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Expert Review of Medical Devices

ISSN: 1743-4440 (Print) 1745-2422 (Online) Journal homepage: https://www.tandfonline.com/loi/ierd20

Medical devices to deliver transcutaneous


electrical stimulation using interferential current
to treat constipation

Bridget R Southwell

To cite this article: Bridget R Southwell (2013) Medical devices to deliver transcutaneous
electrical stimulation using interferential current to treat constipation, Expert Review of
Medical Devices, 10:6, 701-704, DOI: 10.1586/17434440.2013.855507

To link to this article: https://doi.org/10.1586/17434440.2013.855507

Published online: 09 Jan 2014.

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Editorial

Medical devices to deliver


transcutaneous electrical stimulation
using interferential current to treat
constipation
Expert Rev. Med. Devices 10(6), 701–704 (2013)

Bridget R “…interferential current has been used to treat a number of


Southwell bowel motility disorders including dyspepsia, irritable bowel
Murdoch Childrens Research syndrome, slow transit constipation in children and adults and
Institute, Royal Childrens constipation in children with myelomeningocele…”
Hospital, Melbourne, Australia
and
Department of Paediatrics, Transcutaneous electrical stimulation Internet. There is a wide range of qual-
University of Melbourne,
(TES) is a well-known method used by ity products available but only a few are
Melbourne, Australia
bridget.southwell@mcri.edu.au physiotherapists to treat pain and muscle able to deliver IFC.
injury. Interferential current (IFC) is a Our initial studies on constipation
special type of TES using two currents used a device, common in physiotherapy
that cross and produce a beating effect [1]. clinics, the Metron Vectorsurge (Aus-
TES-IFC has been used for over 20 years tralia). This device can deliver current
to treat bladder over-activity and urinary via two or four electrodes. It delivers
incontinence and to strengthen the pelvic interferential, premodulated, TENS and
floor [2–5]. When used for urinary inconti- Russian stimulation. It delivers IFC at
nence, TES also produced diarrhea, lead- 2500, 4000 or 10,000 Hz carrier fre-
ing physiotherapist Janet Chase, who quency. This device is plugged into the
specialized in incontinence, to test TES AC power supply and allows complete
on children with chronic constipation [6]. control by the clinician. Because it is
Since that study, published in the year difficult for patients to attend clinic
2005, IFC has been used to treat a num- every day, treatment was given three-
ber of bowel motility disorders including times a week for 20 min and the total
dyspepsia [7], irritable bowel syndrome [8], number of sessions was 12. Using the
slow transit constipation in children [9–14] stimulation parameters that produced
and adults [11] and constipation in chil- diarrhea during bladder treatment, we
dren with myelomeningocele (a type of gave stimulation using two channels
spina bifida) [15]. In the colon, TES-IFC (channel one at 4000 Hz, channel two
increased the colonic motility, sped up varying from 4080–4150 Hz, at a com-
colonic transit, increased the sensation of fortable setting of 20–30 mAmps) using
the urge to defecate, increased the defeca- 4 cm  4 cm carbon rubber electrodes.
tion frequency and reduced soiling TES-IFC increased defecation and
and bloating. stopped soiling in five of eight children
There are many TES devices on sale. with chronic constipation and improve-
Physiotherapists use devices that are ments lasted for more than 3 months in
plugged into AC (220/240 V) power. some children [6]. In a larger group,
Battery-operated devices that can be there were similar improvements and a
used at home are available on the slight increase in transit speed and

KEYWORDS: bowel motility • electrotherapeutics • physical therapy • physiotherapy

www.expert-reviews.com 10.1586/17434440.2013.855507 Ó 2013 Informa UK Ltd ISSN 1743-4440 701


