• 1. The Non-SurgicalTreatment For LowBack& NeckPain
  • 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 guidedcannula/catheter and pressure monitoring equipment, they watchedand 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 lowera intradiscal pressure in Vivo with a non-surgical treatment. 100 75 0 -100 -150 VAX-D actually lowers disc pressure to negative levels 0102030405060708090VAX-D TENSION(LBS) D I S C P R E S S U R E
  • 4. EffectsofVertebralAxialDecompressionOn IntradiscalPressureHCAHOSPITALSTUDY McAllenTexas Gustavo Ramos MD,William Martin MD Departments of Neurosurgery and Radiology Journal of Neurosurgery81:350-353,1994
  • 5. INTRADISCALPRESSUREMONITORING CATHETERINSERTEDVIAACANNULAINTOTHENUCLEUSPULPOSUS
  • 6. RECORDINGINTRADISCALPRESSURE CHANGESDURINGVAX-D
  • 7. Dr.RAMOSMONITORINGPROCEDURE DUALRECORDINGVAX-DTENSIONANDINTRADISCALPRESSURE
  • 8. 0 -150 +100 25 50 75 I NTRADISCALPRESSURE- mm Hg.- VAX-D - TENSIONIntradiscal Pressure Reduced to Negative Levels During VAX-D Treatment
  • 9. -40mm Hg -100mm Hg
    • HOW DOES VAX-D WORK?
    • VAX-D Decompresses the intervertebral discs and neurological elements. This reduces the hydrostatic effects of the nucleus (protrusion, herniation, extrusion etc.) and the resulting compressive injury.
    • 2.By reducing the disc pressure to negative levels, this increases the diffusion gradient from the vertebral endplate (into the disc), which brings oxygen, fluids, nutrients into the disc. The exchange of fluids reduces the concentration of catabolites and lactic acid.
    • Alongwith the increased flow of fluids into the disc, the flow of prescribed pharmaceutical agents will also be increased.All of this will serve to reduce the INFLAMMATORY CASCADE.
    • Reduction of inflammation in the disc and surrounding structures – means less pain for your patients, and will allow the disc to heal naturally.
    Science & Medicine : VAX-D Decompression Treatment -160mm Hg
  • 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 maximumabove baseline,then logarithmically increasingtension to maximum tension.This cycle is repeated a programmed number oftimes to effect therapy 23 Claims,8 Drawing Sheets United States Patent [19] Dyer [54] OPERATION OF A VERTEBRALAXIAL 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 4,995,3782/1991 Dyer ……128/75 5,115,8025/1992 Dyer ……602/23
  • 12. Fechners Law of Biological Response VAX-Demploys 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) LOGARITHMOFSTIMULUS THEMAGNITUDEOFTHESENSATIONISPROPORTIONAL TOTHELOGARITHMOFTHESTIMULUS
  • 13. LogarithmicFormulaExp [ CxLn (Bti) ]=BTn+[Nx In ] N DECOMPRESSION LOGARITHMICPHASE RETRACTION LOGARITHMICPHASE VAX-DDOUBLELOG THERAPYCURVE 30 60 100 80 60 40 20 PERCENTMAXIMUMTENSION 90 PRETENSION Seconds
  • 14.
    • Column traction devices fail to decompress the discs because:
    • The force is applied in a linear fashion, and proprioceptors recruit back and trunk muscles to contract and guard in a protective mode.
    • The use of chest harnesses and axillary restraints INCREASES intradiscal pressureby significant amounts.
