Publish Clinical Studies

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  • Most of the clinical work on Anodyne Therapy has been done in the area of peripheral neuropathy.
  • Publish Clinical Studies

    1. 1. Published Clinical Studies of Anodyne® Therapy
    2. 2. <ul><li>&quot;MIRE™ may be a safe, drug-free, non-invasive treatment for the consistent and predictable improvement of sensation in diabetic patients with peripheral neuropathy of the feet.&quot; </li></ul><ul><li>Symptomatic Reversal of Peripheral Neuropathy in Patients with Diabetes , Alan Kochman, MSPT, Dale Carnegie, DPM, Thomas Burke, Ph.D. (Aurora Medical Center, Denver Health Medical Center and Integrated Systems Physiology) Journal of the American Podiatric Medical Association , 92; 125-130, 2002. </li></ul><ul><ul><li>Number of subjects: 49 with Diabetes related Peripheral Neuropathy </li></ul></ul><ul><ul><li>Protocol: 12 x 30-min treatments in 4 weeks </li></ul></ul>www.rapidhealing.com.au Clinical Studies Symptomatic Reversal of Peripheral Neuropathy in Patients with Diabetes
    3. 3. www.rapidhealing.com.au Clinical Studies P < .0001 vs. Before Treatment Improvement in Loss of Protective Sensation (LOPS)
    4. 4. www.rapidhealing.com.au Clinical Studies Subjects with diabetic peripheral neuropathy type 1 diabetic patients Quantitative Monofilament LOPS - Insensate to 10 gram filament before MIRE ® 5.07 Monofilament Level sensed after treatment P < .0001 vs. Before Treatment 30 40 50 60 70 80 90 Age 3 4 5 6 7 Improvement in Sensation
    5. 5. www.rapidhealing.com.au Clinical Studies Subjects with diabetic peripheral neuropathy type 2 diabetic patients Improvement in Sensation SW Monofilament LOPS - Insensate to 10 gram filament before MIRE ® 5.07 Monofilament Level sensed after treatment P < .0001 vs. Before Treatment 30 40 50 60 70 80 90 Age 3 4 5 6 7
    6. 6. <ul><li>&quot;[Anodyne® Therapy ] treatments improve sensation in the feet of subjects with DPN, improve balance, and reduce pain.&quot; </li></ul><ul><li>Restoration of Sensation, Reduced Pain, and Improved Balance in Subjects with Diabetic Peripheral Neuropathy; A Randomized, Double Blind, Placebo Controlled Study , David R. Leonard, M.D., F.A.C.E., M. Hamed Farooqi, M.D., F.A.C.E., Sara Myers, R.N. (Joslin Center for Diabetes at Morton Plant Hospital), Diabetes Care, 27:168-172, January 2004. </li></ul><ul><ul><li>Number of subjects: 27 with Diabetes related Peripheral Neuropathy </li></ul></ul><ul><ul><li>Protocol: 6 x 40-min treatments or placebo in 2 weeks, followed by another 2 weeks no placebo </li></ul></ul>www.rapidhealing.com.au Clinical Studies Restoration of Sensation, Reduced Pain, and Improved Balance in Subjects with DPN
    7. 7. www.rapidhealing.com.au Clinical Studies Number of points sensate to 10 Gram (5.07) SWM of 5 tested 106% improvement in sensation with Anodyne® Therapy (placebo NS) P < 0.001 Improvement in Sensation
    8. 8. www.rapidhealing.com.au Clinical Studies Neuropathic pain – 45% reduction in pain levels (VAS 10 point pain scale) Neuropathic Pain Reduction P < 0.0001
    9. 9. www.rapidhealing.com.au Clinical Studies Balance/fear of falling – 70% reported improved balance Reduction in Fear of Falling/Balance Problems P < 0.0001
