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of Pages 6
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Physiotherapy xxx (2014) xxx–xxx

Effect of burst TENS and conventional TENS combined with

cryotherapy on pressure pain threshold: randomised,
controlled, clinical trial
L.B. Macedo, A.M. Josué, P.H.B. Maia, A.E. Câmara, J.S. Brasileiro ∗
Department of Physiotherapy, Federal University of Rio Grande do Norte, Laboratório de Análise da Performance Neuromuscular,
Natal, RN, Brazil

Abstract
Objective To assess the immediate effect of conventional and burst transcutaneous electrical nerve stimulation (TENS) in combination with
cryotherapy on pain threshold and tolerance in healthy individuals.
Design Randomised, controlled trial.
Setting University laboratory.
Participants One hundred and twelve healthy women.
Interventions Volunteers were allocated at random to seven groups (n = 16): (1) control, (2) placebo TENS, (3) conventional TENS, (4)
burst TENS, (5) cryotherapy, (6) cryotherapy in combination with burst TENS, and (7) cryotherapy in combination with conventional TENS.
Pain threshold and tolerance were measured by applying a pressure algometer at the lateral epicondyle of the humerus, before and after each
intervention.
Main outcome measures The primary outcome measure was pressure pain threshold.
Results A significant increase in pain threshold and tolerance at the 5% level of significance was recorded as follows: burst TENS {pain
threshold: mean difference 1.3 [95% confidence interval (CI) 1.4 to 1.2]; pain tolerance: mean difference 3.8 (95% CI 3.9 to 3.7)}, cryotherapy
[pain threshold: mean difference 1.3 (95% CI 1.4 to 1.2); pain tolerance: mean difference 1.9 (95% CI 1.8 to 2.0)] and cryotherapy in
combination with burst TENS [pain threshold: mean difference 2.6 (95% CI 2.4 to 2.8); pain tolerance: mean difference 4.9 (95% CI 5.0 to
4.8)]. Cryotherapy in combination with burst TENS provided greater analgesia compared with the other groups (P < 0.001).
Conclusion These results support the use of cryotherapy in combination with burst TENS to reduce induced pain, and suggest a potentiating
effect when these techniques are combined. No such association was found between cryotherapy and conventional TENS.
© 2014 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Keywords: Ice; Analgesia; Electrotherapy

Introduction stimulation (TENS) and cryotherapy. One technique gaining

Pain is a common symptom in a number of pathological
conditions, and physical therapists have several resources
at their disposal, including transcutaneous electrical nerve
∗ Correspondence: Departamento de Fisioterapia, Universidade Federal
do Rio Grande do Norte, Av. Senador Salgado Filho, 3000, Campus Univer-
sitário, Lagoa Nova, Natal, RN, CEP 59.078-970, Brazil.
Tel.:/fax: +55 08433422001.
E-mail addresses: brasileiro@ufrnet.br, brasileiroj@bol.com.br
(J.S. Brasileiro).
popularity in clinical practice is the simultaneous applica-
tion of ice and TENS [1,2]. Despite the large number of
studies supporting the effectiveness of TENS for analgesia
[3–8], there is no consensus about adequate stimulation
parameters [4,5,9,10] or the action mechanisms involved
[4,11]. Furthermore, studies often have methodological
differences, which may account for the wide range of
conclusions [12,13]. TENS, which consists of applying an
electric current to relieve pain through electrodes placed on
the surface of the skin [3,4,13–15], is commonly used as

http://dx.doi.org/10.1016/j.physio.2014.07.004
0031-9406/© 2014 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Please cite this article in press as: Macedo LB, et al. Effect of burst TENS and conventional TENS combined with cryotherapy on pressure
pain threshold: randomised, controlled, clinical trial. Physiotherapy (2014), http://dx.doi.org/10.1016/j.physio.2014.07.004
PHYST-781; No. of Pages 6
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non-invasive non-pharmacological coadjuvant treatment and
is largely free of side effects [4,14]. Four levels of stimulus
intensity can be adjusted in TENS units: subsensory, sensory,
motor and noxious. The sensory level is most widely used
in clinical practice and research studies [16]. The literature
shows that TENS results depend on the application site [9]
and stimulus characteristics, such as amplitude, frequency
and pulse duration [4,8,10].
