBAR DISC
23. Vertebral Axial Decompression Therapy for pain Associated with Herniated or Degenerated Discs or Facet Syndrome: An Outcome Study. _______________________________________________________________ Earl E. Gose, William K. Naguszewski and Robert Naguszewski [ Journal of Neurological Research, April 1998 ] Relief of pain and Disability PERCENTAGE IMPROVEMENT 50 % 75 % 25 % 65 % MOBILITY 71 % PAIN 78 % ACTIVITY
24. PROSPECTIVE RANDOMIZED CONTROLLED TRIAL VAX-D vs TENS CHRONIC BACK & LEG PAIN NEUROLOGICAL RESEARCH JOURNAL Volume 23, No. 7, 2001 Department of Orthopaedics Sidney University - Australia __________________________________ Eugene Sherry MD, FRCS Peter Kitchener M.B., B.S., FRANZCR Russel Smart M.B., Ch.B.
25. RANDOMIZED CONTROL TRIAL CHRONIC DISCOGENIC BACK & LEG PAIN Statistical significance p < 0.001 6 5 4 3 2 1 0 VAS - PAIN SCALE VAX-D vs TENS PRE VAX-D 5.59 POST VAX-D PRE TENS 5.44 POST TENS 5.97 1.69
26. Randomized Control Trial VAX-D TENS ADL DECLINED -2% -17% PAIN INCREASED PAIN DECREASED 69% ADL IMPROVED 34% 60 80 0 20 40 -20 % CHANGE IN INDICES STATISTICAL SIGNIFICANCE - P < 0.001
27. BLUE CROSS SPONSORED 296 CASES Prospective Outcome Study ________________ Activity-Limiting Low Back Pain Arch. Phys. Med. Rehabil. : Vol 89, 2008 P.F. Beattie, R.M. Nelson, L.A. Michener, J. Cammarata, J. Donley
30. 6 MONTH FOLLOW-UP STUDY Blue Cross Sponsored Study Arch. Phys. Med. Rehabil. , Vol 89, 2008 12 8 6 4 DISABILITY SCALE BEFORE VAX-D STATISTICAL SIGNIFICANCE P < 0.01 12.6 EXIT 30 DAYS 180 DAYS AFTER VAX-D 6.0 7.0 5.9 DISABILITY SIGNIFICANTLY REDUCED
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32. FOUR YEAR FOLLOW-UP STUDY 8 6 4 2 VAS - PAIN SCALE BEFORE VAX-D 4 YRS AFTER VAX-D STATISTICAL SIGNIFICANCE P < 0.001 7.41 1.57
33. FOUR YEAR FOLLOW-UP EMPLOYMENT STATUS 100 % 70 % 30 % BEFORE VAX-D 4 YEARS LATER UNABLE TO WORK FULLY EMPLOYED
34. COMPARATIVE OUTCOME STUDY Journal of Neurological Research Volume 26, April 2004 _______________________________ Valley Neurosurgical Center Center for Neurosurgical Sciences University of Texas REGULAR PROTOCOL VS REDUCED COURSE OF THERAPY
35. COMPARATIVE OUTCOME STUDY Journal of Neurological Research - Vol. 26, April 2004 75 60 45 30 15 PERCENTAGE OF CASES 10 DAILY SESSIONS 20 DAILY SESSIONS COURSE OF THERAPY 43 REMISSION 24 PARTIAL REMISSION 33 NEGATIVE 76 REMISSION 20 PARTIAL REMISSION 5 NEGATIVE 20 vs 10 Sessions Statistical Significance P < 0.001
36. STANDING 100 FLEXED 150 LIFTING 220 FIRM CHAIR 140 SOFT CHAIR 185 BED REST 75 LEGS FLEXED 150 EXTENDED 180 CRUNCH 210 KNEES FLEXED 140 TRACTION 130 EVERY DAY POSITIONS PHYSICAL THERAPY INDRADISCAL PRESSURES
37. INTERVERTEBRAL DISC PRESSURES STANDING +100 BED REST +75 KNEES FLEXED +140 TRACTION +130 VAX-D THERAPY REAL SCIENCE REAL STUDIES REAL RESULTS -150
39. BEFORE VAX-D L4 -L5 left posterior large extruded disc compressing thecal sac AFTER VAX-D “ This the most dramatic reduction of an extruded segment I have seen “ Curvel A. Ferrari MD
40. Left posterior - L4-L5 Extruded disc compressing & retro-displacing left nerve root BEFORE VAX-D Extruded disc retracted Left nerve root decompressed Curvel A. Ferrari MD AFTER VAX-D
41. ANATOMY OF ANNULUS FIBROSUS DISTRACTION CLOSES OBLIQUE LAYERS AND RADIAL DIFFURES
42. Canadian Journal of Clinical Medicine Vol. 5, No. 1, Jan. 1998 Frank Tilaro, M.D. DISC DECOMPRESSION PLUS NEURO- DECOMPRESSION RESEARCH PROOF
43. SCIATIC PAIN NEUROLOGICAL DEFICIT 74 REMISSION 26 NEGATIVE 76 REMISSION 24 NEGATIVE 75 60 45 30 15 PERCENTAGE OF CASES CLINICAL OUTCOME RADICULOPATHY RESPONSE TO VAX-D An Overview of Vertebral Axial Decompression F. Tilaro MD - Can. Jour. Clin. Med. Vol. 6, 1999