    10. 10. <ul><li>&quot;...this easy, safe, and effective modality is an extremely valuable tool for eliminating or reducing pain, inflammation, edema, and loss of range of motion.&quot; </li></ul><ul><li>Effects of Skin-Contact Monochromatic Infrared Irradiation on Tendonitis, Capsulitis, and Myofascial Pain , T.L. Thomasson, D.D.S. (Facial Pain/TMJ Treatment Centre, Denver CO), Journal of Neurological & Orthopaedic Surgeons, (1996) 16:242-245. </li></ul><ul><ul><li>Number of subjects: 784 (TS/SCS – 200 cases; postoperative capsulitis – 28 cases; non-surgical capsulitis – 195 cases; myofacial pain/muscle spasm – 361 cases) </li></ul></ul><ul><ul><li>Protocol: 3 x 45-min sessions a week for 3 weeks or daily 30-min sessions for at-home patients </li></ul></ul>www.rapidhealing.com.au Clinical Studies Effects of MIRE™ on Tendonitis, Capsulitis, and Myofascial Pain
    11. 11. Patients with the following conditions included in the study: chronic tendonitis, capsulitis, TMJ, myofascial muscle spasm, post-operative pain www.rapidhealing.com.au Clinical Studies Even if placebo effect was 50%, reduction in pain was significant! Pain Reduction Outcomes
    12. 12. <ul><li>&quot;[Anodyne Therapy] seems to be a safe and effective treatment to improve sensory impairment associated with peripheral neuropathy due to diabetes and other causes.&quot; </li></ul><ul><li>Reduced Sensory Impairment in Patients with Peripheral Neuropathy , J. Joseph Prendergast, MD, Galdina Miranda, MA, Manuel Sanchez, MA (Endocrine Metabolic Medical Center), Endocrine Practice, 10:24-30, January/February 2004. </li></ul><ul><ul><li>Number of subjects: 27 with Peripheral Neuropathy (6 non-diabetic) </li></ul></ul><ul><ul><li>Protocol: 10 x 40-min treatments in 2 weeks </li></ul></ul>www.rapidhealing.com.au Clinical Studies Reduced Sensory Impairment in Patients with Peripheral Neuropathy
    13. 13. www.rapidhealing.com.au Clinical Studies *Patients with normal function in all three nerve groups: large and small myelinated and small unmyelinated 59.3% of subjects had normal sensory function after MIRE™ as measured by neurometer CPT sNCT Reduced Sensory Impairment
    14. 14. www.rapidhealing.com.au Clinical Studies As determined by neurometer CPT sNCT Changes in Impairment Severity Grade Profound Sensory Loss Moderate Very Mild Normal P < 0.0001
    15. 15. <ul><li>&quot;A comprehensive therapy intervention that includes [MIRE™] has the potential to improve sensation and balance and to reduce fall frequency. These results should be of great interest to patients with peripheral neuropathy, health care providers who treat these patients, and the payor community that incur the cost of treatment.&quot; </li></ul><ul><li>Restoration of Sensation, Improved Balance and Gait and Reduction in Falls in Elderly Patients with Use of Monochromatic Infrared Photo Energy and Physical Therapy , Alan B. Kochman, MSPT (Aurora Medical Center), Journal of Geriatric Physical Therapy , Vol. 27;1:04. </li></ul><ul><ul><li>Number of Subjects: 38 (27 DPN, 6 polyneuropathy alcohol related, 5 peripheral vascular disease – PVD) </li></ul></ul><ul><ul><li>Protocol: mean of 12 treatments once a day for 30-40 min (6 treatments for minor balance impairment, 12 for substantial, 20 for profound) </li></ul></ul>www.rapidhealing.com.au Clinical Studies Restoration of Sensation, Improved Balance and Gait and Reduction in Falls in Elderly Patients