Conventional TENS can be applied to frequency parame-
ters with a range between 50 and 100 Hz, short pulse duration
(from 50 to 100 ␮seconds) [16] and amplitude regulated
according to the patient’s report: strong paresthesia, more
comfortable and no muscle contraction or pain [3,9,15,16]
is considered to be a high-frequency, low-intensity mode
[15]. Studies have indicated that the action mechanism
which underlies the effectiveness of this type of stimulus
for the production of analgesia is based on Melzack and
Wall’s gate control theory of pain [17]. This theory proposes
that pain perception is controlled by the balance between
large-diameter non-nociceptive fibres (A␤ fibres) and their
small-diameter nociceptive counterparts (A␦ and C fibres)
that reach the gelatinous substance, resulting in T-cell exci-
tation or inhibition. Sensory-level TENS, therefore, acts by
selective activation of sensory fibres, increasing their input
and inhibiting T cells, thereby decreasing pain via segmen-
tal inhibition. As such, analgesia will cease as soon as the
stimulus is terminated [3].
Concerning burst TENS, Robinson and Snyder-Mackler
[16] reported that ‘bursts of brief pulses are applied at levels
that cause muscle contraction as a means of controlling pain;
this stimulation mode is known as burst-modulated TENS’.
This mode, characterised as low-frequency, high-intensity
stimulation [4], is applied under high-frequency carrier waves
(80 to 100 Hz), modulated in low-frequency pulse trains (2 to
5 Hz) [18], with a long pulse duration (>150 ␮seconds) and
sufficient amplitude to produce strong and visible, albeit pain-
less [16], muscle contractions. Painless induced contractions
may simply relieve pain in the same way as sensory-level
stimulation (via pain gates). Moreover, it has been demon-
strated that low-frequency TENS activates opioid receptors
in the spinal cord and brain stem, given that motor-level
analgesia is generally non-immediate but long-lasting [4,16].
Although there is no consensus in the literature regarding
the terminology used in the different modes of TENS
(conventional/high-frequency and burst/low-frequency), the
present study adopted the classification proposed by Robin-
son and Snyder-Mackler [16].
The term ‘cryotherapy’ refers to the removal of body heat,
with a reduction in skin temperature in order to reach a ther-
apeutic objective [19]. Saeki [20] reported that ice can be
used in various ways to relieve pain, including decreasing
nerve conduction velocity (NCV), pain gate activation,
activation of descending tracts from the central nervous sys-
tem (release of endogenous opioids) and counter-irritation
mechanisms (via diffuse noxious inhibitory control). In the
latter case, somatic or noxious stimuli can be used to relieve
Please cite this article in press as: Macedo LB, et al. Effect of burst TENS and conventional TENS combined with cryotherapy on pressure
pain threshold: randomised, controlled, clinical trial. Physiotherapy (2014), http://dx.doi.org/10.1016/j.physio.2014.07.004
pain by changing beta-endorphin or encephalin levels in both
plasma and cerebrospinal fluid [16].
A recent technique that has been used increasingly in
physical therapy is cryo-TENS, which consists of the simulta-
neous application of ice and TENS. In addition to enhancing
analgesia, it is suggested that the simultaneous application
of an electric current and a cold stimulus could reduce dis-
comfort by altering pain perception through the nociceptive
pathways [2]. According to Santuzzi et al. [1], treatment with
ice and conventional TENS attenuated electrical activity in
the femoral nerve of rats compared with TENS alone, likely
reversing the analgesic effects produced by separate tech-
niques. Although there are few studies on this technique and
no scientific proof of its effectiveness, clinical use is growing
and patients report greater pain relief and improved comfort
with this therapy [7]. Given patients’ preference for using the
two techniques concomitantly rather than separately, and the
scarcity of studies that confirm its effectiveness, the effects
of applying cryotherapy and TENS simultaneously is called
into question. As such, this study aimed to assess the immedi-
ate effects of TENS, with or without cryotherapy, on pressure
pain threshold and tolerance using pressure algometry.
