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Physiotherapy 95 (2009) 280–288
A comparison of the analgesic efficacy of medium-frequency
alternating current and TENS
Alex R. Ward∗, Stacey Lucas-Toumbourou, Brigid McCarthy
Musculoskeletal Research Centre, Faculty of Health Sciences, La Trobe University, Victoria 3086, Australia
Abstract
Objective To compare the analgesic efficacy of burst-modulated medium-frequency alternating current (BMAC) and transcutaneous electrical
nerve stimulation (TENS) using an experimental cold pain model.
Design Within-group crossover study.
Setting A university research laboratory.
Participants Twenty healthy subjects.
Interventions BMAC (4-kHz AC applied in 4-millisecond bursts at 50 Hz) and TENS (125-microsecond phase duration applied at a frequency
of 50 Hz) administered to each participant on separate occasions.
Main outcome measure Time to cold pain threshold.
Results The mean time to cold pain threshold with the BMAC intervention was no different than with TENS. Statistical analysis showed
that both interventions elevated the cold pain threshold significantly [BMAC: increase = 15.2 seconds, 97.5% confidence interval (CI) 3.1
to 27.2, P = 0.01; TENS: increase = 15.4 seconds, 97.5%CI 2.5 to 28.4, P = 0.02], and the difference between interventions was not simply
insignificant but the intervention effects were ‘significantly the same’ (mean difference = 0.3 seconds, 95%CI −15.3 to 15.9, P = 0.97).
Conclusions BMAC is as effective as TENS in increasing cold pain thresholds in healthy subjects. Since BMAC has been shown to be more
comfortable than TENS in previous studies and is likely to be better accepted and tolerated by patients, clinical investigation is warranted.
Crown Copyright © 2009 Published by Elsevier Ltd on behalf of Chartered Society of Physiotherapy. All rights reserved.
Keywords: Transcutaneous nerve stimulation; Cold pain; Experimental pain; Hypoalgesia
Introduction
Electrical stimulation is a popular treatment used by
physiotherapists for various purposes, including muscle
strengthening, endurance, spasticity management, pain con-
trol, circulation promotion and oedema control [1–4]. Pain
control is the most common use of electrical stimulation,
and the two currents most often used to achieve this inten-
tion are pulsed current, usually referred to as transcutaneous
electrical nerve stimulation (TENS), and burst-modulated,
medium-frequency alternating current (BMAC) in the form
of interferential current (IFC) [1,2].
A literature search was conducted in September 2008 to
locate studies on the effectiveness of TENS and IFC/BMAC
for pain relief. Electronic databases searched were Embase
∗ Corresponding author. Tel.: +61 3 9479 5814; fax: +61 3 9479 5784.
E-mail address: A.Ward@latrobe.edu.au (A.R. Ward).
(1988 to mid-2008), Medline (1966 to mid-2008), Cinahl
(1982 to mid-2008), Sports Discus (1975 to mid-2008),
the Cochrane Library (1970 to mid-2008) and PubMed
(1950 to mid 2008). The search involved four categories
of keywords: ‘transcutaneous electrical stimulation’, ‘inter-
ferential’, ‘burst-modulated alternating current’ and ‘pain’.
Associated synonyms such as ‘TENS’, ‘IFC’, ‘BMAC’ and
‘analgesic’ were also included as keywords. ‘Pain’ or associ-
ated synonyms had to be included in the title or abstract, and
the study had to be laboratory based using experimentally
induced pain. Using these criteria, 18 relevant articles were
identified. Six of the 18 studies only investigated the anal-
gesic effect of TENS. Of these, five compared TENS with a
placebo (sham) group [5–9], and one [6] compared the effects
of several different TENS frequencies. Each study demon-
strated at least one positive statistically significant (P ≤ 0.05)
outcome measure for the analgesic effectiveness of TENS,
and in every study involving a sham group, there was at least
0031-9406/$ – see front matter. Crown Copyright © 2009 Published by Elsevier Ltd on behalf of Chartered Society of Physiotherapy. All rights reserved.
doi:10.1016/j.physio.2009.06.005
A.R. Ward et al. / Physiotherapy 95 (2009) 280–288 281
Fig. 1. (a) Biphasic pulsed current, (b) rectangular burst-modulated alternating current (BMAC), and (c) BMAC with sinusoidal modulation (interferential
current).
one statistically significant outcome measure supporting an
actual TENS effect rather than a placebo response. Thus, it
appears probable that TENS is an effective electrotherapeutic
treatment for pain management.
The analgesic effects of BMAC were examined in six of
the 18 studies identified. These studies only examined one
particular form of IFC/BMAC, namely IFC. Five of these
studies compared IFC with sham, control and/or pre–post
treatment baseline [10–14]. The remaining study compared
different IFC burst (‘beat’) frequencies with one another [15].
Significant results (P ≤ 0.05) confirming positive analgesic
effects with the use of IFC were identified in three of the
five studies [10,12,16]. Of the other two studies, Tabasam
and Johnson reported that the comparative effect of BMAC
versus sham during treatment cycles was not significant [11].
However, small subject numbers were used, raising the possi-
bility of a type II statistical error as opposed to no true effect.
Stephenson and Walker [14] found no significant differ-
ences when comparing BMAC with control and sham groups
(P = 0.49). However, the study design and small number of
subjects reduces confidence in these results. The balance of
evidence suggests that IFC is also an effective electrother-
apeutic treatment for pain management, but the evidence is
less strong than that for TENS.
Only six of the 18 studies identified directly compared
the effectiveness of TENS and BMAC [16–21]. Four of
the studies compared TENS and IFC with either sham
or control groups [16–19]. Three of these four studies
found significant analgesic effects of both TENS and IFC
[16,18,19], but none found any significant difference between
the TENS and IFC interventions. Johnson and Tabasam
[19] used 100-Hz stimulation and measured a greater effect
with TENS than premodulated IFC. The measured dif-
ference was not statistically significant (P = 0.09), but the
study only had seven participants in each group so the
lack of significance could have been due to low statistical
power. Shanahan et al. [21] reported a similar experimental
study using a crossover design with larger participant num-
bers. They found that TENS at a frequency of 100 Hz
had a greater analgesic effect than premodulated IFC at a
beat frequency of 100 Hz (P = 0.015). The balance of evi-
dence thus indicates that IFC is less effective than TENS.
Ward and Oliver [20] surmised that the lesser analgesic
effect of premodulated IFC might be due to the relatively
long and unpredictable effective burst duration with IFC
(Fig. 1c). They compared the analgesic effectiveness of 4-
millisecond bursts of 1-kHz AC applied at a burst frequency
of 50 Hz with 50-Hz pulsed current (TENS) of the same
phase duration. The study found no significant difference
between TENS and this particular form of BMAC, and
little chance of a type II error (P = 0.39). The authors con-
cluded that the lack of difference between the stimulus types
was due to the short burst duration of the BMAC stimu-
lus.
The published evidence thus suggests that both TENS and
BMAC have a significant analgesic effect; however, there has
been very little research into the comparative effectiveness of
TENS and BMAC treatments and optimum analgesic param-
etersforbothmodalities.Ofthefewcomparativestudies,only
one [21] reported a statistically significant result, with 100-
Hz TENS being more effective than premodulated 100-Hz
IFC. The lack of significant results in previous comparative
282 A.R. Ward et al. / Physiotherapy 95 (2009) 280–288
studies is possibly due to more stringent demands on sta-
tistical power and study design. If both TENS and IFC are
effective in inducing hypoalgesia, it is much more demand-
ing to evaluate whether one is better than the other than it is
to evaluate whether each one alone is effective.
Stimulation parameters
The stimulation parameters for TENS and BMAC/IFC
are different, but they have two important parameters in
common: frequency and phase duration. Frequency is the
number of pulses per second (TENS) or bursts per second
(BMAC). Phase duration is the timed length of individual
pulses for TENS or the duration of pulses within a burst for
BMAC. Conventional TENS is low-frequency (usually less
than 200 Hz) pulsed current with a duration in the range of
20–600 microseconds[4].BMACusedforpaincontrolisAC,
usually with a frequency of 4–5 kHz, a low burst frequency of
50–200 Hz, and a phase duration of 100–125 microseconds
[4].
With a frequency of 4–5 kHz, each phase of BMAC cannot
elicit a nerve impulse due to the absolute refractory period
(period of time following a nerve impulse whereby no stim-
ulus can cause a subsequent action potential) [3,22]. Rather,
successive subthreshold pulses in a burst can summate at
kHz frequencies. Summation refers to successive subthresh-
old pulses of AC pushing a nerve fibre closer to threshold with
each pulse in a burst. Membrane threshold is reached when
successive pulses cause sufficient depolarisation to produce
an action potential. Depolarisation due to summation occurs
more readily at higher kHz frequencies because the mem-
brane has less time to recover between successive pulses.
