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Throughout these studies, the term MIRE is also referenced. This term represents the words Monochromatic Infrared Energy and is a trademark of Anodyne Therapy technology specifically.

Pain Study #1

Journal:

Diabetes Care, Volume 27(1), January 2004

Study Site(s):

Joslin Center for Diabetes at Morton Plant Hospital

Number of Subjects:

27 (All Diabetic)

Study Design:

Prospective, Randomized, Double Blind, Placebo Controlled

Protocol Used:

All subjects in the study had chronic pain in the lower extremities. Subjects initially received treatment with active therapy pads on one limb and sham pads on the other limb 3 times per week for 40 minutes each vist for 2 weeks (6 treatments). This was followed by six active treatments of the same duration administered to both limbs duing the following 2 weeks.

Pain Endpoint:

Numeric Visual Analog Scale from 0 - 10 (10 being the worst pain)

Results :

Group	VAS Baseline	After 6 MIRE Treatments	After12 MIRE Treatments	P Value
1 (N=18)	4.2 + 2.3	3.2 + 1.9	2.3 + 1.7	<0.0001
2* (N=9)	4.2 + 3.9	2.6 + 2.3	2.0 + 2.3	NS
* Patients more impaired

Conclusion:

The results of the study demonstrate that treatments with near-infrared photo energy, MIRE delivered in the manner specified in the study protocol resulted in a significant reduction in lower extremity pain.

Pain Study #2

Journal:

Diabetes and Its Complications, Volume 20(2),2006

Study Site(s):

Multiple Site

Number of Subjects:

2239 (1395 Diabetic; 844 Non-Diabetic)

Study Design:

Multiple Site Retrospective Chart Review based on Prospective, Repeated Measures Analysis

Protocol Used:

All subjects in the study had chronic pain in the lower extermities. The average treatment protocol was 3 x per week for 30-45 minutes for 5 weeks and included physical therapy interventions such as therapeutic exercise, neuromuscular re-education and/or gait training.

Pain Endpoint:

Numeric Visual Analog scale from 0 - 10 (10 being the worst pain)

Results :

Patients Reporting Significant Pain Pre and Post Treatment

Pre	Post	# Improved	% Improved
1563	33	1530	98%

Changes in Pain on 11 point VAS (0-10; 10 being the worst pain)

Pre	Post	# Points Improved	P-Value	% Improved
7.2 ± 2.2	2.4 ±2.1	4.8 ± 2.4	<0.0001	67%

Conclusion:

MIRE™ treatments are associated with a reduction in pain, even in patients with lower extremity pain levels between 8-10 on a 0-10 point scale.

Pain Study #3

Journal:

Physical and Occupational Therapy in Geriatrics, Volume 24(2), 2006

Study Site(s):

Genesis Medical Center (Davenport, IA), Premier PT (Evergreen Park, IL, Orland Park, IL and Hinsdale, IL), Westside Retirement Village (Indianapolis, IN), Sonoma Valley Hospital (Sonoma, CA), Helmwood Healthcare (Elizabethtown, KY)

Number of Subjects:

272 (128 Diabetic, 144 Non-Diabetic)

Study Design:

This was a retrospective Chart Review in seven facilities and was based on Prospective, Repeated Measures Analysis.

Protocol Used:

All subjects in the study had chronic pain in the extremities. The therapy intervention included Anodyne® Therapy for pain and circulation and physical therapy interventions such as therapeutic exercise, neuromuscular re-education and/or gait training 3 x per week for an average of 6 weeks.

Pain Endpoint:

Numeric Visual Analog scale from 0 – 10 (10 being the worst pain)

Results :

Patient Demographics (Pre-Treatment)

	Total
Patients	272
Male	135
Female	137
Agea	69 ± 12.3
Mean Number of Treatments	18 ± 10.2
Treatment Time (in minutes)	34.2 ± 9.4

Pain Pre and Post Treatment Results

All Patients (Pain > 4)	(n = 257)
VAS Pre-Treatment	7.7 ± 1.2
VAS Post-Treatment	4.8a ± 2.2
VAS Decreases	2.9 ± 2.2
% Pain Reduction	38%
Horrible to Excruciating Pain (VAS 8.5-10)	(n = 37)
VAS Pre-Treatment	9.4 ± 0.5
VAS Post-Treatment	4.8a ± 2.7
VAS Decreases	4.6 ± 2.9
% Pain Reduction	49%
Distressing Pain (VAS 6.5-8)	(n = 189)
VAS Pre-Treatment	7.8 ± 0.4
VAS Post-Treatment	5.0a ± 1.9
VAS Decreases	2.8 ± 1.9
% Pain Reduction	36%
Discomforting Pain (VAS 4-6)	(n = 31)
VAS Pre-Treatment	5.3 ± 0.9
VAS Post-Treatment	3.5a ± 2.5
VAS Decreases	1.8 ± 2.4
% Pain Reduction	34%
a = Values expressed as mean ± SD; All post treatment measures are P<0.0001 vs. Pretreatment

Conclusion:

Use of MIRE™ in combination with other physical therapy interventions is associated with reduced lower extremity pain.