Materials and methods
Characterisation of the study
This randomised controlled experimental trial assessed
the effect of conventional and burst TENS in combination
with cryotherapy on pressure pain threshold and tolerance.
The study was conducted at the Laboratory of Neuromus-
cular Performance Analysis, located in the Physical Therapy
Department of the Federal University of Rio Grande do Norte,
Natal, Brazil.
Subjects
One hundred and twelve healthy young female volunteers
{mean age 21.9 [standard deviation (SD) 1.95] years, mean
body mass index (BMI) 20.7 (SD 2.05) kg/m2 } were selected
for the study. Based on initial values obtained in pilot studies,
at least 16 subjects were required per group for a power of
80% (α = 0.05).
The inclusion criteria were: age between 18 and 25 years,
no history of upper limb injury in the last 6 months, BMI
<28 kg/m2 , and not using analgesic medication. Furthermore,
for inclusion, subjects could not exhibit skin or vascular alter-
ations or sensitivity. Exclusion criteria were: allergy to ice
(positive ice cube test), or failure to tolerate any of the inter-
ventions. None of the volunteers were excluded from the
study.
Subjects were recruited by non-probability, con-
venience sampling and distributed at random using
www.randomization.com. All of the subjects were volun-
teers and gave their informed consent, in accordance with
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Fig. 1. Position of the pressure algometer on the lateral epicondyle of the
humerus to assess pain threshold and pain tolerance.
criteria established by Resolution 196/96 of the National
Health Council. This project was approved by the Insti-
tutional Ethics Committee (Protocol No. 099/2010). The
CONSORT flow diagram is show in Fig. 2 (see on-line
supplementary material).
Instruments
A pressure algometer (Wagner Force TenTM FDX50;
Wagner Instruments, Greenwich, CT, USA) with a 1-cm2
rubber tip was used to obtain the pain threshold and toler-
ance of each volunteer during initial (pre) and final (post)
assessments. The accuracy of the device is ±0.3% of full
scale, and its calibration was certified by the manufacturer
before the test procedures (Serial No. 10441). A TENS unit
(Quark TensVif 973; Quark Medical, Piracicaba, Brazil), that
operates with a symmetrical biphasic pulsed current and
5-cm × 5-cm self-adhesive electrodes (Palms, Axelgaard,
Fallbrook, California, USA), was used to produce analgesia
by electrotherapy. Cryotherapy was applied using a 700-
g crushed ice pack [1], secured with a non-elastic strip
for greater compression, on the lateral epicondyle of the
humerus. A digital thermometer with an interface (Salvterm
1200K, São Paulo, Brazil) was used to measure skin temper-
ature. The interface of the thermometer was isolated from the
ice pack to ensure that the temperature was recorded on the
skin surface.
Procedures
With the volunteers in a sitting position, arm supported on
a table and elbow flexed at 90◦ [5], the pressure algometer
was applied to the lateral epicondyle of the humerus of the
left arm to determine pain threshold and tolerance, before
and immediately after the conclusion of each intervention
(Fig. 1). The subject was blinded during the procedure and
instructed to look away from the limb being assessed.
The contact pressure applied via the algometer was per-
pendicular and progressive, at a rate of 1 kgf/s [21]. During
Please cite this article in press as: Macedo LB, et al. Effect of burst TENS and conventional TENS combined with cryotherapy on pressure
pain threshold: randomised, controlled, clinical trial. Physiotherapy (2014), http://dx.doi.org/10.1016/j.physio.2014.07.004
3
the initial assessment (pre), volunteers were instructed to
indicate the moment when they first experienced pain (pain
threshold), and to remove the device when they could no
longer tolerate the stimulus (pain tolerance). As a way of
reducing sensitivity in the assessed area, each subject had a
single measurement before and after the intervention, and the
values were recorded for subsequent analysis.
