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Physiotherapy 95 (2009) 185–191

Transcutaneous electrical nerve stimulation and transcutaneous


spinal electroanalgesia: A preliminary efficacy and
mechanisms-based investigation
Shea Palmer ∗ , Fiona Cramp, Kate Propert, Helen Godfrey
School of Health and Social Care, Faculty of Health and Life Sciences, University of the West of England,
Blackberry Hill, Bristol BS16 1DD, UK

Abstract
Objectives To determine the effects of transcutaneous electrical nerve stimulation (TENS) and transcutaneous spinal electroanalgesia (TSE)
on mechanical pain threshold (MPT) and vibration threshold (VT).
Design A prospective, single-blind, randomised, placebo-controlled trial.
Setting Laboratory based.
Participants Thirty-four healthy volunteers (12 men and 22 women; mean age ± standard deviation 30 ± 8 years). Exclusion criteria were
conditions affecting upper limb sensation and contraindications to electrical stimulation.
Interventions Participants were allocated at random to receive TENS (n = 8), TSE (n = 8), placebo (n = 9) or control (n = 9). Electrical
stimulation was applied for 30 minutes (from time 18 minutes to 48 minutes) via electrodes (5 cm × 5 cm) placed centrally above and below
the space between the C6 and C7 spinous processes, with 5 cm between electrodes.
Main outcome measures MPT (using an algometer) and VT (using a vibrameter) were recorded on seven occasions from the first dorsal
interosseous muscle of the right hand – at baseline (0 minutes) and then at 10-minute intervals until the end of the 60-minute testing period.
Results There were no statistically significant group differences in MPT (all p > 0.05). Significant group differences in VT were found at
20, 30 and 40 minutes (all p < 0.05). Post-hoc tests showed that the TENS group had significantly greater VT than both the placebo [median
difference 0.30 ␮m, 95% confidence interval (CI) −0.05 to 0.66] and control (0.51 ␮m, 95% CI 0.05 to 0.97) groups at 20 minutes, and
significantly greater VT than the control group (0.69 ␮m, 95% CI 0.20 to 1.17) at 30 minutes (all p < 0.008).
Conclusions Electrical stimulation did not alter MPT. The increase in VT during TENS may be due to distraction or antidromic block of
large-diameter nerve fibres. TSE failed to alter either outcome measure significantly.
© 2009 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Keywords: TENS; TSE; Mechanical pain threshold; Vibration threshold; Healthy

Introduction of TSE (Bioinduction Limited, Bristol, UK) claim that it is


more comfortable and therefore better tolerated than other
Different forms of electrical stimulation are commonly forms of electrical stimulation [2]. To date, only two pub-
used for the relief of a range of painful conditions [1], lished research studies have directly compared the effects
although evidence to support their effectiveness is equivo- of TENS and TSE [3,4], with conflicting findings. Macdon-
cal. The most commonly used modality is transcutaneous ald and Coates [3] carried out a small crossover study and
electrical nerve stimulation (TENS), but a newer form of suggested that TSE was more effective than TENS for a het-
electrical stimulation, transcutaneous spinal electroanalgesia erogeneous group of patients with a range of chronic pain
(TSE), was developed in the UK in 1991. The manufacturers conditions. Robb et al. [4] found that neither TENS nor TSE
was more effective than placebo stimulation for chronic pain
associated with breast cancer treatment. Further empirical
∗ Corresponding author. Tel.: +44 117 3288919; fax: +44 117 3288437. evidence of the relative effects of these modalities is clearly
E-mail address: Shea.Palmer@uwe.ac.uk (S. Palmer). required.

0031-9406/$ – see front matter © 2009 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.
doi:10.1016/j.physio.2009.04.008
186 S. Palmer et al. / Physiotherapy 95 (2009) 185–191