Pain Study #4

Journal:

Age and Ageing, Volume 35(1), 2006

Study Site(s):

Multiple Sites

Number of Subjects:

252 (All Diabetic)

Study Design:

Retrospective Chart Review and Patient Questionnaire

Protocol Used:

All subjects in the study had chronic pain in the lower extremities. The initial therapy intervention included Anodyne® Therapy/MIRE™ for pain and circulation and physical therapy interventions such as therapeutic exercise, neuromuscular re-education and/or gait training. Patients then used an Anodyne Therapy System at home for an average of 8 months after the initial treatment in a clinical setting.

Pain Endpoint:

Numeric Visual Analog scale from 0 – 10 (10 being the worst pain)

Results :

Pain Reduction Based on Average Number of Months Using MIRE™

	1-3	3-6	6-9	9-12	12+
# of Patients	36	33	22	94	67
Ave. Months after MIRE Clinical Treatment	1.2	4.0	6.7	10.1	13.3
Mean Age	75	74	76	76	76
Male/Female	23/14	20/13	9/13	44/50	40/27
% of Patients Reporting Reduction in Pain	94%	80%	91%	85%	91%

Conclusion:

The medical records indicated that 220 out of 252 patients (87%, p< 0.0001) obtained substantial reduction in lower extremity pain. When patients have continuing access to MIRE™ in their homes following clinical treatment, there is a significant reduction in pain.

Pain Study #5

Journal):

Practical Pain Management, Volume 7(6), 2007

Study Site(s):

Multiple Sites

Number of Subjects:

493 (248 Diabetic; 245 Non-Diabetic)

Study Design:

Multiple Site Retrospective Chart Review based on Prospective, Repeated Measures Analysis in combination with patient phone survey on prescription pain medication use.

Protocol Used:

All subjects in the study had chronic pain in the lower extremities. The average treatment protocol was 3 x per week for 30 minutes for a mean of 15-19 treatments and included physical therapy interventions such as therapeutic exercise, neuromuscular re-education and/or gait training. After therapy was complete, 493 of 550 patients contacted agreed to provide answers to a health questionnaire.

Pain Endpoint:

Numeric Visual Analog scale from 0 - 10 (10 being the worst pain)

Results :

Mean pain reduction overall was 63.4%. 51.4% of patients who were on pain medications were able to reduce or eliminate their pain medications. Pain response to MIRE is not based on the use of medication.

	No Pain Meds During MIRE	DecreasedPain Meds	No Change in Pain Meds	Changed Pain Meds
	Group 1	Group 2	Group 3	Group 3
# of Patients	129	187	151	26
Male	66	72	63	13
Female	63	115	88	13
Age (Range)	74 (53-94)	72 (44-90)	73 (46-93)	69 (54-94)
Duration of Pain (Months)a	41.5 ± 31.4	49.9 ± 32.9	54.3 ± 35.3	54.7 ± 38.8
Number of Treatmentsa	15 ± 9.2	15 ± 8.2	16 ± 9.1	19 ± 8.9
Initial Paina	6.7 ± 2.4	7.2 ± 1.9	6.7 ± 2.3	7.3 ± 1.9
Post Paina	2.4 ± 2.2b	2.5 ± 2.2b	2.6 ± 2.0b	2.6 ± 1.9b
Mean Pain Decreasea	4.3 ± 2.5b	4.7 ± 2.1b	4.2 ± 2.3b	4.7 ± 2.4b
% Pain Reduction	64.2%	65.3%	62.3%	64.4%

a = mean ± SD. b = P<0.0001 vs. initial pain. Meds = medications.
Changed Pain Meds indicates either a different dose or a different medication, or both.
Decreased Pain Meds indicates either a lowered dosage or a frequency or eliminated use of pain medications.

Conclusion:

MIRE, when administered as part of a physical therapy care plan prescribed by a physician, is associated with substantial lower extremity pain relief and the pain-relieving effects of Anodyne Therapy / MIRE appear to be independent of pain medication use.

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Study Summaries

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