After the initial algometry measurements had been
recorded, volunteers adopted the dorsal decubitus position to
initiate the interventions, according to each group: (1) control
(rest for 25 minutes), (2) placebo TENS (TENS unit turned
on, but with zero amplitude), (3) conventional TENS (sym-
metrical biphasic pulsed current, with frequency of 100 Hz,
pulse duration of 100 ␮seconds and sensory-level amplitude),
(4) burst TENS (carrier frequency of 100 Hz burst-modulated
at 4 Hz, pulse duration of 200 ␮seconds and motor-level
amplitude), (5) cryotherapy (700-g crushed ice pack on the
lateral region of the elbow), (6) cryotherapy in combination
with burst TENS, and (7) cryotherapy in combination with
conventional TENS. All interventions lasted for 25 minutes,
thereby standardising re-assessment in all groups. Electrodes
were positioned using the transarticular technique, where one
electrode was fixed on the application point of the algometer
(lateral epicondyle of the humerus) and the other electrode
was fixed on the medial epicondyle of the humerus.
Immediately after the interventions, each subject under-
went their final assessment (post), identical to their first
assessment. Environmental conditions were monitored and
all assessments were performed at temperatures between 22
and 28 ◦ C, with relative humidity between 60% and 80%. At
the end of the experiment, pre- and post-intervention pain
threshold and tolerance values were used for group compar-
ison.
Statistical analysis
Statistical Package for the Social Sciences Version 15.0
(IBM Corp, Armonk, NY, USA) was used at the 5% signif-
icance level. The Kolmogorov–Smirnov test was applied to
determine data normality, and one-way analysis of variance
(ANOVA) was used to verify group homogeneity. Two-way
ANOVA was performed to ascertain whether there were any
differences between the groups or between assessments.
Results
Pain threshold declined significantly in the control and
placebo groups (P = 0.03 and P = 0.02, respectively) after the
intervention, but increased for the groups that received burst
TENS (P = 0.04), cryotherapy (P = 0.008) and burst TENS in
combination with cryotherapy (P < 0.001). No alterations in
algometry values were observed for the groups that received
conventional TENS (P = 0.67) and conventional TENS in
combination with cryotherapy (P = 0.71) (Table 1).
Similar results were found for pain tolerance (Table 2),
with a significant reduction in the control and placebo groups
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Table 1
Mean [standard deviation (SD)] of pain threshold (Kilogram-force), pre- and post-intervention, for each group, mean [95% confidence interval (CI)] difference
within groups and P-value.
Groups Mean (SD) pre Mean (SD) post Mean difference (95% CI) P-value
Control 3.4 (1.1) 2.8 (0.7) −0.6 (−0.8 to −0.4) 0.03
Placebo TENS 3.1 (1.2) 2.3 (0.9) −0.8 (−0.9 to −0.7) 0.02
Conventional TENS 3.4 (1.2) 3.2 (1.0) −0.2 (−0.3 to −0.1) 0.67
Burst TENS 3.0 (0.7) 4.3 (0.9) 1.3 (1.4 to 1.2) 0.04
Cryotherapy 3.1 (0.6) 4.4 (0.9) 1.3 (1.4 to 1.2) 0.008
Cryotherapy + burst TENS 3.1 (1.2) 5.7 (0.8) 2.6 (2.4 to 2.8) <0.001
Cryotherapy + conventional TENS 3.2 (0.7) 3.0 (0.7) −0.2 (−0.2 to −0.2) 0.71
Pre, before intervention; post, after intervention; TENS, transcutaneous electrical nerve stimulation.
Table 2
Mean [standard deviation (SD)] pain tolerance (Kilogram-force), pre- and post-intervention, for each group, mean [95% confidence interval (CI)] difference
within groups and P-value.
