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Electrotherapy for pain

relief: does it work?


A laboratory-based study
to examine the analgesic
effects of electrotherapy on
cold-induced pain in healthy

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

Key words: interferential current therapy, electrotherapy, pain, analgesia, cold-induced


pain
INTRODUCTION
Over the last few decades the administration of electrotherapy for the management of a variety of clinical conditions has become very popular (Paxton
1980, Robinson et al. 1988, Lindsay et al. 1990,
Baxter et al. 1991, Pope et al. 1995). The overall

Clinical Effectiveness in Nursing (I 999) 3, 14-24 9 1999HarcourtBrace& Co. Ltd

costs to the National Health Service of purchasing


new electrotherapy equipment are in the region of
s
million a year with a capital investment of s
million (Ide & Partridge 1988). It has been estimated
that there are currently more than 25 000 electrotherapy devices used by the NHS in the UK (Pope et al.
1995). Two of the most popular electrotherapies

Electrotherapy f o r pain relief: does it work?

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

iA
AV
AVAVAVAVAVA
AV
AV
AVAVAAIL
VA
VA
VA
VA
VV
VA
VA
VA
VA
VV
Time
Current 1 400OHz

~.i AVAVAVAVAVAVVAVAVAVAVAVAVAVAVAVAVAVAVAVAVAVA=
Current 2 41OOHz

Time

Currents l and 2
_~ cancelout here

l'vvVV"""vvvvv"""vvvv"',,s
Where currents 1 and 2 interfere
a 100Hz amplitude modulated
.wave is formed

N
Summation
of
currents

Fig. I The formation of an interference current wave. Two


out of phase currents (a) and (b) are delivered across the
surface of the skin to generate an intereference current (c)
which is modulated in its amplitude. Current (a) and (b) are
delivered in the kilohertz range to overcome the resistance of
the skin. It is claimed that the resultant amplitude modulated
interference wave, which has a frequency of approximately
100 Hz, excites deep-seated nervous tissue leading to
analgesia

IFC to relieve pain, reduce swelling, promote healing


of wounds and bone fractures, and to restore function associated with muscle weakness (Johnson &
Tabasam 1998).
It has been suggested that IFC may be more
effective than TENS for the treatment of pains of
musculoskeletal or visceral origin. IFC may, therefore, be more clinically effective than TENS for certain conditions and, thus, it may be necessary to
indicate IFC and TENS for the treatment of different clinical conditions. This theory, however, is
entirely speculative and at present has no objective
evidence in its support.

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

Problems with IFC literature


The literature on IFC is sparse and there is a lack of
objective evidence supporting its claimed analgesic
effectiveness. Published studies on IFC lack adequate control or placebo groups, and this draws into
question the reliability and validity of the results
and conclusions.
The placebo effect is a powerful phenomenon
which relieves many conditions including pain (Wall
1993) and the importance of determining whether
electrotherapies produce effects over and above those
of placebo cannot be emphasized enough (Georgiou
1996, McQuay & Moore 1996). Placebo interventions are used in research to enable investigators to
discriminate between the effects owing to an active
ingredient in the therapeutic agent and non-specific
effects which can result from many factors including
the interaction between investigator and subject.
Placebos have no known active therapeutic ingredient and they are used to imitate the treatment under
study. If treatment effects are shown to be no greater

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

to check the safety and effectiveness of the


treatment before clinical trials
to assess the efficacy of a treatment under
strictly controlled conditions
to carefully control and manipulate the
outcome measures under study, such as the
intensity and the location of the pain
to carefully control and manipulate the
treatment parameters under investigation.

There are a variety of experimental pain models


which have been used by workers to induce pain in
healthy subjects in laboratory studies (e.g. electrical, thermal, mechanical and chemical). The coldinduced pain technique has been employed for over
50 years to evaluate the analgesic effects of drugs
and electrotherapies in healthy subjects and it is
established as a safe method for the induction of a