    16. 16. www.rapidhealing.com.au Clinical Studies Sensation, Gait and Balance Outcomes Average number sites sensing 5.07 monofilament of 3 sites tested Average gait and balance score (normal = 28) Total falls in 90 days P < .0001 vs. before treatment
    17. 17. www.rapidhealing.com.au Clinical Studies Mean Change 11.2 to 21.6 93% Average Tinetti Score Improvement
    18. 18. P < .0001 vs. before Tx www.rapidhealing.com.au Clinical Studies Number of Falls By Patient Before & After Treatment
    19. 19. <ul><li>&quot;Increased sensory nerve function in patients previously diagnosed with DPN and LOPS...after continued access to the MIRE™ device in the home, seems closely related to a significant reduction in the expected incidence of new diabetic foot wounds.&quot; </li></ul><ul><li>Reversal of Diabetic Peripheral Neuropathy and New Wound Incidence: The Role of MIRE , Mark W. Powell, MD; Dale E. Carnegie, DPM; and Thomas J. Burke, PhD, Advances in Skin & Wound Care , 17(6): 295-300, July/August 2004. </li></ul><ul><ul><li>Number of Subjects: 68 (DPN with LOPS) </li></ul></ul><ul><ul><li>Protocol: Mean 12.5 months of daily 30-40-min treatment at home </li></ul></ul>www.rapidhealing.com.au Clinical Studies Reversal of Diabetic Peripheral Neuropathy and New Wound Incidence
    20. 20. www.rapidhealing.com.au Clinical Studies 79.5% reduction in diabetic ulcer incidence in senior DPN patients Reduced Diabetic Ulcer Incidence
    21. 21. www.rapidhealing.com.au Clinical Studies 100% reduction in non-healing wounds – previous studies show < 33% of diabetic ulcers heal within 20 weeks Reduced Non-Healing Wounds (Diabetic Ulcers)
    22. 22. <ul><li>&quot;Treatment with MIRE was associated with improved foot sensation... in a cohort of 1,047 patients initially diagnosed as having peripheral neuropathy. The extent of this improvement was substantial, even in patients with advanced loss of protective sensation. ...MIRE may also be associated with a reduced incidence of diabetic foot wounds and its sequelae, such as amputations.&quot; </li></ul><ul><li>Improved Sensitivity in Patients with Peripheral Neuropathy After Treatment with Monochromatic Infrared Photo Energy , Salvatore De Lellis, DPM, Dale E. Carnegie, DPM, Thomas J. Burke, PhD., Journal of the American Podiatric Medical Association , 95(2), March/April 2005. </li></ul><ul><ul><li>Number of subjects: 1047 (790 DPN; 257 PNO) </li></ul></ul><ul><ul><li>Protocol: statistical chart review across 5 clinical sites – Mean number of treatments = 18; mean treatment time = 31 minutes </li></ul></ul>www.rapidhealing.com.au Clinical Studies Improved Sensitivity in Patients with Peripheral Neuropathy
    23. 23. www.rapidhealing.com.au Clinical Studies 366% improvement in sensation to 10 gram monofilament Improvement in Sensation
    24. 24. www.rapidhealing.com.au Clinical Studies Mean sites sensate to 5.07 SWM Improvement in Sensation
    25. 25. www.rapidhealing.com.au Clinical Studies Pain Reduction (VAS Scale)
    26. 26. www.rapidhealing.com.au Clinical Studies Gait and Balance Improvement (Tinetti Scores) Mod Low >24 <19 High Fall Risk