    Traction Column Traction Devices FORCE 100 TRACTION Linear Phase RETRACTION Linear Phase HOLD 0 50
  • 15. VAX-D PROPRIOCEPTOR THRESHOLD 150 100 50 0 -50 -100 -150 I N T R A D I S C A LP R E S S U R E -200 200 250 20 40 60 80 100 TENSION - lbs. VAX-DvsTRACTION TRACTION
  • 16. VAX-D ®vs. Traction
    • VAX-D ®
    • Traction
    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
    • Intradiscal Pressure
    • reduced to negative levels (1)
    • Intradiscal Pressure
    • unchanged or increased (2)
    • Negative IDPenhances
    • Oxygen and Nutrient
    • diffusion into the disc (3)
    • Positive IDP
    • inhibits diffusion with
    • lactic acid accumulation (4)
    • Aerobic metabolismfosters
    • bio-physiological functions
    • and cellular repair activity (3,5)
    • Anaerobic metabolism
    • inhibits cellular activity
    • and repair functions (5)
  • 17. VAX-D Genesis G2 System In 2007 VAX-D released theGenesis G2System 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 acircumferentiallift 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 GenesisDynamic Modeallows the operator to program the tensionometerto 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 -HERNIATEDLUMBARDISCS Extrudedand/orSubligamentous Oneormorelevels - DEGENERATEDDISCDISEASE - LUMBAR ANDSCIATICNERVECOMPRESSION - FAILEDBACKSURGERIES - POSTERIORFACETSYNDROMES
  • 21. MULTI-CENTEREFFICACYSTUDY 778 CASES HERNIATED AND DEGENERATED LUMBARDISCS NEUROLOGICALRESEARCHJOURNAL VOLUME 20, 1998 Drs. E. Gose, R. K. Naguszewski, W. K. Naguszewski
  • 22. EXTRUDED 53% MULTIPLE 72% SINGLE 73% FAILED BACKSURGERY 68% DEGEN. DISC 72% FACET SYNDROME 68% Vertebralaxialdecompressiontherapyforpainassociated withherniatedordegenerateddiscsorfacetsyndrome: Anoutcomestudy PainRemission778cases 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 PERCENTAGEIMPROVEMENT 50 % 75 % 25 % 65 % MOBILITY 71 % PAIN 78 % ACTIVITY
  • 24. PROSPECTIVERANDOMIZEDCONTROLLEDTRIAL VAX-DvsTENS CHRONICBACK&LEGPAIN NEUROLOGICALRESEARCHJOURNALVolume23, No. 7, 2001 DepartmentofOrthopaedics Sidney University - Australia __________________________________Eugene Sherry MD, FRCSPeter Kitchener M.B., B.S., FRANZCR Russel Smart M.B., Ch.B.
  • 25. RANDOMIZEDCONTROLTRIAL CHRONICDISCOGENICBACK&LEGPAIN Statisticalsignificancep< 0.001 6 5 4 3 2 1 0 VAS-PAINSCALE VAX-Dvs TENS PRE VAX-D 5.59 POST VAX-D PRE TENS 5.44 POST TENS 5.97 1.69
  • 26. RandomizedControlTrial VAX-D TENS ADL DECLINED -2% -17% PAIN INCREASED PAIN DECREASED 69% ADL IMPROVED 34% 60 80 0 20 40 -20 % CHANGEININDICES STATISTICALSIGNIFICANCE-P < 0.001
  • 27. BLUECROSSSPONSORED 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 LumbarDecompression 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.
    • MONTHFOLLOW-UPSTUDY
    • Blue Cross Sponsored Study
    • Arch. Phys. Med. Rehabil. , Vol 89, 2008
    8 6 4 2 VAS-PAINSCALE BEFORE VAX-D STATISTICAL SIGNIFICANCEP < 0.01 5.8 EXIT30 DAYS180 DAYS AFTERVAX-D 3.5 3.7 3.4 PAINSIGNIFICANTLYREDUCED
  • 30. 6 MONTHFOLLOW-UPSTUDY BlueCrossSponsoredStudy Arch. Phys. Med. Rehabil. , Vol 89, 2008 12 8 6 4 DISABILITYSCALE BEFORE VAX-D STATISTICAL SIGNIFICANCEP < 0.01 12.6 EXIT30 DAYS180 DAYS AFTERVAX-D 6.0 7.0 5.9 DISABILITYSIGNIFICANTLYREDUCED
  • 31.