There are numerous theories upon which electrical stim- group. Towell et al. [18] found that TSE lowered mechan-
ulation is purported to relieve pain, but the main one is ical pain tolerance significantly (i.e. the opposite of what
the ‘pain-gate’ theory. This theory describes how activity would be expected with hypoalgesia) when high-intensity
in large-diameter sensory nerve fibres (A␤ fibres) inhibits TSE (250 V, n = 20) was applied across the spine in healthy
the activity of cells in the spinal cord that normally trans- participants compared with low-intensity TSE (3–4 V, n = 20)
mit nociceptive messages onwards to the brain [5]. Electrical or sham stimulation (n = 20). When TSE was applied over
stimulation devices are specifically designed to stimulate the shoulder joint at a high intensity (n = 10), there were
these large-diameter A␤ fibres. Any treatment that enhances no changes in MPT or mood relative to sham stimulation
the sensitivity of A␤ fibres may therefore enhance the effec- (n = 10), suggesting that the effects were specific to spinal
tiveness of the pain gate in reducing pain. application.
Specialist assessment known as quantitative sensory test- To date, most experimental studies have focused either
ing can use touch, pressure or vibration stimuli of known on determining the specific physiological mechanisms acti-
magnitudes to determine the sensitivity of A␤ fibres and vated by electrical stimulation or, more pragmatically, on its
whether electrical stimulation (or other treatments) can alter efficacy (i.e. whether or not it reduces pain). Few studies
that sensitivity. A previous pilot study on healthy participants have attempted to ascertain both efficacy and mechanisms of
[6] assessed the effects of interferential current on the per- action within the same methodological design. This means
ception of activity within A␤ fibres by assessing the vibration that the relative contribution of different analgesic mecha-
threshold (VT). Although the study failed to determine sig- nisms is unknown. For example, although increased activity
nificant differences, there was a very distinct trend towards in large-diameter sensory nerve fibres relative to pain fibres
interferential current sensitising participants to vibration (i.e. in the spinal cord (the ‘pain-gate’ theory) predominates as
VT was reduced) compared with a control situation (n = 7 in an explanation for pain relief when using electrical stimu-
each group). It was theorised that electrical stimulation may lation, pain may also be relieved through other mechanisms
therefore act to enhance the efficiency of the pain gate by sen- such as the role of the brain in suppressing pain perception
sitising large-diameter nerve pathways [6]. This observation, or the body’s own endogenous analgesics. For this reason,
however, requires further verification. No other published it is important to investigate both efficacy and mechanisms
studies have been found investigating the effects of electrical within the same experimental protocol.
stimulation on VT. This study therefore investigated the effects of TENS and
Quantitative sensory testing may also be used to deter- TSE on both MPT (as an indicator of efficacy) and VT (as an
mine sensitivity to a range of painful stimuli such as heat indicator of the mechanism of action). Control and placebo
or pressure. Such techniques can thus be used to investi- interventions were also incorporated into the experimental
gate whether electrical stimulation can desensitise people to design.
those painful stimuli. The mechanical pain threshold (MPT)
has often been used for this purpose, and there is relatively
consistent evidence that TENS is effective in raising MPT Methods
[7–13]. McManus et al. [14] also found that interferential
current raised MPT significantly during stimulation. How- Ethical approval for this study was granted by the Uni-
ever, Alves-Geurreiro et al. [15] found no significant effects versity of the West of England Bristol, School of Health and
of TENS, interferential current or action potential stimulation Social Care Ethics Sub-Committee.
on MPT.
To date, there has been little empirical investigation of
Recruitment
the analgesic efficacy of TSE. Simpson and Ward [16] found
no effects of TSE on the pain experienced by eight patients
Thirty-four healthy volunteers (12 men and 22 women;
with chronic critical limb ischaemia. Robb et al. [4] also
mean age ± standard deviation 30 ± 8 years) were recruited
found no effect of TSE or TENS when compared with
from the student and staff population of the Health and Life
placebo stimulation on pain associated with breast cancer
Sciences Faculty following advertisements. Those interested
treatment. Thompson et al. [17] found no effects of active
in taking part contacted the lead author (SP) by e-mail, and an
TSE over placebo stimulation in low back pain. Some other
information sheet and consent form were sent electronically.
TSE studies have used MPT as an outcome measure. Mac-
Those replying to confirm their willingness to volunteer were
donald and Coates [3] reported that the ratio of MPT in
then given a convenient appointment time. As part of the
tender areas relative to non-tender areas was reduced in a
informed consent process, participants were told that they
subgroup of 16 patients with unilateral tenderness follow-
might receive electrical stimulation which may or may not
ing 60 minutes of stimulation with TSE. In another study
be working and which they may or may not feel.
reported in the same paper [3], eight pain patients received
TSE or TENS in a double-blind randomised crossover design.
Six efficacy measures, including MPT, were all signifi- Inclusion criteria
cantly increased in the TSE group compared with the TENS Men and women aged 18–45 years.
S. Palmer et al. / Physiotherapy 95 (2009) 185–191 187