deep-seated, aching, pain sensation similar to that


experienced by patients suffering clinical pain (Wolff
et al, 1966, Posner et al. 1985, Gracely 1989, Gracely
1994). The technique involves the immersion of the
distal portion of a limb (usually the hand) into very
cold water to produce a rapid onset of pain sensation.
A variety of outcome measures can be monitored
during the cold-induced pain test including the timeto-pain threshold, and pain tolerance and pain ratings
such as pain intensity and unpleasantness.
Studies which have examined the analgesic
effects of IFC on experimentally-induced pain in
healthy subjects have produced conflicting results.
Scott and Purves (1991) examined the effects of IFC
on ischaemic pain induced by the tourniquet test on
15 healthy volunteers. They found that active IFC
did not elevate time to tolerance of ischaemic pain
when compared to a sham IFC stimulator. In contrast, preliminary work using the cold-induced pain
technique by our group found that IFC can elevate
the time to pain threshold in healthy volunteers,
although a placebo control group was not employed
(Stephenson & Johnson 1995).
The following laboratory-based study was performed to investigate the analgesic effects of IFC
under placebo-controlled conditions using an experimental pain model.

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.

Electrotherapy for pain relief: does it work?


Treatment
Switch on

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~

Fig. 2 Time-course of the experimental procedure


sensation of pain in the hand') when the subject made
the statement 'Pain!'. Time-to-pain threshold was
recorded as the time from hand immersion in cold
water to the very first sensation of pain. The hand
remained immersed in the cold water for a further 30
s after which it was removed. Pain intensity and pain
unpleasantness ratings were recorded as the intensity
and unpleasantness of pain immediately prior to
removal of the hand from the cold water and were
recorded using a 10 cm visual analogue scale (where
0= no pain and 10= worst pain imaginable for pain
intensity, 0= not unpleasant at all and 10= most
unpleasant I could imagine for pain unpleasantness).
If clarification on how to distinguish between
pain intensity and pain unpleasantness was
requested by the subjects they were told that intensity related to 'the severity of the pain in the hand'
and unpleasantness to 'the way that you feel about
the pain in the hand'. The cycle was completed by a
rest period whereby the subject read a magazine.
Prior to the start of the experiment, four selfadhesive electrodes (4 4 cm) were applied to all
subjects in a quadripolar fashion on the anterior
aspect of the subjects forearm 5 cm above the first
wrist crease (Fig. 4). The purpose of these electrode

Subjects were randomly allocated, by pulling a


number out of a hat, to one of the following treatment groups before the start of the experiment:
9
9

active IFC
sham IFC

Each subjects completed 6 10 min cycles of the


cold-induced pain test (two pre, two during and two
post treatment) (see Fig. 2). The outcome measures
during each of the six experimental cycles of the
cold-induced pain test were:
9
9

the time to pain threshold


and the self report of pain intensity and pain
unpleasantness.

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

Fig. 3 One cycle cold-induced pain

~J

5 Min

I
I
i

WorstPain
Imaghlable

scale

10
Most
unpleasantI
couldimagine

18

Clinical Effectiveness in Nursing

--~Anterior aspect of the arm


k~/(

Nerve activity generated


travels toward the central
nervous system

5q

frequency of 100 Hz should be employed when


using IFC for the relief of pain (DeDomenico 1987,
Nikolova 1987, Savage 1992, Low & Reed 1994,
Martin 1994, Pope et al. 1995). There is, however,
at present, no strong evidence to support the use of
this frequency. The amplitude modulated wave was
delivered using a continuous pattern~ which was
achieved by using two sinusoidal carrier waves
delivered at 4000 cycles per second and 4100 cycles
per second (Fig. 1).

Sham I F C .

II Channel 1 electrodes
Channel 2 electrodes

Fig.4 The location of the electrodes used to deliver


treatment. (a) Electrode placement on anterior aspect of the
arm. (b) The location of the resultant interference wave
placements was to target the median nerves (deep
afferents emerging from the painful, immersed
hand). Although the electrodes were applied prior to
the start of the experimental procedure, the treatment was only administered during cycles 3 and 4
(e.g. the two during treatment cycles) during which
all subjects received 20 min of uninterrupted treatment (either active or sham IFC).

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

Sham IFC was used as the placebo control. Sham


IFC was delivered using the same IFC device as
used for the active IFC group except that the subjects received no current output. The placebo effect
was reinforced by a verbal suggestion from the
investigator that, 'The IFC unit relieves pain by subthreshold stimulation which you will not be able to
feel', and by displaying the output from the IFC
device on a cathode ray oscilloscope. No subjects in
the present study questioned this procedure.

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

Electrotherapy f o r pain relief: does it work?