        • VAX-D Research Studies:
        • VAX-D Reduces Chronic Discogenic Low Back Pain
    FOURYEAR FOLLOWUP STUDY Anesthesiology News - Vol 29, March 2003 Odell R. H., MD, PhD. ,Boudreau D. A . , DO
  • 32. FOURYEARFOLLOW-UPSTUDY 8 6 4 2 VAS-PAINSCALE BEFORE VAX-D 4 YRS AFTER VAX-D STATISTICAL SIGNIFICANCEP < 0.001 7.41 1.57
  • 33. FOURYEARFOLLOW-UP EMPLOYMENTSTATUS 100 % 70 % 30 % BEFORE VAX-D 4 YEARS LATER UNABLETOWORK FULLYEMPLOYED
  • 34. COMPARATIVEOUTCOME STUDY Journal of Neurological ResearchVolume 26, April 2004_______________________________ValleyNeurosurgicalCenter Center for Neurosurgical SciencesUniversity of Texas REGULARPROTOCOL VS REDUCED COURSEOFTHERAPY
  • 35. COMPARATIVEOUTCOMESTUDY Journal of Neurological Research - Vol.26, April2004 75 60 45 30 15 PERCENTAGEOFCASES 10DAILYSESSIONS 20DAILYSESSIONS COURSEOFTHERAPY 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 FIRMCHAIR 140 SOFTCHAIR 185 BED REST 75 LEGSFLEXED 150 EXTENDED 180 CRUNCH 210 KNEESFLEXED 140 TRACTION 130 EVERYDAYPOSITIONS PHYSICALTHERAPY INDRADISCALPRESSURES
  • 37. INTERVERTEBRALDISCPRESSURES STANDING +100 BED REST +75 KNEESFLEXED +140 TRACTION +130 VAX-DTHERAPYREAL SCIENCE REAL STUDIES REAL RESULTS -150
  • 38. DECOMPRESSIONREPAIRSDISCS Herniated Nucleus Pulposus Nucleus Retracted by Vacuum EffectAnnular Fissure Closed & Healing
  • 39. BEFOREVAX-D L4 -L5 leftposteriorlargeextrudeddisc compressingthecalsac AFTERVAX-D “Thisthemostdramatic reductionofanextruded segmentIhaveseen “ Curvel A. Ferrari MD
  • 40. Left posterior - L4-L5 Extruded disc compressing & retro-displacingleft nerve root BEFOREVAX-D Extruded discretracted Left nerve root decompressed Curvel A. FerrariMD AFTERVAX-D
  • 41. ANATOMYOFANNULUSFIBROSUS DISTRACTIONCLOSESOBLIQUELAYERS ANDRADIALDIFFURES
  • 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 PERCENTAGEOFCASES CLINICALOUTCOME RADICULOPATHYRESPONSE TO VAX-D AnOverview ofVertebralAxialDecompression 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 VertebralAxial Decompression on SensoryNerveDysfunction
  • 45. BEFORE VAX-D 6.36 AFTER VAX-D 2.09 IMPROVEMENTSIGNIFICANTP < 0.05 7.0 5.0 4.0 3.0 2.0 1.0 6.0 NEUROMETERGRADE CURRENTPERCEPTIONTHRESHOLD EVALUATIONOFSENSORYDEFICIT THEEFFECTSOFVAX-DINSENSORYNERVEDYSFUNCTIONINPATIENTSWITHLOWBACKPAINANDRADICULOPATHY J. CLINICALMEDICINE-JANUARY1999
  • 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.
  • 47.  
  • 48. NERVEROOTDECOMPRESSION (DSSEP) WITHVAX-DTHERAPY PERCENT-DSSEPREADINGS 60 30 STATISTICALSIGNIFICANCE-P < 0.0013 IMPROVED 61 SAME 29 NEGATIVE 10
  • 49. ADJUSTMENTTOPRETENSION BASELINE RELAXATIONPHASE CONTROL CONSOLE COMPUTER Bio- feedbackLoop
  • 50. CONTROL CONSOLE COMPUTER LOWERBODY,PALLET,TENSIONOMETER CONTROLLEDAS AUNIFIEDMOTIONSEGMENT DECOMPRESSIONPHASE BIO- FEEDBACK LOGARITHMICMOTIONCONTROL
  • 51. BEDREST DIFFUSIONGRADIENT INTRADISCALPRESSURES 100 75 50 25 0 -25 -50 -75 -100 -125 -150 -175 DIASTOLICBP -80 mm Hg. VAX-DDIFFUSIONGRADIENT > 200 mm Hg. ACROSSTHE VERTEBRALENDPLATE VAX-DTHERAPY
  • 52. VAX-DDECOMPRESSION
    • “ Vertebraldistractionproducingdecompressioncreates a favorable
    • diffusiongradientacrossthe endplateenhancingdisc
    • nutrient transferpromotingthenaturalhealingprocess ”
    • Kirkaldy-Willis - Managing Low Back pain
  • 53. Non-steroidalAnti-inflammatory Drugs Naproxen Sodium (Aleve)220mgbid Diclofenac (Voltaren)50 mgbid Indomethacin(Indocin)25mg tid or SR 75mg Steroid Methylprednisolone 4 - 8 mg2-3 hrs before Tx (10 days) Prednisone 20 mg tid (10 days) Medrol Dosepak VAX-D PROTOCOL • PHARMACOLOGICALAGENTS Analgesics -Whennecessary Musclerelaxants-When necessary Mucosalprotective agents Misoprostol-Cytotec 100-200mg H2Antagonist-Zantac75 -150mg
