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Improved foot sensitivity and pain, reduction in patients with peripheral neuropathy after treatment with monochromatic infrared photo energy - MIRE


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The medical records of 2239 patients (mean age=73 years) with established peripheral neuropathy (PN) were examined to determine whether treatment with MIRE was, in fact, associated with increased foot sensitivity to the Semmes Weinstein monofilament (SWM) 5.07 and a reduction in neuropathic pain. The PN in 1395 of these patients (62%) was due to diabetes. Prior to treatment with MIRE, of the 10 tested sites (5 on each foot), 7.1+/-2.9 were insensitive to the SWM 5.07, and 2078 patients (93%) exhibited loss of protective sensation defined by Medicare as a loss of sensation at two or more sites on either foot. After treatment, the number of insensate sites on both feet decreased to 2.4+/-2.6, an improvement of 66%. Of the 2078 (93%) patients initially presenting with loss of protective sensation, 1106 (53%) no longer had loss of protective sensation after treatment (P<.0001); 1563 patients (70%) also exhibited neuropathic pain in addition to sensory impairment. Prior to treatment with MIRE, pain measured on the 11-point visual analogue scale (VAS) was 7.2+/-2.2 points, despite the use of a variety of pain-relieving therapeutic agents. After treatment with MIRE, pain was reduced by 4.8+/-2.4 points, a 67% reduction. Therefore, MIRE appears to be associated with significant clinical improvement in foot sensation and, simultaneously, a reduction in neuropathic pain in a large cohort of primarily Medicare aged, community-dwelling patients, initially diagnosed with PN. The quality of life associated with these two outcomes cannot be underappreciated.
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Improved foot sensitivity and pain reduction in patients with
peripheral neuropathy after treatment with monochromatic infrared
photo energy—MIRE
Lawrence B. Harkless
, Salvatore DeLellis
, Dale H. Carnegie
, Thomas J. Burke
Department of Orthopaedics and Podiatry, University of Texas Health Science Center San Antonio, San Antonio, TX 78229, USA
Gulf Coast Foot, Ankle and Wound Center, Tarpon Springs, FL 34689, USA
Podiatric Services, Denver Health Medical Center, Denver, CO 80204, USA
Anodyne Therapy LLC, Tampa, FL 33626, USA
Received 31 January 2005; received in revised form 29 March 2005; accepted 1 June 2005
The medical records of 2239 patients (mean age =73 years) with established peripheral neuropathy (PN) were examined to determine
whether treatment with MIRE was, in fact, associated with increased foot sensitivity to the Semmes Weinstein monofilament (SWM) 5.07
and a reduction in neuropathic pain. The PN in 1395 of these patients (62%) was due to diabetes. Prior to treatment with MIRE, of the
10 tested sites (5 on each foot), 7.1F2.9 were insensitive to the SWM 5.07, and 2078 patients (93%) exhibited loss of protective sensation
defined by Medicare as a loss of sensation at two or more sites on either foot. After treatment, the number of insensate sites on both feet
decreased to 2.4F2.6, an improvement of 66%. Of the 2078 (93%) patients initially presenting with loss of protective sensation, 1106 (53%)
no longer had loss of protective sensation after treatment ( Pb.0001); 1563 patients (70%) also exhibited neuropathic pain in addition to
sensory impairment. Prior to treatment with MIRE, pain measured on the 11-point visual analogue scale (VAS) was 7.2F2.2 points, despite
the use of a variety of pain-relieving therapeutic agents. After treatment with MIRE, pain was reduced by 4.8F2.4 points, a 67% reduction.
Therefore, MIRE appears to be associated with significant clinical improvement in foot sensation and, simultaneously, a reduction in
neuropathic pain in a large cohort of primarily Medicare aged, community-dwelling patients, initially diagnosed with PN. The quality of life
associated with these two outcomes cannot be underappreciated.
D2006 Elsevier Inc. All rights reserved.
Keywords: Diabetic peripheral neuropathy; MIRE; Semmes Weinstein monofilament; Anodyne Therapy System; Monochromatic infrared photo energy
1. Introduction
Disturbance of skin sensation, characterized by pain,
hyperesthesia, hypoesthesia, numbness, and/or tingling, is a
common symptom of peripheral neuropathy (PN ).
Although there are many conditions in which PN is a
comorbid factor, diabetes is the primary cause of PN in the
Western world. Painful manifestations of PN have a
substantial adverse effect on quality of life (Galer, Gianas,
& Jensen, 2000). Foot insensitivity, particularly among
patients with diabetes, is highly correlated with foot
wounds and nontraumatic lower extremity amputations
(LEA); indeed, PN and peripheral vascular disease are the
leading causes of amputations and high mortality rates
among both diabetic and nondiabetic patients (Tentolouris,
Al-Sabbagh, Walker, Boulton, & Jude, 2004). The preva-
lence of PN is extensive. Estimates suggest that 15% of the
population over 40 exhibit this condition, and in those with
diabetes, the rate is 29% (Gregg et al., 2004). Of concern,
although 50% of these patients showed documented
insensitivity to the Semmes Weinstein Monofilament
1056-8727/06/$ – see front matter D2006 Elsevier Inc. All rights reserved.
TCorresponding author. Research and Clinical Affairs, Anodyne
Therapy LLC, 13570 Wright Circle, Tampa, FL 33626, USA. Tel.: +1
303 587 3333; fax: +1 813 342 4417.
E-mail address: (T.J. Burke).
Journal of Diabetes and Its Complications 20 (2006) 81 – 87
(SWM) 5.07 at two or more of six measured plantar sites, a
significant portion were asymptomatic in the sense that
they had not experienced numbness, loss of feeling, painful
sensations, or tingling in their feet. Thus, they did not
recognize the need for foot precautions (Gregg et al., 2004).