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

pre-treatmentbaselinefor sham (- - I -) and IFC @D-) groups


Drg = duringtreatment;Post = post treatment
was switched off. One may postulale that a larger
difference in pain threshold between the groups
would have been observed if the treatment intervention was of a longer duration.

PAIN INTENSITY
UNPLEASANTNESS

AND
RATING

Data for pain intensity and unpleasantness rating


was analysed in an identical manner to that for pain
threshold. There were no significant differences in
pain ratings between the two pre-treatment cycles or
between the two treatment groups for the mean pretreatment baseline (P>0.05). The percentage change
in pain ratings from the pre-treatment baseline for
each of the during and post-treatment observations
was calculated (Fig. 6 & 7). The results of the RMANOVA across the two during- and two post-treatment cycles are shown in Table 2.

Pain intensity

rating

There were no significant group effects for pain


intensity ratings (Fig. 6, Table 2). Significant effects
were found across the different levels of time

20

Clinical Effectiveness in Nursing

Across two during and post


t r e a t m e n t cycles
DF

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

Across two during


t r e a t m e n t cycles
DF

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

(e.g. two during and two post-treatment cycles) for


the percentage change in pain intensity rating from
the pre-treatment baseline. There were no significant effects between the IFC and sham when the different levels of time were taken into account (time x
group interaction, Table 2). An additional RMANOVA was performed using only data from the
two during-treatment cycles. No significant effects
were found (Table 2).

//

Drg 1
t0 min

Drg 2
20 rain

Post 1
10 rain

Post 2
20 rain

Experimental Cycle

Fig. 7 Plean+SE percentage change in pain unpleasantness


from pre-treatment baseline for sham (- -n- -) and IFC (-Q-)
groups
Drg = during treatment; Post = post treatment

unpleasantness occurred during treatment intervention for the sham group, which rapidly returned to
baseline on treatment termination. This change was
not statistically significant.

SUMMARY OFTHE MAIN FINDINGS


The main findings of this study were that:

Pain Unpleasantness rating


Significant effects were found for time (e.g. two
during- and two post-treatment cycles) and for time
group interaction (Table 2).
An additional RM-ANOVA was performed
using only data from the two during treatment
cycles. Significant effects were found for group x
time interaction (P=0.003), but not for time or for
group (Table 2). Subjects in the IFC group rated
pain to be more unpleasant during the second treatment cycle, although the magnitude of the this elevation was small (Fig. 7). A decrease in pain

IFC elevated pain threshold when compared to


sham IFC during the two treatment cycles (e.g.
when treatment was switched on) but not post
treatment
no differences were observed between the IFC
and sham for the percentage change in pain
intensity and unpleasantness ratings
a significant increase in pain intensity occurred
during and after the treatment intervention
although there were no significant difference in
the magnitude of these changes between the
groups.

Electrotherapy for pain reliefi does it work?

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

self-administer IFC as and when required at home


(in a similar manner to TENS). This would increase
the treatment time and, subsequently, the amount of
pain relief obtained by the patient. Key texts on the
clinical use of IFC suggest that IFC should be delivered for no more than 30 rain at a time and the practice of delivering IFC for short periods of time
merits further comment as it highlights the danger
of non-evidence-based practice in physiotherapy.
There is currently no objective evidence to support
the use of IFC for a short period of time (under 30
rain), although it has been suggested that continuous
IFC stimulation may fatigue patients (DeDomenico
1987, Nikolova 1987, Savage 1992). However, clinical studies on TENS have shown that patients who
deliver TENS can use TENS for many hours without any observable fatigue (Johnson et al. 1991).
The findings of studies on conventional TENS have
also shown that analgesia occurs during rather than
after treatment (Johnson et al. 1991). Patients who
self administer TENS for chronic pain deliver
TENS throughout the day, as they find that the
greatest analgesia occurs when the TENS device is
switched on (Johnson et al. 1991). The findings of
the present study suggests IFC analgesia may have a
similar response profile to that of TENS and, therefore, greater therapeutic benefit from this modality
may be gained by administering it in a similar
manner to TENS.
It is important to consider that the IFC treatment
protocols employed by physiotherapists may have
been developed to suit the therapist rather than the
needs of the patient. The majority of IFC devices in
use are large, non-portable and expensive, and are
located in hospital departmcnts or therapists clinics.
Patients, therefore, need to attend the clinic to
obtain treatment. Therapists may be unable to
administer IFC for more than 20 min, as their clinical rota dictates a time-limited consultation. A series
of subsequent treatment sessions may be indicated
to overcome this problem, however, this does not
provide adequate pain relief for the patient.
Anecdotal reports suggest that 1FC analgesia is
cumulative with successive treatment sessions:
However, it is likely that other factors, such as natural fluctuations in the healing of the condition, may
account for the observations. At present, there is
insufficient evidence to support claims that a series
of IFC treatments will produce cumulative effects.
If IFC analgesia is similar in nature to electrotherapy's, such as TENS then patients should be allowed
to use the modality when needed (e.g. when they are
in pain). The development of cheaper portable IFC
devices may allow clinics to loan IFC devices to
patients who will be able to self-administel treatment
as and when it is required. This approach has been
employed by many Pain Clinics successfully for the
management of pain by TENS. However, it may be
more appropriate to invest in TENS rather than IFC,
as TENS is cheaper and easier for both the therapist
and the patient to administer. There are hypothetical

