publish clinical studies

Published Clinical Published Clinical Studies of Anodyne® Studies of Anodyne® TherapyTherapy

Symptomatic Reversal of Peripheral Neuropathy in Patients with Diabetes

"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."

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.– Number of subjects: 49 with Diabetes related Peripheral Neuropathy– Protocol: 12 x 30-min treatments in 4 weeks

www.rapidhealing.com.au Clinical Studies 2

P < .0001 vs. Before Treatment

Improvement in Loss of Protective Sensation (LOPS)



Subjects with diabetic peripheral neuropathytype 1 diabetic patients

QuantitativeMonofilament

LOPS - Insensate to 10 gram filament before MIRE®

5.07 Monofilament

Level sensed after treatment


30 40 50 60 70 80 90

Age

3

4

5

6

7

Improvement in Sensation


Subjects with diabetic peripheral neuropathytype 2 diabetic patients


SWMonofilament

LOPS - Insensate to 10 gram filament before MIRE®

5.07 Monofilament

Level sensed after treatment


30 40 50 60 70 80 90

Age

3

4

5

6

7

Restoration of Sensation, Reduced Pain, and Improved Balance in Subjects with DPN

"[Anodyne® Therapy ] treatments improve sensation in the feet of subjects with DPN, improve balance, and reduce pain."

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.– Number of subjects: 27 with Diabetes related Peripheral Neuropathy– Protocol: 6 x 40-min treatments or placebo in 2 weeks, followed by another 2 weeks no placebo


http://www.rapidhealing.com.au/images/stories/pdfs/CE5_Restoration_of_Sensation_LeonardFarooqi.pdf

http://www.rapidhealing.com.au/images/stories/pdfs/CE5_Restoration_of_Sensation_LeonardFarooqi.pdf

P < 0.001



Number of points sensate to 10 Gram (5.07) SWM of 5 tested106% improvement in sensation with Anodyne® Therapy (placebo NS)

Neuropathic Pain Reduction


P < 0.0001

Neuropathic pain – 45% reduction in pain levels (VAS 10 point pain scale)

Reduction in Fear of Falling/Balance Problems


Balance/fear of falling – 70% reported improved balance

P < 0.0001

Effects of MIRE™ on Tendonitis, Capsulitis, and Myofascial Pain

"...this easy, safe, and effective modality is an extremely valuable tool for eliminating or reducing pain, inflammation, edema, and loss of range of motion."

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.– Number of subjects: 784 (TS/SCS – 200 cases; postoperative capsulitis – 28 cases; non-surgical

capsulitis – 195 cases; myofacial pain/muscle spasm – 361 cases)– Protocol: 3 x 45-min sessions a week for 3 weeks or daily 30-min sessions for at-home patients


http://www.rapidhealing.com.au/images/stories/pdfs/ce12_effects_of_skincontact_thomasson.pdf

http://www.rapidhealing.com.au/images/stories/pdfs/ce12_effects_of_skincontact_thomasson.pdf

Patients with the following conditions included in the study: chronic tendonitis, capsulitis, TMJ, myofascial muscle spasm, post-operative pain

Even if placebo effectwas 50%, reduction inpain was significant!

Pain Reduction Outcomes


Reduced Sensory Impairment in Patients with Peripheral Neuropathy

"[Anodyne Therapy] seems to be a safe and effective treatment to improve sensory impairment associated with peripheral neuropathy due to diabetes and other causes."

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.– Number of subjects: 27 with Peripheral Neuropathy (6 non-diabetic)– Protocol: 10 x 40-min treatments in 2 weeks


http://www.rapidhealing.com.au/images/stories/pdfs/CE4_Improvement_of_Sensation_Prendergastetal.pdf

Reduced Sensory Impairment


*Patients with normal functionin 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

Changes in Impairment Severity Grade


As determined by neurometer CPT sNCT

Profound Sensory Loss Moderate

Very Mild

NormalP < 0.0001

Restoration of Sensation, Improved Balance and Gait and Reduction in Falls in Elderly Patients

"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."