  • 54. INTERNALDISCDISRUPTION VAX-DPROTOCOL METHYLPREDNISOLONE-4TO8 MG . Taken orally 2 to 3 hours before each VAX-D session First week -Onedoseeachday Second week -One dose Monday,Wednesday & Friday DOXYCYCLINE- 200MG.(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. INTERNALDISCDISRUPTION HIZ HIGH INTENSITY ZONE Pathognomonic of IDD
  • 56. DISCOGRAM DYEPENETRATESANNULUSFIBROSUSINDICATESDISRUPTIONOFINTERNALSTRUCTURES INTERNALDISCDISRUPTION
  • 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- LATERALFORAMENAL---------------------------------- disc hydration opens foramen NORMALDISC HEIGHT & LATERAL FORAMEN DEGENERATED DISCFACET SUBLUXATION NARROWS LATERAL FORAMEN DEGENERATED DISCFACET HYPERTROPHY IMPINGESLATERAL FORAMEN DEGENERATED DISCFACET HYPERTROPHY OSTEOPHYTIC SPURS IMPINGES LATERAL FORAMEN
  • 59. IATROGENICFORAMINAL STENOSIS NormalLateral foramen Post fusion Stenotic foramen ---------------------- Refractory to Decompression
  • 60. SPONDYLOLISTHESIS
  • 61. SPONDYLOLYSIS
  • 62. SPONDYLOLYSIS
  • 63. 0 20 K 40 K 60 K 80 K 100 K 120 K 140 K 160 K SurgicalCareVAX-D after 4 wks Standard care Medical Disability Total A Graphic Comparison of Costs Standard ConservativeCare$ 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 theretraction 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, anddressed up with fancy columns and tilt tables.No other devices have published studies proving they decompress the spine.
  • 65.  
  • 66.  
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    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.
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    • 1. The Non-SurgicalTreatment For LowBack& NeckPain
  • 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 guidedcannula/catheter and pressure monitoring equipment, they watchedand 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 lowera intradiscal pressure in Vivo with a non-surgical treatment. 100 75 0 -100 -150 VAX-D actually lowers disc pressure to negative levels 0102030405060708090VAX-D TENSION(LBS) D I S C P R E S S U R E
  • 4. EffectsofVertebralAxialDecompressionOn IntradiscalPressureHCAHOSPITALSTUDY McAllenTexas Gustavo Ramos MD,William Martin MD Departments of Neurosurgery and Radiology Journal of Neurosurgery81:350-353,1994
  • 5. INTRADISCALPRESSUREMONITORING CATHETERINSERTEDVIAACANNULAINTOTHENUCLEUSPULPOSUS
  • 6. RECORDINGINTRADISCALPRESSURE CHANGESDURINGVAX-D
  • 7. Dr.RAMOSMONITORINGPROCEDURE DUALRECORDINGVAX-DTENSIONANDINTRADISCALPRESSURE
  • 8. 0 -150 +100 25 50 75 I NTRADISCALPRESSURE- mm Hg.- VAX-D - TENSIONIntradiscal Pressure Reduced to Negative Levels During VAX-D Treatment
  • 9. -40mm Hg -100mm Hg
    • HOW DOES VAX-D WORK?
    • VAX-D Decompresses the intervertebral discs and neurological elements. This reduces the hydrostatic effects of the nucleus (protrusion, herniation, extrusion etc.) and the resulting compressive injury.
    • 2.By reducing the disc pressure to negative levels, this increases the diffusion gradient from the vertebral endplate (into the disc), which brings oxygen, fluids, nutrients into the disc. The exchange of fluids reduces the concentration of catabolites and lactic acid.
    • Alongwith the increased flow of fluids into the disc, the flow of prescribed pharmaceutical agents will also be increased.All of this will serve to reduce the INFLAMMATORY CASCADE.
    • Reduction of inflammation in the disc and surrounding structures – means less pain for your patients, and will allow the disc to heal naturally.