Groups Mean (SD) pre Mean (SD) post Mean difference (95% CI) P-value
Control 7.2 (2.0) 5.2 (1.6) −2 (−1.8 to −2.2) 0.01
Placebo TENS 6.3 (1.7) 4.8 (1.9) −1.5 (−1.6 to −1.4) 0.03
Conventional TENS 7.8 (1.3) 8.1 (2.0) 0.3 (0 to 0.6) 0.45
Burst TENS 4.9 (1.2) 8.7 (1.0) 3.8 (3.9 to 3.7) 0.02
Cryotherapy 6.6 (1.1) 8.5 (1.3) 1.9 (1.8 to 2.0) 0.01
Cryotherapy + burst TENS 8.1 (1.5) 13 (1.3) 4.9 (5.0 to 4.8) <0.01
Cryotherapy + conventional TENS 6.1 (1.7) 6.3 (1.7) 0.2 (0.2 to 0.2) 0.73
Pre, before intervention; post, after intervention; TENS, transcutaneous electrical nerve stimulation.

(P = 0.01 and P = 0.03, respectively), and an increase for
the groups that received burst TENS (P = 0.02), cryotherapy
(P = 0.01) and burst TENS in combination with cryother-
apy (P < 0.001). The conventional TENS group showed no
alterations after the intervention, whether used alone or in
combination with cryotherapy (P = 0.45 and P = 0.73, respec-
tively).
Intergroup comparison, however, showed that the increase
in pain tolerance produced by burst TENS in combination
with cryotherapy was significantly higher than that produced
by the other modes (P < 0.001). Skin temperature, which
was measured in the groups undergoing cryotherapy, was
recorded every 5 minutes during application, exhibiting a
mean value of 4 (SD 1.2) ◦ C.
Discussion
The results of this study showed a significant reduction in
algometry values for the control and placebo groups for both
pain threshold and tolerance. This may be due to the greater
sensitisation of the area assessed, given that the values were
recorded 25 minutes after the initial assessment on the same
tissues, which did not receive any form of analgesia during
this time interval.
The group that received cryotherapy alone exhibited alter-
ations in pain tolerance after its application, revealing a
significant increase in these values. As demonstrated in ear-
lier studies [7,22,23], this finding supports the use of this
technique as an effective resource for pain relief. Solomon
et al. [24], however, obtained contradictory results, showing
that the use of cooling at 15 ◦ C did not produce analgesia.
These outcomes may be explained by the fact that, according
to Bugaj [25], the skin must be cooled to a temperature below
13.6 ◦ C in order to achieve a significant analgesic effect with
ice. In the present study, skin temperatures were confirmed
using a digital thermometer with an interface, which revealed
a mean value of 4 ◦ C.
Burst TENS led to altered values compared with the initial
recordings for both pain threshold and tolerance, suggesting
that this mode was also effective for producing analgesia.
Brill and Whiffen [26] reported that burst TENS was effec-
tive for producing analgesia by decreasing the amount of
analgesic intake and hospitalisation time after spinal surgery.
Moreover, patients considered burst TENS to be more effec-
tive than conventional TENS for pain relief [26].
In contrast to studies that support the effectiveness of con-
ventional TENS, the present study found that conventional
TENS did not alter either pressure pain threshold or tolerance.
Although these data suggest that conventional TENS is inef-
ficient, it is important to underscore that algometry values in
the control and placebo groups were lower in the final assess-
ment. This is likely to be due to the sensitisation of tissues
stimulated during the initial evaluation, which occurred in all
groups. Thus, the fact that these values showed no decline in
the group that received conventional TENS suggests that it
had some analgesic effect on pressure-induced pain.
The group that received cryotherapy in combination with
burst TENS showed an increase in both pressure pain thresh-
old and tolerance from pre- to post-intervention, and in
comparison with the other groups, suggesting that this tech-
nique is more effective as an analgesic agent. Jelinek and
Barnden [2] compared low-frequency TENS in combina-
tion with cooling and heating, and observed that neither of
the techniques promoted alterations in perceived pain as a
function of stimulus threshold. To date, however, no studies

Please cite this article in press as: Macedo LB, et al. Effect of burst TENS and conventional TENS combined with cryotherapy on pressure
pain threshold: randomised, controlled, clinical trial. Physiotherapy (2014), http://dx.doi.org/10.1016/j.physio.2014.07.004
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have assessed the effect of cryotherapy in combination with
burst TENS on the promotion of analgesia. This precludes
comparisons with other investigations, which have gener-
ally assessed the effects of cryotherapy in combination with
conventional TENS [1,24].
