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The Non-Surgical  Treatment For Low  Back  & Neck  Pain
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.
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
  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
INTRADISCAL  PRESSURE  MONITORING CATHETER  INSERTED  VIA  A  CANNULA  INTO  THE  NUCLEUS  PULPOSUS
RECORDING  INTRADISCAL  PRESSURE CHANGES  DURING  VAX-D
Dr.  RAMOS  MONITORING  PROCEDURE   DUAL  RECORDING  VAX-D  TENSION  AND  INTRADISCAL  PRESSURE
0 -150 +100 25 50 75 I NTRADISCAL  PRESSURE  - mm Hg.- VAX-D - TENSION  Intradiscal Pressure Reduced to Negative Levels During VAX-D Treatment
-40  mm Hg -100  mm Hg ,[object Object],[object Object],[object Object],[object Object],[object Object],Science & Medicine : VAX-D Decompression Treatment -160  mm Hg
 
[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
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
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
[object Object],[object Object],[object Object],Traction Column Traction Devices FORCE 100 TRACTION Linear Phase RETRACTION Linear Phase HOLD 0 50
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
VAX-D ®  vs. Traction ,[object Object],[object Object],1.  Effect of Vertebral Axial Decompression On Intradiscal Pressure.   J Neurosurg 81: 1984. 2.  Intervertebral Disc Pressures During Traction .  Scand. J. Rehabil. Med.  9: 1983 3.  An Overview of Vertebral Axial Decompression .,  Can. J. Clin.  Med. , 5; 1998. 4.  The Effect of Lactate and ph on Proteoglycan and Protein Synthesis rates in the Intervertebral Disc . Spine, 17:  1992.  5.  Nutrition of the Intervertebral Disc: Solute Transport and Metab .,  Connective Tissue Research,8: 1981 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
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.
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.
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.
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
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
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
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
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.
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
  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
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
VAX-D Research Studies: Outcomes After a Prone Lumbar  Decompression Protocol for Patients With Activity-Limiting Low Back Pain: A Prospective Case Series Study  (2008) Paul F. Beattie, PhD, PT, OCS, Roger M. Nelson, PhD, PT, Lori A. Michener, PhD, PT, ATC, SCS, Joseph Cammarata, DC,  Jonathan Donley, DPTS Archives of Physical Medicine And Rehabilitation, Volume 89, February 2008 © 2008 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation •  A two and one-half year study on the treatment of chronic back pain sponsored by   Independence Blue Cross,  a leader in the insurance industry,   confirmed the effectiveness of VAX-D. •  The purpose of the study was to determine short- and long-term outcomes after VAX-D treatment in a large sample of patients with activity-limiting low back pain that had failed at least two previous, non-surgical treatments.  •  A total of 296 subjects with low back pain and evidence of a degenerative and/or herniated intervertebral disk at 1 or more levels were enrolled in the study.  •  In this study all subjects had pre-intervention imaging evidence of lumbar intervertebral disk degeneration and/or herniation. •  The study showed that patients had significantly improved pain and disability scores at end of treatment, at 30 days and at 180 days post-discharge.
[object Object],[object Object],[object Object],8 6 4 2 VAS  -  PAIN  SCALE BEFORE VAX-D STATISTICAL   SIGNIFICANCE  P < 0.01 5.8 EXIT  30 DAYS  180 DAYS AFTER  VAX-D 3.5 3.7 3.4   PAIN  SIGNIFICANTLY  REDUCED
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
[object Object],[object Object],FOUR  YEAR FOLLOW  UP STUDY   Anesthesiology News - Vol 29, March 2003   Odell R. H., MD, PhD. ,  Boudreau D. A . , DO
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
FOUR  YEAR  FOLLOW-UP EMPLOYMENT  STATUS 100 % 70 % 30 % BEFORE VAX-D 4 YEARS LATER UNABLE  TO  WORK FULLY  EMPLOYED
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
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
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
INTERVERTEBRAL  DISC  PRESSURES STANDING +100 BED REST +75 KNEES  FLEXED +140 TRACTION +130 VAX-D  THERAPY  REAL SCIENCE REAL STUDIES REAL RESULTS -150
DECOMPRESSION  REPAIRS  DISCS Herniated Nucleus Pulposus Nucleus   Retracted by Vacuum Effect  Annular Fissure Closed & Healing
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
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
ANATOMY  OF  ANNULUS  FIBROSUS DISTRACTION  CLOSES  OBLIQUE  LAYERS AND  RADIAL  DIFFURES
Canadian Journal of Clinical Medicine Vol. 5,  No. 1,  Jan. 1998 Frank Tilaro, M.D. DISC DECOMPRESSION PLUS NEURO-  DECOMPRESSION RESEARCH PROOF
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
  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
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
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.
 
