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individuals
G.Tabasam and M. I. Johnson
Interferential currents (IFC) are a type of transcutaneous electrical nerve stimulation
(TENS) and are predominantly administered for the management of pain, however,
there is little objective evidence to support their clinical effectiveness.This paper
demonstrates the value of laboratory-based studies in the initial assessment of the
analgesic effects of an electrotherapy and discusses the findings of a single blind
placebo-controlled study which examined the analgesic effects of IFC on cold-induced
pain in 40 healthy individuals. Subjects completed six cycles of the cold-induced pain
test during which the time to pain threshold(s) and the self report of pain intensity and
pain unpleasantness (0-10 cm Visual Analogue Scale) were recorded. Subjects were
randomly allocated to receive either active IFC or sham IFC treatment during the
third and fourth experimental cycles.Two-way repeated measures A N O V A were
performed on the percentage change in each outcome measure from the pretreatment baseline for each subject. Results showed that IFC elevated pain threshold
when compared to sham IFC during treatment but not post treatment.There were no
differences between the IFC and sham treatment groups for the percentage change in
pain intensity and unpleasantness ratings. It was concluded that IFC produced
analgesic effects which were greater than those produced by sham IFC for pain
threshold, but not for the pain intensity and unpleasantness ratings under the present
experimental conditions. However, these effects only occurred when the stimulator
was switched on.The clinical implications of these findings are discussed.
Ghazala Tabasam
Parttime Lecturer in
Health Sciences,D r Mark
I.Johnson Principal
Lecturer- in Human
Physiology,School of
Health Sciences,Faculty of
Health and Environment,
Leeds Metropolitan
University, Calverley Street,
Leeds LSI 3HE, UK
Correspondence to:
GhazalaTabasam
employed by therapists in the UK are transcutaneous electrical nerve stimulation (TENS) and
interferential current therapy (1FC).
TENS is used widely by nurses and midwives to
relieve postoperative pain, labour pain and chronic
pain (Reeve et al. 1996). There is a vast literature
on TENS, although recent systematic reviews suggest that TENS is no more effective than placebo
for postoperative pain (Carroll et al. 1996) and
labour pain (Carroll et al. 1997) and its effectiveness for the management of chronic pain is also at
present unclear (Reeve et al. 1996, Gadsby &
Flowerdew 1997).
IFC is a type of TENS that is used predominantly
by physiotherapists for the management of painful
conditions. To date, no systematic reviews have
been performed to assess the clinical effectiveness
of IFC. The IFC literature consists of many uncontrolled studies and effectiveness is based on anecdotal evidence (Nikolova 1967, 1987, Nelson 1981,
Eigler 1979).
It is common scientific practice to evaluate any
new treatment, before implementing it, and to
catalogue its potential benefits and side effects as
well as its superiority over existing treatments.
Initial insights into the effectiveness of an analgesic
intervention can come from laboratory-based
experiments using healthy subjects. A single-blind
placebo-controlled study which was performed to
examine the analgesic effects of IFC in 40 healthy
volunteers using the cold-induced pain technique
will be used to highlight the importance of such
work. The aim of this paper is to demonstrate the
value of laboratory-based studies in the initial
assessment of an analgesic intervention using a
laboratory-based study as an example.
15
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Where currents 1 and 2 interfere
a 100Hz amplitude modulated
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Summation
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currents
BACKGROUND
IFC are a type of TENS and are used predominantly
by physiotherapists to manage a range of clinical
conditions (DeDomenico 1987, Nikolova 1987,
Savage 1992, Low & Reed 1994, Martin 1994, Pope
et ai. 1995). During IFC therapy two out of phase
medium-frequency electrical currents (2-4 Kh) are
delivered across the surface of the skin. The skin
offers little resistance to electrical currents at this
frequency range and by overcoming skin impedance
the current is able to penetrate deeper into the tissues. At the point where the two currents clash or
interfere a new 'interference' wave is produced. The
resultant interference wave is modulated in its
amplitude and it is claimed that this amplitude modulated wave is able to excite tissue located in deepseated structures to produce a variety of physiological
and effects which contribute to the proposed clinical
effects of this modality (see Fig. 1). IFC is one of
the most frequently used electrotherapies employed
by physiotherapists (Pope et al. 1995). A recent survey by ourselves has found that physiotherapists use
16 ClinicalEffectiveness in Nursing
than placebo, then it is important to question the
physiological rationale underpinning the clinical use
of the treatment. New drugs are required to undergo
thorough evaluations in the laboratory to prove that
the drug produces effects which are greater than
those produced by a placebo drug (Wall 1993). This
is achieved by performing placebo-controlled studies
in the laboratory before the treatment is implemented
in the clinic. This, however, is not the case at present
for electrotherapies, such as TENS and IFC. It is
believed that placebo effects are often greatest for
expensive, and impressive looking therapies such as
TENS and other electrotherapies (Evans 1985, Wall
1994). Modem IFC stimulators look technically
impressive and require active therapist involvement
in the administration of the treatment. The production
of an unfamiliar tingling sensation also further
enhances the placebo effect associated with IFC stimulators (Evans 1985, Kienle & Kiene 1998).