Summation is responsible for the Gildemeister effect, which
is a decrease in threshold intensity as the burst duration is
increased [3,22].
TENS applied clinically is normally a low-frequency
pulsedcurrentappliedforpainrelief[3].Sensory-levelstimu-
lation is referred to as ‘conventional TENS’, in which sensory
fibres (A␤ fibres) are stimulated. As TENS involves single
pulses applied repetitively, frequency and pulse duration can
be altered without having an effect on one another (Fig. 1a).
BMAC applied clinically consists of bursts of AC with a typ-
ical frequency of 1–10 kHz. The AC bursts are applied at
low frequencies (less than 200 Hz), corresponding to the fre-
quencies used for TENS stimulation. BMAC current can be
delivered in rectangular bursts (Russian and Aussie current
[23], Fig. 1b) or sinusoidally modulated (premodulated IFC,
Fig. 1c).
The two types of BMAC that are in common clinical use
are Russian current and premodulated IFC. Russian current
is 2500-Hz AC delivered in a series of bursts (10-millisecond
burst and a 10-millisecond interval, or 50% duty cycle).
This is similar to Fig. 1b but with equal burst and interburst
intervals [3]. Premodulated IFC is a series of sinusoidally
modulated bursts (Fig. 1c).
A less commonly used form of BMAC is Aussie current
[20]. Aussie current is similar to Russian current in being
burst modulated; however, the bursts are of shorter duration.
Aussie current has a lower burst duration than Russian current
(2–4 milliseconds vs 10 milliseconds) (Fig. 1b). In contrast to
premodulated IFC and Russian current, there is less possibil-
ity of multiple nerve firing during a burst with Aussie current
[20,22].
The present study
A limitation of Ward and Oliver’s study [20] was that
1-kHz AC was used and compared with pulsed current of
the same phase duration (500 microseconds). The parameters
chosen were based on conclusions made earlier [24] regard-
ing torque rather than pain relief. Ward et al. [24] compared
different duty cycles and frequencies of BMAC, and found
that a short burst duration (a low duty cycle of 20–25%) was
most effective for torque production and comfort, and that
1 kHz was the optimum AC frequency for torque production
[24]. However, for pain control, higher AC frequencies (typi-
cally 4 kHz in the form of premodulated IFC) and TENS pulse
durations of less than 500 microseconds are normally used
clinically [3]. Furthermore, the earlier study [24] identified
that 4 kHz, while not optimal for torque production, was best
in terms of producing minimal discomfort. Accordingly, it
was decided to compare the analgesic effectiveness of 50-Hz,
4-millisecond bursts of 4-kHz AC with 50-Hz pulsed current
of the same phase duration (125 microseconds). 50 Hz was
selected based on research by Johnson et al. [6] that com-
pared the analgesic effects of TENS on cold-induced pain
at different frequencies. Frequencies of 10, 20, 40, 80 and
160 Hz were compared. The study found that 40-Hz stimula-
tion was more effective than the other frequencies. A plot of
change in pain threshold versus stimulus frequency [6, Fig.
3] illustrated that maximum pain tolerance was achieved with
frequencies in the range of 40–60 Hz, substantially lower than
the common clinically used frequency of 100 Hz.
The present study utilised a single-blinded, within-group
crossover design. Each subject experienced both TENS and
BMAC on separate days in a randomly allocated predeter-
mined order. A sham group was not included since the aim of
the study was to compare the analgesic difference between
the two modalities, rather than their individual effectiveness
compared with sham stimulation. Pain threshold was the
selected outcome measure since it obtained the most con-
sistent results in previous research, most probably because
the outcome is objective and quantifiable (time).
Method
Participants
Twenty subjects volunteered to participate in the research,
11 females and nine males aged between 19 and 25 years
A.R. Ward et al. / Physiotherapy 95 (2009) 280–288 283
(mean age 21 years, standard deviation ±1.7 years). Poten-
tial participants were excluded if their non-dominant arm
was affected by any orthopaedic, neurological or circulatory
pathology, or if the skin in the area under the elec-
trodes was broken or irritated. Participants were instructed
not to take any analgesic or anti-inflammatory medication
(or apply them as creams or gels to their non-dominant
forearm) in the 12 hours prior to each testing session.
No volunteers were excluded when these criteria were
applied.
Research design
The research design used in this study was based on that
used by Shanahan et al. [21] and Ward and Oliver [20]. This
design increased statistical power by allowing more sub-
jects per group, since subjects participated in both TENS
and BMAC trials. More importantly, the design eliminated
any effect of between-subject variation on the outcome mea-
sures. Individual participant comparisons of the effectiveness
of TENS and BMAC allowed for separation of between-
subject effects and intervention effects. This would not have
been possible had a traditional, independent-groups design
been used. Power calculations were not used to establish the
required number of participants; instead, the numbers used
were the same as in previous studies which demonstrated ade-
quate statistical power using the same experimental design
[20,21].
Subjects received TENS and BMAC on two separate days,
in a randomly allocated order to prevent an order bias effect.
Random allocation was performed prior to testing via sealed
gender-specific envelopes selected by the participant. The
dependent variable was the time to pain threshold (seconds).
This variable allowed comparison with previous research
since it has been used commonly in similar studies. Previous
studies [6,19–21,25] found that the subjective pain intensity
and unpleasantness measures were poor indicators of hypoal-
gesic efficacy. These measures required that participants hold
their hands in ice-cold water for a further 30 seconds after
reaching their pain threshold, after which pain intensity and
unpleasantness were rated by subjects on two, 10-cm visual
analogue scales. Since these measures were such poor indi-
cators of hypoalgesic efficacy, they were not included in the
present study.
Electrical stimulation
Subjects received both TENS and BMAC from the same
purpose-built electrical stimulator; thus, a potential source
of bias was eliminated as participants had no indication
of which intervention they were receiving. A BMAC fre-
quency of 4 kHz was chosen for this study as this is the
frequency commonly used for IFC stimulation [3,4]. At
4 kHz, one sinewave is 250 microseconds, so each phase
(one positive, one negative) of a single cycle has a dura-
tion of 125 microseconds. Therefore, to keep parameters as
constant as possible, the pulse width for the monophasic
TENS current was set at 125 microseconds. Finally, a 4-
millisecond burst duration (20% duty cycle) for BMAC was
selected, since a previous study [24] found that a 20–25%
duty cycle was most comfortable, and the study by Ward
and Oliver [20], which used 1-kHz BMAC, found that a
4-millisecond burst duration was as effective as TENS for
hypoalgesia.
Tworectangular44 × 40 mmconductiverubberelectrodes
were applied to each subject’s forearm using conduc-
tive, adhesive skin mounts (American Imex type 00200)
and connected to the electrical stimulator via leads. The
middle of the anterior electrode was positioned on the
midpoint between the medial epicondyle and the radial
styloid. The middle of the posterior electrode was posi-
tioned on the midpoint between the lateral epicondyle
and the ulnar styloid. This procedure ensured accurate
and standardised electrode placement between sessions and
participants.
Procedure
On arrival, participants were invited to read and sign
the informed consent form approved by the Faculty Human
Ethics Committee. Subjects were then screened for exclu-
sion criteria. Once eligibility had been confirmed and the
informed consent form completed, participants were seated
with their non-dominant arm closest to the water baths. The
non-dominant arm was cleaned with an alcohol swab in order
to remove any oil, dead skin cells or other barriers that may
impede current flow through the skin. Electrodes were then
positioned as described above.
Cold pain induction
Cold-induced pain was administered using two water
baths of uniform size and shape, one maintained at 37 ◦C
and the other at 0 ◦C (±0.2 ◦C). A Heidolph heater stirrer
unit (Accurex Equipment, Brunswick, Victoria, Australia)
was used in each bath to ensure that temperatures were kept
constant. The temperature of each bath was checked rou-
tinely at 5-minute intervals with a thermometer. A digital
stopwatch was used during the procedure to measure 5-
minute increments and the time to pain threshold (seconds).
The cold pain method was based on that used in previous
research [6,10,19–21]. On the ‘Start’ command, the par-
ticipant placed their hand into the 37 ◦C water bath down
to the distal wrist crease. The participant’s hand remained
in the bath for 5 minutes in order to standardise the hand
temperature between sessions and across participants. The
subject was then instructed to move their hand into the 0 ◦C
water bath, again down to the distal wrist crease. The par-
ticipant was asked to concentrate on the sensations of the
hand until they felt the onset of a deep, dull aching pain,
at which time the subject was to state ‘Pain’ and withdraw
their hand from the water. The time from hand immer-
284 A.R. Ward et al. / Physiotherapy 95 (2009) 280–288
sion to pain was recorded as the pain threshold (seconds).