NERVE  ROOT  DECOMPRESSION (DSSEP) WITH  VAX-D  THERAPY PERCENT  -  DSSEP  READINGS 60 30 STATISTICAL  SIGNIFICANCE  -  P < 0.0013   IMPROVED 61 SAME 29 NEGATIVE 10
ADJUSTMENT  TO  PRETENSION BASE  LINE RELAXATION  PHASE CONTROL CONSOLE COMPUTER Bio- feedback  Loop
CONTROL CONSOLE COMPUTER LOWER  BODY,  PALLET,  TENSIONOMETER CONTROLLED  AS A  UNIFIED  MOTION  SEGMENT DECOMPRESSION  PHASE BIO- FEEDBACK LOGARITHMIC  MOTION  CONTROL
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
VAX-D  DECOMPRESSION   ,[object Object],[object Object],[object Object],[object Object]
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
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
INTERNAL  DISC  DISRUPTION HIZ HIGH INTENSITY ZONE Pathognomonic of IDD
  DISCOGRAM DYE  PENETRATES  ANNULUS  FIBROSUS  INDICATES  DISRUPTION  OF  INTERNAL  STRUCTURES INTERNAL  DISC  DISRUPTION
CONTRAINDICATIONS and PRECAUTIONS 1. Fracture 2. Neoplasm 3. Unstable Spondylolisthesis 4. Cauda Equina Syndrome 5. Ankylosing Spondylitis 6. Severe Osteoporosis 7. Rotator Cuff Tear 8. Arthrodesis with Instrumentation
-STENOSIS- LATERAL  FORAMENAL  ---------------------------------- disc   hydration opens foramen NORMAL  DISC HEIGHT & LATERAL FORAMEN DEGENERATED DISC  FACET SUBLUXATION NARROWS LATERAL FORAMEN DEGENERATED DISC  FACET HYPERTROPHY IMPINGES  LATERAL FORAMEN DEGENERATED DISC  FACET HYPERTROPHY OSTEOPHYTIC SPURS IMPINGES LATERAL FORAMEN
IATROGENIC  FORAMINAL   STENOSIS Normal  Lateral foramen Post fusion Stenotic foramen ---------------------- Refractory to Decompression
  SPONDYLOLISTHESIS
SPONDYLOLYSIS
SPONDYLOLYSIS
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
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.
 
 

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Vaxd brought to you by the Back Pain Institute of Dallas

  • 1. The Non-Surgical Treatment For Low Back & Neck Pain
  • 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
  • 6. RECORDING INTRADISCAL PRESSURE CHANGES DURING VAX-D
  • 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
  • 9.
  • 10.  
  • 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
  • 14.
  • 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
  • 16.
  • 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
  • 28. VAX-D Research Studies: Outcomes After a Prone Lumbar Decompression Protocol for Patients With Activity-Limiting Low Back Pain: A Prospective Case Series Study (2008) Paul F. Beattie, PhD, PT, OCS, Roger M. Nelson, PhD, PT, Lori A. Michener, PhD, PT, ATC, SCS, Joseph Cammarata, DC, Jonathan Donley, DPTS Archives of Physical Medicine And Rehabilitation, Volume 89, February 2008 © 2008 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation • A two and one-half year study on the treatment of chronic back pain sponsored by Independence Blue Cross, a leader in the insurance industry, confirmed the effectiveness of VAX-D. • The purpose of the study was to determine short- and long-term outcomes after VAX-D treatment in a large sample of patients with activity-limiting low back pain that had failed at least two previous, non-surgical treatments. • A total of 296 subjects with low back pain and evidence of a degenerative and/or herniated intervertebral disk at 1 or more levels were enrolled in the study. • In this study all subjects had pre-intervention imaging evidence of lumbar intervertebral disk degeneration and/or herniation. • The study showed that patients had significantly improved pain and disability scores at end of treatment, at 30 days and at 180 days post-discharge.
  • 29.
  • 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
  • 31.
  • 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
  • 38. DECOMPRESSION REPAIRS DISCS Herniated Nucleus Pulposus Nucleus Retracted by Vacuum Effect Annular Fissure Closed & Healing
  • 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
  • 52.
  • 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
  • 56. DISCOGRAM DYE PENETRATES ANNULUS FIBROSUS INDICATES DISRUPTION OF INTERNAL STRUCTURES INTERNAL DISC DISRUPTION
  • 57. CONTRAINDICATIONS and PRECAUTIONS 1. Fracture 2. Neoplasm 3. Unstable Spondylolisthesis 4. Cauda Equina Syndrome 5. Ankylosing Spondylitis 6. Severe Osteoporosis 7. Rotator Cuff Tear 8. Arthrodesis with Instrumentation
  • 58. -STENOSIS- LATERAL FORAMENAL ---------------------------------- disc hydration opens foramen NORMAL DISC HEIGHT & LATERAL FORAMEN DEGENERATED DISC FACET SUBLUXATION NARROWS LATERAL FORAMEN DEGENERATED DISC FACET HYPERTROPHY IMPINGES LATERAL FORAMEN DEGENERATED DISC FACET HYPERTROPHY OSTEOPHYTIC SPURS IMPINGES LATERAL FORAMEN
  • 59. IATROGENIC FORAMINAL STENOSIS Normal Lateral foramen Post fusion Stenotic foramen ---------------------- Refractory to Decompression
  • 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.
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