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Study Summaries

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.


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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.

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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.

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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.


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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

Decreased Pain 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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Anodyne Therapy is infrared light therapy device, FDA Cleared to reduce pain, stiffness and muscle spasm and increase local circulation.

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