Historically, there have been no effective treatments for
improving foot sensation diminished due to PN (Diabetic
Neuropathy, 1995) other than a surgical procedure champ-
ioned by Dellon and others (Dellon, 2004; Wieman & Patel,
1995; Wood & Wood, 2003). However, not all patients are
acceptable candidates for this surgical procedure. With this
in mind, healthcare professionals vigorously encourage
lower extremity ulcer (LEU) risk-reduction strategies that
currently include patient education, frequent visits to their
physicians, orthotics for off-loading, and accommodative
foot wear. However, despite these strategies, the incidence
of LEU remains at over 8% in patients with PN and loss of
protective sensation (Armstrong et al., 2004). Additionally,
diabetic patients with sensory loss who were assigned to
therapeutic shoes do not have a significantly lower risk of
reulceration compared with controls (Reiber et al., 2002).
Because chronic neuropathic pain is also a long-term
complication of diabetic PN (Ziegler, 2004) and other
neuropathies and has a negative impact on quality of life
(Galer et al., 2000), significant research has been devoted to
therapeutic options for this condition. Unfortunately, avail-
able pharmacological and other treatments for neuropathic
pain have not been totally efficacious (Davies, Crombie,
Lonsdale, & Macrae, 1991). Clearly, neuropathic pain is a
source of frustration to affected patients and the physicians
who deal with this condition on an ongoing basis.
Several recent studies (DeLellis, Carnegie, & Burke,
2005; Kochman, 2004; Kochman, Carnegie, & Burke, 2002;
Leonard, Farooqi, & Myers, 2004; Powell, Carnegie, &
Burke, 2004; Prendergast, Miranda, & Sanchez, 2004) show
that, at least, temporary increases in foot sensitivity,
documented using either the SWM 5.07 or the Neurometer
CPT sNCT, occur following the application of monochro-
matic near infrared photo energy (MIRE) to the feet of
symptomatic diabetic patients with impaired foot sensation
associated with PN. Another study showed that improve-
ment in foot sensation resulting from MIRE treatments was
associated with a substantial reduction in the incidence of
new LEU among a Medicare aged population (Powell et al.,
2004). Moreover, we recently reported improved foot
sensation after MIRE in 1047 patients (790 with diabetes)
for whom sensory data had been collected in the routine
course of medical treatment (DeLellis et al., 2005).
The present results demonstrate improved foot sensation
as well as a reduction in neuropathic pain after MIRE
treatments in 2239 community-dwelling patients with PN
(1395; 62% with diabetes). The improvements in foot
sensitivity to the SWM 5.07 also compare favorably with
those we reported previously (DeLellis et al., 2005).
2. Research and design methods
The insurance claims of a durable medical equipment
supplier (DME) offering Anodyne Therapy System (ATS;
Anodyne Therapy, Tampa, FL), an item of durable medical
equipment delivering MIRE, were reviewed to obtain a list
of patients who had been treated with MIRE in physicians’
Table 1
Patient demographics
Number Percent (%)
Patients with peripheral neuropathy 2239
Male 1069 48
Female 1170 52
Diabetic 1395 62
Nondiabetic 844 38
Mean ageF1 S.D. 73F8.4 (range 29 –100)
Mean number of sites insensate (10 maximum) 7.1F2.9
Table 2
Foot insensitivity to the SWM 5.07 pre- and posttreatment
Current study
Prior study
et al., 2005)
Total number of patients 2239 1047
Pretreatment sites
insensate (max 10)
Posttreatment sites insensate 2.4F2.6T2.3F2.4T
Mean decrease sites insensate 4.7F2.8T5.6F2.7T
Pretreatment patients with LOPS 2078 93% 1033 99.6%
Posttreatment patients regaining
protective sensation
1106 53% 580 56.1%
Posttreatment total number of
patients with LOPS
972 47% 453 43.9%
Pretreatment number of patients
with all 10 sites insensate
770 34% 452 43%
Posttreatment sites insensate 3.8F3.0T3.1F2.7T
Mean decrease sites insensate 6.2F3.0T6.9F2.7T
LOPS: loss of protective sensation.
Fig. 1. Number of patients with insensate sites before (gray bars) and after
(black bars) MIRE treatment.
L.B. Harkless et al. / Journal of Diabetes and Its Complications 20 (2006) 81 – 8782
offices and therapy clinics throughout the United States. The
ATS delivers MIRE through therapy pads, each containing
60 superluminous diodes (890 nm near-infrared wave-
length), which are attached to a control unit, which pulses
the MIRE at 292 times/s (Burke, 2003). The ATS was
cleared by the FDA for use in increasing circulation and
reducing pain. Prior to providing the ATS to patients for use
at home, the supplier had obtained signed physician orders
and therapists’ clinical notes that documented the results of
MIRE treatment in a clinical setting. Collectively, the data
supported a diagnosis of PN in all patients; and, in all
instances, the clinical notes included SWM evaluations of
foot sensitivity both immediately before and shortly after a
course of treatment with MIRE. Additionally, the physician
orders and clinical notes also provided data regarding the
severity of neuropathic pain prior to and after MIRE
treatments. Charts specified the pre- and posttreatment pain
on an 11-point visual analogue scale (VAS).
We used a searchable database containing a record of all
claims filed, including ICD-9 coding of the underlying
conditions for which the ATS had been ordered by referring
physicians. The database, excluding any patient identifiers,
was sorted by the DME supplier to obtain a list of all
patients who had a diagnosis of PN based on ICD-9 code
357 or 782. The list was then stratified to obtain a list of
those with Type 1 or 2 diabetes using ICD-9 codes 250.61
and 250.62, respectively. The period of inquiry was January
26, 2004, to November 30, 2004. In total, 2812 patients
satisfied these criteria. Most patient records contained
bilateral foot sensitivity data for the SWM 5.07 (at 10 sites;
5 on each foot) before and after MIRE treatment. Although
all records contained data relative to improvement in foot
sensation, some were not included in this analysis because
(1) the SWM measurements were done at less than or more
than 10 sites bilaterally, (2) the healthcare professionals used
SWM other than the 5.07 SWM, or (3) they documented
changes with other sensory testing devices, including the
Pressure Specified Sensory Device (PSSD) or the Neuro-
meter sNCT. Thus, 2239 patient records fulfilled the criteria
for analysis in this report.