    27. 27. <ul><li>Augmentation of Wound Healing Using Monochromatic Infrared Energy , Lon Horwitz, DPM, CWS, Thomas Burke, Ph.D., Dale Carnegie, DPM, (Denver Veterans Administration Medical Center, Integrated Systems Physiology and Denver Health Medical Center), Advances in Wound Care , 12:35-40, 1999. </li></ul><ul><li>Monochromatic Infrared Irradiation (890): Effect of a Multisource Array upon Conduction in the Human Median Nerve , J. Gareth Noble, D. Phil., Andrea S. Lowe, D.Phil., and G. David Baxter, D.Phil., Journal of Clinical Laser Medicine and Surgery , 19:291-295, 2001. </li></ul><ul><li>Reversal of diabetic peripheral neuropathy with phototherapy (MIRE™) decreases falls and the fear of falling and improves activities of daily living in seniors , Mark W. Powell, Dale H. Carnegie, Thomas J. Burke, Age and Ageing , 35: 11–16, 2006. </li></ul><ul><li>Effectiveness of Monochromatic Infrared Photo Energy and Physical Therapy for Peripheral Neuropathy: Changes in Sensation, Pain, and Balance – A Preliminary, Multi-Center Study , Wendy Volkert, MSPT, Ahmed Hassan, PT, MS, Mohamed A. Hassan, PT, MHS, Vicki L. Smock, PT, Justin P. Connor, PT, Becky McFee, PT, Shayne K. Ferguson, PT, MHS, PhD, GCS, CWS, Thomas J. Burke, PhD, Physical and Occupational Therapy in Geriatrics , 24(2) Mar/Apr 2006. </li></ul><ul><li>Improved foot sensitivity and pain reduction in patients with peripheral neuropathy after treatment with monochromatic infrared photo energy—MIRE , Lawrence B. Harklessa, Salvatore DeLellisb, Dale H. Carnegiec, Thomas J. Burke, Journal of Diabetes and Its Complications , 20:81– 87, 2006. </li></ul>www.rapidhealing.com.au Clinical Studies Additional Published Peer-Reviewed Studies
    28. 28. <ul><li>Treatment Effect Observation: Monochromatic Near-Infrared Photo Energy (MIRE) Effective Treatment for Diabetic Peripheral Neuropathy, L Jie, XY Cheng, SJ Zhong, DH Hua, SS Xin, CX Qi, Chinese Journal of Diabetes Education, July 2005. </li></ul><ul><li>Application of Anodyne Therapy System (ATS) to Observe the Treatment Effect on Diabetic Peripheral Neuropathy, J Weng, M Chen, Y Li, Z Liao, Chinese Journal of Diabetes Education, August 2005. </li></ul><ul><li>Application of Monochromatic Infrared Therapeutic Apparatus to Diabetic Peripheral Neuropathy and the Lower Limb Ulcer, Yi Zou, Xiaofeng Guan, Tao Zao, Shuyu Huang, Yuping Liu, Fuhua Zhou, Chinese Journal of Diabetes Education, Sept. 2005. </li></ul>www.rapidhealing.com.au Clinical Studies Other Published Studies
    29. 29. <ul><li>Anodyne Therapy in Painful Hypoxic Wounds – Reversal of Gangrene - Oral Abstract - Caroline Fife, MD (University of Texas Health Science Center), 17th Annual Advances in Skin and Wound Care, September 21-24, 2002, Dallas, TX. </li></ul><ul><li>A Case of Resistant Dermatophytosis - Poster, Mary Ann Lillig, DO and Jennifer Stevens, RPT (Lifecare Centers of America), 17thAnnual Advances in Skin and Wound Care, September 21-24, 2002, Dallas, TX. </li></ul><ul><li>The Use of Monochromatic Infrared Energy in Treatment of Ischemic Pain and Foot Ulcerations - Poster, Anders, Walker, Turner, Fife and Bachmann (Texas Wound and Lymphedema Center, Tomball), 17 th Annual Advances in Skin and Wound Care, September 21-24, 2002, Dallas, TX. </li></ul><ul><li>Restoration of Sensation, Improved Balance and Gait and Reduction in Falls in Elderly Patients with Use of Monochromatic Infrared Photo Energy and Physical Therapy - Oral Abstract, Alan Kochman, MSPT, Presented at American Physical Therapy Association Meeting – Combined Sections Meeting – February 2003. </li></ul><ul><li>Can Monochromatic Infrared Photo Energy (MIRE™) Reverse Diabetic Peripheral Neuropathy? A Double Blind Placebo-Controlled Study – Platform Presentation and Poster, David Leonard, MD and Sara