There is a need for more rigorously controlled
studies which incorporate a placebo treatment group
to assess the true treatment effects of IFC. This will
allow both therapist and patient to be confident that
the treatment is producing its effects owing to an
active component of the therapy.
There are many ethical concerns regarding the
administration of a placebo treatment to patients suffering from clinical pain. This makes it difficult to
perform clinical studies which incorporate placebo
control groups that are aimed at assessing the clinical
effectiveness of a therapy. However, initial insights
into the therapeutic effectiveness and placebo effects
associated with a therapy can come from laboratorybased studies on healthy individuals.
Laboratory studies
The initial assessments of any new analgesic
treatment consists of thorough evaluations in the
laboratory on healthy individuals before trials are
conducted on patients in the clinic. Laboratorybased studies allow the investigators:
9
9
9
METHODOLOGY
Subjects
Forty electrotherapy naive, healthy university subjects were recruited from notice-board advertisements (29 females, 11 males; age mean = 26 years).
All subjects attended the laboratory for a brief
familiarization session within the week preceding
the experiment, during which they were given a
verbal and written explanation of the nature of
the experiment. All subjects were also screened for
contraindications to electrotherapy as indicated by
the Chartered Society of Physiotherapy (standards
for the use of electrophysical modalities). Skin was
tested for normal sensation by using standard
sharp/blunt and hot/cold tests, and all subjects
admitted on to the study completed a consent form.
All experiments were approved by the Leeds
Metropolitan University Ethics Committee.
EXPERIMENTAL PROCEDURE
The experiments were conducted by a female investigator (GT) using a similar methodology to that
employed in previous studies performed by the
authors (Johnson et al. 1989, Johnson et al. 1992,
Stephenson & Johnson 1995, Tabason and Johnson
1996, Tabasam & Johnson 1997). All subjects
followed a set of written insmactions during the experimental session under the guidance of the investigator.
Treatment
" h off
Cold-induced
pain test
17
I lOmin/cycleI
Cycle 1
I
0 min
I
10 rain
Cycle 2
Cycle 3
20 rain
Cycle 4
30 rnin
Cycle 5
40 rnin
Cycle 6
50 min
I
60 rain
e~
active IFC
sham IFC
PAIN I N D U C T I O N ( O N E CYCLE OF
T H E C O L D - I N D U C E D PAIN TEST)
During each cycle of the cold-induced pain test, the
subjects non-dominant hand was innnersed into a
warm water bath (37~ for 5 min (Fig. 3). The hand
was then transferred into (iced) cold water (0-2~
until it became definitely painful (e.g. 'the very first
Pain intensityscale
"PAIN"
Pain
Threshold
HAND IN
Warm
Water
at 37~
HAND
OUT
PainRatings
10
No Pain
Pain unpleasantness
HAND IN
Ice Water
0
Not
Unpleasant
at all
Rest
I
I
I
1I 41
I
t
30 sec
~'I
i
I
I
I
I
I
I
5 Min
hi4
I
i
~J
5 Min
I
I
i
WorstPain
Imaghlable
scale
10
Most
unpleasantI
couldimagine
18
5q
Sham I F C .
II Channel 1 electrodes
Channel 2 electrodes
TREATMENT GROUPS
All subjects received treatment which was delivered
using an EMS Medi-Link control module Model 70
and Medi-Link Interferential module model 71. The
current output from this device was regulated en
route to the subject using an electronic circuit which
enabled the investigator to control whether or not
the subjects received a current output from the IFC
device (e.g. received either active IFC or sham
IFC), but it did not alter the output characteristics of
IFC in any way. In addition, the output from the IFC
device was displayed on a cathode ray oscilloscope
during the treatment cycles for both the active and
sham treatment groups.
Active IFC
Active IFC was switched on at the end of the second
pre-treatment cycle and the intensity of stimulation
was adjusted by the subject to produce a 'strong
but comfortable stimulation' (mean~_+SD = 8.45+
2.65 mA). Subjects were requested to maintain this
intensity level throughout the two treatment cycles
by making minor adjustments to the intensity dial of
the IFC unit. The electrical characteristics of active
IFC were chosen following examination of the literature which indicated that an amplitude modulated
STATISTICAL ANALYSIS
A pre-treatment baseline mean was calculated for
the two pre-treatment cycles for each individual.