Exclusion criteria was used to block the participants’ view of the Vibrameter
Any condition of the upper limb that would alter the sensi- and electrical stimulator.
tivity to electrical stimulation, vibration or mechanical pain,
such as neurological impairment or pain. Contraindications to Electrical stimulation
electrical stimulation were as follows, based on the Chartered
Society of Physiotherapy (CSP) guidelines [19]: diagnosed All groups had two self-adhesive electrodes (5 cm × 5 cm)
with cancer in the neck area; recent bleeding in the muscles positioned centrally (in the midline) above and below the
or other tissues in the neck area; and active tuberculosis in space between the C6 and C7 spinous processes, with 5 cm
the neck area. Participants were also asked to discuss any between electrodes. This aimed to stimulate the spinal cord
of the following precautions to electrical stimulation with (the main consideration for TSE) and the nerve roots sup-
the research assistant on an individual basis, based on the plying the lateral aspect of the arm and thenar eminence
CSP guidelines [19]: epilepsy or advanced cardiovascular (a common way of applying TENS). It should be acknowl-
conditions, e.g. severe angina or cardiac arrhythmias; signifi- edged that the central electrode placement used in the present
cant impairment in the circulation or sensory loss in the neck investigation altered slightly from the paravertebral place-
area; devitalised skin in the neck area, e.g. after recent radio- ment recommended for arm pain by the manufacturers [2]. A
therapy; and local acute skin condition in the neck area, e.g. central electrode placement is recommended for TSE treat-
eczema, dermatitis. One potential participant was excluded ment of other pain [2], however, implying effectiveness in
due to a benign meningioma at the base of the skull. None stimulating the spinal cord. The scientific rationale for recom-
of the other volunteers were excluded on the basis of these mending a paravertebral placement for arm pain is therefore
criteria. unclear. Paravertebral arrangement of electrodes was found in
pilot work to cause uncomfortable muscle stimulation dur-
Randomisation ing TENS, and therefore a central placement was used to
facilitate comparison between the two devices.
Following informed consent, participants were randomly All forms of electrical stimulation were applied using
and exclusively assigned to one of four groups: (1) TENS – the Acticare IC device (Bioinduction Ltd., Bristol, UK).
125 ␮s, 100 Hz, ‘strong but comfortable’; (2) TSE – 1.5 ␮s Each type of stimulation was applied for 30 minutes as rec-
biphasic pulse, 2500 Hz, ‘comfortable’; (3) placebo – par- ommended for first-time TSE users [2], beginning at time
ticipants were told that they would receive a form of TSE 18 minutes and ending at time 48 minutes.
that you cannot feel but the device was not switched on; VT and MPT were recorded on seven occasions from a
and (4) control – electrodes were applied but participants point marked on the skin over the belly of the first dorsal
were told that they would not receive any electrical stimula- interosseous muscle of the right hand – at baseline (0 minutes)
tion. Block randomisation using sealed envelopes was used and then at 10-minute intervals until the end of the 60-minute
to ensure approximately equal numbers of participants in testing period.
each group. Separate envelopes were prepared for men and
women to ensure a balance of genders. The envelopes con- Vibration threshold
tained the codes ‘W’, ‘X’, ‘Y’ or ‘Z’ randomised in blocks
of four and were prepared by the lead author (SP) using an VT was measured using the Vibrameter IV (Somedic Pro-
online randomisation tool (http://www.randomization.com, duction AB, Sweden). The Vibrameter probe was placed in
accessed September 2007). Envelopes were opened by the contact with the skin and the reading was adjusted to account
research associate employed on the project (KP), who for the weight of the probe. The vibration amplitude of the
allocated a treatment to each of the codes on a ran- probe was increased slowly until the participant stated that it
dom basis and used this allocation throughout the trial. could be felt. It was then decreased slowly until the partici-
All other members of the research team remained blinded pant stated that the vibration disappeared. A flap was used to
to the identity of groups until data analysis was com- cover the amplitude reading until the appearance and disap-
plete. pearance thresholds were reached; at this point, the research
associate removed the flap and took a reading in micrometres
Participant positioning to two decimal places. This was repeated three times at each
time point. VT was later calculated as the mean of the appear-
Participants sat in a comfortable chair with their back sup- ance and disappearance thresholds at each time point, and this
ported. They were asked in advance to wear clothing with value was used for all data analyses. The manufacturer reports
a loose neckline so that the lower neck area could be easily measurement accuracy of ±5% over the full scale.
accessed (a suitable loose shirt was made available if they for-
got). The right hand was supported on a table placed to their Mechanical pain threshold
side. The hand and forearm were placed in a pronated position
for VT and MPT testing, but participants were free to place MPT was measured using the Algometer II (Somedic Pro-
their arm in any comfortable position at other times. A screen duction AB, Sweden). A 1 cm2 -probe was used and this was
188 S. Palmer et al. / Physiotherapy 95 (2009) 185–191