22

Clinical Effectiveness in Nursing

differences in the mechanism of action of IFC against


TENS, although evidence which has examined the
analgesic effects and clinical effectiveness of the two
modalities is not available at present (DeDomenico
1987, Low & Reed 1994). A preliminary but as yet
unpublished study by our group has found that,
although IFC and TENS significantly increase pain
threshold to experimental pain, there are no differences in the magnitude of this response between
TENS and IFC (Tabasam et al. 1998). Further work
in this area should compare the analgesic effects,
mechanism of action and clinical effectiveness of
TENS and IFC. This information will help therapists
to determine the circumstances where TENS and IFC
should be indicated separately.

Pain intensity and pain unpleasantness


rating
This study found no differences between IFC and
sham for the percentage change in pain intensity
and unpleasantness ratings, and this suggests that
IFC did not modify the self report of pain under the
present experimental conditions. This finding is
consistent with our previous studies on TENS using
the same techniques (Johnson et al. 1992). Despite
the lack of differences between the treatment
groups, there was a significant increase in pain
intensity for both IFC and sham groups when the
treatment intervention was terminated. This
increase in pain intensity rating may be attributed to
a post-treatment increase in pain intensity, although
the magnitude of this rebound effect for IFC may be
no greater than that of sham. Similar rebound
effects have been observed in the clinic when
patients report that pain intensity increases when
TENS is switched off and therapists sometimes use
this to convince patients that TENS is reducing the
magnitude of pain. The authors wish to remain cautious about these findings as they have not been
reproducible in our previous studies using active
and sham electrotherapeutic interventions.
The findings of this study are in agreement with
a previous study on cold-induced pain by
Stephenson and Johnson (1995). This study, however, failed to include a placebo control, and it was
not possible to attribute the effects on pain threshold
observed solely to treatment with IFC.
The findings of this study disagree with previous
studies by Scott and Purves (1991) and Taylor et al.
(1987). Scott and Purves (1991) investigated the
analgesic effects of IFC using experimental pain
and, although their study was placebo controlled,
these investigators employed a different experimental pain model to the one employed by ourselves
(ischaemic pain test). This may have accounted for
the differences observed between the two studies.
The findings of our study also disagree with clinical
studies by Taylor et al. (1987) who investigated the
analgesic effects of IFC on recurrent jaw pain.
Again, although the study was placebo controlled, it

was a clinical study performed on patients suffering


from clinical pain. It is important to acknowledge
the presence of additional psychosocial and behavioural factors which would markedly influence the
response of patients in the clinic. This may have
accounted for the differences observed between
these two studies.

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.

Clinical implications and future


directions for research
The clinical implications for this research are that
IFC may be useful clinically for pain relief as this
study has shown that it can elevate pain threshold in
healthy volunteers. In an earlier study by ourselves
(Johnson & Tabasam 1998) it was shown that IFC is
administered by therapists 3 x 20 min treatments
per week in the clinic, however, it may be more
appropriate to implement a longer treatment time as
this study has indicated minimal post-treatment
analgesia. This study has shown that laboratorybased studies are valuable in the initial evaluation of
the analgesic effects of an electrotherapy.

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.

Electrotherapy for pain relief: does it work?


ACKNOWLEDGEMENTS
This work is funded by an NHS Executive PhD studentship
grant no. RAC 733.

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