2.1. Statistics
The results were analyzed by paired two-tailed ttest with
a null hypothesis that there would be no change in
sensitivity to the SWM 5.07 or neuropathic pain (either an
increase or a decrease) following the use of MIRE.
Significance was accepted if Pb.05. Data are expressed as
meanF1 S.D.
3. Results
The mean age of the study population (1069 male; 48%)
was 73F8.4 years (range: 29–100; Table 1). One thousand
three-hundred ninety-five patients (62%) were diagnosed
with diabetic PN, and 844 patients were diagnosed with PN
associated with other etiologies (PNO). The mean number
of sites insensitive to the SWM 5.07 (bilaterally; maximum
10 sites for both feet) was 7.1F2.9 before treatment and
2.4F2.6 after treatment ( Pb.0001), an improvement of 66%
in foot sensation (Table 2). Prior to treatment, 2078 patients
(93%) exhibited loss of protective sensation as determined
by foot insensitivity to the SWM 5.07 at two or more sites
on either foot. At the conclusion of the MIRE treatments in
the clinic, 53% of these patients no longer exhibited loss of
protective sensation ( Pb.0001; Table 2).
Fig. 1 shows the number of insensate sites pre- and
posttreatment in this group of patients. Prior to treatment
with MIRE, most of the patients exhibited a loss sensation at
8 to 10 sites, and 73% of all patients had documented loss of
sensation at 6 or more sites. After treatment, more than 60%
of the patients were insensate at two sites or less, and more
than 79% were insensate at four sites or less. The change in
the distribution pattern of insensitivity to the SWM 5.07
graphically demonstrates the significance of the MIRE
treatment effect in elderly outpatients with PN.
We also examined the data to determine whether there
was a difference in the sensory responsiveness to MIRE in
patients with diabetic PN as compared with those with PNO
(Table 3). Both diabetic PN and PNO patients were similarly
impaired prior to receiving MIRE treatment, and each group
achieved the same clinical improvement in sensation
We compared the foot sensitivity data that we previously
collected reported on 1047 patients (DeLellis et al., 2005)
with PN to determine the degree of correlation between the
Table 3
Foot insensitivity to the SWM 5.07 pre and posttreatment (diabetic patients compared with nondiabetic patients)
Current study Prior study (DeLellis et al., 2005)
Pre Post Improvement Pvalue Pre Post Improvement Pvalue
All patients 7.2F2.9 2.4F2.6 4.7F2.8 b.0001 7.9F2.4 2.3F2.4 5.6F2.6 b.0001
Diabetics 7.3F2.8 2.5F2.6 4.8F2.8 b.0001 8.0F2.4 2.4F2.4 5.6F2.7 b.0001
Nondiabetics 7.0F3.1 2.3F2.6 4.6F2.8 b.0001 7.9F2.4 2.3F2.4 5.5F2.6 b.0001
The correlation of the improvement between both studies is .98186.
Table 4
Patients reporting significant pain pre- and posttreatment
Pre Post Improvement Percent improvement (%)
All patients 1563 33 1530 98
Diabetic 979 23 956 98
Nondiabetic 584 10 574 98
L.B. Harkless et al. / Journal of Diabetes and Its Complications 20 (2006) 81 – 87 83
results of that study and of the present study. The correlation
of the sensory improvement values between the two studies
was .98186; clearly, the results of the two studies are
virtually identical (Tables 2 and 3).
Interestingly, although the patients exhibited severe
sensory impairment as measured by the SWM 5.07
(mean=7.1F2.9 of 10 sites insensitive), 1563 patients or
70% also exhibited neuropathic pain (Table 4). Physician
notes (verified by analysis of clinical records) showed that
98% of patients initially reporting neuropathic pain obtained
substantial reduction in their pain after treatment. Mean pain
as reported on the 10-point VAS was 7.2F2.2 immediately
prior to MIRE treatment. After MIRE treatment, the mean
pain level was reported to be 2.4F2.1, a mean reduction of
4.8 points, or 67% (Table 5). From a descriptive standpoint,
the mean pain level was reduced from bdistressing Qto
bmild.QAs is the case for changes in foot sensitivity after
MIRE (Table 2), there was no significant difference between
the initial level of pain or in pain reduction between the
diabetic PN and PNO patients (Table 5).
The clinical records of the patients with PNO were quite
detailed and showed that the pretreatment pain continued to
be a complaint of these patients despite the fact that more
than 62% were taking one or more prescription medications
(anticonvulsants, antidepressants, and/or opiates) in an
unsuccessful effort to reduce their neuropathic pain. Of
the remaining patients, 13% had continued to experience
significant levels of neuropathic pain despite the use of
topical analgesics (e.g., capsaicin cream, Lidocaine patches,
and Biofreeze), physical therapy, nerve blocks, and over-
the-counter pain medications. Additionally, the duration of
the PNO was significant, with a mean duration of 70 months
(range, 0.5 to 1020 months; Table 6).
Fig. 2 shows the 11-point VAS reported pre- and
posttreatment in this group of patients. After treatment with
MIRE, more than half of the patients initially reporting high
degrees of neuropathic pain reported pain levels of two or
less. Additionally, 30% of patients initially reporting pain
reported no pain at all after MIRE treatments. The change in
the distribution pattern of pain intensity graphically dem-
onstrates the significance of the MIRE treatment effect in
this patient population.