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.– Number of Subjects: 38 (27 DPN, 6 polyneuropathy alcohol related, 5 peripheral vascular disease – PVD) – Protocol: mean of 12 treatments once a day for 30-40 min (6 treatments for minor balance impairment,

12 for substantial, 20 for profound)


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

93% Average Tinetti Score Improvement


0

5

10

15

20

25

30

55 60 65 70 75 80 85 90 95 100

Age (Years)

After Before

High Fall Risk

Moderate Fall Risk

Risk

Low Fall Risk

Mean Change 11.2 to 21.6

P < .0001

vs. before Tx

Number of Falls By Patient Before & After Treatment


Reversal of Diabetic Peripheral Neuropathy and New Wound Incidence

"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."

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. – Number of Subjects: 68 (DPN with LOPS) – Protocol: Mean 12.5 months of daily 30-40-min treatment at home


http://www.rapidhealing.com.au/images/stories/pdfs/CE7_ReversalofDPN_Powelletal.pdf

http://www.rapidhealing.com.au/images/stories/pdfs/CE7_ReversalofDPN_Powelletal.pdf

Reduced Diabetic Ulcer Incidence


79.5% reduction in diabetic ulcer incidence in senior DPN patients

Reduced Non-Healing Wounds (Diabetic Ulcers)


100% reduction in non-healing wounds – previous studies show < 33% of diabetic ulcers heal within 20 weeks

Improved Sensitivity in Patients with Peripheral Neuropathy

"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."

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.– Number of subjects: 1047 (790 DPN; 257 PNO)– Protocol: statistical chart review across 5 clinical sites – Mean number of treatments = 18; mean

treatment time = 31 minutes


http://www.rapidhealing.com.au/images/stories/pdfs/CE8_ImprovedSensitivity_DeLellisetal.pdf

http://www.rapidhealing.com.au/images/stories/pdfs/CE8_ImprovedSensitivity_DeLellisetal.pdf



366% improvement in sensation to 10 gram monofilament



Mean sites sensate to 5.07 SWM

Pain Reduction (VAS Scale)


Gait and Balance Improvement (Tinetti Scores)


Mod

Low>24

<19HighFallRisk

Additional Published Peer-Reviewed Studies

• 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.

• 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.

• 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.

• 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.

• 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.


Other Published Studies

• 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.

• 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.

• 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.


Presentations at Medical Symposia

• 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.

• 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.

• 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), 17th Annual Advances in Skin and Wound Care, September 21-24, 2002, Dallas, TX.

• 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.

• 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.

• 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.

• 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.

• 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, 18th Annual Symposium on Advanced Wound Care, April 2005, San Diego, CA.


Published Abstracts, Guides & Reviews

• Improved Sensory Perception in Diabetics, American Diabetes Association June 2001 Annual Meeting -Abstract # 1798-PO.

• 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.

• Guidelines for Management of Wounds in Patients with Lower-Extremity Neuropathic Disease, Wound, Ostomy, and Continence Nurses Society (WOCN) Clinical Practice Guideline Series, 2004.

• 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.

• Monochromatic Infrared Photo Energy and DPN, Neil Goldberg, MD, Diabetic Microvascular Complications Today, March/April 2005.

• 5 Questions — and Answers — About MIRE Treatment, Thomas J. Burke, PhD, Advances in Skin & Wound Care, 2003; 16(7): 369-371.


Outcomes After 90 Days of MIRE™ Use 90 Day Study - Conducted at Joslin Diabetes Center


Side Effects During Treatment

• Hypoglycemia in diabetic patients– Increased blood flow to tissue (drops off sugar)– Increased activity levels– Reduced pain reduces stress (stress raises blood sugar)– Resolution of wounds/infections reduces stress (infections raise

blood sugar)• Increased pain, tingling, burning– A great sign treatment is working– Slow it down (lower energy dial)– Shorten treatments– Move up further on leg (to ensure blood flow moving out of

extremity)


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