The most widely accepted mechanism for producing anal-
gesia using burst TENS is the release of endogenous opioids.
Rhythmic muscular contraction caused by depolarisation of
motor nerve fibres using electrostimulation promotes neu-
ronal excitation in the periaqueductal grey matter and rostral
ventromedial medulla, with the consequent release of endor-
phins and encephalins [4]. Given this burst TENS action
mechanism, it is plausible to propose that the effects of
both techniques are enhanced when cryotherapy is performed
in combination with burst TENS. This electrostimulation
mode would have no influence on reducing the counter-
irritation effect of ice, as its primary physiological effect is not
to activate large-diameter fibres (A␤) selectively. However,
ice does not impede the action of burst TENS in depo-
larising motor nerve fibres to produce muscle contraction,
thereby promoting analgesia by releasing endogenous opi-
oids.
The results of conventional TENS in combination with
cryotherapy showed no alterations in pressure pain threshold
and tolerance, corroborating the study conducted by Solomon
et al. [24]. It is suggested that cryotherapy reduced NCV,
compromising the efficiency of conventional TENS, as the
physiological intention is the selective activation of large-
diameter, non-nociceptive cutaneous afferent fibres. Algafly
and George [22] observed a 33% reduction in NCV after
cooling the skin at 10 ◦ C, whereas Herrera et al. [27], who
cooled the skin at an average temperature of 6.68 ◦ C, obtained
a 31.12% decrease in NCV. In the present study, average skin
cooling temperature was 4 ◦ C, and it is believed that NCV
also decreased.
These findings indicate that cooling affected the efficacy
of conventional TENS. However, conventional TENS would
also decrease cryotherapy-induced analgesia due to a reduc-
tion in the counter-irritation effect. According to this theory,
the discomfort caused by applying ice is a counter-irritant that
stimulates endogenous opioid production, via diffuse noxious
inhibitory control, thereby reducing pain.
The counter-irritation effect would lead to a decrease
in the release of endogenous opioids, and consequently
reduce the efficiency of cryotherapy as an analgesic resource.
Thus, the mechanisms proposed by combining the effects
of conventional TENS and cryotherapy are contradictory
and lack neurophysiological mechanisms to support their
applicability. Therefore, the use of this technique to prevent
pressure-induced pain is not justified.
Conclusion
The results of this study support the use of cryotherapy and
burst TENS as effective therapeutic agents for the reduction
of pressure-induced pain. It is further suggested that when
Please cite this article in press as: Macedo LB, et al. Effect of burst TENS and conventional TENS combined with cryotherapy on pressure
pain threshold: randomised, controlled, clinical trial. Physiotherapy (2014), http://dx.doi.org/10.1016/j.physio.2014.07.004
5
these resources are used simultaneously, they enhance the
analgesia produced by either technique applied separately.
However, the simultaneous application of cryotherapy and
conventional TENS was found to reduce the individual effects
of either of these resources. Thus, the data obtained in this
study do not support this association as an effective analgesic
agent for the reduction of pressure-induced pain in healthy
individuals.
The results obtained in this study must be restricted to sub-
jects without established pain processes, as the individuals
were submitted to a pain-induction procedure. Another lim-
itation was the fact that endogenous opioid levels and NCV
were not measured. It is suggested that future clinical trials
should use individuals with established pain syndromes, and
should measure endogenous opioid levels and NCV. It would
also be of interest to investigate the level of comfort pro-
duced by these techniques and individual patient preferences.
Ethical approval: Research Ethics Committees of the
Federal University of Rio Grande do Norte (Ref. No.
99/2010).
Funding: We are grateful for the grant support of the
Brazilian agencies for science: CNPq (Conselho Nacional
de Desenvolvimento Científico e Tecnológico) and CAPES
(Coordenação de Aperfeiçoamento de Pessoal de Nível
Superior).
Conflict of interest: None declared.
Appendix A. Supplementary data
Supplementary data associated with this article can be
found, in the online version, at http://dx.doi.org/10.1016/j.
physio.2014.07.004.
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