    Science & Medicine : VAX-D Decompression Treatment -160mm Hg
  • 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 maximumabove baseline,then logarithmically increasingtension to maximum tension.This cycle is repeated a programmed number oftimes to effect therapy 23 Claims,8 Drawing Sheets United States Patent [19] Dyer [54] OPERATION OF A VERTEBRALAXIAL 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 4,995,3782/1991 Dyer ……128/75 5,115,8025/1992 Dyer ……602/23
  • 12. Fechners Law of Biological Response VAX-Demploys 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) LOGARITHMOFSTIMULUS THEMAGNITUDEOFTHESENSATIONISPROPORTIONAL TOTHELOGARITHMOFTHESTIMULUS
  • 13. LogarithmicFormulaExp [ CxLn (Bti) ]=BTn+[Nx In ] N DECOMPRESSION LOGARITHMICPHASE RETRACTION LOGARITHMICPHASE VAX-DDOUBLELOG THERAPYCURVE 30 60 100 80 60 40 20 PERCENTMAXIMUMTENSION 90 PRETENSION Seconds
  • 14.
    • Column traction devices fail to decompress the discs because:
    • The force is applied in a linear fashion, and proprioceptors recruit back and trunk muscles to contract and guard in a protective mode.
    • The use of chest harnesses and axillary restraints INCREASES intradiscal pressureby significant amounts.
    Traction Column Traction Devices FORCE 100 TRACTION Linear Phase RETRACTION Linear Phase HOLD 0 50
  • 15. VAX-D PROPRIOCEPTOR THRESHOLD 150 100 50 0 -50 -100 -150 I N T R A D I S C A LP R E S S U R E -200 200 250 20 40 60 80 100 TENSION - lbs. VAX-DvsTRACTION TRACTION
  • 16. VAX-D ®vs. Traction
    • VAX-D ®
    • Traction
    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
    • Intradiscal Pressure
    • reduced to negative levels (1)
    • Intradiscal Pressure
    • unchanged or increased (2)
    • Negative IDPenhances
    • Oxygen and Nutrient
    • diffusion into the disc (3)
    • Positive IDP
    • inhibits diffusion with
    • lactic acid accumulation (4)
    • Aerobic metabolismfosters
    • bio-physiological functions
    • and cellular repair activity (3,5)
    • Anaerobic metabolism
    • inhibits cellular activity
    • and repair functions (5)
  • 17. VAX-D Genesis G2 System In 2007 VAX-D released theGenesis G2System 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 acircumferentiallift 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 GenesisDynamic Modeallows the operator to program the tensionometerto 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 -HERNIATEDLUMBARDISCS Extrudedand/orSubligamentous Oneormorelevels - DEGENERATEDDISCDISEASE - LUMBAR ANDSCIATICNERVECOMPRESSION - FAILEDBACKSURGERIES - POSTERIORFACETSYNDROMES
  • 21. MULTI-CENTEREFFICACYSTUDY 778 CASES HERNIATED AND DEGENERATED LUMBARDISCS NEUROLOGICALRESEARCHJOURNAL VOLUME 20, 1998 Drs. E. Gose, R. K. Naguszewski, W. K. Naguszewski
  • 22. EXTRUDED 53% MULTIPLE 72% SINGLE 73% FAILED BACKSURGERY 68% DEGEN. DISC 72% FACET SYNDROME 68% Vertebralaxialdecompressiontherapyforpainassociated withherniatedordegenerateddiscsorfacetsyndrome: Anoutcomestudy PainRemission778cases 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 PERCENTAGEIMPROVEMENT 50 % 75 % 25 % 65 % MOBILITY 71 % PAIN 78 % ACTIVITY
  • 24. PROSPECTIVERANDOMIZEDCONTROLLEDTRIAL VAX-DvsTENS CHRONICBACK&LEGPAIN NEUROLOGICALRESEARCHJOURNALVolume23, No. 7, 2001 DepartmentofOrthopaedics Sidney University - Australia __________________________________Eugene Sherry MD, FRCSPeter Kitchener M.B., B.S., FRANZCR Russel Smart M.B., Ch.B.
