ORIGINAL ARTICLE
Early recognition of diabetic neuropathy: evaluation of a
simple outpatient procedure using thermal perception
V Viswanathan, C Snehalatha, R Seena, A Ramachandran
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Postgrad Med J 2002;78:541–542
Objective: To determine the effectiveness of Tip-therm, a temperature discriminator, in making an early
diagnosis of distal symmetrical polyneuropathy in diabetic patients and to compare its effectiveness
with the Semmes-Weinstein monofilament and biothesiometry, which are established methods of diag-
nosing neuropathy in diabetic patients.
Patients and methods: From the diabetic subjects who came to the hospital for review, 910 consecu-
tive cases were selected. All were tested with the Semmes-Weinstein monofilament (10 g monofilament)
and biothesiometry and also by using the Tip-therm for comparison.
Results: Out of the 241 patients who had no sensation to the monofilament only four (1.7%) felt Tip-
therm whereas 237 (98.3%) patients could not feel Tip-therm. Among 298 patients diagnosed as hav-
ing neuropathy by biothesiometry, only eight (2.7%) patients exhibited sensation with Tip-therm while
290 (97.3%) patients could not feel it.
Conclusion: A simple device, Tip-therm, which tests for temperature discrimination, was compared
with two validated methods for detection of neuropathy—a monofilament and biothesiometry. Tip-therm
appears to be an inexpensive, highly sensitive, and specific device for detection of diabetic neuropathy
when compared with biothesiometry and a monofilament.
Diabetic neuropathy is the most common and trouble-some complication of diabetes mellitus. It also results ina huge economic burden for diabetes care.1 2
The diabetic foot has traditionally been considered to occur
because of the presence of peripheral vascular disease, periph-
eral neuropathy, and infection. Chronic sensory motor
neuropathy is the commonest form of diabetic neuropathy
and occurs in both type 1 and type 2 diabetes. It is the most
common form of neuropathy in developed countries, account-
ing for more admissions to hospitals than all the other diabetic
complications combined and is responsible for 50% to 75% of
non-traumatic amputations.2 3
Methods that are simple, but sensitive and specific, are
required to evaluate sensory neuropathy. In distal symmetric
neuropathy, an early symptom may be a failure to perceive
variations in temperature.
Tip-therm (AXON Gmbh Dusseldorf, Germany) is consid-
ered to be ideal for testing temperature sensitivity. It is a pen-
like instrument with two flat sides. It is not dependent on
external power sources, is practically indestructible, easy to
handle, and small and light enough to fit in any jacket. Owing
to its physical characteristics this simple instrument is easy to
use and is known to give reproducible results in an ambient
temperature of up to 23°C.
PATIENTS AND METHODS
M.V. Hospital in Madras is a large referral centre for diabetes
care, and 910 consecutive patients who came to the foot
department for routine screening for neuropathy were
selected. There were 628 males and 282 females; the mean
(SD) age of the patients was 53.7 (10.4) years and the mean
(SD) duration of diabetes was 9.7 (8.0) years.
The patients were tested by the Semmes-Weinstein
monofilament (10 g monofilament), biothesiometry, and also
by using the Tip-therm for comparison.
All of them had been tested for neuropathy using the bioth-
esiometer (Bio-Medical Instrument Co, Newbury, OH, USA)
for determining the vibration perception threshold (VPT).
Three readings were obtained from each foot on the first
metatarsal at different degrees of voltage increase and a mean
was taken. Patients with a VPT of >25 V were considered to
have significant neuropathy.4
The Semmes-Weinstein monofilament (Gills W Long,
Hansen’s Disease Center, Carville, LA, USA) determines the
protective sensation in the feet. It consists of a series of graded
pressure sensitive nylon filaments of increasing calibre that
buckle at a reproducible stress and can measure the patient’s
cutaneous pressure perception threshold. The 10 g monofila-
ment was used in this study. The filament is applied to at least
five sites on the foot until it buckles, which occurs at 10 g of
linear pressure, when the patient is asked to detect its
presence. If it is not detected on at least three out of five times,
then the protective sensation is considered to be lost.5 A new
monofilament was used only for this study.
Tip-therm examination procedure
The examiner places the two flat surfaces on the tip of the
patient’s great toe at irregular intervals and asks whether it
feels cold or not so cold. The patient is asked to close his eyes
during testing. Only if correct answers are given it is presumed
that the patient’s temperature perception is functioning satis-
factorily. Patients can also use Tip-therm themselves in the
course of regular pedicure treatment. The tests were done in
an air conditioned room with a temperature range of 20–23°C.