After removing their hand from the bath, it was placed on
a table to rest at room temperature for the remainder of the
5 minutes since the beginning of the hand immersion in the
0 ◦C bath. At this point (completion of the 10-minute cycle),
the next cycle was commenced, with hand immersion back
into the 37 ◦C bath. In total, six cycles were performed per
session.
Electrical stimulation
Electrical stimulation was applied via the electrodes
attached to the participant’s forearm. The electrical stimula-
tion, either TENS or BMAC depending on random allocation,
commenced at the beginning of Cycle 3 and continued unin-
terruptedly until the conclusion of Cycle 4, i.e. 20 minutes in
total. The stimulation intensity was increased by the instruc-
tor until the participant felt the sensation was strong but
comfortable, but never above the motor threshold. If a motor
response was detected, the intensity was reduced to eliminate
any muscle contraction. The subject was asked at 1-minute
intervals whether the stimulation remained strong but com-
fortable, or whether it needed to be adjusted in order to fit this
description. The stimulation was not adjusted at all during
cold water immersion.
At the conclusion of the first session, the participants
were advised against taking analgesics or anti-inflammatory
medication, or applying anti-inflammatory cream to the non-
dominant (tested) arm in the 12 hours prior to the following
session.
The second session was conducted no earlier than 12 hours
followingtheinitialtestingprocedureinordertominimisethe
risk of a carry-over effect. The second session was identical
to the first; however, the alternate modality was utilised. At
the end of the second testing session, participants were asked
two questions: ‘Which of the two modalities, if either, seemed
more effective?’ and ‘Which of the two modalities, if either,
felt more comfortable?’ The subjects were also given the
opportunity to make any other comments.
Analysis
Pain threshold
Statistical analyses were performed using Statistical Pack-
age for the Social Sciences Version 14 (SPSS Inc., Chicago,
IL, USA). Prior to analysis, participants were excluded if
the pain threshold during one or more of the six cycles was
300 seconds or more. These results were excludable outliers,
since 300 seconds was 4.2 standard deviations from the mean
(69 seconds in the present study). Furthermore, immersion in
cold water for a minimum of 300 seconds eliminated recovery
time before the start of the following cycle, and thus unless
eliminated may have confounded the results by producing a
carry-over effect.
Pain threshold data for TENS and BMAC were first
analysed separately. Since individual pain thresholds vary
largely, as demonstrated previously [20,21], pain threshold
changes in this study were analysed for each of TENS and
BMAC using a two factor without replication analysis of
variance (ANOVA) in order to separate between-subject and
intervention effects. Post-hoc t-tests were then carried out
and confidence intervals (CI) were calculated to establish
whether the observed intervention effects were statistically
significant. The pain threshold during each type of electri-
cal stimulation (T3 and T4 averaged) was compared with
the baseline pain threshold (T1 and T2 averaged) using a
two-tailed paired t-test. Averaging of intervention data (T3
and T4) was performed since the aim of this study was to
compare the intervention effect of two modalities, rather
than the effect of time on the intervention. This method
was also used to increase statistical power and avoid a large
Bonferroni correction as a result of multiple comparisons.
The same method was applied to the post-intervention data
(T5 and T6 averaged) compared with the baseline threshold.
Since two comparisons were made with baseline (T3 and T4
average, T5 and T6 average), a Bonferroni-corrected accept-
able P-value of 0.05/2 = 0.025 was used and 97.5%CI were
calculated.
In order to establish whether there was a significant dif-
ference between the interventions and whether the effects
of each modality were greater at T4 than T3, a two-way
repeated-measures ANOVA (cycle × intervention type) was
calculated. The pre-intervention data (T1 and T2 averaged)
were subtracted from each of the with-intervention mea-
sures (T3 and T4) and the differences were used for the
analysis.
Results
The outcome measures analysed were pain threshold (time
to pain tolerance limit, measured in seconds) and subjec-
tive comments regarding effectiveness and comfort of each
type of stimulation. These measures were used to test three
hypotheses: (a) that both forms of electrical stimulation ele-
vate pain threshold; (b) that TENS and BMAC are equally
effective;and(c)thatBMACismorecomfortablethanTENS.
When the exclusion criteria were applied, three of the 20 sub-
jects were excluded from the study since they failed to reach
their pain thresholds within 5 minutes of ice-cold immersion
during one or more of the allocated measurement cycles. It
is worth noting that two of the three excluded subjects only
exceeded the 5-minute pain threshold whilst electrical stim-
ulation was applied (one with TENS, one with BMAC). The
data set therefore included 17 subjects for analysis.
Pain threshold
Pain threshold data were analysed in terms of change
from baseline to the time of pain tolerance limit for each
A.R. Ward et al. / Physiotherapy 95 (2009) 280–288 285
Table 1
Group-averagedpainthresholdchangesfrombaselineforCycles3–6.Values
shown are mean ± standard deviation.
Cycle Threshold change
TENS (seconds)
Threshold change
BMAC (seconds)
T3 14.1 ± 23.8 14.7 ± 21.4
T4 16.8 ± 27.4 15.6 ± 24.8
T5 −6.0 ± 20.8 −3.5 ± 13.0
T6 −5.2 ± 25.6 5.3 ± 23.7
TENS, transcutaneous electrical nerve stimulation; BMAC, burst-modulated
medium-frequency alternating current.
modality. Baseline was calculated as the average time (sec-
onds) to pain threshold during Cycles 1 and 2 (T1 and T2).
Change in pain threshold during Cycles 3–6 was calculated
by subtracting the baseline value from the Cycle 3–6 pain
threshold values (T3–T6). Table 1 shows the average change
from baseline (mean ± standard deviation) for Cycles 3–6 for
both interventions.
In Cycle 3, BMAC thresholds were increased, on aver-
age, by 14.7 seconds and TENS thresholds were increased
by 14.1 seconds. Both the TENS and BMAC pain thresh-
olds were greater during Cycle 4 than Cycle 3; TENS by
a further 2.7 seconds and BMAC by 0.9 seconds. Although
the Cycle 4 rise in pain threshold was not as great as that
between baseline and Cycle 3, it does suggest that the
longer the stimulation is applied, the greater the elevation
in pain threshold. The pain threshold during stimulation
(T3 and T4 averaged) was elevated by 15.2 seconds (22%
increase) with TENS and 15.5 seconds (25% increase) with
BMAC.
Once the electrical stimulation was switched off at the
end of Cycle 4, thresholds returned close to baseline. Both
TENS and BMAC pain threshold values fell below base-
line at T5, suggesting no carry-over effect of TENS and
BMAC immediately following stimulation. Pain threshold
changes from baseline continued to remain low during the
final cycle, with T6 for TENS averaging below baseline
and T6 for BMAC averaging above baseline. The variation
observed most likely represents the inherent experimental
error.
Statistical analysis
Intervention effects
The hypotheses of this study were tested using a two
factor (subject × intervention) without replication ANOVA
for each modality to first determine whether an interven-
tion effect was present by separating between-subject and
between-intervention effects. The data were not normally
distributed, and a Huynh-Feldt correction of 0.67 for TENS
and 0.60 for BMAC was required. Both modalities pro-
duced statistically significant intervention effects (TENS:
F(5,16) = 4.75, P = 0.004; BMAC: F(5,16) = 4.28, P = 0.009).
Between-subject effects for both modalities were also found
to be highly significant, presumably because pain thresh-
olds vary greatly between individuals (TENS: F(16,5) = 22.52,
P < 0.001; BMAC: F(16,5) = 24.46, P < 0.001). The lower P-
values indicate that the large standard deviations of each
mean (Table 1) were mainly due to between-subject effects.
Post-hoc tests (paired t-tests) were conducted to answer
two questions: is there a significant intervention effect and
is there a significant carry-over (post-intervention) effect?
To minimise the number of post hoc tests and thus avoid
the need for a large Bonferroni correction, pre-intervention
data (T1 and T2) were averaged, as were the during-
intervention measures (T3 and T4) and post-intervention
measures (T5 and T6). Two paired t-tests were then con-
ducted using a Bonferroni-corrected acceptable P-value of
0.05/2 = 0.025 and 97.5%CI were calculated. Comparing the
pre- and during-intervention averages, a significant interven-
tion effect was found (TENS: 15.4 seconds, 97.5%CI 2.5
to 28.4, P = 0.017; BMAC: 15.2 seconds, 97.5%CI 3.1 to
27.2,P = 0.012).Nosignificantdifferencewasfoundbetween
pre- and post-intervention measures (TENS: −5.6 seconds,
97.5%CI −18.0 to 6.8, P = 0.324; BMAC: 0.9 seconds,
97.5%CI −7.7 to 9.6, P = 0.816).