  • 25. RANDOMIZEDCONTROLTRIAL CHRONICDISCOGENICBACK&LEGPAIN Statisticalsignificancep< 0.001 6 5 4 3 2 1 0 VAS-PAINSCALE VAX-Dvs TENS PRE VAX-D 5.59 POST VAX-D PRE TENS 5.44 POST TENS 5.97 1.69
  • 26. RandomizedControlTrial VAX-D TENS ADL DECLINED -2% -17% PAIN INCREASED PAIN DECREASED 69% ADL IMPROVED 34% 60 80 0 20 40 -20 % CHANGEININDICES STATISTICALSIGNIFICANCE-P < 0.001
  • 27. BLUECROSSSPONSORED 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 LumbarDecompression 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.
    • MONTHFOLLOW-UPSTUDY
    • Blue Cross Sponsored Study
    • Arch. Phys. Med. Rehabil. , Vol 89, 2008
    8 6 4 2 VAS-PAINSCALE BEFORE VAX-D STATISTICAL SIGNIFICANCEP < 0.01 5.8 EXIT30 DAYS180 DAYS AFTERVAX-D 3.5 3.7 3.4 PAINSIGNIFICANTLYREDUCED
  • 30. 6 MONTHFOLLOW-UPSTUDY BlueCrossSponsoredStudy Arch. Phys. Med. Rehabil. , Vol 89, 2008 12 8 6 4 DISABILITYSCALE BEFORE VAX-D STATISTICAL SIGNIFICANCEP < 0.01 12.6 EXIT30 DAYS180 DAYS AFTERVAX-D 6.0 7.0 5.9 DISABILITYSIGNIFICANTLYREDUCED
  • 31.
        • VAX-D Research Studies:
        • VAX-D Reduces Chronic Discogenic Low Back Pain
    FOURYEAR FOLLOWUP STUDY Anesthesiology News - Vol 29, March 2003 Odell R. H., MD, PhD. ,Boudreau D. A . , DO
  • 32. FOURYEARFOLLOW-UPSTUDY 8 6 4 2 VAS-PAINSCALE BEFORE VAX-D 4 YRS AFTER VAX-D STATISTICAL SIGNIFICANCEP < 0.001 7.41 1.57
  • 33. FOURYEARFOLLOW-UP EMPLOYMENTSTATUS 100 % 70 % 30 % BEFORE VAX-D 4 YEARS LATER UNABLETOWORK FULLYEMPLOYED
  • 34. COMPARATIVEOUTCOME STUDY Journal of Neurological ResearchVolume 26, April 2004_______________________________ValleyNeurosurgicalCenter Center for Neurosurgical SciencesUniversity of Texas REGULARPROTOCOL VS REDUCED COURSEOFTHERAPY
  • 35. COMPARATIVEOUTCOMESTUDY Journal of Neurological Research - Vol.26, April2004 75 60 45 30 15 PERCENTAGEOFCASES 10DAILYSESSIONS 20DAILYSESSIONS COURSEOFTHERAPY 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 FIRMCHAIR 140 SOFTCHAIR 185 BED REST 75 LEGSFLEXED 150 EXTENDED 180 CRUNCH 210 KNEESFLEXED 140 TRACTION 130 EVERYDAYPOSITIONS PHYSICALTHERAPY INDRADISCALPRESSURES
  • 37. INTERVERTEBRALDISCPRESSURES STANDING +100 BED REST +75 KNEESFLEXED +140 TRACTION +130 VAX-DTHERAPYREAL SCIENCE REAL STUDIES REAL RESULTS -150
  • 38. DECOMPRESSIONREPAIRSDISCS Herniated Nucleus Pulposus Nucleus Retracted by Vacuum EffectAnnular Fissure Closed & Healing
  • 39. BEFOREVAX-D L4 -L5 leftposteriorlargeextrudeddisc compressingthecalsac AFTERVAX-D “Thisthemostdramatic reductionofanextruded segmentIhaveseen “ Curvel A. Ferrari MD
  • 40. Left posterior - L4-L5 Extruded disc compressing & retro-displacingleft nerve root BEFOREVAX-D Extruded discretracted Left nerve root decompressed Curvel A. FerrariMD AFTERVAX-D
  • 41. ANATOMYOFANNULUSFIBROSUS DISTRACTIONCLOSESOBLIQUELAYERS ANDRADIALDIFFURES
  • 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 PERCENTAGEOFCASES CLINICALOUTCOME RADICULOPATHYRESPONSE TO VAX-D AnOverview ofVertebralAxialDecompression 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 VertebralAxial Decompression on SensoryNerveDysfunction
  • 45. BEFORE VAX-D 6.36 AFTER VAX-D 2.09 IMPROVEMENTSIGNIFICANTP < 0.05 7.0 5.0 4.0 3.0 2.0 1.0 6.0 NEUROMETERGRADE CURRENTPERCEPTIONTHRESHOLD EVALUATIONOFSENSORYDEFICIT THEEFFECTSOFVAX-DINSENSORYNERVEDYSFUNCTIONINPATIENTSWITHLOWBACKPAINANDRADICULOPATHY J. CLINICALMEDICINE-JANUARY1999
  • 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.