4. Discussion
Until recently, sensory impairments associated with PN,
particularly due to diabetes, were thought to be progressive
and irreversible. Several groups have employed a surgical
technique, tarsal tunnel decompression surgery, with very
favorable outcomes in selected patients with neuropathy
(Dellon, 2004; Wieman & Patel, 1995; Wood & Wood,
2003). The present results confirm a recent report in a
similarly large group of patients (1047) that improvement
can occur in a very real world study population (i.e.,
community-dwelling patients with PN) treated in routine
clinical practice with MIRE (DeLellis et al., 2005). These
data support other published studies relative to the
effectiveness of MIRE treatments for PN (Kochman,
2004; Kochman, Carnegie, & Burke, 2002; Leonard et al.,
2004; Prendergast et al., 2004; Powell et al., 2004).
More than half of the patients who were initially
diagnosed with loss of protective sensation (53%) obtained
at least a temporary return of protective sensation, which
compares favorably with the results that we reported
previously in 1047 patients (56%; DeLellis et al., 2005).
Even those patients with the most severe sensory dysfunc-
tion (all 10 sites insensitive to the SWM 5.07) obtained
significant sensory improvement (6.2F3.0 sites were sensed
after MIRE). Again, this result compares favorably with
previous results that demonstrated 6.9F2.7 sites sensed after
Table 6
Descriptive characteristics of nondiabetic patients
Total 844
Duration (months) mean=70;
range, 0.5 to
Idiopathic neuropathy 558 (66%)
Inflammatory and toxic neuropathies 36 (4%)
Mononeuritis 65 (8%)
All other 185 (22%)
Total reporting ineffective prescription drugs
521 (83%)
Total reporting ineffective other treatments
110 (17%)
One or more antidepressants, anticonvulsants, opioids.
More than one of the following: topical analgesics, over-the-counter
analgesics, physical therapy, and nerve block injections.
Fig. 2. Number of patients with pain levels on VAS scale before (gray bars)
and after (black bars) MIRE treatment.
Table 5
Changes in pain on the 11-point VAS
Pre Post Improvement Pvalue
All patients 7.2F2.2 2.4F2.1 4.8F2.4 b.0001 67
Diabetic 7.1F2.2 2.4F2.2 4.7F2.5 b.0001 66
Nondiabetic 7.3F2.1 2.5F2.1 4.8F2.3 b.0001 66
L.B. Harkless et al. / Journal of Diabetes and Its Complications 20 (2006) 81 – 8784
MIRE in patients who were initially totally insensate to the
SWM 5.07 (DeLellis et al., 2005). This result occurred
irrespective of the etiology of the PN because there was no
significant difference in the response of the patients with
diabetic PN as compared with those with PNO. Thus, the
results of this analysis demonstrate that sensory loss
associated with PN, even when it has advanced to and
beyond simply the loss of protective sensation, is not
necessarily irreversible.
These data also demonstrate that neuropathic pain is
closely associated with impaired sensation to the SWM 5.07
because 70% of the patients exhibited both manifestations
of PN. Ninety-eight percent of patients reported having a
bsignificant reduction in painQafter MIRE, as verified
through the review of the clinical notes. We know of no
other intervention that is as successful for patients with PN.
Of importance, the etiology of the PN was not a
determining factor of whether the patients responded to
treatment. There was no significant difference in the response
of the diabetic PN and PNO patients, either in terms of pain
reduction or increased sensation to the SWM 5.07. The
clinical history for the PNO patients showed that the mean
duration of their pain was 70 months and that, prior to
treatment with MIRE, 62% of the patients continued to
exhibit clinically significant symptomatic pain despite taking
anticonvulsants, antidepressants, and/or opiate analgesics.
These data on the relative ineffectiveness of medications for
neuropathic pain are not surprising because a recent survey
of physicians, experienced in treating neuropathic pain,
noted that only a minority would rate the results of these
medications as either excellent or good (Davies et al., 1991).
These observations and the conclusions derived must be
analyzed in the context of certain limitations in our design.
For example, there was no control group against which the
results of this study were measured. However, when a
disease such as diabetic PN is known to be progressive and
irreversible, use of historical controls from published
literature may be appropriate (Sima & Laudadio, 1996). In
the case of diabetic PN, there have been no reports of either
spontaneous reversal of this condition or efficacy of
any nonsurgical intervention (Diabetic Neuropathy, 1995;
Prendergast et al., 2004). In fact, two published randomized
control trials have shown that 4 weeks of either thrice or
biweekly sham photo energy treatment did not result in any
improvement in the ability to detect the SWM 5.07 by
patients with diabetic PN (Leonard et al., 2004; Zinman et al.,
2004). Additionally, the present data were obtained from the
records of patients who all exhibited some improvement in
their neuropathic symptoms. Therefore, although we cannot
generalize these results to all patients with PN, we can
conclude that these 2239 patients, similarly to the 1047
patients on whom we reported previously, obtained objective
improvement in foot sensation to the SWM 5.07 after
treatment with MIRE.
Furthermore, we confirm that insensitivity to the SWM
5.07 is often associated with neuropathic pain, and in the
group of patients that were treated with MIRE, improved
foot sensation resulting from MIRE treatment was paral-
leled by significant reductions in neuropathic pain.
Importantly, in the PNO patients, significant pain reduc-
tions were apparent despite a long history of chronic pain
unrelieved by conventional prescription or OTC medica-
tions and other interventions.
We cannot totally discount physician or therapist bias,
because the SWM 5.07, while broadly accepted and
objective, is only a patient-blinded test. Additionally, all of
the patients knew that they were receiving active treatment.