RESULTS
Comparison of monofilament and Tip-therm
Among the patients who were tested with the monofilament,
the sensation was present in 669 (73.5%) and in 241 (26.5%)
patients the sensation was absent. Out of the 669 patients,
Tip-therm was felt by 616 (92.1%) and in 53 (7.9%) patients it
was not felt. Out of the 241 patients who had no sensation to
the monofilament only four (1.7%) felt Tip-therm whereas
237 (98.3%) could not.
Comparison of biothesiometry and Tip-therm
In this study, biothesiometry was considered as the reference
test for neuropathy. Among 298 patients diagnosed as having
See end of article for
authors’ affiliations
. . . . . . . . . . . . . . . . . . . . . . .
Correspondence to:
Dr Vijay Viswanathan,
Diabetes Research Centre,
No 4, Main Road,
Royapuram, Madras 600
013, India;
dr_vijay@vsnl.com
Submitted
7 November 2001
Accepted 13 May 2002
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541
www.postgradmedj.com
neuropathy by biothesiometry, only eight (2.7%) patients
exhibited sensation with Tip-therm while 290 (sensitivity
97.3%) patients could not feel it. All 612 (specificity 100%)
non-neuropathic patients were able to feel Tip-therm. Table 1
shows the comparison of Tip-therm with biothesiometry. It
was interesting to find that the specificity of Tip-therm was
100% when compared with biothesiometry. Sensitivity of Tip-
therm for neuropathy was better than that of the monofila-
ment. With the monofilament, 241 out of the 290 neuropathy
cases were picked up (sensitivity 83.1%). Among them 237
cases (sensitivity 98.3%) were Tip-therm positive.
DISCUSSION
In this study we have compared a simple device, Tip-therm,
which tests for temperature discrimination, with a monofila-
ment and biothesiometry, both of which have already been
established as validated methods for detection of neuropathy.
Tip-therm showed a high specificity and sensitivity when
compared with these two devices.
Prospective trials have confirmed the role of both large and
small fibre neurological deficit in the pathogenesis of foot
ulceration.6 Small nerve fibre dysfunction usually occurs early
and is often present without objective signs or electrophysi-
ological evidence of nerve damage.7 It is manifested by early
symptoms of pain and hyperalgesia in the lower limbs,
followed by a loss of thermal sensitivity and reduced light
touch and pin prick sensation.8
Temperature discrimination threshold is a measure of small
fibre function. Warm sensation is mediated by the smallest
non-myelinated C fibres and cold sensation by small
myelinated A∆ fibres. Temperature discrimination threshold is
particularly relevant for a number of reasons. First, tempera-
ture sensation may be the first to be affected in diabetic
patients.9 Second, since small fibres also mediate pain
sensation it was hypothesised that selective damage may have
some relevance to positive painful symptoms of neuropathy.10
Finally lack of temperature sensation is of obvious clinical rel-
evance since it may predispose to scalds, burns and other
thermal injuries, although the degree of sensory loss required
for this is actually quite large, which is approximately 10°C .11
Most techniques for the detection of thermal or other tem-
perature discrimination thresholds have used metal elements.
They are based on the Peltier principle whereby they might be
heated or cooled relatively quickly by changing the direction of
flow of electric current through them. Results are often poorly
reproducible, especially in disease states, and the equipment
required is relatively cumbersome and expensive.
CONCLUSIONS
In this study the Tip-therm appears to be an ideal device for
temperature testing with a high sensitivity and specificity
compared with biothesiometry and a monofilament, which
are established methods for the diagnosis of diabetic
neuropathy.
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Authors’ affiliations
V Viswanathan, C Snehalatha, R Seena, A Ramachandran,
Diabetes Research Centre, Madras, India
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Table 1 Comparison of Tip-therm with
biothesiometry and monofilament
Sensitivity
(%)
Specificity
(%)
Neuropathy by biothesiometry (n=298) 97.3 100
Loss of sensation by Tip-therm (n=290) (290/298) (612/612)
Loss of sensation by monofilament (n=241) 98.3 92.1
Loss of sensation by Tip-therm (n=237) (237/241) (616/669)
Key points
• Tip-therm was used to find out temperature perception in
type 2 diabetic subjects without neuropathy and with
sensory neuropathy detected by abnormal biothesiometry
and a monofilament.
• Tip-therm has high specificity (100%) and sensitivity
(97.3%) in diagnosing diabetic neuropathy.
• It is suitable for screening sensation loss in the feet.
• It is a pen-like instrument, easy to use, and is known to give
reproducible test results in an ambient temperature of up to
23°C.
• It can be used as an outpatient procedure for detecting foot
problems in diabetes.
542 Viswanathan, Snehalatha, Seena, et al
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