Between subject variance in pre-treatment baseline
values was large, as evidenced by the SD values
and, therefore, the percentage change in pain threshold from the pre-treatment baseline was used as a
summary measure of response. The percentage
change in outcome measures during and post treatment was calculated by subtracting the pre-treatment mean from each of the during and
post-treatment observations, and representing the
value as a percentage change from the pre-treatment
baseline mean. A two-way analysis of variance for
repeated measures (RM-ANOVA) was performed
on the percentage change for each of the outcome
measures (Jandel Scientific GmbH 1994).
RESULTS
The mear~+SD results for ice pain threshold, pain
intensity and unpleasantness rating are shown in
Table 1. Pre-treatment baseline measures were similar
in magnitude to previous work in this and other laboratories using the same technique (Posner et al. 1985,
Johnson & Wilson 1997, Tabason & Johnson 1996).
ICE PAIN T H R E S H O L D
No significant differences in pain threshold where
found between the two pre-treatment cycles
(mear~+SD difference pre-treatment cycle 1 and 2 =
-0.43s+4.5s, P=0.55, paired t-test, n=40). The mean
P~
treatment I
Pain threshold (s)
active
18.1 + 12.7
sham
18.2_+ 10.7
Pain intensity (cms)
active
5.8 _+2.0
sham
5.7 _+ 1.9
Pain unpleasantness (cms)
active
6,2 _+2.0
sham
6.5 + 2,3
Per
treatment 2
During
treatment I
16.9+ 10.6
20.3_+ 12.6
21.8+ 13.2
20.5+ 12.1
24.4+ 15.2
22.6_+ 12.6
21.0+ 17.2
20.7_+ 12.8
21.4+ 17.8
20.5_+ 12.2
6.0 _+ 1.9
5.6 _+2.2
5.6 + 2. I
5.6 _+ 1.8
5.8 + 1.9
5.4 _+2. I
6.2 + 2.2
6. I + 2.2
6.3 + 2.0
6.3 _+2.5
6.3 _+2.0
6.2 _+ 2.6
5.7 + 2.2
6.0 _+2.7
6.2 _+2.2
5.6 + 2.6
6.7 _+2.4
6.3 _+2.6
6.7 + 2.2
6.2 + 3.0
pre-treatment baseline was calculated for each individual and no significant differences in this baseline
were found between the two treatment groups
(mea~+SD IFC=17.5s+ll.6s, sham=19.2s+ll.4s,
P=0.63, unpaired t-test, n=20 per group).
There was rapid rise in the percentage change in
pain threshold for the IFC group which occurred
within 10 min of ]FC switch on (Fig. 5). This elevation in pain threshold rapidly declined and had
returned to 20% of the baseline value within 10 min
of IFC switch off. The percentage change in pain
threshold for the sham group mirrored that of the
IFC group across the treatment cycles, although it
was significantly smaller in magnitude. This
response profile for the sham IFC group is similar to
that observed for other placebo electrotherapyies
administered in previous experiments by ourselves
and others.
These observations were confirmed in the statistical analysis. A two-way analysis of variance for
repeated measures (RM-ANOVA) was performed
on the percentage change in pain threshold from the
pre-treatment baseline for the two during- and two
post-treatment cycles. Significant effects were
found for time (e.g. across the two during- and two
post-treatment cycles: P<0.05) and effects for
groups just failed to reach statistical significance
(P=0.07, see Table 2). No significant effects were
noted for the group x time interaction.
An additional RM-ANOVA was performed using
only data from the two during-treatment cycles in
order to determine differences between the groups
when the treatment intervention was switched on.
The results indicate that IFC elevated pain threshold
to a greater degree during the two during-treatment
cycles when compared to sham, although this just
failed to reach statistical significance (effects for
groups: P=0.06, Table 2). A cumulative increase in
pain threshold occurred across the during-treatment
cycles 1 and 2 irrespective of the treatment group
(P=0.007), although no significant effects were
noted for the group x time interaction (Table 2).
These findings suggest that IFC elevated pain
threshold during the two treatment cycles when
compared to sham electrotherapy. However, this elevation returned to baseline as soon as the treatment
19
During
Post
Post
treatment 2 treatment I treatment 2
80"~
70-
40
= ~
~- ~
r
Drg 1
10 min
Drg 2
20 min
Post 1
10 rain
i
Post 2
20 rain
~m
Experimental Cycle
Fig. 5 Mean+~SEpercentagechangein painthresholdfrom
PAIN INTENSITY
UNPLEASANTNESS
AND
RATING
Pain intensity
rating
20
3
I
3
5.4
3.4
1.5
3
I
3
3
I
3
Pain threshold
time
group
group x time interaction
Pain-intensity rating
time
group
group x time interaction
Pain-unpleasantness rating
time
group
group x time interaction
.~
2~
.~ ~
20
0.002
0.07
0.2
8.2
3.7
0.33
0.007
0.06
0.57
3.3
0.3
0.7
0.02
0.55
0.54
0.19
0.49
1.5
0.66
0.5
0.22
7.7
1.8
3. I
0.000 I
0.2
0.03
O. 18
0.68
0.28
0.003
1.22
10.2
2015105.