However, it is exceedingly unlikely that the more than 1000
evaluators in testing more than 2239 patients systematically
misinterpreted the sensitivity to the SWM before and after
MIRE treatment. Similarly, the effectiveness of MIRE
treatments in improving sensitivity to the SWM 5.07, as
reported in a recent double-blinded, placebo-controlled
RCT, lessens the likelihood that the present results were
due to evaluator bias (Leonard et al., 2004). Other testing
modalities, namely, PSSD (Aszmann & Dellon, 1998) and
the Neurometer (Pitei, Watkins, Stevens, & Edmonds, 1994),
are currently being used to detect discrete changes in skin
sensation impaired due to PN that cannot be determined with
the SWM 5.07. Nevertheless, the SWM 5.07 is the most
commonly used test to determine loss of protective sensation
resulting from PN. It is highly sensitive (between 85%
and 100%) and specific (between 34% and 100%) based on
the number of sites tested and the testing methodology
(Mayfield & Sugarman, 2000). Additionally, SWM data have
been correlated with abnormal nerve conduction velocity
outcomes, especially with more severe nerve impairment
(Perkins, Olaleye, Zinman, & Brill, 2001). Like all tests in
which the patient is an active participant, the accuracy of the
SWM is dependent upon communication from an alert,
cooperative, and responsive patient (Mayfield & Sugarman,
2000). To maximize the validity of the test results, those
performing the SWM tests were given case report forms
adapted from Feet Can Last a Lifetime (Feet Can Last a
Lifetime, 2005). This document recommends measuring five
sites on the plantar surface of the foot and the use of a bforced
two choice testing method,Qwhich minimizes patient bias
(Sekuler, Nash, & Armstrong, 1973). Finally, the technique
also involves random testing sites on the feet and avoids
heavily callused or active wound sites.
It is obvious that changes in pain are difficult to
objectively measure and are subject possibly to placebo
effect. The 11-point VAS has been widely validated
(Flandry, Hunt, Terry, & Hughston, 1991) and is not subject
to evaluator bias because it is reported by the patient. The
extent of the reduction in reported pain by the patients in
this study (67%) substantially exceeds the reported minimal
level of detectable change (1.3 to 1.6 points on the VAS),
which is considered clinically relevant (Gallagher, Bijur,
Latimer, & Silver, 2002). Moreover, the VAS pain reduction
exceeded 3.0, which has been reported to be a clinically
important difference in pain severity corresponding to
L.B. Harkless et al. / Journal of Diabetes and Its Complications 20 (2006) 81 – 87 85
patient’s perception of adequate analgesic control (Lee,
Hobden, Stiell & Wells, 2003). Zinman et al. (2004)
examined the placebo effect of 12 sham treatments with
low-intensity laser therapy delivered over 6 weeks and
noted an approximately 20% reduction in pain (6.9F1.7 to
5.4F1.9). The patients in the present study had a similar
level of initial pain (7.2F2.2), but they reported more than
three times the pain relief (67%) reported by the sham
treated patients in the Zinman et al. study, making it very
unlikely that the present results are due to a placebo effect.
Lastly, the large number of patients (1563) with neuropathic
pain whose pain decreased in this study would also tend to
discount a placebo effect.
5. Conclusion
MIRE treatments are associated with a substantially
improved foot sensation, assessed by the SWM 5.07, and a
robust reduction in neuropathic pain that had been previously
unresponsive to other interventions (both Pb.0001) in a
cohort of 2239 patients initially diagnosed with PN. The
improvements in foot sensation to the SWM 5.07 are
remarkably similar (correlation=.98186) to our previous
analysis of 1047 patients (DeLellis et al., 2005). Overall,
the magnitude and consistency of these results and those
from other studies using MIRE (Kochman, 2004; Kochman
et al., 2002; Leonard et al., 2004; Prendergast et al., 2004;
Powell et al., 2004) show that sensory disturbances
associated with PN are not necessarily progressive and
irreversible and that this condition can be effectively treated
noninvasively with a high degree of patient safety.
This reported advancement in the treatment of sensory
disturbances associated with PN has enormous potential to
affect health care in other ways. For example, it would seem
likely that a secondary outcome after the restoration of
sensation would be a reduction in the incidence of LEU,
consequent amputations, and high morbidity, particularly
among patients with diabetic PN. One study reported a 1.5%
annual incidence of LEU after symptomatic improvement in
foot sensation to the SWM 5.07 through the use of MIRE
(Powell et al., 2004). This represents more than an 80%
reduction in the 35-week incidence rate (8%) recently
reported by Armstrong et al. (2004) in patients with diabetic
PN who had been prescribed accommodative footwear and
were under the ongoing care of physicians. Additionally, at
least where MIRE is used in conjunction with appropriate
physical therapy, there is a significant improvement in
balance and a substantial reduction in the number of falls
in elderly patients (Kochman, 2004). The improved sen-
sation during MIRE in patients who have a significant fall
history may allow physical therapy interventions to be more
effective. Because of the high reported costs of PN and
its devastating sequelae (Gordois, Scuffham, Shearer,
Oglesby, & Tobian, 2003; Harrington, Zagari, Corea, &
Klitenic, 2000; Hogan, Dall, & Nikolov, 2003; Shearer,
Scuffham, Gordois, & Oglesby, 2003), the use of MIRE in
patients can be expected to improve their quality of life and
simultaneously offer significant cost savings to the U.S. and
international healthcare systems.
We extend our appreciation to the more than 1000
physicians and therapists who first documented PN in their
patients and carefully recorded clinical changes in foot
sensation and pain after treatment with MIRE. In addition,
we extend our appreciation to the staff of the supplier who
worked with us to access their database and identify the
applicable patient records. We also thank Amy Spirides for
her assistance with the statistics and figures.
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... [10][11][12][13][14] Therefore, various adjunctive therapies including monochromatic infrared energy (MIRE) have been used for DPN. [15,16] Few initial studies demonstrated a significant decrease in neuropathic pain [17,18] and improvement in tactile sensitivity with MIRE therapy, [17][18][19] while others have not shown change in symptom scores [20,21] or plantar sensitivity. [22] However, most studies with MIRE therapy had methodological limitations as they were retrospective, lacked a control group, treatment was not supervised, and were of short duration (2-4 weeks). ...