Table 1
Participant characteristics and baseline vibration threshold (VT) and mechanical pain threshold (MPT) scores. The 25th and 75th percentiles describe the lower
and upper limits of the range across which the middle 50% of values lie.
TENS TSE Placebo Control
Male:female 3:5 3:5 3:6 3:6
Median age (years) (25th to 75th percentiles) 32.5 (27.5 to 37.8) 20.0 (19.0 to 32.8) 27. 0 (20.0 to 35.5) 38.0 (29.5 to 43.0)
Median baseline VT (␮m) (25th to 75th percentiles) 0.88 (0.66 to 1.01) 1.19 (0.42 to 1.92) 0.80 (0.66 to 1.12) 0.89 (0.44 to 1.18)
Median baseline MPT (kPa) (25th to 75th percentiles) 204 (167 to 310) 154 (118 to 175) 163 (146 to 243) 131 (120 to 191)
TENS, transcutaneous electrical nerve stimulation; TSE, transcutaneous spinal electroanalgesia.

placed at right angles to the skin surface. The manual pres- change data. Differences in VT and MPT were compared
sure applied to the skin was increased slowly at a rate of between groups at each assessment point using separate
10 kPa/second using the built-in slope indicator. The pres- Kruskal–Wallis tests. Any significant results from this anal-
sure was released as soon as the participant reported that the ysis were explored further using Mann–Whitney U-tests to
pressure reached the ‘very first sensation of pain’. A flap was determine any significant differences between groups. The
used to cover the pressure reading on the device until MPT relationships between change in VT and change in MPT were
was reached. At this point, the research associate removed explored using Pearson’s rank order correlation coefficients.
the flap and took a reading in kilopascals. This procedure
was repeated three times and the mean was taken as the MPT
at each time point. The manufacturer reports measurement Results
accuracy of ±3% over the full scale.
Participant characteristics and baseline values for VT and
Success of blinding MPT are presented in Table 1. The median changes in VT
and MPT from baseline for each of the experimental groups
As recommended by Deyo et al. [20], participants who are presented in Figs. 1 and 2, respectively.
received TENS, TSE or sham electrical stimulation were Overall, there was a significant difference in age between
asked at the end of the trial whether they thought they had groups (Kruskal–Wallis test, p = 0.029). Further analysis
used an active or inactive device. using Mann–Whitney U-tests (with Bonferroni corrections
for multiple testing, α = 0.008) failed to identify signifi-
Sample size cant differences in age between individual group pairs (all
p ≥ 0.008), although the TSE and control group comparison
The sample size for this preliminary study was based on fell on the α cut-off level (p = 0.008). There were no signif-
previous studies where significant changes in MPT were icant differences in raw VT or MPT values between groups
found using eight participants in each group [11,12]. This at baseline (Kruskal–Wallis tests, both p > 0.05).
was therefore used as a minimum recruitment target for the Kruskal–Wallis tests indicated that there were significant
present study, although recruitment continued throughout the differences in VT between experimental groups at 20, 30 and
1-month period available for data collection. To account for 40 minutes (all p < 0.05). There were no significant differ-
the possibility that such participant numbers were insuffi-
cient to detect significant changes, the correlations between
changes in MPT and VT were explored to inform the dis-
cussion. The study aimed to provide important preliminary
data to inform future studies, and a subsequent sample size
calculation was performed.