Myers, LPN, CCRC (Joslin Center for Diabetes, Morton Plant Hospital), Presented at the American Association of Diabetes Educators 30th Annual Meeting and Convention – August 6-9, 2003 - Salt Lake City, UT and also presented at the 7th Annual Wound Care Congress – October 5, 2003 – San Antonio, TX. </li></ul><ul><li>Reduced Sensory Impairment in Patients with Peripheral Neuropathy - Platform Presentation, J. Joseph Prendergast, MD (Endocrine Metabolic Medical Center), American Podiatric Medical Association Annual Meeting, August 2003, Washington, DC. </li></ul><ul><li>Symptomatic Relief of Both Loss of Protective Sensation and Neuropathic Discomfort in Patients with Diabetic Neuropathy Using Monochromatic Infrared Energy - Poster, Stuart Goldman, DPM, FACFAS, American Podiatric Medical Association Annual Meeting, August, 2003, Washington, DC. </li></ul><ul><li>Anodyne Therapy: Healing of a Limb-Threatening Wound with Incapacitating Pain – Poster – Caroline E. Fife, MD (Memorial Hermann Center for Wound Healing), Virginia Albright, RN, Laurie Jones, RN, 18 th Annual Symposium on Advanced Wound Care, April 2005, San Diego, CA. </li></ul>www.rapidhealing.com.au Clinical Studies Presentations at Medical Symposia
    30. 30. <ul><li>Improved Sensory Perception in Diabetics, American Diabetes Association June 2001 Annual Meeting -Abstract # 1798-PO. </li></ul><ul><li>Outcome in Knee Osteoarthritis Intervention with Use of the Anodyne System and Synvisc, Cheryl Riegger-Krugh, ScD, PT (University of Colorado Health Sciences Center), Journal of Orthopedic Sports and Physical Therapy, 2001; 31(1): A - 38-39. </li></ul><ul><li>Guidelines for Management of Wounds in Patients with Lower-Extremity Neuropathic Disease, Wound, Ostomy, and Continence Nurses Society (WOCN) Clinical Practice Guideline Series, 2004. </li></ul><ul><li>Emerging Modalities: Is There Evidence, Modalities for Therapeutic Intervention, 4th Edition (previously titled Thermal Agents in Rehabilitation), Susan L. Michlovitz, PT, PhD, CHT and Thomas P. Nolan, PT, MS, OCS, 2005; pp. 289-291. </li></ul><ul><li>Monochromatic Infrared Photo Energy and DPN, Neil Goldberg, MD, Diabetic Microvascular Complications Today, March/April 2005. </li></ul><ul><li>5 Questions — and Answers — About MIRE Treatment, Thomas J. Burke, PhD, Advances in Skin & Wound Care, 2003; 16(7): 369-371. </li></ul>www.rapidhealing.com.au Clinical Studies Published Abstracts, Guides & Reviews
    31. 31. www.rapidhealing.com.au Clinical Studies Outcomes After 90 Days of MIRE™ Use 90 Day Study - Conducted at Joslin Diabetes Center
    32. 32. <ul><li>Hypoglycemia in diabetic patients </li></ul><ul><ul><li>Increased blood flow to tissue (drops off sugar) </li></ul></ul><ul><ul><li>Increased activity levels </li></ul></ul><ul><ul><li>Reduced pain reduces stress (stress raises blood sugar) </li></ul></ul><ul><ul><li>Resolution of wounds/infections reduces stress (infections raise blood sugar) </li></ul></ul><ul><li>Increased pain , tingling, burning </li></ul><ul><ul><li>A great sign treatment is working </li></ul></ul><ul><ul><li>Slow it down (lower energy dial) </li></ul></ul><ul><ul><li>Shorten treatments </li></ul></ul><ul><ul><li>Move up further on leg (to ensure blood flow moving out of extremity) </li></ul></ul>www.rapidhealing.com.au Clinical Studies Side Effects During Treatment

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