Editorial Southwell

improved quality of life [9–10,16]. Colonic contractions increased [16] User difficulties
and improvements lasted up to 2 years [17]. A recent detailed For home-use, it is important that patients are trained to use
review of our studies is available free online [101]. the device correctly. Physiotherapists are trained to use the elec-
Battery-operated IFC devices became available in the mid- trical therapy but for other clinicians, we found that it takes 5–
2000s. With these, the patient/parent can give stimulation at 10 patients to learn what to do. Ian Yik, a surgeon, reported
home, allowing daily stimulation for a longer time (commonly that it took six patients for him to learn how to teach them, to
1 h). Eleven children, who previously had stimulation three- use the portable machine correctly and to make sure that the
times a week without success, underwent daily treatment for patients had recorded their daily diary and passed it to the
2 months, leading to an increase in defecation frequency into clinician [13]. We have surveyed patients and found that they
the normal range in nine children [12]. In a larger group of have problems in choosing the right settings on devices and
32 children, with treatment-resistant constipation, when given may connect the leads incorrectly so that currents do not cross.
daily stimulation for 3–6 months, more than half of the chil-
dren showed increased defecation into the normal range and Mechanism of action
stopped soiling [13]. It remains to be determined whether TES-IFC is acting via spi-
Three battery-operated IFC devices have been reported for nal pathways, sensory nerves, enteric nerves, interstitial cell of
bowel stimulation. Firstly we used Fuji Dynamics IF Cajal or hormonal systems. Motor control of the intestine is
4160 (Hong Kong). From the year 2008–2012, we used the very complex [101]. Motor activity of the gut is determined by
model FD09. This delivered current from a 9 V rechargeable muscle cells, pacemaker cells (interstitial cells of Cajal), nerves
battery. In the mid of 2012, a new model was released, FD-10, and hormones. The intestine contains its own nerve cell net-
that uses four 1.5 V single-use batteries or can be plugged into work (the enteric nervous system) and has connections to the
AC power. We only used the FD-10 on AC power to provide Central Nervous System (CNS) via the vagal, splanchnic and
enough current for 1 h of treatment. This device is available in pelvic nerves. These carry sympathetic, parasympathetic and
Australia and UK. Other groups have used NOVIN model sensory nerve fibres [19]. Sympathetic innervation inhibits bowel
510 A (Isfahan, Islamic Republic of Iran) [15,18] and Ito motility, while parasympathetic innervation activates the
EU-940 (Germany) [8] with good results. A comparison among bowel. [20]. Spinal nerves (S2-4) carry parasympathetic outflow
the output of the devices would be useful. to the rectum and internal anal sphincter, somatic innervation
Electrical current delivery depends on the electrodes and to the anal sphincter muscle (striated muscle) and sensory fibres
many types are available. Electrodes can be long-use types to the CNS [19]. Direct electrical stimulation of these nerves
made of carbon rubber and used with suction [8] or with wet (using implanted electrodes) is sufficient to activate bowel
sponge pads [6] or can be silicon-coated disposable electro- motility reflexes. For example, in patients with spinal injuries,
des [13]. Different sizes have been used including 2.3  3.5 cm sacral nerve stimulation initiates colonic contraction producing
and 4  4 cm. They have been placed with two electrodes on movement of feces into the anal canal, resulting in reflex pelvic
the front and two on the back, at the level of the belly button floor relaxation and evacuation of the rectum [20]. TES-IFC
[8–10,13,15–16,101] or over the lower pelvic zone [18] or with four would be expected to stimulate these nerves, but might also
on the back [7]. For home use, it is important that patients have effects within the intestine. Animal models are needed to
should be trained in electrode use. If they use disposable elec- investigate the mechanism of action.
trodes, it is important that they are sticky and should create a Ward has studied IFC and thresholds for sensory nerves,
good contact with the skin. Body hair should be removed for pain and muscle contraction. He presented a detailed discus-
best results. sion of the myths and realities of IFC [1]. Interferential stimula-
To produce the highest level evidence, randomized-control tors produce two independent currents applied by two pairs of
trials (RCTs) are required. Two RCTs have been electrodes, positioned diagonally. It is commonly claimed that
performed [9–10,15]. It is not easy to perform a blinded study for there is a maximum stimulation in the region of intersection of
a treatment that can be felt by the patient, that lasts for the currents but Ward argues that the stimulus experienced by
months and is delivered at home by the patient. Some of the a nerve fiber may be continuous (unmodulated), fully modu-
major points of concern are: How can you blind the person lated or partially modulated depending on the fiber location
delivering the treatment?; How can you blind the patient?; and orientation relative to the electrodes. The stimulation
What placebo can be used?; and what features can be measured intensity experienced by nerve fibers has a maximum modula-
to get an objective measure of improvement? Patients can tion if the fibers are oriented optimally and zero modulation
record through diaries but for the evidence-base it is preferable when fibers are oriented along one of the current pathways [1].
to have objective measures also. Those measures used so far, Ward showed that stimulation of nerves that innervate striated
include transit studies [16], gastric emptying [7], anorectal man- muscle at 100 Hz or more, results in fatigue and reduction in
ometry [15] or colonic manometry [16] to measure the rate of torque in the muscle and can also inhibit the release of acetyl-
movement through the bowel or strength or frequency of con- choline [21]. Ward also showed that that premodulated IFC,
tractions. Questionnaires are also used to measure the changes delivered via two large electrodes, may be clinically more effec-
in bowel symptoms or quality of life [9,15]. tive than the traditional true IFC arrangement in terms of

702 Expert Rev. Med. Devices 10(6), (2013)


Transcutaneous electrical stimulation to treat constipation Editorial

depth efficiency, torque production and patient comfort [22]. It looks like TES-IFC could be a useful treatment for
None of these factors have been measured for abdominal stim- patients with bowel motility disorders and should add to the
ulation and bowel activity. techniques available especially for treatment-resistant patients.
The method can be used for children and the elderly, it is
Future perspective cheap (<US$500), non-invasive and has no side effects. We
Transcutaneous stimulation of the intestine is a new use for will also see the development of devices specifically for use on
an established but poorly characterized or understood the bowel in the next few years.
method. In the next 5 years there should be an expansion in
its use to increase intestinal motility and with that, many of
the parameters for its use and mechanism of action should be Financial & competing interests disclosure
addressed. This is a new field and there are many unknown BR Southwell holds patents on the method of transcutaneous electrical
opportunities for improvement in devices and treatment stimulation to treat constipation. She has received Australian Government
parameters. There are still many issues to resolve about the National Health and Medical Research (NHMRC) grants to study the
optimal use of IFC devices for bowel motility, including cur- effect of transcutaneous electrical stimulation on children with slow-transit
rent settings, electrode position and treatment frequency. constipation and with anorectal retention and to develop an electrical
These aspects require active study. There is also much scope stimulation device specifically to treat constipation. She has received invest-
for future improvements in devices that are easier for patients ment from the Medical Research Commercialization Fund to develop the
to use, feedback that electrodes are delivering adequate cur- device and created a startup company – GI Therapies (Melbourne,
rent or which ones are not, determining optimal placement Australia) – to develop and test a prototype device. The author has no
of electrodes, and for studies that determine where current other relevant affiliations or financial involvement with any organization
goes, what are the best electrical parameters for stimulation, or entity with a financial interest in or financial conflict with the subject
what time of day is best to do stimulation and which patients matter or materials discussed in the manuscript apart from those disclosed.
will benefit from IFC treatment. No writing assistance was utilized in the production of this manuscript.

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