44. The Effects Of Canadian Journal of Clinical Medicine Volume 6, Number 1, January 1999 Dr. Frank Tilaro & Dr. Dennis Miscovich Vertebral Axial Decompression on Sensory Nerve Dysfunction
45. BEFORE VAX-D 6.36 AFTER VAX-D 2.09 IMPROVEMENT SIGNIFICANT P < 0.05 7.0 5.0 4.0 3.0 2.0 1.0 6.0 NEUROMETER GRADE CURRENT PERCEPTION THRESHOLD EVALUATION OF SENSORY DEFICIT THE EFFECTS OF VAX-D IN SENSORY NERVE DYSFUNCTION IN PATIENTS WITH LOW BACK PAIN AND RADICULOPATHY J. CLINICAL MEDICINE - JANUARY 1999
46. JOURNAL OF NEUROLOGICAL RESEARCH VOL 23, No. 3, November 2001 DERMATOMAL SOMATOSENSORY EVOKED POTENTIAL (DSSEP) DEMONSTRATION OF NERVE ROOT DECOMPRESSIOIN AFTER VAX-D THERAPY Naguszewski W. K., M.D. Naguszewski R. K., M.D. Gose E., Ph.D.
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48. NERVE ROOT DECOMPRESSION (DSSEP) WITH VAX-D THERAPY PERCENT - DSSEP READINGS 60 30 STATISTICAL SIGNIFICANCE - P < 0.0013 IMPROVED 61 SAME 29 NEGATIVE 10
49. ADJUSTMENT TO PRETENSION BASE LINE RELAXATION PHASE CONTROL CONSOLE COMPUTER Bio- feedback Loop
50. CONTROL CONSOLE COMPUTER LOWER BODY, PALLET, TENSIONOMETER CONTROLLED AS A UNIFIED MOTION SEGMENT DECOMPRESSION PHASE BIO- FEEDBACK LOGARITHMIC MOTION CONTROL
51. BED REST DIFFUSION GRADIENT INTRADISCAL PRESSURES 100 75 50 25 0 -25 -50 -75 -100 -125 -150 -175 DIASTOLIC BP - 80 mm Hg. VAX-D DIFFUSION GRADIENT > 200 mm Hg. ACROSS THE VERTEBRAL END PLATE VAX-D THERAPY
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53. Non-steroidal Anti-inflammatory Drugs Naproxen Sodium (Aleve) 220mg bid Diclofenac (Voltaren) 50 mg bid Indomethacin (Indocin) 25mg tid or SR 75mg Steroid Methylprednisolone 4 - 8 mg 2-3 hrs before Tx (10 days) Prednisone 20 mg tid (10 days) Medrol Dosepak VAX-D PROTOCOL • PHARMACOLOGICAL AGENTS Analgesics - When necessary Muscle relaxants - When necessary Mucosal protective agents Misoprostol - Cytotec 100-200mg H2 Antagonist - Zantac 75 -150 mg
54. INTERNAL DISC DISRUPTION VAX-D PROTOCOL METHYLPREDNISOLONE - 4 TO 8 MG . Taken orally 2 to 3 hours before each VAX-D session First week - One dose each day Second week - One dose Monday,Wednesday & Friday DOXYCYCLINE - 200 MG. (Matrix Metalloproteinase Inhibitor) Taken orally 2 to 3 hours before each VAX-D session One dose each day NB: Doxycycline should not be used for patients allergic to Tetracyclines For optimum absorption: Medications should be ingested on an empty stomach No Antacids with Doxycycline
55. INTERNAL DISC DISRUPTION HIZ HIGH INTENSITY ZONE Pathognomonic of IDD
63. 0 20 K 40 K 60 K 80 K 100 K 120 K 140 K 160 K Surgical Care VAX-D after 4 wks Standard care Medical Disability Total A Graphic Comparison of Costs Standard Conservative Care $ Costs $ Costs
64. Don’t Be Fooled By The Imposters: Real Decompression: Where Science & Technology Meet How does VAX-D compare to its competitors? VAX-D developed and patented the process of non-surgical spinal decompression (not NASA). VAX-D is the only equipment shown in studies to lower intradiscal pressure. VAX-D has demonstrated the retraction of herniations on post treatment MRI’s. VAX-D has established 75-85% success rates in 10 clinical studies, hospitals and private clinics. VAX-D is the only equipment shown to decompress nerve roots using DSSEP and CPT studies. Why buy old technology? Copycat equipment is based upon TRACTION technology that was introduced in 1986, and dressed up with fancy columns and tilt tables. No other devices have published studies proving they decompress the spine.