... [10][11][12][13][14] Therefore, various adjunctive therapies including monochromatic infrared energy (MIRE) have been used for DPN. [15,16] Few initial studies demonstrated a significant decrease in neuropathic pain [17,18] and improvement in tactile sensitivity with MIRE therapy, [17][18][19] while others have not shown change in symptom scores [20,21] or plantar sensitivity. [22] However, most studies with MIRE therapy had methodological limitations as they were retrospective, lacked a control group, treatment was not supervised, and were of short duration (2-4 weeks). ...
... There was a decrease in VAS score by 3.1 (2.6-5.8) points and 2.4 (0.6-2.7) points, (intergroup difference, P = 0.01) at 2 months and 5.1 (4-7.6) points and 3 (0.4-5.6) points (intergroup difference, P = 0.04) at the end of 3 months in the MIRE and sham cohort, respectively. The median Norfolk QOL-DN scores were 24 (17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27) and 23 (13.5-25), P = 0.48 at baseline and 8 (6-12) and 12 (8.2-21), ...
Monochromatic infrared energy (MIRE) has evoked mixed results for symptomatic relief of painful diabetic peripheral neuropathy (DPN). However, intraepidermal nerve-fiber density (IENFD) the gold standard for small-fiber neuropathy has not been evaluated. Objective: We assessed the IENFD, pain symptoms and quality of life (QoL) with MIRE therapy compared to placebo in painful DPN. Material and Methods: Participants with type 2 diabetes and painful DPN were randomized to receive MIRE or sham therapy dosed thrice a week for 12 weeks. Quantitative assessment of IENFD was performed from 3 mm skin punch-biopsy specimens at baseline and after 12 weeks. We also assessed the QoL with Norfolk QOL, symptom severity with visual analogue scale (VAS), and neuropathy assessment with Michigan neuropathy severity instrument and neuropathy disability score. Results: Thirty-eight participants were enrolled and 30 completed the study protocol. The mean age of participants in MIRE cohort was 59.1 ± 9.2 years, duration of diabetes 12.9 ± 3.1 years, and symptom duration of 3.9 ± 3.7 months. The mean IENFD was 0.90 ± 0.73/mm2 (P < 0.01) and 1.71 ± 1.11/mm2 in the MIRE cohort and 0.60 ± 0.89/mm2 and 2.17 ± 0.98/mm2 (P < 0.01) in sham cohort at baseline and after 3 months. The median decline in VAS was 5.1 (4.0-7.6) and 3.0 (0.4-5.6) points (intergroup difference, P = 0.01); and an increase in Norfolk QoL-DN by 15 (11-18) and 4 (4-14.2) points (intergroup difference, P = 0.021) in MIRE and sham cohort, respectively after 3 months. Conclusions: MIRE therapy does not increase IENFD over short-term usage. However, MIRE therapy provides symptomatic benefit and improves QoL in patients with painful DPN.
... In older adults, significant improvements in foot sensation are noted with monochromatic infrared energy (MIRE), which in turn helps in balance improvement 18 . This is infrared energy delivered with aluminum, arsenide, and gallium diodes kept inside flexible pads with a wavelength of about 890 nm. ...
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Objective: This study aimed to evaluate the efficacy of a combination of MIRE exposure and Tai Chi exercise on balance and fall risk in community-dwelling older adults with lower-extremity disease (LED). Patients and methods: In this double-blinded randomized controlled study, 49 older adults were randomly allocated into the MIRE group (n=25), in which the participants were exposed to 30 min of MIRE and performed 40-45 min of Tai Chi exercise, three sessions/week; and the sham group (n=24), in which the participants only performed the Tai Chi exercise. We measured the ankle/brachial index (ABI), as well as scores of the Berg balance scale (BBS), Tinetti clinical scale (TCS), and Timed Up and Go Test (TUG) before and after 3-months of intervention. Results: A significant increase in ABI and scores of BBS, and TCS, was observed, along with a significant decrease in TUG scores in the MIRE group. The sham group showed a significant increase in the ABI, and TCS score, and a significant decrease in the TUG score, with a non-significant change in the BBS score. Comparison between both study groups illustrated that the patients in the MIRE group experienced improved balance and decreased fall risk. Conclusions: Three months of MIRE exposure and Tai Chi exercise improved balance and reduced the risk of falls in community-dwelling older adults with LEDs.
... Clifft in 2005 also reported in a double-blind study that infrared radiation could have a significant effect on improving the sensation of patients with diabetic neuropathy. Some other studies have also described the effect of infrared radiation on sensory restoration(DeLellis, Carnegie & Burke, 2005;Harkless et al., 2006;Powell, Carnegie & Burke, 2004). ...
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Background: Infrared radiation therapy and the use of aloe Vera have been independently suggested to enhance diabetic sensory neuropathy and diabetic foot ulcer. The current case study aimed at investigating the application of aloe Vera gel after the infrared radiation therapy on a diabetic foot ulcer. Case Description: The participant was a 62 year old male patient with a 10 year history of type 2 diabetes and 5 ulcers on both plantar parts of the feet (three ulcers on the left foot, and two on the right foot). The ulcers were graded 1 on Wagner Ulcer Classification. Initially, blood perfusion on both legs was evaluated by Doppler Ultrasound, and the foot with less perfusion (left) was selected as the case and the right foot as the control group, and both feet were washed daily with normal saline solution and draped for 5 weeks. First, the ulcers on the case foot were washed, then, radiotherapy was conducted for 20 minutes from 35 cm with infrared lamp, after that, aloe Vera gel was rubbed on the ulcer and then draped; but, the control foot was just radiated by a normal red lamp that was similar to the infrared lamps at a distance of 35 cm for 20 minutes.
... A large study of 2,239 patients with DPN reported an increase in foot sensation and decreased neuropathic pain levels when treated with MIRE. 15 Leonard and colleagues found that the MIRE treatments resulted in a significant increase in sensation in individuals with baseline sensation of 6.65 Semmes-Weinstein Monofilament (SWM) after 6 and 12 active treatments as well as a decrease in neuropathic symptoms as measured by the Michigan Neuropathy Screening Instrument. 16 Prendergast and colleagues noted improved electrophysical changes in both large and small myelinated nerve fibers of patients with DPN following 10 MIRE treatments. ...