Data were analysed to establish whether either form
of stimulation produced a greater intervention effect and
whether the effects were greater at T4 than T3. Each
participant’s increase in pain threshold was calculated by
averaging the pre-intervention baseline measures (T1 and
T2) and subtracting this from each of the with-intervention
measures (T3 and T4). The increases were used in a
two-way repeated-measures ANOVA (cycle × intervention).
Data for post-intervention measures (T5 and T6) were not
used at this stage of the analysis, as there was no carry-
over (pre- vs post-intervention) effect with either form of
stimulation so any further comparison would be meaning-
less.
The ANOVA established that the between-cycle dif-
ferences (T3 vs T4) were not statistically significant
(F(1,16) = 0.094, P = 0.76), and that between-intervention
effects were not only not significantly different, but TENS
and BMAC were ‘significantly the same’ (F(1,16) = 0.002,
P = 0.97, mean difference = 0.3 seconds, CI −15.3 to 15.9).
When P-values are in the range 0.05–0.95, an acceptable con-
clusion is that there is no significant difference. It cannot,
however, be concluded that the intervention effects are the
same without risking making a type II error. When a P-value
greater than 0.95 is obtained (1 − ␣ < 0.05), the equivalence
of the interventions is considered to be statistically significant
as the risk of a type II statistical error is acceptably minimised
[26].
Comfort of stimulation
At the end of the second session, participants were asked
which of the two types of intervention felt most comfortable.
A majority preferring BMAC was evident. Twelve subjects
286 A.R. Ward et al. / Physiotherapy 95 (2009) 280–288
(71%) reported BMAC to be the most comfortable, and the
remaining five (29%) felt that TENS was the most comfort-
able.
Effectiveness of stimulation
At the end of the second session, participants were also
asked which modality felt more effective for pain relief.
Ten subjects (58%) reported that BMAC was most effec-
tive, three (18%) felt that TENS was the most effective,
and four (24%) reported that both interventions were equally
effective.
Discussion
Hypoalgesic efficacy
The results clearly demonstrate a significant interven-
tion effect for both TENS and BMAC with P-values of
0.017 and 0.012, respectively. These findings confirm the
first hypothesis that both modalities elevate the cold pain
threshold.
The main aim of this study, however, was to compare the
analgesic effectiveness of one particular form of BMAC (4-
kHz AC with a 4-millisecond burst duration) with TENS of
the same phase duration (125 microseconds) and frequency
(50 Hz). TENS and BMAC were found to be statistically
equivalent in elevating the cold-induced pain threshold in
healthy subjects. The P-value obtained (P = 0.97) allows the
conclusion that TENS and BMAC are equally effective in
pain modulation. With these results, one can be confident that
a type II error has not occurred, i.e. a false-negative result,
since the P-value falls outside the conventionally accepted
questionable range (0.05–0.95).
These results provide an important contribution to the
existing literature, since no previous research has compared
theanalgesiceffectivenessofpulsedcurrent(TENS)withthat
of 4-kHz AC with a 4-millisecond burst duration (BMAC) at
the same frequency and using the same phase duration. The
present results support the findings of Ward and Oliver [20]
who used a different AC frequency (1 kHz) but the same 4-
millisecond burst duration and 50-Hz burst/pulse frequency,
and found that with short burst durations for BMAC, the
modalities were equally effective in elevating pain threshold.
In contrast, Shanahan et al. [21] found that TENS (100-Hz
pulsed current) was significantly more effective than pre-
modulated interferential current (5-kHz AC, modulated at
100 Hz) in elevating pain threshold. ‘Premodulated interfer-
ential current’ as used in the study by Shanahan et al. [21]
was sinusoidally modulated (Fig. 1c) so, strictly speaking,
the duty cycle is effectively 100%, as the intensity only drops
to zero instantaneously between each burst. The burst dura-
tion is maximum (20 milliseconds) and the effective burst
duration (i.e. the time that the stimulus is above any effec-
tive threshold) is difficult to predict but, for most nerve
fibres, it would be much larger than the 4-millisecond burst
duration used in the present study and that of Ward and
Oliver [20].
The difference between the present findings and those of
Shanahan et al. [21] can be explained in terms of different
nerve fibre firing rates produced by the two forms of electrical
stimulation. The authors hypothesise that with long bursts of
AC, as used with premodulated interferential currents, sen-
sory nerve fibres fire multiple times during each burst, i.e.
during a burst, sensory fibres undergo repeated cycles of fir-
ing, recovering and firing again. Hence the sensory nerve
firing rate will be some multiple of the burst frequency. While
stimulationat50or100 Hzisbeneficialforhypoalgesia,stim-
ulation at higher multiples (150, 200, 250. . . Hz) might not be
as effective. This seems to be a reasonable, physiologically
based assumption, but only one study has actually tested this
hypothesis and examined a wide range of TENS stimula-
tion frequencies (10–160 Hz). Johnson et al. [6] found that
higher frequencies of pulsed current (above 50 Hz) resulted in
a lesser hypoalgesic effect. The between-frequencies differ-
ences in the study by Johnson et al. [6] were not statistically
significant, possibly due to the small sample size, but a down-
ward trend is clearly evident above 40 Hz. Since the present
studyandapreviousstudy[20]havefoundthatshort-duration
burst-modulated AC is as effective as pulsed current (TENS)
in elevating pain threshold, the authors speculate that a short
burst duration prevents or severely restricts multiple firing of
sensory nerve fibres, and instead produces one action poten-
tial per burst. The hypoalgesic effects are thus equivalent to
TENS.
Subjective comments
The majority of participants subjectively reported that
BMAC was more effective and comfortable than TENS,
thus supporting the original hypothesis. The results are in
accordance with previous studies [20,21,23], which reported
BMAC to be significantly more comfortable than TENS. The
current results and previous TENS and BMAC comparative
studies strengthen the conclusion drawn by Ward et al. [24]
that low-duty-cycle, burst-modulated AC is more comfort-
able than conventional low-frequency pulsed current.
Clinical implications
The present research demonstrates that the particular
forms of TENS and BMAC which were compared are equally
effective, in fact ‘statistically the same’, at elevating the pain
threshold in healthy subjects. Furthermore, since previous
research by Shanahan et al. [21] found that TENS was signif-
icantly more effective than premodulated IFC, one can infer,
with a degree of confidence, that this form of BMAC also has
greater hypoalgesic effects than premodulated IFC.
However, whilst the objective effectiveness of a modal-
ity is an important component of the patient experience,
A.R. Ward et al. / Physiotherapy 95 (2009) 280–288 287
there are other factors that influence the efficacy of the treat-
ment. Patient-perceived comfort and effectiveness are two
other factors. There was a definite preference for BMAC
in terms of both perceived comfort and effectiveness. This
result combined with previous research [20,21,23] suggests
the likelihood of greater patient acceptance and compliance
with BMAC, since it is perceived to be more comfortable and
effective. Therefore, it is concluded that BMAC utilising a 4-
millisecond burst duration should be used clinically for the
treatment of acute pain because it is as effective as TENS in
hypoalgesic effects but is reportedly more comfortable, and
thus provides an overall improved patient experience. A third
factor is the expense of treating a patient with IFC in a clinic
using a mains-powered, high-output machine compared with
the home use of a portable TENS machine and the inconve-
nience of the patient travelling to a clinic for every treatment.
In the case of low back or neck pain, the travelling runs the
risk of undoing any gains made by the treatment. TENS-like,
portable BMAC machines could provide the convenience of
safe, home treatment between clinical consultations.
Conclusion
The major conclusion of the present study is that 50-Hz
TENS with a 125-microsecond pulse duration and 4-kHz
BMAC with a 4-millisecond burst duration (20% duty cycle)
are equally effective in elevating cold-induced pain in healthy
subjects. However, BMAC is subjectively reported to be more
comfortable and effective. It is therefore recommended that
BMAC in the form of 4-millisecond bursts should be trialled
clinically since greater patient compliance and acceptance of
the treatment is a likely consequence of the lesser discomfort.
TENS machines have long been established as a useful
treatment tool since they are effective in elevating pain
threshold and are a cheap and portable option for home use.
The present findings suggest that ‘take home’ TENS units
would be more successful if they delivered 4-kHz BMAC
with a 4-millisecond burst duration rather than pulsed current.