Data analysis

All data analyses were conducted by the lead author (SP)


who remained blind to the identity of specific groups until the
analyses were complete. Appropriate non-parametric anal-
yses were employed throughout the study. A significance
level of α = 0.05 was selected, and Bonferroni corrections
for multiple testing were applied where appropriate. Fig. 1. Median change in vibration threshold (VT). All data are expressed
as a change from the baseline scores. The shaded area represents when elec-
Age differences between groups were explored using a
trical stimulation was switched on (time 18 minutes to 48 minutes). TENS,
Kruskal–Wallis test and separate Mann–Whitney U-tests. transcutaneous electrical nerve stimulation; TSE, transcutaneous spinal elec-
VT and MPT data were expressed as change from base- troanalgesia. *Statistically significant relative to control and placebo groups.
line, and all statistical analyses were conducted using these † Statistically significant relative to control group.
S. Palmer et al. / Physiotherapy 95 (2009) 185–191 189

Discussion

Neither form of electrical stimulation altered MPT; this is


in contrast to previous laboratory studies on healthy partici-
pants which have demonstrated effects of TENS with similar
small participant numbers of 10 or less in each group [11–13].
Another trial with participant numbers of 10 in each group
failed to show significant changes in MPT with TENS [15].
Other studies have used in excess of 30 participants per group
[7,9,10], and all have demonstrated effects of TENS on MPT.
The sample size calculation suggested that the present study
had insufficient statistical power, although there were no clear
trends towards analgesic efficacy that might support such
Fig. 2. Median change in mechanical pain threshold (MPT). All data are a conclusion. Future reproduction of these findings with a
expressed as a change from the baseline scores. The shaded area represents minimum participant number of 28 in each group would be
when electrical stimulation was switched on (time 18 minutes to 48 minutes).
TENS, transcutaneous electrical nerve stimulation; TSE, transcutaneous
necessary to discount a type II error.
spinal electroanalgesia. The parameters of the ‘high-frequency, low-intensity’
TENS groups in previous laboratory studies [7,9–13,15] are
very similar, with frequencies of 100–150 Hz, phase dura-
ences in VT at the other assessment points. Analysis of the tions of 125–200 ␮s and an intensity described as ‘strong but
differences in VT between groups at 20, 30 and 40 minutes comfortable’. This compares very favourably with the present
was conducted using Mann–Whitney U-tests (with Bonfer- study which used TENS settings of 100 Hz, 125 ␮s and a
roni corrections for multiple testing, α = 0.008). The TENS ‘strong but comfortable’ intensity. A number of studies have
group displayed significantly greater thresholds than both the found that such TENS settings were effective in increasing
placebo [median difference 0.30 ␮m, 95% confidence inter- MPT when electrodes were placed over the superficial radial
val (CI) −0.05 to 0.66] and control (0.51 ␮m, 95% CI 0.05 to nerve in the forearm, and MPT measurements were taken
0.97) groups at 20 minutes, and a significantly greater thresh- from the first dorsal web space [7,9,11–13]. Only two studies
old than the control group (0.69 ␮m, 95% CI 0.20 to 1.17) [10,15] found that such TENS settings were ineffective with
at 30 minutes (all p < 0.008). There were no significant dif- a similar methodology.
ferences between groups at the 40-minute assessment point TENS electrode placement represents an important differ-
once the Bonferroni correction had been applied. There were ence between the current study and previous investigations.
also no significant differences in VT between any other group MPT was measured in the same place in all investigations
combinations. but, rather than being placed over the superficial radial nerve,
There were no significant differences in MPT between electrodes were placed over the spinal cord in the present
groups at any assessment point. experiment as this is recommended for TSE application [2].
There were no significant relationships between changes Standardising electrode placement was considered necessary
in VT and changes in MPT at any assessment point (Spear- in order to control a potentially important confounding vari-
man’s rank order correlation coefficient range 0.036 to able. Guidance for TSE electrode placement [2] is more
−0.265, all p > 0.05). prescriptive than for TENS and therefore influenced choice
Overall, there was a significant increase in median ambi- in this investigation. This may have reduced the effective-
ent temperature from 21.2 ◦ C before testing to 22.2 ◦ C after ness of TENS. The complex interaction of different TENS
testing (Wilcoxon signed ranks test, p < 0.001), although parameters, however, complicates attempts to assign causal-
there were no significant differences in ambient temperature ity to the effects of any single factor. Chesterton et al. [9], for
between groups before or after testing (Kruskal–Wallis tests, example, found that low-frequency, high-intensity, extraseg-
both p > 0.05). mental stimulation produced longer lasting effects on MPT
Four participants were unable to correctly identify whether than high-frequency, low-intensity, segmental stimulation.
they had used an active or inactive device. Three of the four Chesterton et al. [10], however, found that high-intensity,
guessed incorrectly and one was unable to guess, even when high-frequency, segmental stimulation (or a mixture of seg-
pressed to do so. All four participants were in the placebo mental and extrasegmental) was most effective in altering
group. MPT. The effects of different combinations of parameters
A sample size calculation was performed on the basis of and modes of application are therefore very complicated and
the mean ± standard deviation of the baseline TENS data require further work.
(234 ± 115 kPa), using 80% power, α = 0.05 and a 38% TSE failed to alter either outcome measure significantly
increase in MPT [12]. This found that a minimum of 28 par- in the current investigation. Previous literature also failed to
ticipants would be required to detect a significant change of show beneficial effects of TSE on low back pain [17], pain
that magnitude. associated with breast cancer treatment [4], chronic critical
190 S. Palmer et al. / Physiotherapy 95 (2009) 185–191