A physical therapy approach using monochromatic infrared energy and a balance program was shown to be effective in significantly reducing fall risk, reversing the loss of protective sensation, and improving functional ability.
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Introduction Diabetic peripheral neuropathy (DPN) is one of the most common complications of diabetes that strongly impact the patients’ quality of life and working ability. Evidence indicated that low level light therapy (LLLT)/photobiomodulation might be effective for neuropathy. However, the effect of LLLT for DPN is not clear. The objective of this systematic review and meta-analysis is to determine the effects and safety of LLLT/photobiomodulation for DPN, in comparison with other methods such as sham light, no treatment, other active treatment and LLLT as an additional treatment compared with another treatment alone. Methods and analysis We will search eight databases from their inception to the date before the review submission. Randomised controlled trials (RCTs) will be included. Two reviewers will independently extract data using a structured data extraction method and assess the risk of bias in the included studies. Data will be synthesised using standardised mean difference or risk ratio with 95% CIs for continuous and dichotomous data, respectively. The primary outcome will be change in pain and secondary outcomes will include global symptom improvement, functional impairment and disability, impairment of sensation, quality of life, nerve conduction, and adverse events. Sensitivity and subgroup analysis will be employed to explore the influence of possible clinical and methodological characteristics. Publication bias will be assessed using funnel plot. We will conduct meta-analysis with RevMan V.5.4 and evaluate quality of the evidence using GRADE approach. Ethics and dissemination This study does not require ethics approval. Our findings will be disseminated in the peer-reviewed publications. PROSPERO registration number CRD42021276056.
Background: Major depressive disorder (MDD) is prevalent and has significant impact on individuals and society. Cognitive symptoms are frequent in MDD and insufficiently treated by antidepressant medications. Transcranial photobiomodulation (t-PBM) is a novel device therapy which shows promise as an antidepressant and pro-cognitive treatment. To date, despite the encouraging results, the optimal stimulation parameters of t-PBM to treat MDD are not established, and clinical studies are very heterogeneous in terms of these parameters. While the literature provides guidance on the appropriate fluence to achieve therapeutic results, little is known on the other parameters. Objective: To evaluate the relationship between different parameters and the antidepressant effect of t-PBM. Methods: We reviewed clinical studies on MDD and on depressive symptoms comorbid with other diseases. We calculated the standardized effect size of the change in symptoms severity before and after t-PBM and we performed a descriptive analysis of the reviewed papers. Results: The greatest effect sizes for the antidepressant effect were found in studies using pulse-wave t-PBM with high peak irradiance (but low average irradiance) over large skin surface. One well-designed and sufficiently powered, double-blind, sham-controlled trial indicated that t-PBM with low irradiance over a small skin surface is ineffective to treat depression. Conclusion: The use of t-PBM for Alzheimer's disease and for dementia is still at its inception; these dosimetry lessons from the use of t-PBM for depression might serve as guidance.
Objective: Transcranial near-infrared stimulation (tNIRS) can penetrate the scalp and skull and can reach the superficial layers of the cerebral cortex. In this study, we evaluated whether an 820-nm tNIRS can modulate the excitability of the primary motor cortex (M1) as measured by transcranial magnetic stimulation (TMS). Methods: tNIRS was applied at a wavelength of 820-nm for 4 minutes over the representation of the right first dorsal interosseous muscle (FDI) in the left M1, in 12 healthy right-handed participants. Motor evoked potentials (MEPs) from the FDI elicited by single-pulse TMS were measured at baseline and up to 30 minutes after the tNIRS. Results: The ΔMEPs percentage was evaluated, and a significant increase in amplitude was observed 10 to 20 minutes post-stimulation compared to that in sham. Conclusion: This study provides evidence that an 820-nm tNIRS induces transitory increase in the excitability of the stimulated cortex.
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Objective: Diabetes is the fifth leading cause of death by disease in the U.S. Diabetes also contributes to higher rates of morbidity-people with diabetes are at higher risk for heart disease, blindness, kidney failure, extremity amputations, and other chronic conditions. The objectives of this study were 1). to estimate the direct medical and indirect productivity-related costs attributable to diabetes and 2). to calculate and compare the total and per capita medical expenditures for people with and without diabetes. Research design and methods: Medical expenditures were estimated for the U.S. population with and without diabetes in 2002 by sex, age, race/ethnicity, type of medical condition, and health care setting. Health care use and total health care expenditures attributable to diabetes were estimated using etiological fractions, calculated based on national health care survey data. The value of lost productivity attributable to diabetes was also estimated based on estimates of lost workdays, restricted activity days, prevalence of permanent disability, and mortality attributable to diabetes. RESULTS-Direct medical and indirect expenditures attributable to diabetes in 2002 were estimated at 132 billion US dollars. Direct medical expenditures alone totaled 91.8 billion US dollars and comprised 23.2 billion US dollars for diabetes care, 24.6 billion US dollars for chronic complications attributable to diabetes, and 44.1 billion US dollars for excess prevalence of general medical conditions. Inpatient days (43.9%), nursing home care (15.1%), and office visits (10.9%) constituted the major expenditure groups by service settings. In addition, 51.8% of direct medical expenditures were incurred by people >65 years old. Attributable indirect expenditures resulting from lost workdays, restricted activity days, mortality, and permanent disability due to diabetes totaled 39.8 billion US dollars. U.S. health expenditures for the health care components included in the study totaled 865 billion US dollars, of which 160 billion US dollars was incurred by people with diabetes. Per capita medical expenditures totaled 13243 US dollars for people with diabetes and 2560 US dollars for people without diabetes. When adjusting for differences in age, sex, and race/ethnicity between the population with and without diabetes, people with diabetes had medical expenditures that were approximately 2.4 times higher than expenditures that would be incurred by the same group in the absence of diabetes. Conclusions: The estimated 132 billion US dollars cost likely underestimates the true burden of diabetes because it omits intangibles, such as pain and suffering, care provided by nonpaid caregivers, and several areas of health care spending where people with diabetes probably use services at higher rates than people without diabetes (e.g., dental care, optometry care, and the use of licensed dietitians). In addition, the cost estimate excludes undiagnosed cases of diabetes. Health care spending in 2002 for people with diabetes is more than double what spending would be without diabetes. Diabetes imposes a substantial cost burden to society and, in particular, to those individuals with diabetes and their families. Eliminating or reducing the health problems caused by diabetes through factors such as better access to preventive care, more widespread diagnosis, more intensive disease management, and the advent of new medical technologies could significantly improve the quality of life for people with diabetes and their families while at the same time potentially reducing national expenditures for health care services and increasing productivity in the U.S. economy.