Ethical approval: Human Research Ethics Committee
of the Faculty of Health Sciences, La Trobe University.
Approval number FHEC06/160.
Funding: Research grants from the Faculty of Health
Sciences, La Trobe University and the School of Human
Biosciences, La Trobe University.
Conflict of interest: None declared.
References
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[3] Robertson VJ, Ward AR, Low J, Reed A. Electrotherapy explained:
principles and practice. 4th ed. Oxford: Butterworth–Heinemann; 2006.
[4] Selkowitz D. Electrical currents. In: Cameron M, editor. Physical agents
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stimulation characteristics for altering pain perception. Phys Ther
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[6] Johnson MI, Ashton CH, Bousfield DR, Thompson JW. Analgesic
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[7] Simmonds M, Wessel J, Scudds R. The effect of pain quality on the
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[10] Johnson MI, Wilson H. The analgesic effects of different swing pat-
terns of interferential currents on cold-induced pain. Physiotherapy
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Available online at www.sciencedirect.com

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A Comparison of the Analgesic Efficacy of medium-frequency alternating Current and TENS 2009

  • 1. Physiotherapy 95 (2009) 280–288 A comparison of the analgesic efficacy of medium-frequency alternating current and TENS Alex R. Ward∗, Stacey Lucas-Toumbourou, Brigid McCarthy Musculoskeletal Research Centre, Faculty of Health Sciences, La Trobe University, Victoria 3086, Australia Abstract Objective To compare the analgesic efficacy of burst-modulated medium-frequency alternating current (BMAC) and transcutaneous electrical nerve stimulation (TENS) using an experimental cold pain model. Design Within-group crossover study. Setting A university research laboratory. Participants Twenty healthy subjects. Interventions BMAC (4-kHz AC applied in 4-millisecond bursts at 50 Hz) and TENS (125-microsecond phase duration applied at a frequency of 50 Hz) administered to each participant on separate occasions. Main outcome measure Time to cold pain threshold. Results The mean time to cold pain threshold with the BMAC intervention was no different than with TENS. Statistical analysis showed that both interventions elevated the cold pain threshold significantly [BMAC: increase = 15.2 seconds, 97.5% confidence interval (CI) 3.1 to 27.2, P = 0.01; TENS: increase = 15.4 seconds, 97.5%CI 2.5 to 28.4, P = 0.02], and the difference between interventions was not simply insignificant but the intervention effects were ‘significantly the same’ (mean difference = 0.3 seconds, 95%CI −15.3 to 15.9, P = 0.97). Conclusions BMAC is as effective as TENS in increasing cold pain thresholds in healthy subjects. Since BMAC has been shown to be more comfortable than TENS in previous studies and is likely to be better accepted and tolerated by patients, clinical investigation is warranted. Crown Copyright © 2009 Published by Elsevier Ltd on behalf of Chartered Society of Physiotherapy. All rights reserved. Keywords: Transcutaneous nerve stimulation; Cold pain; Experimental pain; Hypoalgesia Introduction Electrical stimulation is a popular treatment used by physiotherapists for various purposes, including muscle strengthening, endurance, spasticity management, pain con- trol, circulation promotion and oedema control [1–4]. Pain control is the most common use of electrical stimulation, and the two currents most often used to achieve this inten- tion are pulsed current, usually referred to as transcutaneous electrical nerve stimulation (TENS), and burst-modulated, medium-frequency alternating current (BMAC) in the form of interferential current (IFC) [1,2]. A literature search was conducted in September 2008 to locate studies on the effectiveness of TENS and IFC/BMAC for pain relief. Electronic databases searched were Embase ∗ Corresponding author. Tel.: +61 3 9479 5814; fax: +61 3 9479 5784. E-mail address: A.Ward@latrobe.edu.au (A.R. Ward). (1988 to mid-2008), Medline (1966 to mid-2008), Cinahl (1982 to mid-2008), Sports Discus (1975 to mid-2008), the Cochrane Library (1970 to mid-2008) and PubMed (1950 to mid 2008). The search involved four categories of keywords: ‘transcutaneous electrical stimulation’, ‘inter- ferential’, ‘burst-modulated alternating current’ and ‘pain’. Associated synonyms such as ‘TENS’, ‘IFC’, ‘BMAC’ and ‘analgesic’ were also included as keywords. ‘Pain’ or associ- ated synonyms had to be included in the title or abstract, and the study had to be laboratory based using experimentally induced pain. Using these criteria, 18 relevant articles were identified. Six of the 18 studies only investigated the anal- gesic effect of TENS. Of these, five compared TENS with a placebo (sham) group [5–9], and one [6] compared the effects of several different TENS frequencies. Each study demon- strated at least one positive statistically significant (P ≤ 0.05) outcome measure for the analgesic effectiveness of TENS, and in every study involving a sham group, there was at least 0031-9406/$ – see front matter. Crown Copyright © 2009 Published by Elsevier Ltd on behalf of Chartered Society of Physiotherapy. All rights reserved. doi:10.1016/j.physio.2009.06.005
  • 2. A.R. Ward et al. / Physiotherapy 95 (2009) 280–288 281 Fig. 1. (a) Biphasic pulsed current, (b) rectangular burst-modulated alternating current (BMAC), and (c) BMAC with sinusoidal modulation (interferential current). one statistically significant outcome measure supporting an actual TENS effect rather than a placebo response. Thus, it appears probable that TENS is an effective electrotherapeutic treatment for pain management. The analgesic effects of BMAC were examined in six of the 18 studies identified. These studies only examined one particular form of IFC/BMAC, namely IFC. Five of these studies compared IFC with sham, control and/or pre–post treatment baseline [10–14]. The remaining study compared different IFC burst (‘beat’) frequencies with one another [15]. Significant results (P ≤ 0.05) confirming positive analgesic effects with the use of IFC were identified in three of the five studies [10,12,16]. Of the other two studies, Tabasam and Johnson reported that the comparative effect of BMAC versus sham during treatment cycles was not significant [11]. However, small subject numbers were used, raising the possi- bility of a type II statistical error as opposed to no true effect. Stephenson and Walker [14] found no significant differ- ences when comparing BMAC with control and sham groups (P = 0.49). However, the study design and small number of subjects reduces confidence in these results. The balance of evidence suggests that IFC is also an effective electrother- apeutic treatment for pain management, but the evidence is less strong than that for TENS. Only six of the 18 studies identified directly compared the effectiveness of TENS and BMAC [16–21]. Four of the studies compared TENS and IFC with either sham or control groups [16–19]. Three of these four studies found significant analgesic effects of both TENS and IFC [16,18,19], but none found any significant difference between the TENS and IFC interventions. Johnson and Tabasam [19] used 100-Hz stimulation and measured a greater effect with TENS than premodulated IFC. The measured dif- ference was not statistically significant (P = 0.09), but the study only had seven participants in each group so the lack of significance could have been due to low statistical power. Shanahan et al. [21] reported a similar experimental study using a crossover design with larger participant num- bers. They found that TENS at a frequency of 100 Hz had a greater analgesic effect than premodulated IFC at a beat frequency of 100 Hz (P = 0.015). The balance of evi- dence thus indicates that IFC is less effective than TENS. Ward and Oliver [20] surmised that the lesser analgesic effect of premodulated IFC might be due to the relatively long and unpredictable effective burst duration with IFC (Fig. 1c). They compared the analgesic effectiveness of 4- millisecond bursts of 1-kHz AC applied at a burst frequency of 50 Hz with 50-Hz pulsed current (TENS) of the same phase duration. The study found no significant difference between TENS and this particular form of BMAC, and little chance of a type II error (P = 0.39). The authors con- cluded that the lack of difference between the stimulus types was due to the short burst duration of the BMAC stimu- lus. The published evidence thus suggests that both TENS and BMAC have a significant analgesic effect; however, there has been very little research into the comparative effectiveness of TENS and BMAC treatments and optimum analgesic param- etersforbothmodalities.Ofthefewcomparativestudies,only one [21] reported a statistically significant result, with 100- Hz TENS being more effective than premodulated 100-Hz IFC. The lack of significant results in previous comparative
