Pain Study #1
|
| Journal: |
Diabetes Care, Volume 27(1), January 2004 |
| Study Site(s): |
Joslin Center for Diabetes at Morton Plant Hospital USA |
| Number of Subjects: |
27 |
| Study Design: |
Prospective, Randomized, Double Blind, Placebo Controlled |
| Protocol Used: |
All subjects in the study had chronic pain and/or circulatory deficiency in the 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 delivered in the manner specified in the study protocol resulted in a significant reduction in pain. |
Pain Study #2
|
| Journal: |
Diabetes and Its Complications, Volume 20(2),2006 |
| Study Site(s): |
Multiple Sites in USA |
| Number of Subjects: |
2239 |
| Study Design: |
Multiple Site Retrospective Chart Review based on Prospective, Repeated Measures Analysis |
| Protocol Used: |
All subjects in the study had chronic pain and/or circulatory deficiency. 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 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) USA |
| Number of Subjects: |
272 |
| Study Design: |
This was a retrospective Chart Review in 7 facilities and was based on Prospective, Repeated Measures Analysis. |
| Protocol Used: |
All subjects in the study had chronic pain and/or circulatory deficiency. 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) |
|
Patients: |
272 |
|
|
|
Male: |
135 |
|
|
|
Female: |
137 |
|
|
|
Age (a): |
69 ± 12.3 |
|
|
|
Mean Number of Treatments: |
18 ± 10.2 |
|
|
|
Treatment Time (in minutes): |
34.2 ± 9.4 |
|
|
|
Pain Pre and Post Treatment
|
|
|
All Patients (Pain > 4) (n = 257) |
Horrible to Excruciating Pain (VAS 8.5-10) (n = 37) |
Distressing Pain (VAS 6.5-8) (n = 189) |
Discomforting Pain (VAS 4-6) (n = 31) |
|
VAS Pre-Treatment |
7.7 ± 1.2 |
9.4 ± 0.5 |
7.8 ± 0.4 |
5.3 ± 0.9 |
|
VAS Post-Treatment |
4.8(a) ± 2.2 |
4.8(a) ± 2.7 |
5.0(a) ± 1.9 |
3.5(a) ± 2.5 |
|
VAS Decreases |
2.9 ± 2.2 |
4.6 ± 2.9 |
2.8 ± 1.9 |
1.8 ± 2.4 |
|
% Pain Reduction |
38% |
49% |
36% |
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 pain. |
Pain Study #4
|
| Journal: |
Age and Ageing, Volume 35(1), 2006 |
| Study Site(s): |
Multiple Sites in USA |
| Number of Subjects: |
252 |
| Study Design: |
Retrospective Chart Review and Patient Questionnaire |
| Protocol Used: |
All subjects in the study had chronic pain and/or circulatory deficiency in the extremities. The initial therapy intervention included Anodyne Therapy 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> |
| Average 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 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 in USA |
| Number of Subjects: |
493 |
| 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 and/or circulatory deficiency. 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% and 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!
|
|
Pain Medications:
|
None |
Decreased |
No Change |
Changed |
|
|
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 Treatments (a) |
15 ± 9.2 |
15 ± 8.2 |
16 ± 9.1 |
19 ± 8.9 |
|
Initial Pain (a) |
6.7 ± 2.4 |
7.2 ± 1.9 |
6.7 ± 2.3 |
7.3 ± 1.9 |
|
Post Pain (a) |
2.4 ± 2.2(b) |
2.5 ± 2.2(b) |
2.6 ± 2.0(b) |
2.6 ± 1.9(b) |
|
Mean Pain Decrease (a) |
4.3 ± 2.5(b) |
4.7 ± 2.1(b) |
4.2 ± 2.3(b) |
4.7 ± 2.4(b) |
|
% Pain Reduction |
64.2% |
65.3% |
62.3% |
64.4% |
|
(a) = mean ± SD. (b) = P<0.0001 vs. initial pain. Changed Pain Medications indicates either a different dose or a different medication, or both. Decreased Pain Medications 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 pain relieve and the pain-relieving effects of Anodyne Therapy/MIRE appear to be independent of pain medication use. |
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Research 