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A questionnaire using a system of visual analog scales was developed for analyzing subjective knee com plaints. This system was tested on 117 consecutive patients who had undergone knee surgery and 65 patients at their initial office evaluation of a knee disor der. The validity of and patient affinity for this type of questionnaire was compared with that of three other established subjective evaluation methods. The visual analog scale system was shown to be valid and comparable to other methods while offering several advantages. It brought greater sensitivity and greater statistical power to data collection and analysis by allowing a broader range of responses than did traditional categorical responses. It removed bias that was introduced by examiner questioning, and it allowed graphic temporal comparisons. Most importantly, pa tient affinity was higher for this type of subjective evaluation than for other methods.
Purpose: Elderly patients are at high risk for falls due, in part, to the loss of sensation in the lower extremities. This study examined the effectiveness of a comprehensive therapy intervention that included monochromatic infrared photo energy for improving foot sensation, balance, and fall status. Methods: Thirty-eight patients, average age 78 years, participated in this study. All patients lacked protective sensation in the lower extremities (documented by the Semmes Weinstein 5.07 monofilament), demonstrated a significant fall risk based on Tinetti scores, and had a history of falling. Patients participated in a mean 12 treatments that consisted of infrared photo energy, neuromuscular re-education, balance and strength training, and stretching exercises. Results: Comparisons of patients' status pre- and post- treatment showed that they improved significantly in lower extremity sensation and balance and that they experienced fewer falls. Conclusion: A comprehensive therapy intervention that includes infrared photo energy 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 incurs the cost of treatment. (C) 2004 Lippincott Williams & Wilkins, Inc.
A postal questionnaire survey was carried out to investigate beliefs in the efficacy of specific treatments held by consultants involved in the treatment of chronic nerve-damage pain. One hundred eighty-eight consultants experienced in the treatment of chronic pain were identified by local Pain Clinic consultants in 5 centres. The specialties represented were neurology, neurosurgery, orthopaedic surgery, oncology/radiotherapy, plastic surgery and anaesthesia. Replies were received from 181 consultants (96%). Over one fifth of the consultants expressed no opinion about half of the treatments assessed. Widely divergent views were held by those who did give an opinion. Many clinicians assessed some treatments as 'poor' while other clinicians assessed the same treatments as 'excellent' (neurolytic nerve block, somatic nerve block, cordotomy and opioids). For some treatments divergence of opinion can be explained in part by differences between specialties. For other treatments marked diversity was seen within as well as between specialties. There is a clear need for education in the use of particular treatments, even amongst those clinicians who regularly see this type of patient.
Based on advances in signal detection theory, a method is proposed for the measurement of response to light touch. Comparison was made between this method and 2 others, including the commonly used clinical procedure. Three body areas of 12 male and 12 female subjects were tested by each of the 3 methods. Differences among body parts were discriminated best by the proposed procedure, a forced choice method, and were discriminated most poorly by the standard clinical procedure. No sex differences in sensitivity were found. A clinical method for testing light touch is presented that provides objective measures of changes in sensitivity over time or can compare an area of suspected sensory loss with a normal one.
The Neurometer is a relatively new device for assessing neuropathy by measuring current perception threshold (CPT). The study aim was to assess the ability of the Neurometer to distinguish between different types of nerve fibre damage by using different frequencies (2000 Hz, 250 Hz, and 5 Hz) of electric stimulus (high frequencies for large fibres and low frequencies for small fibres) and comparing the results with standard sensory tests of vibration perception threshold (VPT) and thermal perception threshold (TPT). CPT was determined on index finger and great toe of 51 patients with diabetic neuropathy and 28 non-diabetic control subjects, age and sex matched. CPT in neuropathic patients could be distinguished from controls at all three frequencies in both feet and hands (p < 0.05). The best correlation was found between CPT at 2000 Hz and VPT (r = 0.48, p < 0.001) in the feet suggesting a degree of neuroselectivity. Internal correlations between CPT at the three frequencies showed the weakest correlation between CPT at 2000 Hz and 5 Hz (r = 0.27, p < 0.005), suggesting also that possibly different types of fibres were examined. CPT reproducibility was better in control (CV = 6.4-27.7%), than in neuropathic subjects (CV = 28.4-52.3%), although the coefficient of variation was comparable to that of standard tests of sensory function, VPT and TPT. The Neurometer is a simple instrument to use in clinical practice. It has a degree of neuroselectivity but like all subjective sensory tests has a large variability.
The authors evaluated the causal relationship between entrapment of the posterior tibial nerve and neuropathic pain and describe the results of nerve decompression in a selected group of patients with intractable pain. Painful metabolic neuropathy has, until recently, been thought to be an irreversible and essentially untreatable complication of diabetes. Recent studies have shown that metabolic deterioration is only one component of the disease process. A group of patients with intractable painful neuropathy and a positive percussion sign underwent posterior tibial nerve decompression. Nerve decompression relieved the pain in the majority of treated patients. Return of other sensory function also was noted. Painful diabetic neuropathy of the lower extremities is potentially reversible. It appears to be caused partially by nerve entrapment and can be reversed by decompression.