  • 3. 282 A.R. Ward et al. / Physiotherapy 95 (2009) 280–288 studies is possibly due to more stringent demands on sta- tistical power and study design. If both TENS and IFC are effective in inducing hypoalgesia, it is much more demand- ing to evaluate whether one is better than the other than it is to evaluate whether each one alone is effective. Stimulation parameters The stimulation parameters for TENS and BMAC/IFC are different, but they have two important parameters in common: frequency and phase duration. Frequency is the number of pulses per second (TENS) or bursts per second (BMAC). Phase duration is the timed length of individual pulses for TENS or the duration of pulses within a burst for BMAC. Conventional TENS is low-frequency (usually less than 200 Hz) pulsed current with a duration in the range of 20–600 microseconds[4].BMACusedforpaincontrolisAC, usually with a frequency of 4–5 kHz, a low burst frequency of 50–200 Hz, and a phase duration of 100–125 microseconds [4]. With a frequency of 4–5 kHz, each phase of BMAC cannot elicit a nerve impulse due to the absolute refractory period (period of time following a nerve impulse whereby no stim- ulus can cause a subsequent action potential) [3,22]. Rather, successive subthreshold pulses in a burst can summate at kHz frequencies. Summation refers to successive subthresh- old pulses of AC pushing a nerve fibre closer to threshold with each pulse in a burst. Membrane threshold is reached when successive pulses cause sufficient depolarisation to produce an action potential. Depolarisation due to summation occurs more readily at higher kHz frequencies because the mem- brane has less time to recover between successive pulses. Summation is responsible for the Gildemeister effect, which is a decrease in threshold intensity as the burst duration is increased [3,22]. TENS applied clinically is normally a low-frequency pulsedcurrentappliedforpainrelief[3].Sensory-levelstimu- lation is referred to as ‘conventional TENS’, in which sensory fibres (A␤ fibres) are stimulated. As TENS involves single pulses applied repetitively, frequency and pulse duration can be altered without having an effect on one another (Fig. 1a). BMAC applied clinically consists of bursts of AC with a typ- ical frequency of 1–10 kHz. The AC bursts are applied at low frequencies (less than 200 Hz), corresponding to the fre- quencies used for TENS stimulation. BMAC current can be delivered in rectangular bursts (Russian and Aussie current [23], Fig. 1b) or sinusoidally modulated (premodulated IFC, Fig. 1c). The two types of BMAC that are in common clinical use are Russian current and premodulated IFC. Russian current is 2500-Hz AC delivered in a series of bursts (10-millisecond burst and a 10-millisecond interval, or 50% duty cycle). This is similar to Fig. 1b but with equal burst and interburst intervals [3]. Premodulated IFC is a series of sinusoidally modulated bursts (Fig. 1c). A less commonly used form of BMAC is Aussie current [20]. Aussie current is similar to Russian current in being burst modulated; however, the bursts are of shorter duration. Aussie current has a lower burst duration than Russian current (2–4 milliseconds vs 10 milliseconds) (Fig. 1b). In contrast to premodulated IFC and Russian current, there is less possibil- ity of multiple nerve firing during a burst with Aussie current [20,22]. The present study A limitation of Ward and Oliver’s study [20] was that 1-kHz AC was used and compared with pulsed current of the same phase duration (500 microseconds). The parameters chosen were based on conclusions made earlier [24] regard- ing torque rather than pain relief. Ward et al. [24] compared different duty cycles and frequencies of BMAC, and found that a short burst duration (a low duty cycle of 20–25%) was most effective for torque production and comfort, and that 1 kHz was the optimum AC frequency for torque production [24]. However, for pain control, higher AC frequencies (typi- cally 4 kHz in the form of premodulated IFC) and TENS pulse durations of less than 500 microseconds are normally used clinically [3]. Furthermore, the earlier study [24] identified that 4 kHz, while not optimal for torque production, was best in terms of producing minimal discomfort. Accordingly, it was decided to compare the analgesic effectiveness of 50-Hz, 4-millisecond bursts of 4-kHz AC with 50-Hz pulsed current of the same phase duration (125 microseconds). 50 Hz was selected based on research by Johnson et al. [6] that com- pared the analgesic effects of TENS on cold-induced pain at different frequencies. Frequencies of 10, 20, 40, 80 and 160 Hz were compared. The study found that 40-Hz stimula- tion was more effective than the other frequencies. A plot of change in pain threshold versus stimulus frequency [6, Fig. 3] illustrated that maximum pain tolerance was achieved with frequencies in the range of 40–60 Hz, substantially lower than the common clinically used frequency of 100 Hz. The present study utilised a single-blinded, within-group crossover design. Each subject experienced both TENS and BMAC on separate days in a randomly allocated predeter- mined order. A sham group was not included since the aim of the study was to compare the analgesic difference between the two modalities, rather than their individual effectiveness compared with sham stimulation. Pain threshold was the selected outcome measure since it obtained the most con- sistent results in previous research, most probably because the outcome is objective and quantifiable (time). Method Participants Twenty subjects volunteered to participate in the research, 11 females and nine males aged between 19 and 25 years
  • 4. A.R. Ward et al. / Physiotherapy 95 (2009) 280–288 283 (mean age 21 years, standard deviation ±1.7 years). Poten- tial participants were excluded if their non-dominant arm was affected by any orthopaedic, neurological or circulatory pathology, or if the skin in the area under the elec- trodes was broken or irritated. Participants were instructed not to take any analgesic or anti-inflammatory medication (or apply them as creams or gels to their non-dominant forearm) in the 12 hours prior to each testing session. No volunteers were excluded when these criteria were applied. Research design The research design used in this study was based on that used by Shanahan et al. [21] and Ward and Oliver [20]. This design increased statistical power by allowing more sub- jects per group, since subjects participated in both TENS and BMAC trials. More importantly, the design eliminated any effect of between-subject variation on the outcome mea- sures. Individual participant comparisons of the effectiveness of TENS and BMAC allowed for separation of between- subject effects and intervention effects. This would not have been possible had a traditional, independent-groups design been used. Power calculations were not used to establish the required number of participants; instead, the numbers used were the same as in previous studies which demonstrated ade- quate statistical power using the same experimental design [20,21]. Subjects received TENS and BMAC on two separate days, in a randomly allocated order to prevent an order bias effect. Random allocation was performed prior to testing via sealed gender-specific envelopes selected by the participant. The dependent variable was the time to pain threshold (seconds). This variable allowed comparison with previous research since it has been used commonly in similar studies. Previous studies [6,19–21,25] found that the subjective pain intensity and unpleasantness measures were poor indicators of hypoal- gesic efficacy. These measures required that participants hold their hands in ice-cold water for a further 30 seconds after reaching their pain threshold, after which pain intensity and unpleasantness were rated by subjects on two, 10-cm visual analogue scales. Since these measures were such poor indi- cators of hypoalgesic efficacy, they were not included in the present study. Electrical stimulation Subjects received both TENS and BMAC from the same purpose-built electrical stimulator; thus, a potential source of bias was eliminated as participants had no indication of which intervention they were receiving. A BMAC fre- quency of 4 kHz was chosen for this study as this is the frequency commonly used for IFC stimulation [3,4]. At 4 kHz, one sinewave is 250 microseconds, so each phase (one positive, one negative) of a single cycle has a dura- tion of 125 microseconds. Therefore, to keep parameters as constant as possible, the pulse width for the monophasic TENS current was set at 125 microseconds. Finally, a 4- millisecond burst duration (20% duty cycle) for BMAC was selected, since a previous study [24] found that a 20–25% duty cycle was most comfortable, and the study by Ward and Oliver [20], which used 1-kHz BMAC, found that a 4-millisecond burst duration was as effective as TENS for hypoalgesia. Tworectangular44 × 40 mmconductiverubberelectrodes were applied to each subject’s forearm using conduc- tive, adhesive skin mounts (American Imex type 00200) and connected to the electrical stimulator via leads. The middle of the anterior electrode was positioned on the midpoint between the medial epicondyle and the radial styloid. The middle of the posterior electrode was posi- tioned on the midpoint between the lateral epicondyle and the ulnar styloid. This procedure ensured accurate and standardised electrode placement between sessions and participants. Procedure On arrival, participants were invited to read and sign the informed consent form approved by the Faculty Human Ethics Committee. Subjects were then screened for exclu- sion criteria. Once eligibility had been confirmed and the informed consent form completed, participants were seated with their non-dominant arm closest to the water baths. The non-dominant arm was cleaned with an alcohol swab in order to remove any oil, dead skin cells or other barriers that may impede current flow through the skin. Electrodes were then positioned as described above. Cold pain induction Cold-induced pain was administered using two water baths of uniform size and shape, one maintained at 37 ◦C and the other at 0 ◦C (±0.2 ◦C). A Heidolph heater stirrer unit (Accurex Equipment, Brunswick, Victoria, Australia) was used in each bath to ensure that temperatures were kept constant. The temperature of each bath was checked rou- tinely at 5-minute intervals with a thermometer. A digital stopwatch was used during the procedure to measure 5- minute increments and the time to pain threshold (seconds). The cold pain method was based on that used in previous research [6,10,19–21]. On the ‘Start’ command, the par- ticipant placed their hand into the 37 ◦C water bath down to the distal wrist crease. The participant’s hand remained in the bath for 5 minutes in order to standardise the hand temperature between sessions and across participants. The subject was then instructed to move their hand into the 0 ◦C water bath, again down to the distal wrist crease. The par- ticipant was asked to concentrate on the sensations of the hand until they felt the onset of a deep, dull aching pain, at which time the subject was to state ‘Pain’ and withdraw their hand from the water. The time from hand immer-