0'
g~
o-
-5.
o N -s-
-10 .q
-10
D~g 1
10 min
Org 2
20 rain
e~
Post 1
10 min
Post 2
20 min
\\
-15
~"
~
-20
~
~
Experimental Cycle
~.
Fig. 6 Mean_+SEpercentage change in pain intensity rating
from pre-treatment baseline for sham (- n - -) and IFC ( - 0 - )
groups
Drg = during treatment; Post = post treatment
//
Drg 1
t0 min
Drg 2
20 rain
Post 1
10 rain
Post 2
20 rain
Experimental Cycle
unpleasantness occurred during treatment intervention for the sham group, which rapidly returned to
baseline on treatment termination. This change was
not statistically significant.
DISCUSSION
This study has shown differences in the analgesic
effects of IFC when compared to sham IFC on coldinduced pain in healthy volunteers. Active IFC elevated pain threshold when compared to sham IFC
only when the stimulator was switched on, although
this elevation just failed to reach statistical significance (P=0.06). The elevation in pain threshold
rapidly returned towards the pre-treatment baseline
values when the IFC stimulator was switched off,
suggesting that there was minimal post IFC analgesia under the present experimental conditions.
Changes in pain intensity and pain unpleasantness
ratings were variable throughout the experiment and
there were no significant differences in the magnitude of these ratings between active IFC and sham
IFC. It was, therefore, concluded that IFC can elevate experimental pain threshold but had no effect
on the pain ratings. The main findings of this study
will be discussed below.
Pain threshold
This study found that IFC increased ice pain threshold when compared to sham IFC, although this just
failed to reach statistical significance (P=0.06). This
finding suggests that IFC can modify the experience
of pain in humans over and above that produced by
placebo. At present, there is little objective evidence
to support the analgesic effects of IFC and some
commentators have, therefore, questioned the effectiveness of the modality (Low & Reed 1994, Martin
1994). Moreover, there is confusion on the most
appropriate way of administering IFC. Specific
textbooks on IFC offer prescriptive treatment
regimes incorporating specific electrical characteristics of current delivery for different medical conditions (DeDomenico 1987; Nikolova 1987; Savage
1992). However, physiotherapists continue to
administer the modality on a trial and error basis in
clinical practice. A recent questionnaire survey performed by our team found that physiotherapists
reported that they administered IFC for 11-20 min
(27:35) during each treatment session and that, on
average, each patient received a course of 1-5 IFC
treatment sessions (Johnson & Tabasam 1998). It
was not possible to determine whether therapists
expected that the 11-20 min IFC treatment would
provide long-lasting pain relief which outlasts stimulation. The present study has found that IFC produced an increase in pain threshold which was rapid
in onset and offset, and only occurred when the
stimulator was switched on. As post-stimulation
effects were minimal it is suggested that there will
be limited analgesic benefit once the stimulator is
switched off. Therefore, it is possible that patients
who are managed using IFC stimulation lasting
11-20 rain are receiving no benefit from IFC when
they leave the clinic. IFC may be more effectively
employed to relieve pain if patients were allowed to
21
22
CONCLUSION
In conclusion, this study has shown that IFC can elevate experimental pain threshold, but had no effects
on pain ratings; however, one should be cautious
when extrapolating the findings of laboratory-based
studies using healthy subjects to patients suffering
clinical pain. Nevertheless, this study highlights the
importance in providing experimental evidence from
both basic sciences and clinical practice to support
the treatment approaches by clinicians. This is especially appropriate to nursing where practice can
stem from treatment preferences which are based on
anecdotal evidence.
Overall summary
This paper has highlighted the importance of laboratory-based studies which should be extended into
clinical randomized-controlled trials to confirm the
clinical effectiveness of IFC for the management of
pain. At present, there is little objective evidence in
support of IFC. There is also a need to compare the
effects of IFC with other cheaper, more efficient
electrotherapies, such as TENS, which may have
cost effectiveness implications for the NHS and
may also indicate the administration of IFC and
TENS for different clinical conditions. It is crucial
that clinicians, especially when considering treatment regimes for patients, integrate knowledge
gained through their clinical experience with objective evidence from the available literature in order
to advance existing clinical practice. The importance of reinforcing the implementation of good
evidence-based practice by health care professionals cannot be over emphasized.
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