  • 47.  
  • 48. NERVEROOTDECOMPRESSION (DSSEP) WITHVAX-DTHERAPY PERCENT-DSSEPREADINGS 60 30 STATISTICALSIGNIFICANCE-P < 0.0013 IMPROVED 61 SAME 29 NEGATIVE 10
  • 49. ADJUSTMENTTOPRETENSION BASELINE RELAXATIONPHASE CONTROL CONSOLE COMPUTER Bio- feedbackLoop
  • 50. CONTROL CONSOLE COMPUTER LOWERBODY,PALLET,TENSIONOMETER CONTROLLEDAS AUNIFIEDMOTIONSEGMENT DECOMPRESSIONPHASE BIO- FEEDBACK LOGARITHMICMOTIONCONTROL
  • 51. BEDREST DIFFUSIONGRADIENT INTRADISCALPRESSURES 100 75 50 25 0 -25 -50 -75 -100 -125 -150 -175 DIASTOLICBP -80 mm Hg. VAX-DDIFFUSIONGRADIENT > 200 mm Hg. ACROSSTHE VERTEBRALENDPLATE VAX-DTHERAPY
  • 52. VAX-DDECOMPRESSION
    • “ Vertebraldistractionproducingdecompressioncreates a favorable
    • diffusiongradientacrossthe endplateenhancingdisc
    • nutrient transferpromotingthenaturalhealingprocess ”
    • Kirkaldy-Willis - Managing Low Back pain
  • 53. Non-steroidalAnti-inflammatory Drugs Naproxen Sodium (Aleve)220mgbid Diclofenac (Voltaren)50 mgbid Indomethacin(Indocin)25mg tid or SR 75mg Steroid Methylprednisolone 4 - 8 mg2-3 hrs before Tx (10 days) Prednisone 20 mg tid (10 days) Medrol Dosepak VAX-D PROTOCOL • PHARMACOLOGICALAGENTS Analgesics -Whennecessary Musclerelaxants-When necessary Mucosalprotective agents Misoprostol-Cytotec 100-200mg H2Antagonist-Zantac75 -150mg
  • 54. INTERNALDISCDISRUPTION VAX-DPROTOCOL METHYLPREDNISOLONE-4TO8 MG . Taken orally 2 to 3 hours before each VAX-D session First week -Onedoseeachday Second week -One dose Monday,Wednesday & Friday DOXYCYCLINE- 200MG.(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. INTERNALDISCDISRUPTION HIZ HIGH INTENSITY ZONE Pathognomonic of IDD
  • 56. DISCOGRAM DYEPENETRATESANNULUSFIBROSUSINDICATESDISRUPTIONOFINTERNALSTRUCTURES INTERNALDISCDISRUPTION
  • 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- LATERALFORAMENAL---------------------------------- disc hydration opens foramen NORMALDISC HEIGHT & LATERAL FORAMEN DEGENERATED DISCFACET SUBLUXATION NARROWS LATERAL FORAMEN DEGENERATED DISCFACET HYPERTROPHY IMPINGESLATERAL FORAMEN DEGENERATED DISCFACET HYPERTROPHY OSTEOPHYTIC SPURS IMPINGES LATERAL FORAMEN
  • 59. IATROGENICFORAMINAL STENOSIS NormalLateral foramen Post fusion Stenotic foramen ---------------------- Refractory to Decompression
  • 60. SPONDYLOLISTHESIS
  • 61. SPONDYLOLYSIS
  • 62. SPONDYLOLYSIS
  • 63. 0 20 K 40 K 60 K 80 K 100 K 120 K 140 K 160 K SurgicalCareVAX-D after 4 wks Standard care Medical Disability Total A Graphic Comparison of Costs Standard ConservativeCare$ 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 theretraction 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, anddressed up with fancy columns and tilt tables.No other devices have published studies proving they decompress the spine.
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