limb ischaemia pain [16], or MPT or mechanical pain toler- These findings relate to healthy participants in a controlled
ance in healthy participants [18]. Only Macdonald and Coates laboratory setting. Such experimental designs allow for care-
[3] have demonstrated positive effects of TSE in a series of ful control of extraneous variables and thus are well suited
uncontrolled studies in a heterogeneous group of chronic pain to investigations exploring specific mechanisms of action
patients. On balance, the literature to date does not seem to or the effects of manipulating individual treatment param-
favour the analgesic effectiveness of TSE. eters. However, appropriate care should be taken in direct
The increase in VT (indicating reduced perception of application of these results to the treatment of clinical pain
activity within large-diameter nerve fibres) during TENS sug- conditions.
gests that, in the absence of analgesic effects on MPT, it
may have acted as a distraction. It was expected that VT
would be reduced during electrical stimulation, as suggested Conclusion
in a previous pilot study using interferential current [6]. As
already discussed in relation to MPT, electrode placement TENS and TSE failed to alter MPT relative to a control
may have altered the effects of electrical stimulation on VT. condition in the present investigation on healthy partici-
In contrast to the present study, Palmer and Macmillan [6] pants. This suggests a lack of analgesic efficacy, although
placed electrodes on the forearm and measured VT between the effects of these modalities on clinical pain conditions
the stimulating electrodes. There may also be a difference in are likely to be much more complex than demonstrated in
the effects of different modalities (TENS, TSE and inter- this laboratory setting. The application of TENS increased
ferential current). Antidromic activation of large-diameter VT during stimulation, with distraction of participants or
nerve fibres, extinguishing afferent A␤-fibre impulses [21], antidromic activation of large-diameter nerve fibres being
is another possible mechanism explaining the reduction in possible explanatory mechanisms. TSE failed to alter either
sensitivity to vibration observed during TENS. Such factors outcome measure significantly, supporting the majority of
require further exploration. previous literature.
Walsh et al. [12] explored the relationship between It is likely that the spinal placement of electrodes was
changes in negative peak latency and MPT, finding a sig- suboptimal for the application of TENS, as previous inves-
nificant association (r = 0.90). A similar method of analysis tigations have demonstrated analgesic effects on mechanical
was used in the present investigation, but no significant cor- pain when placed directly over the peripheral nerve. Repe-
relation was found between changes in VT and MPT. This tition of this investigation with a different TENS electrode
suggests that changes in the perception of A␤-fibre activity placement is therefore warranted.
were not associated with changes in pressure pain perception.
Future investigations of such mechanisms using alternative
Acknowledgements
TENS electrode placements (as discussed earlier) would be
interesting. The assistance of Helen French is gratefully acknowl-
Partial success in blinding participants to treatment alloca- edged in developing the study protocol.
tions was evident in this study. The only participants unable to
correctly identify whether they had used an active or inactive Ethical approval: School of Health and Social Care Research
device were in the placebo group. Five participants correctly Ethics Committee, University of the West of England, Bristol
thought that they had used an inactive machine, three thought (Ref. No. HSC/07/09/62).
that they had used an active machine and one was unable to Funding: School of Health and Social Care, University of the
guess. All of those participants receiving active TENS or TSE West of England, Bristol.
were convinced that they had used an active machine, pre-
Conflict of interest: None.
sumably due to the accompanying sensations. The absence
of sensation in the placebo stimulation group introduced an
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