  • 5. 284 A.R. Ward et al. / Physiotherapy 95 (2009) 280–288 sion to pain was recorded as the pain threshold (seconds). After removing their hand from the bath, it was placed on a table to rest at room temperature for the remainder of the 5 minutes since the beginning of the hand immersion in the 0 ◦C bath. At this point (completion of the 10-minute cycle), the next cycle was commenced, with hand immersion back into the 37 ◦C bath. In total, six cycles were performed per session. Electrical stimulation Electrical stimulation was applied via the electrodes attached to the participant’s forearm. The electrical stimula- tion, either TENS or BMAC depending on random allocation, commenced at the beginning of Cycle 3 and continued unin- terruptedly until the conclusion of Cycle 4, i.e. 20 minutes in total. The stimulation intensity was increased by the instruc- tor until the participant felt the sensation was strong but comfortable, but never above the motor threshold. If a motor response was detected, the intensity was reduced to eliminate any muscle contraction. The subject was asked at 1-minute intervals whether the stimulation remained strong but com- fortable, or whether it needed to be adjusted in order to fit this description. The stimulation was not adjusted at all during cold water immersion. At the conclusion of the first session, the participants were advised against taking analgesics or anti-inflammatory medication, or applying anti-inflammatory cream to the non- dominant (tested) arm in the 12 hours prior to the following session. The second session was conducted no earlier than 12 hours followingtheinitialtestingprocedureinordertominimisethe risk of a carry-over effect. The second session was identical to the first; however, the alternate modality was utilised. At the end of the second testing session, participants were asked two questions: ‘Which of the two modalities, if either, seemed more effective?’ and ‘Which of the two modalities, if either, felt more comfortable?’ The subjects were also given the opportunity to make any other comments. Analysis Pain threshold Statistical analyses were performed using Statistical Pack- age for the Social Sciences Version 14 (SPSS Inc., Chicago, IL, USA). Prior to analysis, participants were excluded if the pain threshold during one or more of the six cycles was 300 seconds or more. These results were excludable outliers, since 300 seconds was 4.2 standard deviations from the mean (69 seconds in the present study). Furthermore, immersion in cold water for a minimum of 300 seconds eliminated recovery time before the start of the following cycle, and thus unless eliminated may have confounded the results by producing a carry-over effect. Pain threshold data for TENS and BMAC were first analysed separately. Since individual pain thresholds vary largely, as demonstrated previously [20,21], pain threshold changes in this study were analysed for each of TENS and BMAC using a two factor without replication analysis of variance (ANOVA) in order to separate between-subject and intervention effects. Post-hoc t-tests were then carried out and confidence intervals (CI) were calculated to establish whether the observed intervention effects were statistically significant. The pain threshold during each type of electri- cal stimulation (T3 and T4 averaged) was compared with the baseline pain threshold (T1 and T2 averaged) using a two-tailed paired t-test. Averaging of intervention data (T3 and T4) was performed since the aim of this study was to compare the intervention effect of two modalities, rather than the effect of time on the intervention. This method was also used to increase statistical power and avoid a large Bonferroni correction as a result of multiple comparisons. The same method was applied to the post-intervention data (T5 and T6 averaged) compared with the baseline threshold. Since two comparisons were made with baseline (T3 and T4 average, T5 and T6 average), a Bonferroni-corrected accept- able P-value of 0.05/2 = 0.025 was used and 97.5%CI were calculated. In order to establish whether there was a significant dif- ference between the interventions and whether the effects of each modality were greater at T4 than T3, a two-way repeated-measures ANOVA (cycle × intervention type) was calculated. The pre-intervention data (T1 and T2 averaged) were subtracted from each of the with-intervention mea- sures (T3 and T4) and the differences were used for the analysis. Results The outcome measures analysed were pain threshold (time to pain tolerance limit, measured in seconds) and subjec- tive comments regarding effectiveness and comfort of each type of stimulation. These measures were used to test three hypotheses: (a) that both forms of electrical stimulation ele- vate pain threshold; (b) that TENS and BMAC are equally effective;and(c)thatBMACismorecomfortablethanTENS. When the exclusion criteria were applied, three of the 20 sub- jects were excluded from the study since they failed to reach their pain thresholds within 5 minutes of ice-cold immersion during one or more of the allocated measurement cycles. It is worth noting that two of the three excluded subjects only exceeded the 5-minute pain threshold whilst electrical stim- ulation was applied (one with TENS, one with BMAC). The data set therefore included 17 subjects for analysis. Pain threshold Pain threshold data were analysed in terms of change from baseline to the time of pain tolerance limit for each
  • 6. A.R. Ward et al. / Physiotherapy 95 (2009) 280–288 285 Table 1 Group-averagedpainthresholdchangesfrombaselineforCycles3–6.Values shown are mean ± standard deviation. Cycle Threshold change TENS (seconds) Threshold change BMAC (seconds) T3 14.1 ± 23.8 14.7 ± 21.4 T4 16.8 ± 27.4 15.6 ± 24.8 T5 −6.0 ± 20.8 −3.5 ± 13.0 T6 −5.2 ± 25.6 5.3 ± 23.7 TENS, transcutaneous electrical nerve stimulation; BMAC, burst-modulated medium-frequency alternating current. modality. Baseline was calculated as the average time (sec- onds) to pain threshold during Cycles 1 and 2 (T1 and T2). Change in pain threshold during Cycles 3–6 was calculated by subtracting the baseline value from the Cycle 3–6 pain threshold values (T3–T6). Table 1 shows the average change from baseline (mean ± standard deviation) for Cycles 3–6 for both interventions. In Cycle 3, BMAC thresholds were increased, on aver- age, by 14.7 seconds and TENS thresholds were increased by 14.1 seconds. Both the TENS and BMAC pain thresh- olds were greater during Cycle 4 than Cycle 3; TENS by a further 2.7 seconds and BMAC by 0.9 seconds. Although the Cycle 4 rise in pain threshold was not as great as that between baseline and Cycle 3, it does suggest that the longer the stimulation is applied, the greater the elevation in pain threshold. The pain threshold during stimulation (T3 and T4 averaged) was elevated by 15.2 seconds (22% increase) with TENS and 15.5 seconds (25% increase) with BMAC. Once the electrical stimulation was switched off at the end of Cycle 4, thresholds returned close to baseline. Both TENS and BMAC pain threshold values fell below base- line at T5, suggesting no carry-over effect of TENS and BMAC immediately following stimulation. Pain threshold changes from baseline continued to remain low during the final cycle, with T6 for TENS averaging below baseline and T6 for BMAC averaging above baseline. The variation observed most likely represents the inherent experimental error. Statistical analysis Intervention effects The hypotheses of this study were tested using a two factor (subject × intervention) without replication ANOVA for each modality to first determine whether an interven- tion effect was present by separating between-subject and between-intervention effects. The data were not normally distributed, and a Huynh-Feldt correction of 0.67 for TENS and 0.60 for BMAC was required. Both modalities pro- duced statistically significant intervention effects (TENS: F(5,16) = 4.75, P = 0.004; BMAC: F(5,16) = 4.28, P = 0.009). Between-subject effects for both modalities were also found to be highly significant, presumably because pain thresh- olds vary greatly between individuals (TENS: F(16,5) = 22.52, P < 0.001; BMAC: F(16,5) = 24.46, P < 0.001). The lower P- values indicate that the large standard deviations of each mean (Table 1) were mainly due to between-subject effects. Post-hoc tests (paired t-tests) were conducted to answer two questions: is there a significant intervention effect and is there a significant carry-over (post-intervention) effect? To minimise the number of post hoc tests and thus avoid the need for a large Bonferroni correction, pre-intervention data (T1 and T2) were averaged, as were the during- intervention measures (T3 and T4) and post-intervention measures (T5 and T6). Two paired t-tests were then con- ducted using a Bonferroni-corrected acceptable P-value of 0.05/2 = 0.025 and 97.5%CI were calculated. Comparing the pre- and during-intervention averages, a significant interven- tion effect was found (TENS: 15.4 seconds, 97.5%CI 2.5 to 28.4, P = 0.017; BMAC: 15.2 seconds, 97.5%CI 3.1 to 27.2,P = 0.012).Nosignificantdifferencewasfoundbetween pre- and post-intervention measures (TENS: −5.6 seconds, 97.5%CI −18.0 to 6.8, P = 0.324; BMAC: 0.9 seconds, 97.5%CI −7.7 to 9.6, P = 0.816). Data were analysed to establish whether either form of stimulation produced a greater intervention effect and whether the effects were greater at T4 than T3. Each participant’s increase in pain threshold was calculated by averaging the pre-intervention baseline measures (T1 and T2) and subtracting this from each of the with-intervention measures (T3 and T4). The increases were used in a two-way repeated-measures ANOVA (cycle × intervention). Data for post-intervention measures (T5 and T6) were not used at this stage of the analysis, as there was no carry- over (pre- vs post-intervention) effect with either form of stimulation so any further comparison would be meaning- less. The ANOVA established that the between-cycle dif- ferences (T3 vs T4) were not statistically significant (F(1,16) = 0.094, P = 0.76), and that between-intervention effects were not only not significantly different, but TENS and BMAC were ‘significantly the same’ (F(1,16) = 0.002, P = 0.97, mean difference = 0.3 seconds, CI −15.3 to 15.9). When P-values are in the range 0.05–0.95, an acceptable con- clusion is that there is no significant difference. It cannot, however, be concluded that the intervention effects are the same without risking making a type II error. When a P-value greater than 0.95 is obtained (1 − ␣ < 0.05), the equivalence of the interventions is considered to be statistically significant as the risk of a type II statistical error is acceptably minimised [26]. Comfort of stimulation At the end of the second session, participants were asked which of the two types of intervention felt most comfortable. A majority preferring BMAC was evident. Twelve subjects
  • 7. 286 A.R. Ward et al. / Physiotherapy 95 (2009) 280–288 (71%) reported BMAC to be the most comfortable, and the remaining five (29%) felt that TENS was the most comfort- able. Effectiveness of stimulation At the end of the second session, participants were also asked which modality felt more effective for pain relief. Ten subjects (58%) reported that BMAC was most effec- tive, three (18%) felt that TENS was the most effective, and four (24%) reported that both interventions were equally effective. Discussion Hypoalgesic efficacy The results clearly demonstrate a significant interven- tion effect for both TENS and BMAC with P-values of 0.017 and 0.012, respectively. These findings confirm the first hypothesis that both modalities elevate the cold pain threshold. The main aim of this study, however, was to compare the analgesic effectiveness of one particular form of BMAC (4- kHz AC with a 4-millisecond burst duration) with TENS of the same phase duration (125 microseconds) and frequency (50 Hz). TENS and BMAC were found to be statistically equivalent in elevating the cold-induced pain threshold in healthy subjects. The P-value obtained (P = 0.97) allows the conclusion that TENS and BMAC are equally effective in pain modulation. With these results, one can be confident that a type II error has not occurred, i.e. a false-negative result, since the P-value falls outside the conventionally accepted questionable range (0.05–0.95). These results provide an important contribution to the existing literature, since no previous research has compared theanalgesiceffectivenessofpulsedcurrent(TENS)withthat of 4-kHz AC with a 4-millisecond burst duration (BMAC) at the same frequency and using the same phase duration. The present results support the findings of Ward and Oliver [20] who used a different AC frequency (1 kHz) but the same 4- millisecond burst duration and 50-Hz burst/pulse frequency, and found that with short burst durations for BMAC, the modalities were equally effective in elevating pain threshold. In contrast, Shanahan et al. [21] found that TENS (100-Hz pulsed current) was significantly more effective than pre- modulated interferential current (5-kHz AC, modulated at 100 Hz) in elevating pain threshold. ‘Premodulated interfer- ential current’ as used in the study by Shanahan et al. [21] was sinusoidally modulated (Fig. 1c) so, strictly speaking, the duty cycle is effectively 100%, as the intensity only drops to zero instantaneously between each burst. The burst dura- tion is maximum (20 milliseconds) and the effective burst duration (i.e. the time that the stimulus is above any effec- tive threshold) is difficult to predict but, for most nerve fibres, it would be much larger than the 4-millisecond burst duration used in the present study and that of Ward and Oliver [20]. The difference between the present findings and those of Shanahan et al. [21] can be explained in terms of different nerve fibre firing rates produced by the two forms of electrical stimulation. The authors hypothesise that with long bursts of AC, as used with premodulated interferential currents, sen- sory nerve fibres fire multiple times during each burst, i.e. during a burst, sensory fibres undergo repeated cycles of fir- ing, recovering and firing again. Hence the sensory nerve firing rate will be some multiple of the burst frequency. While stimulationat50or100 Hzisbeneficialforhypoalgesia,stim- ulation at higher multiples (150, 200, 250. . . Hz) might not be as effective. This seems to be a reasonable, physiologically based assumption, but only one study has actually tested this hypothesis and examined a wide range of TENS stimula- tion frequencies (10–160 Hz). Johnson et al. [6] found that higher frequencies of pulsed current (above 50 Hz) resulted in a lesser hypoalgesic effect. The between-frequencies differ- ences in the study by Johnson et al. [6] were not statistically significant, possibly due to the small sample size, but a down- ward trend is clearly evident above 40 Hz. Since the present studyandapreviousstudy[20]havefoundthatshort-duration burst-modulated AC is as effective as pulsed current (TENS) in elevating pain threshold, the authors speculate that a short burst duration prevents or severely restricts multiple firing of sensory nerve fibres, and instead produces one action poten- tial per burst. The hypoalgesic effects are thus equivalent to TENS. Subjective comments The majority of participants subjectively reported that BMAC was more effective and comfortable than TENS, thus supporting the original hypothesis. The results are in accordance with previous studies [20,21,23], which reported BMAC to be significantly more comfortable than TENS. The current results and previous TENS and BMAC comparative studies strengthen the conclusion drawn by Ward et al. [24] that low-duty-cycle, burst-modulated AC is more comfort- able than conventional low-frequency pulsed current. Clinical implications The present research demonstrates that the particular forms of TENS and BMAC which were compared are equally effective, in fact ‘statistically the same’, at elevating the pain threshold in healthy subjects. Furthermore, since previous research by Shanahan et al. [21] found that TENS was signif- icantly more effective than premodulated IFC, one can infer, with a degree of confidence, that this form of BMAC also has greater hypoalgesic effects than premodulated IFC. However, whilst the objective effectiveness of a modal- ity is an important component of the patient experience,
  • 8. A.R. Ward et al. / Physiotherapy 95 (2009) 280–288 287 there are other factors that influence the efficacy of the treat- ment. Patient-perceived comfort and effectiveness are two other factors. There was a definite preference for BMAC in terms of both perceived comfort and effectiveness. This result combined with previous research [20,21,23] suggests the likelihood of greater patient acceptance and compliance with BMAC, since it is perceived to be more comfortable and effective. Therefore, it is concluded that BMAC utilising a 4- millisecond burst duration should be used clinically for the treatment of acute pain because it is as effective as TENS in hypoalgesic effects but is reportedly more comfortable, and thus provides an overall improved patient experience. A third factor is the expense of treating a patient with IFC in a clinic using a mains-powered, high-output machine compared with the home use of a portable TENS machine and the inconve- nience of the patient travelling to a clinic for every treatment. In the case of low back or neck pain, the travelling runs the risk of undoing any gains made by the treatment. TENS-like, portable BMAC machines could provide the convenience of safe, home treatment between clinical consultations. Conclusion The major conclusion of the present study is that 50-Hz TENS with a 125-microsecond pulse duration and 4-kHz BMAC with a 4-millisecond burst duration (20% duty cycle) are equally effective in elevating cold-induced pain in healthy subjects. However, BMAC is subjectively reported to be more comfortable and effective. It is therefore recommended that BMAC in the form of 4-millisecond bursts should be trialled clinically since greater patient compliance and acceptance of the treatment is a likely consequence of the lesser discomfort. TENS machines have long been established as a useful treatment tool since they are effective in elevating pain threshold and are a cheap and portable option for home use. The present findings suggest that ‘take home’ TENS units would be more successful if they delivered 4-kHz BMAC with a 4-millisecond burst duration rather than pulsed current. Ethical approval: Human Research Ethics Committee of the Faculty of Health Sciences, La Trobe University. Approval number FHEC06/160. Funding: Research grants from the Faculty of Health Sciences, La Trobe University and the School of Human Biosciences, La Trobe University. Conflict of interest: None declared. References [1] Robertson VJ, Spurritt D. 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